Damian McNamara

BOCA RATON, FLA. – Clinicians treating alcohol abuse or depression could improve outcomes by adopting a strategy gaining popularity among psychiatry researchers, according to several presentations at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

With “adaptive design,” patients agree to begin a particular treatment with preset time points for gauging response or remission.

This “operationalization” of clinical trials has increased enrollment, improved patient engagement in their treatment, and allowed researchers to switch more patients to a better outcome by study end, Dr. David W. Oslin said.

A protocol that dictates initial treatment duration and when to switch patients to a different treatment removes some clinician judgment. This may make some physicians uncomfortable at first, said Dr. Oslin, Hazelden Research Co-Chair in late life addiction at the University of Pennsylvania, Philadelphia.

For example, Dr. Oslin and his associates are using adaptive design for a trial of naltrexone for alcohol abuse. “We chose 8 weeks. Patients had to make it to 8 weeks to be considered responders. This caused a considerable amount of angst.

The reason? Clinicians were not used to not making the decision of when to determine response,” according to Dr. Oslin.

“Alcoholism is the example, but you can substitute depression if you treat patients who are depressed,” Dr. Oslin said.

Adjusting treatment requires knowledge about when to change, how to define when (for a responder or nonresponder), and what to change to. “It's not trivial deciding when to give up on a particular agent,” Dr. Oslin said.

In the naltrexone study, about 40% of participants were drinking or not having a robust response in the middle of the trial. Changing their treatment resulted in about half of those in the poor outcome group switching to a good outcome by 8 weeks, Dr. Oslin said.

Responders in the naltrexone study are randomized to prescription plus telephone disease management and follow-up at 4 months, or prescription and follow-up at 4 months. Nonresponders receive combined behavioral intervention and medical management and are randomized to either naltrexone or placebo, Dr. Oslin said, “to essentially answer the question about benefits of continuing naltrexone.”

“If we adapt treatment at the point that people relapse, you retain more people and keep them longer in the program,” Dr. Oslin said.

“There may also be a spillover effect to the people who really did not engage at all or would have dropped out early.”

An unexpected finding was an increased willingness of patients to participate in the naltrexone study because of its design. Dr. Oslin said this finding makes sense.

“Most of us would be more willing to start in a program if we know treatment will be adapted depending on how we are doing, versus knowing someone is going to flip a coin and randomly assign us.”

“When we give a patient a medication or psychotherapy, we are doing an experiment. Often, we have to take a second step, third step, and fourth step,” said Dr. A. John Rush Jr., Rosewood Corporation Chair in biomedical science and Betty Jo Hay Distinguished Chair in mental health, University of Texas Southwestern Medical Center, Dallas.

With adaptive design, each treatment may inform the next step, Dr. Rush said at the meeting, which was cosponsored by the American Society for Clinical Psychopharmacology.

In addition, a treatment that appears best initially may not be the best in the long term, said Susan A. Murphy, Ph.D., who is H. Robbins Professor of statistics and senior research scientist at the Institute for Social Research at the University of Michigan, Ann Arbor.

Therefore, using adaptive design makes sense because it collects intermediate outcomes that can guide for whom each treatment works the best, Dr. Murphy added.

BOCA RATON, FLA. – Clinicians treating alcohol abuse or depression could improve outcomes by adopting a strategy gaining popularity among psychiatry researchers, according to several presentations at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

With “adaptive design,” patients agree to begin a particular treatment with preset time points for gauging response or remission.

This “operationalization” of clinical trials has increased enrollment, improved patient engagement in their treatment, and allowed researchers to switch more patients to a better outcome by study end, Dr. David W. Oslin said.

A protocol that dictates initial treatment duration and when to switch patients to a different treatment removes some clinician judgment. This may make some physicians uncomfortable at first, said Dr. Oslin, Hazelden Research Co-Chair in late life addiction at the University of Pennsylvania, Philadelphia.

For example, Dr. Oslin and his associates are using adaptive design for a trial of naltrexone for alcohol abuse. “We chose 8 weeks. Patients had to make it to 8 weeks to be considered responders. This caused a considerable amount of angst.

The reason? Clinicians were not used to not making the decision of when to determine response,” according to Dr. Oslin.

“Alcoholism is the example, but you can substitute depression if you treat patients who are depressed,” Dr. Oslin said.

Adjusting treatment requires knowledge about when to change, how to define when (for a responder or nonresponder), and what to change to. “It's not trivial deciding when to give up on a particular agent,” Dr. Oslin said.

In the naltrexone study, about 40% of participants were drinking or not having a robust response in the middle of the trial. Changing their treatment resulted in about half of those in the poor outcome group switching to a good outcome by 8 weeks, Dr. Oslin said.

Responders in the naltrexone study are randomized to prescription plus telephone disease management and follow-up at 4 months, or prescription and follow-up at 4 months. Nonresponders receive combined behavioral intervention and medical management and are randomized to either naltrexone or placebo, Dr. Oslin said, “to essentially answer the question about benefits of continuing naltrexone.”

“If we adapt treatment at the point that people relapse, you retain more people and keep them longer in the program,” Dr. Oslin said.

“There may also be a spillover effect to the people who really did not engage at all or would have dropped out early.”

An unexpected finding was an increased willingness of patients to participate in the naltrexone study because of its design. Dr. Oslin said this finding makes sense.

“Most of us would be more willing to start in a program if we know treatment will be adapted depending on how we are doing, versus knowing someone is going to flip a coin and randomly assign us.”

“When we give a patient a medication or psychotherapy, we are doing an experiment. Often, we have to take a second step, third step, and fourth step,” said Dr. A. John Rush Jr., Rosewood Corporation Chair in biomedical science and Betty Jo Hay Distinguished Chair in mental health, University of Texas Southwestern Medical Center, Dallas.

With adaptive design, each treatment may inform the next step, Dr. Rush said at the meeting, which was cosponsored by the American Society for Clinical Psychopharmacology.

In addition, a treatment that appears best initially may not be the best in the long term, said Susan A. Murphy, Ph.D., who is H. Robbins Professor of statistics and senior research scientist at the Institute for Social Research at the University of Michigan, Ann Arbor.

Therefore, using adaptive design makes sense because it collects intermediate outcomes that can guide for whom each treatment works the best, Dr. Murphy added.

BOCA RATON, FLA. – Clinicians treating alcohol abuse or depression could improve outcomes by adopting a strategy gaining popularity among psychiatry researchers, according to several presentations at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

With “adaptive design,” patients agree to begin a particular treatment with preset time points for gauging response or remission.

This “operationalization” of clinical trials has increased enrollment, improved patient engagement in their treatment, and allowed researchers to switch more patients to a better outcome by study end, Dr. David W. Oslin said.

A protocol that dictates initial treatment duration and when to switch patients to a different treatment removes some clinician judgment. This may make some physicians uncomfortable at first, said Dr. Oslin, Hazelden Research Co-Chair in late life addiction at the University of Pennsylvania, Philadelphia.

For example, Dr. Oslin and his associates are using adaptive design for a trial of naltrexone for alcohol abuse. “We chose 8 weeks. Patients had to make it to 8 weeks to be considered responders. This caused a considerable amount of angst.

The reason? Clinicians were not used to not making the decision of when to determine response,” according to Dr. Oslin.

“Alcoholism is the example, but you can substitute depression if you treat patients who are depressed,” Dr. Oslin said.

Adjusting treatment requires knowledge about when to change, how to define when (for a responder or nonresponder), and what to change to. “It's not trivial deciding when to give up on a particular agent,” Dr. Oslin said.

In the naltrexone study, about 40% of participants were drinking or not having a robust response in the middle of the trial. Changing their treatment resulted in about half of those in the poor outcome group switching to a good outcome by 8 weeks, Dr. Oslin said.

Responders in the naltrexone study are randomized to prescription plus telephone disease management and follow-up at 4 months, or prescription and follow-up at 4 months. Nonresponders receive combined behavioral intervention and medical management and are randomized to either naltrexone or placebo, Dr. Oslin said, “to essentially answer the question about benefits of continuing naltrexone.”

“If we adapt treatment at the point that people relapse, you retain more people and keep them longer in the program,” Dr. Oslin said.

“There may also be a spillover effect to the people who really did not engage at all or would have dropped out early.”

An unexpected finding was an increased willingness of patients to participate in the naltrexone study because of its design. Dr. Oslin said this finding makes sense.

“Most of us would be more willing to start in a program if we know treatment will be adapted depending on how we are doing, versus knowing someone is going to flip a coin and randomly assign us.”

“When we give a patient a medication or psychotherapy, we are doing an experiment. Often, we have to take a second step, third step, and fourth step,” said Dr. A. John Rush Jr., Rosewood Corporation Chair in biomedical science and Betty Jo Hay Distinguished Chair in mental health, University of Texas Southwestern Medical Center, Dallas.

With adaptive design, each treatment may inform the next step, Dr. Rush said at the meeting, which was cosponsored by the American Society for Clinical Psychopharmacology.

In addition, a treatment that appears best initially may not be the best in the long term, said Susan A. Murphy, Ph.D., who is H. Robbins Professor of statistics and senior research scientist at the Institute for Social Research at the University of Michigan, Ann Arbor.

Therefore, using adaptive design makes sense because it collects intermediate outcomes that can guide for whom each treatment works the best, Dr. Murphy added.

BOCA RATON, FLA. – Residual anxiety symptoms and sleep disturbances predicted recurrence of late-life depression in a study presented as a poster at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

“We know residual symptoms are important. But no study has dissected which residual symptoms are predictive of who is still depressed,” Dr. Alexandre Y. Dombrovski said.

Dr. Dombrovski and his associates assessed data for participants in a randomized, clinical trial. All patients had unipolar depression and were aged 70 years or older. A total of 116 participants were in remission, and remained stable during open pharmacotherapy and interpersonal psychotherapy. Those participants were studied further.

“We looked at core mood symptoms, sleep disturbances, and anxiety over 2 years for predictors of recurrence,” said Dr. Dombrovski of the University of Pittsburgh Medical Center's Western Psychiatric Institute and Clinic.

Recurrence was defined as a score greater than 14 on the Hamilton Depression Rating Scale (HAM-D) and meeting DSM-IV criteria for a major depressive episode.

This was a secondary analysis of a depression maintenance study that compared clinical management with monthly maintenance interpersonal psychotherapy, and paroxetine (Paxil) pharmacotherapy with placebo, he said.

Depressed mood, guilt, suicidality, energy/interests were the core mood symptoms rated with the HAM-D. Also, researchers used the HAM-D to assess early, middle, and/or late insomnia, as well as anxiety symptoms (agitation, psychic and somatic anxiety, hypochondriasis). The Pittsburgh Sleep Quality Index (PSQI) was used to gauge sleep quality.

“We found in these patients that persisting anxiety symptoms predicted early return of depression,” Dr. Dombrovski said.

Total burden of residual anxiety symptoms was the strongest predictor of depression recurrence, nearly doubling the risk, compared with nonanxious participants. “This confirmed our hypothesis and our earlier study,” he said (Am. J. Geriatr. Psychiatry 2006;14:550–4).

