Doug Brunk

Patients with rheumatoid arthritis who received 3 months of treatment with the investigational Janus kinase inhibitor tofacitinib had clinically significant improvements in patient-reported outcomes, compared with those who were given placebo, according to Dr. Vibeke Strand, who reported the 3-month results of a 6-month, phase III trial on May 26.

"I see this drug as being everything that a biologic is. ...There are a lot of places where biologics are not very accessible. ... The data look quite comparable to biologics," Dr. Strand said in an interview.

The study marks the first of five pivotal, phase III, randomized, placebo-controlled trials planned for tofacitinib (CP-690-550), Dr. Strand said in an interview. She described tofacitinib as "the first of several Janus kinase and Syk kinase inhibitors that are promising oral disease-modifying antirheumatic drugs with onset of effect that is rapid and magnitude of effect similar to anti–[tumor necrosis factor] therapies," said Dr. Strand of the division of immunology/rheumatology at Stanford (Calif.) University. Tofacitinib "has been studied vs. monotherapy adalimumab in phase II."

For the current 6-month trial, 610 rheumatoid arthritis (RA) patients were randomized to one of three treatments: tofacitinib 5 mg b.i.d., tofacitinib 10 mg b.i.d., or placebo, all as monotherapy. Patients on placebo were advanced to either tofacitinib 5 mg b.i.d. or tofacitinib 10 mg b.i.d. after month 3. The mean age of the patients was 51 years, and 87% were women.

In her presentation, Dr. Strand reported change-from-baseline results on several patient-reported outcomes at 3 months, including Patient Global Assessment of disease activity on a visual analog scale, pain on a visual analog scale, physical function by the HAQ-DI (Health Assessment Questionnaire–Disability Index), and health-related quality of life by the MOS SF-36 (Medical Outcomes Study 36-item Short Form Health Survey).

Improvements were reported as least square means of changes from baseline. At 3 months, treatment with tofacitinib monotherapy resulted in statistically significant and clinically meaningful improvements, compared with placebo, in all patient-reported outcomes except sleep improvement in the tofacitinib 5-mg group.

Mean Patient Global Assessment scores achieved a minimally clinically important difference (MCID) relative to baseline in 73% of the patients taking 5 mg (number needed to treat, 4), in 75% of patients taking10 mg (NNT, 3.8), and in 48% of the placebo group.

Patients’ pain scores showed an MCID relative to baseline in 70% of the patients on 5 mg (NNT, 4.6), in 77% of the patients on 10 mg (NNT, 3.5), and in 48% of the patients on placebo.

Physical function scores on the HAQ-DI showed an MCID relative to baseline in 61% of the patients on 5 mg (NNT, 5.7), in 68% in patients taking 10 mg (NNT, 4), and in 43% of those on placebo.

The physical component scores on the MOS SF-36 were 2.63, 6.97, and 8.55, respectively. Physical component scores on the MOS SF-36 showed an MCID relative to baseline in 68% of the patients on 5 mg (NNT, 4.2), in 75% of the group on 10 mg (NNT, 3.2), and in 44% of those on placebo.

"Randomized, controlled trial data don’t always reflect what we see in the clinic, but this product has a large phase II database, and these findings are consistent with those data," Dr. Strand said. "Patients clearly have derived early and clinically meaningful benefit from treatment – in pain, fatigue, physical function, and ‘multidimensional function’ [as shown] in the SF-36 – which reflects improvements in those parameters, and not just physical and emotional well-being but also in social functioning and mental health."

Dr. Strand disclosed that she is a paid consultant to Pfizer but said that she received no support for preparation of the abstract or presentation.

Patients with rheumatoid arthritis who received 3 months of treatment with the investigational Janus kinase inhibitor tofacitinib had clinically significant improvements in patient-reported outcomes, compared with those who were given placebo, according to Dr. Vibeke Strand, who reported the 3-month results of a 6-month, phase III trial on May 26.

"I see this drug as being everything that a biologic is. ...There are a lot of places where biologics are not very accessible. ... The data look quite comparable to biologics," Dr. Strand said in an interview.

The study marks the first of five pivotal, phase III, randomized, placebo-controlled trials planned for tofacitinib (CP-690-550), Dr. Strand said in an interview. She described tofacitinib as "the first of several Janus kinase and Syk kinase inhibitors that are promising oral disease-modifying antirheumatic drugs with onset of effect that is rapid and magnitude of effect similar to anti–[tumor necrosis factor] therapies," said Dr. Strand of the division of immunology/rheumatology at Stanford (Calif.) University. Tofacitinib "has been studied vs. monotherapy adalimumab in phase II."

For the current 6-month trial, 610 rheumatoid arthritis (RA) patients were randomized to one of three treatments: tofacitinib 5 mg b.i.d., tofacitinib 10 mg b.i.d., or placebo, all as monotherapy. Patients on placebo were advanced to either tofacitinib 5 mg b.i.d. or tofacitinib 10 mg b.i.d. after month 3. The mean age of the patients was 51 years, and 87% were women.

In her presentation, Dr. Strand reported change-from-baseline results on several patient-reported outcomes at 3 months, including Patient Global Assessment of disease activity on a visual analog scale, pain on a visual analog scale, physical function by the HAQ-DI (Health Assessment Questionnaire–Disability Index), and health-related quality of life by the MOS SF-36 (Medical Outcomes Study 36-item Short Form Health Survey).

Improvements were reported as least square means of changes from baseline. At 3 months, treatment with tofacitinib monotherapy resulted in statistically significant and clinically meaningful improvements, compared with placebo, in all patient-reported outcomes except sleep improvement in the tofacitinib 5-mg group.

Mean Patient Global Assessment scores achieved a minimally clinically important difference (MCID) relative to baseline in 73% of the patients taking 5 mg (number needed to treat, 4), in 75% of patients taking10 mg (NNT, 3.8), and in 48% of the placebo group.

Patients’ pain scores showed an MCID relative to baseline in 70% of the patients on 5 mg (NNT, 4.6), in 77% of the patients on 10 mg (NNT, 3.5), and in 48% of the patients on placebo.

Physical function scores on the HAQ-DI showed an MCID relative to baseline in 61% of the patients on 5 mg (NNT, 5.7), in 68% in patients taking 10 mg (NNT, 4), and in 43% of those on placebo.

The physical component scores on the MOS SF-36 were 2.63, 6.97, and 8.55, respectively. Physical component scores on the MOS SF-36 showed an MCID relative to baseline in 68% of the patients on 5 mg (NNT, 4.2), in 75% of the group on 10 mg (NNT, 3.2), and in 44% of those on placebo.

"Randomized, controlled trial data don’t always reflect what we see in the clinic, but this product has a large phase II database, and these findings are consistent with those data," Dr. Strand said. "Patients clearly have derived early and clinically meaningful benefit from treatment – in pain, fatigue, physical function, and ‘multidimensional function’ [as shown] in the SF-36 – which reflects improvements in those parameters, and not just physical and emotional well-being but also in social functioning and mental health."

Dr. Strand disclosed that she is a paid consultant to Pfizer but said that she received no support for preparation of the abstract or presentation.

Patients with rheumatoid arthritis who received 3 months of treatment with the investigational Janus kinase inhibitor tofacitinib had clinically significant improvements in patient-reported outcomes, compared with those who were given placebo, according to Dr. Vibeke Strand, who reported the 3-month results of a 6-month, phase III trial on May 26.

"I see this drug as being everything that a biologic is. ...There are a lot of places where biologics are not very accessible. ... The data look quite comparable to biologics," Dr. Strand said in an interview.

The study marks the first of five pivotal, phase III, randomized, placebo-controlled trials planned for tofacitinib (CP-690-550), Dr. Strand said in an interview. She described tofacitinib as "the first of several Janus kinase and Syk kinase inhibitors that are promising oral disease-modifying antirheumatic drugs with onset of effect that is rapid and magnitude of effect similar to anti–[tumor necrosis factor] therapies," said Dr. Strand of the division of immunology/rheumatology at Stanford (Calif.) University. Tofacitinib "has been studied vs. monotherapy adalimumab in phase II."

For the current 6-month trial, 610 rheumatoid arthritis (RA) patients were randomized to one of three treatments: tofacitinib 5 mg b.i.d., tofacitinib 10 mg b.i.d., or placebo, all as monotherapy. Patients on placebo were advanced to either tofacitinib 5 mg b.i.d. or tofacitinib 10 mg b.i.d. after month 3. The mean age of the patients was 51 years, and 87% were women.

In her presentation, Dr. Strand reported change-from-baseline results on several patient-reported outcomes at 3 months, including Patient Global Assessment of disease activity on a visual analog scale, pain on a visual analog scale, physical function by the HAQ-DI (Health Assessment Questionnaire–Disability Index), and health-related quality of life by the MOS SF-36 (Medical Outcomes Study 36-item Short Form Health Survey).

Improvements were reported as least square means of changes from baseline. At 3 months, treatment with tofacitinib monotherapy resulted in statistically significant and clinically meaningful improvements, compared with placebo, in all patient-reported outcomes except sleep improvement in the tofacitinib 5-mg group.

Mean Patient Global Assessment scores achieved a minimally clinically important difference (MCID) relative to baseline in 73% of the patients taking 5 mg (number needed to treat, 4), in 75% of patients taking10 mg (NNT, 3.8), and in 48% of the placebo group.

Patients’ pain scores showed an MCID relative to baseline in 70% of the patients on 5 mg (NNT, 4.6), in 77% of the patients on 10 mg (NNT, 3.5), and in 48% of the patients on placebo.

Physical function scores on the HAQ-DI showed an MCID relative to baseline in 61% of the patients on 5 mg (NNT, 5.7), in 68% in patients taking 10 mg (NNT, 4), and in 43% of those on placebo.

The physical component scores on the MOS SF-36 were 2.63, 6.97, and 8.55, respectively. Physical component scores on the MOS SF-36 showed an MCID relative to baseline in 68% of the patients on 5 mg (NNT, 4.2), in 75% of the group on 10 mg (NNT, 3.2), and in 44% of those on placebo.

"Randomized, controlled trial data don’t always reflect what we see in the clinic, but this product has a large phase II database, and these findings are consistent with those data," Dr. Strand said. "Patients clearly have derived early and clinically meaningful benefit from treatment – in pain, fatigue, physical function, and ‘multidimensional function’ [as shown] in the SF-36 – which reflects improvements in those parameters, and not just physical and emotional well-being but also in social functioning and mental health."

Dr. Strand disclosed that she is a paid consultant to Pfizer but said that she received no support for preparation of the abstract or presentation.

SAN DIEGO - In the hands of experienced vascular surgeons, the use of retrievable inferior vena cava filters was less common than with other specialists, except in trauma or bariatric cases, and superior vena cava filter placement was very rare.

Those are two key findings from what is believed to be the first survey to question vascular surgeons about vena cava filter (VCF) placement safety and practice patterns.

"VCF use has skyrocketed over the past 20 years with percutaneous insertion, low-profile retrievable devices, relative and prophylactic indications, and other interventionalists now placing filters," Dr. Mark Friedell said at the meeting.

