Susan London

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 afterward, 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 at the annual meeting of the Society of behavioral Medicine.

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%), Ms. Taber reported.

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 (4.4 vs. 3.7 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.

Perhaps physicians should target control perceptions over detecting a melanoma or perhaps skin self-examination competence, she commented.

Similarly, Ms. Taber noted, the barriers cited by noncarriers who were underscreening provide valuable insight specifically for individuals having negative genetic test results.

Perhaps counseling sessions should "target perceived importance of skin self-exams to make sure that individuals realize that their risk is high enough that they should be performing these behaviors, and perhaps do something like reminder or booster sessions for these individuals," she said.

Ms. Taber reported having no relevant conflicts of interest.

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 afterward, 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 at the annual meeting of the Society of behavioral Medicine.

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%), Ms. Taber reported.

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 (4.4 vs. 3.7 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.

Perhaps physicians should target control perceptions over detecting a melanoma or perhaps skin self-examination competence, she commented.

Similarly, Ms. Taber noted, the barriers cited by noncarriers who were underscreening provide valuable insight specifically for individuals having negative genetic test results.

Perhaps counseling sessions should "target perceived importance of skin self-exams to make sure that individuals realize that their risk is high enough that they should be performing these behaviors, and perhaps do something like reminder or booster sessions for these individuals," she said.

Ms. Taber reported having no relevant conflicts of interest.

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 afterward, 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 at the annual meeting of the Society of behavioral Medicine.

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%), Ms. Taber reported.

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 (4.4 vs. 3.7 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.

Perhaps physicians should target control perceptions over detecting a melanoma or perhaps skin self-examination competence, she commented.

Similarly, Ms. Taber noted, the barriers cited by noncarriers who were underscreening provide valuable insight specifically for individuals having negative genetic test results.

Perhaps counseling sessions should "target perceived importance of skin self-exams to make sure that individuals realize that their risk is high enough that they should be performing these behaviors, and perhaps do something like reminder or booster sessions for these individuals," she said.

Ms. Taber reported having no relevant conflicts of interest.

Major Finding: With each additional hour of fasting, levels of total and HDL cholesterol remained the same, levels of LDL cholesterol increased by 0.46 mg/dL, and levels of triglycerides decreased by 0.86 mg/dL.

Data Source: An observational study in a nationally representative sample of nearly 11,000 children aged 3 years or older.

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

VANCOUVER, B.C. — Children may not need to fast before having their blood drawn for lipid screening, investigators reported at the meeting.

In a cross-sectional study of nearly 11,000 U.S. children aged at least 3 years, levels of total and HDL cholesterol were essentially unaffected by the time since a child had last eaten, and levels of LDL cholesterol increased only slightly. However, levels of triglycerides decreased substantially with the time elapsed.

“Though fasting is often recommended [before lipid screening], compliance with fasting procedures is often difficult for children and may cause delayed or missed testing,” said lead investigator Asheley C. Skinner, Ph.D., of the University of North Carolina at Chapel Hill. Hence, the study's findings could remove a barrier to screening in the pediatric population.

“If confirmed in other research, physicians may be able to decrease the burden of childhood cholesterol screening by not requiring prescreening fasting,” she said.

The investigators analyzed data from the National Health and Nutrition Examination Survey (NHANES) for the years 1999-2006, focusing on children aged 3 years or older who had a lipid measurement.

The children's fasting status depended on the time of day they were examined (morning vs. afternoon), their age (younger than age 12 vs. older), and their compliance with any fasting instructions they had been given. At the time a child's blood was drawn, the parents were asked how long it had been since their child had last had something to eat or drink.

Analyses of total and HDL cholesterol were based on 10,948 children, of whom 48% had fasted more than 8 hours, according to Dr. Skinner. Analyses of LDL cholesterol and triglycerides were based on a subset of 4,424 children, 80% of whom had fasted more than 8 hours.

After the researchers controlled for factors potentially associated with fasting (weight status, age, race/ethnicity, and sex), levels of total cholesterol and HDL cholesterol did not differ significantly with the duration of fasting out to 24 hours, she said.

In contrast, with each additional hour of fasting, levels of LDL cholesterol increased modestly, by 0.46 mg/dL, and levels of triglycerides decreased considerably, by 0.86 mg/dL. Both changes were significantly different.

Regression models indicated that after a period of 12 hours (the ideal duration of fasting for lipid measurement), the difference in LDL cholesterol level between fasted and nonfasted states would be less than 4 mg/dL, whereas the difference in triglyceride levels would be about 10 mg/dL.

“Total cholesterol and HDL cholesterol can likely be interpreted correctly without fasting,” Dr. Skinner concluded. “LDL [cholesterol] without fasting provides a close approximation of fasting LDL; the differences we noted, while statistically significant, are likely not clinically significant.”

On the other hand, fasting does appear to have an important effect on triglyceride levels, she observed, although at least in adults, data now suggest that the nonfasting level may be a better predictor of cardiovascular disease and its morbidity anyway.

The study's main limitation was its population-level nature, which precluded measurement of fasting and nonfasting levels in the same child. “There may be individuals who do have dramatic changes who are hidden within the larger group,” Dr. Skinner said.

Major Finding: With each additional hour of fasting, levels of total and HDL cholesterol remained the same, levels of LDL cholesterol increased by 0.46 mg/dL, and levels of triglycerides decreased by 0.86 mg/dL.

Data Source: An observational study in a nationally representative sample of nearly 11,000 children aged 3 years or older.

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

VANCOUVER, B.C. — Children may not need to fast before having their blood drawn for lipid screening, investigators reported at the meeting.

In a cross-sectional study of nearly 11,000 U.S. children aged at least 3 years, levels of total and HDL cholesterol were essentially unaffected by the time since a child had last eaten, and levels of LDL cholesterol increased only slightly. However, levels of triglycerides decreased substantially with the time elapsed.

“Though fasting is often recommended [before lipid screening], compliance with fasting procedures is often difficult for children and may cause delayed or missed testing,” said lead investigator Asheley C. Skinner, Ph.D., of the University of North Carolina at Chapel Hill. Hence, the study's findings could remove a barrier to screening in the pediatric population.

“If confirmed in other research, physicians may be able to decrease the burden of childhood cholesterol screening by not requiring prescreening fasting,” she said.

The investigators analyzed data from the National Health and Nutrition Examination Survey (NHANES) for the years 1999-2006, focusing on children aged 3 years or older who had a lipid measurement.

The children's fasting status depended on the time of day they were examined (morning vs. afternoon), their age (younger than age 12 vs. older), and their compliance with any fasting instructions they had been given. At the time a child's blood was drawn, the parents were asked how long it had been since their child had last had something to eat or drink.

Analyses of total and HDL cholesterol were based on 10,948 children, of whom 48% had fasted more than 8 hours, according to Dr. Skinner. Analyses of LDL cholesterol and triglycerides were based on a subset of 4,424 children, 80% of whom had fasted more than 8 hours.

After the researchers controlled for factors potentially associated with fasting (weight status, age, race/ethnicity, and sex), levels of total cholesterol and HDL cholesterol did not differ significantly with the duration of fasting out to 24 hours, she said.

In contrast, with each additional hour of fasting, levels of LDL cholesterol increased modestly, by 0.46 mg/dL, and levels of triglycerides decreased considerably, by 0.86 mg/dL. Both changes were significantly different.

Regression models indicated that after a period of 12 hours (the ideal duration of fasting for lipid measurement), the difference in LDL cholesterol level between fasted and nonfasted states would be less than 4 mg/dL, whereas the difference in triglyceride levels would be about 10 mg/dL.

“Total cholesterol and HDL cholesterol can likely be interpreted correctly without fasting,” Dr. Skinner concluded. “LDL [cholesterol] without fasting provides a close approximation of fasting LDL; the differences we noted, while statistically significant, are likely not clinically significant.”

On the other hand, fasting does appear to have an important effect on triglyceride levels, she observed, although at least in adults, data now suggest that the nonfasting level may be a better predictor of cardiovascular disease and its morbidity anyway.

The study's main limitation was its population-level nature, which precluded measurement of fasting and nonfasting levels in the same child. “There may be individuals who do have dramatic changes who are hidden within the larger group,” Dr. Skinner said.

Major Finding: With each additional hour of fasting, levels of total and HDL cholesterol remained the same, levels of LDL cholesterol increased by 0.46 mg/dL, and levels of triglycerides decreased by 0.86 mg/dL.

Data Source: An observational study in a nationally representative sample of nearly 11,000 children aged 3 years or older.

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

VANCOUVER, B.C. — Children may not need to fast before having their blood drawn for lipid screening, investigators reported at the meeting.

In a cross-sectional study of nearly 11,000 U.S. children aged at least 3 years, levels of total and HDL cholesterol were essentially unaffected by the time since a child had last eaten, and levels of LDL cholesterol increased only slightly. However, levels of triglycerides decreased substantially with the time elapsed.

“Though fasting is often recommended [before lipid screening], compliance with fasting procedures is often difficult for children and may cause delayed or missed testing,” said lead investigator Asheley C. Skinner, Ph.D., of the University of North Carolina at Chapel Hill. Hence, the study's findings could remove a barrier to screening in the pediatric population.

“If confirmed in other research, physicians may be able to decrease the burden of childhood cholesterol screening by not requiring prescreening fasting,” she said.

The investigators analyzed data from the National Health and Nutrition Examination Survey (NHANES) for the years 1999-2006, focusing on children aged 3 years or older who had a lipid measurement.

The children's fasting status depended on the time of day they were examined (morning vs. afternoon), their age (younger than age 12 vs. older), and their compliance with any fasting instructions they had been given. At the time a child's blood was drawn, the parents were asked how long it had been since their child had last had something to eat or drink.

Analyses of total and HDL cholesterol were based on 10,948 children, of whom 48% had fasted more than 8 hours, according to Dr. Skinner. Analyses of LDL cholesterol and triglycerides were based on a subset of 4,424 children, 80% of whom had fasted more than 8 hours.

After the researchers controlled for factors potentially associated with fasting (weight status, age, race/ethnicity, and sex), levels of total cholesterol and HDL cholesterol did not differ significantly with the duration of fasting out to 24 hours, she said.

In contrast, with each additional hour of fasting, levels of LDL cholesterol increased modestly, by 0.46 mg/dL, and levels of triglycerides decreased considerably, by 0.86 mg/dL. Both changes were significantly different.

Regression models indicated that after a period of 12 hours (the ideal duration of fasting for lipid measurement), the difference in LDL cholesterol level between fasted and nonfasted states would be less than 4 mg/dL, whereas the difference in triglyceride levels would be about 10 mg/dL.

“Total cholesterol and HDL cholesterol can likely be interpreted correctly without fasting,” Dr. Skinner concluded. “LDL [cholesterol] without fasting provides a close approximation of fasting LDL; the differences we noted, while statistically significant, are likely not clinically significant.”

On the other hand, fasting does appear to have an important effect on triglyceride levels, she observed, although at least in adults, data now suggest that the nonfasting level may be a better predictor of cardiovascular disease and its morbidity anyway.

The study's main limitation was its population-level nature, which precluded measurement of fasting and nonfasting levels in the same child. “There may be individuals who do have dramatic changes who are hidden within the larger group,” Dr. Skinner said.

Major Finding: Children with Kawasaki disease who had persistence of only symptoms other than fever after initial IVIG treatment had 18-fold higher odds of developing coronary artery abnormalities relative to their symptom-free peers.

Data Source: A retrospective cohort study of 77 children with Kawasaki disease treated with IVIG and aspirin or the NSAID flurbiprofen.

Disclosures: None was reported.

VANCOUVER, B.C. — Children with Kawasaki disease who have persistence of symptoms other than fever after intravenous immunoglobulin treatment have sharply elevated odds of progressing to coronary artery abnormalities, a retrospective study showed.

In the study, 9% of children had resolution of fever but persistence of lip erythema or bulbar conjunctivitis, and were 18 times more likely to develop coronary artery abnormalities than were their counterparts whose symptoms had resolved. When it comes to identifying children with Kawasaki disease who have resistance to IVIG and need more treatment, clinicians typically watch for a fever that lingers, lead author Dr. Sayaka Fukuda said in an interview. But the importance of persistence of other symptoms is unknown.

