Doug Brunk

The federal government has taken a two-pronged approach to reinvigorating its efforts in addressing HIV/AIDS.

In June, the Centers for Disease Control and Prevention launched an initiative aimed at helping physicians make HIV testing a routine part of medical care. The initiative, known as “HIV Screening. Standard Care” aims to increase the use of opt-out screening strategies over risk-based screening, which previously has been the more common practice.

Dr. Jonathan Mermin, director of the CDC's division of HIV/AIDS prevention, Atlanta, said the goal of the new initiative is to increase implementation of the CDC's 2006 HIV screening guidelines, which recommend that all patients aged 13-64 years be tested for HIV at least once in their lives—regardless of perceived risk of infection—and that individuals at high risk be tested at least annually (MMWR 2006;55[RR-14]:1-17).

“The need for HIV screening is an ongoing issue,” said Dr. Amir Qaseem, senior medical associate at the American College of Physicians, which recently published a guidance statement for HIV screening (Ann. Intern. Med. 2009;150:125-31). “It's a major public health problem worldwide, even within the United States, where almost 1 million people are living with HIV. Almost 25% of these people are unaware of their HIV infection.”

“Risk-based screening has been an unsuccessful strategy and has failed to identify a substantial number of patients with HIV,” Dr. Qaseem said. “Routine HIV screening is easier to implement in busy practice settings.” Yet few physicians do it. A 2009 Web-based survey from the public relations firm Porter Novelli found that only 17% of primary care physicians routinely screen their patients for HIV.

And in a study from 2007, investigators from the bureau of HIV/AIDS prevention and control in the New York City Department of Health and Mental Hygiene reviewed published and unpublished literature on HIV testing barriers. They divided studies into three categories: prenatal, emergency department, and other medical settings (AIDS 2007;21:1617-24). Several barriers were identified in all three settings: lack of knowledge/training, lack of patient acceptance, pretest counseling requirements, competing priorities, and inadequate reimbursement.

“Some providers [feel] awkward raising issues about HIV testing or sexuality with their patients, because they think someone who's 55 years old may not be at risk,” Dr. Mermin said. “But in fact, people of all ages are at risk for HIV infection. Some of that is because it's a chronic disease and people can live with HIV for many years without showing symptoms.”

Laws and regulations in some states pose another challenge to adoption of routine HIV screening, as they require separate written consent for HIV testing of nonpregnant adults.

Routine HIV screening is supported in the government's National HIV/AIDS Strategy for the United States—the other major federal HIV/AIDS effort.

Released in July, the national strategy is a 45-page blueprint with three main goals: reducing the number of people who become infected with HIV, increasing access to care and optimizing health outcomes for people living with HIV, and reducing HIV health-related disparities.

The strategy emphasizes reduction of new HIV infections by intensifying prevention efforts in communities where HIV is most prevalent, expanding targeted efforts to prevent HIV infection using a combination of effective, evidence-based approaches, and educating all Americans about the threat of HIV and how to prevent it.

“This has been a long time coming,” said Dr. Donna Sweet, professor of internal medicine at the University of Kansas–Wichita. “It reflects, I think, what we all think needs to be done. It really is about reducing new HIV infections, improving care for the people living with HIV/AIDS, and perhaps even most importantly, narrowing the health disparities, because this epidemic has moved into corners of our country where there are very little resources and a lack of education.

“It's important to address the disparities in what's going on so that all Americans, regardless of color or sexual orientation, truly are considered important,” Dr. Sweet continued. “We need to work to maintain their health, both by helping stop the spread of infections in our minority communities as well as making sure people in all communities have access to the best of care.”

The strategy sets certain benchmarks to be reached by 2015, including lowering the annual number of new infections by 25%, reducing the HIV transmission rate by 30%, and increasing the percentage of persons living with HIV who know their serostatus from 79% to 90%.

One challenge that worries Dr. Sweet is recruiting young physicians to the field of HIV/AIDS medicine.

“We're going to have an increasing problem finding doctors to take care of HIV/AIDS, simply because the people who have been doing this for 30 years are starting to age out,” she said.

HIV: Start the Conversation

Dr. Mermin suggested the following approach to starting the conversation on HIV testing with a patient: “The CDC recommends that all patients are offered an HIV test. Would you like to know your HIV status?”

That approach “is very successful,” Dr. Mermin said. “Very few people will ask not to be tested under those circumstances. It takes the onus away from the provider to assess people's risk, and it takes the burden and awkwardness from the patient of having to raise the question of wanting an HIV test.”

The CDC testing initiative, supported by the American College of Physicians, the National Medical Association, the Society for General Internal Medicine, the HIV Medicine Association, and the American Academy of HIV Medicine, provides free a resource kit for physicians to use in primary care settings at

cdc.gov/hivstandardcare

The federal government has taken a two-pronged approach to reinvigorating its efforts in addressing HIV/AIDS.

In June, the Centers for Disease Control and Prevention launched an initiative aimed at helping physicians make HIV testing a routine part of medical care. The initiative, known as “HIV Screening. Standard Care” aims to increase the use of opt-out screening strategies over risk-based screening, which previously has been the more common practice.

Dr. Jonathan Mermin, director of the CDC's division of HIV/AIDS prevention, Atlanta, said the goal of the new initiative is to increase implementation of the CDC's 2006 HIV screening guidelines, which recommend that all patients aged 13-64 years be tested for HIV at least once in their lives—regardless of perceived risk of infection—and that individuals at high risk be tested at least annually (MMWR 2006;55[RR-14]:1-17).

“The need for HIV screening is an ongoing issue,” said Dr. Amir Qaseem, senior medical associate at the American College of Physicians, which recently published a guidance statement for HIV screening (Ann. Intern. Med. 2009;150:125-31). “It's a major public health problem worldwide, even within the United States, where almost 1 million people are living with HIV. Almost 25% of these people are unaware of their HIV infection.”

“Risk-based screening has been an unsuccessful strategy and has failed to identify a substantial number of patients with HIV,” Dr. Qaseem said. “Routine HIV screening is easier to implement in busy practice settings.” Yet few physicians do it. A 2009 Web-based survey from the public relations firm Porter Novelli found that only 17% of primary care physicians routinely screen their patients for HIV.

And in a study from 2007, investigators from the bureau of HIV/AIDS prevention and control in the New York City Department of Health and Mental Hygiene reviewed published and unpublished literature on HIV testing barriers. They divided studies into three categories: prenatal, emergency department, and other medical settings (AIDS 2007;21:1617-24). Several barriers were identified in all three settings: lack of knowledge/training, lack of patient acceptance, pretest counseling requirements, competing priorities, and inadequate reimbursement.

“Some providers [feel] awkward raising issues about HIV testing or sexuality with their patients, because they think someone who's 55 years old may not be at risk,” Dr. Mermin said. “But in fact, people of all ages are at risk for HIV infection. Some of that is because it's a chronic disease and people can live with HIV for many years without showing symptoms.”

Laws and regulations in some states pose another challenge to adoption of routine HIV screening, as they require separate written consent for HIV testing of nonpregnant adults.

Routine HIV screening is supported in the government's National HIV/AIDS Strategy for the United States—the other major federal HIV/AIDS effort.

Released in July, the national strategy is a 45-page blueprint with three main goals: reducing the number of people who become infected with HIV, increasing access to care and optimizing health outcomes for people living with HIV, and reducing HIV health-related disparities.

The strategy emphasizes reduction of new HIV infections by intensifying prevention efforts in communities where HIV is most prevalent, expanding targeted efforts to prevent HIV infection using a combination of effective, evidence-based approaches, and educating all Americans about the threat of HIV and how to prevent it.

“This has been a long time coming,” said Dr. Donna Sweet, professor of internal medicine at the University of Kansas–Wichita. “It reflects, I think, what we all think needs to be done. It really is about reducing new HIV infections, improving care for the people living with HIV/AIDS, and perhaps even most importantly, narrowing the health disparities, because this epidemic has moved into corners of our country where there are very little resources and a lack of education.

“It's important to address the disparities in what's going on so that all Americans, regardless of color or sexual orientation, truly are considered important,” Dr. Sweet continued. “We need to work to maintain their health, both by helping stop the spread of infections in our minority communities as well as making sure people in all communities have access to the best of care.”

The strategy sets certain benchmarks to be reached by 2015, including lowering the annual number of new infections by 25%, reducing the HIV transmission rate by 30%, and increasing the percentage of persons living with HIV who know their serostatus from 79% to 90%.

One challenge that worries Dr. Sweet is recruiting young physicians to the field of HIV/AIDS medicine.

“We're going to have an increasing problem finding doctors to take care of HIV/AIDS, simply because the people who have been doing this for 30 years are starting to age out,” she said.

HIV: Start the Conversation

Dr. Mermin suggested the following approach to starting the conversation on HIV testing with a patient: “The CDC recommends that all patients are offered an HIV test. Would you like to know your HIV status?”

That approach “is very successful,” Dr. Mermin said. “Very few people will ask not to be tested under those circumstances. It takes the onus away from the provider to assess people's risk, and it takes the burden and awkwardness from the patient of having to raise the question of wanting an HIV test.”

The CDC testing initiative, supported by the American College of Physicians, the National Medical Association, the Society for General Internal Medicine, the HIV Medicine Association, and the American Academy of HIV Medicine, provides free a resource kit for physicians to use in primary care settings at

cdc.gov/hivstandardcare

The federal government has taken a two-pronged approach to reinvigorating its efforts in addressing HIV/AIDS.

In June, the Centers for Disease Control and Prevention launched an initiative aimed at helping physicians make HIV testing a routine part of medical care. The initiative, known as “HIV Screening. Standard Care” aims to increase the use of opt-out screening strategies over risk-based screening, which previously has been the more common practice.

Dr. Jonathan Mermin, director of the CDC's division of HIV/AIDS prevention, Atlanta, said the goal of the new initiative is to increase implementation of the CDC's 2006 HIV screening guidelines, which recommend that all patients aged 13-64 years be tested for HIV at least once in their lives—regardless of perceived risk of infection—and that individuals at high risk be tested at least annually (MMWR 2006;55[RR-14]:1-17).

“The need for HIV screening is an ongoing issue,” said Dr. Amir Qaseem, senior medical associate at the American College of Physicians, which recently published a guidance statement for HIV screening (Ann. Intern. Med. 2009;150:125-31). “It's a major public health problem worldwide, even within the United States, where almost 1 million people are living with HIV. Almost 25% of these people are unaware of their HIV infection.”

“Risk-based screening has been an unsuccessful strategy and has failed to identify a substantial number of patients with HIV,” Dr. Qaseem said. “Routine HIV screening is easier to implement in busy practice settings.” Yet few physicians do it. A 2009 Web-based survey from the public relations firm Porter Novelli found that only 17% of primary care physicians routinely screen their patients for HIV.

And in a study from 2007, investigators from the bureau of HIV/AIDS prevention and control in the New York City Department of Health and Mental Hygiene reviewed published and unpublished literature on HIV testing barriers. They divided studies into three categories: prenatal, emergency department, and other medical settings (AIDS 2007;21:1617-24). Several barriers were identified in all three settings: lack of knowledge/training, lack of patient acceptance, pretest counseling requirements, competing priorities, and inadequate reimbursement.

“Some providers [feel] awkward raising issues about HIV testing or sexuality with their patients, because they think someone who's 55 years old may not be at risk,” Dr. Mermin said. “But in fact, people of all ages are at risk for HIV infection. Some of that is because it's a chronic disease and people can live with HIV for many years without showing symptoms.”

Laws and regulations in some states pose another challenge to adoption of routine HIV screening, as they require separate written consent for HIV testing of nonpregnant adults.

Routine HIV screening is supported in the government's National HIV/AIDS Strategy for the United States—the other major federal HIV/AIDS effort.

Released in July, the national strategy is a 45-page blueprint with three main goals: reducing the number of people who become infected with HIV, increasing access to care and optimizing health outcomes for people living with HIV, and reducing HIV health-related disparities.

The strategy emphasizes reduction of new HIV infections by intensifying prevention efforts in communities where HIV is most prevalent, expanding targeted efforts to prevent HIV infection using a combination of effective, evidence-based approaches, and educating all Americans about the threat of HIV and how to prevent it.