Sleep disturbance also was predictive, but only on the PSQI and not the HAM-D measure, univariate analyses showed. In a multiple Cox regression model that controlled for patient assignment to either paroxetine or placebo, HAM-D residual anxiety and PSQI residual sleep disturbance remained significant predictors, Dr. Dombrovski said.

He said that for patients with late-life depression, physicians should identify the subgroup with enduring anxiety, because it is a marker for risk of recurrence. The study was funded by the National Institutes of Health and the John H. Hartford Foundation. The meeting was sponsored by the American Society for Clinical Psychopharmacology.

BOCA RATON, FLA. – Residual anxiety symptoms and sleep disturbances predicted recurrence of late-life depression in a study presented as a poster at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

“We know residual symptoms are important. But no study has dissected which residual symptoms are predictive of who is still depressed,” Dr. Alexandre Y. Dombrovski said.

Dr. Dombrovski and his associates assessed data for participants in a randomized, clinical trial. All patients had unipolar depression and were aged 70 years or older. A total of 116 participants were in remission, and remained stable during open pharmacotherapy and interpersonal psychotherapy. Those participants were studied further.

“We looked at core mood symptoms, sleep disturbances, and anxiety over 2 years for predictors of recurrence,” said Dr. Dombrovski of the University of Pittsburgh Medical Center's Western Psychiatric Institute and Clinic.

Recurrence was defined as a score greater than 14 on the Hamilton Depression Rating Scale (HAM-D) and meeting DSM-IV criteria for a major depressive episode.

This was a secondary analysis of a depression maintenance study that compared clinical management with monthly maintenance interpersonal psychotherapy, and paroxetine (Paxil) pharmacotherapy with placebo, he said.

Depressed mood, guilt, suicidality, energy/interests were the core mood symptoms rated with the HAM-D. Also, researchers used the HAM-D to assess early, middle, and/or late insomnia, as well as anxiety symptoms (agitation, psychic and somatic anxiety, hypochondriasis). The Pittsburgh Sleep Quality Index (PSQI) was used to gauge sleep quality.

“We found in these patients that persisting anxiety symptoms predicted early return of depression,” Dr. Dombrovski said.

Total burden of residual anxiety symptoms was the strongest predictor of depression recurrence, nearly doubling the risk, compared with nonanxious participants. “This confirmed our hypothesis and our earlier study,” he said (Am. J. Geriatr. Psychiatry 2006;14:550–4).

Sleep disturbance also was predictive, but only on the PSQI and not the HAM-D measure, univariate analyses showed. In a multiple Cox regression model that controlled for patient assignment to either paroxetine or placebo, HAM-D residual anxiety and PSQI residual sleep disturbance remained significant predictors, Dr. Dombrovski said.

He said that for patients with late-life depression, physicians should identify the subgroup with enduring anxiety, because it is a marker for risk of recurrence. The study was funded by the National Institutes of Health and the John H. Hartford Foundation. The meeting was sponsored by the American Society for Clinical Psychopharmacology.

BOCA RATON, FLA. – Residual anxiety symptoms and sleep disturbances predicted recurrence of late-life depression in a study presented as a poster at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

“We know residual symptoms are important. But no study has dissected which residual symptoms are predictive of who is still depressed,” Dr. Alexandre Y. Dombrovski said.

Dr. Dombrovski and his associates assessed data for participants in a randomized, clinical trial. All patients had unipolar depression and were aged 70 years or older. A total of 116 participants were in remission, and remained stable during open pharmacotherapy and interpersonal psychotherapy. Those participants were studied further.

“We looked at core mood symptoms, sleep disturbances, and anxiety over 2 years for predictors of recurrence,” said Dr. Dombrovski of the University of Pittsburgh Medical Center's Western Psychiatric Institute and Clinic.

Recurrence was defined as a score greater than 14 on the Hamilton Depression Rating Scale (HAM-D) and meeting DSM-IV criteria for a major depressive episode.

This was a secondary analysis of a depression maintenance study that compared clinical management with monthly maintenance interpersonal psychotherapy, and paroxetine (Paxil) pharmacotherapy with placebo, he said.

Depressed mood, guilt, suicidality, energy/interests were the core mood symptoms rated with the HAM-D. Also, researchers used the HAM-D to assess early, middle, and/or late insomnia, as well as anxiety symptoms (agitation, psychic and somatic anxiety, hypochondriasis). The Pittsburgh Sleep Quality Index (PSQI) was used to gauge sleep quality.

“We found in these patients that persisting anxiety symptoms predicted early return of depression,” Dr. Dombrovski said.

Total burden of residual anxiety symptoms was the strongest predictor of depression recurrence, nearly doubling the risk, compared with nonanxious participants. “This confirmed our hypothesis and our earlier study,” he said (Am. J. Geriatr. Psychiatry 2006;14:550–4).

Sleep disturbance also was predictive, but only on the PSQI and not the HAM-D measure, univariate analyses showed. In a multiple Cox regression model that controlled for patient assignment to either paroxetine or placebo, HAM-D residual anxiety and PSQI residual sleep disturbance remained significant predictors, Dr. Dombrovski said.

He said that for patients with late-life depression, physicians should identify the subgroup with enduring anxiety, because it is a marker for risk of recurrence. The study was funded by the National Institutes of Health and the John H. Hartford Foundation. The meeting was sponsored by the American Society for Clinical Psychopharmacology.

MIAMI – A cognitive-behavioral therapy program designed for children aged 4–7 years significantly improves anxiety symptoms over 6 months, according to a randomized, controlled trial.

Many pediatric cognitive-behavioral therapy (CBT) programs are geared toward older children and teenagers. The typical age range is between 8 and 14 years, for example.

“But anxiety disorders have an earlier onset than age 8,” Dina R. Hirshfeld-Becker, Ph.D., said in an interview at her poster at the annual conference of the Anxiety Disorders Association of America.

“People thought for a while that CBT was not suitable for younger children. They thought kids did not have enough perception into their cognition and would not be compliant enough with their homework,” said Dr. Hirshfeld-Becker, who serves as director of anxiety research in the pediatric psychopharmacology program at Massachusetts General Hospital, Boston.

However, the findings of this study counter that perception. Dr. Hirshfeld-Becker and her associates assessed 65 children. All but one had a DSM-IV anxiety disorder; the other child was at high risk for anxiety.

A total of 71% had multiple anxiety diagnoses. More than half of the children had a parent with an anxiety disorder, and 20% had comorbid oppositional defiant disorder.

Mean age was 5 years, 54% were female, 80% were white, and 88% came from intact families.

The researchers randomized 35 participants to CBT treatment–up to 20 sessions over 6 months–and an additional 30 to a monitoring-only group as a control.

The CBT protocol is called “Being Brave: A Program for Coping With Anxiety,” adapted from the Coping Cat program for children aged 8–13 years developed by Philip C. Kendall, Ph.D., at Temple University in Philadelphia.

The first six sessions are a parent-only module, during which time parents learn anxiety management and how to coach their children to cope in feared situations. A child-parent module for an additional 8–13 sessions incorporates effective techniques for preschoolers with phobia analogs, in vivo exposure, modeling, and reinforced practice. A final session for parents is designed to maintain gains and continue progress.

“We teach relaxation exercises and coping self-statements like, 'I'm a brave boy,' and that can help,” Dr. Hirshfeld-Becker said.

All attempts at success are rewarded, for example, with stickers or extra time with the parent. “We do graded exposure therapy, but we make it fun.”

A total of 58 children completed the study. At 6 months, a blinded clinician rated 70% of the 30 CBT completers as having much or maximal improvement on global ratings of improvement for anxiety compared with 32% of the 28 control group completers.

An intent-to-treat analysis yielded similar findings: 60% achievement with CBT, vs. 30% for controls.

“I was happy the improvement rates they showed were comparable to CBT protocols in older kids,” Dr. Hirshfeld-Becker said.

Initially, parents expressed concern with the graded exposure component of CBT, Dr. Hirshfeld-Becker said. “Parents might expect the kid is going to suffer, but they come to respect their children when they show resiliency.”

The CBT protocol helped parents as well, Dr. Hirshfeld-Becker added. “I was surprised the parents tended to benefit as well as the child.”

ELSEVIER GLOBAL MEDICAL NEWS

MIAMI – A cognitive-behavioral therapy program designed for children aged 4–7 years significantly improves anxiety symptoms over 6 months, according to a randomized, controlled trial.

Many pediatric cognitive-behavioral therapy (CBT) programs are geared toward older children and teenagers. The typical age range is between 8 and 14 years, for example.

“But anxiety disorders have an earlier onset than age 8,” Dina R. Hirshfeld-Becker, Ph.D., said in an interview at her poster at the annual conference of the Anxiety Disorders Association of America.

“People thought for a while that CBT was not suitable for younger children. They thought kids did not have enough perception into their cognition and would not be compliant enough with their homework,” said Dr. Hirshfeld-Becker, who serves as director of anxiety research in the pediatric psychopharmacology program at Massachusetts General Hospital, Boston.

However, the findings of this study counter that perception. Dr. Hirshfeld-Becker and her associates assessed 65 children. All but one had a DSM-IV anxiety disorder; the other child was at high risk for anxiety.

A total of 71% had multiple anxiety diagnoses. More than half of the children had a parent with an anxiety disorder, and 20% had comorbid oppositional defiant disorder.

Mean age was 5 years, 54% were female, 80% were white, and 88% came from intact families.

The researchers randomized 35 participants to CBT treatment–up to 20 sessions over 6 months–and an additional 30 to a monitoring-only group as a control.

The CBT protocol is called “Being Brave: A Program for Coping With Anxiety,” adapted from the Coping Cat program for children aged 8–13 years developed by Philip C. Kendall, Ph.D., at Temple University in Philadelphia.

The first six sessions are a parent-only module, during which time parents learn anxiety management and how to coach their children to cope in feared situations. A child-parent module for an additional 8–13 sessions incorporates effective techniques for preschoolers with phobia analogs, in vivo exposure, modeling, and reinforced practice. A final session for parents is designed to maintain gains and continue progress.

“We teach relaxation exercises and coping self-statements like, 'I'm a brave boy,' and that can help,” Dr. Hirshfeld-Becker said.

All attempts at success are rewarded, for example, with stickers or extra time with the parent. “We do graded exposure therapy, but we make it fun.”

A total of 58 children completed the study. At 6 months, a blinded clinician rated 70% of the 30 CBT completers as having much or maximal improvement on global ratings of improvement for anxiety compared with 32% of the 28 control group completers.

An intent-to-treat analysis yielded similar findings: 60% achievement with CBT, vs. 30% for controls.

“I was happy the improvement rates they showed were comparable to CBT protocols in older kids,” Dr. Hirshfeld-Becker said.

Initially, parents expressed concern with the graded exposure component of CBT, Dr. Hirshfeld-Becker said. “Parents might expect the kid is going to suffer, but they come to respect their children when they show resiliency.”

