Susan London

Major Finding: Women who had gestational diabetes were 41% more likely to develop hypertension during a 14-year follow-up, compared with those who had not had the condition.

Data Source: A nested prospective cohort study of 26,384 women initially aged 25-44 years who had at least one singleton pregnancy.

Disclosures: Ms. Tobias reported that she had no relevant conflicts of interest.

SEATTLE — Women who have had gestational diabetes may be at elevated risk for hypertension even after established risk factors are taken into account, a nested cohort study indicates.

Using data from the Nurses' Health Study II, researchers followed more than 26,000 women from an index pregnancy for up to 14 years. Those with gestational diabetes during that pregnancy were 41% more likely to develop hypertension even after adjustment for potential confounders such as body mass index, diet, and family history of hypertension.

“These women may represent a target group for intervention to prevent or delay the onset of hypertension, which is a public health concern in the United States,” lead investigator Deirdre K. Tobias concluded.

“The mechanism by which gestational diabetes mellitus could lead to an increased risk of hypertension and other metabolic complications is not yet established,” said Ms. Tobias, who is a doctoral student at the Harvard School of Public Health, Boston.

One possibility is that these conditions have shared risk factors, she noted. Another is that gestational diabetes itself increases the risk of hypertension, for example, by causing vascular damage that manifests later in time.

The Nurses' Health Study II is a prospective cohort study of women aged 25-44 years at baseline that began in 1989.

Extensive questionnaires completed at baseline and biennially include questions about physician-diagnosed gestational diabetes and hypertension.

Ms. Tobias and her colleagues included in their sample the 26,384 women who reported having at least one singleton pregnancy between 1991 (the first year in which dietary data were collected) and 2005, did not have type 2 diabetes or hypertension, had not experienced gestational diabetes in a previous pregnancy, and had not had previous cardiovascular disease.

Study results showed that 6% of the women had gestational diabetes during their index pregnancy. Women with and without gestational diabetes had a mean age of 32 years at baseline, and 7% in each group were current smokers.

However, those with gestational diabetes had a higher body mass index (25 vs. 23 kg/m

Overall, 9% of the women developed hypertension during follow-up, and the cumulative incidence was higher among those who had had gestational diabetes.

After adjustment for potential confounders, women who experienced gestational diabetes still had a 41% higher risk of developing hypertension.

Moreover, compared with women who experienced neither gestational diabetes nor type 2 diabetes, those who experienced both had a near tripling of the risk of developing hypertension.

“It is possible that there was residual or unmeasured confounding,” acknowledged Ms. Tobias. “For example, in our cohort, we were unable to capture pregnancy-related characteristics, such as weight gain or severity of gestational diabetes.”

The generalizability of the findings may be limited, given the women's higher age at baseline and the fact that most were white, she noted.

Major Finding: Women who had gestational diabetes were 41% more likely to develop hypertension during a 14-year follow-up, compared with those who had not had the condition.

Data Source: A nested prospective cohort study of 26,384 women initially aged 25-44 years who had at least one singleton pregnancy.

Disclosures: Ms. Tobias reported that she had no relevant conflicts of interest.

SEATTLE — Women who have had gestational diabetes may be at elevated risk for hypertension even after established risk factors are taken into account, a nested cohort study indicates.

Using data from the Nurses' Health Study II, researchers followed more than 26,000 women from an index pregnancy for up to 14 years. Those with gestational diabetes during that pregnancy were 41% more likely to develop hypertension even after adjustment for potential confounders such as body mass index, diet, and family history of hypertension.

“These women may represent a target group for intervention to prevent or delay the onset of hypertension, which is a public health concern in the United States,” lead investigator Deirdre K. Tobias concluded.

“The mechanism by which gestational diabetes mellitus could lead to an increased risk of hypertension and other metabolic complications is not yet established,” said Ms. Tobias, who is a doctoral student at the Harvard School of Public Health, Boston.

One possibility is that these conditions have shared risk factors, she noted. Another is that gestational diabetes itself increases the risk of hypertension, for example, by causing vascular damage that manifests later in time.

The Nurses' Health Study II is a prospective cohort study of women aged 25-44 years at baseline that began in 1989.

Extensive questionnaires completed at baseline and biennially include questions about physician-diagnosed gestational diabetes and hypertension.

Ms. Tobias and her colleagues included in their sample the 26,384 women who reported having at least one singleton pregnancy between 1991 (the first year in which dietary data were collected) and 2005, did not have type 2 diabetes or hypertension, had not experienced gestational diabetes in a previous pregnancy, and had not had previous cardiovascular disease.

Study results showed that 6% of the women had gestational diabetes during their index pregnancy. Women with and without gestational diabetes had a mean age of 32 years at baseline, and 7% in each group were current smokers.

However, those with gestational diabetes had a higher body mass index (25 vs. 23 kg/m

Overall, 9% of the women developed hypertension during follow-up, and the cumulative incidence was higher among those who had had gestational diabetes.

After adjustment for potential confounders, women who experienced gestational diabetes still had a 41% higher risk of developing hypertension.

Moreover, compared with women who experienced neither gestational diabetes nor type 2 diabetes, those who experienced both had a near tripling of the risk of developing hypertension.

“It is possible that there was residual or unmeasured confounding,” acknowledged Ms. Tobias. “For example, in our cohort, we were unable to capture pregnancy-related characteristics, such as weight gain or severity of gestational diabetes.”

The generalizability of the findings may be limited, given the women's higher age at baseline and the fact that most were white, she noted.

Major Finding: Women who had gestational diabetes were 41% more likely to develop hypertension during a 14-year follow-up, compared with those who had not had the condition.

Data Source: A nested prospective cohort study of 26,384 women initially aged 25-44 years who had at least one singleton pregnancy.

Disclosures: Ms. Tobias reported that she had no relevant conflicts of interest.

SEATTLE — Women who have had gestational diabetes may be at elevated risk for hypertension even after established risk factors are taken into account, a nested cohort study indicates.

Using data from the Nurses' Health Study II, researchers followed more than 26,000 women from an index pregnancy for up to 14 years. Those with gestational diabetes during that pregnancy were 41% more likely to develop hypertension even after adjustment for potential confounders such as body mass index, diet, and family history of hypertension.

“These women may represent a target group for intervention to prevent or delay the onset of hypertension, which is a public health concern in the United States,” lead investigator Deirdre K. Tobias concluded.

“The mechanism by which gestational diabetes mellitus could lead to an increased risk of hypertension and other metabolic complications is not yet established,” said Ms. Tobias, who is a doctoral student at the Harvard School of Public Health, Boston.

One possibility is that these conditions have shared risk factors, she noted. Another is that gestational diabetes itself increases the risk of hypertension, for example, by causing vascular damage that manifests later in time.

The Nurses' Health Study II is a prospective cohort study of women aged 25-44 years at baseline that began in 1989.

Extensive questionnaires completed at baseline and biennially include questions about physician-diagnosed gestational diabetes and hypertension.

Ms. Tobias and her colleagues included in their sample the 26,384 women who reported having at least one singleton pregnancy between 1991 (the first year in which dietary data were collected) and 2005, did not have type 2 diabetes or hypertension, had not experienced gestational diabetes in a previous pregnancy, and had not had previous cardiovascular disease.

Study results showed that 6% of the women had gestational diabetes during their index pregnancy. Women with and without gestational diabetes had a mean age of 32 years at baseline, and 7% in each group were current smokers.

However, those with gestational diabetes had a higher body mass index (25 vs. 23 kg/m

Overall, 9% of the women developed hypertension during follow-up, and the cumulative incidence was higher among those who had had gestational diabetes.

After adjustment for potential confounders, women who experienced gestational diabetes still had a 41% higher risk of developing hypertension.

Moreover, compared with women who experienced neither gestational diabetes nor type 2 diabetes, those who experienced both had a near tripling of the risk of developing hypertension.

“It is possible that there was residual or unmeasured confounding,” acknowledged Ms. Tobias. “For example, in our cohort, we were unable to capture pregnancy-related characteristics, such as weight gain or severity of gestational diabetes.”

The generalizability of the findings may be limited, given the women's higher age at baseline and the fact that most were white, she noted.

SEATTLE — Careful timing in measuring high-sensitivity C-reactive protein during the menstrual cycle can make all the difference in classifying young women's risk of cardiovascular disease, new data show.

In a study of 259 healthy premenopausal women, high-sensitivity C-reactive protein (hs-CRP) levels fluctuated over the course of the menstrual cycle, with the highest (and most variable) levels seen during menses and the lowest seen at ovulation, researchers noted.

The proportion of women classified as having a high or moderate risk for cardiovascular (CV) disease based on their levels of hs-CRP was significantly greater when levels measured during menses were used (41%) than when levels at ovulation were used (29%).

“The measurement of CRP in clinical settings and in future research studies should be standardized to the menstrual cycle phase,” said lead investigator Audrey J. Gaskins, a postbaccalaureate fellow at the National Institute of Child Health and Human Development in Rockville, Md.

Since ovulation can be difficult to time, “Any time other than menses, would be ideal,” she said.

Evidence suggests that estrogen may modulate inflammation to a clinically relevant extent when it comes to CV outcomes, Ms. Gaskins noted.

“The risk of coronary events rises in women after menopause, and this corresponds to when endogenous estrogen levels decrease,” she said. “Studies have shown that in regularly menstruating women, there are more acute coronary events in the early follicular phase, when estrogen levels are lowest.”

Ms. Gaskins and colleagues analyzed data from normally menstruating women, average age 27 years, who were followed for up to two menstrual cycles in the BioCycle Study. Serum samples collected at eight distinct times during the menstrual cycle were assayed for levels of hormones and hs-CRP. Any hs-CRP values exceeding 10 mg/L were excluded.

Ms. Gaskins noted that the population was more diverse than those in previous studies. Some 59% of the women were white, 20% were black, and 21% were of other races. Although 61% had a body mass index in the normal range, 25% were overweight, 10% obese, and 3% underweight (percentages rounded). Seventy four percent were nulliparous, and 4% were smokers.

Hs-CRP levels varied widely over the menstrual cycle. They were highest and also showed the greatest inter-individual variability during menses, and lowest at ovulation, with a 1.6-fold difference in values between these two times.

In adjusted models, hs-CRP was significantly associated both with estradiol across the menstrual cycle and with progesterone during the luteal phase. Specifically, hs-CRP levels fell by 24% with each tenfold increase in estradiol level and increased by 19% with each tenfold increase in luteal progesterone level.

In a final analysis, the investigators used the American Heart Association risk classification system, whereby CV disease risk is considered high if hs-CRP level is greater than 3 mg/L and moderate if it is 1-3 mg/L.

Although 32% of women had hs-CRP levels in the high-risk category at at least one time point during the menstrual cycle, only 2% consistently had levels in this category at all eight time points.

Some 41% of the women had hs-CRP levels that placed them in the high- or moderate-risk category during menses; only 29% had high levels at ovulation. The percentages at all other times, except for the midluteal time point, were also significantly lower than those at menses.

“This is the largest study by far to look at hs-CRP and reproductive hormones in healthy premenopausal women,” noted Ms. Gaskins. “Our results support the hypothesis that estrogen might have anti-inflammatory effects. In regard to progesterone, our results support an inflammatory role.”

Ms. Gaskins reported that she had no relevant conflicts of interest.

SEATTLE — Careful timing in measuring high-sensitivity C-reactive protein during the menstrual cycle can make all the difference in classifying young women's risk of cardiovascular disease, new data show.

In a study of 259 healthy premenopausal women, high-sensitivity C-reactive protein (hs-CRP) levels fluctuated over the course of the menstrual cycle, with the highest (and most variable) levels seen during menses and the lowest seen at ovulation, researchers noted.

The proportion of women classified as having a high or moderate risk for cardiovascular (CV) disease based on their levels of hs-CRP was significantly greater when levels measured during menses were used (41%) than when levels at ovulation were used (29%).

“The measurement of CRP in clinical settings and in future research studies should be standardized to the menstrual cycle phase,” said lead investigator Audrey J. Gaskins, a postbaccalaureate fellow at the National Institute of Child Health and Human Development in Rockville, Md.

Since ovulation can be difficult to time, “Any time other than menses, would be ideal,” she said.

Evidence suggests that estrogen may modulate inflammation to a clinically relevant extent when it comes to CV outcomes, Ms. Gaskins noted.

“The risk of coronary events rises in women after menopause, and this corresponds to when endogenous estrogen levels decrease,” she said. “Studies have shown that in regularly menstruating women, there are more acute coronary events in the early follicular phase, when estrogen levels are lowest.”

Ms. Gaskins and colleagues analyzed data from normally menstruating women, average age 27 years, who were followed for up to two menstrual cycles in the BioCycle Study. Serum samples collected at eight distinct times during the menstrual cycle were assayed for levels of hormones and hs-CRP. Any hs-CRP values exceeding 10 mg/L were excluded.

Ms. Gaskins noted that the population was more diverse than those in previous studies. Some 59% of the women were white, 20% were black, and 21% were of other races. Although 61% had a body mass index in the normal range, 25% were overweight, 10% obese, and 3% underweight (percentages rounded). Seventy four percent were nulliparous, and 4% were smokers.