Using electronic medical records, Dr. Fukuda and her colleagues retrospectively studied the characteristics and outcomes of children hospitalized with Kawasaki disease who received aspirin (or the NSAID flurbiprofen) plus IVIG as initial treatment.

The children were classified into four groups according to persistence of fever in the 24-36 hours after initial IVIG treatment (yes or no) and persistence of nonfever symptoms 1 month after initial IVIG treatment (yes or no).

Study results reported in a poster session at the meeting were based on 77 children, of whom 8% had persistence of both fever and nonfever symptoms, 9% had persistence of only nonfever symptoms, 18% had persistence of only fever, and 65% had resolution of all their symptoms.

In the group with only nonfever symptoms, these symptoms were lip erythema and bulbar conjunctivitis, according to Dr. Fukuda of the National Center for Child Health and Development in Tokyo.

The only significant difference among the four groups was the duration of hospitalization (P less than .01). The groups were similar with respect to age, sex, season of presentation, presenting symptom, fever duration, and more than a dozen laboratory measures of inflammation and coagulation.

All children with persistent fever had received a second course of IVIG or an alternative treatment, whereas only one of the seven children with persistence of just nonfever symptoms had received further treatment.

Overall, 14% of the children developed coronary artery abnormalities as assessed by ultrasound 1 month after initial treatment. By group, the rate was highest (67%) in those with persistence of both fever and nonfever symptoms, but it was also high (43%) in those with persistence of only nonfever symptoms.

In an adjusted analysis, children with persistence of both fever and nonfever symptoms had 48-fold higher odds of developing coronary artery abnormalities than did the symptom-free group. But children with persistence of only nonfever symptoms had 18-fold higher odds as well. Those with persistence of only fever were not at significantly elevated risk.

Major Finding: Children with Kawasaki disease who had persistence of only symptoms other than fever after initial IVIG treatment had 18-fold higher odds of developing coronary artery abnormalities relative to their symptom-free peers.

Data Source: A retrospective cohort study of 77 children with Kawasaki disease treated with IVIG and aspirin or the NSAID flurbiprofen.

Disclosures: None was reported.

VANCOUVER, B.C. — Children with Kawasaki disease who have persistence of symptoms other than fever after intravenous immunoglobulin treatment have sharply elevated odds of progressing to coronary artery abnormalities, a retrospective study showed.

In the study, 9% of children had resolution of fever but persistence of lip erythema or bulbar conjunctivitis, and were 18 times more likely to develop coronary artery abnormalities than were their counterparts whose symptoms had resolved. When it comes to identifying children with Kawasaki disease who have resistance to IVIG and need more treatment, clinicians typically watch for a fever that lingers, lead author Dr. Sayaka Fukuda said in an interview. But the importance of persistence of other symptoms is unknown.

Using electronic medical records, Dr. Fukuda and her colleagues retrospectively studied the characteristics and outcomes of children hospitalized with Kawasaki disease who received aspirin (or the NSAID flurbiprofen) plus IVIG as initial treatment.

The children were classified into four groups according to persistence of fever in the 24-36 hours after initial IVIG treatment (yes or no) and persistence of nonfever symptoms 1 month after initial IVIG treatment (yes or no).

Study results reported in a poster session at the meeting were based on 77 children, of whom 8% had persistence of both fever and nonfever symptoms, 9% had persistence of only nonfever symptoms, 18% had persistence of only fever, and 65% had resolution of all their symptoms.

In the group with only nonfever symptoms, these symptoms were lip erythema and bulbar conjunctivitis, according to Dr. Fukuda of the National Center for Child Health and Development in Tokyo.

The only significant difference among the four groups was the duration of hospitalization (P less than .01). The groups were similar with respect to age, sex, season of presentation, presenting symptom, fever duration, and more than a dozen laboratory measures of inflammation and coagulation.

All children with persistent fever had received a second course of IVIG or an alternative treatment, whereas only one of the seven children with persistence of just nonfever symptoms had received further treatment.

Overall, 14% of the children developed coronary artery abnormalities as assessed by ultrasound 1 month after initial treatment. By group, the rate was highest (67%) in those with persistence of both fever and nonfever symptoms, but it was also high (43%) in those with persistence of only nonfever symptoms.

In an adjusted analysis, children with persistence of both fever and nonfever symptoms had 48-fold higher odds of developing coronary artery abnormalities than did the symptom-free group. But children with persistence of only nonfever symptoms had 18-fold higher odds as well. Those with persistence of only fever were not at significantly elevated risk.

Major Finding: Children with Kawasaki disease who had persistence of only symptoms other than fever after initial IVIG treatment had 18-fold higher odds of developing coronary artery abnormalities relative to their symptom-free peers.

Data Source: A retrospective cohort study of 77 children with Kawasaki disease treated with IVIG and aspirin or the NSAID flurbiprofen.

Disclosures: None was reported.

VANCOUVER, B.C. — Children with Kawasaki disease who have persistence of symptoms other than fever after intravenous immunoglobulin treatment have sharply elevated odds of progressing to coronary artery abnormalities, a retrospective study showed.

In the study, 9% of children had resolution of fever but persistence of lip erythema or bulbar conjunctivitis, and were 18 times more likely to develop coronary artery abnormalities than were their counterparts whose symptoms had resolved. When it comes to identifying children with Kawasaki disease who have resistance to IVIG and need more treatment, clinicians typically watch for a fever that lingers, lead author Dr. Sayaka Fukuda said in an interview. But the importance of persistence of other symptoms is unknown.

Using electronic medical records, Dr. Fukuda and her colleagues retrospectively studied the characteristics and outcomes of children hospitalized with Kawasaki disease who received aspirin (or the NSAID flurbiprofen) plus IVIG as initial treatment.

The children were classified into four groups according to persistence of fever in the 24-36 hours after initial IVIG treatment (yes or no) and persistence of nonfever symptoms 1 month after initial IVIG treatment (yes or no).

Study results reported in a poster session at the meeting were based on 77 children, of whom 8% had persistence of both fever and nonfever symptoms, 9% had persistence of only nonfever symptoms, 18% had persistence of only fever, and 65% had resolution of all their symptoms.

In the group with only nonfever symptoms, these symptoms were lip erythema and bulbar conjunctivitis, according to Dr. Fukuda of the National Center for Child Health and Development in Tokyo.

The only significant difference among the four groups was the duration of hospitalization (P less than .01). The groups were similar with respect to age, sex, season of presentation, presenting symptom, fever duration, and more than a dozen laboratory measures of inflammation and coagulation.

All children with persistent fever had received a second course of IVIG or an alternative treatment, whereas only one of the seven children with persistence of just nonfever symptoms had received further treatment.

Overall, 14% of the children developed coronary artery abnormalities as assessed by ultrasound 1 month after initial treatment. By group, the rate was highest (67%) in those with persistence of both fever and nonfever symptoms, but it was also high (43%) in those with persistence of only nonfever symptoms.

In an adjusted analysis, children with persistence of both fever and nonfever symptoms had 48-fold higher odds of developing coronary artery abnormalities than did the symptom-free group. But children with persistence of only nonfever symptoms had 18-fold higher odds as well. Those with persistence of only fever were not at significantly elevated risk.

Major Finding: Before providers were prompted to obtain a confidential phone number, only 45% of female adolescents who were seen in the emergency department and had positive STI test results were contacted within a week, compared with 65% afterward.

Data Source: A longitudinal pre- and postintervention study involving 238 female adolescents aged 14-21 years seen in the emergency department who had positive STI test results.

Disclosures: None was reported.

VANCOUVER, B.C. — A simple prompt to obtain a confidential phone number from all teen girls tested for sexually transmitted infections in the emergency department increases the likelihood that they will be contacted in a timely manner if their results are positive, data showed.

In a study reported at the meetingo, the percentage of female adolescents with positive results who were contacted within a week rose from 45% to 65% when the prompt was added to the electronic medical record (EMR).

The findings suggest that the intervention is an effective means of improving communication of sexually transmitted infection (STI) results in this population, said lead investigator Dr. Jennifer L. Reed of the division of emergency medicine at Cincinnati Children's Hospital Medical Center. “Ultimately, we hope to develop a change packet that other institutions may use to implement a similar process.”

By way of background, Dr. Reed noted that rates of STIs are exceptionally high in the medical center's emergency department (ED): Up to 25% of female adolescents tested there are positive for at least one infection, compared with 4% nationally.

Previous work in this population has shown that those who believe they have positive STI results are more likely to abstain from sexual activity and notify their partners, whereas those who are given antibiotics but believe their test results are negative do not change their behavior.

“Therefore, improving contact of patients with STIs from the pediatric emergency department may address the larger community STI epidemic,” said Dr. Reed. The investigators tested a sequential, six-component intervention implemented over a 1-year period in the ED. Staff members were sent e-mail reminders to document a confidential phone number at the time of STI testing. A field was created in the EMR for such documentation, cards were distributed to adolescents encouraging them to provide this phone number, and flyers were posted in staff and patient restrooms. Paramedics and nursing staff were educated, and finally, the EMR was modified so that it prompted providers to obtain the phone number whenever they ordered a pelvic exam setup.

The last component “is actually an order,” Dr. Reed explained in a poster symposium.

“The nurses have to click off that they have completed the order,” and it cannot be ignored or overridden.

In this study of female patients aged 14-21 years who tested positive for STIs, with 120 seen in the preintervention period and 118 seen in the postintervention period, implementing the initial five components did not alter rates of documentation of confidential phone numbers from the preintervention level, Dr. Reed reported. However, adding the EMR prompt did.

The percentage of female adolescents for whom a confidential phone number was recorded increased from 24% before the EMR prompt to 61% afterward (P less than .01), and the percentage who were contacted within a week increased from 45% to 65% (P less than .01).

“Implementing a systematic change, the EMR prompt, provided the greatest impact and the most sustainable results in contacting these adolescents,” said Dr. Reed.

If the intervention proves to be sustainable without grant funding, it can be disseminated to other institutions—provided they have sufficiently flexible EMRs, she noted.

Conversations with some of the adolescents studied have provided valuable insights about using this approach for contact and possibly more reliable ways of reaching them, according to Dr. Reed.

The majority gave their cell phone number as their confidential number, she explained.

“We learned … that if you leave or try to leave messages for them, they will not check their messages because it costs minutes,” she said.

So it is important to actually speak with them.

In addition, early exploration of text messaging is suggesting that it may be a promising alternative in this population, possibly in part because text messages are still displayed even when a cell phone is out of minutes.

My Take

Study May Motivate Change in EDs

The most valuable thing is that the investigators describe an addition to their standard practice that made it possible to provide better care.

Some emergency departments may already be getting confidential phone numbers. Others may not have a routine way to get this information.

Showing EDs the impact of doing this will help them get their facilities to either change their electronic records or put some other practice in place such as getting the phone number at triage. This will allow them to improve the quality of their care and provide better patient outcomes.

ELLEN F. CRAIN, M.D., is professor of pediatrics and emergency medicine at Albert Einstein College of Medicine, New York. Dr. Crain said she had no relevant conflicts of interest.

Major Finding: Before providers were prompted to obtain a confidential phone number, only 45% of female adolescents who were seen in the emergency department and had positive STI test results were contacted within a week, compared with 65% afterward.

Data Source: A longitudinal pre- and postintervention study involving 238 female adolescents aged 14-21 years seen in the emergency department who had positive STI test results.

Disclosures: None was reported.

VANCOUVER, B.C. — A simple prompt to obtain a confidential phone number from all teen girls tested for sexually transmitted infections in the emergency department increases the likelihood that they will be contacted in a timely manner if their results are positive, data showed.

In a study reported at the meetingo, the percentage of female adolescents with positive results who were contacted within a week rose from 45% to 65% when the prompt was added to the electronic medical record (EMR).

The findings suggest that the intervention is an effective means of improving communication of sexually transmitted infection (STI) results in this population, said lead investigator Dr. Jennifer L. Reed of the division of emergency medicine at Cincinnati Children's Hospital Medical Center. “Ultimately, we hope to develop a change packet that other institutions may use to implement a similar process.”