“This has been a long time coming,” said Dr. Donna Sweet, professor of internal medicine at the University of Kansas–Wichita. “It reflects, I think, what we all think needs to be done. It really is about reducing new HIV infections, improving care for the people living with HIV/AIDS, and perhaps even most importantly, narrowing the health disparities, because this epidemic has moved into corners of our country where there are very little resources and a lack of education.

“It's important to address the disparities in what's going on so that all Americans, regardless of color or sexual orientation, truly are considered important,” Dr. Sweet continued. “We need to work to maintain their health, both by helping stop the spread of infections in our minority communities as well as making sure people in all communities have access to the best of care.”

The strategy sets certain benchmarks to be reached by 2015, including lowering the annual number of new infections by 25%, reducing the HIV transmission rate by 30%, and increasing the percentage of persons living with HIV who know their serostatus from 79% to 90%.

One challenge that worries Dr. Sweet is recruiting young physicians to the field of HIV/AIDS medicine.

“We're going to have an increasing problem finding doctors to take care of HIV/AIDS, simply because the people who have been doing this for 30 years are starting to age out,” she said.

HIV: Start the Conversation

Dr. Mermin suggested the following approach to starting the conversation on HIV testing with a patient: “The CDC recommends that all patients are offered an HIV test. Would you like to know your HIV status?”

That approach “is very successful,” Dr. Mermin said. “Very few people will ask not to be tested under those circumstances. It takes the onus away from the provider to assess people's risk, and it takes the burden and awkwardness from the patient of having to raise the question of wanting an HIV test.”

The CDC testing initiative, supported by the American College of Physicians, the National Medical Association, the Society for General Internal Medicine, the HIV Medicine Association, and the American Academy of HIV Medicine, provides free a resource kit for physicians to use in primary care settings at

cdc.gov/hivstandardcare

SAN DIEGO — Many adults with diabetes do not understand how living in a hot climate impacts their disease self-management, results from a survey of 152 patients demonstrated.

For example, 29% of respondents did not initiate personal protective measures until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risk their exposure to heat.

“This was quite concerning, because they wouldn't have the means to check their blood sugars if they began to feel faint if they got behind the wheel to start driving; or if they needed to seek medical attention, they wouldn't have the means to know if they should,” Dr. Adrienne Nassar, a third-year resident in internal medicine at the Mayo Clinic, Scottsdale, Ariz., said at the meeting.

Studies have shown that people with diabetes have higher rates of emergency room visits, hospitalizations, and deaths caused by to heat illness during hot weather than during more temperate weather, but few published studies have assessed how patients manage their disease in extremely hot temperatures, said Dr. Nassar. “Furthermore, the number of diabetes cases is increasing in the Southwestern United States,” she said. “The primary way in which we cool ourselves is through sweating, and diabetes patients may have an impaired ability to do so.”

In collaboration with the National Weather Service and the National Oceanic and Atmospheric Administration, Dr. Nassar and her associates surveyed 152 adults who attended the diabetes clinic at Mayo between Nov. 30, 2009, and Dec. 31, 2009, to assess the types of personal protective measures they take against the heat, and their knowledge of safe temperatures and exposure times.

Respondents' mean age was 64 years, 51% were female, 58% were non-Hispanic white, 83% had type 2, and 77% used insulin. Sixty percent reported staying indoors to protect themselves against the heat, 56% drank fluids frequently, 45% applied sunscreen, and 45% wore protective clothing. But 23% reported drinking only when they became thirsty, suggesting that they “were starting to get behind on their fluid status,” Dr. Nassar said.

Nearly three-quarters (71%) reported spending less than 1 hour in the heat, but 29% did not initiate protective measures until temperatures reached 101°F. “Heat-related illness can take place at 80°–90° when you factor in the heat index,” she noted.

While 73% of patients said they knew about heat's harmful effects on insulin, fewer said they knew about extreme heat on glucose meters (41%), oral medications (39%), and glucose testing strips (38%), and 20% did not know when to begin taking precautions, although precautions are included in the product inserts, she said.

The study is expected to appear in the September 2010 issue of the Journal of Diabetes Science and Technology.

Disclosures: Dr. Nassar reported no conflicts.

We cool ourselves through sweating, 'and diabetes patients may have an impaired ability to do so.'

Source DR. NASSAR

Advise patients to stay hydrated before thirst sets in.

Source ©Dana Heinemann/Fotolia.com

SAN DIEGO — Many adults with diabetes do not understand how living in a hot climate impacts their disease self-management, results from a survey of 152 patients demonstrated.

For example, 29% of respondents did not initiate personal protective measures until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risk their exposure to heat.

“This was quite concerning, because they wouldn't have the means to check their blood sugars if they began to feel faint if they got behind the wheel to start driving; or if they needed to seek medical attention, they wouldn't have the means to know if they should,” Dr. Adrienne Nassar, a third-year resident in internal medicine at the Mayo Clinic, Scottsdale, Ariz., said at the meeting.

Studies have shown that people with diabetes have higher rates of emergency room visits, hospitalizations, and deaths caused by to heat illness during hot weather than during more temperate weather, but few published studies have assessed how patients manage their disease in extremely hot temperatures, said Dr. Nassar. “Furthermore, the number of diabetes cases is increasing in the Southwestern United States,” she said. “The primary way in which we cool ourselves is through sweating, and diabetes patients may have an impaired ability to do so.”

In collaboration with the National Weather Service and the National Oceanic and Atmospheric Administration, Dr. Nassar and her associates surveyed 152 adults who attended the diabetes clinic at Mayo between Nov. 30, 2009, and Dec. 31, 2009, to assess the types of personal protective measures they take against the heat, and their knowledge of safe temperatures and exposure times.

Respondents' mean age was 64 years, 51% were female, 58% were non-Hispanic white, 83% had type 2, and 77% used insulin. Sixty percent reported staying indoors to protect themselves against the heat, 56% drank fluids frequently, 45% applied sunscreen, and 45% wore protective clothing. But 23% reported drinking only when they became thirsty, suggesting that they “were starting to get behind on their fluid status,” Dr. Nassar said.

Nearly three-quarters (71%) reported spending less than 1 hour in the heat, but 29% did not initiate protective measures until temperatures reached 101°F. “Heat-related illness can take place at 80°–90° when you factor in the heat index,” she noted.

While 73% of patients said they knew about heat's harmful effects on insulin, fewer said they knew about extreme heat on glucose meters (41%), oral medications (39%), and glucose testing strips (38%), and 20% did not know when to begin taking precautions, although precautions are included in the product inserts, she said.

The study is expected to appear in the September 2010 issue of the Journal of Diabetes Science and Technology.

Disclosures: Dr. Nassar reported no conflicts.

We cool ourselves through sweating, 'and diabetes patients may have an impaired ability to do so.'

Source DR. NASSAR

Advise patients to stay hydrated before thirst sets in.

Source ©Dana Heinemann/Fotolia.com

SAN DIEGO — Many adults with diabetes do not understand how living in a hot climate impacts their disease self-management, results from a survey of 152 patients demonstrated.

For example, 29% of respondents did not initiate personal protective measures until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risk their exposure to heat.

“This was quite concerning, because they wouldn't have the means to check their blood sugars if they began to feel faint if they got behind the wheel to start driving; or if they needed to seek medical attention, they wouldn't have the means to know if they should,” Dr. Adrienne Nassar, a third-year resident in internal medicine at the Mayo Clinic, Scottsdale, Ariz., said at the meeting.

Studies have shown that people with diabetes have higher rates of emergency room visits, hospitalizations, and deaths caused by to heat illness during hot weather than during more temperate weather, but few published studies have assessed how patients manage their disease in extremely hot temperatures, said Dr. Nassar. “Furthermore, the number of diabetes cases is increasing in the Southwestern United States,” she said. “The primary way in which we cool ourselves is through sweating, and diabetes patients may have an impaired ability to do so.”

In collaboration with the National Weather Service and the National Oceanic and Atmospheric Administration, Dr. Nassar and her associates surveyed 152 adults who attended the diabetes clinic at Mayo between Nov. 30, 2009, and Dec. 31, 2009, to assess the types of personal protective measures they take against the heat, and their knowledge of safe temperatures and exposure times.

Respondents' mean age was 64 years, 51% were female, 58% were non-Hispanic white, 83% had type 2, and 77% used insulin. Sixty percent reported staying indoors to protect themselves against the heat, 56% drank fluids frequently, 45% applied sunscreen, and 45% wore protective clothing. But 23% reported drinking only when they became thirsty, suggesting that they “were starting to get behind on their fluid status,” Dr. Nassar said.

Nearly three-quarters (71%) reported spending less than 1 hour in the heat, but 29% did not initiate protective measures until temperatures reached 101°F. “Heat-related illness can take place at 80°–90° when you factor in the heat index,” she noted.

While 73% of patients said they knew about heat's harmful effects on insulin, fewer said they knew about extreme heat on glucose meters (41%), oral medications (39%), and glucose testing strips (38%), and 20% did not know when to begin taking precautions, although precautions are included in the product inserts, she said.

The study is expected to appear in the September 2010 issue of the Journal of Diabetes Science and Technology.

Disclosures: Dr. Nassar reported no conflicts.

We cool ourselves through sweating, 'and diabetes patients may have an impaired ability to do so.'

Source DR. NASSAR

Advise patients to stay hydrated before thirst sets in.

Source ©Dana Heinemann/Fotolia.com

Major Finding: The specificity of a new screening approach developed for post-menopausal women at average risk for ovarian cancer was 99.9%.

Data Source: A single arm, prospective, multi-center study of 3,252 women aged 50-74.

Disclosures: One of the study authors, Dr. Herbert A. Fritsche, disclosed that he received research funding from Roche Diagnostics. Another study author, Dr. Robert C. Bast, Jr., disclosed that he serves as a consultant and advisor to Fujiresio Diagnostics, Inc. He also receives other remuneration and royalties for helping to invent the CA-125 assay.

A staged algorithm that incorporates the CA-125 assay to screen postmenopausal women for ovarian cancer has a near-perfect specificity of 99.9%, according to a single arm, multicenter study that enrolled more than 3,200 women at average risk of the disease.

If confirmed in larger studies, this approach could be used to detect ovarian cancer in its early, more curable stages, lead author Dr. Karen Lu said.

“Ovarian cancer is the most lethal gynecologic cancer,” said Dr. Lu, professor of gynecologic oncology at the University of Texas M.D. Anderson Cancer Center, Houston. “Greater than 75% of cases present with advanced stage disease, when cure rates are less than 30%. If caught at an early stage, cure rates are 60%-90%, but at the current time there are no effective screening methods.”

For the 9-year study, scheduled to be presented during ASCO's annual meeting in Chicago, Dr. Lu and her associates enrolled 3,252 women aged 50-74 years with no significant family history of breast or ovarian cancer to be screened with the Risk of Ovarian Cancer Algorithm (ROCA). She described ROCA as a mathematical model that takes into account a woman's age as well as changes in the values of her CA-125 assay over time.

“From here there are three possibilities,” she explained. “Those individuals who have a low ROCA score are told to come back at 1 year for a repeat CA-125. Those who have an intermediate ROCA score are told to come back at 3 months for another CA-125, and those who have a high ROCA score are triaged to a transvaginal ultrasound and referral to a gynecologic oncologist.”

After following the women for 9 years the researchers found that the average annual rate of referral for CA-125 assays every 3 months was 6.8% and that the average annual rate of transvaginal ultrasound and referral to a gynecologic oncologist was only 0.9%. “Each year the overwhelming majority of women were triaged to the low-risk category—an annual CA-125,” Dr. Lu said.

Cumulatively, 85 women (2.6%) received transvaginal ultrasound and subsequent referral to a gynecologic oncologist. Of these, eight required surgery: three for invasive ovarian cancers (two stage 1C and one stage IIB), two for borderline ovarian tumors, and three for benign ovarian tumors. This translated into a positive predictive value of 37.5%. “This means that three operations would be necessary to detect one case of invasive ovarian cancer,” she said.

The combined specificity of ROCA followed by transvaginal ultrasound was 99.9%, “which means that there were very few false positive.”