Hs-CRP levels varied widely over the menstrual cycle. They were highest and also showed the greatest inter-individual variability during menses, and lowest at ovulation, with a 1.6-fold difference in values between these two times.

In adjusted models, hs-CRP was significantly associated both with estradiol across the menstrual cycle and with progesterone during the luteal phase. Specifically, hs-CRP levels fell by 24% with each tenfold increase in estradiol level and increased by 19% with each tenfold increase in luteal progesterone level.

In a final analysis, the investigators used the American Heart Association risk classification system, whereby CV disease risk is considered high if hs-CRP level is greater than 3 mg/L and moderate if it is 1-3 mg/L.

Although 32% of women had hs-CRP levels in the high-risk category at at least one time point during the menstrual cycle, only 2% consistently had levels in this category at all eight time points.

Some 41% of the women had hs-CRP levels that placed them in the high- or moderate-risk category during menses; only 29% had high levels at ovulation. The percentages at all other times, except for the midluteal time point, were also significantly lower than those at menses.

“This is the largest study by far to look at hs-CRP and reproductive hormones in healthy premenopausal women,” noted Ms. Gaskins. “Our results support the hypothesis that estrogen might have anti-inflammatory effects. In regard to progesterone, our results support an inflammatory role.”

Ms. Gaskins reported that she had no relevant conflicts of interest.

SEATTLE — Careful timing in measuring high-sensitivity C-reactive protein during the menstrual cycle can make all the difference in classifying young women's risk of cardiovascular disease, new data show.

In a study of 259 healthy premenopausal women, high-sensitivity C-reactive protein (hs-CRP) levels fluctuated over the course of the menstrual cycle, with the highest (and most variable) levels seen during menses and the lowest seen at ovulation, researchers noted.

The proportion of women classified as having a high or moderate risk for cardiovascular (CV) disease based on their levels of hs-CRP was significantly greater when levels measured during menses were used (41%) than when levels at ovulation were used (29%).

“The measurement of CRP in clinical settings and in future research studies should be standardized to the menstrual cycle phase,” said lead investigator Audrey J. Gaskins, a postbaccalaureate fellow at the National Institute of Child Health and Human Development in Rockville, Md.

Since ovulation can be difficult to time, “Any time other than menses, would be ideal,” she said.

Evidence suggests that estrogen may modulate inflammation to a clinically relevant extent when it comes to CV outcomes, Ms. Gaskins noted.

“The risk of coronary events rises in women after menopause, and this corresponds to when endogenous estrogen levels decrease,” she said. “Studies have shown that in regularly menstruating women, there are more acute coronary events in the early follicular phase, when estrogen levels are lowest.”

Ms. Gaskins and colleagues analyzed data from normally menstruating women, average age 27 years, who were followed for up to two menstrual cycles in the BioCycle Study. Serum samples collected at eight distinct times during the menstrual cycle were assayed for levels of hormones and hs-CRP. Any hs-CRP values exceeding 10 mg/L were excluded.

Ms. Gaskins noted that the population was more diverse than those in previous studies. Some 59% of the women were white, 20% were black, and 21% were of other races. Although 61% had a body mass index in the normal range, 25% were overweight, 10% obese, and 3% underweight (percentages rounded). Seventy four percent were nulliparous, and 4% were smokers.

Hs-CRP levels varied widely over the menstrual cycle. They were highest and also showed the greatest inter-individual variability during menses, and lowest at ovulation, with a 1.6-fold difference in values between these two times.

In adjusted models, hs-CRP was significantly associated both with estradiol across the menstrual cycle and with progesterone during the luteal phase. Specifically, hs-CRP levels fell by 24% with each tenfold increase in estradiol level and increased by 19% with each tenfold increase in luteal progesterone level.

In a final analysis, the investigators used the American Heart Association risk classification system, whereby CV disease risk is considered high if hs-CRP level is greater than 3 mg/L and moderate if it is 1-3 mg/L.

Although 32% of women had hs-CRP levels in the high-risk category at at least one time point during the menstrual cycle, only 2% consistently had levels in this category at all eight time points.

Some 41% of the women had hs-CRP levels that placed them in the high- or moderate-risk category during menses; only 29% had high levels at ovulation. The percentages at all other times, except for the midluteal time point, were also significantly lower than those at menses.

“This is the largest study by far to look at hs-CRP and reproductive hormones in healthy premenopausal women,” noted Ms. Gaskins. “Our results support the hypothesis that estrogen might have anti-inflammatory effects. In regard to progesterone, our results support an inflammatory role.”

Ms. Gaskins reported that she had no relevant conflicts of interest.

Major Finding: Some 65% of pediatricians and 35% of family medicine physicians reported adhering to expanded ACIP recommendations to immunize all children 6 months to 18 years of age against influenza.

Data Source: A national survey of 330 pediatricians and 298 family medicine physicians.

Disclosures: Dr. O'Leary reported that he had no conflicts of interest related to the study.

VANCOUVER, B.C. — In the year after national recommendations for yearly influenza vaccination were expanded to include all children aged 6 months to 18 years, about half of primary care physicians who see children reported following this practice, new data show.

In a national survey, 65% of pediatricians and 35% of family medicine physicians said that they routinely immunized all children this in this age-group during the 2008-2009 season, according to results reported in a poster session.

However, the physicians' reported rates of routine immunization specifically for 5- to 18-year-olds—the newest age-group to be included with the expansion—were two to four times higher than this group's actual rate of vaccine receipt, as assessed from surveillance data in the general population.

“Our thought is that the discrepancy between the reported practice and the actual rate is because a lot of these kids just aren't coming in,” which suggests that innovative immunizations strategies are called for, lead investigator Dr. Sean O'Leary said in an interview.

“Maybe we need a real focused effort on school-based immunization, public-private collaborations with health departments and VNAs [Visiting Nurses Associations], or something like that,” he commented.

In the survey, the investigators polled a national sample of 628 pediatric primary care providers about their immunization practices during the 2008-2009 flu season, the first one after the Advisory Committee on Immunization Practices (ACIP) expanded its recommendations for annual influenza vaccination to include all children between the ages of 6 months and 18 years.

A total of 330 pediatricians and 298 family medicine physicians completed questionnaires online or by mail, reported Dr. O'Leary, who is a pediatric infectious disease fellow and a primary care research fellow at the University of Colorado in Denver.

When it came to specific age-groups, 70% of pediatricians and 43% of family physicians, respectively, reported routinely immunizing 5- to 18-year-olds—values that are much higher than the 21% rate of actual vaccine receipt seen in this age-group during the same flu season from surveillance data (MMWR 2009;58:1091-5).

To implement influenza vaccination, many pediatricians and family medicine physicians displayed posters and pamphlets in their office (89% of each specialty), held dedicated flu vaccination clinics after hours or on weekends (57% and 41%, respectively), added extra staff for vaccine-only visits during regular office hours (56% and 53%), and offered vaccination without an appointment (48% and 79%).

However, Dr. O'Leary noted, “one of the big things that came out of our survey was that some of the proven methods are not being used.”

Specifically, only small minorities of pediatricians and family physicians used ongoing tracking of influenza vaccine receipt (30% and 23%, respectively) and written, telephone, or e-mail reminders (23% and 14%) for all children covered by the expanded recommendations.

In adjusted analyses, physicians were more likely to report routinely immunizing all children aged 6 months to 18 years if they had dedicated influenza vaccination clinics after hours or on weekends (risk ratio, 1.26), used reminders for all children in this age-group (risk ratio, 1.28), or rated themselves as expending intense effort on this objective (risk ratio, 1.43).

On the other hand, rural physicians were less likely to report routinely immunizing all children in this age-group relative to their urban counterparts (risk ratio, 0.79), as were family medicine physicians compared with pediatricians (risk ratio, 0.67).

The reason for the difference between specialties is unclear, according to Dr. O'Leary.

“It may be that because it was the first year of the recommendation, the family medicine physicians had ordered a certain amount of the vaccine, and they needed to prioritize their older-than-65-year-old patients, as opposed to these healthy 5- to 18-year-olds,” he speculated.

Major Finding: Some 65% of pediatricians and 35% of family medicine physicians reported adhering to expanded ACIP recommendations to immunize all children 6 months to 18 years of age against influenza.

Data Source: A national survey of 330 pediatricians and 298 family medicine physicians.

Disclosures: Dr. O'Leary reported that he had no conflicts of interest related to the study.

VANCOUVER, B.C. — In the year after national recommendations for yearly influenza vaccination were expanded to include all children aged 6 months to 18 years, about half of primary care physicians who see children reported following this practice, new data show.

In a national survey, 65% of pediatricians and 35% of family medicine physicians said that they routinely immunized all children this in this age-group during the 2008-2009 season, according to results reported in a poster session.

However, the physicians' reported rates of routine immunization specifically for 5- to 18-year-olds—the newest age-group to be included with the expansion—were two to four times higher than this group's actual rate of vaccine receipt, as assessed from surveillance data in the general population.

“Our thought is that the discrepancy between the reported practice and the actual rate is because a lot of these kids just aren't coming in,” which suggests that innovative immunizations strategies are called for, lead investigator Dr. Sean O'Leary said in an interview.

“Maybe we need a real focused effort on school-based immunization, public-private collaborations with health departments and VNAs [Visiting Nurses Associations], or something like that,” he commented.

In the survey, the investigators polled a national sample of 628 pediatric primary care providers about their immunization practices during the 2008-2009 flu season, the first one after the Advisory Committee on Immunization Practices (ACIP) expanded its recommendations for annual influenza vaccination to include all children between the ages of 6 months and 18 years.

A total of 330 pediatricians and 298 family medicine physicians completed questionnaires online or by mail, reported Dr. O'Leary, who is a pediatric infectious disease fellow and a primary care research fellow at the University of Colorado in Denver.

When it came to specific age-groups, 70% of pediatricians and 43% of family physicians, respectively, reported routinely immunizing 5- to 18-year-olds—values that are much higher than the 21% rate of actual vaccine receipt seen in this age-group during the same flu season from surveillance data (MMWR 2009;58:1091-5).

To implement influenza vaccination, many pediatricians and family medicine physicians displayed posters and pamphlets in their office (89% of each specialty), held dedicated flu vaccination clinics after hours or on weekends (57% and 41%, respectively), added extra staff for vaccine-only visits during regular office hours (56% and 53%), and offered vaccination without an appointment (48% and 79%).

However, Dr. O'Leary noted, “one of the big things that came out of our survey was that some of the proven methods are not being used.”

Specifically, only small minorities of pediatricians and family physicians used ongoing tracking of influenza vaccine receipt (30% and 23%, respectively) and written, telephone, or e-mail reminders (23% and 14%) for all children covered by the expanded recommendations.

In adjusted analyses, physicians were more likely to report routinely immunizing all children aged 6 months to 18 years if they had dedicated influenza vaccination clinics after hours or on weekends (risk ratio, 1.26), used reminders for all children in this age-group (risk ratio, 1.28), or rated themselves as expending intense effort on this objective (risk ratio, 1.43).

On the other hand, rural physicians were less likely to report routinely immunizing all children in this age-group relative to their urban counterparts (risk ratio, 0.79), as were family medicine physicians compared with pediatricians (risk ratio, 0.67).

The reason for the difference between specialties is unclear, according to Dr. O'Leary.

“It may be that because it was the first year of the recommendation, the family medicine physicians had ordered a certain amount of the vaccine, and they needed to prioritize their older-than-65-year-old patients, as opposed to these healthy 5- to 18-year-olds,” he speculated.

Major Finding: Some 65% of pediatricians and 35% of family medicine physicians reported adhering to expanded ACIP recommendations to immunize all children 6 months to 18 years of age against influenza.

Data Source: A national survey of 330 pediatricians and 298 family medicine physicians.

Disclosures: Dr. O'Leary reported that he had no conflicts of interest related to the study.

VANCOUVER, B.C. — In the year after national recommendations for yearly influenza vaccination were expanded to include all children aged 6 months to 18 years, about half of primary care physicians who see children reported following this practice, new data show.

In a national survey, 65% of pediatricians and 35% of family medicine physicians said that they routinely immunized all children this in this age-group during the 2008-2009 season, according to results reported in a poster session.

However, the physicians' reported rates of routine immunization specifically for 5- to 18-year-olds—the newest age-group to be included with the expansion—were two to four times higher than this group's actual rate of vaccine receipt, as assessed from surveillance data in the general population.

“Our thought is that the discrepancy between the reported practice and the actual rate is because a lot of these kids just aren't coming in,” which suggests that innovative immunizations strategies are called for, lead investigator Dr. Sean O'Leary said in an interview.

“Maybe we need a real focused effort on school-based immunization, public-private collaborations with health departments and VNAs [Visiting Nurses Associations], or something like that,” he commented.

In the survey, the investigators polled a national sample of 628 pediatric primary care providers about their immunization practices during the 2008-2009 flu season, the first one after the Advisory Committee on Immunization Practices (ACIP) expanded its recommendations for annual influenza vaccination to include all children between the ages of 6 months and 18 years.

