Miriam E. Tucker

ATLANTA — Women with diabetes in the United States frequently are not receiving recommended and needed preventive services.

Women with diabetes who are at the extremes of the life cycle, are poor, and are poorly educated appear to be at the greatest risk for not receiving either diabetes-specific or general preventive care services, according to the findings of a report from the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention.

Data on women aged 18 and older with and without diabetes were obtained from three large nationally representative databases: The Medical Expenditure Panel Survey, 2004; the National Health and Nutrition Examination Survey, 1999-2004; and the National Health Interview Survey, 2005. The report is one of the few such documents to examine any women's health issue by age across the lifespan, Michelle D. Owens-Gary, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

Although the data are a few years old, they still represent the current situation, coauthor Dr. Gloria L.A. Beckles said in an interview.

“The notion that this is any different in 2009 than in 2004 is a myth. Things change very slowly in chronic disease delivery of care, which depends on the organization of systems. It's not just going to change overnight,” said Dr. Beckles, an epidemiologist, who works with Dr. Owens-Gary, a behavioral psychologist, at the CDC's Division of Diabetes Translation, Atlanta.

Overall, 92% of 1,276 women with diabetes surveyed in 2004 reported having received a hemoglobin A_1c measurement in the past year. However, there was a gradient with age, with older women having the greatest likelihood of an HbA_1c test and the youngest having the lowest. The proportions for those aged 18-44 years, 45-64, and 65 and older were 84%, 91%, and 96%, respectively. The youngest adult women “could be a vulnerable population we need to pay more attention to,” Dr. Owens-Gary noted.

Compared with HbA_1c testing, the proportions of diabetic women receiving recommended annual retinal eye exams and foot exams were far lower. In all, 67% of 1,595 respondents reported having had a retinal exam in the past year. By age group, the proportions were 47%, 66%, and 75%, respectively, for those aged 18-44, 45-64, and 65-plus. Foot exams were somewhat more frequent, with 70% of 1,556 total reporting having received one in the past year, and 61%, 74%, and 69%, respectively, from the youngest group to the oldest.

Receipt of all three diabetes-specific preventive care services was less than 50% for all age groups: 45% of a total 1,430 respondents, and just 30% of the 18- to 44-year-old group, 49% of the 45-64 group and 47% of those aged 65 years and older. There were no significant ethnic differences in receipt of the three recommended services. In women of all ethnic origins, the percentage receiving all three recommended preventive care services was low, ranging from 41% (Hispanic, all races) to 51% (non-Hispanic, African American).

By family income, the women who were poor or near-poor were less likely than were those with diabetes from households with high income to have received all three services, ranging from 38% for the lowest quartile to 57% for the highest, she said.

For Pap tests and mammograms, there were no significant differences across the life stages for women with and without diabetes: 71% of 1,336 with diabetes and 79% of 14,967 without reported having a Pap smear within the past 3 years. Among women over 40, 66.5% of 6,829 with diabetes and 66.8% of 8,887 without reported having a mammogram in the past 2 years. There was no significant difference for receipt of Pap test or mammogram by race/ethnic group.

The proportion of women over 50 who had ever received a colonoscopy, sigmoidoscopy, or proctoscopy did not differ between 1,031 with diabetes (48.5%) and 6,041 without (48.4%). However, younger women were less likely to receive them than were older women, and Hispanic women with diabetes were less likely than were white or African American women with diabetes to be screened for colon cancer. Women with less than a high school education and those with the lowest family incomes also were less likely to receive Pap smears, mammograms, or colonoscopies, she reported.

Women with diabetes were more likely than were those without to have received an influenza vaccination in the past 12 months (50% vs. 22%). However, the rate is still low considering that all persons with diabetes are recommended to receive annual flu shots. And younger women with diabetes were far less likely than were those older to be immunized, with just 33% of those aged 18-44 receiving the shot, compared with 43% of those aged 45-64 and 65% of those aged 65 and above. Hispanic women with diabetes had the lowest rate of all racial/ethnic groups, at 39%, compared with 55% of whites. And again there was a gradient by family income, ranging from 42% for the lowest quartile to 55% for the highest.

“This study demonstrates that women in the reproductive years are a vulnerable population for receipt of low levels of preventive care services. We tend to focus on race and ethnicity when we talk about disparities. This study showed that we found very little difference across racial/ethnic groups. However, we see that being young, poor, or near poor, and having low educational levels, places women with diabetes at risk for suboptimal care in various areas,” Dr. Owens-Gary said.

Health care providers “should consider the vulnerable populations identified when providing outreach and in designing, monitoring, and evaluating the impact of programs,” she concluded.

The report, entitled Women With Diabetes: Quality of Health Care, 2004-2005, is available online at http://tinyurl.com/QualityofCareReport

ATLANTA — Women with diabetes in the United States frequently are not receiving recommended and needed preventive services.

Women with diabetes who are at the extremes of the life cycle, are poor, and are poorly educated appear to be at the greatest risk for not receiving either diabetes-specific or general preventive care services, according to the findings of a report from the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention.

Data on women aged 18 and older with and without diabetes were obtained from three large nationally representative databases: The Medical Expenditure Panel Survey, 2004; the National Health and Nutrition Examination Survey, 1999-2004; and the National Health Interview Survey, 2005. The report is one of the few such documents to examine any women's health issue by age across the lifespan, Michelle D. Owens-Gary, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

Although the data are a few years old, they still represent the current situation, coauthor Dr. Gloria L.A. Beckles said in an interview.

“The notion that this is any different in 2009 than in 2004 is a myth. Things change very slowly in chronic disease delivery of care, which depends on the organization of systems. It's not just going to change overnight,” said Dr. Beckles, an epidemiologist, who works with Dr. Owens-Gary, a behavioral psychologist, at the CDC's Division of Diabetes Translation, Atlanta.

Overall, 92% of 1,276 women with diabetes surveyed in 2004 reported having received a hemoglobin A_1c measurement in the past year. However, there was a gradient with age, with older women having the greatest likelihood of an HbA_1c test and the youngest having the lowest. The proportions for those aged 18-44 years, 45-64, and 65 and older were 84%, 91%, and 96%, respectively. The youngest adult women “could be a vulnerable population we need to pay more attention to,” Dr. Owens-Gary noted.

Compared with HbA_1c testing, the proportions of diabetic women receiving recommended annual retinal eye exams and foot exams were far lower. In all, 67% of 1,595 respondents reported having had a retinal exam in the past year. By age group, the proportions were 47%, 66%, and 75%, respectively, for those aged 18-44, 45-64, and 65-plus. Foot exams were somewhat more frequent, with 70% of 1,556 total reporting having received one in the past year, and 61%, 74%, and 69%, respectively, from the youngest group to the oldest.

Receipt of all three diabetes-specific preventive care services was less than 50% for all age groups: 45% of a total 1,430 respondents, and just 30% of the 18- to 44-year-old group, 49% of the 45-64 group and 47% of those aged 65 years and older. There were no significant ethnic differences in receipt of the three recommended services. In women of all ethnic origins, the percentage receiving all three recommended preventive care services was low, ranging from 41% (Hispanic, all races) to 51% (non-Hispanic, African American).

By family income, the women who were poor or near-poor were less likely than were those with diabetes from households with high income to have received all three services, ranging from 38% for the lowest quartile to 57% for the highest, she said.

For Pap tests and mammograms, there were no significant differences across the life stages for women with and without diabetes: 71% of 1,336 with diabetes and 79% of 14,967 without reported having a Pap smear within the past 3 years. Among women over 40, 66.5% of 6,829 with diabetes and 66.8% of 8,887 without reported having a mammogram in the past 2 years. There was no significant difference for receipt of Pap test or mammogram by race/ethnic group.

The proportion of women over 50 who had ever received a colonoscopy, sigmoidoscopy, or proctoscopy did not differ between 1,031 with diabetes (48.5%) and 6,041 without (48.4%). However, younger women were less likely to receive them than were older women, and Hispanic women with diabetes were less likely than were white or African American women with diabetes to be screened for colon cancer. Women with less than a high school education and those with the lowest family incomes also were less likely to receive Pap smears, mammograms, or colonoscopies, she reported.

Women with diabetes were more likely than were those without to have received an influenza vaccination in the past 12 months (50% vs. 22%). However, the rate is still low considering that all persons with diabetes are recommended to receive annual flu shots. And younger women with diabetes were far less likely than were those older to be immunized, with just 33% of those aged 18-44 receiving the shot, compared with 43% of those aged 45-64 and 65% of those aged 65 and above. Hispanic women with diabetes had the lowest rate of all racial/ethnic groups, at 39%, compared with 55% of whites. And again there was a gradient by family income, ranging from 42% for the lowest quartile to 55% for the highest.

“This study demonstrates that women in the reproductive years are a vulnerable population for receipt of low levels of preventive care services. We tend to focus on race and ethnicity when we talk about disparities. This study showed that we found very little difference across racial/ethnic groups. However, we see that being young, poor, or near poor, and having low educational levels, places women with diabetes at risk for suboptimal care in various areas,” Dr. Owens-Gary said.

Health care providers “should consider the vulnerable populations identified when providing outreach and in designing, monitoring, and evaluating the impact of programs,” she concluded.

The report, entitled Women With Diabetes: Quality of Health Care, 2004-2005, is available online at http://tinyurl.com/QualityofCareReport

ATLANTA — Women with diabetes in the United States frequently are not receiving recommended and needed preventive services.

Women with diabetes who are at the extremes of the life cycle, are poor, and are poorly educated appear to be at the greatest risk for not receiving either diabetes-specific or general preventive care services, according to the findings of a report from the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention.

Data on women aged 18 and older with and without diabetes were obtained from three large nationally representative databases: The Medical Expenditure Panel Survey, 2004; the National Health and Nutrition Examination Survey, 1999-2004; and the National Health Interview Survey, 2005. The report is one of the few such documents to examine any women's health issue by age across the lifespan, Michelle D. Owens-Gary, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

Although the data are a few years old, they still represent the current situation, coauthor Dr. Gloria L.A. Beckles said in an interview.

“The notion that this is any different in 2009 than in 2004 is a myth. Things change very slowly in chronic disease delivery of care, which depends on the organization of systems. It's not just going to change overnight,” said Dr. Beckles, an epidemiologist, who works with Dr. Owens-Gary, a behavioral psychologist, at the CDC's Division of Diabetes Translation, Atlanta.

Overall, 92% of 1,276 women with diabetes surveyed in 2004 reported having received a hemoglobin A_1c measurement in the past year. However, there was a gradient with age, with older women having the greatest likelihood of an HbA_1c test and the youngest having the lowest. The proportions for those aged 18-44 years, 45-64, and 65 and older were 84%, 91%, and 96%, respectively. The youngest adult women “could be a vulnerable population we need to pay more attention to,” Dr. Owens-Gary noted.

Compared with HbA_1c testing, the proportions of diabetic women receiving recommended annual retinal eye exams and foot exams were far lower. In all, 67% of 1,595 respondents reported having had a retinal exam in the past year. By age group, the proportions were 47%, 66%, and 75%, respectively, for those aged 18-44, 45-64, and 65-plus. Foot exams were somewhat more frequent, with 70% of 1,556 total reporting having received one in the past year, and 61%, 74%, and 69%, respectively, from the youngest group to the oldest.

Receipt of all three diabetes-specific preventive care services was less than 50% for all age groups: 45% of a total 1,430 respondents, and just 30% of the 18- to 44-year-old group, 49% of the 45-64 group and 47% of those aged 65 years and older. There were no significant ethnic differences in receipt of the three recommended services. In women of all ethnic origins, the percentage receiving all three recommended preventive care services was low, ranging from 41% (Hispanic, all races) to 51% (non-Hispanic, African American).

By family income, the women who were poor or near-poor were less likely than were those with diabetes from households with high income to have received all three services, ranging from 38% for the lowest quartile to 57% for the highest, she said.

For Pap tests and mammograms, there were no significant differences across the life stages for women with and without diabetes: 71% of 1,336 with diabetes and 79% of 14,967 without reported having a Pap smear within the past 3 years. Among women over 40, 66.5% of 6,829 with diabetes and 66.8% of 8,887 without reported having a mammogram in the past 2 years. There was no significant difference for receipt of Pap test or mammogram by race/ethnic group.

The proportion of women over 50 who had ever received a colonoscopy, sigmoidoscopy, or proctoscopy did not differ between 1,031 with diabetes (48.5%) and 6,041 without (48.4%). However, younger women were less likely to receive them than were older women, and Hispanic women with diabetes were less likely than were white or African American women with diabetes to be screened for colon cancer. Women with less than a high school education and those with the lowest family incomes also were less likely to receive Pap smears, mammograms, or colonoscopies, she reported.