However, in August 2010 the Food and Drug Administration released a communication indicating that it had received 921 reports of adverse events with inferior vena cava (IVC) filters since 2005.

The communication, which went out to implanting physicians and clinicians responsible for the ongoing care of patients with IVC filters, recommended that patients be referred for removal of retrievable filters when feasible and clinically indicated.

Dr. Friedell, director of surgical education for Orlando Health, and his associate, Dr. Peter Nelson, assistant professor of vascular surgery at the University of Florida, Gainesville, sent a 17-question survey about VCF practices to all 276 members of the Southern Association for Vascular Surgery, an organization composed exclusively of board-certified vascular surgeons. Of the 276 members, 126 responded, for a response rate of 46%.

When asked about the IVC, the respondents cited the Greenfield filter as their preferred permanent device (31%), followed by a variety of retrievable devices.

Half of the respondents said that they rarely placed retrievable filters, 26% said that they placed them selectively, and 24% said that they usually placed them. They cited the Bard as their preferred retrievable filter (45%).

Despite the fact that 52% and 46% of respondents placed vena cava filters in trauma and bariatric patients, respectively, filters were placed for prophylactic indications less than 50% of the time by 63% of respondents.

When asked how often they removed retrievable filters, 64% estimated that they did so less than 25% of the time and 78% estimated that they did so less than 50% of the time.

There were few major complications, including one case of atrial perforation and one case of migration to the heart. There were also 12 cases of IVC thrombosis (4 with TrapEase filters); 3 cases of strut emboli (all Bard filters), and 9 cases of severe tilting (eight Bard filters).

"Experienced vascular surgeons appear more conservative with filter use in the management of venous thromboembolism than other specialists, because there are fewer retrievable and more permanent filters placed, fewer prophylactic filters except in trauma and bariatrics, and probably fewer filters placed altogether," Dr. Friedell said.

"The interest in retrievable filters reflects a preference for a low-profile, potentially removable device. However, retrievable filter removal is uncommon, both in the literature and in the [Southern Association for Vascular Surgery] experience."

Until more experience is accrued with retrievable devices - particularly since the removal rate is low - he said that they should not be used as permanent filters, and they should be removed as soon as possible.
 
"Ideally, filters should be placed by those who can provide complete care to the VTE patient, including the management of anticoagulation."

Dr. Friedell said that he had no relevant financial disclosures.

SAN DIEGO - In the hands of experienced vascular surgeons, the use of retrievable inferior vena cava filters was less common than with other specialists, except in trauma or bariatric cases, and superior vena cava filter placement was very rare.

Those are two key findings from what is believed to be the first survey to question vascular surgeons about vena cava filter (VCF) placement safety and practice patterns.

"VCF use has skyrocketed over the past 20 years with percutaneous insertion, low-profile retrievable devices, relative and prophylactic indications, and other interventionalists now placing filters," Dr. Mark Friedell said at the meeting.

However, in August 2010 the Food and Drug Administration released a communication indicating that it had received 921 reports of adverse events with inferior vena cava (IVC) filters since 2005.

The communication, which went out to implanting physicians and clinicians responsible for the ongoing care of patients with IVC filters, recommended that patients be referred for removal of retrievable filters when feasible and clinically indicated.

Dr. Friedell, director of surgical education for Orlando Health, and his associate, Dr. Peter Nelson, assistant professor of vascular surgery at the University of Florida, Gainesville, sent a 17-question survey about VCF practices to all 276 members of the Southern Association for Vascular Surgery, an organization composed exclusively of board-certified vascular surgeons. Of the 276 members, 126 responded, for a response rate of 46%.

When asked about the IVC, the respondents cited the Greenfield filter as their preferred permanent device (31%), followed by a variety of retrievable devices.

Half of the respondents said that they rarely placed retrievable filters, 26% said that they placed them selectively, and 24% said that they usually placed them. They cited the Bard as their preferred retrievable filter (45%).

Despite the fact that 52% and 46% of respondents placed vena cava filters in trauma and bariatric patients, respectively, filters were placed for prophylactic indications less than 50% of the time by 63% of respondents.

When asked how often they removed retrievable filters, 64% estimated that they did so less than 25% of the time and 78% estimated that they did so less than 50% of the time.

There were few major complications, including one case of atrial perforation and one case of migration to the heart. There were also 12 cases of IVC thrombosis (4 with TrapEase filters); 3 cases of strut emboli (all Bard filters), and 9 cases of severe tilting (eight Bard filters).

"Experienced vascular surgeons appear more conservative with filter use in the management of venous thromboembolism than other specialists, because there are fewer retrievable and more permanent filters placed, fewer prophylactic filters except in trauma and bariatrics, and probably fewer filters placed altogether," Dr. Friedell said.

"The interest in retrievable filters reflects a preference for a low-profile, potentially removable device. However, retrievable filter removal is uncommon, both in the literature and in the [Southern Association for Vascular Surgery] experience."

Until more experience is accrued with retrievable devices - particularly since the removal rate is low - he said that they should not be used as permanent filters, and they should be removed as soon as possible.
 
"Ideally, filters should be placed by those who can provide complete care to the VTE patient, including the management of anticoagulation."

Dr. Friedell said that he had no relevant financial disclosures.

SAN DIEGO - In the hands of experienced vascular surgeons, the use of retrievable inferior vena cava filters was less common than with other specialists, except in trauma or bariatric cases, and superior vena cava filter placement was very rare.

Those are two key findings from what is believed to be the first survey to question vascular surgeons about vena cava filter (VCF) placement safety and practice patterns.

"VCF use has skyrocketed over the past 20 years with percutaneous insertion, low-profile retrievable devices, relative and prophylactic indications, and other interventionalists now placing filters," Dr. Mark Friedell said at the meeting.

However, in August 2010 the Food and Drug Administration released a communication indicating that it had received 921 reports of adverse events with inferior vena cava (IVC) filters since 2005.

The communication, which went out to implanting physicians and clinicians responsible for the ongoing care of patients with IVC filters, recommended that patients be referred for removal of retrievable filters when feasible and clinically indicated.

Dr. Friedell, director of surgical education for Orlando Health, and his associate, Dr. Peter Nelson, assistant professor of vascular surgery at the University of Florida, Gainesville, sent a 17-question survey about VCF practices to all 276 members of the Southern Association for Vascular Surgery, an organization composed exclusively of board-certified vascular surgeons. Of the 276 members, 126 responded, for a response rate of 46%.

When asked about the IVC, the respondents cited the Greenfield filter as their preferred permanent device (31%), followed by a variety of retrievable devices.

Half of the respondents said that they rarely placed retrievable filters, 26% said that they placed them selectively, and 24% said that they usually placed them. They cited the Bard as their preferred retrievable filter (45%).

Despite the fact that 52% and 46% of respondents placed vena cava filters in trauma and bariatric patients, respectively, filters were placed for prophylactic indications less than 50% of the time by 63% of respondents.

When asked how often they removed retrievable filters, 64% estimated that they did so less than 25% of the time and 78% estimated that they did so less than 50% of the time.

There were few major complications, including one case of atrial perforation and one case of migration to the heart. There were also 12 cases of IVC thrombosis (4 with TrapEase filters); 3 cases of strut emboli (all Bard filters), and 9 cases of severe tilting (eight Bard filters).

"Experienced vascular surgeons appear more conservative with filter use in the management of venous thromboembolism than other specialists, because there are fewer retrievable and more permanent filters placed, fewer prophylactic filters except in trauma and bariatrics, and probably fewer filters placed altogether," Dr. Friedell said.

"The interest in retrievable filters reflects a preference for a low-profile, potentially removable device. However, retrievable filter removal is uncommon, both in the literature and in the [Southern Association for Vascular Surgery] experience."

Until more experience is accrued with retrievable devices - particularly since the removal rate is low - he said that they should not be used as permanent filters, and they should be removed as soon as possible.
 
"Ideally, filters should be placed by those who can provide complete care to the VTE patient, including the management of anticoagulation."

Dr. Friedell said that he had no relevant financial disclosures.

DENVER – Provider recommendation is strongly associated with initiation of the human papillomavirus vaccine in teenage females, results from a national survey demonstrated.

"It’s important for providers to take the time to counsel and recommend the HPV vaccine and communicate the benefits and the risks of the vaccination, as well as the risk of getting HPV disease as teenagers," Dr. Christina G. Dorell said in an interview during a poster session at the annual meeting of the Pediatric Academic Societies.

Dr. Dorell of the immunization services division at the Centers for Disease Control and Prevention, Atlanta, presented findings from the 2008-2009 National Immunization Survey Teen (NIS-Teen), which was analyzed to determine human papillomavirus (HPV) vaccination coverage among females aged 13-17 years. The NIS-Teen is composed of two parts: a random-digit–dialed telephone survey of parents or guardians of adolescents aged 13-17 years, and a mailed survey to all vaccination providers identified by the parent and for which consent was granted.

The researchers evaluated associations of select socioeconomic characteristics, intention to vaccinate, and HPV status. They used multivariable logistic regression to examine associations while controlling for other factors, including state of residence.

Of the 18,288 females surveyed, 41% received at least one HPV dose. Of those, 53% completed the three-dose series.

The probability of HPV vaccination occurring is 2.6 times higher for adolescents who receive a provider recommendation than for adolescents who do not receive a provider recommendation. Other factors independently associated with HPV vaccine initiation were older age, having a preventive visit at age 11 or 12 years, being eligible for state Children’s Health Insurance Program (CHIP) or Vaccines for Children (VFC) program, having a mother younger than age 34 years, having a mother who never married, and not receiving all vaccines at public facilities.

More than half of white females (60%) completed the vaccination series, compared with 46% of blacks and 40% of Hispanics. Other factors independently associated with completing the vaccination series were having a mother aged 45 or older, being knowledgeable about HPV disease, and not receiving all vaccines at public facilities.

The main reported reasons parents do not intend for their daughters to receive the HPV vaccination in the next 12 months were lack of knowledge (19%), considering it not needed or not necessary (19%), the fact that their daughters were not sexually active (18%), and that they did not receive a provider recommendation (13%).

Dr. Dorell acknowledged certain limitations of the study, including the fact that the telephone portion of the survey was using land line phones only, thus contributing to a noncoverage bias of wireless-only households. It’s also possible that some of the provider data or vaccination histories may be incomplete, she said. However, she pointed out that one of the main strengths of the NIS-Teen "is that it is the only nationally representative survey that reports vaccination coverage estimates from provider-reported data, which is the gold standard for measuring vaccination coverage."

Dr. Dorell said that she had no relevant financial disclosures.

DENVER – Provider recommendation is strongly associated with initiation of the human papillomavirus vaccine in teenage females, results from a national survey demonstrated.

"It’s important for providers to take the time to counsel and recommend the HPV vaccine and communicate the benefits and the risks of the vaccination, as well as the risk of getting HPV disease as teenagers," Dr. Christina G. Dorell said in an interview during a poster session at the annual meeting of the Pediatric Academic Societies.