A total of 330 pediatricians and 298 family medicine physicians completed questionnaires online or by mail, reported Dr. O'Leary, who is a pediatric infectious disease fellow and a primary care research fellow at the University of Colorado in Denver.

When it came to specific age-groups, 70% of pediatricians and 43% of family physicians, respectively, reported routinely immunizing 5- to 18-year-olds—values that are much higher than the 21% rate of actual vaccine receipt seen in this age-group during the same flu season from surveillance data (MMWR 2009;58:1091-5).

To implement influenza vaccination, many pediatricians and family medicine physicians displayed posters and pamphlets in their office (89% of each specialty), held dedicated flu vaccination clinics after hours or on weekends (57% and 41%, respectively), added extra staff for vaccine-only visits during regular office hours (56% and 53%), and offered vaccination without an appointment (48% and 79%).

However, Dr. O'Leary noted, “one of the big things that came out of our survey was that some of the proven methods are not being used.”

Specifically, only small minorities of pediatricians and family physicians used ongoing tracking of influenza vaccine receipt (30% and 23%, respectively) and written, telephone, or e-mail reminders (23% and 14%) for all children covered by the expanded recommendations.

In adjusted analyses, physicians were more likely to report routinely immunizing all children aged 6 months to 18 years if they had dedicated influenza vaccination clinics after hours or on weekends (risk ratio, 1.26), used reminders for all children in this age-group (risk ratio, 1.28), or rated themselves as expending intense effort on this objective (risk ratio, 1.43).

On the other hand, rural physicians were less likely to report routinely immunizing all children in this age-group relative to their urban counterparts (risk ratio, 0.79), as were family medicine physicians compared with pediatricians (risk ratio, 0.67).

The reason for the difference between specialties is unclear, according to Dr. O'Leary.

“It may be that because it was the first year of the recommendation, the family medicine physicians had ordered a certain amount of the vaccine, and they needed to prioritize their older-than-65-year-old patients, as opposed to these healthy 5- to 18-year-olds,” he speculated.

VANCOUVER, B.C. — An initiative that promotes improved asthma education and care at the family and community levels has reduced health care use and morbidity among disadvantaged children with asthma in Boston, according to Dr. Elizabeth R. Woods.

Four years into the Community Asthma Initiative, there was an 81% reduction in the percentage of participating children with asthma-related admissions, a 65% cut in the percentage of children making emergency department visits, a 39% reduction in the percentage missing school because of asthma, and a 37% reduction in the percentage having limitations in physical activity because of the disease.

“The program demonstrates a successful model that can be developed and is starting to be replicated in Massachusetts as well as nationally,” Dr. Woods said at the meeting. “It also promotes policy changes that substantially improve asthma education and care, including access to case management, home visits, and affordable medications.”

The initiative targeted children from the four Boston neighborhoods with the highest asthma rates and the greatest health disparities. The children were identified through asthma-related ED visits or hospital admissions, or were referred by primary care providers.

They and their families received case management and home visits by providers who helped them develop individualized management plans, performed environmental assessments, and supplied products such as vacuum cleaners with high-efficiency particulate air (HEPA) filters and bedding casings. Providers also instructed families in pest control techniques and connected them to community resources.

The initiative also targeted the community (families, providers, and teachers) through an educational campaign. Advocacy efforts were launched to encourage payers to address prohibitively high copayments for asthma medications.

Dr. Woods and her colleagues evaluated the effects of the initiative by analyzing parental reports obtained at 6-month intervals and administrative data.

Results were based on 441 children who had received case management through the initiative, the majority of whom had also received home visits. They were 7.8 years old on average. Most were African American (48%) or Latino/Hispanic (45%), and had public health insurance (70%).

From baseline to 12 months, the proportion of children making asthma-related ED visits fell from 63% to 22%, hospital admissions due to asthma fell from 51% to 10%, and the proportion of children who missed school because of asthma dropped from 93% to 56%. The proportion of children who had physical activity limitations due to asthma dropped from 55% to 35%.

The proportion of children with an up-to-date asthma action plan increased by 71% (from 49% to 84%).

In logistic regression analyses that controlled for potential confounders, the children had significant 90%–100% reductions in the odds of each adverse outcome, noted Dr. Woods, a pediatrician at Children's Hospital Boston.

In the initiative's first year, the cost of care per child was similar to that in a control neighborhood ($1,335 vs. $1,340). In the second year, it was approximately half as expensive in the initiative group ($750 vs. $1,322).

“There was clearly a cost saving, giving a return on investment of 1.46. … That's a return on investment not to hospitals, but to insurance companies and society at large,” Dr. Woods said.

The initiative is helping families in two main ways. “No. 1, it is helping them understand their medications,” she said, as many families are found to have bags and boxes of medications and a poor grasp of which ones to use in which circumstances. “The other big improvement relates to the environmental issues. Very few of these families had even a vacuum cleaner, let alone ones with HEPA bags and filters. These are incredibly helpful and much less costly than additional medication.”

VANCOUVER, B.C. — An initiative that promotes improved asthma education and care at the family and community levels has reduced health care use and morbidity among disadvantaged children with asthma in Boston, according to Dr. Elizabeth R. Woods.

Four years into the Community Asthma Initiative, there was an 81% reduction in the percentage of participating children with asthma-related admissions, a 65% cut in the percentage of children making emergency department visits, a 39% reduction in the percentage missing school because of asthma, and a 37% reduction in the percentage having limitations in physical activity because of the disease.

“The program demonstrates a successful model that can be developed and is starting to be replicated in Massachusetts as well as nationally,” Dr. Woods said at the meeting. “It also promotes policy changes that substantially improve asthma education and care, including access to case management, home visits, and affordable medications.”

The initiative targeted children from the four Boston neighborhoods with the highest asthma rates and the greatest health disparities. The children were identified through asthma-related ED visits or hospital admissions, or were referred by primary care providers.

They and their families received case management and home visits by providers who helped them develop individualized management plans, performed environmental assessments, and supplied products such as vacuum cleaners with high-efficiency particulate air (HEPA) filters and bedding casings. Providers also instructed families in pest control techniques and connected them to community resources.

The initiative also targeted the community (families, providers, and teachers) through an educational campaign. Advocacy efforts were launched to encourage payers to address prohibitively high copayments for asthma medications.

Dr. Woods and her colleagues evaluated the effects of the initiative by analyzing parental reports obtained at 6-month intervals and administrative data.

Results were based on 441 children who had received case management through the initiative, the majority of whom had also received home visits. They were 7.8 years old on average. Most were African American (48%) or Latino/Hispanic (45%), and had public health insurance (70%).

From baseline to 12 months, the proportion of children making asthma-related ED visits fell from 63% to 22%, hospital admissions due to asthma fell from 51% to 10%, and the proportion of children who missed school because of asthma dropped from 93% to 56%. The proportion of children who had physical activity limitations due to asthma dropped from 55% to 35%.

The proportion of children with an up-to-date asthma action plan increased by 71% (from 49% to 84%).

In logistic regression analyses that controlled for potential confounders, the children had significant 90%–100% reductions in the odds of each adverse outcome, noted Dr. Woods, a pediatrician at Children's Hospital Boston.

In the initiative's first year, the cost of care per child was similar to that in a control neighborhood ($1,335 vs. $1,340). In the second year, it was approximately half as expensive in the initiative group ($750 vs. $1,322).

“There was clearly a cost saving, giving a return on investment of 1.46. … That's a return on investment not to hospitals, but to insurance companies and society at large,” Dr. Woods said.

The initiative is helping families in two main ways. “No. 1, it is helping them understand their medications,” she said, as many families are found to have bags and boxes of medications and a poor grasp of which ones to use in which circumstances. “The other big improvement relates to the environmental issues. Very few of these families had even a vacuum cleaner, let alone ones with HEPA bags and filters. These are incredibly helpful and much less costly than additional medication.”

VANCOUVER, B.C. — An initiative that promotes improved asthma education and care at the family and community levels has reduced health care use and morbidity among disadvantaged children with asthma in Boston, according to Dr. Elizabeth R. Woods.

Four years into the Community Asthma Initiative, there was an 81% reduction in the percentage of participating children with asthma-related admissions, a 65% cut in the percentage of children making emergency department visits, a 39% reduction in the percentage missing school because of asthma, and a 37% reduction in the percentage having limitations in physical activity because of the disease.

“The program demonstrates a successful model that can be developed and is starting to be replicated in Massachusetts as well as nationally,” Dr. Woods said at the meeting. “It also promotes policy changes that substantially improve asthma education and care, including access to case management, home visits, and affordable medications.”

The initiative targeted children from the four Boston neighborhoods with the highest asthma rates and the greatest health disparities. The children were identified through asthma-related ED visits or hospital admissions, or were referred by primary care providers.

They and their families received case management and home visits by providers who helped them develop individualized management plans, performed environmental assessments, and supplied products such as vacuum cleaners with high-efficiency particulate air (HEPA) filters and bedding casings. Providers also instructed families in pest control techniques and connected them to community resources.

The initiative also targeted the community (families, providers, and teachers) through an educational campaign. Advocacy efforts were launched to encourage payers to address prohibitively high copayments for asthma medications.

Dr. Woods and her colleagues evaluated the effects of the initiative by analyzing parental reports obtained at 6-month intervals and administrative data.

Results were based on 441 children who had received case management through the initiative, the majority of whom had also received home visits. They were 7.8 years old on average. Most were African American (48%) or Latino/Hispanic (45%), and had public health insurance (70%).

From baseline to 12 months, the proportion of children making asthma-related ED visits fell from 63% to 22%, hospital admissions due to asthma fell from 51% to 10%, and the proportion of children who missed school because of asthma dropped from 93% to 56%. The proportion of children who had physical activity limitations due to asthma dropped from 55% to 35%.

The proportion of children with an up-to-date asthma action plan increased by 71% (from 49% to 84%).

In logistic regression analyses that controlled for potential confounders, the children had significant 90%–100% reductions in the odds of each adverse outcome, noted Dr. Woods, a pediatrician at Children's Hospital Boston.

In the initiative's first year, the cost of care per child was similar to that in a control neighborhood ($1,335 vs. $1,340). In the second year, it was approximately half as expensive in the initiative group ($750 vs. $1,322).

“There was clearly a cost saving, giving a return on investment of 1.46. … That's a return on investment not to hospitals, but to insurance companies and society at large,” Dr. Woods said.

The initiative is helping families in two main ways. “No. 1, it is helping them understand their medications,” she said, as many families are found to have bags and boxes of medications and a poor grasp of which ones to use in which circumstances. “The other big improvement relates to the environmental issues. Very few of these families had even a vacuum cleaner, let alone ones with HEPA bags and filters. These are incredibly helpful and much less costly than additional medication.”

SEATTLE — Careful timing in measuring high-sensitivity C-reactive protein during the menstrual cycle can make all the difference in classifying young women's risk of cardiovascular disease, new data show.

In a study of 259 healthy premenopausal women, high-sensitivity C-reactive protein (hs-CRP) levels fluctuated considerably over the course of the menstrual cycle, with the highest (and most variable) levels seen during menses and the lowest seen at ovulation.

The proportion of women classified as having a high or moderate risk for cardiovascular disease based on their levels of hs-CRP, a marker of chronic inflammation, was significantly greater when levels measured during menses were used (41%) than when levels at ovulation were used (29%).

“The take-home message here is that the measurement of CRP in clinical settings and in future research studies should be standardized to the menstrual cycle phase,” said lead investigator Audrey J. Gaskins, a postbaccalaureate fellow at the National Institute of Child Health and Human Development in Rockville, Md.

“Ideally, [one should] measure CRP around ovulation, when levels are lowest, but that is generally hard to time,” she commented. “So I would say any time other than menses, would be ideal.”

Several lines of evidence suggest that estrogen may modulate inflammation to a clinically relevant extent when it comes to cardiovascular outcomes, according to Ms. Gaskins.

“The risk of coronary events rises in women after menopause, and this corresponds to when endogenous estrogen levels decrease,” she explained. “Also, two recent studies have shown that in regularly menstruating women, there are more acute coronary events in the early follicular phase, when estrogen levels are lowest.”

Ms. Gaskins and her colleagues analyzed data from 259 healthy, normally menstruating women, aged an average of 27 years, and who were followed for up to two menstrual cycles in the BioCycle Study.

Serum samples collected at eight distinct time points during the menstrual cycle were assayed for levels of hormones and hs-CRP. Any hs-CRP values exceeding 10 mg/L were excluded under the assumption that they reflected acute illness.

Ms. Gaskins noted that the population was more diverse than those in previous studies. Some 59% of the women were white, 20% were black, and 21% were of other races. Although 61% had a body mass index in the normal range, 25% were overweight, 10% obese, and 3% underweight (percentages rounded). Seventy four percent were nulliparous, and 4% were smokers.

Study results showed that hs-CRP levels varied widely over the menstrual cycle, she reported. They were highest and also showed the greatest inter-individual variability during menses, and lowest at ovulation, with about a 1.6-fold difference in values between these two time points.