The CBT protocol helped parents as well, Dr. Hirshfeld-Becker added. “I was surprised the parents tended to benefit as well as the child.”

ELSEVIER GLOBAL MEDICAL NEWS

MIAMI – A cognitive-behavioral therapy program designed for children aged 4–7 years significantly improves anxiety symptoms over 6 months, according to a randomized, controlled trial.

Many pediatric cognitive-behavioral therapy (CBT) programs are geared toward older children and teenagers. The typical age range is between 8 and 14 years, for example.

“But anxiety disorders have an earlier onset than age 8,” Dina R. Hirshfeld-Becker, Ph.D., said in an interview at her poster at the annual conference of the Anxiety Disorders Association of America.

“People thought for a while that CBT was not suitable for younger children. They thought kids did not have enough perception into their cognition and would not be compliant enough with their homework,” said Dr. Hirshfeld-Becker, who serves as director of anxiety research in the pediatric psychopharmacology program at Massachusetts General Hospital, Boston.

However, the findings of this study counter that perception. Dr. Hirshfeld-Becker and her associates assessed 65 children. All but one had a DSM-IV anxiety disorder; the other child was at high risk for anxiety.

A total of 71% had multiple anxiety diagnoses. More than half of the children had a parent with an anxiety disorder, and 20% had comorbid oppositional defiant disorder.

Mean age was 5 years, 54% were female, 80% were white, and 88% came from intact families.

The researchers randomized 35 participants to CBT treatment–up to 20 sessions over 6 months–and an additional 30 to a monitoring-only group as a control.

The CBT protocol is called “Being Brave: A Program for Coping With Anxiety,” adapted from the Coping Cat program for children aged 8–13 years developed by Philip C. Kendall, Ph.D., at Temple University in Philadelphia.

The first six sessions are a parent-only module, during which time parents learn anxiety management and how to coach their children to cope in feared situations. A child-parent module for an additional 8–13 sessions incorporates effective techniques for preschoolers with phobia analogs, in vivo exposure, modeling, and reinforced practice. A final session for parents is designed to maintain gains and continue progress.

“We teach relaxation exercises and coping self-statements like, 'I'm a brave boy,' and that can help,” Dr. Hirshfeld-Becker said.

All attempts at success are rewarded, for example, with stickers or extra time with the parent. “We do graded exposure therapy, but we make it fun.”

A total of 58 children completed the study. At 6 months, a blinded clinician rated 70% of the 30 CBT completers as having much or maximal improvement on global ratings of improvement for anxiety compared with 32% of the 28 control group completers.

An intent-to-treat analysis yielded similar findings: 60% achievement with CBT, vs. 30% for controls.

“I was happy the improvement rates they showed were comparable to CBT protocols in older kids,” Dr. Hirshfeld-Becker said.

Initially, parents expressed concern with the graded exposure component of CBT, Dr. Hirshfeld-Becker said. “Parents might expect the kid is going to suffer, but they come to respect their children when they show resiliency.”

The CBT protocol helped parents as well, Dr. Hirshfeld-Becker added. “I was surprised the parents tended to benefit as well as the child.”

ELSEVIER GLOBAL MEDICAL NEWS

MIAMI – Clinicians can help children and adolescents with cognitive, physical, and behavioral symptoms of anxiety through cognitive-behavioral therapy. However, readiness for treatment must first be established, according to a presentation at the annual conference of the Anxiety Disorders Association of America.

“The better you can get a child to understand some of the concepts behind the treatment, the more they will be engaged,” said Aureen Pinto Wagner, Ph.D., a child psychologist at the department of neurology at the University of Rochester (N.Y.).

Readiness for treatment is a key to success with cognitive-behavioral therapy (CBT), Dr. Pinto Wagner said. Do not confuse readiness with motivation, however. “Everyone at some level is motivated. Readiness is the ability to channel that desire to get well into the action to get well,” Dr. Pinto Wagner said.

CBT, particularly the exposure therapy component, may seem counterintuitive to patients with anxiety and to their parents. So educate patients and families about how CBT works, and the reasons why testing the reality of fears by facing them can be beneficial, Dr. Pinto Wagner suggested. “When children understand the concepts, there is an 'Aha' moment.”

Assure anxious children that they will not be forced to do anything they don't want to do, Dr. Pinto Wagner suggested. Instead, clinicians should tell the patient that they will act as a guide.

Sometimes children still do not engage. A bit of role reversal might help, Dr. Pinto Wagner said. For example, she consulted with a child who was fearful of vampires. She assured him that vampires are not real, but the child said everyone told him that, and it did not help. “I told him that I was afraid of roller coasters. I asked him how to get over my fear,” she said. “He told me to go ride them. I said no, I was afraid of falling out. He suggested that I ride the kiddy coaster … I said: 'Aha, you've helped me with my fear; now let's work on yours.'”

A person attending the meeting asked what to do about a pediatric patient who remains recalcitrant. “I ask them if they want to participate in the treatment. I tell them to go home and think about it, and to let me know,” Dr. Pinto Wagner said. “In some ways I give up the control, but then 95% of the time kids will come back and say they want to do it.”

The goal with CBT is to change or modify the anxiety triad of thoughts, physical arousal, and behaviors. An overestimation of danger, expectation of the worst outcome, and a “sense of uncontrollability” are common cognitions. A pounding heart, sweating, tension, disturbed sleep, and hypervigilance are physical symptoms. Safety checks, reassurance-seeking, escape, and avoidance are common behaviors.

“CBT teaches children that they can take back control of how they think and how they feel,” Dr. Pinto Wagner said.

Realistic thinking, self-instruction training, and problem-solving strategies can help alleviate anxious thoughts, Dr. Pinto Wagner said.

Socratic thinking is one approach. The clinician asks systematic questions to guide the child to arrive at a desired conclusion on his own. For example, ask a child what she would first think about if she heard a noise at the window. Eight out of 10 children would say a burglar, she said. Then ask them what else it could be–could it be a tree rubbing against the window? “The point is, it's the same noise at the window, and depending on how they think of it, they will feel differently.”

Mathematics and probability can help some children. “Kids like to use math to get perspective on their fear,” Dr. Pinto Wagner said.

She cited the example of a girl with school refusal. When asked why she did not want to go to school, she might reply that she does not want to be away from her mother. The clinician might ask about her specific fears. She states she is afraid her mother will get into a car accident while driving her to or from school. Then ask how many times her mom has driven to school. Do the math together to figure out how many days over how many years, Dr. Pinto Wagner advised. Then ask how many accidents she has had during that time to demonstrate how low the probability is.

“Acknowledge that bad things do happen, but they happen rarely, compared to the level of their fear,” Dr. Pinto Wagner said.

Less mature children may not be able to engage in Socratic thinking, however. “For younger children, we use self-instruction training,” Dr. Pinto Wagner said. Self-instruction teaches a child to recognize anxious self-talk and replace it with calming thoughts.

Another tactic is to invoke support from a favorite superhero. Ask the child: “What would Michael Jordan say to you? What would Kim Possible do in this situation?”

Relaxation and interoceptive exposure are CBT techniques that can allay physical symptoms of anxiety. “Relaxation training is the most common approach in kids but also the least effective,” Dr. Pinto Wagner said. “Some kids might need it when they are very worked up, but in general this only works with mild anxiety in kids who get anxious occasionally. I use it in about 10% of the kids I work with.”

Exposure is the most potent technique for overcoming anxious behaviors, Dr. Pinto Wagner said. “I tell patients [that] to overcome your fear, you must face your fear. Do the things you are afraid to do, and stop the avoidance and escape.” From exposure, patients habituate and get to test the reality of their fear. “Because 99.9% of it does not come true, it gives them an ability to invalidate their fear,” she added.

Rather than use a flooding approach, take little steps toward gradual exposure in children, Dr. Pinto Wagner advised. “It's more natural and less frightening for kids. Start with almost ridiculously easy things. Experience easy success and build confidence. If you go too far, the child gets scared, and you have to backtrack.”

Any child can relate to the metaphor of riding a bicycle, Dr. Pinto Wagner said. “I tell children [that] facing their anxiety is like riding up a big hill. You may want to quit and go back down, which is escape and avoidance. But if you keep going, you will get to the peak of your anxiety and then you will be able to coast downhill on the other side.”

MIAMI – Clinicians can help children and adolescents with cognitive, physical, and behavioral symptoms of anxiety through cognitive-behavioral therapy. However, readiness for treatment must first be established, according to a presentation at the annual conference of the Anxiety Disorders Association of America.

“The better you can get a child to understand some of the concepts behind the treatment, the more they will be engaged,” said Aureen Pinto Wagner, Ph.D., a child psychologist at the department of neurology at the University of Rochester (N.Y.).

Readiness for treatment is a key to success with cognitive-behavioral therapy (CBT), Dr. Pinto Wagner said. Do not confuse readiness with motivation, however. “Everyone at some level is motivated. Readiness is the ability to channel that desire to get well into the action to get well,” Dr. Pinto Wagner said.

CBT, particularly the exposure therapy component, may seem counterintuitive to patients with anxiety and to their parents. So educate patients and families about how CBT works, and the reasons why testing the reality of fears by facing them can be beneficial, Dr. Pinto Wagner suggested. “When children understand the concepts, there is an 'Aha' moment.”

Assure anxious children that they will not be forced to do anything they don't want to do, Dr. Pinto Wagner suggested. Instead, clinicians should tell the patient that they will act as a guide.

Sometimes children still do not engage. A bit of role reversal might help, Dr. Pinto Wagner said. For example, she consulted with a child who was fearful of vampires. She assured him that vampires are not real, but the child said everyone told him that, and it did not help. “I told him that I was afraid of roller coasters. I asked him how to get over my fear,” she said. “He told me to go ride them. I said no, I was afraid of falling out. He suggested that I ride the kiddy coaster … I said: 'Aha, you've helped me with my fear; now let's work on yours.'”

A person attending the meeting asked what to do about a pediatric patient who remains recalcitrant. “I ask them if they want to participate in the treatment. I tell them to go home and think about it, and to let me know,” Dr. Pinto Wagner said. “In some ways I give up the control, but then 95% of the time kids will come back and say they want to do it.”

The goal with CBT is to change or modify the anxiety triad of thoughts, physical arousal, and behaviors. An overestimation of danger, expectation of the worst outcome, and a “sense of uncontrollability” are common cognitions. A pounding heart, sweating, tension, disturbed sleep, and hypervigilance are physical symptoms. Safety checks, reassurance-seeking, escape, and avoidance are common behaviors.

“CBT teaches children that they can take back control of how they think and how they feel,” Dr. Pinto Wagner said.

Realistic thinking, self-instruction training, and problem-solving strategies can help alleviate anxious thoughts, Dr. Pinto Wagner said.

Socratic thinking is one approach. The clinician asks systematic questions to guide the child to arrive at a desired conclusion on his own. For example, ask a child what she would first think about if she heard a noise at the window. Eight out of 10 children would say a burglar, she said. Then ask them what else it could be–could it be a tree rubbing against the window? “The point is, it's the same noise at the window, and depending on how they think of it, they will feel differently.”