Women with diabetes were more likely than were those without to have received an influenza vaccination in the past 12 months (50% vs. 22%). However, the rate is still low considering that all persons with diabetes are recommended to receive annual flu shots. And younger women with diabetes were far less likely than were those older to be immunized, with just 33% of those aged 18-44 receiving the shot, compared with 43% of those aged 45-64 and 65% of those aged 65 and above. Hispanic women with diabetes had the lowest rate of all racial/ethnic groups, at 39%, compared with 55% of whites. And again there was a gradient by family income, ranging from 42% for the lowest quartile to 55% for the highest.

“This study demonstrates that women in the reproductive years are a vulnerable population for receipt of low levels of preventive care services. We tend to focus on race and ethnicity when we talk about disparities. This study showed that we found very little difference across racial/ethnic groups. However, we see that being young, poor, or near poor, and having low educational levels, places women with diabetes at risk for suboptimal care in various areas,” Dr. Owens-Gary said.

Health care providers “should consider the vulnerable populations identified when providing outreach and in designing, monitoring, and evaluating the impact of programs,” she concluded.

The report, entitled Women With Diabetes: Quality of Health Care, 2004-2005, is available online at http://tinyurl.com/QualityofCareReport

Hire great employees. Train and treat them well. Give a lot of positive reinforcement.

Those were three pieces of advice offered by Dr. Suzanne L. Kilmer at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Allowing your employees autonomy and letting them rise to the occasion while providing a comfortable environment in a state-of-the-art facility will go a long way toward ensuring a harmonious workplace. Of course, offering competitive pay and benefits will also help. But above all: "Always keep your patients' happiness a priority," said Dr. Kilmer, of the Laser & Skin Surgery Center of Northern California, in Sacramento.

In her 41-employee practice—which includes five physicians and one nurse practitioner—there are several managers, including a practice manager who coordinates with the all the physicians and answers directly to Dr. Kilmer. In addition, the staff includes a front office manager, a back office manager, and a business manager.

"It's very important to have good people at the top to set the tone, and to make sure that all management has your philosophy in mind," Dr. Kilmer said in an interview. Be sure to hire positive team players. "It's better to have a smart, happy, trainable employee than a trained, unhappy, slow-to-learn, or set-in-their-ways person," she said.

Use of a 3-month probation period for all new hires allows time to make sure that the right people have been chosen and that they fit in with other employees.

All employees should be given thorough initial training that matches their job description. Follow that with ongoing updates and in-service training for all levels of employees. Continuing medical education training should be encouraged and supported by management. Hold monthly staff meetings to help employees keep up to date on what is happening in the practice. And when you attend a meeting, be sure to relay any pertinent information to all employees to offer a true sense of transparency.

A positive attitude is key. In addition to hiring people with positive attitudes, always remember to have a positive attitude yourself during interactions with staff.

Negative personal issues should not be brought into the office. Nonetheless, any employee problems—personal or work-related—should be handled with respect, being sensitive to personal needs. To keep the staff positive, be careful not to over-work or over-schedule them.

Your facility should reflect your high-expectation philosophy. All necessary tools to best facilitate practice needs should be available, including high-quality devices, tables, instruments, and equipment. Keep all waiting room and treatment areas clean and comfortable.

If possible, provide a separate check-out station with products, payment for procedures, and scheduling for future appointments.

Obtaining accreditation as a certified ambulatory surgery center (such as that offered by the Accreditation Association for Ambulatory Health Care, www.aaahc.org

Do everything you can to ensure your patients' happiness. Happy patients are:

▸ Greeted warmly on arrival;

▸ Escorted courteously to the room;

▸ Well educated about their treatments via pamphlets, DVDs, Web site information, and direct communication with staff;

▸ Successfully treated with minimal side effects; and

▸ Provided with satisfaction surveys to complete.

Dr. Kilmer's overriding approach comes from a department store: "Keep in mind the Nordstrom's philosophy of exceeding expectations."

SDEF and this news organization are both owned by Elsevier.

'It's better to have a smart, happy, trainable employee than a trained, unhappy, slow-to-learn' employee.

Source Dr. Kilmer

Hire great employees. Train and treat them well. Give a lot of positive reinforcement.

Those were three pieces of advice offered by Dr. Suzanne L. Kilmer at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Allowing your employees autonomy and letting them rise to the occasion while providing a comfortable environment in a state-of-the-art facility will go a long way toward ensuring a harmonious workplace. Of course, offering competitive pay and benefits will also help. But above all: "Always keep your patients' happiness a priority," said Dr. Kilmer, of the Laser & Skin Surgery Center of Northern California, in Sacramento.

In her 41-employee practice—which includes five physicians and one nurse practitioner—there are several managers, including a practice manager who coordinates with the all the physicians and answers directly to Dr. Kilmer. In addition, the staff includes a front office manager, a back office manager, and a business manager.

"It's very important to have good people at the top to set the tone, and to make sure that all management has your philosophy in mind," Dr. Kilmer said in an interview. Be sure to hire positive team players. "It's better to have a smart, happy, trainable employee than a trained, unhappy, slow-to-learn, or set-in-their-ways person," she said.

Use of a 3-month probation period for all new hires allows time to make sure that the right people have been chosen and that they fit in with other employees.

All employees should be given thorough initial training that matches their job description. Follow that with ongoing updates and in-service training for all levels of employees. Continuing medical education training should be encouraged and supported by management. Hold monthly staff meetings to help employees keep up to date on what is happening in the practice. And when you attend a meeting, be sure to relay any pertinent information to all employees to offer a true sense of transparency.

A positive attitude is key. In addition to hiring people with positive attitudes, always remember to have a positive attitude yourself during interactions with staff.

Negative personal issues should not be brought into the office. Nonetheless, any employee problems—personal or work-related—should be handled with respect, being sensitive to personal needs. To keep the staff positive, be careful not to over-work or over-schedule them.

Your facility should reflect your high-expectation philosophy. All necessary tools to best facilitate practice needs should be available, including high-quality devices, tables, instruments, and equipment. Keep all waiting room and treatment areas clean and comfortable.

If possible, provide a separate check-out station with products, payment for procedures, and scheduling for future appointments.

Obtaining accreditation as a certified ambulatory surgery center (such as that offered by the Accreditation Association for Ambulatory Health Care, www.aaahc.org

Do everything you can to ensure your patients' happiness. Happy patients are:

▸ Greeted warmly on arrival;

▸ Escorted courteously to the room;

▸ Well educated about their treatments via pamphlets, DVDs, Web site information, and direct communication with staff;

▸ Successfully treated with minimal side effects; and

▸ Provided with satisfaction surveys to complete.

Dr. Kilmer's overriding approach comes from a department store: "Keep in mind the Nordstrom's philosophy of exceeding expectations."

SDEF and this news organization are both owned by Elsevier.

'It's better to have a smart, happy, trainable employee than a trained, unhappy, slow-to-learn' employee.

Source Dr. Kilmer

Hire great employees. Train and treat them well. Give a lot of positive reinforcement.

Those were three pieces of advice offered by Dr. Suzanne L. Kilmer at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

Allowing your employees autonomy and letting them rise to the occasion while providing a comfortable environment in a state-of-the-art facility will go a long way toward ensuring a harmonious workplace. Of course, offering competitive pay and benefits will also help. But above all: "Always keep your patients' happiness a priority," said Dr. Kilmer, of the Laser & Skin Surgery Center of Northern California, in Sacramento.

In her 41-employee practice—which includes five physicians and one nurse practitioner—there are several managers, including a practice manager who coordinates with the all the physicians and answers directly to Dr. Kilmer. In addition, the staff includes a front office manager, a back office manager, and a business manager.

"It's very important to have good people at the top to set the tone, and to make sure that all management has your philosophy in mind," Dr. Kilmer said in an interview. Be sure to hire positive team players. "It's better to have a smart, happy, trainable employee than a trained, unhappy, slow-to-learn, or set-in-their-ways person," she said.

Use of a 3-month probation period for all new hires allows time to make sure that the right people have been chosen and that they fit in with other employees.

All employees should be given thorough initial training that matches their job description. Follow that with ongoing updates and in-service training for all levels of employees. Continuing medical education training should be encouraged and supported by management. Hold monthly staff meetings to help employees keep up to date on what is happening in the practice. And when you attend a meeting, be sure to relay any pertinent information to all employees to offer a true sense of transparency.

A positive attitude is key. In addition to hiring people with positive attitudes, always remember to have a positive attitude yourself during interactions with staff.

Negative personal issues should not be brought into the office. Nonetheless, any employee problems—personal or work-related—should be handled with respect, being sensitive to personal needs. To keep the staff positive, be careful not to over-work or over-schedule them.

Your facility should reflect your high-expectation philosophy. All necessary tools to best facilitate practice needs should be available, including high-quality devices, tables, instruments, and equipment. Keep all waiting room and treatment areas clean and comfortable.

If possible, provide a separate check-out station with products, payment for procedures, and scheduling for future appointments.

Obtaining accreditation as a certified ambulatory surgery center (such as that offered by the Accreditation Association for Ambulatory Health Care, www.aaahc.org

Do everything you can to ensure your patients' happiness. Happy patients are:

▸ Greeted warmly on arrival;

▸ Escorted courteously to the room;

▸ Well educated about their treatments via pamphlets, DVDs, Web site information, and direct communication with staff;

▸ Successfully treated with minimal side effects; and

▸ Provided with satisfaction surveys to complete.

Dr. Kilmer's overriding approach comes from a department store: "Keep in mind the Nordstrom's philosophy of exceeding expectations."

SDEF and this news organization are both owned by Elsevier.

'It's better to have a smart, happy, trainable employee than a trained, unhappy, slow-to-learn' employee.

Source Dr. Kilmer

ATLANTA — The clanging tuning fork test is far more accurate and sensitive than is the 10-g monofilament in screening diabetes patients for peripheral neuropathy, results from two studies suggest.

In fact, relying on the monofilament alone to screen patients for diabetic peripheral neuropathy (DPN) will miss all but the most severe, advanced cases, Dr. David S. Oyer and Dr. David Saxon said at the annual meeting of the American Association of Diabetes Educators.

“The clanging tuning fork [CTF] test detects diabetic peripheral neuropathy and increased risk of ulcer earlier than the monofilament. It should be the standard test for DPN. I don't think you need the monofilament at all. The CTF should be the A_1c of the foot,” said Dr. Oyer, an endocrinologist at Northwestern University, Chicago.

He presented data from two studies, one of which showed that the 10-g Semmes-Weinstein monofilament test was normal in more than two-thirds of patients who were found by the CTF test to have severe DPN. Yet guidelines from the American Diabetes Association—endorsed by the American Association of Clinical Endocrinologists—recommend the 10-g monofilament as the main screening tool, along with one of four other tests. The 128-Hz tuning fork is among those four choices, along with pinprick sensation, ankle reflexes, and vibration perception threshold testing (Diabetes Care 2008;31:1679–85).

Dr. Saxon, an endocrinology resident at the University of Michigan, Ann Arbor, enumerated several limitations of the monofilament, including the fact that those distributed free by drug companies often are not reliable and do not always give 10 g of force. Moreover, cold monofilaments must be warmed up to work properly. After about 100 bends, monofilaments tend to “fatigue” and need to “rest” for 24 hours, Dr. Saxon said.

In a previously published study, Dr. Oyer demonstrated reproducibility of the CTF in 12 patients with diabetes on whom he performed the test 10 times on the same toe for each. Scores ranged from 3.4 to 18.8 seconds, with a mean of 10.2.

In a second part of that study, a single reading from the right foot versus the left foot was compared in 30 randomly selected patients with diabetes. The vibration duration sensation averaged was 10.9 seconds on the right foot and 9.7 seconds on the left. The two feet will almost always be nearly the same unless the patient has sciatica, Dr. Oyer noted.

Monofilament testing was done in patients whose mean vibration duration was 8 seconds or less, and was consistently reported as normal among the 26 patients who had vibration durations of 5 seconds or more. Only at vibration perceptions of 4 seconds or less did the monofilament testing begin to demonstrate abnormal results, but even then patients with abnormal CTF scores were missed. Of 32 patients with vibration perception of 4 seconds or less, 50% still had normal monofilament test results, including 5 of 17 (29%) with completely absent vibration sensation, Dr. Oyer and his associates reported (Endocr. Pract. 2007;13:5–10).