In adjusted models, hs-CRP was significantly associated both with estradiol across the menstrual cycle and with progesterone during the luteal phase. Specifically, hs-CRP levels fell by 24% with each 10-fold increase in estradiol level and increased by 19% with each 10-fold increase in luteal progesterone level.

In a final analysis, the investigators classified the women according to the American Heart Association risk classification system, whereby cardiovascular disease risk is considered high if hs-CRP level is greater than 3 mg/L and moderate if it is 1–3 mg/L.

Although 32% of women had hs-CRP levels in the high-risk category at at least one time point during the menstrual cycle, only 2% consistently had levels in this category at all eight time points.

Some 41% of the women had hs-CRP levels that placed them in the high- or moderate-risk category during menses, whereas only 29% had high levels at ovulation, a significant difference. The percentages at all other time points, except for the midluteal time point, were also significantly lower than those at menses.

Ms. Gaskins said she had no conflicts of interest.

SEATTLE — Careful timing in measuring high-sensitivity C-reactive protein during the menstrual cycle can make all the difference in classifying young women's risk of cardiovascular disease, new data show.

In a study of 259 healthy premenopausal women, high-sensitivity C-reactive protein (hs-CRP) levels fluctuated considerably over the course of the menstrual cycle, with the highest (and most variable) levels seen during menses and the lowest seen at ovulation.

The proportion of women classified as having a high or moderate risk for cardiovascular disease based on their levels of hs-CRP, a marker of chronic inflammation, was significantly greater when levels measured during menses were used (41%) than when levels at ovulation were used (29%).

“The take-home message here is that the measurement of CRP in clinical settings and in future research studies should be standardized to the menstrual cycle phase,” said lead investigator Audrey J. Gaskins, a postbaccalaureate fellow at the National Institute of Child Health and Human Development in Rockville, Md.

“Ideally, [one should] measure CRP around ovulation, when levels are lowest, but that is generally hard to time,” she commented. “So I would say any time other than menses, would be ideal.”

Several lines of evidence suggest that estrogen may modulate inflammation to a clinically relevant extent when it comes to cardiovascular outcomes, according to Ms. Gaskins.

“The risk of coronary events rises in women after menopause, and this corresponds to when endogenous estrogen levels decrease,” she explained. “Also, two recent studies have shown that in regularly menstruating women, there are more acute coronary events in the early follicular phase, when estrogen levels are lowest.”

Ms. Gaskins and her colleagues analyzed data from 259 healthy, normally menstruating women, aged an average of 27 years, and who were followed for up to two menstrual cycles in the BioCycle Study.

Serum samples collected at eight distinct time points during the menstrual cycle were assayed for levels of hormones and hs-CRP. Any hs-CRP values exceeding 10 mg/L were excluded under the assumption that they reflected acute illness.

Ms. Gaskins noted that the population was more diverse than those in previous studies. Some 59% of the women were white, 20% were black, and 21% were of other races. Although 61% had a body mass index in the normal range, 25% were overweight, 10% obese, and 3% underweight (percentages rounded). Seventy four percent were nulliparous, and 4% were smokers.

Study results showed that hs-CRP levels varied widely over the menstrual cycle, she reported. They were highest and also showed the greatest inter-individual variability during menses, and lowest at ovulation, with about a 1.6-fold difference in values between these two time points.

In adjusted models, hs-CRP was significantly associated both with estradiol across the menstrual cycle and with progesterone during the luteal phase. Specifically, hs-CRP levels fell by 24% with each 10-fold increase in estradiol level and increased by 19% with each 10-fold increase in luteal progesterone level.

In a final analysis, the investigators classified the women according to the American Heart Association risk classification system, whereby cardiovascular disease risk is considered high if hs-CRP level is greater than 3 mg/L and moderate if it is 1–3 mg/L.

Although 32% of women had hs-CRP levels in the high-risk category at at least one time point during the menstrual cycle, only 2% consistently had levels in this category at all eight time points.

Some 41% of the women had hs-CRP levels that placed them in the high- or moderate-risk category during menses, whereas only 29% had high levels at ovulation, a significant difference. The percentages at all other time points, except for the midluteal time point, were also significantly lower than those at menses.

Ms. Gaskins said she had no conflicts of interest.

SEATTLE — Careful timing in measuring high-sensitivity C-reactive protein during the menstrual cycle can make all the difference in classifying young women's risk of cardiovascular disease, new data show.

In a study of 259 healthy premenopausal women, high-sensitivity C-reactive protein (hs-CRP) levels fluctuated considerably over the course of the menstrual cycle, with the highest (and most variable) levels seen during menses and the lowest seen at ovulation.

The proportion of women classified as having a high or moderate risk for cardiovascular disease based on their levels of hs-CRP, a marker of chronic inflammation, was significantly greater when levels measured during menses were used (41%) than when levels at ovulation were used (29%).

“The take-home message here is that the measurement of CRP in clinical settings and in future research studies should be standardized to the menstrual cycle phase,” said lead investigator Audrey J. Gaskins, a postbaccalaureate fellow at the National Institute of Child Health and Human Development in Rockville, Md.

“Ideally, [one should] measure CRP around ovulation, when levels are lowest, but that is generally hard to time,” she commented. “So I would say any time other than menses, would be ideal.”

Several lines of evidence suggest that estrogen may modulate inflammation to a clinically relevant extent when it comes to cardiovascular outcomes, according to Ms. Gaskins.

“The risk of coronary events rises in women after menopause, and this corresponds to when endogenous estrogen levels decrease,” she explained. “Also, two recent studies have shown that in regularly menstruating women, there are more acute coronary events in the early follicular phase, when estrogen levels are lowest.”

Ms. Gaskins and her colleagues analyzed data from 259 healthy, normally menstruating women, aged an average of 27 years, and who were followed for up to two menstrual cycles in the BioCycle Study.

Serum samples collected at eight distinct time points during the menstrual cycle were assayed for levels of hormones and hs-CRP. Any hs-CRP values exceeding 10 mg/L were excluded under the assumption that they reflected acute illness.

Ms. Gaskins noted that the population was more diverse than those in previous studies. Some 59% of the women were white, 20% were black, and 21% were of other races. Although 61% had a body mass index in the normal range, 25% were overweight, 10% obese, and 3% underweight (percentages rounded). Seventy four percent were nulliparous, and 4% were smokers.

Study results showed that hs-CRP levels varied widely over the menstrual cycle, she reported. They were highest and also showed the greatest inter-individual variability during menses, and lowest at ovulation, with about a 1.6-fold difference in values between these two time points.

In adjusted models, hs-CRP was significantly associated both with estradiol across the menstrual cycle and with progesterone during the luteal phase. Specifically, hs-CRP levels fell by 24% with each 10-fold increase in estradiol level and increased by 19% with each 10-fold increase in luteal progesterone level.

In a final analysis, the investigators classified the women according to the American Heart Association risk classification system, whereby cardiovascular disease risk is considered high if hs-CRP level is greater than 3 mg/L and moderate if it is 1–3 mg/L.

Although 32% of women had hs-CRP levels in the high-risk category at at least one time point during the menstrual cycle, only 2% consistently had levels in this category at all eight time points.

Some 41% of the women had hs-CRP levels that placed them in the high- or moderate-risk category during menses, whereas only 29% had high levels at ovulation, a significant difference. The percentages at all other time points, except for the midluteal time point, were also significantly lower than those at menses.

Ms. Gaskins said she had no conflicts of interest.

Major Finding: The 12-month rate of survival was 38% with both bevacizumab alone and bevacizumab plus irinotecan in updated analyses, and no new adverse effects were noted.

Data Source: A randomized, noncomparative, open-label phase II trial among 167 patients with relapsed glioblastoma multiforme (the BRAIN trial).

Disclosures: Genentech sponsored the trial. Some of the investigators are employees of or consultants to Genentech, or have received honoraria or research funding from the company. Dr. Brandes disclosed having a consultant or advisory role with and receiving honoraria from Roche, which owns Genentech.

CHICAGO — Bevacizumab, alone or in combination with irinotecan, is generally safe and active in patients with relapsed glioblastoma, according to updated results of the phase II BRAIN trial.

“Up to 16% of patients who received bevacizumab-based therapy remained alive at 30 months,” lead investigator Dr. Timothy Cloughesy reported. “The incidence of selected [adverse events] in the updated safety data was consistent with what was previously reported—there were no new safety signals that were identified.”

The Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN) trial's efficacy results compare favorably with those of similar trials testing other regimens, Dr. Cloughesy said: the 12-month survival rate was 38% whereas it has been 14%-27% with cytotoxic agents such as temozolomide (Temo-dar) or lomustine (CCNU).

Sorting out the specific contributions of bevacizumab (Avastin) and irinotecan (Camptosar) to the observed outcomes is difficult because of the trial's design, he said. However, “when we look at what is providing the majority of the effect that we are seeing, I think it is coming from bevacizumab.”

The multicenter trial, sponsored by Genentech (manufacturer of bevacizumab), opened in July 2006 to patients with glioblastoma in first or second relapse who had previously received radiation therapy and temozolomide.

They were randomly assigned in nearly equal numbers to open-label treatment with bevacizumab alone or bevacizumab plus irinotecan.

Updated results were based on data cutoffs of July 2008 (treatment exposure, safety, and median survival) and July 2009 (survival rates), according to Dr. Cloughesy. The 167 enrolled patients had a median age of about 55 years. The majority were male (68%) and white (90%), and experiencing a first relapse (81%). Progression occurred in 59% of the patients in the bevacizumab arm, and these patients went on to receive the combination therapy.

The median number of bevacizumab doses received was 9 in the bevacizumab group and 11 in the bevacizumab-irinotecan group during the main phase of the trial, reported Dr. Cloughesy, director of the neuro-oncology program and a clinical professor at the Ronald Reagan UCLA Medical Center in Los Angeles. The median number was three during the post-progression phase.

The updated safety data showed little change from the initial results, he said. Some 51% of patients in the bevacizumab group and 71% in the bevacizumab-irinotecan group had adverse events of grade 3 or higher. Hypertension was the predominant event with monotherapy (11%), whereas venous thromboembolism was the predominant event with combination therapy (10%).

“The things that… we are concerned about with regard to patients who are taking anti-VEGF [vascular endothelial growth factor] therapy—cerebral hemorrhage, wound healing, arterial thrombotic embolism, and gastrointestinal perforation—these all stayed fairly low,” he commented. These events occurred at a severity of grade 3 or higher in only 0%-3.6% of patients.

Median overall survival was 9.3 months with bevacizumab alone and 8.9 months with both drugs. The proportion of patients still alive was 38% in each arm at 12 months; 24% and 18%, respectively, at 18 months; 16% and 17%, at 24 months; and 11% and 16%, at 30 months.

Dr. Alba A. Brandes, a medical oncologist at Azienda USL in Bologna, Italy, noted that the trial's size and promising results were strengths, but said its evaluation criteria and lack of a standard control arm and biomarker studies were weaknesses.

“Bevacizumab has brought light into the treatment of recurrent GBM, a setting with scarce options and dismal results,” she commented. “The advantage of bevacizumab over classical cytotoxics seems to be in the range of 2 to 3 months. That represents a prolongation of 30% in survival at recurrence,” said Dr. Brandes. “However, this advantage should be proven in phase III trials.”

We think the majority of the effect that we are seeing with the two drugs in this trial comes from bevacizumab.

Source DR. CLOUGHESY

Major Finding: The 12-month rate of survival was 38% with both bevacizumab alone and bevacizumab plus irinotecan in updated analyses, and no new adverse effects were noted.

Data Source: A randomized, noncomparative, open-label phase II trial among 167 patients with relapsed glioblastoma multiforme (the BRAIN trial).

Disclosures: Genentech sponsored the trial. Some of the investigators are employees of or consultants to Genentech, or have received honoraria or research funding from the company. Dr. Brandes disclosed having a consultant or advisory role with and receiving honoraria from Roche, which owns Genentech.

CHICAGO — Bevacizumab, alone or in combination with irinotecan, is generally safe and active in patients with relapsed glioblastoma, according to updated results of the phase II BRAIN trial.

“Up to 16% of patients who received bevacizumab-based therapy remained alive at 30 months,” lead investigator Dr. Timothy Cloughesy reported. “The incidence of selected [adverse events] in the updated safety data was consistent with what was previously reported—there were no new safety signals that were identified.”

The Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN) trial's efficacy results compare favorably with those of similar trials testing other regimens, Dr. Cloughesy said: the 12-month survival rate was 38% whereas it has been 14%-27% with cytotoxic agents such as temozolomide (Temo-dar) or lomustine (CCNU).

Sorting out the specific contributions of bevacizumab (Avastin) and irinotecan (Camptosar) to the observed outcomes is difficult because of the trial's design, he said. However, “when we look at what is providing the majority of the effect that we are seeing, I think it is coming from bevacizumab.”

The multicenter trial, sponsored by Genentech (manufacturer of bevacizumab), opened in July 2006 to patients with glioblastoma in first or second relapse who had previously received radiation therapy and temozolomide.

They were randomly assigned in nearly equal numbers to open-label treatment with bevacizumab alone or bevacizumab plus irinotecan.