By way of background, Dr. Reed noted that rates of STIs are exceptionally high in the medical center's emergency department (ED): Up to 25% of female adolescents tested there are positive for at least one infection, compared with 4% nationally.

Previous work in this population has shown that those who believe they have positive STI results are more likely to abstain from sexual activity and notify their partners, whereas those who are given antibiotics but believe their test results are negative do not change their behavior.

“Therefore, improving contact of patients with STIs from the pediatric emergency department may address the larger community STI epidemic,” said Dr. Reed. The investigators tested a sequential, six-component intervention implemented over a 1-year period in the ED. Staff members were sent e-mail reminders to document a confidential phone number at the time of STI testing. A field was created in the EMR for such documentation, cards were distributed to adolescents encouraging them to provide this phone number, and flyers were posted in staff and patient restrooms. Paramedics and nursing staff were educated, and finally, the EMR was modified so that it prompted providers to obtain the phone number whenever they ordered a pelvic exam setup.

The last component “is actually an order,” Dr. Reed explained in a poster symposium.

“The nurses have to click off that they have completed the order,” and it cannot be ignored or overridden.

In this study of female patients aged 14-21 years who tested positive for STIs, with 120 seen in the preintervention period and 118 seen in the postintervention period, implementing the initial five components did not alter rates of documentation of confidential phone numbers from the preintervention level, Dr. Reed reported. However, adding the EMR prompt did.

The percentage of female adolescents for whom a confidential phone number was recorded increased from 24% before the EMR prompt to 61% afterward (P less than .01), and the percentage who were contacted within a week increased from 45% to 65% (P less than .01).

“Implementing a systematic change, the EMR prompt, provided the greatest impact and the most sustainable results in contacting these adolescents,” said Dr. Reed.

If the intervention proves to be sustainable without grant funding, it can be disseminated to other institutions—provided they have sufficiently flexible EMRs, she noted.

Conversations with some of the adolescents studied have provided valuable insights about using this approach for contact and possibly more reliable ways of reaching them, according to Dr. Reed.

The majority gave their cell phone number as their confidential number, she explained.

“We learned … that if you leave or try to leave messages for them, they will not check their messages because it costs minutes,” she said.

So it is important to actually speak with them.

In addition, early exploration of text messaging is suggesting that it may be a promising alternative in this population, possibly in part because text messages are still displayed even when a cell phone is out of minutes.

My Take

Study May Motivate Change in EDs

The most valuable thing is that the investigators describe an addition to their standard practice that made it possible to provide better care.

Some emergency departments may already be getting confidential phone numbers. Others may not have a routine way to get this information.

Showing EDs the impact of doing this will help them get their facilities to either change their electronic records or put some other practice in place such as getting the phone number at triage. This will allow them to improve the quality of their care and provide better patient outcomes.

ELLEN F. CRAIN, M.D., is professor of pediatrics and emergency medicine at Albert Einstein College of Medicine, New York. Dr. Crain said she had no relevant conflicts of interest.

Major Finding: Before providers were prompted to obtain a confidential phone number, only 45% of female adolescents who were seen in the emergency department and had positive STI test results were contacted within a week, compared with 65% afterward.

Data Source: A longitudinal pre- and postintervention study involving 238 female adolescents aged 14-21 years seen in the emergency department who had positive STI test results.

Disclosures: None was reported.

VANCOUVER, B.C. — A simple prompt to obtain a confidential phone number from all teen girls tested for sexually transmitted infections in the emergency department increases the likelihood that they will be contacted in a timely manner if their results are positive, data showed.

In a study reported at the meetingo, the percentage of female adolescents with positive results who were contacted within a week rose from 45% to 65% when the prompt was added to the electronic medical record (EMR).

The findings suggest that the intervention is an effective means of improving communication of sexually transmitted infection (STI) results in this population, said lead investigator Dr. Jennifer L. Reed of the division of emergency medicine at Cincinnati Children's Hospital Medical Center. “Ultimately, we hope to develop a change packet that other institutions may use to implement a similar process.”

By way of background, Dr. Reed noted that rates of STIs are exceptionally high in the medical center's emergency department (ED): Up to 25% of female adolescents tested there are positive for at least one infection, compared with 4% nationally.

Previous work in this population has shown that those who believe they have positive STI results are more likely to abstain from sexual activity and notify their partners, whereas those who are given antibiotics but believe their test results are negative do not change their behavior.

“Therefore, improving contact of patients with STIs from the pediatric emergency department may address the larger community STI epidemic,” said Dr. Reed. The investigators tested a sequential, six-component intervention implemented over a 1-year period in the ED. Staff members were sent e-mail reminders to document a confidential phone number at the time of STI testing. A field was created in the EMR for such documentation, cards were distributed to adolescents encouraging them to provide this phone number, and flyers were posted in staff and patient restrooms. Paramedics and nursing staff were educated, and finally, the EMR was modified so that it prompted providers to obtain the phone number whenever they ordered a pelvic exam setup.

The last component “is actually an order,” Dr. Reed explained in a poster symposium.

“The nurses have to click off that they have completed the order,” and it cannot be ignored or overridden.

In this study of female patients aged 14-21 years who tested positive for STIs, with 120 seen in the preintervention period and 118 seen in the postintervention period, implementing the initial five components did not alter rates of documentation of confidential phone numbers from the preintervention level, Dr. Reed reported. However, adding the EMR prompt did.

The percentage of female adolescents for whom a confidential phone number was recorded increased from 24% before the EMR prompt to 61% afterward (P less than .01), and the percentage who were contacted within a week increased from 45% to 65% (P less than .01).

“Implementing a systematic change, the EMR prompt, provided the greatest impact and the most sustainable results in contacting these adolescents,” said Dr. Reed.

If the intervention proves to be sustainable without grant funding, it can be disseminated to other institutions—provided they have sufficiently flexible EMRs, she noted.

Conversations with some of the adolescents studied have provided valuable insights about using this approach for contact and possibly more reliable ways of reaching them, according to Dr. Reed.

The majority gave their cell phone number as their confidential number, she explained.

“We learned … that if you leave or try to leave messages for them, they will not check their messages because it costs minutes,” she said.

So it is important to actually speak with them.

In addition, early exploration of text messaging is suggesting that it may be a promising alternative in this population, possibly in part because text messages are still displayed even when a cell phone is out of minutes.

My Take

Study May Motivate Change in EDs

The most valuable thing is that the investigators describe an addition to their standard practice that made it possible to provide better care.

Some emergency departments may already be getting confidential phone numbers. Others may not have a routine way to get this information.

Showing EDs the impact of doing this will help them get their facilities to either change their electronic records or put some other practice in place such as getting the phone number at triage. This will allow them to improve the quality of their care and provide better patient outcomes.

ELLEN F. CRAIN, M.D., is professor of pediatrics and emergency medicine at Albert Einstein College of Medicine, New York. Dr. Crain said she had no relevant conflicts of interest.

Major Finding: Very low-birth-weight infants with symptomatic, postnatally acquired CMV infection had high rates of pneumonitis (73%) and late-onset sepsis (43%).

Data Source: A retrospective cohort study of 34 infants with symptomatic CMV infection.

Disclosures: None was reported.

VANCOUVER, B.C. — Postnatally acquired cytomegalovirus infection can cause severe illness in very low-birth-weight infants in the short term, based on findings from a retrospective study.

Infants in the study who became infected and symptomatic with cytomegalovirus (CMV) infection in the postnatal period had high rates of complications.

In fact, their clinical and laboratory findings were similar to those of congenitally infected infants.

“The biggest take-home message is that postnatal CMV infection can cause significant morbidity, and it can potentially lead to [poor] long-term outcomes,” lead investigator Dr. Sarah A. Meyer said in an interview.

“It is often something that we don't think about a lot, and we just need to keep it in our mind that if we have babies that present with some of these symptoms, we should be testing them and following their outcomes,” she said.

Much is known about congenitally acquired CMV, according to Dr. Meyer of Children's Hospital Boston. But comparatively little is know about CMV acquired in the postnatal period through breast milk.

Using hospital records for the years 1997-2009, she and her colleagues retrospectively studied 34 infants who had symptomatic, culture-positive CMV infection and were cared for in a neonatal intensive care unit.

Of the infants (all but 1 of whom met criteria for very low birth weight [VLBW]), 22 had been infected postnatally, whereas the other 12 infants (having a range of birth weights) had been infected congenitally.

Compared with their congenitally infected counterparts, the postnatally infected infants had a lower median birth weight (688 vs. 1,500 g), had a younger median gestational age (26 vs. 32 weeks), were older on the day of diagnosis (52.5 vs. 3.5 days of life), and were more likely to have been breastfed (100% vs. 67%).

The proportions delivered by cesarean section were similar, she reported in a poster at the meeting.

Among those infected in the postnatal period, the time to CMV diagnosis was correlated with the length of exposure to breast milk (r = 0.84), indicating that the risk of viral transmission persisted with continued exposure. In contrast, the time to CMV diagnosis was not correlated with the day of life on which infants were first fed breast milk.

The most common complications with postnatal infection were pneumonitis (present in 73% of infants), colitis (50%), hepatosplenomegaly (36%), and intracranial findings (27%).

Relative to their congenitally infected counterparts, postnatally infected infants had generally similar clinical findings, but were more likely to have pneumonitis (73% vs. 0%) and less likely to have petechiae and purpura (10% vs. 50%) and retinitis (0% vs. 25%).

The two groups were also similar in rates of hematologic and cerebrospinal fluid laboratory abnormalities, presence of cerebrospinal fluid CMV positivity by polymerase chain reaction testing, and median blood CMV viral load.

Among the 15 infants overall with neurologic follow-up, the rate of hearing loss was 71% in those congenitally infected, compared with 13% in those postnatally infected, with numbers too small to permit statistical comparison.

Rates of developmental delay and cerebral palsy were similar, although these sequelae in the postnatally infected infants also could have been related to their prematurity, noted Dr. Meyer.

A final analysis did suggest that symptomatic postnatal CMV infection may add substantial morbidity above and beyond that due to having a very low birth weight, she said.

Compared with 1,226 infants from the general VLBW population, the VLBW infants with postnatal cytomegalovirus infection had a higher rate of bronchopulmonary dysplasia (81% vs. 16%) and late-onset sepsis (43% vs. 18%).

Rates of necrotizing enterocolitis and intraventricular hemorrhage did not differ significantly between the two groups.

Dr. Meyer said that teasing out causal associations is difficult in the VLBW population.

“Whether or not these babies are immunosuppressed to begin with and that predisposes them to late-onset sepsis and acquiring CMV, or acquiring CMV reduces their immunity level and that predisposes them to late-onset sepsis—which one came first is not exactly clear,” she explained.

“Hopefully, that can be separated out in future studies.”

Monitoring infants with postnatally acquired CMV infection long term, while important, is just an initial step, according to Dr. Meyer.

“An area of study that is still really needed is to look at how treating babies with antivirals affects their outcomes,” she said.

Major Finding: Very low-birth-weight infants with symptomatic, postnatally acquired CMV infection had high rates of pneumonitis (73%) and late-onset sepsis (43%).

Data Source: A retrospective cohort study of 34 infants with symptomatic CMV infection.

Disclosures: None was reported.

VANCOUVER, B.C. — Postnatally acquired cytomegalovirus infection can cause severe illness in very low-birth-weight infants in the short term, based on findings from a retrospective study.

Infants in the study who became infected and symptomatic with cytomegalovirus (CMV) infection in the postnatal period had high rates of complications.

In fact, their clinical and laboratory findings were similar to those of congenitally infected infants.

“The biggest take-home message is that postnatal CMV infection can cause significant morbidity, and it can potentially lead to [poor] long-term outcomes,” lead investigator Dr. Sarah A. Meyer said in an interview.

“It is often something that we don't think about a lot, and we just need to keep it in our mind that if we have babies that present with some of these symptoms, we should be testing them and following their outcomes,” she said.

Much is known about congenitally acquired CMV, according to Dr. Meyer of Children's Hospital Boston. But comparatively little is know about CMV acquired in the postnatal period through breast milk.

Using hospital records for the years 1997-2009, she and her colleagues retrospectively studied 34 infants who had symptomatic, culture-positive CMV infection and were cared for in a neonatal intensive care unit.