Mathematics and probability can help some children. “Kids like to use math to get perspective on their fear,” Dr. Pinto Wagner said.

She cited the example of a girl with school refusal. When asked why she did not want to go to school, she might reply that she does not want to be away from her mother. The clinician might ask about her specific fears. She states she is afraid her mother will get into a car accident while driving her to or from school. Then ask how many times her mom has driven to school. Do the math together to figure out how many days over how many years, Dr. Pinto Wagner advised. Then ask how many accidents she has had during that time to demonstrate how low the probability is.

“Acknowledge that bad things do happen, but they happen rarely, compared to the level of their fear,” Dr. Pinto Wagner said.

Less mature children may not be able to engage in Socratic thinking, however. “For younger children, we use self-instruction training,” Dr. Pinto Wagner said. Self-instruction teaches a child to recognize anxious self-talk and replace it with calming thoughts.

Another tactic is to invoke support from a favorite superhero. Ask the child: “What would Michael Jordan say to you? What would Kim Possible do in this situation?”

Relaxation and interoceptive exposure are CBT techniques that can allay physical symptoms of anxiety. “Relaxation training is the most common approach in kids but also the least effective,” Dr. Pinto Wagner said. “Some kids might need it when they are very worked up, but in general this only works with mild anxiety in kids who get anxious occasionally. I use it in about 10% of the kids I work with.”

Exposure is the most potent technique for overcoming anxious behaviors, Dr. Pinto Wagner said. “I tell patients [that] to overcome your fear, you must face your fear. Do the things you are afraid to do, and stop the avoidance and escape.” From exposure, patients habituate and get to test the reality of their fear. “Because 99.9% of it does not come true, it gives them an ability to invalidate their fear,” she added.

Rather than use a flooding approach, take little steps toward gradual exposure in children, Dr. Pinto Wagner advised. “It's more natural and less frightening for kids. Start with almost ridiculously easy things. Experience easy success and build confidence. If you go too far, the child gets scared, and you have to backtrack.”

Any child can relate to the metaphor of riding a bicycle, Dr. Pinto Wagner said. “I tell children [that] facing their anxiety is like riding up a big hill. You may want to quit and go back down, which is escape and avoidance. But if you keep going, you will get to the peak of your anxiety and then you will be able to coast downhill on the other side.”

MIAMI – Clinicians can help children and adolescents with cognitive, physical, and behavioral symptoms of anxiety through cognitive-behavioral therapy. However, readiness for treatment must first be established, according to a presentation at the annual conference of the Anxiety Disorders Association of America.

“The better you can get a child to understand some of the concepts behind the treatment, the more they will be engaged,” said Aureen Pinto Wagner, Ph.D., a child psychologist at the department of neurology at the University of Rochester (N.Y.).

Readiness for treatment is a key to success with cognitive-behavioral therapy (CBT), Dr. Pinto Wagner said. Do not confuse readiness with motivation, however. “Everyone at some level is motivated. Readiness is the ability to channel that desire to get well into the action to get well,” Dr. Pinto Wagner said.

CBT, particularly the exposure therapy component, may seem counterintuitive to patients with anxiety and to their parents. So educate patients and families about how CBT works, and the reasons why testing the reality of fears by facing them can be beneficial, Dr. Pinto Wagner suggested. “When children understand the concepts, there is an 'Aha' moment.”

Assure anxious children that they will not be forced to do anything they don't want to do, Dr. Pinto Wagner suggested. Instead, clinicians should tell the patient that they will act as a guide.

Sometimes children still do not engage. A bit of role reversal might help, Dr. Pinto Wagner said. For example, she consulted with a child who was fearful of vampires. She assured him that vampires are not real, but the child said everyone told him that, and it did not help. “I told him that I was afraid of roller coasters. I asked him how to get over my fear,” she said. “He told me to go ride them. I said no, I was afraid of falling out. He suggested that I ride the kiddy coaster … I said: 'Aha, you've helped me with my fear; now let's work on yours.'”

A person attending the meeting asked what to do about a pediatric patient who remains recalcitrant. “I ask them if they want to participate in the treatment. I tell them to go home and think about it, and to let me know,” Dr. Pinto Wagner said. “In some ways I give up the control, but then 95% of the time kids will come back and say they want to do it.”

The goal with CBT is to change or modify the anxiety triad of thoughts, physical arousal, and behaviors. An overestimation of danger, expectation of the worst outcome, and a “sense of uncontrollability” are common cognitions. A pounding heart, sweating, tension, disturbed sleep, and hypervigilance are physical symptoms. Safety checks, reassurance-seeking, escape, and avoidance are common behaviors.

“CBT teaches children that they can take back control of how they think and how they feel,” Dr. Pinto Wagner said.

Realistic thinking, self-instruction training, and problem-solving strategies can help alleviate anxious thoughts, Dr. Pinto Wagner said.

Socratic thinking is one approach. The clinician asks systematic questions to guide the child to arrive at a desired conclusion on his own. For example, ask a child what she would first think about if she heard a noise at the window. Eight out of 10 children would say a burglar, she said. Then ask them what else it could be–could it be a tree rubbing against the window? “The point is, it's the same noise at the window, and depending on how they think of it, they will feel differently.”

Mathematics and probability can help some children. “Kids like to use math to get perspective on their fear,” Dr. Pinto Wagner said.

She cited the example of a girl with school refusal. When asked why she did not want to go to school, she might reply that she does not want to be away from her mother. The clinician might ask about her specific fears. She states she is afraid her mother will get into a car accident while driving her to or from school. Then ask how many times her mom has driven to school. Do the math together to figure out how many days over how many years, Dr. Pinto Wagner advised. Then ask how many accidents she has had during that time to demonstrate how low the probability is.

“Acknowledge that bad things do happen, but they happen rarely, compared to the level of their fear,” Dr. Pinto Wagner said.

Less mature children may not be able to engage in Socratic thinking, however. “For younger children, we use self-instruction training,” Dr. Pinto Wagner said. Self-instruction teaches a child to recognize anxious self-talk and replace it with calming thoughts.

Another tactic is to invoke support from a favorite superhero. Ask the child: “What would Michael Jordan say to you? What would Kim Possible do in this situation?”

Relaxation and interoceptive exposure are CBT techniques that can allay physical symptoms of anxiety. “Relaxation training is the most common approach in kids but also the least effective,” Dr. Pinto Wagner said. “Some kids might need it when they are very worked up, but in general this only works with mild anxiety in kids who get anxious occasionally. I use it in about 10% of the kids I work with.”

Exposure is the most potent technique for overcoming anxious behaviors, Dr. Pinto Wagner said. “I tell patients [that] to overcome your fear, you must face your fear. Do the things you are afraid to do, and stop the avoidance and escape.” From exposure, patients habituate and get to test the reality of their fear. “Because 99.9% of it does not come true, it gives them an ability to invalidate their fear,” she added.

Rather than use a flooding approach, take little steps toward gradual exposure in children, Dr. Pinto Wagner advised. “It's more natural and less frightening for kids. Start with almost ridiculously easy things. Experience easy success and build confidence. If you go too far, the child gets scared, and you have to backtrack.”

Any child can relate to the metaphor of riding a bicycle, Dr. Pinto Wagner said. “I tell children [that] facing their anxiety is like riding up a big hill. You may want to quit and go back down, which is escape and avoidance. But if you keep going, you will get to the peak of your anxiety and then you will be able to coast downhill on the other side.”

MIAMI — Private insurers are likely to follow the Centers for Medicare and Medicaid Services in a move to expand coverage for cardiac rehabilitation services, according to a presentation at the annual meeting of the American Medical Society for Sports Medicine.

“In March 2006, Medicare made a big shift for cardiac rehab,” the first major coverage change in decades, Steven Keteyian, Ph.D., said. Since the 1980s, Medicare has covered cardiac rehabilitation for patients following a heart attack, coronary artery bypass surgery, or angina.

The expanded coverage includes heart valve repair or replacement, percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting, and heart or combined heart-lung transplantation. These CMS changes are important because private insurers usually follow suit.

“Missing for me is the heart failure patient,” said Dr. Keteyian, program director of Preventive Cardiology at Henry Ford Hospital in Detroit. Data are insufficient regarding benefits of rehabilitation in patients with heart failure, although current studies might provide some answers.

Previously, CMS reimbursed only the exercise component of cardiac rehabilitation. Now coverage includes medical evaluation, risk factor modification, exercise, and education.

Historically, rehabilitation was limited to 36 visits in 12 weeks. Now physicians have up to 18 weeks to complete the same number of visits, Dr. Keteyian said. “This will give us a lot of flexibility in how we manage these patients.” In addition, following a review and approval, rehabilitation can be extended to 72 visits over 36 weeks.

ECG rhythm strips were mandatory for reimbursement prior to the policy change. Now the need for such monitoring is at the discretion of the physician.

Previously, requirements for physician supervision were unclear, Dr. Keteyian said. CMS only stipulated that physicians were proximal to the exercise area. More specific requirements now state that physicians should be on the premise or within 250 yards if the area is in a separate building on the hospital campus. They must be immediately available if the rehabilitation unit is freestanding, Dr. Keteyian said.

CMS had proposed identifying the “incident to” physician as the ordering physician only. However, the agency decided it would not be appropriate to have “incident to” rules specific for cardiac rehabilitation. The “incident to” physician can therefore be the ordering physician, a primary care physician, or a program medical director.

Not all patients will take advantage of the added coverage, Dr. Keteyian said. “We are doing an okay job with discharge recommendations—54% to 74% recommend cardiac rehab.” However, actual utilization is in the “25% to 40% range,” possibly because of insurance, social issues, or because of transportation concerns.

MIAMI — Private insurers are likely to follow the Centers for Medicare and Medicaid Services in a move to expand coverage for cardiac rehabilitation services, according to a presentation at the annual meeting of the American Medical Society for Sports Medicine.

“In March 2006, Medicare made a big shift for cardiac rehab,” the first major coverage change in decades, Steven Keteyian, Ph.D., said. Since the 1980s, Medicare has covered cardiac rehabilitation for patients following a heart attack, coronary artery bypass surgery, or angina.

The expanded coverage includes heart valve repair or replacement, percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting, and heart or combined heart-lung transplantation. These CMS changes are important because private insurers usually follow suit.

“Missing for me is the heart failure patient,” said Dr. Keteyian, program director of Preventive Cardiology at Henry Ford Hospital in Detroit. Data are insufficient regarding benefits of rehabilitation in patients with heart failure, although current studies might provide some answers.

Previously, CMS reimbursed only the exercise component of cardiac rehabilitation. Now coverage includes medical evaluation, risk factor modification, exercise, and education.

Historically, rehabilitation was limited to 36 visits in 12 weeks. Now physicians have up to 18 weeks to complete the same number of visits, Dr. Keteyian said. “This will give us a lot of flexibility in how we manage these patients.” In addition, following a review and approval, rehabilitation can be extended to 72 visits over 36 weeks.