In a review of 81 patients with a history of diabetic foot ulcers (also reported in the Endocrine Practice article), among those with a CTF vibration perception duration of 4 seconds or less, 10 of 32 had diabetic foot ulcers, compared with 1 ulcer in 49 patients who had a CTF score of 5 seconds or more. Thus, there was a 15-fold increased relative risk for foot ulcers in patients with a CTF score of 4 seconds or less, compared with those having a vibration perception duration of 5 seconds or above, Dr. Oyer said.

In a second study, published as an abstract for the 2008 American Diabetes Association's annual scientific sessions, 68% of 148 patients with CTF scores of 8 seconds or less had normal monofilament test results. In 112 patients with CTF scores indicating severe neuropathy (4 seconds or less), 68% had a normal monofilament test. And in 49 patients with CTF scores of 0 seconds, 16 (33%) still had a normal monofilament test.

A history of a diabetic foot ulcer was present in 21 patients. All had CTF scores of 4 seconds or less, while 5 (24%) had normal monofilament tests. When the CTF score was 5 seconds or more, monofilament testing was normal in 96% of patients. Thus, a CTF score of 4 seconds or less was 100% sensitive for ulcer risk, whereas the 10-g monofilament was only 76% sensitive.

The increased sensitivity of the CTF comes at the expense of identifying many at-risk patients who would not end up developing an ulcer if left untreated. Specificity is just 20%, compared with 75% for the monofilament. “But that doesn't bother me. If you want to prevent ulcers, you have to identify everyone at risk, so you can do everything you can to prevent them,” he noted.

But Dr. Andrew J.M. Boulton, chair of the American Diabetes Association's Foot Care Interest Group, said he believes that it's too soon to replace the monofilament with the CTF as a first-line screening test for diabetic neuropathy. The CTF results are “of course very interesting, and I think that this is certainly a useful addition to the monofilaments,” he said in an interview.

Dr. Boulton, who divides his time between the Manchester (England) Diabetes Centre and the University of Miami, noted that data from prospective studies also support the monofilaments. In one review of six such studies, the increased risk of ulceration ranged from an odds ratio of 2.2 to 9.99, and the relative risk of amputation was 2.9 with an abnormal monofilament test (J. Fam. Pract. 2000;49[11 Suppl]:S17–29).

“What is needed with this test is a prospective study. …This new tuning fork test may well be useful but before it can replace the monofilament—if it is to at all—good longitudinal studies must be done,” said Dr. Boulton, who has received honoraria/consulting fees from Pfizer and Eli Lilly & Co.

Dr. Oyer and Dr. Saxon stated that they had no conflicts of interest to disclose.

ATLANTA — The clanging tuning fork test is far more accurate and sensitive than is the 10-g monofilament in screening diabetes patients for peripheral neuropathy, results from two studies suggest.

In fact, relying on the monofilament alone to screen patients for diabetic peripheral neuropathy (DPN) will miss all but the most severe, advanced cases, Dr. David S. Oyer and Dr. David Saxon said at the annual meeting of the American Association of Diabetes Educators.

“The clanging tuning fork [CTF] test detects diabetic peripheral neuropathy and increased risk of ulcer earlier than the monofilament. It should be the standard test for DPN. I don't think you need the monofilament at all. The CTF should be the A_1c of the foot,” said Dr. Oyer, an endocrinologist at Northwestern University, Chicago.

He presented data from two studies, one of which showed that the 10-g Semmes-Weinstein monofilament test was normal in more than two-thirds of patients who were found by the CTF test to have severe DPN. Yet guidelines from the American Diabetes Association—endorsed by the American Association of Clinical Endocrinologists—recommend the 10-g monofilament as the main screening tool, along with one of four other tests. The 128-Hz tuning fork is among those four choices, along with pinprick sensation, ankle reflexes, and vibration perception threshold testing (Diabetes Care 2008;31:1679–85).

Dr. Saxon, an endocrinology resident at the University of Michigan, Ann Arbor, enumerated several limitations of the monofilament, including the fact that those distributed free by drug companies often are not reliable and do not always give 10 g of force. Moreover, cold monofilaments must be warmed up to work properly. After about 100 bends, monofilaments tend to “fatigue” and need to “rest” for 24 hours, Dr. Saxon said.

In a previously published study, Dr. Oyer demonstrated reproducibility of the CTF in 12 patients with diabetes on whom he performed the test 10 times on the same toe for each. Scores ranged from 3.4 to 18.8 seconds, with a mean of 10.2.

In a second part of that study, a single reading from the right foot versus the left foot was compared in 30 randomly selected patients with diabetes. The vibration duration sensation averaged was 10.9 seconds on the right foot and 9.7 seconds on the left. The two feet will almost always be nearly the same unless the patient has sciatica, Dr. Oyer noted.

Monofilament testing was done in patients whose mean vibration duration was 8 seconds or less, and was consistently reported as normal among the 26 patients who had vibration durations of 5 seconds or more. Only at vibration perceptions of 4 seconds or less did the monofilament testing begin to demonstrate abnormal results, but even then patients with abnormal CTF scores were missed. Of 32 patients with vibration perception of 4 seconds or less, 50% still had normal monofilament test results, including 5 of 17 (29%) with completely absent vibration sensation, Dr. Oyer and his associates reported (Endocr. Pract. 2007;13:5–10).

In a review of 81 patients with a history of diabetic foot ulcers (also reported in the Endocrine Practice article), among those with a CTF vibration perception duration of 4 seconds or less, 10 of 32 had diabetic foot ulcers, compared with 1 ulcer in 49 patients who had a CTF score of 5 seconds or more. Thus, there was a 15-fold increased relative risk for foot ulcers in patients with a CTF score of 4 seconds or less, compared with those having a vibration perception duration of 5 seconds or above, Dr. Oyer said.

In a second study, published as an abstract for the 2008 American Diabetes Association's annual scientific sessions, 68% of 148 patients with CTF scores of 8 seconds or less had normal monofilament test results. In 112 patients with CTF scores indicating severe neuropathy (4 seconds or less), 68% had a normal monofilament test. And in 49 patients with CTF scores of 0 seconds, 16 (33%) still had a normal monofilament test.

A history of a diabetic foot ulcer was present in 21 patients. All had CTF scores of 4 seconds or less, while 5 (24%) had normal monofilament tests. When the CTF score was 5 seconds or more, monofilament testing was normal in 96% of patients. Thus, a CTF score of 4 seconds or less was 100% sensitive for ulcer risk, whereas the 10-g monofilament was only 76% sensitive.

The increased sensitivity of the CTF comes at the expense of identifying many at-risk patients who would not end up developing an ulcer if left untreated. Specificity is just 20%, compared with 75% for the monofilament. “But that doesn't bother me. If you want to prevent ulcers, you have to identify everyone at risk, so you can do everything you can to prevent them,” he noted.

But Dr. Andrew J.M. Boulton, chair of the American Diabetes Association's Foot Care Interest Group, said he believes that it's too soon to replace the monofilament with the CTF as a first-line screening test for diabetic neuropathy. The CTF results are “of course very interesting, and I think that this is certainly a useful addition to the monofilaments,” he said in an interview.

Dr. Boulton, who divides his time between the Manchester (England) Diabetes Centre and the University of Miami, noted that data from prospective studies also support the monofilaments. In one review of six such studies, the increased risk of ulceration ranged from an odds ratio of 2.2 to 9.99, and the relative risk of amputation was 2.9 with an abnormal monofilament test (J. Fam. Pract. 2000;49[11 Suppl]:S17–29).

“What is needed with this test is a prospective study. …This new tuning fork test may well be useful but before it can replace the monofilament—if it is to at all—good longitudinal studies must be done,” said Dr. Boulton, who has received honoraria/consulting fees from Pfizer and Eli Lilly & Co.

Dr. Oyer and Dr. Saxon stated that they had no conflicts of interest to disclose.

ATLANTA — The clanging tuning fork test is far more accurate and sensitive than is the 10-g monofilament in screening diabetes patients for peripheral neuropathy, results from two studies suggest.

In fact, relying on the monofilament alone to screen patients for diabetic peripheral neuropathy (DPN) will miss all but the most severe, advanced cases, Dr. David S. Oyer and Dr. David Saxon said at the annual meeting of the American Association of Diabetes Educators.

“The clanging tuning fork [CTF] test detects diabetic peripheral neuropathy and increased risk of ulcer earlier than the monofilament. It should be the standard test for DPN. I don't think you need the monofilament at all. The CTF should be the A_1c of the foot,” said Dr. Oyer, an endocrinologist at Northwestern University, Chicago.

He presented data from two studies, one of which showed that the 10-g Semmes-Weinstein monofilament test was normal in more than two-thirds of patients who were found by the CTF test to have severe DPN. Yet guidelines from the American Diabetes Association—endorsed by the American Association of Clinical Endocrinologists—recommend the 10-g monofilament as the main screening tool, along with one of four other tests. The 128-Hz tuning fork is among those four choices, along with pinprick sensation, ankle reflexes, and vibration perception threshold testing (Diabetes Care 2008;31:1679–85).

Dr. Saxon, an endocrinology resident at the University of Michigan, Ann Arbor, enumerated several limitations of the monofilament, including the fact that those distributed free by drug companies often are not reliable and do not always give 10 g of force. Moreover, cold monofilaments must be warmed up to work properly. After about 100 bends, monofilaments tend to “fatigue” and need to “rest” for 24 hours, Dr. Saxon said.

In a previously published study, Dr. Oyer demonstrated reproducibility of the CTF in 12 patients with diabetes on whom he performed the test 10 times on the same toe for each. Scores ranged from 3.4 to 18.8 seconds, with a mean of 10.2.

In a second part of that study, a single reading from the right foot versus the left foot was compared in 30 randomly selected patients with diabetes. The vibration duration sensation averaged was 10.9 seconds on the right foot and 9.7 seconds on the left. The two feet will almost always be nearly the same unless the patient has sciatica, Dr. Oyer noted.

Monofilament testing was done in patients whose mean vibration duration was 8 seconds or less, and was consistently reported as normal among the 26 patients who had vibration durations of 5 seconds or more. Only at vibration perceptions of 4 seconds or less did the monofilament testing begin to demonstrate abnormal results, but even then patients with abnormal CTF scores were missed. Of 32 patients with vibration perception of 4 seconds or less, 50% still had normal monofilament test results, including 5 of 17 (29%) with completely absent vibration sensation, Dr. Oyer and his associates reported (Endocr. Pract. 2007;13:5–10).

In a review of 81 patients with a history of diabetic foot ulcers (also reported in the Endocrine Practice article), among those with a CTF vibration perception duration of 4 seconds or less, 10 of 32 had diabetic foot ulcers, compared with 1 ulcer in 49 patients who had a CTF score of 5 seconds or more. Thus, there was a 15-fold increased relative risk for foot ulcers in patients with a CTF score of 4 seconds or less, compared with those having a vibration perception duration of 5 seconds or above, Dr. Oyer said.

In a second study, published as an abstract for the 2008 American Diabetes Association's annual scientific sessions, 68% of 148 patients with CTF scores of 8 seconds or less had normal monofilament test results. In 112 patients with CTF scores indicating severe neuropathy (4 seconds or less), 68% had a normal monofilament test. And in 49 patients with CTF scores of 0 seconds, 16 (33%) still had a normal monofilament test.

A history of a diabetic foot ulcer was present in 21 patients. All had CTF scores of 4 seconds or less, while 5 (24%) had normal monofilament tests. When the CTF score was 5 seconds or more, monofilament testing was normal in 96% of patients. Thus, a CTF score of 4 seconds or less was 100% sensitive for ulcer risk, whereas the 10-g monofilament was only 76% sensitive.

The increased sensitivity of the CTF comes at the expense of identifying many at-risk patients who would not end up developing an ulcer if left untreated. Specificity is just 20%, compared with 75% for the monofilament. “But that doesn't bother me. If you want to prevent ulcers, you have to identify everyone at risk, so you can do everything you can to prevent them,” he noted.

But Dr. Andrew J.M. Boulton, chair of the American Diabetes Association's Foot Care Interest Group, said he believes that it's too soon to replace the monofilament with the CTF as a first-line screening test for diabetic neuropathy. The CTF results are “of course very interesting, and I think that this is certainly a useful addition to the monofilaments,” he said in an interview.

Dr. Boulton, who divides his time between the Manchester (England) Diabetes Centre and the University of Miami, noted that data from prospective studies also support the monofilaments. In one review of six such studies, the increased risk of ulceration ranged from an odds ratio of 2.2 to 9.99, and the relative risk of amputation was 2.9 with an abnormal monofilament test (J. Fam. Pract. 2000;49[11 Suppl]:S17–29).