Dr. Lu emphasized that while results of the ROCA screening strategy are encouraging, “they are not practice changing at this time. We need to await the results of a definitive ovarian cancer screening trial that uses mortality as an end point, and uses the same ROCA algorithm.” That trial of more than 200,000 women is underway in the United Kingdom, she said. Results are expected in 2015.

ASCO President Dr. Douglas W. Blayney said that the ROCA algorithm “represents yet another example of personalized medicine. Here, we have a personalized screening strategy for a vicious type of cancer. This also represents a more refined application of known technology. The CA-125 is widely available, as is transvaginal ultrasound, which is intrusive and technologically somewhat difficult to interpret. Here, we have a staged application.”

Major Finding: The specificity of a new screening approach developed for post-menopausal women at average risk for ovarian cancer was 99.9%.

Data Source: A single arm, prospective, multi-center study of 3,252 women aged 50-74.

Disclosures: One of the study authors, Dr. Herbert A. Fritsche, disclosed that he received research funding from Roche Diagnostics. Another study author, Dr. Robert C. Bast, Jr., disclosed that he serves as a consultant and advisor to Fujiresio Diagnostics, Inc. He also receives other remuneration and royalties for helping to invent the CA-125 assay.

A staged algorithm that incorporates the CA-125 assay to screen postmenopausal women for ovarian cancer has a near-perfect specificity of 99.9%, according to a single arm, multicenter study that enrolled more than 3,200 women at average risk of the disease.

If confirmed in larger studies, this approach could be used to detect ovarian cancer in its early, more curable stages, lead author Dr. Karen Lu said.

“Ovarian cancer is the most lethal gynecologic cancer,” said Dr. Lu, professor of gynecologic oncology at the University of Texas M.D. Anderson Cancer Center, Houston. “Greater than 75% of cases present with advanced stage disease, when cure rates are less than 30%. If caught at an early stage, cure rates are 60%-90%, but at the current time there are no effective screening methods.”

For the 9-year study, scheduled to be presented during ASCO's annual meeting in Chicago, Dr. Lu and her associates enrolled 3,252 women aged 50-74 years with no significant family history of breast or ovarian cancer to be screened with the Risk of Ovarian Cancer Algorithm (ROCA). She described ROCA as a mathematical model that takes into account a woman's age as well as changes in the values of her CA-125 assay over time.

“From here there are three possibilities,” she explained. “Those individuals who have a low ROCA score are told to come back at 1 year for a repeat CA-125. Those who have an intermediate ROCA score are told to come back at 3 months for another CA-125, and those who have a high ROCA score are triaged to a transvaginal ultrasound and referral to a gynecologic oncologist.”

After following the women for 9 years the researchers found that the average annual rate of referral for CA-125 assays every 3 months was 6.8% and that the average annual rate of transvaginal ultrasound and referral to a gynecologic oncologist was only 0.9%. “Each year the overwhelming majority of women were triaged to the low-risk category—an annual CA-125,” Dr. Lu said.

Cumulatively, 85 women (2.6%) received transvaginal ultrasound and subsequent referral to a gynecologic oncologist. Of these, eight required surgery: three for invasive ovarian cancers (two stage 1C and one stage IIB), two for borderline ovarian tumors, and three for benign ovarian tumors. This translated into a positive predictive value of 37.5%. “This means that three operations would be necessary to detect one case of invasive ovarian cancer,” she said.

The combined specificity of ROCA followed by transvaginal ultrasound was 99.9%, “which means that there were very few false positive.”

Dr. Lu emphasized that while results of the ROCA screening strategy are encouraging, “they are not practice changing at this time. We need to await the results of a definitive ovarian cancer screening trial that uses mortality as an end point, and uses the same ROCA algorithm.” That trial of more than 200,000 women is underway in the United Kingdom, she said. Results are expected in 2015.

ASCO President Dr. Douglas W. Blayney said that the ROCA algorithm “represents yet another example of personalized medicine. Here, we have a personalized screening strategy for a vicious type of cancer. This also represents a more refined application of known technology. The CA-125 is widely available, as is transvaginal ultrasound, which is intrusive and technologically somewhat difficult to interpret. Here, we have a staged application.”

Major Finding: The specificity of a new screening approach developed for post-menopausal women at average risk for ovarian cancer was 99.9%.

Data Source: A single arm, prospective, multi-center study of 3,252 women aged 50-74.

Disclosures: One of the study authors, Dr. Herbert A. Fritsche, disclosed that he received research funding from Roche Diagnostics. Another study author, Dr. Robert C. Bast, Jr., disclosed that he serves as a consultant and advisor to Fujiresio Diagnostics, Inc. He also receives other remuneration and royalties for helping to invent the CA-125 assay.

A staged algorithm that incorporates the CA-125 assay to screen postmenopausal women for ovarian cancer has a near-perfect specificity of 99.9%, according to a single arm, multicenter study that enrolled more than 3,200 women at average risk of the disease.

If confirmed in larger studies, this approach could be used to detect ovarian cancer in its early, more curable stages, lead author Dr. Karen Lu said.

“Ovarian cancer is the most lethal gynecologic cancer,” said Dr. Lu, professor of gynecologic oncology at the University of Texas M.D. Anderson Cancer Center, Houston. “Greater than 75% of cases present with advanced stage disease, when cure rates are less than 30%. If caught at an early stage, cure rates are 60%-90%, but at the current time there are no effective screening methods.”

For the 9-year study, scheduled to be presented during ASCO's annual meeting in Chicago, Dr. Lu and her associates enrolled 3,252 women aged 50-74 years with no significant family history of breast or ovarian cancer to be screened with the Risk of Ovarian Cancer Algorithm (ROCA). She described ROCA as a mathematical model that takes into account a woman's age as well as changes in the values of her CA-125 assay over time.

“From here there are three possibilities,” she explained. “Those individuals who have a low ROCA score are told to come back at 1 year for a repeat CA-125. Those who have an intermediate ROCA score are told to come back at 3 months for another CA-125, and those who have a high ROCA score are triaged to a transvaginal ultrasound and referral to a gynecologic oncologist.”

After following the women for 9 years the researchers found that the average annual rate of referral for CA-125 assays every 3 months was 6.8% and that the average annual rate of transvaginal ultrasound and referral to a gynecologic oncologist was only 0.9%. “Each year the overwhelming majority of women were triaged to the low-risk category—an annual CA-125,” Dr. Lu said.

Cumulatively, 85 women (2.6%) received transvaginal ultrasound and subsequent referral to a gynecologic oncologist. Of these, eight required surgery: three for invasive ovarian cancers (two stage 1C and one stage IIB), two for borderline ovarian tumors, and three for benign ovarian tumors. This translated into a positive predictive value of 37.5%. “This means that three operations would be necessary to detect one case of invasive ovarian cancer,” she said.

The combined specificity of ROCA followed by transvaginal ultrasound was 99.9%, “which means that there were very few false positive.”

Dr. Lu emphasized that while results of the ROCA screening strategy are encouraging, “they are not practice changing at this time. We need to await the results of a definitive ovarian cancer screening trial that uses mortality as an end point, and uses the same ROCA algorithm.” That trial of more than 200,000 women is underway in the United Kingdom, she said. Results are expected in 2015.

ASCO President Dr. Douglas W. Blayney said that the ROCA algorithm “represents yet another example of personalized medicine. Here, we have a personalized screening strategy for a vicious type of cancer. This also represents a more refined application of known technology. The CA-125 is widely available, as is transvaginal ultrasound, which is intrusive and technologically somewhat difficult to interpret. Here, we have a staged application.”

Major Finding: The proposed ACR/EULAR cut point for “definite RA” may be held at 6, whereas 3 may be an appropriate cut point for “probable RA.”

Data Source: A cohort of 566 patients with early undifferentiated arthritis.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

The revised classification criteria for rheumatoid arthritis that were developed jointly by the American College of Rheumatology and the European League Against Rheumatism are valid to predict future persistent arthritis and joint erosions in patients with early undifferentiated arthritis, judging from results from a large study.

“Methotrexate is the cornerstone of RA management and frequently initiated as the first [disease-modifying antirheumatic drug] if the suspicion for RA is raised,” lead author Dr. Henk Visser said in an interview with Rheumatology News.

“However, the new ACR/EULAR criteria were not validated against what RA is considered to be: persistent and erosive arthritis,” according to Dr. Visser.

For the study, the researchers validated the new ACR/EULAR criteria for their ability to predict persistent and erosive arthritis in an existing early arthritis cohort of 566 patients who were followed for 2 years (Arthritis Rheum. 2002;46:357–65).

They were included in the current study if at baseline they had had arthritis of at least one joint, arthritis that was not explained by another diagnosis, and no joint erosions on x-ray, and if they had also completed 2 years of follow-up.

The data were presented by Jaap Fransen, Ph.D., of St. Radboud University Medical Centre Nijmegen (the Netherlands).

The mean age of patients at baseline was 52 years; 56% were female.

Dr. Visser, a rheumatologist at Rijnstate Hospital in Arnhem, the Netherlands, said in an interview that at 2 years of follow-up, 45% of patients had persistent arthritis, and 48% of them had erosions.

At baseline, patients had a median of two swollen joints, 23% were positive for IgM rheumatoid factor, 18% were positive for anticitrullinated protein antibodies, 25% had symptoms lasting longer than 6 weeks, and the patients' median erythrocyte sedimentation rate was 26 mm/h.

The researchers found that joint involvement, serology, symptoms lasting longer than 6 weeks, and elevated acute phase reactants were significantly associated with persistent arthritis, whereas joint involvement and serology were significantly associated with erosions.

The strength of the 0–10 “risk” score of the revised classification criteria was significantly associated with persistent arthritis (odds ratio, 1.6) and erosions (OR, 1.8), with areas under the ROC curve of .79 and .81, respectively.

Patients with a risk score of 6 or higher at baseline had a .74 probability to develop persistent arthritis at year 2, and given persistence there was a .68 probability to develop erosions. The discriminative ability of the new ACR/EULAR criteria and the earlier prediction model developed for early diagnosis of RA by Dr. Visser and his colleagues are comparable.

The previous ACR classification criteria performed much more poorly.

Dr. Visser and his associates concluded that the proposed cut point for “definite RA” may be held at a risk score of 6, whereas a score of 3 may be an appropriate cut point for “probable RA,” according to Dr. Visser and associates.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

Effusion and bone edema can be seen on this wrist MRI of a patient with rheumatoid arthritis.

Source ©2010 Kevin Shea, M.D/Custom Medical Stock Photo, All Rights Reserved

Major Finding: The proposed ACR/EULAR cut point for “definite RA” may be held at 6, whereas 3 may be an appropriate cut point for “probable RA.”

Data Source: A cohort of 566 patients with early undifferentiated arthritis.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

The revised classification criteria for rheumatoid arthritis that were developed jointly by the American College of Rheumatology and the European League Against Rheumatism are valid to predict future persistent arthritis and joint erosions in patients with early undifferentiated arthritis, judging from results from a large study.

“Methotrexate is the cornerstone of RA management and frequently initiated as the first [disease-modifying antirheumatic drug] if the suspicion for RA is raised,” lead author Dr. Henk Visser said in an interview with Rheumatology News.

“However, the new ACR/EULAR criteria were not validated against what RA is considered to be: persistent and erosive arthritis,” according to Dr. Visser.

For the study, the researchers validated the new ACR/EULAR criteria for their ability to predict persistent and erosive arthritis in an existing early arthritis cohort of 566 patients who were followed for 2 years (Arthritis Rheum. 2002;46:357–65).

They were included in the current study if at baseline they had had arthritis of at least one joint, arthritis that was not explained by another diagnosis, and no joint erosions on x-ray, and if they had also completed 2 years of follow-up.

The data were presented by Jaap Fransen, Ph.D., of St. Radboud University Medical Centre Nijmegen (the Netherlands).

The mean age of patients at baseline was 52 years; 56% were female.

Dr. Visser, a rheumatologist at Rijnstate Hospital in Arnhem, the Netherlands, said in an interview that at 2 years of follow-up, 45% of patients had persistent arthritis, and 48% of them had erosions.

At baseline, patients had a median of two swollen joints, 23% were positive for IgM rheumatoid factor, 18% were positive for anticitrullinated protein antibodies, 25% had symptoms lasting longer than 6 weeks, and the patients' median erythrocyte sedimentation rate was 26 mm/h.