ECG rhythm strips were mandatory for reimbursement prior to the policy change. Now the need for such monitoring is at the discretion of the physician.

Previously, requirements for physician supervision were unclear, Dr. Keteyian said. CMS only stipulated that physicians were proximal to the exercise area. More specific requirements now state that physicians should be on the premise or within 250 yards if the area is in a separate building on the hospital campus. They must be immediately available if the rehabilitation unit is freestanding, Dr. Keteyian said.

CMS had proposed identifying the “incident to” physician as the ordering physician only. However, the agency decided it would not be appropriate to have “incident to” rules specific for cardiac rehabilitation. The “incident to” physician can therefore be the ordering physician, a primary care physician, or a program medical director.

Not all patients will take advantage of the added coverage, Dr. Keteyian said. “We are doing an okay job with discharge recommendations—54% to 74% recommend cardiac rehab.” However, actual utilization is in the “25% to 40% range,” possibly because of insurance, social issues, or because of transportation concerns.

MIAMI — Private insurers are likely to follow the Centers for Medicare and Medicaid Services in a move to expand coverage for cardiac rehabilitation services, according to a presentation at the annual meeting of the American Medical Society for Sports Medicine.

“In March 2006, Medicare made a big shift for cardiac rehab,” the first major coverage change in decades, Steven Keteyian, Ph.D., said. Since the 1980s, Medicare has covered cardiac rehabilitation for patients following a heart attack, coronary artery bypass surgery, or angina.

The expanded coverage includes heart valve repair or replacement, percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting, and heart or combined heart-lung transplantation. These CMS changes are important because private insurers usually follow suit.

“Missing for me is the heart failure patient,” said Dr. Keteyian, program director of Preventive Cardiology at Henry Ford Hospital in Detroit. Data are insufficient regarding benefits of rehabilitation in patients with heart failure, although current studies might provide some answers.

Previously, CMS reimbursed only the exercise component of cardiac rehabilitation. Now coverage includes medical evaluation, risk factor modification, exercise, and education.

Historically, rehabilitation was limited to 36 visits in 12 weeks. Now physicians have up to 18 weeks to complete the same number of visits, Dr. Keteyian said. “This will give us a lot of flexibility in how we manage these patients.” In addition, following a review and approval, rehabilitation can be extended to 72 visits over 36 weeks.

ECG rhythm strips were mandatory for reimbursement prior to the policy change. Now the need for such monitoring is at the discretion of the physician.

Previously, requirements for physician supervision were unclear, Dr. Keteyian said. CMS only stipulated that physicians were proximal to the exercise area. More specific requirements now state that physicians should be on the premise or within 250 yards if the area is in a separate building on the hospital campus. They must be immediately available if the rehabilitation unit is freestanding, Dr. Keteyian said.

CMS had proposed identifying the “incident to” physician as the ordering physician only. However, the agency decided it would not be appropriate to have “incident to” rules specific for cardiac rehabilitation. The “incident to” physician can therefore be the ordering physician, a primary care physician, or a program medical director.

Not all patients will take advantage of the added coverage, Dr. Keteyian said. “We are doing an okay job with discharge recommendations—54% to 74% recommend cardiac rehab.” However, actual utilization is in the “25% to 40% range,” possibly because of insurance, social issues, or because of transportation concerns.

JACKSONVILLE, FLA. — Financial and logistic barriers will limit the implementation and impact of human papillomavirus vaccine, Dr. Lance Rodewald said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

New vaccines incorporated into the child immunization schedule are typically adopted quickly across the nation. “For adolescents, we don't do as well,” Dr. Rodewald said. “For example, there is 74% coverage for the three shots for hepatitis B. It is better for MMR and Td [tetanus-diphtheria], but our adolescent platform is not well established now.”

To improve distribution to those at highest risk, primary care physicians and ob.gyns. will be encouraged to join the federal government's Vaccines for Children (VFC) program. VFC pays for vaccinations for certain vulnerable children through age 18 years, including those on Medicaid, Native Americans or Alaska natives, the uninsured, and those insured without a vaccine benefit.

Underinsured children are not covered by VFC, nor are they covered in most cases by a smaller federal program—Section 317—or state funding.

“HPV [human papillomavirus] vaccine is certainly going to be delivered in a two-tiered system. There is no way around it unless something changes,” said Dr. Rodewald, a pediatrician and director of the Immunization Services Division, National Immunization Program, at the Centers for Disease Control and Prevention.

Because of inadequate state and Section 317 funding, many states cannot purchase vaccine for underinsured children, resulting in the two-tiered policy.

“There is some indication the president might increase funding to include underinsured children who could get vaccinated at federal public health sites—but it's unlikely to happen this year,” he said.

Financing the HPV vaccine for women over age 18 is another challenge. “The provider may have to purchase adult vaccines up front and get reimbursed later. So there is a financial risk if the vaccine is not used,” Dr. Rodewald said.

The financial considerations are not unique to HPV prevention. Other new vaccines likely to come soon include a second-dose varicella product and protection against shingles/postherpetic neuralgia, Dr. Rodewald said. “These new vaccines are great, but they come at a cost,” he said. The cost to protect each child has grown from $45 in 1985 to $155 in 1995 to $837 in 2006.

“The U.S. immunization system is highly effective and highly successful at protecting children from vaccine-preventable diseases,” Dr. Rodewald said. “But the most important stress in the U.S. system is financing access to the many new vaccines.”

JACKSONVILLE, FLA. — Financial and logistic barriers will limit the implementation and impact of human papillomavirus vaccine, Dr. Lance Rodewald said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

New vaccines incorporated into the child immunization schedule are typically adopted quickly across the nation. “For adolescents, we don't do as well,” Dr. Rodewald said. “For example, there is 74% coverage for the three shots for hepatitis B. It is better for MMR and Td [tetanus-diphtheria], but our adolescent platform is not well established now.”

To improve distribution to those at highest risk, primary care physicians and ob.gyns. will be encouraged to join the federal government's Vaccines for Children (VFC) program. VFC pays for vaccinations for certain vulnerable children through age 18 years, including those on Medicaid, Native Americans or Alaska natives, the uninsured, and those insured without a vaccine benefit.

Underinsured children are not covered by VFC, nor are they covered in most cases by a smaller federal program—Section 317—or state funding.

“HPV [human papillomavirus] vaccine is certainly going to be delivered in a two-tiered system. There is no way around it unless something changes,” said Dr. Rodewald, a pediatrician and director of the Immunization Services Division, National Immunization Program, at the Centers for Disease Control and Prevention.

Because of inadequate state and Section 317 funding, many states cannot purchase vaccine for underinsured children, resulting in the two-tiered policy.

“There is some indication the president might increase funding to include underinsured children who could get vaccinated at federal public health sites—but it's unlikely to happen this year,” he said.

Financing the HPV vaccine for women over age 18 is another challenge. “The provider may have to purchase adult vaccines up front and get reimbursed later. So there is a financial risk if the vaccine is not used,” Dr. Rodewald said.

The financial considerations are not unique to HPV prevention. Other new vaccines likely to come soon include a second-dose varicella product and protection against shingles/postherpetic neuralgia, Dr. Rodewald said. “These new vaccines are great, but they come at a cost,” he said. The cost to protect each child has grown from $45 in 1985 to $155 in 1995 to $837 in 2006.

“The U.S. immunization system is highly effective and highly successful at protecting children from vaccine-preventable diseases,” Dr. Rodewald said. “But the most important stress in the U.S. system is financing access to the many new vaccines.”

JACKSONVILLE, FLA. — Financial and logistic barriers will limit the implementation and impact of human papillomavirus vaccine, Dr. Lance Rodewald said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

New vaccines incorporated into the child immunization schedule are typically adopted quickly across the nation. “For adolescents, we don't do as well,” Dr. Rodewald said. “For example, there is 74% coverage for the three shots for hepatitis B. It is better for MMR and Td [tetanus-diphtheria], but our adolescent platform is not well established now.”

To improve distribution to those at highest risk, primary care physicians and ob.gyns. will be encouraged to join the federal government's Vaccines for Children (VFC) program. VFC pays for vaccinations for certain vulnerable children through age 18 years, including those on Medicaid, Native Americans or Alaska natives, the uninsured, and those insured without a vaccine benefit.

Underinsured children are not covered by VFC, nor are they covered in most cases by a smaller federal program—Section 317—or state funding.

“HPV [human papillomavirus] vaccine is certainly going to be delivered in a two-tiered system. There is no way around it unless something changes,” said Dr. Rodewald, a pediatrician and director of the Immunization Services Division, National Immunization Program, at the Centers for Disease Control and Prevention.

Because of inadequate state and Section 317 funding, many states cannot purchase vaccine for underinsured children, resulting in the two-tiered policy.

“There is some indication the president might increase funding to include underinsured children who could get vaccinated at federal public health sites—but it's unlikely to happen this year,” he said.

Financing the HPV vaccine for women over age 18 is another challenge. “The provider may have to purchase adult vaccines up front and get reimbursed later. So there is a financial risk if the vaccine is not used,” Dr. Rodewald said.

The financial considerations are not unique to HPV prevention. Other new vaccines likely to come soon include a second-dose varicella product and protection against shingles/postherpetic neuralgia, Dr. Rodewald said. “These new vaccines are great, but they come at a cost,” he said. The cost to protect each child has grown from $45 in 1985 to $155 in 1995 to $837 in 2006.

“The U.S. immunization system is highly effective and highly successful at protecting children from vaccine-preventable diseases,” Dr. Rodewald said. “But the most important stress in the U.S. system is financing access to the many new vaccines.”

JACKSONVILLE, FLA. — Both vaccines to prevent human papillomavirus infection will be highly effective, Dr. Diane M. Harper predicted at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Approximately 600 women participated in efficacy studies for a quadrivalent vaccine (Gardasil, Merck), and another 1,100 participated in efficacy studies for a bivalent vaccine (Cervarix, GlaxoSmithKline). All women were screened at baseline to ensure seronegativity for high-risk strains 16 and 18 of the human papillomavirus (HPV) as well as for strains 6 and 11, which are also included in the quadrivalent product.

“The response was 100% for the bivalent and 89% for the quadrivalent for persistent, vaccine-specific HPV types for those who got the vaccine on time,” Dr. Harper said. The recommended regimen for both vaccines is a 0.5-cc injection at 0, 2, and 6 months. In the studies, 94% of participants received all three doses, although not all according to protocol. The off-schedule efficacy was 95% and 89%, respectively, but these differences were not statistically different. “It indicated these will work in a real-world setting,” she added.

Goals of vaccination include reduction of HPV transmission and anogenital lesions, “but most importantly we want to reduce incidence of cervical cancer,” said Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center, Lebanon, N.H. She added that prevention of other anogenital cancers may be a serendipitous benefit of the vaccines. The quadrivalent vaccine has been licensed, and the bivalent vaccine may be cleared for marketing by the end of this year.