“What is needed with this test is a prospective study. …This new tuning fork test may well be useful but before it can replace the monofilament—if it is to at all—good longitudinal studies must be done,” said Dr. Boulton, who has received honoraria/consulting fees from Pfizer and Eli Lilly & Co.

Dr. Oyer and Dr. Saxon stated that they had no conflicts of interest to disclose.

ATLANTA — Women with diabetes in the United States frequently are not receiving recommended and needed preventive services.

Women with diabetes who are at the extremes of the life cycle, are poor, and are poorly educated appear to be at the greatest risk for not receiving either diabetes-specific or general preventive care services, according to the findings of a report from the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention.

Data on women aged 18 and older with and without diabetes were obtained from three large nationally representative databases: the Medical Expenditure Panel Survey, 2004; the National Health and Nutrition Examination Survey, 1999–2004; and the National Health Interview Survey, 2005. The report is one of the few such documents to examine any women's health issue by age across the lifespan, Michelle D. Owens-Gary, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

Although the data are a few years old, they still represent the current situation, coauthor Dr. Gloria L.A. Beckles said in an interview.

“The notion that this is any different in 2009 than in 2004 is a myth. Things change very slowly in chronic disease delivery of care, which depends on the organization of systems. It's not just going to change overnight,” said Dr. Beckles, an epidemiologist, who works with Dr. Owens-Gary, a behavioral psychologist, at the CDC's division of diabetes translation in Atlanta.

Overall, 91.8% of 1,276 women with diabetes surveyed in 2004 reported having received a hemoglobin A_1c measurement in the past year. However, there was a gradient with age, with older women having the greatest likelihood of an A_1c test and the youngest having the lowest. The proportions for those aged 18–44 years, 45–64, and 65 and older were 83.9%, 91.3%, and 95.5%, respectively. The youngest adult women “could be a vulnerable population we need to pay more attention to,” Dr. Owens-Gary noted.

Compared with A_1c testing, the proportions of diabetic women receiving recommended annual retinal eye exams and foot exams were far lower. In all, 67% of 1,595 respondents reported having had a retinal exam in the past year. By age group, the proportions were 47.4%, 66.2%, and 74.6%, respectively, for those aged 18–44, 45–64, and 65-plus. Foot exams were somewhat more frequent, with 70.1% of 1,556 total reporting having received one in the past year, and 60.7%, 73.8%, and 69.4%, respectively, from the youngest group to the oldest.

Receipt of all three diabetes-specific preventive care services was less than 50% for all age groups: 45.2% of a total 1,430 respondents, and just 30.5% of the 18- to 44-year-old group, 48.7% of the 45–64 group and 46.7% of those aged 65 years and older. There were no significant ethnic differences in receipt of the three recommended services. In women of all ethnic origins, the percentage receiving all three recommended preventive care services was low, ranging from 41.0% (Hispanic, all races) to 50.9% (Non-Hispanic, African American).

By family income, the women who were poor or near-poor were less likely than those with diabetes from households with high income to have received all three services, ranging from 38.2% for the lowest quartile to 56.7% for the highest, she said.

For Pap tests and mammograms, there were no significant differences across the life stages for women with and without diabetes: 71.0% of 1,336 with diabetes and 78.7% of 14,967 without reported having a Pap smear within the past 3 years. Among women over 40, 66.5% of 6,829 with diabetes and 66.8% of 8,887 without reported having a mammogram in the past 2 years. There was no significant difference for receipt of Pap test or mammogram by race/ethnic group.

The proportion of women over 50 who had ever received a colonoscopy, sigmoidoscopy, or proctoscopy did not differ between 1,031 with diabetes (48.5%) and 6,041 without (48.4%). However, younger women were less likely to receive them than were older women, and Hispanic women with diabetes were less likely than white or African American women with diabetes to be screened for colon cancer, she reported.

The report is available at http://tinyurl.com/QualityofCareReport

ATLANTA — Women with diabetes in the United States frequently are not receiving recommended and needed preventive services.

Women with diabetes who are at the extremes of the life cycle, are poor, and are poorly educated appear to be at the greatest risk for not receiving either diabetes-specific or general preventive care services, according to the findings of a report from the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention.

Data on women aged 18 and older with and without diabetes were obtained from three large nationally representative databases: the Medical Expenditure Panel Survey, 2004; the National Health and Nutrition Examination Survey, 1999–2004; and the National Health Interview Survey, 2005. The report is one of the few such documents to examine any women's health issue by age across the lifespan, Michelle D. Owens-Gary, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

Although the data are a few years old, they still represent the current situation, coauthor Dr. Gloria L.A. Beckles said in an interview.

“The notion that this is any different in 2009 than in 2004 is a myth. Things change very slowly in chronic disease delivery of care, which depends on the organization of systems. It's not just going to change overnight,” said Dr. Beckles, an epidemiologist, who works with Dr. Owens-Gary, a behavioral psychologist, at the CDC's division of diabetes translation in Atlanta.

Overall, 91.8% of 1,276 women with diabetes surveyed in 2004 reported having received a hemoglobin A_1c measurement in the past year. However, there was a gradient with age, with older women having the greatest likelihood of an A_1c test and the youngest having the lowest. The proportions for those aged 18–44 years, 45–64, and 65 and older were 83.9%, 91.3%, and 95.5%, respectively. The youngest adult women “could be a vulnerable population we need to pay more attention to,” Dr. Owens-Gary noted.

Compared with A_1c testing, the proportions of diabetic women receiving recommended annual retinal eye exams and foot exams were far lower. In all, 67% of 1,595 respondents reported having had a retinal exam in the past year. By age group, the proportions were 47.4%, 66.2%, and 74.6%, respectively, for those aged 18–44, 45–64, and 65-plus. Foot exams were somewhat more frequent, with 70.1% of 1,556 total reporting having received one in the past year, and 60.7%, 73.8%, and 69.4%, respectively, from the youngest group to the oldest.

Receipt of all three diabetes-specific preventive care services was less than 50% for all age groups: 45.2% of a total 1,430 respondents, and just 30.5% of the 18- to 44-year-old group, 48.7% of the 45–64 group and 46.7% of those aged 65 years and older. There were no significant ethnic differences in receipt of the three recommended services. In women of all ethnic origins, the percentage receiving all three recommended preventive care services was low, ranging from 41.0% (Hispanic, all races) to 50.9% (Non-Hispanic, African American).

By family income, the women who were poor or near-poor were less likely than those with diabetes from households with high income to have received all three services, ranging from 38.2% for the lowest quartile to 56.7% for the highest, she said.

For Pap tests and mammograms, there were no significant differences across the life stages for women with and without diabetes: 71.0% of 1,336 with diabetes and 78.7% of 14,967 without reported having a Pap smear within the past 3 years. Among women over 40, 66.5% of 6,829 with diabetes and 66.8% of 8,887 without reported having a mammogram in the past 2 years. There was no significant difference for receipt of Pap test or mammogram by race/ethnic group.

The proportion of women over 50 who had ever received a colonoscopy, sigmoidoscopy, or proctoscopy did not differ between 1,031 with diabetes (48.5%) and 6,041 without (48.4%). However, younger women were less likely to receive them than were older women, and Hispanic women with diabetes were less likely than white or African American women with diabetes to be screened for colon cancer, she reported.

The report is available at http://tinyurl.com/QualityofCareReport

ATLANTA — Women with diabetes in the United States frequently are not receiving recommended and needed preventive services.

Women with diabetes who are at the extremes of the life cycle, are poor, and are poorly educated appear to be at the greatest risk for not receiving either diabetes-specific or general preventive care services, according to the findings of a report from the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention.

Data on women aged 18 and older with and without diabetes were obtained from three large nationally representative databases: the Medical Expenditure Panel Survey, 2004; the National Health and Nutrition Examination Survey, 1999–2004; and the National Health Interview Survey, 2005. The report is one of the few such documents to examine any women's health issue by age across the lifespan, Michelle D. Owens-Gary, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

Although the data are a few years old, they still represent the current situation, coauthor Dr. Gloria L.A. Beckles said in an interview.

“The notion that this is any different in 2009 than in 2004 is a myth. Things change very slowly in chronic disease delivery of care, which depends on the organization of systems. It's not just going to change overnight,” said Dr. Beckles, an epidemiologist, who works with Dr. Owens-Gary, a behavioral psychologist, at the CDC's division of diabetes translation in Atlanta.

Overall, 91.8% of 1,276 women with diabetes surveyed in 2004 reported having received a hemoglobin A_1c measurement in the past year. However, there was a gradient with age, with older women having the greatest likelihood of an A_1c test and the youngest having the lowest. The proportions for those aged 18–44 years, 45–64, and 65 and older were 83.9%, 91.3%, and 95.5%, respectively. The youngest adult women “could be a vulnerable population we need to pay more attention to,” Dr. Owens-Gary noted.

Compared with A_1c testing, the proportions of diabetic women receiving recommended annual retinal eye exams and foot exams were far lower. In all, 67% of 1,595 respondents reported having had a retinal exam in the past year. By age group, the proportions were 47.4%, 66.2%, and 74.6%, respectively, for those aged 18–44, 45–64, and 65-plus. Foot exams were somewhat more frequent, with 70.1% of 1,556 total reporting having received one in the past year, and 60.7%, 73.8%, and 69.4%, respectively, from the youngest group to the oldest.

Receipt of all three diabetes-specific preventive care services was less than 50% for all age groups: 45.2% of a total 1,430 respondents, and just 30.5% of the 18- to 44-year-old group, 48.7% of the 45–64 group and 46.7% of those aged 65 years and older. There were no significant ethnic differences in receipt of the three recommended services. In women of all ethnic origins, the percentage receiving all three recommended preventive care services was low, ranging from 41.0% (Hispanic, all races) to 50.9% (Non-Hispanic, African American).

By family income, the women who were poor or near-poor were less likely than those with diabetes from households with high income to have received all three services, ranging from 38.2% for the lowest quartile to 56.7% for the highest, she said.

For Pap tests and mammograms, there were no significant differences across the life stages for women with and without diabetes: 71.0% of 1,336 with diabetes and 78.7% of 14,967 without reported having a Pap smear within the past 3 years. Among women over 40, 66.5% of 6,829 with diabetes and 66.8% of 8,887 without reported having a mammogram in the past 2 years. There was no significant difference for receipt of Pap test or mammogram by race/ethnic group.

The proportion of women over 50 who had ever received a colonoscopy, sigmoidoscopy, or proctoscopy did not differ between 1,031 with diabetes (48.5%) and 6,041 without (48.4%). However, younger women were less likely to receive them than were older women, and Hispanic women with diabetes were less likely than white or African American women with diabetes to be screened for colon cancer, she reported.

The report is available at http://tinyurl.com/QualityofCareReport

ATLANTA — The clanging tuning fork test is far more accurate and sensitive than is the 10-g monofilament in screening diabetes patients for peripheral neuropathy, results from two studies suggest.

In fact, relying on the monofilament alone to screen patients for diabetic peripheral neuropathy (DPN) will miss all but the most severe, advanced cases, Dr. David S. Oyer and Dr. David Saxon said at the annual meeting of the American Association of Diabetes Educators.

“The clanging tuning fork [CTF] test detects diabetic peripheral neuropathy and increased risk of ulcer earlier than the monofilament. It should be the standard test for DPN. I don't think you need the monofilament at all. The CTF should be the A_1c of the foot,” said Dr. Oyer, an endocrinologist at Northwestern University, Chicago.

He presented data from two studies, one of which showed that the 10-g Semmes-Weinstein monofilament test was normal in more than two-thirds of patients who were found by the CTF test to have severe DPN. Yet guidelines from the American Diabetes Association—endorsed by the American Association of Clinical Endocrinologists—recommend the 10-g monofilament as the main screening tool for diabetic foot evaluation, along with a choice of one of four other tests. The 128-Hz tuning fork is among those four choices (the others are pinprick sensation, ankle reflexes, and vibration perception threshold testing), but no specific parameters are given for how to use it (Diabetes Care 2008;31:1679-85).

Dr. Saxon, an endocrinology resident at the University of Michigan, Ann Arbor, enumerated several limitations of the monofilament, including the fact that those distributed free by drug companies often are not reliable and do not always give 10 g of force. Moreover, cold monofilaments must be warmed up to work properly. After about 100 bends, monofilaments tend to “fatigue” and need to “rest” for 24 hours. Also, testing on a callus can give an inaccurate result, Dr. Saxon said.