Dr. Dorell of the immunization services division at the Centers for Disease Control and Prevention, Atlanta, presented findings from the 2008-2009 National Immunization Survey Teen (NIS-Teen), which was analyzed to determine human papillomavirus (HPV) vaccination coverage among females aged 13-17 years. The NIS-Teen is composed of two parts: a random-digit–dialed telephone survey of parents or guardians of adolescents aged 13-17 years, and a mailed survey to all vaccination providers identified by the parent and for which consent was granted.

The researchers evaluated associations of select socioeconomic characteristics, intention to vaccinate, and HPV status. They used multivariable logistic regression to examine associations while controlling for other factors, including state of residence.

Of the 18,288 females surveyed, 41% received at least one HPV dose. Of those, 53% completed the three-dose series.

The probability of HPV vaccination occurring is 2.6 times higher for adolescents who receive a provider recommendation than for adolescents who do not receive a provider recommendation. Other factors independently associated with HPV vaccine initiation were older age, having a preventive visit at age 11 or 12 years, being eligible for state Children’s Health Insurance Program (CHIP) or Vaccines for Children (VFC) program, having a mother younger than age 34 years, having a mother who never married, and not receiving all vaccines at public facilities.

More than half of white females (60%) completed the vaccination series, compared with 46% of blacks and 40% of Hispanics. Other factors independently associated with completing the vaccination series were having a mother aged 45 or older, being knowledgeable about HPV disease, and not receiving all vaccines at public facilities.

The main reported reasons parents do not intend for their daughters to receive the HPV vaccination in the next 12 months were lack of knowledge (19%), considering it not needed or not necessary (19%), the fact that their daughters were not sexually active (18%), and that they did not receive a provider recommendation (13%).

Dr. Dorell acknowledged certain limitations of the study, including the fact that the telephone portion of the survey was using land line phones only, thus contributing to a noncoverage bias of wireless-only households. It’s also possible that some of the provider data or vaccination histories may be incomplete, she said. However, she pointed out that one of the main strengths of the NIS-Teen "is that it is the only nationally representative survey that reports vaccination coverage estimates from provider-reported data, which is the gold standard for measuring vaccination coverage."

Dr. Dorell said that she had no relevant financial disclosures.

DENVER – Provider recommendation is strongly associated with initiation of the human papillomavirus vaccine in teenage females, results from a national survey demonstrated.

"It’s important for providers to take the time to counsel and recommend the HPV vaccine and communicate the benefits and the risks of the vaccination, as well as the risk of getting HPV disease as teenagers," Dr. Christina G. Dorell said in an interview during a poster session at the annual meeting of the Pediatric Academic Societies.

Dr. Dorell of the immunization services division at the Centers for Disease Control and Prevention, Atlanta, presented findings from the 2008-2009 National Immunization Survey Teen (NIS-Teen), which was analyzed to determine human papillomavirus (HPV) vaccination coverage among females aged 13-17 years. The NIS-Teen is composed of two parts: a random-digit–dialed telephone survey of parents or guardians of adolescents aged 13-17 years, and a mailed survey to all vaccination providers identified by the parent and for which consent was granted.

The researchers evaluated associations of select socioeconomic characteristics, intention to vaccinate, and HPV status. They used multivariable logistic regression to examine associations while controlling for other factors, including state of residence.

Of the 18,288 females surveyed, 41% received at least one HPV dose. Of those, 53% completed the three-dose series.

The probability of HPV vaccination occurring is 2.6 times higher for adolescents who receive a provider recommendation than for adolescents who do not receive a provider recommendation. Other factors independently associated with HPV vaccine initiation were older age, having a preventive visit at age 11 or 12 years, being eligible for state Children’s Health Insurance Program (CHIP) or Vaccines for Children (VFC) program, having a mother younger than age 34 years, having a mother who never married, and not receiving all vaccines at public facilities.

More than half of white females (60%) completed the vaccination series, compared with 46% of blacks and 40% of Hispanics. Other factors independently associated with completing the vaccination series were having a mother aged 45 or older, being knowledgeable about HPV disease, and not receiving all vaccines at public facilities.

The main reported reasons parents do not intend for their daughters to receive the HPV vaccination in the next 12 months were lack of knowledge (19%), considering it not needed or not necessary (19%), the fact that their daughters were not sexually active (18%), and that they did not receive a provider recommendation (13%).

Dr. Dorell acknowledged certain limitations of the study, including the fact that the telephone portion of the survey was using land line phones only, thus contributing to a noncoverage bias of wireless-only households. It’s also possible that some of the provider data or vaccination histories may be incomplete, she said. However, she pointed out that one of the main strengths of the NIS-Teen "is that it is the only nationally representative survey that reports vaccination coverage estimates from provider-reported data, which is the gold standard for measuring vaccination coverage."

Dr. Dorell said that she had no relevant financial disclosures.

DENVER – Provider recommendation is strongly associated with initiation of the human papillomavirus vaccine in teenage females, results from a national survey demonstrated.

"It’s important for providers to take the time to counsel and recommend the HPV vaccine and communicate the benefits and the risks of the vaccination, as well as the risk of getting HPV disease as teenagers," Dr. Christina G. Dorell said in an interview during a poster session at the annual meeting of the Pediatric Academic Societies.

Dr. Dorell of the immunization services division at the Centers for Disease Control and Prevention, Atlanta, presented findings from the 2008-2009 National Immunization Survey Teen (NIS-Teen), which was analyzed to determine human papillomavirus (HPV) vaccination coverage among females aged 13-17 years. The NIS-Teen is composed of two parts: a random-digit–dialed telephone survey of parents or guardians of adolescents aged 13-17 years, and a mailed survey to all vaccination providers identified by the parent and for which consent was granted.

The researchers evaluated associations of select socioeconomic characteristics, intention to vaccinate, and HPV status. They used multivariable logistic regression to examine associations while controlling for other factors, including state of residence.

Of the 18,288 females surveyed, 41% received at least one HPV dose. Of those, 53% completed the three-dose series.

The probability of HPV vaccination occurring is 2.6 times higher for adolescents who receive a provider recommendation than for adolescents who do not receive a provider recommendation. Other factors independently associated with HPV vaccine initiation were older age, having a preventive visit at age 11 or 12 years, being eligible for state Children’s Health Insurance Program (CHIP) or Vaccines for Children (VFC) program, having a mother younger than age 34 years, having a mother who never married, and not receiving all vaccines at public facilities.

More than half of white females (60%) completed the vaccination series, compared with 46% of blacks and 40% of Hispanics. Other factors independently associated with completing the vaccination series were having a mother aged 45 or older, being knowledgeable about HPV disease, and not receiving all vaccines at public facilities.

The main reported reasons parents do not intend for their daughters to receive the HPV vaccination in the next 12 months were lack of knowledge (19%), considering it not needed or not necessary (19%), the fact that their daughters were not sexually active (18%), and that they did not receive a provider recommendation (13%).

Dr. Dorell acknowledged certain limitations of the study, including the fact that the telephone portion of the survey was using land line phones only, thus contributing to a noncoverage bias of wireless-only households. It’s also possible that some of the provider data or vaccination histories may be incomplete, she said. However, she pointed out that one of the main strengths of the NIS-Teen "is that it is the only nationally representative survey that reports vaccination coverage estimates from provider-reported data, which is the gold standard for measuring vaccination coverage."

Dr. Dorell said that she had no relevant financial disclosures.

DENVER – Provider recommendation is strongly associated with initiation of the human papillomavirus vaccine in teenage females, results from a national survey demonstrated.

"It’s important for providers to take the time to counsel and recommend the HPV vaccine and communicate the benefits and the risks of the vaccination, as well as the risk of getting HPV disease as teenagers," Dr. Christina G. Dorell said in an interview during a poster session at the annual meeting of the Pediatric Academic Societies.

Dr. Dorell of the immunization services division at the Centers for Disease Control and Prevention, Atlanta, presented findings from the 2008-2009 National Immunization Survey Teen (NIS-Teen), which was analyzed to determine human papillomavirus (HPV) vaccination coverage among females aged 13-17 years. The NIS-Teen is composed of two parts: a random-digit–dialed telephone survey of parents or guardians of adolescents aged 13-17 years, and a mailed survey to all vaccination providers identified by the parent and for which consent was granted.

The researchers evaluated associations of select socioeconomic characteristics, intention to vaccinate, and HPV status. They used multivariable logistic regression to examine associations while controlling for other factors, including state of residence.

Of the 18,288 females surveyed, 41% received at least one HPV dose. Of those, 53% completed the three-dose series.

The probability of HPV vaccination occurring is 2.6 times higher for adolescents who receive a provider recommendation than for adolescents who do not receive a provider recommendation. Other factors independently associated with HPV vaccine initiation were older age, having a preventive visit at age 11 or 12 years, being eligible for state Children’s Health Insurance Program (CHIP) or Vaccines for Children (VFC) program, having a mother younger than age 34 years, having a mother who never married, and not receiving all vaccines at public facilities.

More than half of white females (60%) completed the vaccination series, compared with 46% of blacks and 40% of Hispanics. Other factors independently associated with completing the vaccination series were having a mother aged 45 or older, being knowledgeable about HPV disease, and not receiving all vaccines at public facilities.

The main reported reasons parents do not intend for their daughters to receive the HPV vaccination in the next 12 months were lack of knowledge (19%), considering it not needed or not necessary (19%), the fact that their daughters were not sexually active (18%), and that they did not receive a provider recommendation (13%).

Dr. Dorell acknowledged certain limitations of the study, including the fact that the telephone portion of the survey was using land line phones only, thus contributing to a noncoverage bias of wireless-only households. It’s also possible that some of the provider data or vaccination histories may be incomplete, she said. However, she pointed out that one of the main strengths of the NIS-Teen "is that it is the only nationally representative survey that reports vaccination coverage estimates from provider-reported data, which is the gold standard for measuring vaccination coverage."

Dr. Dorell said that she had no relevant financial disclosures.

DENVER – Provider recommendation is strongly associated with initiation of the human papillomavirus vaccine in teenage females, results from a national survey demonstrated.

"It’s important for providers to take the time to counsel and recommend the HPV vaccine and communicate the benefits and the risks of the vaccination, as well as the risk of getting HPV disease as teenagers," Dr. Christina G. Dorell said in an interview during a poster session at the annual meeting of the Pediatric Academic Societies.

Dr. Dorell of the immunization services division at the Centers for Disease Control and Prevention, Atlanta, presented findings from the 2008-2009 National Immunization Survey Teen (NIS-Teen), which was analyzed to determine human papillomavirus (HPV) vaccination coverage among females aged 13-17 years. The NIS-Teen is composed of two parts: a random-digit–dialed telephone survey of parents or guardians of adolescents aged 13-17 years, and a mailed survey to all vaccination providers identified by the parent and for which consent was granted.

The researchers evaluated associations of select socioeconomic characteristics, intention to vaccinate, and HPV status. They used multivariable logistic regression to examine associations while controlling for other factors, including state of residence.