The researchers found that joint involvement, serology, symptoms lasting longer than 6 weeks, and elevated acute phase reactants were significantly associated with persistent arthritis, whereas joint involvement and serology were significantly associated with erosions.

The strength of the 0–10 “risk” score of the revised classification criteria was significantly associated with persistent arthritis (odds ratio, 1.6) and erosions (OR, 1.8), with areas under the ROC curve of .79 and .81, respectively.

Patients with a risk score of 6 or higher at baseline had a .74 probability to develop persistent arthritis at year 2, and given persistence there was a .68 probability to develop erosions. The discriminative ability of the new ACR/EULAR criteria and the earlier prediction model developed for early diagnosis of RA by Dr. Visser and his colleagues are comparable.

The previous ACR classification criteria performed much more poorly.

Dr. Visser and his associates concluded that the proposed cut point for “definite RA” may be held at a risk score of 6, whereas a score of 3 may be an appropriate cut point for “probable RA,” according to Dr. Visser and associates.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

Effusion and bone edema can be seen on this wrist MRI of a patient with rheumatoid arthritis.

Source ©2010 Kevin Shea, M.D/Custom Medical Stock Photo, All Rights Reserved

Major Finding: The proposed ACR/EULAR cut point for “definite RA” may be held at 6, whereas 3 may be an appropriate cut point for “probable RA.”

Data Source: A cohort of 566 patients with early undifferentiated arthritis.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

The revised classification criteria for rheumatoid arthritis that were developed jointly by the American College of Rheumatology and the European League Against Rheumatism are valid to predict future persistent arthritis and joint erosions in patients with early undifferentiated arthritis, judging from results from a large study.

“Methotrexate is the cornerstone of RA management and frequently initiated as the first [disease-modifying antirheumatic drug] if the suspicion for RA is raised,” lead author Dr. Henk Visser said in an interview with Rheumatology News.

“However, the new ACR/EULAR criteria were not validated against what RA is considered to be: persistent and erosive arthritis,” according to Dr. Visser.

For the study, the researchers validated the new ACR/EULAR criteria for their ability to predict persistent and erosive arthritis in an existing early arthritis cohort of 566 patients who were followed for 2 years (Arthritis Rheum. 2002;46:357–65).

They were included in the current study if at baseline they had had arthritis of at least one joint, arthritis that was not explained by another diagnosis, and no joint erosions on x-ray, and if they had also completed 2 years of follow-up.

The data were presented by Jaap Fransen, Ph.D., of St. Radboud University Medical Centre Nijmegen (the Netherlands).

The mean age of patients at baseline was 52 years; 56% were female.

Dr. Visser, a rheumatologist at Rijnstate Hospital in Arnhem, the Netherlands, said in an interview that at 2 years of follow-up, 45% of patients had persistent arthritis, and 48% of them had erosions.

At baseline, patients had a median of two swollen joints, 23% were positive for IgM rheumatoid factor, 18% were positive for anticitrullinated protein antibodies, 25% had symptoms lasting longer than 6 weeks, and the patients' median erythrocyte sedimentation rate was 26 mm/h.

The researchers found that joint involvement, serology, symptoms lasting longer than 6 weeks, and elevated acute phase reactants were significantly associated with persistent arthritis, whereas joint involvement and serology were significantly associated with erosions.

The strength of the 0–10 “risk” score of the revised classification criteria was significantly associated with persistent arthritis (odds ratio, 1.6) and erosions (OR, 1.8), with areas under the ROC curve of .79 and .81, respectively.

Patients with a risk score of 6 or higher at baseline had a .74 probability to develop persistent arthritis at year 2, and given persistence there was a .68 probability to develop erosions. The discriminative ability of the new ACR/EULAR criteria and the earlier prediction model developed for early diagnosis of RA by Dr. Visser and his colleagues are comparable.

The previous ACR classification criteria performed much more poorly.

Dr. Visser and his associates concluded that the proposed cut point for “definite RA” may be held at a risk score of 6, whereas a score of 3 may be an appropriate cut point for “probable RA,” according to Dr. Visser and associates.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

Effusion and bone edema can be seen on this wrist MRI of a patient with rheumatoid arthritis.

Source ©2010 Kevin Shea, M.D/Custom Medical Stock Photo, All Rights Reserved

Higher-than-standard doses of rituximab improved clinical response rates in patients with rheumatoid arthritis who had an incomplete B-lymphocyte depletion as determined by highly sensitive flow cytometry, judging from results from a small study.

“Not only is B-cell depletion important in determining clinical response, it can be enhanced by increasing the dose of rituximab,” according to Dr. Edward Vital of the U.K. National Institute for Health Research's Leeds (England) Musculoskeletal Biomedical Research Unit.

Rituximab is administered as two 1-g doses, “but a significant proportion [of patients] fail to achieve a EULAR response after standard therapy,” he said.

Dr. Vital and his associates used highly sensitive flow cytometry to identify 26 patients with active RA and incomplete deletion 2 weeks after they received an initial 1-g dose of rituximab. The patients were then randomized 1:1 to a total of either 2 g or 3 g rituximab.

At the end of 40 weeks, a significantly higher proportion of patients who received 3 g of rituximab had EULAR moderate/good response rates, compared with their counterparts who received 2 g (92% vs. 54%, respectively). Data from 1 year of follow-up on 20 of the patients showed EULAR moderate/good responses in 67% of patients who received 3 g vs. 27% in those who received 2 g.

Disclosures: Dr. Vital disclosed that he received research support from Roche to conduct the study.

Higher-than-standard doses of rituximab improved clinical response rates in patients with rheumatoid arthritis who had an incomplete B-lymphocyte depletion as determined by highly sensitive flow cytometry, judging from results from a small study.

“Not only is B-cell depletion important in determining clinical response, it can be enhanced by increasing the dose of rituximab,” according to Dr. Edward Vital of the U.K. National Institute for Health Research's Leeds (England) Musculoskeletal Biomedical Research Unit.

Rituximab is administered as two 1-g doses, “but a significant proportion [of patients] fail to achieve a EULAR response after standard therapy,” he said.

Dr. Vital and his associates used highly sensitive flow cytometry to identify 26 patients with active RA and incomplete deletion 2 weeks after they received an initial 1-g dose of rituximab. The patients were then randomized 1:1 to a total of either 2 g or 3 g rituximab.

At the end of 40 weeks, a significantly higher proportion of patients who received 3 g of rituximab had EULAR moderate/good response rates, compared with their counterparts who received 2 g (92% vs. 54%, respectively). Data from 1 year of follow-up on 20 of the patients showed EULAR moderate/good responses in 67% of patients who received 3 g vs. 27% in those who received 2 g.

Disclosures: Dr. Vital disclosed that he received research support from Roche to conduct the study.

Higher-than-standard doses of rituximab improved clinical response rates in patients with rheumatoid arthritis who had an incomplete B-lymphocyte depletion as determined by highly sensitive flow cytometry, judging from results from a small study.

“Not only is B-cell depletion important in determining clinical response, it can be enhanced by increasing the dose of rituximab,” according to Dr. Edward Vital of the U.K. National Institute for Health Research's Leeds (England) Musculoskeletal Biomedical Research Unit.

Rituximab is administered as two 1-g doses, “but a significant proportion [of patients] fail to achieve a EULAR response after standard therapy,” he said.

Dr. Vital and his associates used highly sensitive flow cytometry to identify 26 patients with active RA and incomplete deletion 2 weeks after they received an initial 1-g dose of rituximab. The patients were then randomized 1:1 to a total of either 2 g or 3 g rituximab.

At the end of 40 weeks, a significantly higher proportion of patients who received 3 g of rituximab had EULAR moderate/good response rates, compared with their counterparts who received 2 g (92% vs. 54%, respectively). Data from 1 year of follow-up on 20 of the patients showed EULAR moderate/good responses in 67% of patients who received 3 g vs. 27% in those who received 2 g.

Disclosures: Dr. Vital disclosed that he received research support from Roche to conduct the study.

Major Finding: Inpatient hospital admission among high-risk patients randomized to a telephone-based diabetes care management program for 1 year decreased significantly from 1.029 per member per year to 0.774 per member per year.

Data Source: A study of 526 members enrolled in a Medicare Advantage plan with Health Net of Arizona.

Disclosures: The study was funded by Alere, an Atlanta-based health management company. Dr. Rosenzweig is a member of the company's scientific advisory board.

SAN DIEGO — Elderly patients with type 2 diabetes and coronary artery disease who participated in a telephone-based disease management intervention had significant reductions in hospital inpatient admissions and total health care costs after 1 year, compared with those who did not receive the intervention.

“The results show that you can get short-term results by focusing on a few key indicators that include cardiac risk,” Dr. James L. Rosenzweig said during a press briefing.

The researchers conducted a prospective controlled repeated-measures study of 526 patients enrolled in a Medicare Advantage health plan with Health Net of Arizona who were identified as having diabetes and coronary artery disease. Of the 526 patients, 462 received the disease management program (intervention) and 64 received usual care (controls) for 1 year.

The goal of the intervention was to provide patients with access to nurse care managers via telephone so they could “address gaps of care with respect to both diabetes and its associated cardiovascular risk factors,” including blood pressure, lipids, and cholesterol management, said Dr. Rosenzweig, associate professor of medicine at Boston University, who carried out the study with Michael Taitel, Ph.D., vice president of the Alere Center for Health Intelligence, Atlanta.

“Diabetes education was delivered by the care managers in the course of their telephonic interactions with patients [and] there was close communication between the nurse care managers and the physicians' offices,” Dr. Rosenzweig explained.

“In addition, a subpopulation of these patients had home glucose monitoring data which they downloaded into the disease management system. This was uploaded to the care managers who would also evaluate the patients. They would send reports to [the patients'] physicians on a regular basis,” Dr. Rosenzweig added.

After 1 year, the number of all-cause inpatient hospital admissions among patients in the intervention group decreased from 1.029 per member per year to 0.774 per member per year, a difference that was statistically significant.

The slight decline among controls during the same time period—from 1.165 all-cause inpatient hospital admissions per member per year to 1.110—was not significant.

The number of diabetes-specific hospital admissions decreased from 0.717 per member per year to 0.445 among patients in the intervention group, but there were no significant differences among patients in the control group.

Dr. Rosenzweig also reported that annual medical costs dropped by about $1,000 for each patient in the intervention group but were nearly $5,000 higher for each patient in the control group, “suggesting that this kind of intervention could potentially involve savings of perhaps $6,000 per year per patient.”

Compared with patients in the control group, he added, those in the intervention group “reported having better monitoring of blood glucose levels. They also had more frequent cholesterol tests done by the physicians, more frequent eye examinations, more frequent screenings for kidney disease, hemoglobin A_1c tests, and foot examinations.”

Dr. Rosenzweig said that he did not know what the administrative costs were to run the intervention component.

The study is expected to appear in the July 2010 issue of the American Journal of Managed Care.

'This kind of intervention could potentially involve savings of perhaps $6,000 per year per patient.'

Source DR. ROSENZWEIG

Major Finding: Inpatient hospital admission among high-risk patients randomized to a telephone-based diabetes care management program for 1 year decreased significantly from 1.029 per member per year to 0.774 per member per year.

Data Source: A study of 526 members enrolled in a Medicare Advantage plan with Health Net of Arizona.

Disclosures: The study was funded by Alere, an Atlanta-based health management company. Dr. Rosenzweig is a member of the company's scientific advisory board.

SAN DIEGO — Elderly patients with type 2 diabetes and coronary artery disease who participated in a telephone-based disease management intervention had significant reductions in hospital inpatient admissions and total health care costs after 1 year, compared with those who did not receive the intervention.

“The results show that you can get short-term results by focusing on a few key indicators that include cardiac risk,” Dr. James L. Rosenzweig said during a press briefing.

The researchers conducted a prospective controlled repeated-measures study of 526 patients enrolled in a Medicare Advantage health plan with Health Net of Arizona who were identified as having diabetes and coronary artery disease. Of the 526 patients, 462 received the disease management program (intervention) and 64 received usual care (controls) for 1 year.