Updated results were based on data cutoffs of July 2008 (treatment exposure, safety, and median survival) and July 2009 (survival rates), according to Dr. Cloughesy. The 167 enrolled patients had a median age of about 55 years. The majority were male (68%) and white (90%), and experiencing a first relapse (81%). Progression occurred in 59% of the patients in the bevacizumab arm, and these patients went on to receive the combination therapy.

The median number of bevacizumab doses received was 9 in the bevacizumab group and 11 in the bevacizumab-irinotecan group during the main phase of the trial, reported Dr. Cloughesy, director of the neuro-oncology program and a clinical professor at the Ronald Reagan UCLA Medical Center in Los Angeles. The median number was three during the post-progression phase.

The updated safety data showed little change from the initial results, he said. Some 51% of patients in the bevacizumab group and 71% in the bevacizumab-irinotecan group had adverse events of grade 3 or higher. Hypertension was the predominant event with monotherapy (11%), whereas venous thromboembolism was the predominant event with combination therapy (10%).

“The things that… we are concerned about with regard to patients who are taking anti-VEGF [vascular endothelial growth factor] therapy—cerebral hemorrhage, wound healing, arterial thrombotic embolism, and gastrointestinal perforation—these all stayed fairly low,” he commented. These events occurred at a severity of grade 3 or higher in only 0%-3.6% of patients.

Median overall survival was 9.3 months with bevacizumab alone and 8.9 months with both drugs. The proportion of patients still alive was 38% in each arm at 12 months; 24% and 18%, respectively, at 18 months; 16% and 17%, at 24 months; and 11% and 16%, at 30 months.

Dr. Alba A. Brandes, a medical oncologist at Azienda USL in Bologna, Italy, noted that the trial's size and promising results were strengths, but said its evaluation criteria and lack of a standard control arm and biomarker studies were weaknesses.

“Bevacizumab has brought light into the treatment of recurrent GBM, a setting with scarce options and dismal results,” she commented. “The advantage of bevacizumab over classical cytotoxics seems to be in the range of 2 to 3 months. That represents a prolongation of 30% in survival at recurrence,” said Dr. Brandes. “However, this advantage should be proven in phase III trials.”

We think the majority of the effect that we are seeing with the two drugs in this trial comes from bevacizumab.

Source DR. CLOUGHESY

Major Finding: The 12-month rate of survival was 38% with both bevacizumab alone and bevacizumab plus irinotecan in updated analyses, and no new adverse effects were noted.

Data Source: A randomized, noncomparative, open-label phase II trial among 167 patients with relapsed glioblastoma multiforme (the BRAIN trial).

Disclosures: Genentech sponsored the trial. Some of the investigators are employees of or consultants to Genentech, or have received honoraria or research funding from the company. Dr. Brandes disclosed having a consultant or advisory role with and receiving honoraria from Roche, which owns Genentech.

CHICAGO — Bevacizumab, alone or in combination with irinotecan, is generally safe and active in patients with relapsed glioblastoma, according to updated results of the phase II BRAIN trial.

“Up to 16% of patients who received bevacizumab-based therapy remained alive at 30 months,” lead investigator Dr. Timothy Cloughesy reported. “The incidence of selected [adverse events] in the updated safety data was consistent with what was previously reported—there were no new safety signals that were identified.”

The Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN) trial's efficacy results compare favorably with those of similar trials testing other regimens, Dr. Cloughesy said: the 12-month survival rate was 38% whereas it has been 14%-27% with cytotoxic agents such as temozolomide (Temo-dar) or lomustine (CCNU).

Sorting out the specific contributions of bevacizumab (Avastin) and irinotecan (Camptosar) to the observed outcomes is difficult because of the trial's design, he said. However, “when we look at what is providing the majority of the effect that we are seeing, I think it is coming from bevacizumab.”

The multicenter trial, sponsored by Genentech (manufacturer of bevacizumab), opened in July 2006 to patients with glioblastoma in first or second relapse who had previously received radiation therapy and temozolomide.

They were randomly assigned in nearly equal numbers to open-label treatment with bevacizumab alone or bevacizumab plus irinotecan.

Updated results were based on data cutoffs of July 2008 (treatment exposure, safety, and median survival) and July 2009 (survival rates), according to Dr. Cloughesy. The 167 enrolled patients had a median age of about 55 years. The majority were male (68%) and white (90%), and experiencing a first relapse (81%). Progression occurred in 59% of the patients in the bevacizumab arm, and these patients went on to receive the combination therapy.

The median number of bevacizumab doses received was 9 in the bevacizumab group and 11 in the bevacizumab-irinotecan group during the main phase of the trial, reported Dr. Cloughesy, director of the neuro-oncology program and a clinical professor at the Ronald Reagan UCLA Medical Center in Los Angeles. The median number was three during the post-progression phase.

The updated safety data showed little change from the initial results, he said. Some 51% of patients in the bevacizumab group and 71% in the bevacizumab-irinotecan group had adverse events of grade 3 or higher. Hypertension was the predominant event with monotherapy (11%), whereas venous thromboembolism was the predominant event with combination therapy (10%).

“The things that… we are concerned about with regard to patients who are taking anti-VEGF [vascular endothelial growth factor] therapy—cerebral hemorrhage, wound healing, arterial thrombotic embolism, and gastrointestinal perforation—these all stayed fairly low,” he commented. These events occurred at a severity of grade 3 or higher in only 0%-3.6% of patients.

Median overall survival was 9.3 months with bevacizumab alone and 8.9 months with both drugs. The proportion of patients still alive was 38% in each arm at 12 months; 24% and 18%, respectively, at 18 months; 16% and 17%, at 24 months; and 11% and 16%, at 30 months.

Dr. Alba A. Brandes, a medical oncologist at Azienda USL in Bologna, Italy, noted that the trial's size and promising results were strengths, but said its evaluation criteria and lack of a standard control arm and biomarker studies were weaknesses.

“Bevacizumab has brought light into the treatment of recurrent GBM, a setting with scarce options and dismal results,” she commented. “The advantage of bevacizumab over classical cytotoxics seems to be in the range of 2 to 3 months. That represents a prolongation of 30% in survival at recurrence,” said Dr. Brandes. “However, this advantage should be proven in phase III trials.”

We think the majority of the effect that we are seeing with the two drugs in this trial comes from bevacizumab.

Source DR. CLOUGHESY

Major Finding: Median overall survival in patients having recurrent glioblastoma was 6.6 months with NovoTTF vs. 6.0 months with best standard chemotherapy, and NovoTTF had minimal adverse effects.

Data Source: A randomized, open-label phase III trial (the EF11 trial) among 237 patients with recurrent glioblastoma.

Disclosures: Some of the investigators were employees of, owned stock in, or received research funding from NovoCure, the manufacturer of NovoTTF.

CHICAGO — Treatment with electric fields that disrupt tumor cell processes appears to be at least as effective as the best standard chemotherapy for recurrent glioblastoma and is safe and well tolerated, according to the results of a randomized, open-label, phase III trial.

In the study of 237 patients with recurrent glioblastoma, some of whom were heavily pretreated, median overall survival was 6.6 months among those assigned to treatment with NovoTTF-100A, an investigational device that delivers low-amplitude alternating electric fields through noninvasive, disposable electrodes applied to the shaved head. Among those treated with the standard chemotherapy selected by their physicians, median survival was 6.0 months.

The main adverse event associated with NovoTTF-100A use was mild to moderate skin irritation related to the electrodes in 17% of patients, whereas patients treated with chemotherapy had higher rates of grade 3/4 hematologic adverse events and gastrointestinal adverse events.

“We were afraid that we would… induce seizures with this device,” commented lead investigator Dr. Roger Stupp, an oncologist at the University of Lausanne (Switzerland) Hospitals. But “actually, there was no increase in seizure frequency in the patients who got the NovoTTF.”

Dr. Stupp explained that the device, which is powered through a portable battery pack, “should generate forces that will disrupt and interfere with cell division and assembly of organelles, either directly or by indirect mechanisms.”

Adult patients in the United States, Europe, and Israel were eligible for the trial, called EF-11, if they had recurrent glioblastoma and a good performance status. There was no limitation on the number of prior therapies, and previous surgery for the recurrence was also allowed.

In all, 120 patients were randomized to NovoTTF, with a target of at least 20 hours of use daily, while 117 patients were randomized to best standard chemotherapy at their physician's discretion. All underwent magnetic resonance imaging every 2 months.

The patients had a median age of 54 years, and 70% were men. The median time from initial glioblastoma diagnosis was 11 months.

On average, the patients had received two prior lines of chemotherapy (range, one to five), and 26% had had surgery for their recurrence. Overall, 53% were being treated for a second or third recurrence.

Fully 78% of patients in the NovoTTF group were treated per protocol, defined as having received a dose intensity of at least 70% of that planned during the first month, Dr. Stupp reported. The median daily duration of use was 20 hours.

Similarly, 79% of patients in the chemotherapy group were treated per protocol. The chemotherapies were most often nitrosoureas, PCV (procarbazine, lomustine, and vincristine), or procarbazine (33%); bevacizumab with or without other agents (13%); platinum-based therapy (11%); and temozolomide (11%).

In an intent-to-treat analysis, median overall survival—the trial's primary efficacy end point—was 6.6 months with NovoTTF and 6.0 months with chemotherapy. The 1-year rate of survival was 23.6% vs. 20.7%, respectively, a statistically nonsignificant difference.

However, in a per-protocol analysis, median overall survival was 7.8 months with NovoTTF and 6.1 months with chemotherapy. The 1-year rate of survival in this case was 29.5% vs.19.1%, respectively (hazard ratio, 0.64; P = .01).

Similarly, the 6-month rate of progression-free survival did not differ significantly between groups on an intent-to-treat basis (24% vs. 17%), but was twice as high in the NovoTTF group on a per-protocol basis (28% vs. 14%, P = .04), according to Dr. Stupp.

He cautioned that the effects of NovoTTF may not become apparent on scans for at least several months.

The effects of NovoTTF-100A may not become apparent on MR imaging scans for at least several months.

Source DR. STUPP

My Take

Option for Failed, Intolerable Chemo

This study is intriguing because it potentially offers our patients a novel therapy with improved tolerability compared to chemotherapy. Once patients with recurrent glioblastoma have had tumor progression in spite of bevacizumab, treatment options are limited. The per-protocol data analysis was most compelling with a statistically significant overall survival of 7.8 months and 1-year survival of 29.5% with the use of the NovoTTF-100A, compared with 6.1 months and 19.1% in the chemotherapy arm.

Imaging was performed in 2-month intervals, and Dr. Stupp alludes to the fact that tumor regression may not be seen on MRI for several months. Therefore, adequate treatment time must be allowed prior to abandoning therapy. One must assume from this statement that the imaging was revealing for tumor stability rather than progression followed by regression. I question whether or not the device has any adverse radiographic effects comparable to radiation necrosis that improves over time. NovoTTF-100A is a promising therapy for patients with recurrent glioblastoma and is an exciting option for patients in whom chemotherapy has failed and or has been intolerable.

ALYX B. PORTER, M.D., is a neuro-oncologist at the Mayo Clinic Arizona. She has no relevant disclosures and wrote her commentary upon request.

Major Finding: Median overall survival in patients having recurrent glioblastoma was 6.6 months with NovoTTF vs. 6.0 months with best standard chemotherapy, and NovoTTF had minimal adverse effects.

Data Source: A randomized, open-label phase III trial (the EF11 trial) among 237 patients with recurrent glioblastoma.

Disclosures: Some of the investigators were employees of, owned stock in, or received research funding from NovoCure, the manufacturer of NovoTTF.

CHICAGO — Treatment with electric fields that disrupt tumor cell processes appears to be at least as effective as the best standard chemotherapy for recurrent glioblastoma and is safe and well tolerated, according to the results of a randomized, open-label, phase III trial.

In the study of 237 patients with recurrent glioblastoma, some of whom were heavily pretreated, median overall survival was 6.6 months among those assigned to treatment with NovoTTF-100A, an investigational device that delivers low-amplitude alternating electric fields through noninvasive, disposable electrodes applied to the shaved head. Among those treated with the standard chemotherapy selected by their physicians, median survival was 6.0 months.

The main adverse event associated with NovoTTF-100A use was mild to moderate skin irritation related to the electrodes in 17% of patients, whereas patients treated with chemotherapy had higher rates of grade 3/4 hematologic adverse events and gastrointestinal adverse events.

“We were afraid that we would… induce seizures with this device,” commented lead investigator Dr. Roger Stupp, an oncologist at the University of Lausanne (Switzerland) Hospitals. But “actually, there was no increase in seizure frequency in the patients who got the NovoTTF.”

Dr. Stupp explained that the device, which is powered through a portable battery pack, “should generate forces that will disrupt and interfere with cell division and assembly of organelles, either directly or by indirect mechanisms.”

Adult patients in the United States, Europe, and Israel were eligible for the trial, called EF-11, if they had recurrent glioblastoma and a good performance status. There was no limitation on the number of prior therapies, and previous surgery for the recurrence was also allowed.