Of the 18,288 females surveyed, 41% received at least one HPV dose. Of those, 53% completed the three-dose series.

The probability of HPV vaccination occurring is 2.6 times higher for adolescents who receive a provider recommendation than for adolescents who do not receive a provider recommendation. Other factors independently associated with HPV vaccine initiation were older age, having a preventive visit at age 11 or 12 years, being eligible for state Children’s Health Insurance Program (CHIP) or Vaccines for Children (VFC) program, having a mother younger than age 34 years, having a mother who never married, and not receiving all vaccines at public facilities.

More than half of white females (60%) completed the vaccination series, compared with 46% of blacks and 40% of Hispanics. Other factors independently associated with completing the vaccination series were having a mother aged 45 or older, being knowledgeable about HPV disease, and not receiving all vaccines at public facilities.

The main reported reasons parents do not intend for their daughters to receive the HPV vaccination in the next 12 months were lack of knowledge (19%), considering it not needed or not necessary (19%), the fact that their daughters were not sexually active (18%), and that they did not receive a provider recommendation (13%).

Dr. Dorell acknowledged certain limitations of the study, including the fact that the telephone portion of the survey was using land line phones only, thus contributing to a noncoverage bias of wireless-only households. It’s also possible that some of the provider data or vaccination histories may be incomplete, she said. However, she pointed out that one of the main strengths of the NIS-Teen "is that it is the only nationally representative survey that reports vaccination coverage estimates from provider-reported data, which is the gold standard for measuring vaccination coverage."

Dr. Dorell said that she had no relevant financial disclosures.

HONOLULU – The way Dr. Robert C. Griggs sees it, neurology lags behind other medical specialties when it comes to practice-based research that emphasizes changing physician and patient behavior to optimize outcomes.

During his presidential address at the annual meeting of the American Academy of Neurology, he said that while surgeons, cardiologists, and other nonneurology specialists have implemented checklists, patient safety measures, system engineering, and outcome reporting, neurologists have been slow to adapt standardized care algorithms.

"I sometimes worry that when our academy practice guidelines state that there’s a lack of evidence [for a certain treatment], we say to ourselves, ‘Great. I can continue to do it my way,’ " said Dr. Griggs, professor of neurology, medicine, pathology, laboratory medicine, and pediatrics at the University of Rochester (N.Y.). "Changing physician and patient behavior has to move to the top of our agenda in order for us to bring the benefits of what we’ve worked hard to do for all of our patients."

He made his remarks while giving a progress report on the categories of T1, T2, and T3 translational science research in the neurology field. He defined T1 as laboratory work that translates the understanding of disease into new diagnostic tests, new treatments, and disease prevention, from mice up to the first work in humans.

"For T1 we’re brilliant" as a field, said Dr. Griggs, who also is a professor in the center for human experimental therapeutics at the university. "We’ve defined hundreds of mutated genes, we can make animal models, and we can find possible treatments off of small molecules that improve a mouse model. We’re not as good yet on gene-modified treatments, but on the whole, we’re confident that we will be able to do it soon."

He defined T2 as translating basic research into clinical trials for a diagnostic test, prevention strategy, or new treatment. This consists of phase 2, 3, and 4 clinical trials and includes cost/benefit analyses, as well as research on disparities and outcomes.

"We’re not quite as good at T2 research as we are in T1 research, but we have many new treatments, some that are truly breakthroughs," Dr. Griggs said. "However, lots of tough questions remain. The big one is dealing with those which we can afford and which we can’t afford, and ultimately who should receive the expensive new treatments."

He described T3 as practice-based research focused on disseminating and implementing research advances, and changing physician and patient behavior through quality and safety measures, checklists, and being mindful of economic and health policy considerations. T3 may be "less familiar territory to neurologists" than T1 or T2 research, he added, but he recommended that it become a priority.

"In preparing this talk over the past 2 years I realized over a year ago that I had not been sufficiently aware of [this] key aspect of treating patients," said Dr. Griggs. "I knew but hadn’t realized how important it is to teach in the context of what has been termed by oncologists as ‘the teachable moment,’ or riding the crest of the teachable moment, taking advantage of the time when a patient is first diagnosed, to get your messages across to the patient and to their family and friends. How do we get our patients to do what they should, take what they should, prevent what they should? How do we change neurologist behavior so that they set a high priority on changing the behaviors of patients?"

One easy way to implement T3 research into your clinical practice, he said, is to advise your patients to follow the American Heart Association’s "Life’s Simple 7" ways to prevent stroke. Those seven steps are get active, control cholesterol, eat better, manage blood pressure, lose weight, reduce blood sugar, and stop smoking.

"We see hundreds of patients who are worried about having a stroke, and hundreds of patients who have had a stroke," Dr. Griggs said. Imparting this recommendation is a "teachable moment."

Dr. Griggs said that he had no relevant financial disclosures.

HONOLULU – The way Dr. Robert C. Griggs sees it, neurology lags behind other medical specialties when it comes to practice-based research that emphasizes changing physician and patient behavior to optimize outcomes.

During his presidential address at the annual meeting of the American Academy of Neurology, he said that while surgeons, cardiologists, and other nonneurology specialists have implemented checklists, patient safety measures, system engineering, and outcome reporting, neurologists have been slow to adapt standardized care algorithms.

"I sometimes worry that when our academy practice guidelines state that there’s a lack of evidence [for a certain treatment], we say to ourselves, ‘Great. I can continue to do it my way,’ " said Dr. Griggs, professor of neurology, medicine, pathology, laboratory medicine, and pediatrics at the University of Rochester (N.Y.). "Changing physician and patient behavior has to move to the top of our agenda in order for us to bring the benefits of what we’ve worked hard to do for all of our patients."

He made his remarks while giving a progress report on the categories of T1, T2, and T3 translational science research in the neurology field. He defined T1 as laboratory work that translates the understanding of disease into new diagnostic tests, new treatments, and disease prevention, from mice up to the first work in humans.

"For T1 we’re brilliant" as a field, said Dr. Griggs, who also is a professor in the center for human experimental therapeutics at the university. "We’ve defined hundreds of mutated genes, we can make animal models, and we can find possible treatments off of small molecules that improve a mouse model. We’re not as good yet on gene-modified treatments, but on the whole, we’re confident that we will be able to do it soon."

He defined T2 as translating basic research into clinical trials for a diagnostic test, prevention strategy, or new treatment. This consists of phase 2, 3, and 4 clinical trials and includes cost/benefit analyses, as well as research on disparities and outcomes.

"We’re not quite as good at T2 research as we are in T1 research, but we have many new treatments, some that are truly breakthroughs," Dr. Griggs said. "However, lots of tough questions remain. The big one is dealing with those which we can afford and which we can’t afford, and ultimately who should receive the expensive new treatments."

He described T3 as practice-based research focused on disseminating and implementing research advances, and changing physician and patient behavior through quality and safety measures, checklists, and being mindful of economic and health policy considerations. T3 may be "less familiar territory to neurologists" than T1 or T2 research, he added, but he recommended that it become a priority.

"In preparing this talk over the past 2 years I realized over a year ago that I had not been sufficiently aware of [this] key aspect of treating patients," said Dr. Griggs. "I knew but hadn’t realized how important it is to teach in the context of what has been termed by oncologists as ‘the teachable moment,’ or riding the crest of the teachable moment, taking advantage of the time when a patient is first diagnosed, to get your messages across to the patient and to their family and friends. How do we get our patients to do what they should, take what they should, prevent what they should? How do we change neurologist behavior so that they set a high priority on changing the behaviors of patients?"

One easy way to implement T3 research into your clinical practice, he said, is to advise your patients to follow the American Heart Association’s "Life’s Simple 7" ways to prevent stroke. Those seven steps are get active, control cholesterol, eat better, manage blood pressure, lose weight, reduce blood sugar, and stop smoking.

"We see hundreds of patients who are worried about having a stroke, and hundreds of patients who have had a stroke," Dr. Griggs said. Imparting this recommendation is a "teachable moment."

Dr. Griggs said that he had no relevant financial disclosures.

HONOLULU – The way Dr. Robert C. Griggs sees it, neurology lags behind other medical specialties when it comes to practice-based research that emphasizes changing physician and patient behavior to optimize outcomes.

During his presidential address at the annual meeting of the American Academy of Neurology, he said that while surgeons, cardiologists, and other nonneurology specialists have implemented checklists, patient safety measures, system engineering, and outcome reporting, neurologists have been slow to adapt standardized care algorithms.

"I sometimes worry that when our academy practice guidelines state that there’s a lack of evidence [for a certain treatment], we say to ourselves, ‘Great. I can continue to do it my way,’ " said Dr. Griggs, professor of neurology, medicine, pathology, laboratory medicine, and pediatrics at the University of Rochester (N.Y.). "Changing physician and patient behavior has to move to the top of our agenda in order for us to bring the benefits of what we’ve worked hard to do for all of our patients."

He made his remarks while giving a progress report on the categories of T1, T2, and T3 translational science research in the neurology field. He defined T1 as laboratory work that translates the understanding of disease into new diagnostic tests, new treatments, and disease prevention, from mice up to the first work in humans.

"For T1 we’re brilliant" as a field, said Dr. Griggs, who also is a professor in the center for human experimental therapeutics at the university. "We’ve defined hundreds of mutated genes, we can make animal models, and we can find possible treatments off of small molecules that improve a mouse model. We’re not as good yet on gene-modified treatments, but on the whole, we’re confident that we will be able to do it soon."

He defined T2 as translating basic research into clinical trials for a diagnostic test, prevention strategy, or new treatment. This consists of phase 2, 3, and 4 clinical trials and includes cost/benefit analyses, as well as research on disparities and outcomes.

"We’re not quite as good at T2 research as we are in T1 research, but we have many new treatments, some that are truly breakthroughs," Dr. Griggs said. "However, lots of tough questions remain. The big one is dealing with those which we can afford and which we can’t afford, and ultimately who should receive the expensive new treatments."

He described T3 as practice-based research focused on disseminating and implementing research advances, and changing physician and patient behavior through quality and safety measures, checklists, and being mindful of economic and health policy considerations. T3 may be "less familiar territory to neurologists" than T1 or T2 research, he added, but he recommended that it become a priority.

"In preparing this talk over the past 2 years I realized over a year ago that I had not been sufficiently aware of [this] key aspect of treating patients," said Dr. Griggs. "I knew but hadn’t realized how important it is to teach in the context of what has been termed by oncologists as ‘the teachable moment,’ or riding the crest of the teachable moment, taking advantage of the time when a patient is first diagnosed, to get your messages across to the patient and to their family and friends. How do we get our patients to do what they should, take what they should, prevent what they should? How do we change neurologist behavior so that they set a high priority on changing the behaviors of patients?"

One easy way to implement T3 research into your clinical practice, he said, is to advise your patients to follow the American Heart Association’s "Life’s Simple 7" ways to prevent stroke. Those seven steps are get active, control cholesterol, eat better, manage blood pressure, lose weight, reduce blood sugar, and stop smoking.