Both vaccines target high-risk HPV type 16, the type primarily implicated in cervical cancer. Type 16, taken together with types 18 (also in both vaccines), 31, and 45, accounts for 81% of cervical cancers, Dr. Harper said. The bivalent vaccine, “although it was designed for 16 and 18, is just as efficacious for HPV 45 and half effective for HPV 31, so that is exciting,” said Dr. Harper, who is also a professor of community and family medicine and obstetrics and gynecology at Dartmouth Medical School, Hanover, N.H. Dr. Harper was also a consultant for Merck and GlaxoSmithKline and a researcher for the efficacy trials of each vaccine.

“These vaccines are preventive, they are not therapeutic—that is important to know,” Dr. Harper said. “These prevent possible infection by HPV. These are not vaccines that prevent cancer.” Because it is important that prevention lasts a long time, the need for a booster shot is anticipated with the bivalent vaccine 7–10 years later, Dr. Harper said. “We don't know if the quadrivalent vaccine will require a booster.”

Researchers found high antibody titers at 7 months in the study participants who received all doses by 6 months. “This is the only disease other than infant influenza where you see higher titers from the vaccine than from the disease itself,” Dr. Harper said.

Participants in the quadrivalent vaccine efficacy trials who reported prior exposure to HPV had antibody titers twice those of participants who were exposure naive. Dr. Harper said, “It's important to know that the vaccine works well in people previously exposed to HPV. It is good because women at all ages are at risk.”

Adverse effects at local injection sites, including pain, erythema, and edema, were similar for both vaccines versus placebo. Other side effects such as headaches, gastrointestinal problems, and fatigue occurred at similar, “acceptable” rates in placebo and vaccine recipients, Dr. Harper said.

Other safety concerns with vaccines include new-onset autoimmune disease and musculoskeletal problems. “We can say no in both cases,” Dr. Harper said. “So there is no concern about new-onset diseases, at least up to 4.5 years. We will continue to follow that.”

'This is the only disease other than infant influenza where you see higher titers from the vaccine than from the disease.' DR. HARPER

JACKSONVILLE, FLA. — Both vaccines to prevent human papillomavirus infection will be highly effective, Dr. Diane M. Harper predicted at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Approximately 600 women participated in efficacy studies for a quadrivalent vaccine (Gardasil, Merck), and another 1,100 participated in efficacy studies for a bivalent vaccine (Cervarix, GlaxoSmithKline). All women were screened at baseline to ensure seronegativity for high-risk strains 16 and 18 of the human papillomavirus (HPV) as well as for strains 6 and 11, which are also included in the quadrivalent product.

“The response was 100% for the bivalent and 89% for the quadrivalent for persistent, vaccine-specific HPV types for those who got the vaccine on time,” Dr. Harper said. The recommended regimen for both vaccines is a 0.5-cc injection at 0, 2, and 6 months. In the studies, 94% of participants received all three doses, although not all according to protocol. The off-schedule efficacy was 95% and 89%, respectively, but these differences were not statistically different. “It indicated these will work in a real-world setting,” she added.

Goals of vaccination include reduction of HPV transmission and anogenital lesions, “but most importantly we want to reduce incidence of cervical cancer,” said Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center, Lebanon, N.H. She added that prevention of other anogenital cancers may be a serendipitous benefit of the vaccines. The quadrivalent vaccine has been licensed, and the bivalent vaccine may be cleared for marketing by the end of this year.

Both vaccines target high-risk HPV type 16, the type primarily implicated in cervical cancer. Type 16, taken together with types 18 (also in both vaccines), 31, and 45, accounts for 81% of cervical cancers, Dr. Harper said. The bivalent vaccine, “although it was designed for 16 and 18, is just as efficacious for HPV 45 and half effective for HPV 31, so that is exciting,” said Dr. Harper, who is also a professor of community and family medicine and obstetrics and gynecology at Dartmouth Medical School, Hanover, N.H. Dr. Harper was also a consultant for Merck and GlaxoSmithKline and a researcher for the efficacy trials of each vaccine.

“These vaccines are preventive, they are not therapeutic—that is important to know,” Dr. Harper said. “These prevent possible infection by HPV. These are not vaccines that prevent cancer.” Because it is important that prevention lasts a long time, the need for a booster shot is anticipated with the bivalent vaccine 7–10 years later, Dr. Harper said. “We don't know if the quadrivalent vaccine will require a booster.”

Researchers found high antibody titers at 7 months in the study participants who received all doses by 6 months. “This is the only disease other than infant influenza where you see higher titers from the vaccine than from the disease itself,” Dr. Harper said.

Participants in the quadrivalent vaccine efficacy trials who reported prior exposure to HPV had antibody titers twice those of participants who were exposure naive. Dr. Harper said, “It's important to know that the vaccine works well in people previously exposed to HPV. It is good because women at all ages are at risk.”

Adverse effects at local injection sites, including pain, erythema, and edema, were similar for both vaccines versus placebo. Other side effects such as headaches, gastrointestinal problems, and fatigue occurred at similar, “acceptable” rates in placebo and vaccine recipients, Dr. Harper said.

Other safety concerns with vaccines include new-onset autoimmune disease and musculoskeletal problems. “We can say no in both cases,” Dr. Harper said. “So there is no concern about new-onset diseases, at least up to 4.5 years. We will continue to follow that.”

'This is the only disease other than infant influenza where you see higher titers from the vaccine than from the disease.' DR. HARPER

JACKSONVILLE, FLA. — Both vaccines to prevent human papillomavirus infection will be highly effective, Dr. Diane M. Harper predicted at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Approximately 600 women participated in efficacy studies for a quadrivalent vaccine (Gardasil, Merck), and another 1,100 participated in efficacy studies for a bivalent vaccine (Cervarix, GlaxoSmithKline). All women were screened at baseline to ensure seronegativity for high-risk strains 16 and 18 of the human papillomavirus (HPV) as well as for strains 6 and 11, which are also included in the quadrivalent product.

“The response was 100% for the bivalent and 89% for the quadrivalent for persistent, vaccine-specific HPV types for those who got the vaccine on time,” Dr. Harper said. The recommended regimen for both vaccines is a 0.5-cc injection at 0, 2, and 6 months. In the studies, 94% of participants received all three doses, although not all according to protocol. The off-schedule efficacy was 95% and 89%, respectively, but these differences were not statistically different. “It indicated these will work in a real-world setting,” she added.

Goals of vaccination include reduction of HPV transmission and anogenital lesions, “but most importantly we want to reduce incidence of cervical cancer,” said Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center, Lebanon, N.H. She added that prevention of other anogenital cancers may be a serendipitous benefit of the vaccines. The quadrivalent vaccine has been licensed, and the bivalent vaccine may be cleared for marketing by the end of this year.

Both vaccines target high-risk HPV type 16, the type primarily implicated in cervical cancer. Type 16, taken together with types 18 (also in both vaccines), 31, and 45, accounts for 81% of cervical cancers, Dr. Harper said. The bivalent vaccine, “although it was designed for 16 and 18, is just as efficacious for HPV 45 and half effective for HPV 31, so that is exciting,” said Dr. Harper, who is also a professor of community and family medicine and obstetrics and gynecology at Dartmouth Medical School, Hanover, N.H. Dr. Harper was also a consultant for Merck and GlaxoSmithKline and a researcher for the efficacy trials of each vaccine.

“These vaccines are preventive, they are not therapeutic—that is important to know,” Dr. Harper said. “These prevent possible infection by HPV. These are not vaccines that prevent cancer.” Because it is important that prevention lasts a long time, the need for a booster shot is anticipated with the bivalent vaccine 7–10 years later, Dr. Harper said. “We don't know if the quadrivalent vaccine will require a booster.”

Researchers found high antibody titers at 7 months in the study participants who received all doses by 6 months. “This is the only disease other than infant influenza where you see higher titers from the vaccine than from the disease itself,” Dr. Harper said.

Participants in the quadrivalent vaccine efficacy trials who reported prior exposure to HPV had antibody titers twice those of participants who were exposure naive. Dr. Harper said, “It's important to know that the vaccine works well in people previously exposed to HPV. It is good because women at all ages are at risk.”

Adverse effects at local injection sites, including pain, erythema, and edema, were similar for both vaccines versus placebo. Other side effects such as headaches, gastrointestinal problems, and fatigue occurred at similar, “acceptable” rates in placebo and vaccine recipients, Dr. Harper said.

Other safety concerns with vaccines include new-onset autoimmune disease and musculoskeletal problems. “We can say no in both cases,” Dr. Harper said. “So there is no concern about new-onset diseases, at least up to 4.5 years. We will continue to follow that.”

'This is the only disease other than infant influenza where you see higher titers from the vaccine than from the disease.' DR. HARPER

NAPLES, FLA. — Many recommendations about long-term oxygen therapy emerged from the Sixth Oxygen Consensus Conference, according to a presentation by Dr. Dennis E. Doherty at the annual meeting of the National Association for Medical Direction of Respiratory Care.

About 1 million Americans receive long-term oxygen therapy (LTOT) at a cost of more than $2 billion per year. This cost is anticipated to increase to $3 billion per year and to account for 1% of the annual budget of the Centers for Medicare and Medicaid Services, said Dr. Doherty, chief of the pulmonary, critical care, and sleep medicine division at the University of Kentucky, Lexington. Many new LTOT technologies are emerging, and evidence to support their use can lag a few years behind. “Some areas are weak in evidence-based medicine. Sometimes, it takes common sense or consensus to make a decision,” he said.

The Sixth Oxygen Consensus Conference, held in Denver in August 2005, was designed to reach consensus on prescriptions, reimbursement, access, education, and research for LTOT. Participants included LTOT patients, who were “the central focus for most of the recommendations,” Dr. Doherty said.

“All societies and professional and lay organizations should incorporate LTOT patients into their advocacy efforts for LTOT. This is very important,” he added.

The consensus conference was attended by physicians, nurses, respiratory therapists, and other respiratory care professionals, as well as representatives from government and regulatory agencies, LTOT patient groups, device manufacturers, and providers. “I'll tell you, getting about 100 people into a room to reach consensus is not easy,” Dr. Doherty said.

An official summary of what transpired at the conference was published (Respir. Care 2006;51:519–25).

Attendees agreed on categories for LTOT delivery devices (stationary, portable, and wearable), but they did not reach a consensus on specifications, such as the weight or configuration of such devices. “Evidence-based criteria are needed to define what is ambulatory, portable, or wearable. Until we have this evidence, we need the physician, patient, and HME [home medical equipment] provider to collaborate effectively,” Dr. Doherty said.

Consensus was reached on these issues:

▸ LTOT education is needed. “To ensure quality LTOT patient care, comprehensive education is necessary,” Dr. Doherty said. One recommendation at the meeting was further development of educational materials in different modalities, including print, Internet, and audiovisual-based formats.

▸ All health professionals in disciplines caring for LTOT patients need training.

▸ All patients should have access to the appropriate LTOT delivery systems and accessories to optimize care. There are many technologies, including liquid oxygen systems, oxygen concentrator systems, and lightweight, portable oxygen concentrator systems. “It is laudable to all the investigators that so many devices that are of benefit to patients have come to market,” Dr. Doherty said.