In a previously published study, Dr. Oyer demonstrated reproducibility of the CTF in 12 patients with diabetes on whom he performed the test 10 times on the same toe for each. Scores ranged from 3.4 to 18.8 seconds, with a mean of 10.2 and standard deviation of 1.3 seconds, representing less than a 10% error.

In a second part of that study, a single reading from the right foot versus the left foot was compared in 30 randomly selected patients with diabetes. The vibration duration sensation averaged was 10.9 seconds on the right foot and 9.7 seconds on the left. The two feet will almost always be nearly the same unless the patient has sciatica, Dr. Oyer noted.

Monofilament testing was done in patients whose mean vibration duration was 8 seconds or less, and was consistently reported as normal (correctly identified and patient able to feel all eight spots touched) among the 26 patients who had vibration durations of 5 seconds or more. Only at vibration perceptions of 4 seconds or less did the monofilament testing begin to demonstrate abnormal results, but even then patients with abnormal CTF scores were missed. Of 32 patients with vibration perception of 4 seconds or less, 50% still had normal monofilament test results, including 5 of 17 (29%) with completely absent vibration sensation, Dr. Oyer and his associates reported (Endocr. Pract. 2007;13:5-10).

In a review of 81 patients with a history of diabetic foot ulcers, among those with a CTF vibration perception duration of 4 seconds or less, 10 of 32 had diabetic foot ulcers, compared with 1 ulcer in 49 patients who had a CTF score of 5 seconds or more (Endocr. Pract. 2007;13:5-10). Thus, there was a 15-fold increased relative risk for foot ulcers in patients with a CTF score of 4 seconds or less, compared with those having a vibration perception duration of 5 seconds or above, Dr. Oyer said.

In a second study, published as an abstract for the ADA's 2008 annual scientific sessions, 68% of 148 patients with CTF scores of 8 seconds or less had normal monofilament test results. In 112 patients with CTF scores indicating severe neuropathy (4 seconds or less), 68% had a normal monofilament test. And in 49 patients with CTF scores of 0 seconds, 16 (33%) still had a normal monofilament test.

A history of a diabetic foot ulcer was present in 21 patients. All had CTF scores of 4 seconds or less, while 5 (24%) had normal monofilament tests. When the CTF score was 5 seconds or more, monofilament testing was normal in 96% of patients. Thus, a CTF score of 4 seconds or less was 100% sensitive for ulcer risk, whereas the 10-g monofilament was only 76% sensitive.

The increased sensitivity of the CTF comes at the expense of specificity, however, identifying many at-risk patients who would not end up developing an ulcer if left untreated. Specificity of the CTF is just 20%, compared with 75% for the monofilament. “If you want to prevent ulcers, you have to identify everyone at risk, so you can do everything you can to prevent them, with measures such as teaching patients to use mirrors to inspect their feet, and in some cases provide custom footwear,” he noted.

But Dr. Andrew J.M. Boulton, chair of the ADA's Foot Care Interest Group, said he believes that it's too soon to replace the monofilament with the CTF as a first-line screening test for diabetic neuropathy. The CTF results are “very interesting, and I think that this is certainly a useful addition to the monofilaments,” he said in an interview, adding that they are consistent with last year's recommendation of using monofilaments together with one other of four tests.

Dr. Boulton, who divides his time between the Manchester (England) Diabetes Centre and the division of endocrinology, diabetes, and metabolism at the University of Miami, noted that data from prospective studies also support the monofilaments. In one review of six such studies, the increased risk of ulceration ranged from an odds ratio of 2.2 to 9.99, and the relative risk of amputation was 2.9 with an abnormal monofilament test (J. Fam. Pract. 2000;49[11 suppl]:S17-29).

“What is needed with this test is a prospective study…. This new tuning fork test may well be useful but before it can replace the monofilament—if it is to at all—good longitudinal studies must be done to show its predictive value,” said Dr. Boulton, who has received honoraria/consulting fees from Pfizer and Eli Lilly & Co.

Dr. Oyer and Dr. Saxon are conducting two ongoing trials with the CTF test. One is seeking to establish vibration perception ranges for nondiabetic people aged 40 and older. The other is looking at whether Metanx, a widely-used vitamin therapy for diabetic neuropathy, improves the CTF score, he said in an interview.

Dr. Oyer and Dr. Saxon stated they had no conflicts of interest to disclose.

Although the method takes some practice, the clanging tuning fork test is simple and reliable, Dr. Saxon said, using these steps:

▸ Using a standard C-128 tuning fork, strike the tuning fork against the palm with an upstroke, just hard enough to make the ends clang together. If there is no metallic “clang,” try hitting harder. But if there is an extra-loud “clang,” dampen it and try again more lightly.

▸ Hold the tuning fork with only two fingers. “Pretend you're at a bar holding a dart,” Dr. Saxon said. Don't rest your hand against the tines because contact will shorten the vibration time.

▸ When using the CTF on patients for the first time, it's a good idea to demonstrate on one of their hands to make sure they understand the difference between vibration and pressure by checking if they recognize when the vibration stops.

▸ For the actual test on the foot, immediately after striking, the tuning fork is placed on the dorsal toe just proximal to the nail, and the seconds counted until the patient says “now,” signifying the point at which he or she begins to doubt that the vibration is perceptible.

▸ The test is repeated on the other foot, and the score from both toes is averaged.

ATLANTA — The clanging tuning fork test is far more accurate and sensitive than is the 10-g monofilament in screening diabetes patients for peripheral neuropathy, results from two studies suggest.

In fact, relying on the monofilament alone to screen patients for diabetic peripheral neuropathy (DPN) will miss all but the most severe, advanced cases, Dr. David S. Oyer and Dr. David Saxon said at the annual meeting of the American Association of Diabetes Educators.

“The clanging tuning fork [CTF] test detects diabetic peripheral neuropathy and increased risk of ulcer earlier than the monofilament. It should be the standard test for DPN. I don't think you need the monofilament at all. The CTF should be the A_1c of the foot,” said Dr. Oyer, an endocrinologist at Northwestern University, Chicago.

He presented data from two studies, one of which showed that the 10-g Semmes-Weinstein monofilament test was normal in more than two-thirds of patients who were found by the CTF test to have severe DPN. Yet guidelines from the American Diabetes Association—endorsed by the American Association of Clinical Endocrinologists—recommend the 10-g monofilament as the main screening tool for diabetic foot evaluation, along with a choice of one of four other tests. The 128-Hz tuning fork is among those four choices (the others are pinprick sensation, ankle reflexes, and vibration perception threshold testing), but no specific parameters are given for how to use it (Diabetes Care 2008;31:1679-85).

Dr. Saxon, an endocrinology resident at the University of Michigan, Ann Arbor, enumerated several limitations of the monofilament, including the fact that those distributed free by drug companies often are not reliable and do not always give 10 g of force. Moreover, cold monofilaments must be warmed up to work properly. After about 100 bends, monofilaments tend to “fatigue” and need to “rest” for 24 hours. Also, testing on a callus can give an inaccurate result, Dr. Saxon said.

In a previously published study, Dr. Oyer demonstrated reproducibility of the CTF in 12 patients with diabetes on whom he performed the test 10 times on the same toe for each. Scores ranged from 3.4 to 18.8 seconds, with a mean of 10.2 and standard deviation of 1.3 seconds, representing less than a 10% error.

In a second part of that study, a single reading from the right foot versus the left foot was compared in 30 randomly selected patients with diabetes. The vibration duration sensation averaged was 10.9 seconds on the right foot and 9.7 seconds on the left. The two feet will almost always be nearly the same unless the patient has sciatica, Dr. Oyer noted.

Monofilament testing was done in patients whose mean vibration duration was 8 seconds or less, and was consistently reported as normal (correctly identified and patient able to feel all eight spots touched) among the 26 patients who had vibration durations of 5 seconds or more. Only at vibration perceptions of 4 seconds or less did the monofilament testing begin to demonstrate abnormal results, but even then patients with abnormal CTF scores were missed. Of 32 patients with vibration perception of 4 seconds or less, 50% still had normal monofilament test results, including 5 of 17 (29%) with completely absent vibration sensation, Dr. Oyer and his associates reported (Endocr. Pract. 2007;13:5-10).

In a review of 81 patients with a history of diabetic foot ulcers, among those with a CTF vibration perception duration of 4 seconds or less, 10 of 32 had diabetic foot ulcers, compared with 1 ulcer in 49 patients who had a CTF score of 5 seconds or more (Endocr. Pract. 2007;13:5-10). Thus, there was a 15-fold increased relative risk for foot ulcers in patients with a CTF score of 4 seconds or less, compared with those having a vibration perception duration of 5 seconds or above, Dr. Oyer said.

In a second study, published as an abstract for the ADA's 2008 annual scientific sessions, 68% of 148 patients with CTF scores of 8 seconds or less had normal monofilament test results. In 112 patients with CTF scores indicating severe neuropathy (4 seconds or less), 68% had a normal monofilament test. And in 49 patients with CTF scores of 0 seconds, 16 (33%) still had a normal monofilament test.

A history of a diabetic foot ulcer was present in 21 patients. All had CTF scores of 4 seconds or less, while 5 (24%) had normal monofilament tests. When the CTF score was 5 seconds or more, monofilament testing was normal in 96% of patients. Thus, a CTF score of 4 seconds or less was 100% sensitive for ulcer risk, whereas the 10-g monofilament was only 76% sensitive.

The increased sensitivity of the CTF comes at the expense of specificity, however, identifying many at-risk patients who would not end up developing an ulcer if left untreated. Specificity of the CTF is just 20%, compared with 75% for the monofilament. “If you want to prevent ulcers, you have to identify everyone at risk, so you can do everything you can to prevent them, with measures such as teaching patients to use mirrors to inspect their feet, and in some cases provide custom footwear,” he noted.

But Dr. Andrew J.M. Boulton, chair of the ADA's Foot Care Interest Group, said he believes that it's too soon to replace the monofilament with the CTF as a first-line screening test for diabetic neuropathy. The CTF results are “very interesting, and I think that this is certainly a useful addition to the monofilaments,” he said in an interview, adding that they are consistent with last year's recommendation of using monofilaments together with one other of four tests.

Dr. Boulton, who divides his time between the Manchester (England) Diabetes Centre and the division of endocrinology, diabetes, and metabolism at the University of Miami, noted that data from prospective studies also support the monofilaments. In one review of six such studies, the increased risk of ulceration ranged from an odds ratio of 2.2 to 9.99, and the relative risk of amputation was 2.9 with an abnormal monofilament test (J. Fam. Pract. 2000;49[11 suppl]:S17-29).

“What is needed with this test is a prospective study…. This new tuning fork test may well be useful but before it can replace the monofilament—if it is to at all—good longitudinal studies must be done to show its predictive value,” said Dr. Boulton, who has received honoraria/consulting fees from Pfizer and Eli Lilly & Co.

Dr. Oyer and Dr. Saxon are conducting two ongoing trials with the CTF test. One is seeking to establish vibration perception ranges for nondiabetic people aged 40 and older. The other is looking at whether Metanx, a widely-used vitamin therapy for diabetic neuropathy, improves the CTF score, he said in an interview.

Dr. Oyer and Dr. Saxon stated they had no conflicts of interest to disclose.

Although the method takes some practice, the clanging tuning fork test is simple and reliable, Dr. Saxon said, using these steps:

▸ Using a standard C-128 tuning fork, strike the tuning fork against the palm with an upstroke, just hard enough to make the ends clang together. If there is no metallic “clang,” try hitting harder. But if there is an extra-loud “clang,” dampen it and try again more lightly.

▸ Hold the tuning fork with only two fingers. “Pretend you're at a bar holding a dart,” Dr. Saxon said. Don't rest your hand against the tines because contact will shorten the vibration time.

▸ When using the CTF on patients for the first time, it's a good idea to demonstrate on one of their hands to make sure they understand the difference between vibration and pressure by checking if they recognize when the vibration stops.

▸ For the actual test on the foot, immediately after striking, the tuning fork is placed on the dorsal toe just proximal to the nail, and the seconds counted until the patient says “now,” signifying the point at which he or she begins to doubt that the vibration is perceptible.

▸ The test is repeated on the other foot, and the score from both toes is averaged.

ATLANTA — The clanging tuning fork test is far more accurate and sensitive than is the 10-g monofilament in screening diabetes patients for peripheral neuropathy, results from two studies suggest.

In fact, relying on the monofilament alone to screen patients for diabetic peripheral neuropathy (DPN) will miss all but the most severe, advanced cases, Dr. David S. Oyer and Dr. David Saxon said at the annual meeting of the American Association of Diabetes Educators.