"We see hundreds of patients who are worried about having a stroke, and hundreds of patients who have had a stroke," Dr. Griggs said. Imparting this recommendation is a "teachable moment."

Dr. Griggs said that he had no relevant financial disclosures.

HONOLULU – The way Dr. Robert C. Griggs sees it, neurology lags behind other medical specialties when it comes to practice-based research that emphasizes changing physician and patient behavior to optimize outcomes.

During his presidential address at the annual meeting of the American Academy of Neurology, he said that while surgeons, cardiologists, and other nonneurology specialists have implemented checklists, patient safety measures, system engineering, and outcome reporting, neurologists have been slow to adapt standardized care algorithms.

"I sometimes worry that when our academy practice guidelines state that there’s a lack of evidence [for a certain treatment], we say to ourselves, ‘Great. I can continue to do it my way,’ " said Dr. Griggs, professor of neurology, medicine, pathology, laboratory medicine, and pediatrics at the University of Rochester (N.Y.). "Changing physician and patient behavior has to move to the top of our agenda in order for us to bring the benefits of what we’ve worked hard to do for all of our patients."

He made his remarks while giving a progress report on the categories of T1, T2, and T3 translational science research in the neurology field. He defined T1 as laboratory work that translates the understanding of disease into new diagnostic tests, new treatments, and disease prevention, from mice up to the first work in humans.

"For T1 we’re brilliant" as a field, said Dr. Griggs, who also is a professor in the center for human experimental therapeutics at the university. "We’ve defined hundreds of mutated genes, we can make animal models, and we can find possible treatments off of small molecules that improve a mouse model. We’re not as good yet on gene-modified treatments, but on the whole, we’re confident that we will be able to do it soon."

He defined T2 as translating basic research into clinical trials for a diagnostic test, prevention strategy, or new treatment. This consists of phase 2, 3, and 4 clinical trials and includes cost/benefit analyses, as well as research on disparities and outcomes.

"We’re not quite as good at T2 research as we are in T1 research, but we have many new treatments, some that are truly breakthroughs," Dr. Griggs said. "However, lots of tough questions remain. The big one is dealing with those which we can afford and which we can’t afford, and ultimately who should receive the expensive new treatments."

He described T3 as practice-based research focused on disseminating and implementing research advances, and changing physician and patient behavior through quality and safety measures, checklists, and being mindful of economic and health policy considerations. T3 may be "less familiar territory to neurologists" than T1 or T2 research, he added, but he recommended that it become a priority.

"In preparing this talk over the past 2 years I realized over a year ago that I had not been sufficiently aware of [this] key aspect of treating patients," said Dr. Griggs. "I knew but hadn’t realized how important it is to teach in the context of what has been termed by oncologists as ‘the teachable moment,’ or riding the crest of the teachable moment, taking advantage of the time when a patient is first diagnosed, to get your messages across to the patient and to their family and friends. How do we get our patients to do what they should, take what they should, prevent what they should? How do we change neurologist behavior so that they set a high priority on changing the behaviors of patients?"

One easy way to implement T3 research into your clinical practice, he said, is to advise your patients to follow the American Heart Association’s "Life’s Simple 7" ways to prevent stroke. Those seven steps are get active, control cholesterol, eat better, manage blood pressure, lose weight, reduce blood sugar, and stop smoking.

"We see hundreds of patients who are worried about having a stroke, and hundreds of patients who have had a stroke," Dr. Griggs said. Imparting this recommendation is a "teachable moment."

Dr. Griggs said that he had no relevant financial disclosures.

HONOLULU – The way Dr. Robert C. Griggs sees it, neurology lags behind other medical specialties when it comes to practice-based research that emphasizes changing physician and patient behavior to optimize outcomes.

During his presidential address at the annual meeting of the American Academy of Neurology, he said that while surgeons, cardiologists, and other nonneurology specialists have implemented checklists, patient safety measures, system engineering, and outcome reporting, neurologists have been slow to adapt standardized care algorithms.

"I sometimes worry that when our academy practice guidelines state that there’s a lack of evidence [for a certain treatment], we say to ourselves, ‘Great. I can continue to do it my way,’ " said Dr. Griggs, professor of neurology, medicine, pathology, laboratory medicine, and pediatrics at the University of Rochester (N.Y.). "Changing physician and patient behavior has to move to the top of our agenda in order for us to bring the benefits of what we’ve worked hard to do for all of our patients."

He made his remarks while giving a progress report on the categories of T1, T2, and T3 translational science research in the neurology field. He defined T1 as laboratory work that translates the understanding of disease into new diagnostic tests, new treatments, and disease prevention, from mice up to the first work in humans.

"For T1 we’re brilliant" as a field, said Dr. Griggs, who also is a professor in the center for human experimental therapeutics at the university. "We’ve defined hundreds of mutated genes, we can make animal models, and we can find possible treatments off of small molecules that improve a mouse model. We’re not as good yet on gene-modified treatments, but on the whole, we’re confident that we will be able to do it soon."

He defined T2 as translating basic research into clinical trials for a diagnostic test, prevention strategy, or new treatment. This consists of phase 2, 3, and 4 clinical trials and includes cost/benefit analyses, as well as research on disparities and outcomes.

"We’re not quite as good at T2 research as we are in T1 research, but we have many new treatments, some that are truly breakthroughs," Dr. Griggs said. "However, lots of tough questions remain. The big one is dealing with those which we can afford and which we can’t afford, and ultimately who should receive the expensive new treatments."

He described T3 as practice-based research focused on disseminating and implementing research advances, and changing physician and patient behavior through quality and safety measures, checklists, and being mindful of economic and health policy considerations. T3 may be "less familiar territory to neurologists" than T1 or T2 research, he added, but he recommended that it become a priority.

"In preparing this talk over the past 2 years I realized over a year ago that I had not been sufficiently aware of [this] key aspect of treating patients," said Dr. Griggs. "I knew but hadn’t realized how important it is to teach in the context of what has been termed by oncologists as ‘the teachable moment,’ or riding the crest of the teachable moment, taking advantage of the time when a patient is first diagnosed, to get your messages across to the patient and to their family and friends. How do we get our patients to do what they should, take what they should, prevent what they should? How do we change neurologist behavior so that they set a high priority on changing the behaviors of patients?"

One easy way to implement T3 research into your clinical practice, he said, is to advise your patients to follow the American Heart Association’s "Life’s Simple 7" ways to prevent stroke. Those seven steps are get active, control cholesterol, eat better, manage blood pressure, lose weight, reduce blood sugar, and stop smoking.

"We see hundreds of patients who are worried about having a stroke, and hundreds of patients who have had a stroke," Dr. Griggs said. Imparting this recommendation is a "teachable moment."

Dr. Griggs said that he had no relevant financial disclosures.

HONOLULU – The way Dr. Robert C. Griggs sees it, neurology lags behind other medical specialties when it comes to practice-based research that emphasizes changing physician and patient behavior to optimize outcomes.

During his presidential address at the annual meeting of the American Academy of Neurology, he said that while surgeons, cardiologists, and other nonneurology specialists have implemented checklists, patient safety measures, system engineering, and outcome reporting, neurologists have been slow to adapt standardized care algorithms.

"I sometimes worry that when our academy practice guidelines state that there’s a lack of evidence [for a certain treatment], we say to ourselves, ‘Great. I can continue to do it my way,’ " said Dr. Griggs, professor of neurology, medicine, pathology, laboratory medicine, and pediatrics at the University of Rochester (N.Y.). "Changing physician and patient behavior has to move to the top of our agenda in order for us to bring the benefits of what we’ve worked hard to do for all of our patients."

He made his remarks while giving a progress report on the categories of T1, T2, and T3 translational science research in the neurology field. He defined T1 as laboratory work that translates the understanding of disease into new diagnostic tests, new treatments, and disease prevention, from mice up to the first work in humans.

"For T1 we’re brilliant" as a field, said Dr. Griggs, who also is a professor in the center for human experimental therapeutics at the university. "We’ve defined hundreds of mutated genes, we can make animal models, and we can find possible treatments off of small molecules that improve a mouse model. We’re not as good yet on gene-modified treatments, but on the whole, we’re confident that we will be able to do it soon."

He defined T2 as translating basic research into clinical trials for a diagnostic test, prevention strategy, or new treatment. This consists of phase 2, 3, and 4 clinical trials and includes cost/benefit analyses, as well as research on disparities and outcomes.

"We’re not quite as good at T2 research as we are in T1 research, but we have many new treatments, some that are truly breakthroughs," Dr. Griggs said. "However, lots of tough questions remain. The big one is dealing with those which we can afford and which we can’t afford, and ultimately who should receive the expensive new treatments."

He described T3 as practice-based research focused on disseminating and implementing research advances, and changing physician and patient behavior through quality and safety measures, checklists, and being mindful of economic and health policy considerations. T3 may be "less familiar territory to neurologists" than T1 or T2 research, he added, but he recommended that it become a priority.

"In preparing this talk over the past 2 years I realized over a year ago that I had not been sufficiently aware of [this] key aspect of treating patients," said Dr. Griggs. "I knew but hadn’t realized how important it is to teach in the context of what has been termed by oncologists as ‘the teachable moment,’ or riding the crest of the teachable moment, taking advantage of the time when a patient is first diagnosed, to get your messages across to the patient and to their family and friends. How do we get our patients to do what they should, take what they should, prevent what they should? How do we change neurologist behavior so that they set a high priority on changing the behaviors of patients?"

One easy way to implement T3 research into your clinical practice, he said, is to advise your patients to follow the American Heart Association’s "Life’s Simple 7" ways to prevent stroke. Those seven steps are get active, control cholesterol, eat better, manage blood pressure, lose weight, reduce blood sugar, and stop smoking.

"We see hundreds of patients who are worried about having a stroke, and hundreds of patients who have had a stroke," Dr. Griggs said. Imparting this recommendation is a "teachable moment."

Dr. Griggs said that he had no relevant financial disclosures.

HONOLULU – The way Dr. Robert C. Griggs sees it, neurology lags behind other medical specialties when it comes to practice-based research that emphasizes changing physician and patient behavior to optimize outcomes.

During his presidential address at the annual meeting of the American Academy of Neurology, he said that while surgeons, cardiologists, and other nonneurology specialists have implemented checklists, patient safety measures, system engineering, and outcome reporting, neurologists have been slow to adapt standardized care algorithms.

"I sometimes worry that when our academy practice guidelines state that there’s a lack of evidence [for a certain treatment], we say to ourselves, ‘Great. I can continue to do it my way,’ " said Dr. Griggs, professor of neurology, medicine, pathology, laboratory medicine, and pediatrics at the University of Rochester (N.Y.). "Changing physician and patient behavior has to move to the top of our agenda in order for us to bring the benefits of what we’ve worked hard to do for all of our patients."

He made his remarks while giving a progress report on the categories of T1, T2, and T3 translational science research in the neurology field. He defined T1 as laboratory work that translates the understanding of disease into new diagnostic tests, new treatments, and disease prevention, from mice up to the first work in humans.