Of the infants (all but 1 of whom met criteria for very low birth weight [VLBW]), 22 had been infected postnatally, whereas the other 12 infants (having a range of birth weights) had been infected congenitally.

Compared with their congenitally infected counterparts, the postnatally infected infants had a lower median birth weight (688 vs. 1,500 g), had a younger median gestational age (26 vs. 32 weeks), were older on the day of diagnosis (52.5 vs. 3.5 days of life), and were more likely to have been breastfed (100% vs. 67%).

The proportions delivered by cesarean section were similar, she reported in a poster at the meeting.

Among those infected in the postnatal period, the time to CMV diagnosis was correlated with the length of exposure to breast milk (r = 0.84), indicating that the risk of viral transmission persisted with continued exposure. In contrast, the time to CMV diagnosis was not correlated with the day of life on which infants were first fed breast milk.

The most common complications with postnatal infection were pneumonitis (present in 73% of infants), colitis (50%), hepatosplenomegaly (36%), and intracranial findings (27%).

Relative to their congenitally infected counterparts, postnatally infected infants had generally similar clinical findings, but were more likely to have pneumonitis (73% vs. 0%) and less likely to have petechiae and purpura (10% vs. 50%) and retinitis (0% vs. 25%).

The two groups were also similar in rates of hematologic and cerebrospinal fluid laboratory abnormalities, presence of cerebrospinal fluid CMV positivity by polymerase chain reaction testing, and median blood CMV viral load.

Among the 15 infants overall with neurologic follow-up, the rate of hearing loss was 71% in those congenitally infected, compared with 13% in those postnatally infected, with numbers too small to permit statistical comparison.

Rates of developmental delay and cerebral palsy were similar, although these sequelae in the postnatally infected infants also could have been related to their prematurity, noted Dr. Meyer.

A final analysis did suggest that symptomatic postnatal CMV infection may add substantial morbidity above and beyond that due to having a very low birth weight, she said.

Compared with 1,226 infants from the general VLBW population, the VLBW infants with postnatal cytomegalovirus infection had a higher rate of bronchopulmonary dysplasia (81% vs. 16%) and late-onset sepsis (43% vs. 18%).

Rates of necrotizing enterocolitis and intraventricular hemorrhage did not differ significantly between the two groups.

Dr. Meyer said that teasing out causal associations is difficult in the VLBW population.

“Whether or not these babies are immunosuppressed to begin with and that predisposes them to late-onset sepsis and acquiring CMV, or acquiring CMV reduces their immunity level and that predisposes them to late-onset sepsis—which one came first is not exactly clear,” she explained.

“Hopefully, that can be separated out in future studies.”

Monitoring infants with postnatally acquired CMV infection long term, while important, is just an initial step, according to Dr. Meyer.

“An area of study that is still really needed is to look at how treating babies with antivirals affects their outcomes,” she said.

Major Finding: Very low-birth-weight infants with symptomatic, postnatally acquired CMV infection had high rates of pneumonitis (73%) and late-onset sepsis (43%).

Data Source: A retrospective cohort study of 34 infants with symptomatic CMV infection.

Disclosures: None was reported.

VANCOUVER, B.C. — Postnatally acquired cytomegalovirus infection can cause severe illness in very low-birth-weight infants in the short term, based on findings from a retrospective study.

Infants in the study who became infected and symptomatic with cytomegalovirus (CMV) infection in the postnatal period had high rates of complications.

In fact, their clinical and laboratory findings were similar to those of congenitally infected infants.

“The biggest take-home message is that postnatal CMV infection can cause significant morbidity, and it can potentially lead to [poor] long-term outcomes,” lead investigator Dr. Sarah A. Meyer said in an interview.

“It is often something that we don't think about a lot, and we just need to keep it in our mind that if we have babies that present with some of these symptoms, we should be testing them and following their outcomes,” she said.

Much is known about congenitally acquired CMV, according to Dr. Meyer of Children's Hospital Boston. But comparatively little is know about CMV acquired in the postnatal period through breast milk.

Using hospital records for the years 1997-2009, she and her colleagues retrospectively studied 34 infants who had symptomatic, culture-positive CMV infection and were cared for in a neonatal intensive care unit.

Of the infants (all but 1 of whom met criteria for very low birth weight [VLBW]), 22 had been infected postnatally, whereas the other 12 infants (having a range of birth weights) had been infected congenitally.

Compared with their congenitally infected counterparts, the postnatally infected infants had a lower median birth weight (688 vs. 1,500 g), had a younger median gestational age (26 vs. 32 weeks), were older on the day of diagnosis (52.5 vs. 3.5 days of life), and were more likely to have been breastfed (100% vs. 67%).

The proportions delivered by cesarean section were similar, she reported in a poster at the meeting.

Among those infected in the postnatal period, the time to CMV diagnosis was correlated with the length of exposure to breast milk (r = 0.84), indicating that the risk of viral transmission persisted with continued exposure. In contrast, the time to CMV diagnosis was not correlated with the day of life on which infants were first fed breast milk.

The most common complications with postnatal infection were pneumonitis (present in 73% of infants), colitis (50%), hepatosplenomegaly (36%), and intracranial findings (27%).

Relative to their congenitally infected counterparts, postnatally infected infants had generally similar clinical findings, but were more likely to have pneumonitis (73% vs. 0%) and less likely to have petechiae and purpura (10% vs. 50%) and retinitis (0% vs. 25%).

The two groups were also similar in rates of hematologic and cerebrospinal fluid laboratory abnormalities, presence of cerebrospinal fluid CMV positivity by polymerase chain reaction testing, and median blood CMV viral load.

Among the 15 infants overall with neurologic follow-up, the rate of hearing loss was 71% in those congenitally infected, compared with 13% in those postnatally infected, with numbers too small to permit statistical comparison.

Rates of developmental delay and cerebral palsy were similar, although these sequelae in the postnatally infected infants also could have been related to their prematurity, noted Dr. Meyer.

A final analysis did suggest that symptomatic postnatal CMV infection may add substantial morbidity above and beyond that due to having a very low birth weight, she said.

Compared with 1,226 infants from the general VLBW population, the VLBW infants with postnatal cytomegalovirus infection had a higher rate of bronchopulmonary dysplasia (81% vs. 16%) and late-onset sepsis (43% vs. 18%).

Rates of necrotizing enterocolitis and intraventricular hemorrhage did not differ significantly between the two groups.

Dr. Meyer said that teasing out causal associations is difficult in the VLBW population.

“Whether or not these babies are immunosuppressed to begin with and that predisposes them to late-onset sepsis and acquiring CMV, or acquiring CMV reduces their immunity level and that predisposes them to late-onset sepsis—which one came first is not exactly clear,” she explained.

“Hopefully, that can be separated out in future studies.”

Monitoring infants with postnatally acquired CMV infection long term, while important, is just an initial step, according to Dr. Meyer.

“An area of study that is still really needed is to look at how treating babies with antivirals affects their outcomes,” she said.

Major Finding: The overall rate of admission for bronchiolitis fell from about 40% before implementation of the home oxygen protocol to 28% afterward.

Data Source: A retrospective study of 5,065 cases of bronchiolitis seen in the ED of a tertiary-care children's hospital, 13% of whom were managed with home oxygen therapy.

Disclosures: None was reported.

VANCOUVER, B.C. — Selected children with bronchiolitis seen in the emergency department can be safely managed with home oxygen therapy and thereby avoid hospital admission, according to Dr. Sarah M. Halstead.

In a retrospective study of more than 5,000 pediatric cases of bronchiolitis with hypoxia seen in the emergency department (ED), only 6% of children sent home on oxygen had to be admitted to the hospital at a later time.

None of them had adverse outcomes or required intensive care or placement of an advanced airway, Dr. Halstead reported.

Moreover, the ED's overall rate of hospital admission for children with bronchiolitis fell by about a third from historical levels before the home oxygen protocol was used, based on results reported at the meeting.

“To improve clinical care, we hope that this data, which does support the safety of a home oxygen program for patients with bronchiolitis seen in the ED, will encourage other institutions to consider similar home oxygen protocols,” Dr. Halstead, the lead investigator, said in a poster.

“Increasing ED overcrowding and boarding of inpatients makes the development and analysis of this and other novel outpatient care strategies imperative,” she added.

The investigators used electronic medical records to assess outcomes among children aged 1-18 months seen in the ED with bronchiolitis during the 2005 through 2009 bronchiolitis seasons, a period when the ED had a home oxygen protocol in place.

Children with cardiopulmonary conditions who required oxygen at baseline were excluded.

“Prior to discharge on home oxygen, we observed patients in the ED for 8 hours,” explained Dr. Halstead, a pediatrician at the Children's Hospital in Aurora, Colo.

“If they had oxygen saturations of greater than 90% on half a liter or less of nasal cannula oxygen, they were able to maintain adequate hydration without frequent deep suctioning, they had no signs of respiratory deterioration, and both the caregiver and the attending were comfortable with discharge home, then a follow-up appointment was arranged and … home oxygen was supplied for the family,” the pediatrician said.

Study results were based on 5,065 cases of bronchiolitis seen in the ED, 13% of whom were discharged on home oxygen therapy.

Within this group, only 6% had to be admitted at a later time—a value that did not differ significantly from the 4% seen among children discharged on room air.

The leading reason for admission after a discharge on home oxygen was an increased oxygen requirement (51%), followed by increased work of breathing (46%), parental concern or compliance issues (24%), a need for intravenous fluids (8%), and difficulties with home oxygen therapy (5%).

“There were no adverse outcomes, ICU admissions, or need for advanced airways in any of these patients,” Dr. Halstead reported at the meeting.

The ED's overall hospital admission rate for bronchiolitis (which captured both children initially admitted and children admitted after initially being sent home) was 28% during the study period'substantially lower than the 39%-40% seen historically before implementation of the home oxygen protocol.

Because some children sent home on oxygen may have been admitted later to outside institutions, the admission rate found in the study may be an underestimate, Dr. Halstead said.

She attributed the success of the home oxygen protocol in large part to support from respiratory therapists and primary care providers.

“We have respiratory therapists available in the ED 24 hours a day, 7 days a week.

“They perform home oxygen teaching and arrange for oxygen to be delivered to the family,” she noted.

“We also have support from the [primary care providers] in the community who have made themselves available for follow-up within 24 hours of discharge.

“They are comfortable caring for their patients on home oxygen, including weaning them off oxygen in an outpatient setting,” Dr. Halstead commented.

Major Finding: The overall rate of admission for bronchiolitis fell from about 40% before implementation of the home oxygen protocol to 28% afterward.

Data Source: A retrospective study of 5,065 cases of bronchiolitis seen in the ED of a tertiary-care children's hospital, 13% of whom were managed with home oxygen therapy.

Disclosures: None was reported.

VANCOUVER, B.C. — Selected children with bronchiolitis seen in the emergency department can be safely managed with home oxygen therapy and thereby avoid hospital admission, according to Dr. Sarah M. Halstead.

In a retrospective study of more than 5,000 pediatric cases of bronchiolitis with hypoxia seen in the emergency department (ED), only 6% of children sent home on oxygen had to be admitted to the hospital at a later time.

None of them had adverse outcomes or required intensive care or placement of an advanced airway, Dr. Halstead reported.

Moreover, the ED's overall rate of hospital admission for children with bronchiolitis fell by about a third from historical levels before the home oxygen protocol was used, based on results reported at the meeting.

“To improve clinical care, we hope that this data, which does support the safety of a home oxygen program for patients with bronchiolitis seen in the ED, will encourage other institutions to consider similar home oxygen protocols,” Dr. Halstead, the lead investigator, said in a poster.

“Increasing ED overcrowding and boarding of inpatients makes the development and analysis of this and other novel outpatient care strategies imperative,” she added.

The investigators used electronic medical records to assess outcomes among children aged 1-18 months seen in the ED with bronchiolitis during the 2005 through 2009 bronchiolitis seasons, a period when the ED had a home oxygen protocol in place.

Children with cardiopulmonary conditions who required oxygen at baseline were excluded.