In all, 120 patients were randomized to NovoTTF, with a target of at least 20 hours of use daily, while 117 patients were randomized to best standard chemotherapy at their physician's discretion. All underwent magnetic resonance imaging every 2 months.

The patients had a median age of 54 years, and 70% were men. The median time from initial glioblastoma diagnosis was 11 months.

On average, the patients had received two prior lines of chemotherapy (range, one to five), and 26% had had surgery for their recurrence. Overall, 53% were being treated for a second or third recurrence.

Fully 78% of patients in the NovoTTF group were treated per protocol, defined as having received a dose intensity of at least 70% of that planned during the first month, Dr. Stupp reported. The median daily duration of use was 20 hours.

Similarly, 79% of patients in the chemotherapy group were treated per protocol. The chemotherapies were most often nitrosoureas, PCV (procarbazine, lomustine, and vincristine), or procarbazine (33%); bevacizumab with or without other agents (13%); platinum-based therapy (11%); and temozolomide (11%).

In an intent-to-treat analysis, median overall survival—the trial's primary efficacy end point—was 6.6 months with NovoTTF and 6.0 months with chemotherapy. The 1-year rate of survival was 23.6% vs. 20.7%, respectively, a statistically nonsignificant difference.

However, in a per-protocol analysis, median overall survival was 7.8 months with NovoTTF and 6.1 months with chemotherapy. The 1-year rate of survival in this case was 29.5% vs.19.1%, respectively (hazard ratio, 0.64; P = .01).

Similarly, the 6-month rate of progression-free survival did not differ significantly between groups on an intent-to-treat basis (24% vs. 17%), but was twice as high in the NovoTTF group on a per-protocol basis (28% vs. 14%, P = .04), according to Dr. Stupp.

He cautioned that the effects of NovoTTF may not become apparent on scans for at least several months.

The effects of NovoTTF-100A may not become apparent on MR imaging scans for at least several months.

Source DR. STUPP

My Take

Option for Failed, Intolerable Chemo

This study is intriguing because it potentially offers our patients a novel therapy with improved tolerability compared to chemotherapy. Once patients with recurrent glioblastoma have had tumor progression in spite of bevacizumab, treatment options are limited. The per-protocol data analysis was most compelling with a statistically significant overall survival of 7.8 months and 1-year survival of 29.5% with the use of the NovoTTF-100A, compared with 6.1 months and 19.1% in the chemotherapy arm.

Imaging was performed in 2-month intervals, and Dr. Stupp alludes to the fact that tumor regression may not be seen on MRI for several months. Therefore, adequate treatment time must be allowed prior to abandoning therapy. One must assume from this statement that the imaging was revealing for tumor stability rather than progression followed by regression. I question whether or not the device has any adverse radiographic effects comparable to radiation necrosis that improves over time. NovoTTF-100A is a promising therapy for patients with recurrent glioblastoma and is an exciting option for patients in whom chemotherapy has failed and or has been intolerable.

ALYX B. PORTER, M.D., is a neuro-oncologist at the Mayo Clinic Arizona. She has no relevant disclosures and wrote her commentary upon request.

Major Finding: Median overall survival in patients having recurrent glioblastoma was 6.6 months with NovoTTF vs. 6.0 months with best standard chemotherapy, and NovoTTF had minimal adverse effects.

Data Source: A randomized, open-label phase III trial (the EF11 trial) among 237 patients with recurrent glioblastoma.

Disclosures: Some of the investigators were employees of, owned stock in, or received research funding from NovoCure, the manufacturer of NovoTTF.

CHICAGO — Treatment with electric fields that disrupt tumor cell processes appears to be at least as effective as the best standard chemotherapy for recurrent glioblastoma and is safe and well tolerated, according to the results of a randomized, open-label, phase III trial.

In the study of 237 patients with recurrent glioblastoma, some of whom were heavily pretreated, median overall survival was 6.6 months among those assigned to treatment with NovoTTF-100A, an investigational device that delivers low-amplitude alternating electric fields through noninvasive, disposable electrodes applied to the shaved head. Among those treated with the standard chemotherapy selected by their physicians, median survival was 6.0 months.

The main adverse event associated with NovoTTF-100A use was mild to moderate skin irritation related to the electrodes in 17% of patients, whereas patients treated with chemotherapy had higher rates of grade 3/4 hematologic adverse events and gastrointestinal adverse events.

“We were afraid that we would… induce seizures with this device,” commented lead investigator Dr. Roger Stupp, an oncologist at the University of Lausanne (Switzerland) Hospitals. But “actually, there was no increase in seizure frequency in the patients who got the NovoTTF.”

Dr. Stupp explained that the device, which is powered through a portable battery pack, “should generate forces that will disrupt and interfere with cell division and assembly of organelles, either directly or by indirect mechanisms.”

Adult patients in the United States, Europe, and Israel were eligible for the trial, called EF-11, if they had recurrent glioblastoma and a good performance status. There was no limitation on the number of prior therapies, and previous surgery for the recurrence was also allowed.

In all, 120 patients were randomized to NovoTTF, with a target of at least 20 hours of use daily, while 117 patients were randomized to best standard chemotherapy at their physician's discretion. All underwent magnetic resonance imaging every 2 months.

The patients had a median age of 54 years, and 70% were men. The median time from initial glioblastoma diagnosis was 11 months.

On average, the patients had received two prior lines of chemotherapy (range, one to five), and 26% had had surgery for their recurrence. Overall, 53% were being treated for a second or third recurrence.

Fully 78% of patients in the NovoTTF group were treated per protocol, defined as having received a dose intensity of at least 70% of that planned during the first month, Dr. Stupp reported. The median daily duration of use was 20 hours.

Similarly, 79% of patients in the chemotherapy group were treated per protocol. The chemotherapies were most often nitrosoureas, PCV (procarbazine, lomustine, and vincristine), or procarbazine (33%); bevacizumab with or without other agents (13%); platinum-based therapy (11%); and temozolomide (11%).

In an intent-to-treat analysis, median overall survival—the trial's primary efficacy end point—was 6.6 months with NovoTTF and 6.0 months with chemotherapy. The 1-year rate of survival was 23.6% vs. 20.7%, respectively, a statistically nonsignificant difference.

However, in a per-protocol analysis, median overall survival was 7.8 months with NovoTTF and 6.1 months with chemotherapy. The 1-year rate of survival in this case was 29.5% vs.19.1%, respectively (hazard ratio, 0.64; P = .01).

Similarly, the 6-month rate of progression-free survival did not differ significantly between groups on an intent-to-treat basis (24% vs. 17%), but was twice as high in the NovoTTF group on a per-protocol basis (28% vs. 14%, P = .04), according to Dr. Stupp.

He cautioned that the effects of NovoTTF may not become apparent on scans for at least several months.

The effects of NovoTTF-100A may not become apparent on MR imaging scans for at least several months.

Source DR. STUPP

My Take

Option for Failed, Intolerable Chemo

This study is intriguing because it potentially offers our patients a novel therapy with improved tolerability compared to chemotherapy. Once patients with recurrent glioblastoma have had tumor progression in spite of bevacizumab, treatment options are limited. The per-protocol data analysis was most compelling with a statistically significant overall survival of 7.8 months and 1-year survival of 29.5% with the use of the NovoTTF-100A, compared with 6.1 months and 19.1% in the chemotherapy arm.

Imaging was performed in 2-month intervals, and Dr. Stupp alludes to the fact that tumor regression may not be seen on MRI for several months. Therefore, adequate treatment time must be allowed prior to abandoning therapy. One must assume from this statement that the imaging was revealing for tumor stability rather than progression followed by regression. I question whether or not the device has any adverse radiographic effects comparable to radiation necrosis that improves over time. NovoTTF-100A is a promising therapy for patients with recurrent glioblastoma and is an exciting option for patients in whom chemotherapy has failed and or has been intolerable.

ALYX B. PORTER, M.D., is a neuro-oncologist at the Mayo Clinic Arizona. She has no relevant disclosures and wrote her commentary upon request.

Major Finding: Overall, 55% of children with rheumatologic conditions had vitamin D deficiency or insufficiency, with no significant difference between children with autoimmune conditions (56%) and children with nonautoimmune conditions (52%).

Data Source: An observational study of 254 consecutive children seen in a pediatric rheumatology clinic.

Disclosures: Dr. Pelajo reported that she had no conflicts of interest related to the study.

VANCOUVER, B.C. — Vitamin D deficiency and insufficiency are highly prevalent in the pediatric rheumatology population, according to the findings of retrospective chart review.

Slightly more than half of patients who were seen in a pediatric rheumatology clinic at Tufts Medical Center in Boston during an 11-month period had levels of vitamin D that were in the deficient or insufficient range, with no significant difference in prevalence between children with autoimmune conditions and children with nonautoimmune conditions.

“The most important take-home message is to look for it, no matter what their baseline condition,” lead researcher Dr. Christina F. Pelajo recommended.

“And I would look even more carefully in children with the risk factors”—namely, overweight status, black race/ethnicity, older age, and nonsummer season of the visit, she added.

The investigators reviewed the medical records of consecutive children visiting the center's pediatric rheumatology clinic between November 2008 and September 2009, and assessed associations between mean levels of vitamin D (serum 25-hydroxyvitamin D) and various factors. Study results were based on 169 children with autoimmune conditions (predominantly juvenile idiopathic arthritis and juvenile systemic lupus erythematosus) and 85 children with nonautoimmune conditions (Lyme disease, patellofemoral syndrome, hypermobility, and others). Two-thirds were girls, and the average age was 12 years.

The mean level of vitamin D was 28.1 ng/mL in the group with autoimmune conditions and 29.7 ng/mL in the group with nonautoimmune conditions, a nonsignificant difference, reported Dr. Pelajo, who is a research fellow at the center. Overall, 55% of children had levels of vitamin D in the range for deficiency (less than 20 ng/mL) or insufficiency (20–29 ng/mL), with no significant difference between the two groups.

The prevalence of deficiency was 23% in the children with autoimmune conditions and 14% in the children without; the prevalence of insufficiency was 33% and 38%, respectively.

Vitamin D levels did differ by race/ethnicity: Mean values were highest among white children (30.7 ng/mL), lowest among black children (17.9 ng/mL), and intermediate among children who were Hispanic (21.3 ng/mL), Asian Indian (20.2 ng/mL), and Asian (21.1 ng/mL).

Levels were lower in overweight children, compared with their counterparts who had a normal body mass index (24.1 vs. 29.5 ng/mL, respectively), and they decreased with increasing age.

Finally, levels varied by season of visit, with the highest values seen in summer (36.0 ng/mL) and considerably lower ones seen in fall (27.7 ng/mL), winter (25.7 ng/mL), and spring (26.3 ng/mL).

Children who took supplements had higher vitamin D levels than did their peers who took no supplements. However, when the supplemented group was stratified by dose, the difference relative to the nonsupplemented group was significant only for children who took supplements containing more than 400 IU of vitamin D₃.

“Taking 400 IU is the same as not taking anything because it's such a low dose,” commented Dr. Pelajo.

Major Finding: Overall, 55% of children with rheumatologic conditions had vitamin D deficiency or insufficiency, with no significant difference between children with autoimmune conditions (56%) and children with nonautoimmune conditions (52%).

Data Source: An observational study of 254 consecutive children seen in a pediatric rheumatology clinic.

Disclosures: Dr. Pelajo reported that she had no conflicts of interest related to the study.

VANCOUVER, B.C. — Vitamin D deficiency and insufficiency are highly prevalent in the pediatric rheumatology population, according to the findings of retrospective chart review.

Slightly more than half of patients who were seen in a pediatric rheumatology clinic at Tufts Medical Center in Boston during an 11-month period had levels of vitamin D that were in the deficient or insufficient range, with no significant difference in prevalence between children with autoimmune conditions and children with nonautoimmune conditions.

“The most important take-home message is to look for it, no matter what their baseline condition,” lead researcher Dr. Christina F. Pelajo recommended.

“And I would look even more carefully in children with the risk factors”—namely, overweight status, black race/ethnicity, older age, and nonsummer season of the visit, she added.

The investigators reviewed the medical records of consecutive children visiting the center's pediatric rheumatology clinic between November 2008 and September 2009, and assessed associations between mean levels of vitamin D (serum 25-hydroxyvitamin D) and various factors. Study results were based on 169 children with autoimmune conditions (predominantly juvenile idiopathic arthritis and juvenile systemic lupus erythematosus) and 85 children with nonautoimmune conditions (Lyme disease, patellofemoral syndrome, hypermobility, and others). Two-thirds were girls, and the average age was 12 years.

The mean level of vitamin D was 28.1 ng/mL in the group with autoimmune conditions and 29.7 ng/mL in the group with nonautoimmune conditions, a nonsignificant difference, reported Dr. Pelajo, who is a research fellow at the center. Overall, 55% of children had levels of vitamin D in the range for deficiency (less than 20 ng/mL) or insufficiency (20–29 ng/mL), with no significant difference between the two groups.

The prevalence of deficiency was 23% in the children with autoimmune conditions and 14% in the children without; the prevalence of insufficiency was 33% and 38%, respectively.