"For T1 we’re brilliant" as a field, said Dr. Griggs, who also is a professor in the center for human experimental therapeutics at the university. "We’ve defined hundreds of mutated genes, we can make animal models, and we can find possible treatments off of small molecules that improve a mouse model. We’re not as good yet on gene-modified treatments, but on the whole, we’re confident that we will be able to do it soon."

He defined T2 as translating basic research into clinical trials for a diagnostic test, prevention strategy, or new treatment. This consists of phase 2, 3, and 4 clinical trials and includes cost/benefit analyses, as well as research on disparities and outcomes.

"We’re not quite as good at T2 research as we are in T1 research, but we have many new treatments, some that are truly breakthroughs," Dr. Griggs said. "However, lots of tough questions remain. The big one is dealing with those which we can afford and which we can’t afford, and ultimately who should receive the expensive new treatments."

He described T3 as practice-based research focused on disseminating and implementing research advances, and changing physician and patient behavior through quality and safety measures, checklists, and being mindful of economic and health policy considerations. T3 may be "less familiar territory to neurologists" than T1 or T2 research, he added, but he recommended that it become a priority.

"In preparing this talk over the past 2 years I realized over a year ago that I had not been sufficiently aware of [this] key aspect of treating patients," said Dr. Griggs. "I knew but hadn’t realized how important it is to teach in the context of what has been termed by oncologists as ‘the teachable moment,’ or riding the crest of the teachable moment, taking advantage of the time when a patient is first diagnosed, to get your messages across to the patient and to their family and friends. How do we get our patients to do what they should, take what they should, prevent what they should? How do we change neurologist behavior so that they set a high priority on changing the behaviors of patients?"

One easy way to implement T3 research into your clinical practice, he said, is to advise your patients to follow the American Heart Association’s "Life’s Simple 7" ways to prevent stroke. Those seven steps are get active, control cholesterol, eat better, manage blood pressure, lose weight, reduce blood sugar, and stop smoking.

"We see hundreds of patients who are worried about having a stroke, and hundreds of patients who have had a stroke," Dr. Griggs said. Imparting this recommendation is a "teachable moment."

Dr. Griggs said that he had no relevant financial disclosures.

HONOLULU – The way Dr. Robert C. Griggs sees it, neurology lags behind other medical specialties when it comes to practice-based research that emphasizes changing physician and patient behavior to optimize outcomes.

During his presidential address at the annual meeting of the American Academy of Neurology, he said that while surgeons, cardiologists, and other nonneurology specialists have implemented checklists, patient safety measures, system engineering, and outcome reporting, neurologists have been slow to adapt standardized care algorithms.

"I sometimes worry that when our academy practice guidelines state that there’s a lack of evidence [for a certain treatment], we say to ourselves, ‘Great. I can continue to do it my way,’ " said Dr. Griggs, professor of neurology, medicine, pathology, laboratory medicine, and pediatrics at the University of Rochester (N.Y.). "Changing physician and patient behavior has to move to the top of our agenda in order for us to bring the benefits of what we’ve worked hard to do for all of our patients."

He made his remarks while giving a progress report on the categories of T1, T2, and T3 translational science research in the neurology field. He defined T1 as laboratory work that translates the understanding of disease into new diagnostic tests, new treatments, and disease prevention, from mice up to the first work in humans.

"For T1 we’re brilliant" as a field, said Dr. Griggs, who also is a professor in the center for human experimental therapeutics at the university. "We’ve defined hundreds of mutated genes, we can make animal models, and we can find possible treatments off of small molecules that improve a mouse model. We’re not as good yet on gene-modified treatments, but on the whole, we’re confident that we will be able to do it soon."

He defined T2 as translating basic research into clinical trials for a diagnostic test, prevention strategy, or new treatment. This consists of phase 2, 3, and 4 clinical trials and includes cost/benefit analyses, as well as research on disparities and outcomes.

"We’re not quite as good at T2 research as we are in T1 research, but we have many new treatments, some that are truly breakthroughs," Dr. Griggs said. "However, lots of tough questions remain. The big one is dealing with those which we can afford and which we can’t afford, and ultimately who should receive the expensive new treatments."

He described T3 as practice-based research focused on disseminating and implementing research advances, and changing physician and patient behavior through quality and safety measures, checklists, and being mindful of economic and health policy considerations. T3 may be "less familiar territory to neurologists" than T1 or T2 research, he added, but he recommended that it become a priority.

"In preparing this talk over the past 2 years I realized over a year ago that I had not been sufficiently aware of [this] key aspect of treating patients," said Dr. Griggs. "I knew but hadn’t realized how important it is to teach in the context of what has been termed by oncologists as ‘the teachable moment,’ or riding the crest of the teachable moment, taking advantage of the time when a patient is first diagnosed, to get your messages across to the patient and to their family and friends. How do we get our patients to do what they should, take what they should, prevent what they should? How do we change neurologist behavior so that they set a high priority on changing the behaviors of patients?"

One easy way to implement T3 research into your clinical practice, he said, is to advise your patients to follow the American Heart Association’s "Life’s Simple 7" ways to prevent stroke. Those seven steps are get active, control cholesterol, eat better, manage blood pressure, lose weight, reduce blood sugar, and stop smoking.

"We see hundreds of patients who are worried about having a stroke, and hundreds of patients who have had a stroke," Dr. Griggs said. Imparting this recommendation is a "teachable moment."

Dr. Griggs said that he had no relevant financial disclosures.

HONOLULU – The way Dr. Robert C. Griggs sees it, neurology lags behind other medical specialties when it comes to practice-based research that emphasizes changing physician and patient behavior to optimize outcomes.

During his presidential address at the annual meeting of the American Academy of Neurology, he said that while surgeons, cardiologists, and other nonneurology specialists have implemented checklists, patient safety measures, system engineering, and outcome reporting, neurologists have been slow to adapt standardized care algorithms.

"I sometimes worry that when our academy practice guidelines state that there’s a lack of evidence [for a certain treatment], we say to ourselves, ‘Great. I can continue to do it my way,’ " said Dr. Griggs, professor of neurology, medicine, pathology, laboratory medicine, and pediatrics at the University of Rochester (N.Y.). "Changing physician and patient behavior has to move to the top of our agenda in order for us to bring the benefits of what we’ve worked hard to do for all of our patients."

He made his remarks while giving a progress report on the categories of T1, T2, and T3 translational science research in the neurology field. He defined T1 as laboratory work that translates the understanding of disease into new diagnostic tests, new treatments, and disease prevention, from mice up to the first work in humans.

"For T1 we’re brilliant" as a field, said Dr. Griggs, who also is a professor in the center for human experimental therapeutics at the university. "We’ve defined hundreds of mutated genes, we can make animal models, and we can find possible treatments off of small molecules that improve a mouse model. We’re not as good yet on gene-modified treatments, but on the whole, we’re confident that we will be able to do it soon."

He defined T2 as translating basic research into clinical trials for a diagnostic test, prevention strategy, or new treatment. This consists of phase 2, 3, and 4 clinical trials and includes cost/benefit analyses, as well as research on disparities and outcomes.

"We’re not quite as good at T2 research as we are in T1 research, but we have many new treatments, some that are truly breakthroughs," Dr. Griggs said. "However, lots of tough questions remain. The big one is dealing with those which we can afford and which we can’t afford, and ultimately who should receive the expensive new treatments."

He described T3 as practice-based research focused on disseminating and implementing research advances, and changing physician and patient behavior through quality and safety measures, checklists, and being mindful of economic and health policy considerations. T3 may be "less familiar territory to neurologists" than T1 or T2 research, he added, but he recommended that it become a priority.

"In preparing this talk over the past 2 years I realized over a year ago that I had not been sufficiently aware of [this] key aspect of treating patients," said Dr. Griggs. "I knew but hadn’t realized how important it is to teach in the context of what has been termed by oncologists as ‘the teachable moment,’ or riding the crest of the teachable moment, taking advantage of the time when a patient is first diagnosed, to get your messages across to the patient and to their family and friends. How do we get our patients to do what they should, take what they should, prevent what they should? How do we change neurologist behavior so that they set a high priority on changing the behaviors of patients?"

One easy way to implement T3 research into your clinical practice, he said, is to advise your patients to follow the American Heart Association’s "Life’s Simple 7" ways to prevent stroke. Those seven steps are get active, control cholesterol, eat better, manage blood pressure, lose weight, reduce blood sugar, and stop smoking.

"We see hundreds of patients who are worried about having a stroke, and hundreds of patients who have had a stroke," Dr. Griggs said. Imparting this recommendation is a "teachable moment."

Dr. Griggs said that he had no relevant financial disclosures.

HONOLULU – Certain maternal autoantibodies are associated with the development of autism spectrum disorders, results from a large ongoing analysis demonstrate.

The finding lays the groundwork for an eventual diagnostic test for autism, Judy Van de Water, Ph.D., said at the annual meeting of the American Academy of Neurology.

"Currently there is no biologic marker for autism," said Dr. Van de Water, an immunologist at the University of California, Davis. "It’s completely defined by behaviors."

The maternal immune response in autism is of interest to researchers because of its role in neurodevelopment. "Maternal IgG isotype antibodies readily cross the placenta and are known to persist for up to 6 months postnatally in the child," Dr. Van de Water said. "In addition, maternal antibodies have been shown to cause changes in fetal development in several known autoimmune disorders, such as SLE."

In 2002, Dr. Van de Water and her associates began to collect blood samples from families as part of the Childhood Autism Risk from Genetics and the Environment (CHARGE) study. They sampled the study population from three groups of children aged 2-5 years: children with autism (currently includes more than 800 families); typically developing children without autism or other developmental disabilities selected from the general population (currently 600 families enrolled); and children with developmental disabilities without autism (currently 220 families enrolled).

In the original experimental design, Western blots against human fetal brain protein were performed with 61 mothers of children with autism (36 regressive and 25 early onset), 40 mothers of children with developmental delay, and 62 mothers of typically developing children. The mothers were matched for age and parity (Neurotoxicology 2008;29:226-31). The investigators found that seven mothers of children with autism (12%) had IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa. "We did not see this pattern in the typically developing controls or in the developmentally delayed population, so this seemed to be very specific for autism," Dr. Van de Water said.

Analysis of autoantibody profiles of an additional 458 mothers – 204 mothers of children diagnosed with autism, 71 mothers of children diagnosed with an autism spectrum disorder, and 183 mothers of typically developing children – continues to yield highly significant associations between the presence of IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa and a diagnosis of full autism. Dr. Van de Water and her associates also discovered an association between the 39kDa and 73kDa bands and a diagnosis of the broader autism phenotype, "though this pattern is less frequent in the full autism group," she said. Some mothers had reactivity to fetal brain proteins at all three bands.