The goal of the intervention was to provide patients with access to nurse care managers via telephone so they could “address gaps of care with respect to both diabetes and its associated cardiovascular risk factors,” including blood pressure, lipids, and cholesterol management, said Dr. Rosenzweig, associate professor of medicine at Boston University, who carried out the study with Michael Taitel, Ph.D., vice president of the Alere Center for Health Intelligence, Atlanta.

“Diabetes education was delivered by the care managers in the course of their telephonic interactions with patients [and] there was close communication between the nurse care managers and the physicians' offices,” Dr. Rosenzweig explained.

“In addition, a subpopulation of these patients had home glucose monitoring data which they downloaded into the disease management system. This was uploaded to the care managers who would also evaluate the patients. They would send reports to [the patients'] physicians on a regular basis,” Dr. Rosenzweig added.

After 1 year, the number of all-cause inpatient hospital admissions among patients in the intervention group decreased from 1.029 per member per year to 0.774 per member per year, a difference that was statistically significant.

The slight decline among controls during the same time period—from 1.165 all-cause inpatient hospital admissions per member per year to 1.110—was not significant.

The number of diabetes-specific hospital admissions decreased from 0.717 per member per year to 0.445 among patients in the intervention group, but there were no significant differences among patients in the control group.

Dr. Rosenzweig also reported that annual medical costs dropped by about $1,000 for each patient in the intervention group but were nearly $5,000 higher for each patient in the control group, “suggesting that this kind of intervention could potentially involve savings of perhaps $6,000 per year per patient.”

Compared with patients in the control group, he added, those in the intervention group “reported having better monitoring of blood glucose levels. They also had more frequent cholesterol tests done by the physicians, more frequent eye examinations, more frequent screenings for kidney disease, hemoglobin A_1c tests, and foot examinations.”

Dr. Rosenzweig said that he did not know what the administrative costs were to run the intervention component.

The study is expected to appear in the July 2010 issue of the American Journal of Managed Care.

'This kind of intervention could potentially involve savings of perhaps $6,000 per year per patient.'

Source DR. ROSENZWEIG

Major Finding: Inpatient hospital admission among high-risk patients randomized to a telephone-based diabetes care management program for 1 year decreased significantly from 1.029 per member per year to 0.774 per member per year.

Data Source: A study of 526 members enrolled in a Medicare Advantage plan with Health Net of Arizona.

Disclosures: The study was funded by Alere, an Atlanta-based health management company. Dr. Rosenzweig is a member of the company's scientific advisory board.

SAN DIEGO — Elderly patients with type 2 diabetes and coronary artery disease who participated in a telephone-based disease management intervention had significant reductions in hospital inpatient admissions and total health care costs after 1 year, compared with those who did not receive the intervention.

“The results show that you can get short-term results by focusing on a few key indicators that include cardiac risk,” Dr. James L. Rosenzweig said during a press briefing.

The researchers conducted a prospective controlled repeated-measures study of 526 patients enrolled in a Medicare Advantage health plan with Health Net of Arizona who were identified as having diabetes and coronary artery disease. Of the 526 patients, 462 received the disease management program (intervention) and 64 received usual care (controls) for 1 year.

The goal of the intervention was to provide patients with access to nurse care managers via telephone so they could “address gaps of care with respect to both diabetes and its associated cardiovascular risk factors,” including blood pressure, lipids, and cholesterol management, said Dr. Rosenzweig, associate professor of medicine at Boston University, who carried out the study with Michael Taitel, Ph.D., vice president of the Alere Center for Health Intelligence, Atlanta.

“Diabetes education was delivered by the care managers in the course of their telephonic interactions with patients [and] there was close communication between the nurse care managers and the physicians' offices,” Dr. Rosenzweig explained.

“In addition, a subpopulation of these patients had home glucose monitoring data which they downloaded into the disease management system. This was uploaded to the care managers who would also evaluate the patients. They would send reports to [the patients'] physicians on a regular basis,” Dr. Rosenzweig added.

After 1 year, the number of all-cause inpatient hospital admissions among patients in the intervention group decreased from 1.029 per member per year to 0.774 per member per year, a difference that was statistically significant.

The slight decline among controls during the same time period—from 1.165 all-cause inpatient hospital admissions per member per year to 1.110—was not significant.

The number of diabetes-specific hospital admissions decreased from 0.717 per member per year to 0.445 among patients in the intervention group, but there were no significant differences among patients in the control group.

Dr. Rosenzweig also reported that annual medical costs dropped by about $1,000 for each patient in the intervention group but were nearly $5,000 higher for each patient in the control group, “suggesting that this kind of intervention could potentially involve savings of perhaps $6,000 per year per patient.”

Compared with patients in the control group, he added, those in the intervention group “reported having better monitoring of blood glucose levels. They also had more frequent cholesterol tests done by the physicians, more frequent eye examinations, more frequent screenings for kidney disease, hemoglobin A_1c tests, and foot examinations.”

Dr. Rosenzweig said that he did not know what the administrative costs were to run the intervention component.

The study is expected to appear in the July 2010 issue of the American Journal of Managed Care.

'This kind of intervention could potentially involve savings of perhaps $6,000 per year per patient.'

Source DR. ROSENZWEIG

A report from the American Academy of Pediatrics Task Force on Mental Health offers clinicians a comprehensive blueprint for improving delivery of mental health care services in pediatric settings.

The 135-page document, entitled “Enhancing Pediatric Mental Health Care,” describes “what pediatricians and other primary care physicians can do at the community level, what they can do at the practice level, and how they can integrate the process of providing mental health services into the primary care flow,” Dr. Jane Meschan Foy, chair of the task force, said in an interview.

Four years in the making, the report (Pediatrics 2010;125[suppl. 3]:S1-135) builds on three key documents previously published by the task force: “Strategies for System Change in Children's Mental Health: A Chapter Action Kit” (available at www.aap.org/mentalhealth/mh2ch.html

The new report contains three main chapters followed by eight appendices and six supplemental appendices. Together with the previous reports, it addresses three main goals set by the task force: Facilitate system changes, build skills, and incrementally change practice.

“This is really a tour de force,” said Dr. Martin T. Stein, who was not involved in developing the report. “It's an exceptionally comprehensive, well-written, and practical guideline for including psychological/psychosocial/mental health issues in the practice of primary care pediatrics. There are many practical tools such as thinking about your referral patterns, being aware of what's available in the community, and knowing the insurance sources.”

“There is also a chapter on how to code for billing for mental health services, which is a critical issue in primary care. In addition, there is a practice readiness inventory, algorithms for early recognition of conditions, and good references to support the recommendations for diagnosis and screening in primary care,” Dr. Stein, professor of pediatrics at the University of California, San Diego, said in an interview.

Dr. Foy, professor of pediatrics at Wake Forest University, Winston-Salem, N.C., called the pediatric primary care setting “a really good place to provide mental health services. It's a place where families are comfortable, a place where they have a trusting long-term relationship with a clinician.”

In the report's first chapter, “Strategies for Preparing a Community,” the task force outlines ways to gauge the mental health needs of children and youth in the community, and emphasizes the importance of developing or strengthening relationships with mental health advocates, schools, human service agencies, mental health and substance abuse providers, and developmental specialists.

For example, clinicians “might consider initiating previsit data collection from children in foster care,” the report states. “Sharing the responsibility for previsit data collection with the foster care agency increases the likelihood that adults with knowledge of the child's mental health strengths and needs provide critical information.”

In the second chapter, “Strategies for Preparing a Primary Care Practice,” the task force recommends applying principles of the chronic care model to the care of children and youth with mental health problems. One critical element is a wide variety of partnerships to support and coordinate with primary care services.

“There are many new models of collaborative practice,” Dr. Foy said. “We are excited about those that integrate a mental health professional into the primary care setting.”

Dr. Foy acknowledged that while chronic care model principles have worked well in primary care for medical conditions such as asthma and diabetes, less is known about how these principles will affect the delivery of mental health care to children and youth.

The third chapter, “Algorithms for Primary Care,” grew out of the work of four separate teams convened by the task force, including youth and families who have had mental health problems.

The chapter proposes a clinical process for promoting mental health, identifying mental health symptoms and concerns, engaging the family as early and effectively as possible to address emerging problems, collaborating with mental health specialists when needed, and monitoring the child's progress toward recovery or further care.

For her part, Dr. Foy said she hopes the report sends a message that primary care physicians are well positioned to provide a broad range of mental health care services to patients and their families.

Dr. Foy noted that primary care clinicians who care for children are “in a widely varied state of readiness to follow” the recommendations contained in the report. “Some are just beginning to think about expanding their mental health practice,” she said. “Others have very sophisticated multidisciplinary approaches to mental health practice, and the majority is in between. I do think that most primary care clinicians will be able to find some action steps in the wide variety of recommendations that we have made.”

The report was supported by the AAP, the AAP Friends of Children Fund, and the Substance Abuse and Mental Health Services Administration. Dr. Foy and Dr. Stein said that they had no financial conflicts of interest.

Dr. Jane Meschan Foy (far right) and family nurse practitioner Beth Spangle (far left) talk with patient Garrett Locklear.

Source Courtesy Wake Forest University Baptist Medical Center Photography

A report from the American Academy of Pediatrics Task Force on Mental Health offers clinicians a comprehensive blueprint for improving delivery of mental health care services in pediatric settings.

The 135-page document, entitled “Enhancing Pediatric Mental Health Care,” describes “what pediatricians and other primary care physicians can do at the community level, what they can do at the practice level, and how they can integrate the process of providing mental health services into the primary care flow,” Dr. Jane Meschan Foy, chair of the task force, said in an interview.

Four years in the making, the report (Pediatrics 2010;125[suppl. 3]:S1-135) builds on three key documents previously published by the task force: “Strategies for System Change in Children's Mental Health: A Chapter Action Kit” (available at www.aap.org/mentalhealth/mh2ch.html

The new report contains three main chapters followed by eight appendices and six supplemental appendices. Together with the previous reports, it addresses three main goals set by the task force: Facilitate system changes, build skills, and incrementally change practice.

“This is really a tour de force,” said Dr. Martin T. Stein, who was not involved in developing the report. “It's an exceptionally comprehensive, well-written, and practical guideline for including psychological/psychosocial/mental health issues in the practice of primary care pediatrics. There are many practical tools such as thinking about your referral patterns, being aware of what's available in the community, and knowing the insurance sources.”

“There is also a chapter on how to code for billing for mental health services, which is a critical issue in primary care. In addition, there is a practice readiness inventory, algorithms for early recognition of conditions, and good references to support the recommendations for diagnosis and screening in primary care,” Dr. Stein, professor of pediatrics at the University of California, San Diego, said in an interview.

Dr. Foy, professor of pediatrics at Wake Forest University, Winston-Salem, N.C., called the pediatric primary care setting “a really good place to provide mental health services. It's a place where families are comfortable, a place where they have a trusting long-term relationship with a clinician.”

In the report's first chapter, “Strategies for Preparing a Community,” the task force outlines ways to gauge the mental health needs of children and youth in the community, and emphasizes the importance of developing or strengthening relationships with mental health advocates, schools, human service agencies, mental health and substance abuse providers, and developmental specialists.

For example, clinicians “might consider initiating previsit data collection from children in foster care,” the report states. “Sharing the responsibility for previsit data collection with the foster care agency increases the likelihood that adults with knowledge of the child's mental health strengths and needs provide critical information.”

In the second chapter, “Strategies for Preparing a Primary Care Practice,” the task force recommends applying principles of the chronic care model to the care of children and youth with mental health problems. One critical element is a wide variety of partnerships to support and coordinate with primary care services.

“There are many new models of collaborative practice,” Dr. Foy said. “We are excited about those that integrate a mental health professional into the primary care setting.”

Dr. Foy acknowledged that while chronic care model principles have worked well in primary care for medical conditions such as asthma and diabetes, less is known about how these principles will affect the delivery of mental health care to children and youth.

The third chapter, “Algorithms for Primary Care,” grew out of the work of four separate teams convened by the task force, including youth and families who have had mental health problems.

The chapter proposes a clinical process for promoting mental health, identifying mental health symptoms and concerns, engaging the family as early and effectively as possible to address emerging problems, collaborating with mental health specialists when needed, and monitoring the child's progress toward recovery or further care.