“Prior to discharge on home oxygen, we observed patients in the ED for 8 hours,” explained Dr. Halstead, a pediatrician at the Children's Hospital in Aurora, Colo.

“If they had oxygen saturations of greater than 90% on half a liter or less of nasal cannula oxygen, they were able to maintain adequate hydration without frequent deep suctioning, they had no signs of respiratory deterioration, and both the caregiver and the attending were comfortable with discharge home, then a follow-up appointment was arranged and … home oxygen was supplied for the family,” the pediatrician said.

Study results were based on 5,065 cases of bronchiolitis seen in the ED, 13% of whom were discharged on home oxygen therapy.

Within this group, only 6% had to be admitted at a later time—a value that did not differ significantly from the 4% seen among children discharged on room air.

The leading reason for admission after a discharge on home oxygen was an increased oxygen requirement (51%), followed by increased work of breathing (46%), parental concern or compliance issues (24%), a need for intravenous fluids (8%), and difficulties with home oxygen therapy (5%).

“There were no adverse outcomes, ICU admissions, or need for advanced airways in any of these patients,” Dr. Halstead reported at the meeting.

The ED's overall hospital admission rate for bronchiolitis (which captured both children initially admitted and children admitted after initially being sent home) was 28% during the study period'substantially lower than the 39%-40% seen historically before implementation of the home oxygen protocol.

Because some children sent home on oxygen may have been admitted later to outside institutions, the admission rate found in the study may be an underestimate, Dr. Halstead said.

She attributed the success of the home oxygen protocol in large part to support from respiratory therapists and primary care providers.

“We have respiratory therapists available in the ED 24 hours a day, 7 days a week.

“They perform home oxygen teaching and arrange for oxygen to be delivered to the family,” she noted.

“We also have support from the [primary care providers] in the community who have made themselves available for follow-up within 24 hours of discharge.

“They are comfortable caring for their patients on home oxygen, including weaning them off oxygen in an outpatient setting,” Dr. Halstead commented.

Major Finding: The overall rate of admission for bronchiolitis fell from about 40% before implementation of the home oxygen protocol to 28% afterward.

Data Source: A retrospective study of 5,065 cases of bronchiolitis seen in the ED of a tertiary-care children's hospital, 13% of whom were managed with home oxygen therapy.

Disclosures: None was reported.

VANCOUVER, B.C. — Selected children with bronchiolitis seen in the emergency department can be safely managed with home oxygen therapy and thereby avoid hospital admission, according to Dr. Sarah M. Halstead.

In a retrospective study of more than 5,000 pediatric cases of bronchiolitis with hypoxia seen in the emergency department (ED), only 6% of children sent home on oxygen had to be admitted to the hospital at a later time.

None of them had adverse outcomes or required intensive care or placement of an advanced airway, Dr. Halstead reported.

Moreover, the ED's overall rate of hospital admission for children with bronchiolitis fell by about a third from historical levels before the home oxygen protocol was used, based on results reported at the meeting.

“To improve clinical care, we hope that this data, which does support the safety of a home oxygen program for patients with bronchiolitis seen in the ED, will encourage other institutions to consider similar home oxygen protocols,” Dr. Halstead, the lead investigator, said in a poster.

“Increasing ED overcrowding and boarding of inpatients makes the development and analysis of this and other novel outpatient care strategies imperative,” she added.

The investigators used electronic medical records to assess outcomes among children aged 1-18 months seen in the ED with bronchiolitis during the 2005 through 2009 bronchiolitis seasons, a period when the ED had a home oxygen protocol in place.

Children with cardiopulmonary conditions who required oxygen at baseline were excluded.

“Prior to discharge on home oxygen, we observed patients in the ED for 8 hours,” explained Dr. Halstead, a pediatrician at the Children's Hospital in Aurora, Colo.

“If they had oxygen saturations of greater than 90% on half a liter or less of nasal cannula oxygen, they were able to maintain adequate hydration without frequent deep suctioning, they had no signs of respiratory deterioration, and both the caregiver and the attending were comfortable with discharge home, then a follow-up appointment was arranged and … home oxygen was supplied for the family,” the pediatrician said.

Study results were based on 5,065 cases of bronchiolitis seen in the ED, 13% of whom were discharged on home oxygen therapy.

Within this group, only 6% had to be admitted at a later time—a value that did not differ significantly from the 4% seen among children discharged on room air.

The leading reason for admission after a discharge on home oxygen was an increased oxygen requirement (51%), followed by increased work of breathing (46%), parental concern or compliance issues (24%), a need for intravenous fluids (8%), and difficulties with home oxygen therapy (5%).

“There were no adverse outcomes, ICU admissions, or need for advanced airways in any of these patients,” Dr. Halstead reported at the meeting.

The ED's overall hospital admission rate for bronchiolitis (which captured both children initially admitted and children admitted after initially being sent home) was 28% during the study period'substantially lower than the 39%-40% seen historically before implementation of the home oxygen protocol.

Because some children sent home on oxygen may have been admitted later to outside institutions, the admission rate found in the study may be an underestimate, Dr. Halstead said.

She attributed the success of the home oxygen protocol in large part to support from respiratory therapists and primary care providers.

“We have respiratory therapists available in the ED 24 hours a day, 7 days a week.

“They perform home oxygen teaching and arrange for oxygen to be delivered to the family,” she noted.

“We also have support from the [primary care providers] in the community who have made themselves available for follow-up within 24 hours of discharge.

“They are comfortable caring for their patients on home oxygen, including weaning them off oxygen in an outpatient setting,” Dr. Halstead commented.

Major Finding: Adolescents assigned to a stepped intervention were 1.8 times more likely to receive new vaccines and 1.7 times more likely to have a recent well-child visit than those given usual care.

Data Source: Randomized controlled trial involving 6,684 high-risk adolescents.

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

VANCOUVER, B.C. — A stepped intervention in primary care practices can improve rates of immunization and well-child visits among urban adolescents at high risk for poor health outcomes.

Data from a randomized trial conducted in Rochester, N.Y., showed that adolescents assigned to the intervention were 1.8 times more likely to receive new vaccines than were their peers assigned to usual care. In addition, they were 1.7 times more likely to have made a well-child visit in the past year.

“A stepped tracking-reminder-recall-outreach program can improve immunization rates for high-risk urban adolescents, and it has spillover benefits on improving preventive care visits,” said Dr. Peter G. Szilagyi, professor and chief of the division of general pediatrics and professor at the center for community health at the University of Rochester.

The 15-month trial was conducted in eight primary care practices among adolescents aged 11–15 years. Within each practice, the adolescents were randomized to an intervention group or a control group given usual care.

In the intervention group, outreach workers tracked all adolescents to monitor their immunization status. For those identified as being behind, progressively intense measures were used until they were up to date: reminders, then recalls, and finally outreach in the form of a home visit, which was used to assess barriers, link the families with social services, and stress the importance of a medical home.

Outreach workers mainly targeted the parents but often did speak with the adolescents. “Reaching them is a constant problem,” he commented. “This is why we put human beings here rather than computers or auto-dialers.”

The researchers assessed rates of receipt for three new vaccines for adolescents—meningococcal conjugate (MCV4); tetanus, diphtheria, and pertussis (Tdap); and human papillomavirus (HPV) vaccines—and rates of well-child care visits.

Analyses were based on 3,365 adolescents in the intervention group and 3,319 adolescents in the control group. They were a mean 13.5 years old, and half were male. Most were either black (63%) or Hispanic (23%) and most had Medicaid (73%).

Results showed that in the intervention group, 71% of adolescents needed reminders and recall, and 12% needed home visits.

After adjustment for potential confounders, relative to their peers in the control group, adolescents in the intervention group were 1.8-fold more likely to have received all three vaccines at the study's end (P less than .001), Dr. Szilagyi said.

In absolute terms, 44% of adolescents in the intervention group were fully immunized at that point, compared with 32% in the control group. Differences were significant for each vaccine as well.

Similarly, after statistical adjustment, adolescents in the intervention group were 1.7-fold more likely to have had a well-child visit in the past year at the study's end (P less than .001), he said.

In absolute terms, 67% in the intervention group had made such a visit, compared with 55% in the control group.

The difference in immunization rates between groups was significant within each of the eight practices, and the difference between groups in well-child visits was significant within all but one, Dr. Szilagyi noted. Furthermore, improvements in rates of these outcomes were similar by age, sex, race/ethnicity, and type of insurance.

The cost of the intervention (excluding research costs) was $43 per year per adolescent. The cost per additional fully vaccinated adolescent was $465, and the cost per additional adolescent with a recent well-child visit was $417. The number needed to treat (enroll in the intervention) was nine for an additional adolescent to be fully vaccinated and nine for an additional adolescent to have a well-child visit.

Major Finding: Adolescents assigned to a stepped intervention were 1.8 times more likely to receive new vaccines and 1.7 times more likely to have a recent well-child visit than those given usual care.

Data Source: Randomized controlled trial involving 6,684 high-risk adolescents.

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

VANCOUVER, B.C. — A stepped intervention in primary care practices can improve rates of immunization and well-child visits among urban adolescents at high risk for poor health outcomes.

Data from a randomized trial conducted in Rochester, N.Y., showed that adolescents assigned to the intervention were 1.8 times more likely to receive new vaccines than were their peers assigned to usual care. In addition, they were 1.7 times more likely to have made a well-child visit in the past year.

“A stepped tracking-reminder-recall-outreach program can improve immunization rates for high-risk urban adolescents, and it has spillover benefits on improving preventive care visits,” said Dr. Peter G. Szilagyi, professor and chief of the division of general pediatrics and professor at the center for community health at the University of Rochester.

The 15-month trial was conducted in eight primary care practices among adolescents aged 11–15 years. Within each practice, the adolescents were randomized to an intervention group or a control group given usual care.

In the intervention group, outreach workers tracked all adolescents to monitor their immunization status. For those identified as being behind, progressively intense measures were used until they were up to date: reminders, then recalls, and finally outreach in the form of a home visit, which was used to assess barriers, link the families with social services, and stress the importance of a medical home.

Outreach workers mainly targeted the parents but often did speak with the adolescents. “Reaching them is a constant problem,” he commented. “This is why we put human beings here rather than computers or auto-dialers.”

The researchers assessed rates of receipt for three new vaccines for adolescents—meningococcal conjugate (MCV4); tetanus, diphtheria, and pertussis (Tdap); and human papillomavirus (HPV) vaccines—and rates of well-child care visits.

Analyses were based on 3,365 adolescents in the intervention group and 3,319 adolescents in the control group. They were a mean 13.5 years old, and half were male. Most were either black (63%) or Hispanic (23%) and most had Medicaid (73%).

Results showed that in the intervention group, 71% of adolescents needed reminders and recall, and 12% needed home visits.

After adjustment for potential confounders, relative to their peers in the control group, adolescents in the intervention group were 1.8-fold more likely to have received all three vaccines at the study's end (P less than .001), Dr. Szilagyi said.

In absolute terms, 44% of adolescents in the intervention group were fully immunized at that point, compared with 32% in the control group. Differences were significant for each vaccine as well.

Similarly, after statistical adjustment, adolescents in the intervention group were 1.7-fold more likely to have had a well-child visit in the past year at the study's end (P less than .001), he said.

In absolute terms, 67% in the intervention group had made such a visit, compared with 55% in the control group.

The difference in immunization rates between groups was significant within each of the eight practices, and the difference between groups in well-child visits was significant within all but one, Dr. Szilagyi noted. Furthermore, improvements in rates of these outcomes were similar by age, sex, race/ethnicity, and type of insurance.

The cost of the intervention (excluding research costs) was $43 per year per adolescent. The cost per additional fully vaccinated adolescent was $465, and the cost per additional adolescent with a recent well-child visit was $417. The number needed to treat (enroll in the intervention) was nine for an additional adolescent to be fully vaccinated and nine for an additional adolescent to have a well-child visit.

Major Finding: Adolescents assigned to a stepped intervention were 1.8 times more likely to receive new vaccines and 1.7 times more likely to have a recent well-child visit than those given usual care.

Data Source: Randomized controlled trial involving 6,684 high-risk adolescents.

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

VANCOUVER, B.C. — A stepped intervention in primary care practices can improve rates of immunization and well-child visits among urban adolescents at high risk for poor health outcomes.