"We think we may have a very interesting biomarker, but is there a pathologic significance to these antibodies?" she asked. To find out, the researchers analyzed behavioral characteristics associated with maternal antibodies to fetal brain proteins. Children of mothers who demonstrated reactivity at bands 37kDa and 73kDa had less expressive language based on the Expressive Language Scale of the Mullen Scales of Early Learning. Similar results were seen in children of mothers who demonstrated reactivity at all three bands. In contrast, children of mothers who demonstrated reactivity at bands 39kDa and 73kDa had higher scores on the Aberrant Behavior Checklist irritability subscale, "so we can see that we’re starting to phenotypically separate these children."

A pilot study in monkeys conducted by Dr. Van de Water and her associates demonstrated behavioral changes in offspring following passive transfer of maternal IgG during the late first and early second trimesters (Brain Behav. Immun. 2008;22:806-16). Subsequent studies have confirmed that passive transfer of these antibodies into an animal model can recapitulate some behaviors characteristic of autism. More confirmatory studies are underway.

"We are currently verifying the identity of the protein antigens recognized by these autoantibodies," Dr. Van de Water said. "We intend to develop a preconception test to use for mothers at risk of having a second child with autism."

Dr. Van de Water disclosed that she has received personal compensation for activities with Pediatric Bioscience as a consultant, and holds stock and/or stock options in the company. She has also received royalty payments from the University of California, Davis.

HONOLULU – Certain maternal autoantibodies are associated with the development of autism spectrum disorders, results from a large ongoing analysis demonstrate.

The finding lays the groundwork for an eventual diagnostic test for autism, Judy Van de Water, Ph.D., said at the annual meeting of the American Academy of Neurology.

"Currently there is no biologic marker for autism," said Dr. Van de Water, an immunologist at the University of California, Davis. "It’s completely defined by behaviors."

The maternal immune response in autism is of interest to researchers because of its role in neurodevelopment. "Maternal IgG isotype antibodies readily cross the placenta and are known to persist for up to 6 months postnatally in the child," Dr. Van de Water said. "In addition, maternal antibodies have been shown to cause changes in fetal development in several known autoimmune disorders, such as SLE."

In 2002, Dr. Van de Water and her associates began to collect blood samples from families as part of the Childhood Autism Risk from Genetics and the Environment (CHARGE) study. They sampled the study population from three groups of children aged 2-5 years: children with autism (currently includes more than 800 families); typically developing children without autism or other developmental disabilities selected from the general population (currently 600 families enrolled); and children with developmental disabilities without autism (currently 220 families enrolled).

In the original experimental design, Western blots against human fetal brain protein were performed with 61 mothers of children with autism (36 regressive and 25 early onset), 40 mothers of children with developmental delay, and 62 mothers of typically developing children. The mothers were matched for age and parity (Neurotoxicology 2008;29:226-31). The investigators found that seven mothers of children with autism (12%) had IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa. "We did not see this pattern in the typically developing controls or in the developmentally delayed population, so this seemed to be very specific for autism," Dr. Van de Water said.

Analysis of autoantibody profiles of an additional 458 mothers – 204 mothers of children diagnosed with autism, 71 mothers of children diagnosed with an autism spectrum disorder, and 183 mothers of typically developing children – continues to yield highly significant associations between the presence of IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa and a diagnosis of full autism. Dr. Van de Water and her associates also discovered an association between the 39kDa and 73kDa bands and a diagnosis of the broader autism phenotype, "though this pattern is less frequent in the full autism group," she said. Some mothers had reactivity to fetal brain proteins at all three bands.

"We think we may have a very interesting biomarker, but is there a pathologic significance to these antibodies?" she asked. To find out, the researchers analyzed behavioral characteristics associated with maternal antibodies to fetal brain proteins. Children of mothers who demonstrated reactivity at bands 37kDa and 73kDa had less expressive language based on the Expressive Language Scale of the Mullen Scales of Early Learning. Similar results were seen in children of mothers who demonstrated reactivity at all three bands. In contrast, children of mothers who demonstrated reactivity at bands 39kDa and 73kDa had higher scores on the Aberrant Behavior Checklist irritability subscale, "so we can see that we’re starting to phenotypically separate these children."

A pilot study in monkeys conducted by Dr. Van de Water and her associates demonstrated behavioral changes in offspring following passive transfer of maternal IgG during the late first and early second trimesters (Brain Behav. Immun. 2008;22:806-16). Subsequent studies have confirmed that passive transfer of these antibodies into an animal model can recapitulate some behaviors characteristic of autism. More confirmatory studies are underway.

"We are currently verifying the identity of the protein antigens recognized by these autoantibodies," Dr. Van de Water said. "We intend to develop a preconception test to use for mothers at risk of having a second child with autism."

Dr. Van de Water disclosed that she has received personal compensation for activities with Pediatric Bioscience as a consultant, and holds stock and/or stock options in the company. She has also received royalty payments from the University of California, Davis.

HONOLULU – Certain maternal autoantibodies are associated with the development of autism spectrum disorders, results from a large ongoing analysis demonstrate.

The finding lays the groundwork for an eventual diagnostic test for autism, Judy Van de Water, Ph.D., said at the annual meeting of the American Academy of Neurology.

"Currently there is no biologic marker for autism," said Dr. Van de Water, an immunologist at the University of California, Davis. "It’s completely defined by behaviors."

The maternal immune response in autism is of interest to researchers because of its role in neurodevelopment. "Maternal IgG isotype antibodies readily cross the placenta and are known to persist for up to 6 months postnatally in the child," Dr. Van de Water said. "In addition, maternal antibodies have been shown to cause changes in fetal development in several known autoimmune disorders, such as SLE."

In 2002, Dr. Van de Water and her associates began to collect blood samples from families as part of the Childhood Autism Risk from Genetics and the Environment (CHARGE) study. They sampled the study population from three groups of children aged 2-5 years: children with autism (currently includes more than 800 families); typically developing children without autism or other developmental disabilities selected from the general population (currently 600 families enrolled); and children with developmental disabilities without autism (currently 220 families enrolled).

In the original experimental design, Western blots against human fetal brain protein were performed with 61 mothers of children with autism (36 regressive and 25 early onset), 40 mothers of children with developmental delay, and 62 mothers of typically developing children. The mothers were matched for age and parity (Neurotoxicology 2008;29:226-31). The investigators found that seven mothers of children with autism (12%) had IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa. "We did not see this pattern in the typically developing controls or in the developmentally delayed population, so this seemed to be very specific for autism," Dr. Van de Water said.

Analysis of autoantibody profiles of an additional 458 mothers – 204 mothers of children diagnosed with autism, 71 mothers of children diagnosed with an autism spectrum disorder, and 183 mothers of typically developing children – continues to yield highly significant associations between the presence of IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa and a diagnosis of full autism. Dr. Van de Water and her associates also discovered an association between the 39kDa and 73kDa bands and a diagnosis of the broader autism phenotype, "though this pattern is less frequent in the full autism group," she said. Some mothers had reactivity to fetal brain proteins at all three bands.

"We think we may have a very interesting biomarker, but is there a pathologic significance to these antibodies?" she asked. To find out, the researchers analyzed behavioral characteristics associated with maternal antibodies to fetal brain proteins. Children of mothers who demonstrated reactivity at bands 37kDa and 73kDa had less expressive language based on the Expressive Language Scale of the Mullen Scales of Early Learning. Similar results were seen in children of mothers who demonstrated reactivity at all three bands. In contrast, children of mothers who demonstrated reactivity at bands 39kDa and 73kDa had higher scores on the Aberrant Behavior Checklist irritability subscale, "so we can see that we’re starting to phenotypically separate these children."

A pilot study in monkeys conducted by Dr. Van de Water and her associates demonstrated behavioral changes in offspring following passive transfer of maternal IgG during the late first and early second trimesters (Brain Behav. Immun. 2008;22:806-16). Subsequent studies have confirmed that passive transfer of these antibodies into an animal model can recapitulate some behaviors characteristic of autism. More confirmatory studies are underway.

"We are currently verifying the identity of the protein antigens recognized by these autoantibodies," Dr. Van de Water said. "We intend to develop a preconception test to use for mothers at risk of having a second child with autism."

Dr. Van de Water disclosed that she has received personal compensation for activities with Pediatric Bioscience as a consultant, and holds stock and/or stock options in the company. She has also received royalty payments from the University of California, Davis.

HONOLULU – Certain maternal autoantibodies are associated with the development of autism spectrum disorders, results from a large ongoing analysis demonstrate.

The finding lays the groundwork for an eventual diagnostic test for autism, Judy Van de Water, Ph.D., said at the annual meeting of the American Academy of Neurology.

"Currently there is no biologic marker for autism," said Dr. Van de Water, an immunologist at the University of California, Davis. "It’s completely defined by behaviors."

The maternal immune response in autism is of interest to researchers because of its role in neurodevelopment. "Maternal IgG isotype antibodies readily cross the placenta and are known to persist for up to 6 months postnatally in the child," Dr. Van de Water said. "In addition, maternal antibodies have been shown to cause changes in fetal development in several known autoimmune disorders, such as SLE."

In 2002, Dr. Van de Water and her associates began to collect blood samples from families as part of the Childhood Autism Risk from Genetics and the Environment (CHARGE) study. They sampled the study population from three groups of children aged 2-5 years: children with autism (currently includes more than 800 families); typically developing children without autism or other developmental disabilities selected from the general population (currently 600 families enrolled); and children with developmental disabilities without autism (currently 220 families enrolled).

In the original experimental design, Western blots against human fetal brain protein were performed with 61 mothers of children with autism (36 regressive and 25 early onset), 40 mothers of children with developmental delay, and 62 mothers of typically developing children. The mothers were matched for age and parity (Neurotoxicology 2008;29:226-31). The investigators found that seven mothers of children with autism (12%) had IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa. "We did not see this pattern in the typically developing controls or in the developmentally delayed population, so this seemed to be very specific for autism," Dr. Van de Water said.

Analysis of autoantibody profiles of an additional 458 mothers – 204 mothers of children diagnosed with autism, 71 mothers of children diagnosed with an autism spectrum disorder, and 183 mothers of typically developing children – continues to yield highly significant associations between the presence of IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa and a diagnosis of full autism. Dr. Van de Water and her associates also discovered an association between the 39kDa and 73kDa bands and a diagnosis of the broader autism phenotype, "though this pattern is less frequent in the full autism group," she said. Some mothers had reactivity to fetal brain proteins at all three bands.

"We think we may have a very interesting biomarker, but is there a pathologic significance to these antibodies?" she asked. To find out, the researchers analyzed behavioral characteristics associated with maternal antibodies to fetal brain proteins. Children of mothers who demonstrated reactivity at bands 37kDa and 73kDa had less expressive language based on the Expressive Language Scale of the Mullen Scales of Early Learning. Similar results were seen in children of mothers who demonstrated reactivity at all three bands. In contrast, children of mothers who demonstrated reactivity at bands 39kDa and 73kDa had higher scores on the Aberrant Behavior Checklist irritability subscale, "so we can see that we’re starting to phenotypically separate these children."

A pilot study in monkeys conducted by Dr. Van de Water and her associates demonstrated behavioral changes in offspring following passive transfer of maternal IgG during the late first and early second trimesters (Brain Behav. Immun. 2008;22:806-16). Subsequent studies have confirmed that passive transfer of these antibodies into an animal model can recapitulate some behaviors characteristic of autism. More confirmatory studies are underway.