For her part, Dr. Foy said she hopes the report sends a message that primary care physicians are well positioned to provide a broad range of mental health care services to patients and their families.

Dr. Foy noted that primary care clinicians who care for children are “in a widely varied state of readiness to follow” the recommendations contained in the report. “Some are just beginning to think about expanding their mental health practice,” she said. “Others have very sophisticated multidisciplinary approaches to mental health practice, and the majority is in between. I do think that most primary care clinicians will be able to find some action steps in the wide variety of recommendations that we have made.”

The report was supported by the AAP, the AAP Friends of Children Fund, and the Substance Abuse and Mental Health Services Administration. Dr. Foy and Dr. Stein said that they had no financial conflicts of interest.

Dr. Jane Meschan Foy (far right) and family nurse practitioner Beth Spangle (far left) talk with patient Garrett Locklear.

Source Courtesy Wake Forest University Baptist Medical Center Photography

A report from the American Academy of Pediatrics Task Force on Mental Health offers clinicians a comprehensive blueprint for improving delivery of mental health care services in pediatric settings.

The 135-page document, entitled “Enhancing Pediatric Mental Health Care,” describes “what pediatricians and other primary care physicians can do at the community level, what they can do at the practice level, and how they can integrate the process of providing mental health services into the primary care flow,” Dr. Jane Meschan Foy, chair of the task force, said in an interview.

Four years in the making, the report (Pediatrics 2010;125[suppl. 3]:S1-135) builds on three key documents previously published by the task force: “Strategies for System Change in Children's Mental Health: A Chapter Action Kit” (available at www.aap.org/mentalhealth/mh2ch.html

The new report contains three main chapters followed by eight appendices and six supplemental appendices. Together with the previous reports, it addresses three main goals set by the task force: Facilitate system changes, build skills, and incrementally change practice.

“This is really a tour de force,” said Dr. Martin T. Stein, who was not involved in developing the report. “It's an exceptionally comprehensive, well-written, and practical guideline for including psychological/psychosocial/mental health issues in the practice of primary care pediatrics. There are many practical tools such as thinking about your referral patterns, being aware of what's available in the community, and knowing the insurance sources.”

“There is also a chapter on how to code for billing for mental health services, which is a critical issue in primary care. In addition, there is a practice readiness inventory, algorithms for early recognition of conditions, and good references to support the recommendations for diagnosis and screening in primary care,” Dr. Stein, professor of pediatrics at the University of California, San Diego, said in an interview.

Dr. Foy, professor of pediatrics at Wake Forest University, Winston-Salem, N.C., called the pediatric primary care setting “a really good place to provide mental health services. It's a place where families are comfortable, a place where they have a trusting long-term relationship with a clinician.”

In the report's first chapter, “Strategies for Preparing a Community,” the task force outlines ways to gauge the mental health needs of children and youth in the community, and emphasizes the importance of developing or strengthening relationships with mental health advocates, schools, human service agencies, mental health and substance abuse providers, and developmental specialists.

For example, clinicians “might consider initiating previsit data collection from children in foster care,” the report states. “Sharing the responsibility for previsit data collection with the foster care agency increases the likelihood that adults with knowledge of the child's mental health strengths and needs provide critical information.”

In the second chapter, “Strategies for Preparing a Primary Care Practice,” the task force recommends applying principles of the chronic care model to the care of children and youth with mental health problems. One critical element is a wide variety of partnerships to support and coordinate with primary care services.

“There are many new models of collaborative practice,” Dr. Foy said. “We are excited about those that integrate a mental health professional into the primary care setting.”

Dr. Foy acknowledged that while chronic care model principles have worked well in primary care for medical conditions such as asthma and diabetes, less is known about how these principles will affect the delivery of mental health care to children and youth.

The third chapter, “Algorithms for Primary Care,” grew out of the work of four separate teams convened by the task force, including youth and families who have had mental health problems.

The chapter proposes a clinical process for promoting mental health, identifying mental health symptoms and concerns, engaging the family as early and effectively as possible to address emerging problems, collaborating with mental health specialists when needed, and monitoring the child's progress toward recovery or further care.

For her part, Dr. Foy said she hopes the report sends a message that primary care physicians are well positioned to provide a broad range of mental health care services to patients and their families.

Dr. Foy noted that primary care clinicians who care for children are “in a widely varied state of readiness to follow” the recommendations contained in the report. “Some are just beginning to think about expanding their mental health practice,” she said. “Others have very sophisticated multidisciplinary approaches to mental health practice, and the majority is in between. I do think that most primary care clinicians will be able to find some action steps in the wide variety of recommendations that we have made.”

The report was supported by the AAP, the AAP Friends of Children Fund, and the Substance Abuse and Mental Health Services Administration. Dr. Foy and Dr. Stein said that they had no financial conflicts of interest.

Dr. Jane Meschan Foy (far right) and family nurse practitioner Beth Spangle (far left) talk with patient Garrett Locklear.

Source Courtesy Wake Forest University Baptist Medical Center Photography

Major Finding: Women who had menopause before the age of 46 were 2.1 times more likely to have a cardiovascular disease event later in life, compared with those who did not have early menopause.

Data Source: A cohort analysis of 2,509 women in MESA followed for an average of 7 years.

Disclosures: The study was funded by the National Heart, Lung, and Blood Institute.

SAN DIEGO — Women who go through menopause before the age of 46 are twice as likely to have a heart attack, stroke, or other cardiovascular event later in life as are women who do not go through early menopause, results from a large, multiethnic study showed.

“Our study is observational, so we cannot conclude that early menopause somehow causes these cardiovascular disease events, but our findings support using early menopause as a marker of increased cardiovascular disease risk,” Dr. Melissa F. Wellons said during a press briefing at the meeting. “Therefore, getting clinicians to ask women about menopause and about when they went through menopause is an important part of potentially determining what their risk of CVD is in the future. Doing that can give them information on placing these women with early menopause into a higher risk group and counseling them appropriately, such as encouraging them to stop smoking, exercise, and lose weight.”

Dr. Wellons, a fellow in the department of medicine at the University of Alabama, Birmingham, and her associates evaluated data from 2,509 women enrolled in the observational Multi-Ethnic Study of Atherosclerosis (MESA), funded by the National Institutes of Health. It included more than 6,000 women, from six communities in the United States, who were recruited in 2000 and followed for an average of 7 years. Most (40%) were white, 25% were black, 22% were Hispanic, and 13% were Chinese American.

“Our work is important because previous studies that have found a relationship between early menopause and cardiovascular disease events have taken place in primarily European and white cohorts,” Dr. Wellons noted.

The researchers defined early menopause as occurring before age 46, either naturally or surgically through removal of both ovaries, and they tracked the incidence of CVD among all study participants. This included heart attack, nonfatal cardiac arrest, a definite angina, probable angina (if followed by revascularization), a stroke, or death due to stroke, heart attack, or other cardiovascular disease.

At baseline, the women ranged in age from 45 to 84 years. Of the 2,509 women, 693 (28%) reported early menopause. Of these, 446 (64%) had natural menopause and 247 (36%) had surgical menopause.

In the early menopause group, 41 women (5.9%) had CVD events during the study period. Among those who did not have early menopause, 47 women (2.6%), had CVD events. The difference was statistically significant.

No woman in either group had a CVD event before the age of 55.

After adjusting for race/ethnicity, level of education, smoking history, hypertension, total cholesterol, HDL cholesterol, diabetes, and whether the menopause was natural or surgical, Dr. Wellons and her associates found that women in the early menopause group were 2.1 times more likely to experience a CVD event, compared with women who did not have early menopause. Further adjustment for current or previous use of hormone replacement therapy and body mass index produced identical results.

“The risk of having a heart attack, stroke, or other cardiovascular disease event later in life doubles in women with early menopause,” Dr. Wellons concluded. “We found [this] in a large, U.S., multiethnic cohort, so our findings are generalizable to the U.S. population.”

Dr. Wellons was the recipient of an NHLBI Career Development Award.

'Our findings support using early menopause as a marker of increased cardiovascular disease risk.'

Source DR. WELLONS

Major Finding: Women who had menopause before the age of 46 were 2.1 times more likely to have a cardiovascular disease event later in life, compared with those who did not have early menopause.

Data Source: A cohort analysis of 2,509 women in MESA followed for an average of 7 years.

Disclosures: The study was funded by the National Heart, Lung, and Blood Institute.

SAN DIEGO — Women who go through menopause before the age of 46 are twice as likely to have a heart attack, stroke, or other cardiovascular event later in life as are women who do not go through early menopause, results from a large, multiethnic study showed.

“Our study is observational, so we cannot conclude that early menopause somehow causes these cardiovascular disease events, but our findings support using early menopause as a marker of increased cardiovascular disease risk,” Dr. Melissa F. Wellons said during a press briefing at the meeting. “Therefore, getting clinicians to ask women about menopause and about when they went through menopause is an important part of potentially determining what their risk of CVD is in the future. Doing that can give them information on placing these women with early menopause into a higher risk group and counseling them appropriately, such as encouraging them to stop smoking, exercise, and lose weight.”

Dr. Wellons, a fellow in the department of medicine at the University of Alabama, Birmingham, and her associates evaluated data from 2,509 women enrolled in the observational Multi-Ethnic Study of Atherosclerosis (MESA), funded by the National Institutes of Health. It included more than 6,000 women, from six communities in the United States, who were recruited in 2000 and followed for an average of 7 years. Most (40%) were white, 25% were black, 22% were Hispanic, and 13% were Chinese American.

“Our work is important because previous studies that have found a relationship between early menopause and cardiovascular disease events have taken place in primarily European and white cohorts,” Dr. Wellons noted.

The researchers defined early menopause as occurring before age 46, either naturally or surgically through removal of both ovaries, and they tracked the incidence of CVD among all study participants. This included heart attack, nonfatal cardiac arrest, a definite angina, probable angina (if followed by revascularization), a stroke, or death due to stroke, heart attack, or other cardiovascular disease.

At baseline, the women ranged in age from 45 to 84 years. Of the 2,509 women, 693 (28%) reported early menopause. Of these, 446 (64%) had natural menopause and 247 (36%) had surgical menopause.

In the early menopause group, 41 women (5.9%) had CVD events during the study period. Among those who did not have early menopause, 47 women (2.6%), had CVD events. The difference was statistically significant.

No woman in either group had a CVD event before the age of 55.

After adjusting for race/ethnicity, level of education, smoking history, hypertension, total cholesterol, HDL cholesterol, diabetes, and whether the menopause was natural or surgical, Dr. Wellons and her associates found that women in the early menopause group were 2.1 times more likely to experience a CVD event, compared with women who did not have early menopause. Further adjustment for current or previous use of hormone replacement therapy and body mass index produced identical results.

“The risk of having a heart attack, stroke, or other cardiovascular disease event later in life doubles in women with early menopause,” Dr. Wellons concluded. “We found [this] in a large, U.S., multiethnic cohort, so our findings are generalizable to the U.S. population.”

Dr. Wellons was the recipient of an NHLBI Career Development Award.

'Our findings support using early menopause as a marker of increased cardiovascular disease risk.'

Source DR. WELLONS

Major Finding: Women who had menopause before the age of 46 were 2.1 times more likely to have a cardiovascular disease event later in life, compared with those who did not have early menopause.

Data Source: A cohort analysis of 2,509 women in MESA followed for an average of 7 years.

Disclosures: The study was funded by the National Heart, Lung, and Blood Institute.

SAN DIEGO — Women who go through menopause before the age of 46 are twice as likely to have a heart attack, stroke, or other cardiovascular event later in life as are women who do not go through early menopause, results from a large, multiethnic study showed.

“Our study is observational, so we cannot conclude that early menopause somehow causes these cardiovascular disease events, but our findings support using early menopause as a marker of increased cardiovascular disease risk,” Dr. Melissa F. Wellons said during a press briefing at the meeting. “Therefore, getting clinicians to ask women about menopause and about when they went through menopause is an important part of potentially determining what their risk of CVD is in the future. Doing that can give them information on placing these women with early menopause into a higher risk group and counseling them appropriately, such as encouraging them to stop smoking, exercise, and lose weight.”