“The clanging tuning fork [CTF] test detects diabetic peripheral neuropathy and increased risk of ulcer earlier than the monofilament. It should be the standard test for DPN. I don't think you need the monofilament at all. The CTF should be the A_1c of the foot,” said Dr. Oyer, an endocrinologist at Northwestern University, Chicago.

He presented data from two studies, one of which showed that the 10-g Semmes-Weinstein monofilament test was normal in more than two-thirds of patients who were found by the CTF test to have severe DPN. Yet guidelines from the American Diabetes Association—endorsed by the American Association of Clinical Endocrinologists—recommend the 10-g monofilament as the main screening tool for diabetic foot evaluation, along with a choice of one of four other tests. The 128-Hz tuning fork is among those four choices (the others are pinprick sensation, ankle reflexes, and vibration perception threshold testing), but no specific parameters are given for how to use it (Diabetes Care 2008;31:1679-85).

Dr. Saxon, an endocrinology resident at the University of Michigan, Ann Arbor, enumerated several limitations of the monofilament, including the fact that those distributed free by drug companies often are not reliable and do not always give 10 g of force. Moreover, cold monofilaments must be warmed up to work properly. After about 100 bends, monofilaments tend to “fatigue” and need to “rest” for 24 hours. Also, testing on a callus can give an inaccurate result, Dr. Saxon said.

In a previously published study, Dr. Oyer demonstrated reproducibility of the CTF in 12 patients with diabetes on whom he performed the test 10 times on the same toe for each. Scores ranged from 3.4 to 18.8 seconds, with a mean of 10.2 and standard deviation of 1.3 seconds, representing less than a 10% error.

In a second part of that study, a single reading from the right foot versus the left foot was compared in 30 randomly selected patients with diabetes. The vibration duration sensation averaged was 10.9 seconds on the right foot and 9.7 seconds on the left. The two feet will almost always be nearly the same unless the patient has sciatica, Dr. Oyer noted.

Monofilament testing was done in patients whose mean vibration duration was 8 seconds or less, and was consistently reported as normal (correctly identified and patient able to feel all eight spots touched) among the 26 patients who had vibration durations of 5 seconds or more. Only at vibration perceptions of 4 seconds or less did the monofilament testing begin to demonstrate abnormal results, but even then patients with abnormal CTF scores were missed. Of 32 patients with vibration perception of 4 seconds or less, 50% still had normal monofilament test results, including 5 of 17 (29%) with completely absent vibration sensation, Dr. Oyer and his associates reported (Endocr. Pract. 2007;13:5-10).

In a review of 81 patients with a history of diabetic foot ulcers, among those with a CTF vibration perception duration of 4 seconds or less, 10 of 32 had diabetic foot ulcers, compared with 1 ulcer in 49 patients who had a CTF score of 5 seconds or more (Endocr. Pract. 2007;13:5-10). Thus, there was a 15-fold increased relative risk for foot ulcers in patients with a CTF score of 4 seconds or less, compared with those having a vibration perception duration of 5 seconds or above, Dr. Oyer said.

In a second study, published as an abstract for the ADA's 2008 annual scientific sessions, 68% of 148 patients with CTF scores of 8 seconds or less had normal monofilament test results. In 112 patients with CTF scores indicating severe neuropathy (4 seconds or less), 68% had a normal monofilament test. And in 49 patients with CTF scores of 0 seconds, 16 (33%) still had a normal monofilament test.

A history of a diabetic foot ulcer was present in 21 patients. All had CTF scores of 4 seconds or less, while 5 (24%) had normal monofilament tests. When the CTF score was 5 seconds or more, monofilament testing was normal in 96% of patients. Thus, a CTF score of 4 seconds or less was 100% sensitive for ulcer risk, whereas the 10-g monofilament was only 76% sensitive.

The increased sensitivity of the CTF comes at the expense of specificity, however, identifying many at-risk patients who would not end up developing an ulcer if left untreated. Specificity of the CTF is just 20%, compared with 75% for the monofilament. “If you want to prevent ulcers, you have to identify everyone at risk, so you can do everything you can to prevent them, with measures such as teaching patients to use mirrors to inspect their feet, and in some cases provide custom footwear,” he noted.

But Dr. Andrew J.M. Boulton, chair of the ADA's Foot Care Interest Group, said he believes that it's too soon to replace the monofilament with the CTF as a first-line screening test for diabetic neuropathy. The CTF results are “very interesting, and I think that this is certainly a useful addition to the monofilaments,” he said in an interview, adding that they are consistent with last year's recommendation of using monofilaments together with one other of four tests.

Dr. Boulton, who divides his time between the Manchester (England) Diabetes Centre and the division of endocrinology, diabetes, and metabolism at the University of Miami, noted that data from prospective studies also support the monofilaments. In one review of six such studies, the increased risk of ulceration ranged from an odds ratio of 2.2 to 9.99, and the relative risk of amputation was 2.9 with an abnormal monofilament test (J. Fam. Pract. 2000;49[11 suppl]:S17-29).

“What is needed with this test is a prospective study…. This new tuning fork test may well be useful but before it can replace the monofilament—if it is to at all—good longitudinal studies must be done to show its predictive value,” said Dr. Boulton, who has received honoraria/consulting fees from Pfizer and Eli Lilly & Co.

Dr. Oyer and Dr. Saxon are conducting two ongoing trials with the CTF test. One is seeking to establish vibration perception ranges for nondiabetic people aged 40 and older. The other is looking at whether Metanx, a widely-used vitamin therapy for diabetic neuropathy, improves the CTF score, he said in an interview.

Dr. Oyer and Dr. Saxon stated they had no conflicts of interest to disclose.

Although the method takes some practice, the clanging tuning fork test is simple and reliable, Dr. Saxon said, using these steps:

▸ Using a standard C-128 tuning fork, strike the tuning fork against the palm with an upstroke, just hard enough to make the ends clang together. If there is no metallic “clang,” try hitting harder. But if there is an extra-loud “clang,” dampen it and try again more lightly.

▸ Hold the tuning fork with only two fingers. “Pretend you're at a bar holding a dart,” Dr. Saxon said. Don't rest your hand against the tines because contact will shorten the vibration time.

▸ When using the CTF on patients for the first time, it's a good idea to demonstrate on one of their hands to make sure they understand the difference between vibration and pressure by checking if they recognize when the vibration stops.

▸ For the actual test on the foot, immediately after striking, the tuning fork is placed on the dorsal toe just proximal to the nail, and the seconds counted until the patient says “now,” signifying the point at which he or she begins to doubt that the vibration is perceptible.

▸ The test is repeated on the other foot, and the score from both toes is averaged.

ATLANTA — Revaccination against meningococcal disease with the quadrivalent meningococcal conjugate vaccine was recommended for certain high-risk individuals by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

Although the Food and Drug Administration labeling of the quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) is only for a single dose, ACIP voted to recommend revaccination for specific groups at high risk for meningococcal disease “out of an abundance of caution,” Dr. Amanda Cohn said at a meeting of ACIP.

The committee recommended a second dose of MCV4—or a first dose of MCV4 in people who already received one dose of polysaccharide meningococcal vaccine—after 5 years for the following high-risk groups of people aged 7-55 years:

▸ Persons with persistent complement deficiencies.

▸ Persons with anatomic or functional asplenia.

▸ Microbiologists who are routinely exposed to isolates of Neisseria meningitidis.

▸ Frequent travelers to or people living in areas with high rates of meningococcal disease, such as the African meningitis belt.

At this time, ACIP did not recommend revaccination for college freshmen living in dorms who were previously vaccinated with MCV4 at age 11-18 years, nor did they recommend it for military recruits. “We will continue to monitor if there is a need for more broad revaccination with MCV4,” said Dr. Cohn of the CDC's division of bacterial diseases.

ATLANTA — Revaccination against meningococcal disease with the quadrivalent meningococcal conjugate vaccine was recommended for certain high-risk individuals by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

Although the Food and Drug Administration labeling of the quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) is only for a single dose, ACIP voted to recommend revaccination for specific groups at high risk for meningococcal disease “out of an abundance of caution,” Dr. Amanda Cohn said at a meeting of ACIP.

The committee recommended a second dose of MCV4—or a first dose of MCV4 in people who already received one dose of polysaccharide meningococcal vaccine—after 5 years for the following high-risk groups of people aged 7-55 years:

▸ Persons with persistent complement deficiencies.

▸ Persons with anatomic or functional asplenia.

▸ Microbiologists who are routinely exposed to isolates of Neisseria meningitidis.

▸ Frequent travelers to or people living in areas with high rates of meningococcal disease, such as the African meningitis belt.

At this time, ACIP did not recommend revaccination for college freshmen living in dorms who were previously vaccinated with MCV4 at age 11-18 years, nor did they recommend it for military recruits. “We will continue to monitor if there is a need for more broad revaccination with MCV4,” said Dr. Cohn of the CDC's division of bacterial diseases.

ATLANTA — Revaccination against meningococcal disease with the quadrivalent meningococcal conjugate vaccine was recommended for certain high-risk individuals by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

Although the Food and Drug Administration labeling of the quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) is only for a single dose, ACIP voted to recommend revaccination for specific groups at high risk for meningococcal disease “out of an abundance of caution,” Dr. Amanda Cohn said at a meeting of ACIP.

The committee recommended a second dose of MCV4—or a first dose of MCV4 in people who already received one dose of polysaccharide meningococcal vaccine—after 5 years for the following high-risk groups of people aged 7-55 years:

▸ Persons with persistent complement deficiencies.

▸ Persons with anatomic or functional asplenia.

▸ Microbiologists who are routinely exposed to isolates of Neisseria meningitidis.

▸ Frequent travelers to or people living in areas with high rates of meningococcal disease, such as the African meningitis belt.

At this time, ACIP did not recommend revaccination for college freshmen living in dorms who were previously vaccinated with MCV4 at age 11-18 years, nor did they recommend it for military recruits. “We will continue to monitor if there is a need for more broad revaccination with MCV4,” said Dr. Cohn of the CDC's division of bacterial diseases.

ATLANTA — The effectiveness of the meningococcal conjugate vaccine within 3 years of vaccination is estimated to be between 80% and 90%, an analysis by the Centers for Disease Control and Prevention found.

The quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) was licensed based on safety and immunogenicity data showing that it was noninferior to the meningococcal polysaccharide vaccine, which is 85% effective against serogroup C. In prelicensure clinical trials, the seroresponse of MCV4 was 92% for serogroup C and 82% for serogroup Y. The current study provides the first estimate of clinical vaccine effectiveness of MCV4, which is recommended for routine immunization of 11- to 18-year-olds. The results suggest that it is about as effective as the meningococcal polysaccharide vaccine, Jessica MacNeil said at a meeting of the CDC's Advisory Committee on Immunization Practices.

The data came from 20 participating sites of CDC's Active Bacterial Core Surveillance (ABCs) and MeningNet sites between January 2005 (when MCV4 was licensed) and December 2008.

Among vaccinated individuals, 14 confirmed cases of meningococcal disease—8 (57%) serogroup C and 6 (43%) serogroup Y—were identified at 6 of the 20 sites. All had received MCV4, but there was no common lot among them. The median time from vaccination to disease onset was 395 days (range, 43-1,021), said Ms. MacNeil of the CDC's division of bacterial diseases, National Center for Immunization and Respiratory Diseases.

Half of the 14 cases were among college students, and 2 were in military recruits. The median age at vaccination was 18 years (range, 13-20), and the median age at the time of disease was 20 years (range, 15-22).

Nearly half of the cases occurred within the first year following vaccination, with the other cases occurring at either 1-2 years or more than 2 years post vaccination. Because MCV4 coverage was low in 2005 and 2006, only individuals who were vaccinated early have had time to be observed 2 or 3 years after vaccination. This distribution is expected to change with time, Ms. MacNeil noted.

All but one of the infected patients was hospitalized, with a mean hospitalization duration of 3 days (range, 0-46). Meningitis was reported in six of the patients (43%) and bacteremia in eight (57%). Nine had underlying medical conditions. There were three deaths, for a 21% case fatality rate.

A simulation approach using varying estimates of vaccine effectiveness was used to determine whether the 14 cases represent an expected number among vaccinated individuals. The analysis used an incidence of serogroup C and Y disease among 13- to 18-year-olds of 0.38/100,000. This incidence rate is similar to the observed rates in the unvaccinated individuals that were calculated using data from the 20 participating case-control study sites, she said.