Vitamin D levels did differ by race/ethnicity: Mean values were highest among white children (30.7 ng/mL), lowest among black children (17.9 ng/mL), and intermediate among children who were Hispanic (21.3 ng/mL), Asian Indian (20.2 ng/mL), and Asian (21.1 ng/mL).

Levels were lower in overweight children, compared with their counterparts who had a normal body mass index (24.1 vs. 29.5 ng/mL, respectively), and they decreased with increasing age.

Finally, levels varied by season of visit, with the highest values seen in summer (36.0 ng/mL) and considerably lower ones seen in fall (27.7 ng/mL), winter (25.7 ng/mL), and spring (26.3 ng/mL).

Children who took supplements had higher vitamin D levels than did their peers who took no supplements. However, when the supplemented group was stratified by dose, the difference relative to the nonsupplemented group was significant only for children who took supplements containing more than 400 IU of vitamin D₃.

“Taking 400 IU is the same as not taking anything because it's such a low dose,” commented Dr. Pelajo.

Major Finding: Overall, 55% of children with rheumatologic conditions had vitamin D deficiency or insufficiency, with no significant difference between children with autoimmune conditions (56%) and children with nonautoimmune conditions (52%).

Data Source: An observational study of 254 consecutive children seen in a pediatric rheumatology clinic.

Disclosures: Dr. Pelajo reported that she had no conflicts of interest related to the study.

VANCOUVER, B.C. — Vitamin D deficiency and insufficiency are highly prevalent in the pediatric rheumatology population, according to the findings of retrospective chart review.

Slightly more than half of patients who were seen in a pediatric rheumatology clinic at Tufts Medical Center in Boston during an 11-month period had levels of vitamin D that were in the deficient or insufficient range, with no significant difference in prevalence between children with autoimmune conditions and children with nonautoimmune conditions.

“The most important take-home message is to look for it, no matter what their baseline condition,” lead researcher Dr. Christina F. Pelajo recommended.

“And I would look even more carefully in children with the risk factors”—namely, overweight status, black race/ethnicity, older age, and nonsummer season of the visit, she added.

The investigators reviewed the medical records of consecutive children visiting the center's pediatric rheumatology clinic between November 2008 and September 2009, and assessed associations between mean levels of vitamin D (serum 25-hydroxyvitamin D) and various factors. Study results were based on 169 children with autoimmune conditions (predominantly juvenile idiopathic arthritis and juvenile systemic lupus erythematosus) and 85 children with nonautoimmune conditions (Lyme disease, patellofemoral syndrome, hypermobility, and others). Two-thirds were girls, and the average age was 12 years.

The mean level of vitamin D was 28.1 ng/mL in the group with autoimmune conditions and 29.7 ng/mL in the group with nonautoimmune conditions, a nonsignificant difference, reported Dr. Pelajo, who is a research fellow at the center. Overall, 55% of children had levels of vitamin D in the range for deficiency (less than 20 ng/mL) or insufficiency (20–29 ng/mL), with no significant difference between the two groups.

The prevalence of deficiency was 23% in the children with autoimmune conditions and 14% in the children without; the prevalence of insufficiency was 33% and 38%, respectively.

Vitamin D levels did differ by race/ethnicity: Mean values were highest among white children (30.7 ng/mL), lowest among black children (17.9 ng/mL), and intermediate among children who were Hispanic (21.3 ng/mL), Asian Indian (20.2 ng/mL), and Asian (21.1 ng/mL).

Levels were lower in overweight children, compared with their counterparts who had a normal body mass index (24.1 vs. 29.5 ng/mL, respectively), and they decreased with increasing age.

Finally, levels varied by season of visit, with the highest values seen in summer (36.0 ng/mL) and considerably lower ones seen in fall (27.7 ng/mL), winter (25.7 ng/mL), and spring (26.3 ng/mL).

Children who took supplements had higher vitamin D levels than did their peers who took no supplements. However, when the supplemented group was stratified by dose, the difference relative to the nonsupplemented group was significant only for children who took supplements containing more than 400 IU of vitamin D₃.

“Taking 400 IU is the same as not taking anything because it's such a low dose,” commented Dr. Pelajo.

Major Finding: Compared with parents whose adolescent daughters had not been vaccinated for HPV, parents with vaccinated daughters were more likely to believe that vaccines are safe (94% vs. 76%) and that the HPV vaccine prevents cervical cancer (91% vs. 50%).

Data Source: A survey of 95 parents of adolescent girls who were visiting a free clinic that serves a largely Latino population.

Disclosures: None was reported.

VANCOUVER, B.C. — Parental beliefs regarding both vaccine safety in general and the effectiveness of the human papillomavirus vaccine appear to be one of the main drivers of this vaccine's receipt among adolescent girls from a predominantly Latino population, according to the results of a small study.

A physician recommendation to vaccinate is also key, Dr. Nava Yeganeh reported in a poster at the meeting.

In a survey of 95 parents of adolescent girls who visited a free clinic in Los Angeles, 37% of the daughters had been vaccinated. Compared with parents of nonvaccinated daughters, parents of vaccinated daughters were more likely to believe that vaccines in general are safe (94% vs. 76%) and that the human papillomavirus (HPV) vaccine prevents cervical cancer (91% vs. 50%).

Parents most often cited the prevention of cervical cancer and a physician's recommendation as their reasons for having vaccinated their daughter, or for wanting her to get the vaccine.

“Our findings support that clinical physicians should emphasize the vaccine, recommend it, and talk about its safety as well as its efficacy in preventing cervical cancer,” Dr. Yeganeh said in an interview.

HPV-related disease disproportionately affects Latino Americans. “And they have the highest morbidity and mortality with it,” she noted.

Hence, understanding the facilitators of and barriers to HPV vaccination in this population is especially important.

She and her colleagues approached parents who were waiting for an appointment at the clinic, where the HPV vaccine had been offered at no charge for more than 1 year.

Those having daughters aged 11–17 years were asked to complete a verbally administered questionnaire in private.

Of the 95 parents who participated, most were the mothers (98%) and were Latino (91%), reported Dr. Yeganeh, an infectious disease fellow at the University of California, Los Angeles. On average, the daughters were 14.6 years old.

Overall, 77% of the parents had heard of the HPV vaccine, and 37% had already had their daughters vaccinated.

In analyses that were restricted to the parents who had heard of the vaccine, those with vaccinated daughters were more likely to be Latino (100% vs. 82%; P = .01), and to believe that vaccines in general are safe (94% vs. 76%; P = .03) and that the HPV vaccine prevents cervical cancer (91% vs. 50%; P less than .01).

In contrast, the groups did not differ significantly with respect to other demographic factors (education, household income, or political views) and other health-related factors (having a primary care provider, having health insurance, believing that the HPV vaccine prevents warts, having received a Pap test in the past year, or being concerned about cervical cancer, among others).

The leading sources of information about the HPV vaccine were the TV, news, and the Internet, cited by 70% of parents, followed by doctors and clinics, cited by roughly 60%. None of the parents mentioned their daughter's school as an information source.

The leading reasons for having vaccinated their daughters or wanting them to receive the vaccine were to prevent cervical cancer, cited by 97% of parents, and because a doctor recommended it, cited by about 55%.

“That, I think, is really key,” Dr. Yeganeh commented. “A lot of studies have shown that if a doctor recommends it, people are more likely to vaccinate their child.”

When the parents who had heard of the vaccine but had not had their daughters vaccinated were asked why, 55% said they needed more information and 29% cited missed opportunities (for example, the clinic did not have the vaccine or their doctor did not recommend it).

“There has been a lot of backlash in the media about this being a sexually transmitted disease,” she continued.

However, only 8% of these parents said that they had not had their daughters vaccinated because they were worried that doing so would encourage promiscuity. About 18% had concerns about safety.

Major Finding: Compared with parents whose adolescent daughters had not been vaccinated for HPV, parents with vaccinated daughters were more likely to believe that vaccines are safe (94% vs. 76%) and that the HPV vaccine prevents cervical cancer (91% vs. 50%).

Data Source: A survey of 95 parents of adolescent girls who were visiting a free clinic that serves a largely Latino population.

Disclosures: None was reported.

VANCOUVER, B.C. — Parental beliefs regarding both vaccine safety in general and the effectiveness of the human papillomavirus vaccine appear to be one of the main drivers of this vaccine's receipt among adolescent girls from a predominantly Latino population, according to the results of a small study.

A physician recommendation to vaccinate is also key, Dr. Nava Yeganeh reported in a poster at the meeting.

In a survey of 95 parents of adolescent girls who visited a free clinic in Los Angeles, 37% of the daughters had been vaccinated. Compared with parents of nonvaccinated daughters, parents of vaccinated daughters were more likely to believe that vaccines in general are safe (94% vs. 76%) and that the human papillomavirus (HPV) vaccine prevents cervical cancer (91% vs. 50%).

Parents most often cited the prevention of cervical cancer and a physician's recommendation as their reasons for having vaccinated their daughter, or for wanting her to get the vaccine.

“Our findings support that clinical physicians should emphasize the vaccine, recommend it, and talk about its safety as well as its efficacy in preventing cervical cancer,” Dr. Yeganeh said in an interview.

HPV-related disease disproportionately affects Latino Americans. “And they have the highest morbidity and mortality with it,” she noted.

Hence, understanding the facilitators of and barriers to HPV vaccination in this population is especially important.

She and her colleagues approached parents who were waiting for an appointment at the clinic, where the HPV vaccine had been offered at no charge for more than 1 year.

Those having daughters aged 11–17 years were asked to complete a verbally administered questionnaire in private.

Of the 95 parents who participated, most were the mothers (98%) and were Latino (91%), reported Dr. Yeganeh, an infectious disease fellow at the University of California, Los Angeles. On average, the daughters were 14.6 years old.

Overall, 77% of the parents had heard of the HPV vaccine, and 37% had already had their daughters vaccinated.

In analyses that were restricted to the parents who had heard of the vaccine, those with vaccinated daughters were more likely to be Latino (100% vs. 82%; P = .01), and to believe that vaccines in general are safe (94% vs. 76%; P = .03) and that the HPV vaccine prevents cervical cancer (91% vs. 50%; P less than .01).

In contrast, the groups did not differ significantly with respect to other demographic factors (education, household income, or political views) and other health-related factors (having a primary care provider, having health insurance, believing that the HPV vaccine prevents warts, having received a Pap test in the past year, or being concerned about cervical cancer, among others).

The leading sources of information about the HPV vaccine were the TV, news, and the Internet, cited by 70% of parents, followed by doctors and clinics, cited by roughly 60%. None of the parents mentioned their daughter's school as an information source.

The leading reasons for having vaccinated their daughters or wanting them to receive the vaccine were to prevent cervical cancer, cited by 97% of parents, and because a doctor recommended it, cited by about 55%.

“That, I think, is really key,” Dr. Yeganeh commented. “A lot of studies have shown that if a doctor recommends it, people are more likely to vaccinate their child.”

When the parents who had heard of the vaccine but had not had their daughters vaccinated were asked why, 55% said they needed more information and 29% cited missed opportunities (for example, the clinic did not have the vaccine or their doctor did not recommend it).

“There has been a lot of backlash in the media about this being a sexually transmitted disease,” she continued.

However, only 8% of these parents said that they had not had their daughters vaccinated because they were worried that doing so would encourage promiscuity. About 18% had concerns about safety.

Major Finding: Compared with parents whose adolescent daughters had not been vaccinated for HPV, parents with vaccinated daughters were more likely to believe that vaccines are safe (94% vs. 76%) and that the HPV vaccine prevents cervical cancer (91% vs. 50%).

Data Source: A survey of 95 parents of adolescent girls who were visiting a free clinic that serves a largely Latino population.

Disclosures: None was reported.

VANCOUVER, B.C. — Parental beliefs regarding both vaccine safety in general and the effectiveness of the human papillomavirus vaccine appear to be one of the main drivers of this vaccine's receipt among adolescent girls from a predominantly Latino population, according to the results of a small study.

A physician recommendation to vaccinate is also key, Dr. Nava Yeganeh reported in a poster at the meeting.

In a survey of 95 parents of adolescent girls who visited a free clinic in Los Angeles, 37% of the daughters had been vaccinated. Compared with parents of nonvaccinated daughters, parents of vaccinated daughters were more likely to believe that vaccines in general are safe (94% vs. 76%) and that the human papillomavirus (HPV) vaccine prevents cervical cancer (91% vs. 50%).

Parents most often cited the prevention of cervical cancer and a physician's recommendation as their reasons for having vaccinated their daughter, or for wanting her to get the vaccine.

“Our findings support that clinical physicians should emphasize the vaccine, recommend it, and talk about its safety as well as its efficacy in preventing cervical cancer,” Dr. Yeganeh said in an interview.

HPV-related disease disproportionately affects Latino Americans. “And they have the highest morbidity and mortality with it,” she noted.

Hence, understanding the facilitators of and barriers to HPV vaccination in this population is especially important.

She and her colleagues approached parents who were waiting for an appointment at the clinic, where the HPV vaccine had been offered at no charge for more than 1 year.

Those having daughters aged 11–17 years were asked to complete a verbally administered questionnaire in private.