▸ LTOT standards should be developed further into clinical practice guidelines.

▸ Reimbursement should be based on the LTOT device that is “best for the patient” as prescribed by a physician.

▸ LTOT should be reimbursed adequately for the specific device or class of device. “CMS and other payer organizations should be encouraged to support appropriate reimbursement so new technologies can be developed,” Dr. Doherty said.

▸ LTOT should be incorporated into disease management or a health maintenance approach to comprehensive patient care.

▸ A demonstration project should be developed to evaluate resource utilization for LTOT and to incorporate data into a recertification process when LTOT is prescribed in an acute setting. “This was somewhat controversial,” Dr. Doherty said.

▸ Funding is needed for research to evaluate the outcomes and cost-effectiveness of LTOT.

NAPLES, FLA. — Many recommendations about long-term oxygen therapy emerged from the Sixth Oxygen Consensus Conference, according to a presentation by Dr. Dennis E. Doherty at the annual meeting of the National Association for Medical Direction of Respiratory Care.

About 1 million Americans receive long-term oxygen therapy (LTOT) at a cost of more than $2 billion per year. This cost is anticipated to increase to $3 billion per year and to account for 1% of the annual budget of the Centers for Medicare and Medicaid Services, said Dr. Doherty, chief of the pulmonary, critical care, and sleep medicine division at the University of Kentucky, Lexington. Many new LTOT technologies are emerging, and evidence to support their use can lag a few years behind. “Some areas are weak in evidence-based medicine. Sometimes, it takes common sense or consensus to make a decision,” he said.

The Sixth Oxygen Consensus Conference, held in Denver in August 2005, was designed to reach consensus on prescriptions, reimbursement, access, education, and research for LTOT. Participants included LTOT patients, who were “the central focus for most of the recommendations,” Dr. Doherty said.

“All societies and professional and lay organizations should incorporate LTOT patients into their advocacy efforts for LTOT. This is very important,” he added.

The consensus conference was attended by physicians, nurses, respiratory therapists, and other respiratory care professionals, as well as representatives from government and regulatory agencies, LTOT patient groups, device manufacturers, and providers. “I'll tell you, getting about 100 people into a room to reach consensus is not easy,” Dr. Doherty said.

An official summary of what transpired at the conference was published (Respir. Care 2006;51:519–25).

Attendees agreed on categories for LTOT delivery devices (stationary, portable, and wearable), but they did not reach a consensus on specifications, such as the weight or configuration of such devices. “Evidence-based criteria are needed to define what is ambulatory, portable, or wearable. Until we have this evidence, we need the physician, patient, and HME [home medical equipment] provider to collaborate effectively,” Dr. Doherty said.

Consensus was reached on these issues:

▸ LTOT education is needed. “To ensure quality LTOT patient care, comprehensive education is necessary,” Dr. Doherty said. One recommendation at the meeting was further development of educational materials in different modalities, including print, Internet, and audiovisual-based formats.

▸ All health professionals in disciplines caring for LTOT patients need training.

▸ All patients should have access to the appropriate LTOT delivery systems and accessories to optimize care. There are many technologies, including liquid oxygen systems, oxygen concentrator systems, and lightweight, portable oxygen concentrator systems. “It is laudable to all the investigators that so many devices that are of benefit to patients have come to market,” Dr. Doherty said.

▸ LTOT standards should be developed further into clinical practice guidelines.

▸ Reimbursement should be based on the LTOT device that is “best for the patient” as prescribed by a physician.

▸ LTOT should be reimbursed adequately for the specific device or class of device. “CMS and other payer organizations should be encouraged to support appropriate reimbursement so new technologies can be developed,” Dr. Doherty said.

▸ LTOT should be incorporated into disease management or a health maintenance approach to comprehensive patient care.

▸ A demonstration project should be developed to evaluate resource utilization for LTOT and to incorporate data into a recertification process when LTOT is prescribed in an acute setting. “This was somewhat controversial,” Dr. Doherty said.

▸ Funding is needed for research to evaluate the outcomes and cost-effectiveness of LTOT.

NAPLES, FLA. — Many recommendations about long-term oxygen therapy emerged from the Sixth Oxygen Consensus Conference, according to a presentation by Dr. Dennis E. Doherty at the annual meeting of the National Association for Medical Direction of Respiratory Care.

About 1 million Americans receive long-term oxygen therapy (LTOT) at a cost of more than $2 billion per year. This cost is anticipated to increase to $3 billion per year and to account for 1% of the annual budget of the Centers for Medicare and Medicaid Services, said Dr. Doherty, chief of the pulmonary, critical care, and sleep medicine division at the University of Kentucky, Lexington. Many new LTOT technologies are emerging, and evidence to support their use can lag a few years behind. “Some areas are weak in evidence-based medicine. Sometimes, it takes common sense or consensus to make a decision,” he said.

The Sixth Oxygen Consensus Conference, held in Denver in August 2005, was designed to reach consensus on prescriptions, reimbursement, access, education, and research for LTOT. Participants included LTOT patients, who were “the central focus for most of the recommendations,” Dr. Doherty said.

“All societies and professional and lay organizations should incorporate LTOT patients into their advocacy efforts for LTOT. This is very important,” he added.

The consensus conference was attended by physicians, nurses, respiratory therapists, and other respiratory care professionals, as well as representatives from government and regulatory agencies, LTOT patient groups, device manufacturers, and providers. “I'll tell you, getting about 100 people into a room to reach consensus is not easy,” Dr. Doherty said.

An official summary of what transpired at the conference was published (Respir. Care 2006;51:519–25).

Attendees agreed on categories for LTOT delivery devices (stationary, portable, and wearable), but they did not reach a consensus on specifications, such as the weight or configuration of such devices. “Evidence-based criteria are needed to define what is ambulatory, portable, or wearable. Until we have this evidence, we need the physician, patient, and HME [home medical equipment] provider to collaborate effectively,” Dr. Doherty said.

Consensus was reached on these issues:

▸ LTOT education is needed. “To ensure quality LTOT patient care, comprehensive education is necessary,” Dr. Doherty said. One recommendation at the meeting was further development of educational materials in different modalities, including print, Internet, and audiovisual-based formats.

▸ All health professionals in disciplines caring for LTOT patients need training.

▸ All patients should have access to the appropriate LTOT delivery systems and accessories to optimize care. There are many technologies, including liquid oxygen systems, oxygen concentrator systems, and lightweight, portable oxygen concentrator systems. “It is laudable to all the investigators that so many devices that are of benefit to patients have come to market,” Dr. Doherty said.

▸ LTOT standards should be developed further into clinical practice guidelines.

▸ Reimbursement should be based on the LTOT device that is “best for the patient” as prescribed by a physician.

▸ LTOT should be reimbursed adequately for the specific device or class of device. “CMS and other payer organizations should be encouraged to support appropriate reimbursement so new technologies can be developed,” Dr. Doherty said.

▸ LTOT should be incorporated into disease management or a health maintenance approach to comprehensive patient care.

▸ A demonstration project should be developed to evaluate resource utilization for LTOT and to incorporate data into a recertification process when LTOT is prescribed in an acute setting. “This was somewhat controversial,” Dr. Doherty said.

▸ Funding is needed for research to evaluate the outcomes and cost-effectiveness of LTOT.

JACKSONVILLE, FLA. — Pediatricians were the specialists most likely to ask patients about sexual history—followed by obstetricians and gynecologists, family physicians, and internists, according to a survey of physicians in the Atlanta metropolitan area.

The results, presented in a poster at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention, came as a surprise to investigator Dr. Yolanda Wimberly.

“In most other studies, obstetrician-gynecologists are number one. This is part of what they do,” she said in an interview.

Respondents were primary care physicians; 51% were men, and the mean age was 44 years. Being black, female, and a pediatrician were the demographic factors most often associated with taking a sexual history.

There appears to be a disconnect between beliefs and practices, said Dr. Wimberly, of Morehouse School of Medicine in Atlanta. Most of the 414 primary care physicians rated sexual history taking as important, relevant, and something they were comfortable discussing with a patient. A majority, 77%, rated sexual history taking as fairly or extremely important; 85% said it was fairly or extremely relevant to medical care; and 79% indicated they were fairly or extremely comfortable with the practice.

Yet only 55% reported routinely asking patients.

Most of the metropolitan Atlanta physicians surveyed do not take a comprehensive history, but simply ask patients if they are sexually active, Dr. Wimberly said. “Instead of just asking: 'Do you take a sexual history?' we broke it down into components of a complete sexual history.”

Although 55% of respondents ask at the time of an annual exam about sexual history, “the numbers go down for the other components,” Dr. Wimberly said. For example, only 11% of physicians ask about sexual abuse and only 12% ask about sexual orientation. The findings suggest primary care physicians could benefit from additional training or use of a standardized questionnaire about sexual history, she added.

A total of 56% of physicians reported adequate or more than adequate training for sexual history taking. The practice rarely or never takes too much time, according to 57% of respondents.

JACKSONVILLE, FLA. — Pediatricians were the specialists most likely to ask patients about sexual history—followed by obstetricians and gynecologists, family physicians, and internists, according to a survey of physicians in the Atlanta metropolitan area.

The results, presented in a poster at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention, came as a surprise to investigator Dr. Yolanda Wimberly.

“In most other studies, obstetrician-gynecologists are number one. This is part of what they do,” she said in an interview.

Respondents were primary care physicians; 51% were men, and the mean age was 44 years. Being black, female, and a pediatrician were the demographic factors most often associated with taking a sexual history.

There appears to be a disconnect between beliefs and practices, said Dr. Wimberly, of Morehouse School of Medicine in Atlanta. Most of the 414 primary care physicians rated sexual history taking as important, relevant, and something they were comfortable discussing with a patient. A majority, 77%, rated sexual history taking as fairly or extremely important; 85% said it was fairly or extremely relevant to medical care; and 79% indicated they were fairly or extremely comfortable with the practice.

Yet only 55% reported routinely asking patients.

Most of the metropolitan Atlanta physicians surveyed do not take a comprehensive history, but simply ask patients if they are sexually active, Dr. Wimberly said. “Instead of just asking: 'Do you take a sexual history?' we broke it down into components of a complete sexual history.”

Although 55% of respondents ask at the time of an annual exam about sexual history, “the numbers go down for the other components,” Dr. Wimberly said. For example, only 11% of physicians ask about sexual abuse and only 12% ask about sexual orientation. The findings suggest primary care physicians could benefit from additional training or use of a standardized questionnaire about sexual history, she added.

A total of 56% of physicians reported adequate or more than adequate training for sexual history taking. The practice rarely or never takes too much time, according to 57% of respondents.

JACKSONVILLE, FLA. — Pediatricians were the specialists most likely to ask patients about sexual history—followed by obstetricians and gynecologists, family physicians, and internists, according to a survey of physicians in the Atlanta metropolitan area.

The results, presented in a poster at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention, came as a surprise to investigator Dr. Yolanda Wimberly.