Data from a randomized trial conducted in Rochester, N.Y., showed that adolescents assigned to the intervention were 1.8 times more likely to receive new vaccines than were their peers assigned to usual care. In addition, they were 1.7 times more likely to have made a well-child visit in the past year.

“A stepped tracking-reminder-recall-outreach program can improve immunization rates for high-risk urban adolescents, and it has spillover benefits on improving preventive care visits,” said Dr. Peter G. Szilagyi, professor and chief of the division of general pediatrics and professor at the center for community health at the University of Rochester.

The 15-month trial was conducted in eight primary care practices among adolescents aged 11–15 years. Within each practice, the adolescents were randomized to an intervention group or a control group given usual care.

In the intervention group, outreach workers tracked all adolescents to monitor their immunization status. For those identified as being behind, progressively intense measures were used until they were up to date: reminders, then recalls, and finally outreach in the form of a home visit, which was used to assess barriers, link the families with social services, and stress the importance of a medical home.

Outreach workers mainly targeted the parents but often did speak with the adolescents. “Reaching them is a constant problem,” he commented. “This is why we put human beings here rather than computers or auto-dialers.”

The researchers assessed rates of receipt for three new vaccines for adolescents—meningococcal conjugate (MCV4); tetanus, diphtheria, and pertussis (Tdap); and human papillomavirus (HPV) vaccines—and rates of well-child care visits.

Analyses were based on 3,365 adolescents in the intervention group and 3,319 adolescents in the control group. They were a mean 13.5 years old, and half were male. Most were either black (63%) or Hispanic (23%) and most had Medicaid (73%).

Results showed that in the intervention group, 71% of adolescents needed reminders and recall, and 12% needed home visits.

After adjustment for potential confounders, relative to their peers in the control group, adolescents in the intervention group were 1.8-fold more likely to have received all three vaccines at the study's end (P less than .001), Dr. Szilagyi said.

In absolute terms, 44% of adolescents in the intervention group were fully immunized at that point, compared with 32% in the control group. Differences were significant for each vaccine as well.

Similarly, after statistical adjustment, adolescents in the intervention group were 1.7-fold more likely to have had a well-child visit in the past year at the study's end (P less than .001), he said.

In absolute terms, 67% in the intervention group had made such a visit, compared with 55% in the control group.

The difference in immunization rates between groups was significant within each of the eight practices, and the difference between groups in well-child visits was significant within all but one, Dr. Szilagyi noted. Furthermore, improvements in rates of these outcomes were similar by age, sex, race/ethnicity, and type of insurance.

The cost of the intervention (excluding research costs) was $43 per year per adolescent. The cost per additional fully vaccinated adolescent was $465, and the cost per additional adolescent with a recent well-child visit was $417. The number needed to treat (enroll in the intervention) was nine for an additional adolescent to be fully vaccinated and nine for an additional adolescent to have a well-child visit.

SAN FRANCISCO — The use of new, more expensive therapies for prostate cancer increased rapidly during a recent 4-year period, despite a lack of consensus on their effectiveness relative to that of older, less expensive therapies, researchers reported at a symposium on genitourinary cancers.

In a cross-sectional sample of 58,581 older U.S. men with nonmetastatic prostate cancer, the use of minimally invasive radical prostatectomy rose 19-fold, of intensity-modulated radiation therapy (IMRT) almost 3-fold, and of the combination of brachytherapy plus IMRT roughly 4-fold. The use of older therapies fell correspondingly.

“Despite limited comparative effectiveness data, there was a rapid increase in utilization of these more expensive therapies for prostate cancer,” said lead investigator Dr. Paul L. Nguyen. “Potential benefits really must be weighed against the added costs as newer, expensive therapies are introduced.”

The researchers used the linked SEER (Surveillance, Epidemiology, and End Results)–Medicare database to identify men aged 65 years or older who received a diagnosis of nonmetastatic prostate cancer between 2002 and 2005 and who were not enrolled in an HMO. Treatments were ascertained by using procedural codes.

The pattern of relative use of treatment modalities remained constant between 2002 and 2005, with external-beam radiation therapy used most commonly, followed by brachytherapy, and then by surgery. But there were major shifts within each modality in the specific therapies used, Dr. Nguyen reported at the symposium, which was sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Among men who had surgery, the proportion who had minimally invasive (laparoscopic or robotic) radical prostatectomy increased 19-fold, from 1.5% in 2002 to 28.7% in 2005. Meanwhile, the proportion having open prostatectomy fell.

Among men who had external-beam radiation therapy, the proportion who had IMRT almost tripled, from 28.7% to 81.7%. At the same time, the use of 3D-conformal radiation therapy decreased.

Finally, among men who had brachytherapy, the proportion also treated with IMRT roughly quadrupled, from 8.5% to 31.1%. Meanwhile, the proportion receiving brachytherapy plus 3D-conformal radiation therapy fell, and the proportion receiving brachytherapy alone was unchanged, said<Dr. Nguyen, director of prostate brachytherapy at the Dana-Farber Cancer Institute and Brigham and Women's Hospital, both in Boston.

Compared with men who had open prostatectomy, men who had minimally invasive radical prostatectomy were more likely to be highly educated, reside in a high-income neighborhood, and live in the Northeast or the West; were more likely to have a high tumor grade, a clinical T1 stage, and limited comorbidity; and were more likely to be Asian and less likely to be black or Hispanic.

All of these factors were also associated with receiving IMRT as opposed to 3D-conformal radiation therapy, except for race/ethnicity. IMRT recipients were more likely to be Asian and more likely to be white (but less likely to be black (P

“Comparative effectiveness research into these more expensive therapies has been pretty limited. Certainly, there are no randomized trials that tell us that the more expensive therapy is better than the less expensive therapy,” Dr. Nguyen commented.

An analysis suggesting that IMRT is cost effective (Int. J. Radiat. Oncol. Biol. Phys. 2006;66:408-15) was published after the use of this therapy was already widespread. “So we have to ask ourselves, did we do this backwards, because … it was after the fact that we found it was cost effective,” he said. “What if we had found out it wasn't?”

The findings have important implications for guiding the use of future technologies, such as proton therapy, Dr. Nguyen observed. “Even if there is a clinical benefit to these more expensive therapies, it's still fair to ask [whether] these benefits [will] outweigh the added costs,” he said.

Disclosures: Dr. Nguyen reported having no conflicts of interest related to the study.

SAN FRANCISCO — The use of new, more expensive therapies for prostate cancer increased rapidly during a recent 4-year period, despite a lack of consensus on their effectiveness relative to that of older, less expensive therapies, researchers reported at a symposium on genitourinary cancers.

In a cross-sectional sample of 58,581 older U.S. men with nonmetastatic prostate cancer, the use of minimally invasive radical prostatectomy rose 19-fold, of intensity-modulated radiation therapy (IMRT) almost 3-fold, and of the combination of brachytherapy plus IMRT roughly 4-fold. The use of older therapies fell correspondingly.

“Despite limited comparative effectiveness data, there was a rapid increase in utilization of these more expensive therapies for prostate cancer,” said lead investigator Dr. Paul L. Nguyen. “Potential benefits really must be weighed against the added costs as newer, expensive therapies are introduced.”

The researchers used the linked SEER (Surveillance, Epidemiology, and End Results)–Medicare database to identify men aged 65 years or older who received a diagnosis of nonmetastatic prostate cancer between 2002 and 2005 and who were not enrolled in an HMO. Treatments were ascertained by using procedural codes.

The pattern of relative use of treatment modalities remained constant between 2002 and 2005, with external-beam radiation therapy used most commonly, followed by brachytherapy, and then by surgery. But there were major shifts within each modality in the specific therapies used, Dr. Nguyen reported at the symposium, which was sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Among men who had surgery, the proportion who had minimally invasive (laparoscopic or robotic) radical prostatectomy increased 19-fold, from 1.5% in 2002 to 28.7% in 2005. Meanwhile, the proportion having open prostatectomy fell.

Among men who had external-beam radiation therapy, the proportion who had IMRT almost tripled, from 28.7% to 81.7%. At the same time, the use of 3D-conformal radiation therapy decreased.

Finally, among men who had brachytherapy, the proportion also treated with IMRT roughly quadrupled, from 8.5% to 31.1%. Meanwhile, the proportion receiving brachytherapy plus 3D-conformal radiation therapy fell, and the proportion receiving brachytherapy alone was unchanged, said<Dr. Nguyen, director of prostate brachytherapy at the Dana-Farber Cancer Institute and Brigham and Women's Hospital, both in Boston.

Compared with men who had open prostatectomy, men who had minimally invasive radical prostatectomy were more likely to be highly educated, reside in a high-income neighborhood, and live in the Northeast or the West; were more likely to have a high tumor grade, a clinical T1 stage, and limited comorbidity; and were more likely to be Asian and less likely to be black or Hispanic.

All of these factors were also associated with receiving IMRT as opposed to 3D-conformal radiation therapy, except for race/ethnicity. IMRT recipients were more likely to be Asian and more likely to be white (but less likely to be black (P

“Comparative effectiveness research into these more expensive therapies has been pretty limited. Certainly, there are no randomized trials that tell us that the more expensive therapy is better than the less expensive therapy,” Dr. Nguyen commented.

An analysis suggesting that IMRT is cost effective (Int. J. Radiat. Oncol. Biol. Phys. 2006;66:408-15) was published after the use of this therapy was already widespread. “So we have to ask ourselves, did we do this backwards, because … it was after the fact that we found it was cost effective,” he said. “What if we had found out it wasn't?”

The findings have important implications for guiding the use of future technologies, such as proton therapy, Dr. Nguyen observed. “Even if there is a clinical benefit to these more expensive therapies, it's still fair to ask [whether] these benefits [will] outweigh the added costs,” he said.

Disclosures: Dr. Nguyen reported having no conflicts of interest related to the study.

SAN FRANCISCO — The use of new, more expensive therapies for prostate cancer increased rapidly during a recent 4-year period, despite a lack of consensus on their effectiveness relative to that of older, less expensive therapies, researchers reported at a symposium on genitourinary cancers.

In a cross-sectional sample of 58,581 older U.S. men with nonmetastatic prostate cancer, the use of minimally invasive radical prostatectomy rose 19-fold, of intensity-modulated radiation therapy (IMRT) almost 3-fold, and of the combination of brachytherapy plus IMRT roughly 4-fold. The use of older therapies fell correspondingly.

“Despite limited comparative effectiveness data, there was a rapid increase in utilization of these more expensive therapies for prostate cancer,” said lead investigator Dr. Paul L. Nguyen. “Potential benefits really must be weighed against the added costs as newer, expensive therapies are introduced.”

The researchers used the linked SEER (Surveillance, Epidemiology, and End Results)–Medicare database to identify men aged 65 years or older who received a diagnosis of nonmetastatic prostate cancer between 2002 and 2005 and who were not enrolled in an HMO. Treatments were ascertained by using procedural codes.

The pattern of relative use of treatment modalities remained constant between 2002 and 2005, with external-beam radiation therapy used most commonly, followed by brachytherapy, and then by surgery. But there were major shifts within each modality in the specific therapies used, Dr. Nguyen reported at the symposium, which was sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Among men who had surgery, the proportion who had minimally invasive (laparoscopic or robotic) radical prostatectomy increased 19-fold, from 1.5% in 2002 to 28.7% in 2005. Meanwhile, the proportion having open prostatectomy fell.

Among men who had external-beam radiation therapy, the proportion who had IMRT almost tripled, from 28.7% to 81.7%. At the same time, the use of 3D-conformal radiation therapy decreased.

Finally, among men who had brachytherapy, the proportion also treated with IMRT roughly quadrupled, from 8.5% to 31.1%. Meanwhile, the proportion receiving brachytherapy plus 3D-conformal radiation therapy fell, and the proportion receiving brachytherapy alone was unchanged, said<Dr. Nguyen, director of prostate brachytherapy at the Dana-Farber Cancer Institute and Brigham and Women's Hospital, both in Boston.

Compared with men who had open prostatectomy, men who had minimally invasive radical prostatectomy were more likely to be highly educated, reside in a high-income neighborhood, and live in the Northeast or the West; were more likely to have a high tumor grade, a clinical T1 stage, and limited comorbidity; and were more likely to be Asian and less likely to be black or Hispanic.