Of the 95 parents who participated, most were the mothers (98%) and were Latino (91%), reported Dr. Yeganeh, an infectious disease fellow at the University of California, Los Angeles. On average, the daughters were 14.6 years old.

Overall, 77% of the parents had heard of the HPV vaccine, and 37% had already had their daughters vaccinated.

In analyses that were restricted to the parents who had heard of the vaccine, those with vaccinated daughters were more likely to be Latino (100% vs. 82%; P = .01), and to believe that vaccines in general are safe (94% vs. 76%; P = .03) and that the HPV vaccine prevents cervical cancer (91% vs. 50%; P less than .01).

In contrast, the groups did not differ significantly with respect to other demographic factors (education, household income, or political views) and other health-related factors (having a primary care provider, having health insurance, believing that the HPV vaccine prevents warts, having received a Pap test in the past year, or being concerned about cervical cancer, among others).

The leading sources of information about the HPV vaccine were the TV, news, and the Internet, cited by 70% of parents, followed by doctors and clinics, cited by roughly 60%. None of the parents mentioned their daughter's school as an information source.

The leading reasons for having vaccinated their daughters or wanting them to receive the vaccine were to prevent cervical cancer, cited by 97% of parents, and because a doctor recommended it, cited by about 55%.

“That, I think, is really key,” Dr. Yeganeh commented. “A lot of studies have shown that if a doctor recommends it, people are more likely to vaccinate their child.”

When the parents who had heard of the vaccine but had not had their daughters vaccinated were asked why, 55% said they needed more information and 29% cited missed opportunities (for example, the clinic did not have the vaccine or their doctor did not recommend it).

“There has been a lot of backlash in the media about this being a sexually transmitted disease,” she continued.

However, only 8% of these parents said that they had not had their daughters vaccinated because they were worried that doing so would encourage promiscuity. About 18% had concerns about safety.

Major Finding: Percentage of participants doing skin self-exams at least monthly remained the same among those with a history of melanoma who were mutation carriers (73%) and doubled among unaffected mutation carriers (from 30% to 60%), but increased only slightly among noncarriers (from 38% to 44%).

Data Source: Prospective, 2-year longitudinal study among 37 individuals at high risk for melanoma.

Disclosures: Ms. Taber reported that she had no conflicts of interest related to the study.

SEATTLE — The impact of genetic testing on skin self-examination behavior among individuals at high risk for melanoma varies with personal history of the disease and test results, according to the first prospective study of this issue in a tested population.

Of 37 individuals at high risk for melanoma because of family history, those who had previously had the disease and who learned that they carried a mutation that sharply increased risk did not alter their skin self-exam behavior. Both before testing and 2 years later, 73% were doing these exams about every month, as is recommended, or more often.

Individuals who had not had melanoma but who learned that they carried the mutation stepped up their skin self-exam behavior: Only 30% were doing these exams at least monthly before testing, but 60% were doing so 2 years afterward.

By contrast, individuals who had not had melanoma and who learned that they did not carry the mutation had little change in their behavior, even though regular skin self-exams are also recommended for this group: 38% were doing these exams roughly once a month or more often before testing, and 44% were doing so at follow-up.

“Researchers and genetic counselors believe that learning one's objective risk will actually motivate behavior change,” said lead investigator Jennifer M. Taber.

There are several concerns, however.

“One is that individuals who test negative will feel that their risk is so low that they don't need to engage in prevention or screening behaviors anymore, that they might feel a false sense of security and not change their behavior,” she explained. “Another concern is that for those who test positive, they will feel a sense of fatalism—that there is nothing they can do, their risk is so high anyway, so why bother engaging in the behaviors,” she added.

Ms. Taber, a graduate student in psychology at the University of Utah in Salt Lake City, and her coinvestigators studied 37 adults from families with very high rates of melanoma. All underwent genetic testing for the p16 mutation, which sharply increases melanoma risk, and were followed for 2 years.

Nearly a third (30%) of participants were affected carriers, meaning they had a history of melanoma and had the mutation; 27% were unaffected carriers, meaning they did not have a history of the disease and did have the mutation; and 43% were noncarriers who did not have a history of the disease and did not have the mutation.

Monthly skin self-exams are recommended for all individuals from families with high rates of melanoma, regardless of their genetic test results, Ms. Taber noted, because even those with a negative result have a lifetime probability of the disease twice that of the general population.

The investigators classified the participants' skin self-exam behavior, according to the number of these exams performed in a 6-month period, as being on target (four to eight exams); overscreening (more than eight), which may actually hamper detection of changes; and underscreening (fewer than four), which may lead to missed lesions.

Two years after testing, the percentage of participants who were either on target or overscreening remained at the same high baseline level among affected carriers (73%) and had doubled among unaffected carriers (from 30% to 60%), but had increased only slightly among noncarriers (from 38% to 44%).

When the results were viewed another way, the percentage of participants who improved their skin self-exam practice during the 2-year period—to comply with the once-a-month recommendation—was 46% in the affected carrier group, 60% in the unaffected carrier group, and 25% in the noncarrier group.

Compared with participants who did not improve, those who did improve reported feeling that they had more control over detecting melanoma early (4.41 vs. 3.68 points on a 5-point scale).

In a subanalysis of the noncarriers, those who were underscreening at 2 years gave as their reason being busy or forgetful, feeling unqualified to perform the exams, and/or believing that their risk was not high enough.

In addition, noncarriers who improved their skin self-exam performance had a gain in their perceived control over early detection during follow-up, whereas those failing to improve did not.

The consistent finding of a link between an improvement in self-exam behavior and perceived control over detecting melanoma early has implications for strategies to increase this behavior, Ms. Taber said.

Major Finding: Percentage of participants doing skin self-exams at least monthly remained the same among those with a history of melanoma who were mutation carriers (73%) and doubled among unaffected mutation carriers (from 30% to 60%), but increased only slightly among noncarriers (from 38% to 44%).

Data Source: Prospective, 2-year longitudinal study among 37 individuals at high risk for melanoma.

Disclosures: Ms. Taber reported that she had no conflicts of interest related to the study.

SEATTLE — The impact of genetic testing on skin self-examination behavior among individuals at high risk for melanoma varies with personal history of the disease and test results, according to the first prospective study of this issue in a tested population.

Of 37 individuals at high risk for melanoma because of family history, those who had previously had the disease and who learned that they carried a mutation that sharply increased risk did not alter their skin self-exam behavior. Both before testing and 2 years later, 73% were doing these exams about every month, as is recommended, or more often.

Individuals who had not had melanoma but who learned that they carried the mutation stepped up their skin self-exam behavior: Only 30% were doing these exams at least monthly before testing, but 60% were doing so 2 years afterward.

By contrast, individuals who had not had melanoma and who learned that they did not carry the mutation had little change in their behavior, even though regular skin self-exams are also recommended for this group: 38% were doing these exams roughly once a month or more often before testing, and 44% were doing so at follow-up.

“Researchers and genetic counselors believe that learning one's objective risk will actually motivate behavior change,” said lead investigator Jennifer M. Taber.

There are several concerns, however.

“One is that individuals who test negative will feel that their risk is so low that they don't need to engage in prevention or screening behaviors anymore, that they might feel a false sense of security and not change their behavior,” she explained. “Another concern is that for those who test positive, they will feel a sense of fatalism—that there is nothing they can do, their risk is so high anyway, so why bother engaging in the behaviors,” she added.

Ms. Taber, a graduate student in psychology at the University of Utah in Salt Lake City, and her coinvestigators studied 37 adults from families with very high rates of melanoma. All underwent genetic testing for the p16 mutation, which sharply increases melanoma risk, and were followed for 2 years.

Nearly a third (30%) of participants were affected carriers, meaning they had a history of melanoma and had the mutation; 27% were unaffected carriers, meaning they did not have a history of the disease and did have the mutation; and 43% were noncarriers who did not have a history of the disease and did not have the mutation.

Monthly skin self-exams are recommended for all individuals from families with high rates of melanoma, regardless of their genetic test results, Ms. Taber noted, because even those with a negative result have a lifetime probability of the disease twice that of the general population.

The investigators classified the participants' skin self-exam behavior, according to the number of these exams performed in a 6-month period, as being on target (four to eight exams); overscreening (more than eight), which may actually hamper detection of changes; and underscreening (fewer than four), which may lead to missed lesions.

Two years after testing, the percentage of participants who were either on target or overscreening remained at the same high baseline level among affected carriers (73%) and had doubled among unaffected carriers (from 30% to 60%), but had increased only slightly among noncarriers (from 38% to 44%).

When the results were viewed another way, the percentage of participants who improved their skin self-exam practice during the 2-year period—to comply with the once-a-month recommendation—was 46% in the affected carrier group, 60% in the unaffected carrier group, and 25% in the noncarrier group.

Compared with participants who did not improve, those who did improve reported feeling that they had more control over detecting melanoma early (4.41 vs. 3.68 points on a 5-point scale).

In a subanalysis of the noncarriers, those who were underscreening at 2 years gave as their reason being busy or forgetful, feeling unqualified to perform the exams, and/or believing that their risk was not high enough.

In addition, noncarriers who improved their skin self-exam performance had a gain in their perceived control over early detection during follow-up, whereas those failing to improve did not.

The consistent finding of a link between an improvement in self-exam behavior and perceived control over detecting melanoma early has implications for strategies to increase this behavior, Ms. Taber said.

Major Finding: Percentage of participants doing skin self-exams at least monthly remained the same among those with a history of melanoma who were mutation carriers (73%) and doubled among unaffected mutation carriers (from 30% to 60%), but increased only slightly among noncarriers (from 38% to 44%).

Data Source: Prospective, 2-year longitudinal study among 37 individuals at high risk for melanoma.

Disclosures: Ms. Taber reported that she had no conflicts of interest related to the study.

SEATTLE — The impact of genetic testing on skin self-examination behavior among individuals at high risk for melanoma varies with personal history of the disease and test results, according to the first prospective study of this issue in a tested population.

Of 37 individuals at high risk for melanoma because of family history, those who had previously had the disease and who learned that they carried a mutation that sharply increased risk did not alter their skin self-exam behavior. Both before testing and 2 years later, 73% were doing these exams about every month, as is recommended, or more often.

Individuals who had not had melanoma but who learned that they carried the mutation stepped up their skin self-exam behavior: Only 30% were doing these exams at least monthly before testing, but 60% were doing so 2 years afterward.

By contrast, individuals who had not had melanoma and who learned that they did not carry the mutation had little change in their behavior, even though regular skin self-exams are also recommended for this group: 38% were doing these exams roughly once a month or more often before testing, and 44% were doing so at follow-up.

“Researchers and genetic counselors believe that learning one's objective risk will actually motivate behavior change,” said lead investigator Jennifer M. Taber.

There are several concerns, however.

“One is that individuals who test negative will feel that their risk is so low that they don't need to engage in prevention or screening behaviors anymore, that they might feel a false sense of security and not change their behavior,” she explained. “Another concern is that for those who test positive, they will feel a sense of fatalism—that there is nothing they can do, their risk is so high anyway, so why bother engaging in the behaviors,” she added.

Ms. Taber, a graduate student in psychology at the University of Utah in Salt Lake City, and her coinvestigators studied 37 adults from families with very high rates of melanoma. All underwent genetic testing for the p16 mutation, which sharply increases melanoma risk, and were followed for 2 years.

Nearly a third (30%) of participants were affected carriers, meaning they had a history of melanoma and had the mutation; 27% were unaffected carriers, meaning they did not have a history of the disease and did have the mutation; and 43% were noncarriers who did not have a history of the disease and did not have the mutation.

Monthly skin self-exams are recommended for all individuals from families with high rates of melanoma, regardless of their genetic test results, Ms. Taber noted, because even those with a negative result have a lifetime probability of the disease twice that of the general population.

The investigators classified the participants' skin self-exam behavior, according to the number of these exams performed in a 6-month period, as being on target (four to eight exams); overscreening (more than eight), which may actually hamper detection of changes; and underscreening (fewer than four), which may lead to missed lesions.

Two years after testing, the percentage of participants who were either on target or overscreening remained at the same high baseline level among affected carriers (73%) and had doubled among unaffected carriers (from 30% to 60%), but had increased only slightly among noncarriers (from 38% to 44%).

When the results were viewed another way, the percentage of participants who improved their skin self-exam practice during the 2-year period—to comply with the once-a-month recommendation—was 46% in the affected carrier group, 60% in the unaffected carrier group, and 25% in the noncarrier group.

Compared with participants who did not improve, those who did improve reported feeling that they had more control over detecting melanoma early (4.41 vs. 3.68 points on a 5-point scale).

In a subanalysis of the noncarriers, those who were underscreening at 2 years gave as their reason being busy or forgetful, feeling unqualified to perform the exams, and/or believing that their risk was not high enough.

In addition, noncarriers who improved their skin self-exam performance had a gain in their perceived control over early detection during follow-up, whereas those failing to improve did not.

The consistent finding of a link between an improvement in self-exam behavior and perceived control over detecting melanoma early has implications for strategies to increase this behavior, Ms. Taber said.