“In most other studies, obstetrician-gynecologists are number one. This is part of what they do,” she said in an interview.

Respondents were primary care physicians; 51% were men, and the mean age was 44 years. Being black, female, and a pediatrician were the demographic factors most often associated with taking a sexual history.

There appears to be a disconnect between beliefs and practices, said Dr. Wimberly, of Morehouse School of Medicine in Atlanta. Most of the 414 primary care physicians rated sexual history taking as important, relevant, and something they were comfortable discussing with a patient. A majority, 77%, rated sexual history taking as fairly or extremely important; 85% said it was fairly or extremely relevant to medical care; and 79% indicated they were fairly or extremely comfortable with the practice.

Yet only 55% reported routinely asking patients.

Most of the metropolitan Atlanta physicians surveyed do not take a comprehensive history, but simply ask patients if they are sexually active, Dr. Wimberly said. “Instead of just asking: 'Do you take a sexual history?' we broke it down into components of a complete sexual history.”

Although 55% of respondents ask at the time of an annual exam about sexual history, “the numbers go down for the other components,” Dr. Wimberly said. For example, only 11% of physicians ask about sexual abuse and only 12% ask about sexual orientation. The findings suggest primary care physicians could benefit from additional training or use of a standardized questionnaire about sexual history, she added.

A total of 56% of physicians reported adequate or more than adequate training for sexual history taking. The practice rarely or never takes too much time, according to 57% of respondents.

JACKSONVILLE, FLA. — Tailored and targeted interventions to educate men who have sex with men and to reduce ethnic disparities are key components of a revised Syphilis Elimination Effort recently released by the Centers for Disease Control and Prevention.

“The new syphilis elimination effort is a very comprehensive plan. It is targeted toward urban areas and men who have sex with men [MSM] in the United States,” Dr. John F. Beltrami said at a conference on STD prevention sponsored by the CDC.

Syphilis prevalence has been increasing since 2000, when it reached its lowest rate since 1941. In 2005, the overall primary and secondary syphilis rate was 3.0 per 100,000 people in the United States, according to provisional CDC data.

The CDC launched the Syphilis Elimination Effort (SEE) in 1999. The initial effort addressed the primarily heterosexual route of transmission from the late 1980s to late 1990s. The CDC has now released a revised syphilis elimination plan, because the epidemiology of syphilis has changed enough to warrant new strategies. “The elimination plan has about 75 specific activities, and the … MSM disparity is highly emphasized in the new plan,” said Dr. Beltrami, epidemiologist at the epidemiology and surveillance branch of the CDC.

MSM now account for the largest increases in new syphilis cases, Dr. Beltrami said. For example, of the 7,389 primary and secondary syphilis cases among males reported in provisional 2005 CDC data, 5,702 (77%) were among MSM.

Previously, outbreaks among MSM were inferred from an increasing male-to-female ratio. This ratio increased steadily in recent years up to 2.7:1 in 2004, although it dropped slightly to 2.5:1 in 2005, Dr. Beltrami said.

Another indirect measure is location: Increases are occurring in urban areas with large MSM populations. The highest incidence of new syphilis cases in 2004 occurred in New York, Los Angeles, San Francisco, Chicago, Atlanta, and Miami, “suggesting substantial MSM transmission,” he said.

The revised SEE plan includes a new MSM variable that calls for partner gender reporting. This will be more accurate but prone to underreporting, Dr. Beltrami predicted. “Only since 2005 has CDC requested gender-of-partner information.” He added that not all states are providing complete data.

To support education and outreach to MSM, the new plan also calls for data collection on recreational drug use—including methamphetamine and Viagra—and venues people use to meet and have sex with partners. To aid clinicians and enhance surveillance, “the CDC divisions for STD and HIV prevention are working together to develop a combined interview form,” Dr. Beltrami said.

Although white MSM in recent years have driven the syphilis epidemic in terms of the number of new cases, syphilis goes beyond this population. “Racial disparities are growing,” he said. “African Americans consistently have had the highest primary and secondary syphilis rates compared to other races and ethnicities.” The incidence of new syphilis cases was 14.8 per 100,000 African American males in 2005.

Ethnic disparities occur with congenital syphilis as well. Reflecting higher overall prevalence, congenital rates among African Americans are consistently higher than are those of other groups, but they are decreasing, Dr. Beltrami said.

Overall, congenital and female primary and secondary syphilis rates have decreased each year from 1997 to 2005.

During the next 6 months to 2 years, the agency will develop a specific action plan with a 5-year timetable of activities, a syphilis elimination research and development strategy, and a template “outbreak response plan” to be adapted by state and local health departments.

The 63-page SEE document is available online at www.cdc.gov/stopsyphilis

JACKSONVILLE, FLA. — Tailored and targeted interventions to educate men who have sex with men and to reduce ethnic disparities are key components of a revised Syphilis Elimination Effort recently released by the Centers for Disease Control and Prevention.

“The new syphilis elimination effort is a very comprehensive plan. It is targeted toward urban areas and men who have sex with men [MSM] in the United States,” Dr. John F. Beltrami said at a conference on STD prevention sponsored by the CDC.

Syphilis prevalence has been increasing since 2000, when it reached its lowest rate since 1941. In 2005, the overall primary and secondary syphilis rate was 3.0 per 100,000 people in the United States, according to provisional CDC data.

The CDC launched the Syphilis Elimination Effort (SEE) in 1999. The initial effort addressed the primarily heterosexual route of transmission from the late 1980s to late 1990s. The CDC has now released a revised syphilis elimination plan, because the epidemiology of syphilis has changed enough to warrant new strategies. “The elimination plan has about 75 specific activities, and the … MSM disparity is highly emphasized in the new plan,” said Dr. Beltrami, epidemiologist at the epidemiology and surveillance branch of the CDC.

MSM now account for the largest increases in new syphilis cases, Dr. Beltrami said. For example, of the 7,389 primary and secondary syphilis cases among males reported in provisional 2005 CDC data, 5,702 (77%) were among MSM.

Previously, outbreaks among MSM were inferred from an increasing male-to-female ratio. This ratio increased steadily in recent years up to 2.7:1 in 2004, although it dropped slightly to 2.5:1 in 2005, Dr. Beltrami said.

Another indirect measure is location: Increases are occurring in urban areas with large MSM populations. The highest incidence of new syphilis cases in 2004 occurred in New York, Los Angeles, San Francisco, Chicago, Atlanta, and Miami, “suggesting substantial MSM transmission,” he said.

The revised SEE plan includes a new MSM variable that calls for partner gender reporting. This will be more accurate but prone to underreporting, Dr. Beltrami predicted. “Only since 2005 has CDC requested gender-of-partner information.” He added that not all states are providing complete data.

To support education and outreach to MSM, the new plan also calls for data collection on recreational drug use—including methamphetamine and Viagra—and venues people use to meet and have sex with partners. To aid clinicians and enhance surveillance, “the CDC divisions for STD and HIV prevention are working together to develop a combined interview form,” Dr. Beltrami said.

Although white MSM in recent years have driven the syphilis epidemic in terms of the number of new cases, syphilis goes beyond this population. “Racial disparities are growing,” he said. “African Americans consistently have had the highest primary and secondary syphilis rates compared to other races and ethnicities.” The incidence of new syphilis cases was 14.8 per 100,000 African American males in 2005.

Ethnic disparities occur with congenital syphilis as well. Reflecting higher overall prevalence, congenital rates among African Americans are consistently higher than are those of other groups, but they are decreasing, Dr. Beltrami said.

Overall, congenital and female primary and secondary syphilis rates have decreased each year from 1997 to 2005.

During the next 6 months to 2 years, the agency will develop a specific action plan with a 5-year timetable of activities, a syphilis elimination research and development strategy, and a template “outbreak response plan” to be adapted by state and local health departments.

The 63-page SEE document is available online at www.cdc.gov/stopsyphilis

JACKSONVILLE, FLA. — Tailored and targeted interventions to educate men who have sex with men and to reduce ethnic disparities are key components of a revised Syphilis Elimination Effort recently released by the Centers for Disease Control and Prevention.

“The new syphilis elimination effort is a very comprehensive plan. It is targeted toward urban areas and men who have sex with men [MSM] in the United States,” Dr. John F. Beltrami said at a conference on STD prevention sponsored by the CDC.

Syphilis prevalence has been increasing since 2000, when it reached its lowest rate since 1941. In 2005, the overall primary and secondary syphilis rate was 3.0 per 100,000 people in the United States, according to provisional CDC data.

The CDC launched the Syphilis Elimination Effort (SEE) in 1999. The initial effort addressed the primarily heterosexual route of transmission from the late 1980s to late 1990s. The CDC has now released a revised syphilis elimination plan, because the epidemiology of syphilis has changed enough to warrant new strategies. “The elimination plan has about 75 specific activities, and the … MSM disparity is highly emphasized in the new plan,” said Dr. Beltrami, epidemiologist at the epidemiology and surveillance branch of the CDC.

MSM now account for the largest increases in new syphilis cases, Dr. Beltrami said. For example, of the 7,389 primary and secondary syphilis cases among males reported in provisional 2005 CDC data, 5,702 (77%) were among MSM.

Previously, outbreaks among MSM were inferred from an increasing male-to-female ratio. This ratio increased steadily in recent years up to 2.7:1 in 2004, although it dropped slightly to 2.5:1 in 2005, Dr. Beltrami said.

Another indirect measure is location: Increases are occurring in urban areas with large MSM populations. The highest incidence of new syphilis cases in 2004 occurred in New York, Los Angeles, San Francisco, Chicago, Atlanta, and Miami, “suggesting substantial MSM transmission,” he said.

The revised SEE plan includes a new MSM variable that calls for partner gender reporting. This will be more accurate but prone to underreporting, Dr. Beltrami predicted. “Only since 2005 has CDC requested gender-of-partner information.” He added that not all states are providing complete data.

To support education and outreach to MSM, the new plan also calls for data collection on recreational drug use—including methamphetamine and Viagra—and venues people use to meet and have sex with partners. To aid clinicians and enhance surveillance, “the CDC divisions for STD and HIV prevention are working together to develop a combined interview form,” Dr. Beltrami said.

Although white MSM in recent years have driven the syphilis epidemic in terms of the number of new cases, syphilis goes beyond this population. “Racial disparities are growing,” he said. “African Americans consistently have had the highest primary and secondary syphilis rates compared to other races and ethnicities.” The incidence of new syphilis cases was 14.8 per 100,000 African American males in 2005.

Ethnic disparities occur with congenital syphilis as well. Reflecting higher overall prevalence, congenital rates among African Americans are consistently higher than are those of other groups, but they are decreasing, Dr. Beltrami said.

Overall, congenital and female primary and secondary syphilis rates have decreased each year from 1997 to 2005.

During the next 6 months to 2 years, the agency will develop a specific action plan with a 5-year timetable of activities, a syphilis elimination research and development strategy, and a template “outbreak response plan” to be adapted by state and local health departments.

The 63-page SEE document is available online at www.cdc.gov/stopsyphilis