All of these factors were also associated with receiving IMRT as opposed to 3D-conformal radiation therapy, except for race/ethnicity. IMRT recipients were more likely to be Asian and more likely to be white (but less likely to be black (P

“Comparative effectiveness research into these more expensive therapies has been pretty limited. Certainly, there are no randomized trials that tell us that the more expensive therapy is better than the less expensive therapy,” Dr. Nguyen commented.

An analysis suggesting that IMRT is cost effective (Int. J. Radiat. Oncol. Biol. Phys. 2006;66:408-15) was published after the use of this therapy was already widespread. “So we have to ask ourselves, did we do this backwards, because … it was after the fact that we found it was cost effective,” he said. “What if we had found out it wasn't?”

The findings have important implications for guiding the use of future technologies, such as proton therapy, Dr. Nguyen observed. “Even if there is a clinical benefit to these more expensive therapies, it's still fair to ask [whether] these benefits [will] outweigh the added costs,” he said.

Disclosures: Dr. Nguyen reported having no conflicts of interest related to the study.

Major Finding: NSAIDs, statins, and thiazide diuretics were associated with lower PSA levels of 1%, 3%, and 6%, respectively.

Data Source: 1,846 men aged 40 years or older who completed the National Health and Nutrition Examination Survey for 2003-2006.

Disclosures: Some of the investigators are consultants to Veridex LLC, a manufacturer of diagnostic tests.

SAN FRANCISCO — Commonly used medications were associated with clinically important reductions in prostate-specific antigen levels among roughly 2,000 middle-aged and older men in a cross-sectional study.

After 1 year of regular use, PSA levels were 1% lower in users of nonsteroidal anti-inflammatory drugs (NSAIDs), 3% lower in statin users, and—an apparently novel observation—6% lower in thiazide diuretic users, according to data reported at a symposium on genitourinary cancers. The difference in PSA levels among users and nonusers of the common medications increased over time, with reductions of 6%, 13%, and 26% seen with 5 years of regular use of NSAIDs, statins, and thiazide diuretics, respectively.

“If taking these medications alters serum PSA, it could affect the quality of prostate cancer screening,” said lead investigator Dr. Steven L. Chang of Stanford (Calif.) University. On the other hand, “perhaps these medications may influence prostate growth.”

Using data from the National Health and Nutrition Examination Survey (NHANES) for 2003-2006, the researchers assessed associations between medication use and log-transformed PSA levels in 1,846 men aged 40 years or older who had a serum PSA measurement; did not have a history of prostate cancer, prostatitis, or recent prostate manipulation; and were not taking 5-alpha reductase inhibitors or hormone therapy.

Statins topped the list of the 10 medications most commonly used in the study cohort (taken by 20% of the men), according to study results, which were reported in a poster session.

They were followed by beta-blockers (13%), angiotensin-converting enzyme (ACE) inhibitors (11%), NSAIDs (9%), proton pump inhibitors (9%), calcium channel blockers (6%), selective serotonin reuptake inhibitors (6%), thiazide diuretics (5%), alpha-blockers (4%), and sulfonylureas (4%).

In multivariate analyses, PSA levels after 1 year of regular use were 1% lower in NSAID users (P = .03), 3% lower in statin users (P = .01), and 6% lower in thiazide diuretic users (P = .03), relative to those in the respective nonusers. The remaining medications were not independently associated with PSA levels.

The effects of statins and NSAIDs on PSA have been previously reported, but the finding for thiazide diuretics appears to be new and was somewhat surprising in magnitude, Dr. Chang commented in an interview at the symposium, which was sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Certain medication combinations also were associated with reduced PSA levels, including fixed-dose combinations of beta-blockers plus thiazide diuretics (6% reduction, P = .03) and ACE inhibitors plus thiazide diuretics (7%, P = .02), and concurrently used statins and beta-blockers (3%, P = .03), statins and ACE inhibitors (3%, P = .04), and statins and thiazide diuretics (8%, P = .002).

Among the combinations, the reduction was greatest for concurrently used statins and thiazide diuretics, with a 36% difference after 5 years of regular use of both medications.

However, the link between statin use and lower PSA levels was minimized or negated in men who were concurrently taking calcium channel blockers, Dr. Chang noted.

“It's unclear as to the true mechanism behind what we are observing here, but it certainly raises a number of questions that should be addressed,” Dr. Chang said.

One possibility is that these medications simply reduce PSA levels without influencing the development or growth of prostate cancer.

“In that case, patients who develop prostate cancer would be identified later because their PSA levels would be lower than in others (all other things being equal) who are not on these medications,” Dr. Chang observed.

Alternatively, the medications might have some effect on the prostate gland, for example, reducing cancer development or prostate size and thereby lowering PSA levels.

In sum, Dr. Chang concluded, if the observed associations are proved to be causal, “future work is necessary to determine how medication use should be factored into prostate cancer screening. If any of these medications actually affect prostate cells, perhaps they may have a role in prevention or therapy of prostatic diseases.”

“If taking these medications alters serum PSA, it could affect the quality of prostate cancer screening,” said lead investigator Dr. Steven L. Chang.

Source Courtesy Dr. Steven L. Changhttp://circ.ahajournals.org/cgi/reprint/circulationaha.105.555482v1

Major Finding: NSAIDs, statins, and thiazide diuretics were associated with lower PSA levels of 1%, 3%, and 6%, respectively.

Data Source: 1,846 men aged 40 years or older who completed the National Health and Nutrition Examination Survey for 2003-2006.

Disclosures: Some of the investigators are consultants to Veridex LLC, a manufacturer of diagnostic tests.

SAN FRANCISCO — Commonly used medications were associated with clinically important reductions in prostate-specific antigen levels among roughly 2,000 middle-aged and older men in a cross-sectional study.

After 1 year of regular use, PSA levels were 1% lower in users of nonsteroidal anti-inflammatory drugs (NSAIDs), 3% lower in statin users, and—an apparently novel observation—6% lower in thiazide diuretic users, according to data reported at a symposium on genitourinary cancers. The difference in PSA levels among users and nonusers of the common medications increased over time, with reductions of 6%, 13%, and 26% seen with 5 years of regular use of NSAIDs, statins, and thiazide diuretics, respectively.

“If taking these medications alters serum PSA, it could affect the quality of prostate cancer screening,” said lead investigator Dr. Steven L. Chang of Stanford (Calif.) University. On the other hand, “perhaps these medications may influence prostate growth.”

Using data from the National Health and Nutrition Examination Survey (NHANES) for 2003-2006, the researchers assessed associations between medication use and log-transformed PSA levels in 1,846 men aged 40 years or older who had a serum PSA measurement; did not have a history of prostate cancer, prostatitis, or recent prostate manipulation; and were not taking 5-alpha reductase inhibitors or hormone therapy.

Statins topped the list of the 10 medications most commonly used in the study cohort (taken by 20% of the men), according to study results, which were reported in a poster session.

They were followed by beta-blockers (13%), angiotensin-converting enzyme (ACE) inhibitors (11%), NSAIDs (9%), proton pump inhibitors (9%), calcium channel blockers (6%), selective serotonin reuptake inhibitors (6%), thiazide diuretics (5%), alpha-blockers (4%), and sulfonylureas (4%).

In multivariate analyses, PSA levels after 1 year of regular use were 1% lower in NSAID users (P = .03), 3% lower in statin users (P = .01), and 6% lower in thiazide diuretic users (P = .03), relative to those in the respective nonusers. The remaining medications were not independently associated with PSA levels.

The effects of statins and NSAIDs on PSA have been previously reported, but the finding for thiazide diuretics appears to be new and was somewhat surprising in magnitude, Dr. Chang commented in an interview at the symposium, which was sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Certain medication combinations also were associated with reduced PSA levels, including fixed-dose combinations of beta-blockers plus thiazide diuretics (6% reduction, P = .03) and ACE inhibitors plus thiazide diuretics (7%, P = .02), and concurrently used statins and beta-blockers (3%, P = .03), statins and ACE inhibitors (3%, P = .04), and statins and thiazide diuretics (8%, P = .002).

Among the combinations, the reduction was greatest for concurrently used statins and thiazide diuretics, with a 36% difference after 5 years of regular use of both medications.

However, the link between statin use and lower PSA levels was minimized or negated in men who were concurrently taking calcium channel blockers, Dr. Chang noted.

“It's unclear as to the true mechanism behind what we are observing here, but it certainly raises a number of questions that should be addressed,” Dr. Chang said.

One possibility is that these medications simply reduce PSA levels without influencing the development or growth of prostate cancer.

“In that case, patients who develop prostate cancer would be identified later because their PSA levels would be lower than in others (all other things being equal) who are not on these medications,” Dr. Chang observed.

Alternatively, the medications might have some effect on the prostate gland, for example, reducing cancer development or prostate size and thereby lowering PSA levels.

In sum, Dr. Chang concluded, if the observed associations are proved to be causal, “future work is necessary to determine how medication use should be factored into prostate cancer screening. If any of these medications actually affect prostate cells, perhaps they may have a role in prevention or therapy of prostatic diseases.”

“If taking these medications alters serum PSA, it could affect the quality of prostate cancer screening,” said lead investigator Dr. Steven L. Chang.

Source Courtesy Dr. Steven L. Changhttp://circ.ahajournals.org/cgi/reprint/circulationaha.105.555482v1

Major Finding: NSAIDs, statins, and thiazide diuretics were associated with lower PSA levels of 1%, 3%, and 6%, respectively.

Data Source: 1,846 men aged 40 years or older who completed the National Health and Nutrition Examination Survey for 2003-2006.

Disclosures: Some of the investigators are consultants to Veridex LLC, a manufacturer of diagnostic tests.

SAN FRANCISCO — Commonly used medications were associated with clinically important reductions in prostate-specific antigen levels among roughly 2,000 middle-aged and older men in a cross-sectional study.

After 1 year of regular use, PSA levels were 1% lower in users of nonsteroidal anti-inflammatory drugs (NSAIDs), 3% lower in statin users, and—an apparently novel observation—6% lower in thiazide diuretic users, according to data reported at a symposium on genitourinary cancers. The difference in PSA levels among users and nonusers of the common medications increased over time, with reductions of 6%, 13%, and 26% seen with 5 years of regular use of NSAIDs, statins, and thiazide diuretics, respectively.

“If taking these medications alters serum PSA, it could affect the quality of prostate cancer screening,” said lead investigator Dr. Steven L. Chang of Stanford (Calif.) University. On the other hand, “perhaps these medications may influence prostate growth.”

Using data from the National Health and Nutrition Examination Survey (NHANES) for 2003-2006, the researchers assessed associations between medication use and log-transformed PSA levels in 1,846 men aged 40 years or older who had a serum PSA measurement; did not have a history of prostate cancer, prostatitis, or recent prostate manipulation; and were not taking 5-alpha reductase inhibitors or hormone therapy.

Statins topped the list of the 10 medications most commonly used in the study cohort (taken by 20% of the men), according to study results, which were reported in a poster session.

They were followed by beta-blockers (13%), angiotensin-converting enzyme (ACE) inhibitors (11%), NSAIDs (9%), proton pump inhibitors (9%), calcium channel blockers (6%), selective serotonin reuptake inhibitors (6%), thiazide diuretics (5%), alpha-blockers (4%), and sulfonylureas (4%).

In multivariate analyses, PSA levels after 1 year of regular use were 1% lower in NSAID users (P = .03), 3% lower in statin users (P = .01), and 6% lower in thiazide diuretic users (P = .03), relative to those in the respective nonusers. The remaining medications were not independently associated with PSA levels.

The effects of statins and NSAIDs on PSA have been previously reported, but the finding for thiazide diuretics appears to be new and was somewhat surprising in magnitude, Dr. Chang commented in an interview at the symposium, which was sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

Certain medication combinations also were associated with reduced PSA levels, including fixed-dose combinations of beta-blockers plus thiazide diuretics (6% reduction, P = .03) and ACE inhibitors plus thiazide diuretics (7%, P = .02), and concurrently used statins and beta-blockers (3%, P = .03), statins and ACE inhibitors (3%, P = .04), and statins and thiazide diuretics (8%, P = .002).