Dr. Wellons, a fellow in the department of medicine at the University of Alabama, Birmingham, and her associates evaluated data from 2,509 women enrolled in the observational Multi-Ethnic Study of Atherosclerosis (MESA), funded by the National Institutes of Health. It included more than 6,000 women, from six communities in the United States, who were recruited in 2000 and followed for an average of 7 years. Most (40%) were white, 25% were black, 22% were Hispanic, and 13% were Chinese American.

“Our work is important because previous studies that have found a relationship between early menopause and cardiovascular disease events have taken place in primarily European and white cohorts,” Dr. Wellons noted.

The researchers defined early menopause as occurring before age 46, either naturally or surgically through removal of both ovaries, and they tracked the incidence of CVD among all study participants. This included heart attack, nonfatal cardiac arrest, a definite angina, probable angina (if followed by revascularization), a stroke, or death due to stroke, heart attack, or other cardiovascular disease.

At baseline, the women ranged in age from 45 to 84 years. Of the 2,509 women, 693 (28%) reported early menopause. Of these, 446 (64%) had natural menopause and 247 (36%) had surgical menopause.

In the early menopause group, 41 women (5.9%) had CVD events during the study period. Among those who did not have early menopause, 47 women (2.6%), had CVD events. The difference was statistically significant.

No woman in either group had a CVD event before the age of 55.

After adjusting for race/ethnicity, level of education, smoking history, hypertension, total cholesterol, HDL cholesterol, diabetes, and whether the menopause was natural or surgical, Dr. Wellons and her associates found that women in the early menopause group were 2.1 times more likely to experience a CVD event, compared with women who did not have early menopause. Further adjustment for current or previous use of hormone replacement therapy and body mass index produced identical results.

“The risk of having a heart attack, stroke, or other cardiovascular disease event later in life doubles in women with early menopause,” Dr. Wellons concluded. “We found [this] in a large, U.S., multiethnic cohort, so our findings are generalizable to the U.S. population.”

Dr. Wellons was the recipient of an NHLBI Career Development Award.

'Our findings support using early menopause as a marker of increased cardiovascular disease risk.'

Source DR. WELLONS

SAN DIEGO — The scale that weighs risks and benefits tips more favorably for newly menopausal women who begin hormone therapy at age 50-59 years and who use it for 5 years, compared with women who start the therapy in their 60s, according to a systematic review of several studies and position statements.

Younger women who are newly menopausal and who use hormone therapy have a 30%-40% reduction in total mortality, a phenomenon “that's not seen in older women,” said Dr. Richard J. Santen, professor of medicine at the University of Virginia, Charlottesville, who called the findings “very surprising.”

“Physicians and their patients need to rethink the use of menopausal hormonal therapy” on the basis of these findings, said Dr. Santen, who chaired the 12-member task force that wrote a scientific statement on behalf of the Endocrine Society suggesting that menopausal hormone therapy may benefit women who start it in their 50s rather than in their 60s.

Importantly, the new analysis points to the need to look beyond data from the Women's Health Initiative, in which the average age was 63 years, in order to advise younger women. “The therapy clearly needs to be individualized, primarily based on symptoms. But if a woman has an underlying risk of breast cancer … you're going to be very cautious about this,” Dr. Santen said.

He said that the new analysis is more applicable to the typical menopausal patient whom physicians see in practice: the 53-year-old who had her last period a year ago, and is now trying to make a decision about whether to start menopausal hormonal therapy.

Dr. Santen and his associates used the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system to evaluate the benefits and risks associated with menopausal hormone therapy based on published randomized controlled trials, cohort studies, and case-control studies, as well as position statements related to the topic.

Overall, the researchers found that women who start menopausal hormone therapy at age 50-59 years experienced a 30%-40% decrease in mortality, no increased risk of heart disease, and a 90% reduction of menopausal symptom such as hot flashes or overactive bladder.

“Relief of symptoms is really the key issue,” Dr. Santen said.

Compared with women who did not take hormone therapy, newly menopausal women experienced 10 fewer diagnoses of diabetes per 1,000 women, 4 fewer cases of heart disease (among those on estrogen only), 5 fewer bone fractures, and 2 fewer cases of colon cancer per 1,000 women (among those on estrogen plus progestin only).

Risks associated with menopausal hormone therapy included gallbladder disease (10 more per 1,000 women), blood clots in the legs and lungs (5 more women), and stroke (2 more women).

Women who were on estrogen therapy alone had no increased risk of developing breast cancer, but there were 7 more cases of breast cancer per 1,000 women among those who took estrogen and progestin for 5 years, compared with non-HT users.

“Our tentative conclusion is that estrogen plus progesterone actually didn't cause tumors; it caused preexisting tumors to grow to a size where they became detectable,” Dr. Santen said.

The statement is published in the July 2010 issue of the Journal of Clinical Endocrinology and Metabolism.

Disclosures: Dr. Santen reported having no conflicts of interest.

My Take

Statement Shores Up NAMS Advice

This has been a banner season for statements regarding postmenopausal hormone therapy (HT). Recently, the North American Menopause Society (NAMS) and the Endocrine Society (ES) issued complementary statements; five senior authors contributed to both documents.

Philosophically, the two societies agree on the fundamentals. While NAMS limits their discussion to estrogen and estrogen combined with progestogen therapy, the ES touches on the use of alternative forms of HT such as tibolone and raloxifene, as well as bioidentical forms of HT, such as testosterone and dehydroepiandrosterone. The NAMS statement, at 14 pages, presents concise, bottom-line risk/benefit assessment and practical clinical recommendations. The ES scientific statement, at 66 pages, presents a tour de force analysis of the literature, carefully weighed according to level of evidence.

The 12 pages dedicated to breast cancer in the ES document clearly illustrate why the relationship between HT and the breast is so complex, and why generalizations regarding risks are so challenging.

Both groups acknowledge the important influences of age and time since menopause on benefits and risks of HT. Both agree that more research is necessary to accurately assess benefits and risks in recently menopausal women most likely to request HT. And both conclude with the familiar mantra to individualize therapy, and use the lowest effective dose for symptom relief for the shortest duration possible.

CYNTHIA A. STUENKEL, M.D., is clinical professor of medicine at the University of California, San Diego School of Medicine and an attending physician for the University's Endocrinology and Metabolism Service. She also is president of NAMS.

Vitals

SAN DIEGO — The scale that weighs risks and benefits tips more favorably for newly menopausal women who begin hormone therapy at age 50-59 years and who use it for 5 years, compared with women who start the therapy in their 60s, according to a systematic review of several studies and position statements.

Younger women who are newly menopausal and who use hormone therapy have a 30%-40% reduction in total mortality, a phenomenon “that's not seen in older women,” said Dr. Richard J. Santen, professor of medicine at the University of Virginia, Charlottesville, who called the findings “very surprising.”

“Physicians and their patients need to rethink the use of menopausal hormonal therapy” on the basis of these findings, said Dr. Santen, who chaired the 12-member task force that wrote a scientific statement on behalf of the Endocrine Society suggesting that menopausal hormone therapy may benefit women who start it in their 50s rather than in their 60s.

Importantly, the new analysis points to the need to look beyond data from the Women's Health Initiative, in which the average age was 63 years, in order to advise younger women. “The therapy clearly needs to be individualized, primarily based on symptoms. But if a woman has an underlying risk of breast cancer … you're going to be very cautious about this,” Dr. Santen said.

He said that the new analysis is more applicable to the typical menopausal patient whom physicians see in practice: the 53-year-old who had her last period a year ago, and is now trying to make a decision about whether to start menopausal hormonal therapy.

Dr. Santen and his associates used the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system to evaluate the benefits and risks associated with menopausal hormone therapy based on published randomized controlled trials, cohort studies, and case-control studies, as well as position statements related to the topic.

Overall, the researchers found that women who start menopausal hormone therapy at age 50-59 years experienced a 30%-40% decrease in mortality, no increased risk of heart disease, and a 90% reduction of menopausal symptom such as hot flashes or overactive bladder.

“Relief of symptoms is really the key issue,” Dr. Santen said.

Compared with women who did not take hormone therapy, newly menopausal women experienced 10 fewer diagnoses of diabetes per 1,000 women, 4 fewer cases of heart disease (among those on estrogen only), 5 fewer bone fractures, and 2 fewer cases of colon cancer per 1,000 women (among those on estrogen plus progestin only).

Risks associated with menopausal hormone therapy included gallbladder disease (10 more per 1,000 women), blood clots in the legs and lungs (5 more women), and stroke (2 more women).

Women who were on estrogen therapy alone had no increased risk of developing breast cancer, but there were 7 more cases of breast cancer per 1,000 women among those who took estrogen and progestin for 5 years, compared with non-HT users.

“Our tentative conclusion is that estrogen plus progesterone actually didn't cause tumors; it caused preexisting tumors to grow to a size where they became detectable,” Dr. Santen said.

The statement is published in the July 2010 issue of the Journal of Clinical Endocrinology and Metabolism.

Disclosures: Dr. Santen reported having no conflicts of interest.

My Take

Statement Shores Up NAMS Advice

This has been a banner season for statements regarding postmenopausal hormone therapy (HT). Recently, the North American Menopause Society (NAMS) and the Endocrine Society (ES) issued complementary statements; five senior authors contributed to both documents.

Philosophically, the two societies agree on the fundamentals. While NAMS limits their discussion to estrogen and estrogen combined with progestogen therapy, the ES touches on the use of alternative forms of HT such as tibolone and raloxifene, as well as bioidentical forms of HT, such as testosterone and dehydroepiandrosterone. The NAMS statement, at 14 pages, presents concise, bottom-line risk/benefit assessment and practical clinical recommendations. The ES scientific statement, at 66 pages, presents a tour de force analysis of the literature, carefully weighed according to level of evidence.

The 12 pages dedicated to breast cancer in the ES document clearly illustrate why the relationship between HT and the breast is so complex, and why generalizations regarding risks are so challenging.

Both groups acknowledge the important influences of age and time since menopause on benefits and risks of HT. Both agree that more research is necessary to accurately assess benefits and risks in recently menopausal women most likely to request HT. And both conclude with the familiar mantra to individualize therapy, and use the lowest effective dose for symptom relief for the shortest duration possible.

CYNTHIA A. STUENKEL, M.D., is clinical professor of medicine at the University of California, San Diego School of Medicine and an attending physician for the University's Endocrinology and Metabolism Service. She also is president of NAMS.

Vitals

SAN DIEGO — The scale that weighs risks and benefits tips more favorably for newly menopausal women who begin hormone therapy at age 50-59 years and who use it for 5 years, compared with women who start the therapy in their 60s, according to a systematic review of several studies and position statements.

Younger women who are newly menopausal and who use hormone therapy have a 30%-40% reduction in total mortality, a phenomenon “that's not seen in older women,” said Dr. Richard J. Santen, professor of medicine at the University of Virginia, Charlottesville, who called the findings “very surprising.”

“Physicians and their patients need to rethink the use of menopausal hormonal therapy” on the basis of these findings, said Dr. Santen, who chaired the 12-member task force that wrote a scientific statement on behalf of the Endocrine Society suggesting that menopausal hormone therapy may benefit women who start it in their 50s rather than in their 60s.

Importantly, the new analysis points to the need to look beyond data from the Women's Health Initiative, in which the average age was 63 years, in order to advise younger women. “The therapy clearly needs to be individualized, primarily based on symptoms. But if a woman has an underlying risk of breast cancer … you're going to be very cautious about this,” Dr. Santen said.

He said that the new analysis is more applicable to the typical menopausal patient whom physicians see in practice: the 53-year-old who had her last period a year ago, and is now trying to make a decision about whether to start menopausal hormonal therapy.

Dr. Santen and his associates used the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system to evaluate the benefits and risks associated with menopausal hormone therapy based on published randomized controlled trials, cohort studies, and case-control studies, as well as position statements related to the topic.

Overall, the researchers found that women who start menopausal hormone therapy at age 50-59 years experienced a 30%-40% decrease in mortality, no increased risk of heart disease, and a 90% reduction of menopausal symptom such as hot flashes or overactive bladder.

“Relief of symptoms is really the key issue,” Dr. Santen said.