If MCV4 were 90% effective, there would be an expected median of 7 cases, with a 2.9% probability of observing 14 or more cases of meningococcal disease in vaccinated persons. If vaccine efficacy were just 80%, there would be an expected median of 15 cases, with a 66.1% probability of seeing 14 or more cases. Thus, “based on our best estimates of MCV4 coverage, vaccine effectiveness appears to be greater than 80% but is unlikely to be 90% effective,” Ms. MacNeil said.

With coverage held constant at 50% for all persons 18 years of age or older during 2005-2008, if MCV4 were 90% effective, there is a 5% chance of seeing 14 cases in vaccinated persons; if MCV4 were 85% effective, there is a 47% chance of seeing 14 cases. “Even with high estimates of coverage in our sensitivity analysis, MCV4 appears to be between 80% to 90% effective,” she added.

The ACIP meningococcal working group expects more data to be available in 1-3 years to further evaluate vaccine effectiveness, Ms. MacNeil said. The CDC is in the process of expanding its MCV4 effectiveness case-control study to additional sites.

ATLANTA — The effectiveness of the meningococcal conjugate vaccine within 3 years of vaccination is estimated to be between 80% and 90%, an analysis by the Centers for Disease Control and Prevention found.

The quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) was licensed based on safety and immunogenicity data showing that it was noninferior to the meningococcal polysaccharide vaccine, which is 85% effective against serogroup C. In prelicensure clinical trials, the seroresponse of MCV4 was 92% for serogroup C and 82% for serogroup Y. The current study provides the first estimate of clinical vaccine effectiveness of MCV4, which is recommended for routine immunization of 11- to 18-year-olds. The results suggest that it is about as effective as the meningococcal polysaccharide vaccine, Jessica MacNeil said at a meeting of the CDC's Advisory Committee on Immunization Practices.

The data came from 20 participating sites of CDC's Active Bacterial Core Surveillance (ABCs) and MeningNet sites between January 2005 (when MCV4 was licensed) and December 2008.

Among vaccinated individuals, 14 confirmed cases of meningococcal disease—8 (57%) serogroup C and 6 (43%) serogroup Y—were identified at 6 of the 20 sites. All had received MCV4, but there was no common lot among them. The median time from vaccination to disease onset was 395 days (range, 43-1,021), said Ms. MacNeil of the CDC's division of bacterial diseases, National Center for Immunization and Respiratory Diseases.

Half of the 14 cases were among college students, and 2 were in military recruits. The median age at vaccination was 18 years (range, 13-20), and the median age at the time of disease was 20 years (range, 15-22).

Nearly half of the cases occurred within the first year following vaccination, with the other cases occurring at either 1-2 years or more than 2 years post vaccination. Because MCV4 coverage was low in 2005 and 2006, only individuals who were vaccinated early have had time to be observed 2 or 3 years after vaccination. This distribution is expected to change with time, Ms. MacNeil noted.

All but one of the infected patients was hospitalized, with a mean hospitalization duration of 3 days (range, 0-46). Meningitis was reported in six of the patients (43%) and bacteremia in eight (57%). Nine had underlying medical conditions. There were three deaths, for a 21% case fatality rate.

A simulation approach using varying estimates of vaccine effectiveness was used to determine whether the 14 cases represent an expected number among vaccinated individuals. The analysis used an incidence of serogroup C and Y disease among 13- to 18-year-olds of 0.38/100,000. This incidence rate is similar to the observed rates in the unvaccinated individuals that were calculated using data from the 20 participating case-control study sites, she said.

If MCV4 were 90% effective, there would be an expected median of 7 cases, with a 2.9% probability of observing 14 or more cases of meningococcal disease in vaccinated persons. If vaccine efficacy were just 80%, there would be an expected median of 15 cases, with a 66.1% probability of seeing 14 or more cases. Thus, “based on our best estimates of MCV4 coverage, vaccine effectiveness appears to be greater than 80% but is unlikely to be 90% effective,” Ms. MacNeil said.

With coverage held constant at 50% for all persons 18 years of age or older during 2005-2008, if MCV4 were 90% effective, there is a 5% chance of seeing 14 cases in vaccinated persons; if MCV4 were 85% effective, there is a 47% chance of seeing 14 cases. “Even with high estimates of coverage in our sensitivity analysis, MCV4 appears to be between 80% to 90% effective,” she added.

The ACIP meningococcal working group expects more data to be available in 1-3 years to further evaluate vaccine effectiveness, Ms. MacNeil said. The CDC is in the process of expanding its MCV4 effectiveness case-control study to additional sites.

ATLANTA — The effectiveness of the meningococcal conjugate vaccine within 3 years of vaccination is estimated to be between 80% and 90%, an analysis by the Centers for Disease Control and Prevention found.

The quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) was licensed based on safety and immunogenicity data showing that it was noninferior to the meningococcal polysaccharide vaccine, which is 85% effective against serogroup C. In prelicensure clinical trials, the seroresponse of MCV4 was 92% for serogroup C and 82% for serogroup Y. The current study provides the first estimate of clinical vaccine effectiveness of MCV4, which is recommended for routine immunization of 11- to 18-year-olds. The results suggest that it is about as effective as the meningococcal polysaccharide vaccine, Jessica MacNeil said at a meeting of the CDC's Advisory Committee on Immunization Practices.

The data came from 20 participating sites of CDC's Active Bacterial Core Surveillance (ABCs) and MeningNet sites between January 2005 (when MCV4 was licensed) and December 2008.

Among vaccinated individuals, 14 confirmed cases of meningococcal disease—8 (57%) serogroup C and 6 (43%) serogroup Y—were identified at 6 of the 20 sites. All had received MCV4, but there was no common lot among them. The median time from vaccination to disease onset was 395 days (range, 43-1,021), said Ms. MacNeil of the CDC's division of bacterial diseases, National Center for Immunization and Respiratory Diseases.

Half of the 14 cases were among college students, and 2 were in military recruits. The median age at vaccination was 18 years (range, 13-20), and the median age at the time of disease was 20 years (range, 15-22).

Nearly half of the cases occurred within the first year following vaccination, with the other cases occurring at either 1-2 years or more than 2 years post vaccination. Because MCV4 coverage was low in 2005 and 2006, only individuals who were vaccinated early have had time to be observed 2 or 3 years after vaccination. This distribution is expected to change with time, Ms. MacNeil noted.

All but one of the infected patients was hospitalized, with a mean hospitalization duration of 3 days (range, 0-46). Meningitis was reported in six of the patients (43%) and bacteremia in eight (57%). Nine had underlying medical conditions. There were three deaths, for a 21% case fatality rate.

A simulation approach using varying estimates of vaccine effectiveness was used to determine whether the 14 cases represent an expected number among vaccinated individuals. The analysis used an incidence of serogroup C and Y disease among 13- to 18-year-olds of 0.38/100,000. This incidence rate is similar to the observed rates in the unvaccinated individuals that were calculated using data from the 20 participating case-control study sites, she said.

If MCV4 were 90% effective, there would be an expected median of 7 cases, with a 2.9% probability of observing 14 or more cases of meningococcal disease in vaccinated persons. If vaccine efficacy were just 80%, there would be an expected median of 15 cases, with a 66.1% probability of seeing 14 or more cases. Thus, “based on our best estimates of MCV4 coverage, vaccine effectiveness appears to be greater than 80% but is unlikely to be 90% effective,” Ms. MacNeil said.

With coverage held constant at 50% for all persons 18 years of age or older during 2005-2008, if MCV4 were 90% effective, there is a 5% chance of seeing 14 cases in vaccinated persons; if MCV4 were 85% effective, there is a 47% chance of seeing 14 cases. “Even with high estimates of coverage in our sensitivity analysis, MCV4 appears to be between 80% to 90% effective,” she added.

The ACIP meningococcal working group expects more data to be available in 1-3 years to further evaluate vaccine effectiveness, Ms. MacNeil said. The CDC is in the process of expanding its MCV4 effectiveness case-control study to additional sites.

Atlanta — The clanging tuning fork test is far more accurate and sensitive than is the 10-g monofilament in screening diabetes patients for peripheral neuropathy, results from two studies suggest.

In fact, relying on the monofilament alone to screen patients for diabetic peripheral neuropathy (DPN) will miss all but the most severe, advanced cases, Dr. David S. Oyer and Dr. David Saxon said at the annual meeting of the American Association of Diabetes Educators.

But Dr. Andrew J.M. Boulton, chair of the American Diabetes Association's Foot Care Interest Group, said he believes that it's too soon to replace the monofilament with the CTF as a first-line screening test for diabetic neuropathy. The CTF results are “of course very interesting, and I think that this is certainly a useful addition to the monofilaments,” he said in an interview, adding that they are consistent with last year's recommendation of using monofilaments together with one other of four tests. Dr. Boulton, who divides his time between the Manchester (England) Diabetes Centre and the division of endocrinology, diabetes, and metabolism at the University of Miami, noted that data from prospective studies also support the monofilaments.

Dr. Oyer presented data from two studies, one of which showed that the 10-g Semmes-Weinstein monofilament test was normal in more than two-thirds of patients who were found by the CTF test to have severe DPN. Guidelines from the American Diabetes Association—endorsed by the American Association of Clinical Endocrinologists—recommend the 10-g monofilament as the main screening tool for diabetic foot evaluation, along with a choice of one of four other tests. (Diabetes Care 2008;31:1679-85).

Dr. Saxon, an endocrinology resident at the University of Michigan, Ann Arbor, enumerated several limitations of the monofilament, including the fact that those distributed free by drug companies often are not reliable and do not always give 10 g of force. Moreover, cold monofilaments must be warmed up to work properly. After about 100 bends, monofilaments tend to “fatigue” and need to “rest” for 24 hours. Also, testing on a callus can give an inaccurate result, Dr. Saxon said.

In a previously published study, Dr. Oyer demonstrated reproducibility of the CTF in 12 patients with diabetes on whom he performed the test 10 times on the same toe for each. Scores ranged from 3.4 to 18.8 seconds, with a mean of 10.2 and standard deviation of 1.3 seconds, representing less than a 10% error.

In a second part of that study, a single reading from the right foot versus the left foot was compared in 30 randomly selected patients with diabetes. The vibration duration sensation averaged was 10.9 seconds on the right foot and 9.7 seconds on the left, said Dr. Oyer, an endocrinologist at Northwestern University, Chicago.

Monofilament testing was done in patients whose mean vibration duration was 8 seconds or less, and was consistently reported as normal among the 26 patients who had vibration durations of 5 seconds or more. Only at vibration perceptions of 4 seconds or less did the monofilament testing begin to demonstrate abnormal results (Endocr. Pract. 2007;13:5-10).

Dr. Oyer and Dr. Saxon stated that they had no conflicts of interest to disclose.

Atlanta — The clanging tuning fork test is far more accurate and sensitive than is the 10-g monofilament in screening diabetes patients for peripheral neuropathy, results from two studies suggest.

In fact, relying on the monofilament alone to screen patients for diabetic peripheral neuropathy (DPN) will miss all but the most severe, advanced cases, Dr. David S. Oyer and Dr. David Saxon said at the annual meeting of the American Association of Diabetes Educators.

But Dr. Andrew J.M. Boulton, chair of the American Diabetes Association's Foot Care Interest Group, said he believes that it's too soon to replace the monofilament with the CTF as a first-line screening test for diabetic neuropathy. The CTF results are “of course very interesting, and I think that this is certainly a useful addition to the monofilaments,” he said in an interview, adding that they are consistent with last year's recommendation of using monofilaments together with one other of four tests. Dr. Boulton, who divides his time between the Manchester (England) Diabetes Centre and the division of endocrinology, diabetes, and metabolism at the University of Miami, noted that data from prospective studies also support the monofilaments.

Dr. Oyer presented data from two studies, one of which showed that the 10-g Semmes-Weinstein monofilament test was normal in more than two-thirds of patients who were found by the CTF test to have severe DPN. Guidelines from the American Diabetes Association—endorsed by the American Association of Clinical Endocrinologists—recommend the 10-g monofilament as the main screening tool for diabetic foot evaluation, along with a choice of one of four other tests. (Diabetes Care 2008;31:1679-85).

Dr. Saxon, an endocrinology resident at the University of Michigan, Ann Arbor, enumerated several limitations of the monofilament, including the fact that those distributed free by drug companies often are not reliable and do not always give 10 g of force. Moreover, cold monofilaments must be warmed up to work properly. After about 100 bends, monofilaments tend to “fatigue” and need to “rest” for 24 hours. Also, testing on a callus can give an inaccurate result, Dr. Saxon said.

In a previously published study, Dr. Oyer demonstrated reproducibility of the CTF in 12 patients with diabetes on whom he performed the test 10 times on the same toe for each. Scores ranged from 3.4 to 18.8 seconds, with a mean of 10.2 and standard deviation of 1.3 seconds, representing less than a 10% error.