Among the combinations, the reduction was greatest for concurrently used statins and thiazide diuretics, with a 36% difference after 5 years of regular use of both medications.

However, the link between statin use and lower PSA levels was minimized or negated in men who were concurrently taking calcium channel blockers, Dr. Chang noted.

“It's unclear as to the true mechanism behind what we are observing here, but it certainly raises a number of questions that should be addressed,” Dr. Chang said.

One possibility is that these medications simply reduce PSA levels without influencing the development or growth of prostate cancer.

“In that case, patients who develop prostate cancer would be identified later because their PSA levels would be lower than in others (all other things being equal) who are not on these medications,” Dr. Chang observed.

Alternatively, the medications might have some effect on the prostate gland, for example, reducing cancer development or prostate size and thereby lowering PSA levels.

In sum, Dr. Chang concluded, if the observed associations are proved to be causal, “future work is necessary to determine how medication use should be factored into prostate cancer screening. If any of these medications actually affect prostate cells, perhaps they may have a role in prevention or therapy of prostatic diseases.”

“If taking these medications alters serum PSA, it could affect the quality of prostate cancer screening,” said lead investigator Dr. Steven L. Chang.

Source Courtesy Dr. Steven L. Changhttp://circ.ahajournals.org/cgi/reprint/circulationaha.105.555482v1

SAN FRANCISCO — A new urinary assay for a common gene rearrangement in prostate cancer improves the detection of this disease and the differentiation of its more aggressive forms, according to two cohort studies reported at a symposium on genitourinary cancers.

The studies, conducted among men who were scheduled for prostate biopsy or prostatectomy, found that the assay supplemented conventional risk factors for accurately identifying those having prostate cancer. In addition, higher assay scores correlated with the presence of adverse tumor features.

Dr. John T. Wei presented results of the first study on behalf of Sheila M.J. Aubin, Ph.D., of Gen-Probe Inc., the company that is developing the assay.

Prostate-specific antigen (PSA) level and digital rectal examination both have poor specificity for detecting prostate cancer. Moreover, these tests are unable to differentiate indolent from aggressive cancer, said the professor of urology at the University of Michigan in Ann Arbor.

About half of prostate cancers exhibit fusion of the androgen-regulated TMPRSS2 gene and the ERG oncogene. Cancers that harbor this fusion gene (abbreviated T2:ERG) have increased cell growth, invasion, and metastasis, and decreased apoptosis, Dr. Wei said at the symposium, which was sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

In the first study, the investigators assessed the performance of the novel assay, which measures levels of T2:ERG messenger RNA in urine, using urine specimens collected after digital rectal examination and before either prostate biopsy (623 men) or prostatectomy (142 men).

Analyses of biopsy-based indicators showed that the T2:ERG score was correlated with the number of cores that were positive, the percentage of cores that were positive, and the greatest percentage involvement of any core by cancer, according to Dr. Wei. Also, the median score was higher among patients with biopsy-significant cancer as defined by Epstein criteria.

Analyses of prostatectomy-based indicators showed that the T2:ERG score was correlated with the maximum tumor dimension. In addition, the median score was higher among patients who had an upgrade of the Gleason score between biopsy and prostatectomy, a prostatectomy Gleason score of greater than 6, and prostatectomy-significant cancer as defined from tumor characteristics.

Compared with the PCPT (Prostate Cancer Prevention Trial) risk score alone, the combination of this score with the T2:ERG score more accurately identified men who had prostate cancer (area under the curve, 0.75 vs. 0.65).

Dr. Wei noted that at cutoff scores of 100 and 200, the T2:ERG assay had high specificity for distinguishing between patients with and without cancer (88%–93%), with biopsy-significant and -insignificant cancer (85%–95%), and with prostatectomy-significant and -insignificant cancer (95%–100%).

Independent trials of the assay are needed, Dr. Wei acknowledged.

In the second study, investigators tested the same T2:ERG assay using urine specimens that were collected after digital rectal examination from 471 men who were scheduled for prostate cancer biopsy at community clinics, according to Dr. James B. Amberson.

Some 44% of patients had positive biopsies, he reported. The median age was 66 years in the patients with cancer and 63 years in the patients without it. The median serum PSA level was 5.0 and 4.3 ng/mL, respectively.

When used alone, the T2:ERG score had a high specificity (87%) for detection of biopsy-proven cancer, reported Dr. Amberson, divisional medical director of Dianon Systems Inc., the manufacturer of another test that was also used in the study. Sensitivity was 39%.

The median T2:ERG score was higher in patients who had a Gleason score of 7 or greater, involvement of more than 50% of positive cores by cancer, and three or more positive cores.

“The T2:ERG assay significantly improved the diagnostic accuracy of a logistic regression model” for prostate cancer detection, said Dr. Amberson.

Dr. Wei and Dr. Amberson reported receiving research funding from Gen-Probe Inc. Some coauthors of both studies disclosed employment or leadership roles and stock ownership in Gen-Probe.

SAN FRANCISCO — A new urinary assay for a common gene rearrangement in prostate cancer improves the detection of this disease and the differentiation of its more aggressive forms, according to two cohort studies reported at a symposium on genitourinary cancers.

The studies, conducted among men who were scheduled for prostate biopsy or prostatectomy, found that the assay supplemented conventional risk factors for accurately identifying those having prostate cancer. In addition, higher assay scores correlated with the presence of adverse tumor features.

Dr. John T. Wei presented results of the first study on behalf of Sheila M.J. Aubin, Ph.D., of Gen-Probe Inc., the company that is developing the assay.

Prostate-specific antigen (PSA) level and digital rectal examination both have poor specificity for detecting prostate cancer. Moreover, these tests are unable to differentiate indolent from aggressive cancer, said the professor of urology at the University of Michigan in Ann Arbor.

About half of prostate cancers exhibit fusion of the androgen-regulated TMPRSS2 gene and the ERG oncogene. Cancers that harbor this fusion gene (abbreviated T2:ERG) have increased cell growth, invasion, and metastasis, and decreased apoptosis, Dr. Wei said at the symposium, which was sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

In the first study, the investigators assessed the performance of the novel assay, which measures levels of T2:ERG messenger RNA in urine, using urine specimens collected after digital rectal examination and before either prostate biopsy (623 men) or prostatectomy (142 men).

Analyses of biopsy-based indicators showed that the T2:ERG score was correlated with the number of cores that were positive, the percentage of cores that were positive, and the greatest percentage involvement of any core by cancer, according to Dr. Wei. Also, the median score was higher among patients with biopsy-significant cancer as defined by Epstein criteria.

Analyses of prostatectomy-based indicators showed that the T2:ERG score was correlated with the maximum tumor dimension. In addition, the median score was higher among patients who had an upgrade of the Gleason score between biopsy and prostatectomy, a prostatectomy Gleason score of greater than 6, and prostatectomy-significant cancer as defined from tumor characteristics.

Compared with the PCPT (Prostate Cancer Prevention Trial) risk score alone, the combination of this score with the T2:ERG score more accurately identified men who had prostate cancer (area under the curve, 0.75 vs. 0.65).

Dr. Wei noted that at cutoff scores of 100 and 200, the T2:ERG assay had high specificity for distinguishing between patients with and without cancer (88%–93%), with biopsy-significant and -insignificant cancer (85%–95%), and with prostatectomy-significant and -insignificant cancer (95%–100%).

Independent trials of the assay are needed, Dr. Wei acknowledged.

In the second study, investigators tested the same T2:ERG assay using urine specimens that were collected after digital rectal examination from 471 men who were scheduled for prostate cancer biopsy at community clinics, according to Dr. James B. Amberson.

Some 44% of patients had positive biopsies, he reported. The median age was 66 years in the patients with cancer and 63 years in the patients without it. The median serum PSA level was 5.0 and 4.3 ng/mL, respectively.

When used alone, the T2:ERG score had a high specificity (87%) for detection of biopsy-proven cancer, reported Dr. Amberson, divisional medical director of Dianon Systems Inc., the manufacturer of another test that was also used in the study. Sensitivity was 39%.

The median T2:ERG score was higher in patients who had a Gleason score of 7 or greater, involvement of more than 50% of positive cores by cancer, and three or more positive cores.

“The T2:ERG assay significantly improved the diagnostic accuracy of a logistic regression model” for prostate cancer detection, said Dr. Amberson.

Dr. Wei and Dr. Amberson reported receiving research funding from Gen-Probe Inc. Some coauthors of both studies disclosed employment or leadership roles and stock ownership in Gen-Probe.

SAN FRANCISCO — A new urinary assay for a common gene rearrangement in prostate cancer improves the detection of this disease and the differentiation of its more aggressive forms, according to two cohort studies reported at a symposium on genitourinary cancers.

The studies, conducted among men who were scheduled for prostate biopsy or prostatectomy, found that the assay supplemented conventional risk factors for accurately identifying those having prostate cancer. In addition, higher assay scores correlated with the presence of adverse tumor features.

Dr. John T. Wei presented results of the first study on behalf of Sheila M.J. Aubin, Ph.D., of Gen-Probe Inc., the company that is developing the assay.

Prostate-specific antigen (PSA) level and digital rectal examination both have poor specificity for detecting prostate cancer. Moreover, these tests are unable to differentiate indolent from aggressive cancer, said the professor of urology at the University of Michigan in Ann Arbor.

About half of prostate cancers exhibit fusion of the androgen-regulated TMPRSS2 gene and the ERG oncogene. Cancers that harbor this fusion gene (abbreviated T2:ERG) have increased cell growth, invasion, and metastasis, and decreased apoptosis, Dr. Wei said at the symposium, which was sponsored by the American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Urologic Oncology.

In the first study, the investigators assessed the performance of the novel assay, which measures levels of T2:ERG messenger RNA in urine, using urine specimens collected after digital rectal examination and before either prostate biopsy (623 men) or prostatectomy (142 men).

Analyses of biopsy-based indicators showed that the T2:ERG score was correlated with the number of cores that were positive, the percentage of cores that were positive, and the greatest percentage involvement of any core by cancer, according to Dr. Wei. Also, the median score was higher among patients with biopsy-significant cancer as defined by Epstein criteria.

Analyses of prostatectomy-based indicators showed that the T2:ERG score was correlated with the maximum tumor dimension. In addition, the median score was higher among patients who had an upgrade of the Gleason score between biopsy and prostatectomy, a prostatectomy Gleason score of greater than 6, and prostatectomy-significant cancer as defined from tumor characteristics.

Compared with the PCPT (Prostate Cancer Prevention Trial) risk score alone, the combination of this score with the T2:ERG score more accurately identified men who had prostate cancer (area under the curve, 0.75 vs. 0.65).

Dr. Wei noted that at cutoff scores of 100 and 200, the T2:ERG assay had high specificity for distinguishing between patients with and without cancer (88%–93%), with biopsy-significant and -insignificant cancer (85%–95%), and with prostatectomy-significant and -insignificant cancer (95%–100%).

Independent trials of the assay are needed, Dr. Wei acknowledged.

In the second study, investigators tested the same T2:ERG assay using urine specimens that were collected after digital rectal examination from 471 men who were scheduled for prostate cancer biopsy at community clinics, according to Dr. James B. Amberson.

Some 44% of patients had positive biopsies, he reported. The median age was 66 years in the patients with cancer and 63 years in the patients without it. The median serum PSA level was 5.0 and 4.3 ng/mL, respectively.

When used alone, the T2:ERG score had a high specificity (87%) for detection of biopsy-proven cancer, reported Dr. Amberson, divisional medical director of Dianon Systems Inc., the manufacturer of another test that was also used in the study. Sensitivity was 39%.

The median T2:ERG score was higher in patients who had a Gleason score of 7 or greater, involvement of more than 50% of positive cores by cancer, and three or more positive cores.

“The T2:ERG assay significantly improved the diagnostic accuracy of a logistic regression model” for prostate cancer detection, said Dr. Amberson.

Dr. Wei and Dr. Amberson reported receiving research funding from Gen-Probe Inc. Some coauthors of both studies disclosed employment or leadership roles and stock ownership in Gen-Probe.