Compared with women who did not take hormone therapy, newly menopausal women experienced 10 fewer diagnoses of diabetes per 1,000 women, 4 fewer cases of heart disease (among those on estrogen only), 5 fewer bone fractures, and 2 fewer cases of colon cancer per 1,000 women (among those on estrogen plus progestin only).

Risks associated with menopausal hormone therapy included gallbladder disease (10 more per 1,000 women), blood clots in the legs and lungs (5 more women), and stroke (2 more women).

Women who were on estrogen therapy alone had no increased risk of developing breast cancer, but there were 7 more cases of breast cancer per 1,000 women among those who took estrogen and progestin for 5 years, compared with non-HT users.

“Our tentative conclusion is that estrogen plus progesterone actually didn't cause tumors; it caused preexisting tumors to grow to a size where they became detectable,” Dr. Santen said.

The statement is published in the July 2010 issue of the Journal of Clinical Endocrinology and Metabolism.

Disclosures: Dr. Santen reported having no conflicts of interest.

My Take

Statement Shores Up NAMS Advice

This has been a banner season for statements regarding postmenopausal hormone therapy (HT). Recently, the North American Menopause Society (NAMS) and the Endocrine Society (ES) issued complementary statements; five senior authors contributed to both documents.

Philosophically, the two societies agree on the fundamentals. While NAMS limits their discussion to estrogen and estrogen combined with progestogen therapy, the ES touches on the use of alternative forms of HT such as tibolone and raloxifene, as well as bioidentical forms of HT, such as testosterone and dehydroepiandrosterone. The NAMS statement, at 14 pages, presents concise, bottom-line risk/benefit assessment and practical clinical recommendations. The ES scientific statement, at 66 pages, presents a tour de force analysis of the literature, carefully weighed according to level of evidence.

The 12 pages dedicated to breast cancer in the ES document clearly illustrate why the relationship between HT and the breast is so complex, and why generalizations regarding risks are so challenging.

Both groups acknowledge the important influences of age and time since menopause on benefits and risks of HT. Both agree that more research is necessary to accurately assess benefits and risks in recently menopausal women most likely to request HT. And both conclude with the familiar mantra to individualize therapy, and use the lowest effective dose for symptom relief for the shortest duration possible.

CYNTHIA A. STUENKEL, M.D., is clinical professor of medicine at the University of California, San Diego School of Medicine and an attending physician for the University's Endocrinology and Metabolism Service. She also is president of NAMS.

Vitals

Major Finding: Nearly one-third of patients with diabetes who live in a hot climate (29%) did not initiate personal protective measures for self-management of their disease until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

Data Source: A survey of 152 adult patients with diabetes at the Mayo Clinic, Scottsdale, Ariz.

Disclosures: Dr. Nassar said that she had no conflicts to disclose.

SAN DIEGO — Many adults with diabetes who live in a hot climate don't understand how hot weather affects their disease self-management, results from a survey of 152 patients demonstrated.

For example, 29% of respondents did not initiate personal protective measures until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

“This was quite concerning, because they wouldn't have the means to check their blood sugars if they began to feel faint if they got behind the wheel to start driving; or if they needed to seek medical attention, they wouldn't have the means to know if they should,” Dr. Adrienne Nassar said during a press briefing.

Previous studies have shown that people with diabetes have higher rates of emergency room visits, hospitalizations, and deaths caused by heat illness during hot weather than during more temperate weather, but few published studies have assessed how patients manage their disease during extremely hot temperatures, said Dr. Nassar, a third-year resident in the department of internal medicine at Mayo Clinic, Scottsdale, Ariz.

“Furthermore, the number of diabetes cases is increasing in the Southwestern United States,” she said. “From a physiologic standpoint, the primary way in which we cool ourselves is through sweating, and diabetes patients may have an impaired ability to do so.”

In collaboration with the National Weather Service and the National Oceanic and Atmospheric Administration, Dr. Nassar and her associates surveyed 152 adults who attended the diabetes clinic at Mayo between Nov. 30, 2009, and Dec. 31, 2009, to assess the types of personal protective measures they take against the heat, as well as their knowledge of safe temperatures and exposure times.

The mean age of respondents was 64 years, 51% were female, 58% were non-Hispanic white, 83% had type 2 diabetes, and 77% used insulin.

More than half of the patients (60%) reported staying indoors to protect themselves against the heat, 56% drank fluids frequently, 45% applied sunscreen, and 45% wore protective clothing. However, 23% reported drinking only when they became thirsty, suggesting that they “were starting to get behind on their fluid status,” Dr. Nassar said.

Nearly three-quarters of patients (71%) reported spending less than 1 hour in the heat, but 29% did not initiate personal protective measures until temperatures reached 101°F. “Heat-related illness can take place at 80°-90° when you factor in the heat index,” Dr. Nassar noted.

While 73% of patients said they had received information about the harmful effects of heat on insulin, fewer indicated that they had received information about extreme heat on glucose meters (41%), oral medications (39%), and glucose testing strips (38%), and 20% “did not know when to begin [taking precautions], although this information is included in the product information inserts [contained in packaging for] medications and glucose meters,” she said.

In addition, 37% of patients left their diabetes medications and supplies at home during hot days, rather than risk them to heat exposure.

Patients reported television as their primary source for weather information (89%), followed by radio, the Internet, and newspapers.

“Overall, we found that many patients expose themselves to high temperatures before initiating protective measures,” Dr. Nassar concluded. “We would like to repeat our survey in other populations, for example, outdoor laborers [who may employ unique protective strategies], adolescents, younger adults, and different socioeconomic groups.”

The study is expected to appear in the September 2010 issue of the Journal of Diabetes Science and Technology.

On hot days, 37% of patients left their diabetes drugs and supplies at home.

Source ©Dana Heinemann/Fotolia.com

Major Finding: Nearly one-third of patients with diabetes who live in a hot climate (29%) did not initiate personal protective measures for self-management of their disease until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

Data Source: A survey of 152 adult patients with diabetes at the Mayo Clinic, Scottsdale, Ariz.

Disclosures: Dr. Nassar said that she had no conflicts to disclose.

SAN DIEGO — Many adults with diabetes who live in a hot climate don't understand how hot weather affects their disease self-management, results from a survey of 152 patients demonstrated.

For example, 29% of respondents did not initiate personal protective measures until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

“This was quite concerning, because they wouldn't have the means to check their blood sugars if they began to feel faint if they got behind the wheel to start driving; or if they needed to seek medical attention, they wouldn't have the means to know if they should,” Dr. Adrienne Nassar said during a press briefing.

Previous studies have shown that people with diabetes have higher rates of emergency room visits, hospitalizations, and deaths caused by heat illness during hot weather than during more temperate weather, but few published studies have assessed how patients manage their disease during extremely hot temperatures, said Dr. Nassar, a third-year resident in the department of internal medicine at Mayo Clinic, Scottsdale, Ariz.

“Furthermore, the number of diabetes cases is increasing in the Southwestern United States,” she said. “From a physiologic standpoint, the primary way in which we cool ourselves is through sweating, and diabetes patients may have an impaired ability to do so.”

In collaboration with the National Weather Service and the National Oceanic and Atmospheric Administration, Dr. Nassar and her associates surveyed 152 adults who attended the diabetes clinic at Mayo between Nov. 30, 2009, and Dec. 31, 2009, to assess the types of personal protective measures they take against the heat, as well as their knowledge of safe temperatures and exposure times.

The mean age of respondents was 64 years, 51% were female, 58% were non-Hispanic white, 83% had type 2 diabetes, and 77% used insulin.

More than half of the patients (60%) reported staying indoors to protect themselves against the heat, 56% drank fluids frequently, 45% applied sunscreen, and 45% wore protective clothing. However, 23% reported drinking only when they became thirsty, suggesting that they “were starting to get behind on their fluid status,” Dr. Nassar said.

Nearly three-quarters of patients (71%) reported spending less than 1 hour in the heat, but 29% did not initiate personal protective measures until temperatures reached 101°F. “Heat-related illness can take place at 80°-90° when you factor in the heat index,” Dr. Nassar noted.

While 73% of patients said they had received information about the harmful effects of heat on insulin, fewer indicated that they had received information about extreme heat on glucose meters (41%), oral medications (39%), and glucose testing strips (38%), and 20% “did not know when to begin [taking precautions], although this information is included in the product information inserts [contained in packaging for] medications and glucose meters,” she said.

In addition, 37% of patients left their diabetes medications and supplies at home during hot days, rather than risk them to heat exposure.

Patients reported television as their primary source for weather information (89%), followed by radio, the Internet, and newspapers.

“Overall, we found that many patients expose themselves to high temperatures before initiating protective measures,” Dr. Nassar concluded. “We would like to repeat our survey in other populations, for example, outdoor laborers [who may employ unique protective strategies], adolescents, younger adults, and different socioeconomic groups.”

The study is expected to appear in the September 2010 issue of the Journal of Diabetes Science and Technology.

On hot days, 37% of patients left their diabetes drugs and supplies at home.

Source ©Dana Heinemann/Fotolia.com

Major Finding: Nearly one-third of patients with diabetes who live in a hot climate (29%) did not initiate personal protective measures for self-management of their disease until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

Data Source: A survey of 152 adult patients with diabetes at the Mayo Clinic, Scottsdale, Ariz.

Disclosures: Dr. Nassar said that she had no conflicts to disclose.

SAN DIEGO — Many adults with diabetes who live in a hot climate don't understand how hot weather affects their disease self-management, results from a survey of 152 patients demonstrated.

For example, 29% of respondents did not initiate personal protective measures until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

“This was quite concerning, because they wouldn't have the means to check their blood sugars if they began to feel faint if they got behind the wheel to start driving; or if they needed to seek medical attention, they wouldn't have the means to know if they should,” Dr. Adrienne Nassar said during a press briefing.

Previous studies have shown that people with diabetes have higher rates of emergency room visits, hospitalizations, and deaths caused by heat illness during hot weather than during more temperate weather, but few published studies have assessed how patients manage their disease during extremely hot temperatures, said Dr. Nassar, a third-year resident in the department of internal medicine at Mayo Clinic, Scottsdale, Ariz.

“Furthermore, the number of diabetes cases is increasing in the Southwestern United States,” she said. “From a physiologic standpoint, the primary way in which we cool ourselves is through sweating, and diabetes patients may have an impaired ability to do so.”

In collaboration with the National Weather Service and the National Oceanic and Atmospheric Administration, Dr. Nassar and her associates surveyed 152 adults who attended the diabetes clinic at Mayo between Nov. 30, 2009, and Dec. 31, 2009, to assess the types of personal protective measures they take against the heat, as well as their knowledge of safe temperatures and exposure times.

The mean age of respondents was 64 years, 51% were female, 58% were non-Hispanic white, 83% had type 2 diabetes, and 77% used insulin.

More than half of the patients (60%) reported staying indoors to protect themselves against the heat, 56% drank fluids frequently, 45% applied sunscreen, and 45% wore protective clothing. However, 23% reported drinking only when they became thirsty, suggesting that they “were starting to get behind on their fluid status,” Dr. Nassar said.

Nearly three-quarters of patients (71%) reported spending less than 1 hour in the heat, but 29% did not initiate personal protective measures until temperatures reached 101°F. “Heat-related illness can take place at 80°-90° when you factor in the heat index,” Dr. Nassar noted.

While 73% of patients said they had received information about the harmful effects of heat on insulin, fewer indicated that they had received information about extreme heat on glucose meters (41%), oral medications (39%), and glucose testing strips (38%), and 20% “did not know when to begin [taking precautions], although this information is included in the product information inserts [contained in packaging for] medications and glucose meters,” she said.

In addition, 37% of patients left their diabetes medications and supplies at home during hot days, rather than risk them to heat exposure.

Patients reported television as their primary source for weather information (89%), followed by radio, the Internet, and newspapers.

“Overall, we found that many patients expose themselves to high temperatures before initiating protective measures,” Dr. Nassar concluded. “We would like to repeat our survey in other populations, for example, outdoor laborers [who may employ unique protective strategies], adolescents, younger adults, and different socioeconomic groups.”

The study is expected to appear in the September 2010 issue of the Journal of Diabetes Science and Technology.

On hot days, 37% of patients left their diabetes drugs and supplies at home.

Source ©Dana Heinemann/Fotolia.com