In a second part of that study, a single reading from the right foot versus the left foot was compared in 30 randomly selected patients with diabetes. The vibration duration sensation averaged was 10.9 seconds on the right foot and 9.7 seconds on the left, said Dr. Oyer, an endocrinologist at Northwestern University, Chicago.

Monofilament testing was done in patients whose mean vibration duration was 8 seconds or less, and was consistently reported as normal among the 26 patients who had vibration durations of 5 seconds or more. Only at vibration perceptions of 4 seconds or less did the monofilament testing begin to demonstrate abnormal results (Endocr. Pract. 2007;13:5-10).

Dr. Oyer and Dr. Saxon stated that they had no conflicts of interest to disclose.

Atlanta — The clanging tuning fork test is far more accurate and sensitive than is the 10-g monofilament in screening diabetes patients for peripheral neuropathy, results from two studies suggest.

In fact, relying on the monofilament alone to screen patients for diabetic peripheral neuropathy (DPN) will miss all but the most severe, advanced cases, Dr. David S. Oyer and Dr. David Saxon said at the annual meeting of the American Association of Diabetes Educators.

But Dr. Andrew J.M. Boulton, chair of the American Diabetes Association's Foot Care Interest Group, said he believes that it's too soon to replace the monofilament with the CTF as a first-line screening test for diabetic neuropathy. The CTF results are “of course very interesting, and I think that this is certainly a useful addition to the monofilaments,” he said in an interview, adding that they are consistent with last year's recommendation of using monofilaments together with one other of four tests. Dr. Boulton, who divides his time between the Manchester (England) Diabetes Centre and the division of endocrinology, diabetes, and metabolism at the University of Miami, noted that data from prospective studies also support the monofilaments.

Dr. Oyer presented data from two studies, one of which showed that the 10-g Semmes-Weinstein monofilament test was normal in more than two-thirds of patients who were found by the CTF test to have severe DPN. Guidelines from the American Diabetes Association—endorsed by the American Association of Clinical Endocrinologists—recommend the 10-g monofilament as the main screening tool for diabetic foot evaluation, along with a choice of one of four other tests. (Diabetes Care 2008;31:1679-85).

Dr. Saxon, an endocrinology resident at the University of Michigan, Ann Arbor, enumerated several limitations of the monofilament, including the fact that those distributed free by drug companies often are not reliable and do not always give 10 g of force. Moreover, cold monofilaments must be warmed up to work properly. After about 100 bends, monofilaments tend to “fatigue” and need to “rest” for 24 hours. Also, testing on a callus can give an inaccurate result, Dr. Saxon said.

In a previously published study, Dr. Oyer demonstrated reproducibility of the CTF in 12 patients with diabetes on whom he performed the test 10 times on the same toe for each. Scores ranged from 3.4 to 18.8 seconds, with a mean of 10.2 and standard deviation of 1.3 seconds, representing less than a 10% error.

In a second part of that study, a single reading from the right foot versus the left foot was compared in 30 randomly selected patients with diabetes. The vibration duration sensation averaged was 10.9 seconds on the right foot and 9.7 seconds on the left, said Dr. Oyer, an endocrinologist at Northwestern University, Chicago.

Monofilament testing was done in patients whose mean vibration duration was 8 seconds or less, and was consistently reported as normal among the 26 patients who had vibration durations of 5 seconds or more. Only at vibration perceptions of 4 seconds or less did the monofilament testing begin to demonstrate abnormal results (Endocr. Pract. 2007;13:5-10).

Dr. Oyer and Dr. Saxon stated that they had no conflicts of interest to disclose.

Two trials are underway to test the safety and efficacy of a candidate pediatric vaccine for novel influenza A(H1N1).

An independent safety monitoring committee recommended in mid-August that trials of a candidate vaccine begin in children. The National Institute of Allergy and Infectious Diseases (NIAID) concurred with the recommendation. The two trials are being conducted through the agency's Vaccine and Treatment Evaluation Unit (VTEU) network.

The safety monitoring committee reviewed data from more than 500 healthy adult and elderly volunteers enrolled in three VTEU trials of candidate novel H1N1 vaccines that began Aug. 7 and found no safety concerns in those trials that would preclude the start of pediatric trials, the NIAID said in a statement.

One trial is investigating the immune response to two different strengths of a candidate vaccine manufactured by Sanofi Pasteur. Led by the VTEU at the University of Maryland, Baltimore, the trial is enrolling up to 650 children aged 6 months to 17 years at five locations. Immune responses will be measured following doses of either 15 mcg or 30 mcg of vaccine at the first visit and a second dose 3 weeks later.

The second trial, led by the VTEU at St. Louis University and occurring at five other institutions, is testing administration of seasonal influenza vaccine along with a candidate novel H1N1 vaccine. The study will assess the candidate vaccine's safety and how immune responses vary when the novel H1N1 vaccine is given before, after, or at the same time as the seasonal vaccine.

Two trials are underway to test the safety and efficacy of a candidate pediatric vaccine for novel influenza A(H1N1).

An independent safety monitoring committee recommended in mid-August that trials of a candidate vaccine begin in children. The National Institute of Allergy and Infectious Diseases (NIAID) concurred with the recommendation. The two trials are being conducted through the agency's Vaccine and Treatment Evaluation Unit (VTEU) network.

The safety monitoring committee reviewed data from more than 500 healthy adult and elderly volunteers enrolled in three VTEU trials of candidate novel H1N1 vaccines that began Aug. 7 and found no safety concerns in those trials that would preclude the start of pediatric trials, the NIAID said in a statement.

One trial is investigating the immune response to two different strengths of a candidate vaccine manufactured by Sanofi Pasteur. Led by the VTEU at the University of Maryland, Baltimore, the trial is enrolling up to 650 children aged 6 months to 17 years at five locations. Immune responses will be measured following doses of either 15 mcg or 30 mcg of vaccine at the first visit and a second dose 3 weeks later.

The second trial, led by the VTEU at St. Louis University and occurring at five other institutions, is testing administration of seasonal influenza vaccine along with a candidate novel H1N1 vaccine. The study will assess the candidate vaccine's safety and how immune responses vary when the novel H1N1 vaccine is given before, after, or at the same time as the seasonal vaccine.

Two trials are underway to test the safety and efficacy of a candidate pediatric vaccine for novel influenza A(H1N1).

An independent safety monitoring committee recommended in mid-August that trials of a candidate vaccine begin in children. The National Institute of Allergy and Infectious Diseases (NIAID) concurred with the recommendation. The two trials are being conducted through the agency's Vaccine and Treatment Evaluation Unit (VTEU) network.

The safety monitoring committee reviewed data from more than 500 healthy adult and elderly volunteers enrolled in three VTEU trials of candidate novel H1N1 vaccines that began Aug. 7 and found no safety concerns in those trials that would preclude the start of pediatric trials, the NIAID said in a statement.

One trial is investigating the immune response to two different strengths of a candidate vaccine manufactured by Sanofi Pasteur. Led by the VTEU at the University of Maryland, Baltimore, the trial is enrolling up to 650 children aged 6 months to 17 years at five locations. Immune responses will be measured following doses of either 15 mcg or 30 mcg of vaccine at the first visit and a second dose 3 weeks later.

The second trial, led by the VTEU at St. Louis University and occurring at five other institutions, is testing administration of seasonal influenza vaccine along with a candidate novel H1N1 vaccine. The study will assess the candidate vaccine's safety and how immune responses vary when the novel H1N1 vaccine is given before, after, or at the same time as the seasonal vaccine.

Oseltamivir-resistant novel influenza A (H1N1) virus infection has been identified in the United States for the first time, in two severely immunosuppressed patients in Seattle.

The two cases—a teenaged male and a woman in her 40s—are both leukemia patients who have undergone hematopoietic stem cell transplants. Both were initially infected with oseltamivir-susceptible viruses which later developed resistance during antiviral treatment, the Centers for Disease Control and Prevention reported.

The two patients were treated at different hospitals and were not linked epidemiologically. There was no evidence of transmission of the oseltamivir-resistant virus to health care providers or contacts of either patient, the CDC said.

In both patients, the viruses were found to be susceptible to zanamivir by neuraminidase inhibition assay. Sequence analysis showed that the oseltamivir resistance was not the result of gene reassortment with seasonal influenza A (H1N1) virus.

The CDC recommends that immunosuppressed patients receive annual influenza vaccination, even though in some the immune response can be decreased. Clinicians caring for immunosuppressed patients who are infected with novel H1N1 should be aware of the potential of antiviral drug resistance during therapy and prolonged viral shedding, the CDC said.

The public health risk of virus transmission from these two cases appears to be low. Washington state, in collaboration with CDC, is conducting enhanced surveillance for oseltamivir resistance among novel H1N1 virus strains isolated from patients in hospitals and in the community.

Oseltamivir or zanamivir are recommended for treatment of all hospitalized patients with suspected or confirmed novel H1N1 and for outpatients at increased risk for influenza-related complications.

Zanamivir should be considered the treatment of choice in immunosuppressed patients with oseltamivir-resistant novel H1N1 infection, except for those with underlying airway disease.

Guidance on treatment and prevention is available atwww.cdc.gov/h1n1flu

Oseltamivir-resistant novel influenza A (H1N1) virus infection has been identified in the United States for the first time, in two severely immunosuppressed patients in Seattle.

The two cases—a teenaged male and a woman in her 40s—are both leukemia patients who have undergone hematopoietic stem cell transplants. Both were initially infected with oseltamivir-susceptible viruses which later developed resistance during antiviral treatment, the Centers for Disease Control and Prevention reported.

The two patients were treated at different hospitals and were not linked epidemiologically. There was no evidence of transmission of the oseltamivir-resistant virus to health care providers or contacts of either patient, the CDC said.

In both patients, the viruses were found to be susceptible to zanamivir by neuraminidase inhibition assay. Sequence analysis showed that the oseltamivir resistance was not the result of gene reassortment with seasonal influenza A (H1N1) virus.

The CDC recommends that immunosuppressed patients receive annual influenza vaccination, even though in some the immune response can be decreased. Clinicians caring for immunosuppressed patients who are infected with novel H1N1 should be aware of the potential of antiviral drug resistance during therapy and prolonged viral shedding, the CDC said.

The public health risk of virus transmission from these two cases appears to be low. Washington state, in collaboration with CDC, is conducting enhanced surveillance for oseltamivir resistance among novel H1N1 virus strains isolated from patients in hospitals and in the community.

Oseltamivir or zanamivir are recommended for treatment of all hospitalized patients with suspected or confirmed novel H1N1 and for outpatients at increased risk for influenza-related complications.

Zanamivir should be considered the treatment of choice in immunosuppressed patients with oseltamivir-resistant novel H1N1 infection, except for those with underlying airway disease.

Guidance on treatment and prevention is available atwww.cdc.gov/h1n1flu

Oseltamivir-resistant novel influenza A (H1N1) virus infection has been identified in the United States for the first time, in two severely immunosuppressed patients in Seattle.

The two cases—a teenaged male and a woman in her 40s—are both leukemia patients who have undergone hematopoietic stem cell transplants. Both were initially infected with oseltamivir-susceptible viruses which later developed resistance during antiviral treatment, the Centers for Disease Control and Prevention reported.

The two patients were treated at different hospitals and were not linked epidemiologically. There was no evidence of transmission of the oseltamivir-resistant virus to health care providers or contacts of either patient, the CDC said.

In both patients, the viruses were found to be susceptible to zanamivir by neuraminidase inhibition assay. Sequence analysis showed that the oseltamivir resistance was not the result of gene reassortment with seasonal influenza A (H1N1) virus.

The CDC recommends that immunosuppressed patients receive annual influenza vaccination, even though in some the immune response can be decreased. Clinicians caring for immunosuppressed patients who are infected with novel H1N1 should be aware of the potential of antiviral drug resistance during therapy and prolonged viral shedding, the CDC said.

The public health risk of virus transmission from these two cases appears to be low. Washington state, in collaboration with CDC, is conducting enhanced surveillance for oseltamivir resistance among novel H1N1 virus strains isolated from patients in hospitals and in the community.

Oseltamivir or zanamivir are recommended for treatment of all hospitalized patients with suspected or confirmed novel H1N1 and for outpatients at increased risk for influenza-related complications.

Zanamivir should be considered the treatment of choice in immunosuppressed patients with oseltamivir-resistant novel H1N1 infection, except for those with underlying airway disease.

Guidance on treatment and prevention is available atwww.cdc.gov/h1n1flu