"We are currently verifying the identity of the protein antigens recognized by these autoantibodies," Dr. Van de Water said. "We intend to develop a preconception test to use for mothers at risk of having a second child with autism."

Dr. Van de Water disclosed that she has received personal compensation for activities with Pediatric Bioscience as a consultant, and holds stock and/or stock options in the company. She has also received royalty payments from the University of California, Davis.

HONOLULU – Certain maternal autoantibodies are associated with the development of autism spectrum disorders, results from a large ongoing analysis demonstrate.

The finding lays the groundwork for an eventual diagnostic test for autism, Judy Van de Water, Ph.D., said at the annual meeting of the American Academy of Neurology.

"Currently there is no biologic marker for autism," said Dr. Van de Water, an immunologist at the University of California, Davis. "It’s completely defined by behaviors."

The maternal immune response in autism is of interest to researchers because of its role in neurodevelopment. "Maternal IgG isotype antibodies readily cross the placenta and are known to persist for up to 6 months postnatally in the child," Dr. Van de Water said. "In addition, maternal antibodies have been shown to cause changes in fetal development in several known autoimmune disorders, such as SLE."

In 2002, Dr. Van de Water and her associates began to collect blood samples from families as part of the Childhood Autism Risk from Genetics and the Environment (CHARGE) study. They sampled the study population from three groups of children aged 2-5 years: children with autism (currently includes more than 800 families); typically developing children without autism or other developmental disabilities selected from the general population (currently 600 families enrolled); and children with developmental disabilities without autism (currently 220 families enrolled).

In the original experimental design, Western blots against human fetal brain protein were performed with 61 mothers of children with autism (36 regressive and 25 early onset), 40 mothers of children with developmental delay, and 62 mothers of typically developing children. The mothers were matched for age and parity (Neurotoxicology 2008;29:226-31). The investigators found that seven mothers of children with autism (12%) had IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa. "We did not see this pattern in the typically developing controls or in the developmentally delayed population, so this seemed to be very specific for autism," Dr. Van de Water said.

Analysis of autoantibody profiles of an additional 458 mothers – 204 mothers of children diagnosed with autism, 71 mothers of children diagnosed with an autism spectrum disorder, and 183 mothers of typically developing children – continues to yield highly significant associations between the presence of IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa and a diagnosis of full autism. Dr. Van de Water and her associates also discovered an association between the 39kDa and 73kDa bands and a diagnosis of the broader autism phenotype, "though this pattern is less frequent in the full autism group," she said. Some mothers had reactivity to fetal brain proteins at all three bands.

"We think we may have a very interesting biomarker, but is there a pathologic significance to these antibodies?" she asked. To find out, the researchers analyzed behavioral characteristics associated with maternal antibodies to fetal brain proteins. Children of mothers who demonstrated reactivity at bands 37kDa and 73kDa had less expressive language based on the Expressive Language Scale of the Mullen Scales of Early Learning. Similar results were seen in children of mothers who demonstrated reactivity at all three bands. In contrast, children of mothers who demonstrated reactivity at bands 39kDa and 73kDa had higher scores on the Aberrant Behavior Checklist irritability subscale, "so we can see that we’re starting to phenotypically separate these children."

A pilot study in monkeys conducted by Dr. Van de Water and her associates demonstrated behavioral changes in offspring following passive transfer of maternal IgG during the late first and early second trimesters (Brain Behav. Immun. 2008;22:806-16). Subsequent studies have confirmed that passive transfer of these antibodies into an animal model can recapitulate some behaviors characteristic of autism. More confirmatory studies are underway.

"We are currently verifying the identity of the protein antigens recognized by these autoantibodies," Dr. Van de Water said. "We intend to develop a preconception test to use for mothers at risk of having a second child with autism."

Dr. Van de Water disclosed that she has received personal compensation for activities with Pediatric Bioscience as a consultant, and holds stock and/or stock options in the company. She has also received royalty payments from the University of California, Davis.

HONOLULU – Certain maternal autoantibodies are associated with the development of autism spectrum disorders, results from a large ongoing analysis demonstrate.

The finding lays the groundwork for an eventual diagnostic test for autism, Judy Van de Water, Ph.D., said at the annual meeting of the American Academy of Neurology.

"Currently there is no biologic marker for autism," said Dr. Van de Water, an immunologist at the University of California, Davis. "It’s completely defined by behaviors."

The maternal immune response in autism is of interest to researchers because of its role in neurodevelopment. "Maternal IgG isotype antibodies readily cross the placenta and are known to persist for up to 6 months postnatally in the child," Dr. Van de Water said. "In addition, maternal antibodies have been shown to cause changes in fetal development in several known autoimmune disorders, such as SLE."

In 2002, Dr. Van de Water and her associates began to collect blood samples from families as part of the Childhood Autism Risk from Genetics and the Environment (CHARGE) study. They sampled the study population from three groups of children aged 2-5 years: children with autism (currently includes more than 800 families); typically developing children without autism or other developmental disabilities selected from the general population (currently 600 families enrolled); and children with developmental disabilities without autism (currently 220 families enrolled).

In the original experimental design, Western blots against human fetal brain protein were performed with 61 mothers of children with autism (36 regressive and 25 early onset), 40 mothers of children with developmental delay, and 62 mothers of typically developing children. The mothers were matched for age and parity (Neurotoxicology 2008;29:226-31). The investigators found that seven mothers of children with autism (12%) had IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa. "We did not see this pattern in the typically developing controls or in the developmentally delayed population, so this seemed to be very specific for autism," Dr. Van de Water said.

Analysis of autoantibody profiles of an additional 458 mothers – 204 mothers of children diagnosed with autism, 71 mothers of children diagnosed with an autism spectrum disorder, and 183 mothers of typically developing children – continues to yield highly significant associations between the presence of IgG reactivity to fetal brain proteins at bands 37kDa and 73kDa and a diagnosis of full autism. Dr. Van de Water and her associates also discovered an association between the 39kDa and 73kDa bands and a diagnosis of the broader autism phenotype, "though this pattern is less frequent in the full autism group," she said. Some mothers had reactivity to fetal brain proteins at all three bands.

"We think we may have a very interesting biomarker, but is there a pathologic significance to these antibodies?" she asked. To find out, the researchers analyzed behavioral characteristics associated with maternal antibodies to fetal brain proteins. Children of mothers who demonstrated reactivity at bands 37kDa and 73kDa had less expressive language based on the Expressive Language Scale of the Mullen Scales of Early Learning. Similar results were seen in children of mothers who demonstrated reactivity at all three bands. In contrast, children of mothers who demonstrated reactivity at bands 39kDa and 73kDa had higher scores on the Aberrant Behavior Checklist irritability subscale, "so we can see that we’re starting to phenotypically separate these children."

A pilot study in monkeys conducted by Dr. Van de Water and her associates demonstrated behavioral changes in offspring following passive transfer of maternal IgG during the late first and early second trimesters (Brain Behav. Immun. 2008;22:806-16). Subsequent studies have confirmed that passive transfer of these antibodies into an animal model can recapitulate some behaviors characteristic of autism. More confirmatory studies are underway.

"We are currently verifying the identity of the protein antigens recognized by these autoantibodies," Dr. Van de Water said. "We intend to develop a preconception test to use for mothers at risk of having a second child with autism."

Dr. Van de Water disclosed that she has received personal compensation for activities with Pediatric Bioscience as a consultant, and holds stock and/or stock options in the company. She has also received royalty payments from the University of California, Davis.

HONOLULU – Women and minorities with Parkinson’s disease obtained care from a neurologist less often than did white men, in a large national analysis of Medicare data.

In addition, Parkinson’s patients who received care from a neurologist had significant improvement in certain clinical outcomes as well as better overall survival compared with patients who received care from physicians in other specialties.

"Neurological disorders are common," Dr. Allison Wright Willis said at the annual meeting of the American Academy of Neurology. "However, medical students and new physicians report feeling least secure in their ability to diagnose and manage neurologic disease. Unfortunately, primary care training programs may not be able to provide sufficient training in the management of complicated neurodegenerative diseases such as Parkinson’s disease."

Dr. Willis of the department of neurology at Washington University in St. Louis and her associates set out to determine if treatment of Parkinson’s patients by a neurologist is associated with improved selected health outcomes, including hip fracture, skilled nursing facility placement, and survival. They evaluated more than 138,000 incident cases of Parkinson’s disease from Medicare beneficiaries with outpatient or carrier file claims for Parkinson’s disease in 2002.

For the period of 2002-2008, Dr. Willis and her colleagues used a Cox proportional hazards model to compare survival in patients with Parkinson’s disease who were treated by either a neurologist or primary care physician. They included the variables of race, age, sex, comorbidity index, socioeconomic deprivation score, and physician specialty.

Dr. Willis reported that only 57% of newly diagnosed Parkinson’s patients saw a neurologist at any time during the 48-month period in which neurologist encounter rates were calculated. Men and whites had the highest specialist treatment rates. Women and blacks both had 23% lower odds of receiving neurologist care than did men and whites, after adjustment for covariates.

Investigation of race and gender pairs revealed that white women, black men, black women, Hispanic women, and Asian women all had significantly lower odds, compared with white men, of receiving care from a neurologist after adjustment for age, comorbidity, and economic disparity. A sensitivity analysis performed using 469,000 prevalent cases of Parkinson’s disease yielded similar findings.

In a subgroup analysis of nearly 130,000 Parkinson’s patients without incident stroke or transient ischemic attack, patients cared for by a neurologist had 21% lower odds of being placed in a skilled nursing home, compared with patients treated by primary care physicians. Treatment by a neurologist also was associated with 14% lower odds of hip fracture than was treatment by primary care physicians.

The odds of survival over a 6-year period was 23% greater when patients received care from a neurologist rather than a primary care physician, with the greatest increase in survival seen in white men, white women, and black men.

"Should these results be confirmed using individual-level data, measures to lessen these disparities are vital," Dr. Willis commented. "Furthermore, by demonstrating that neurologist treatment improves Parkinson’s disease outcomes, our data highlight the need for health policy measures that support neurology practice and neurological education. However, the finding that fewer women and nonwhites received neurologist care may have broader implications for health care disparity and medical education."

She went on to point out that in addition to what she described as "the clear social and policy implications of our research, these data are important to Parkinson’s researchers. Parkinson’s disease epidemiological studies and clinical trials typically rely on speciality centers or neurologist practices for case identification and recruitment. Our data suggest that this may produce a significant referral bias, [which is] critical when attempting to perform gene or environmental risk studies, and may result in a distortion of the Parkinson’s disease risk literature or possibly confound clinical trial results. Additionally, the exclusive use of speciality center populations for recruitment may propagate a treatment bias resulting in fewer women and fewer minorities receiving state-of-the-art care."

Dr. Willis acknowledged certain limitations of the study, including the fact that the Medicare data set analyzed does not provide information on severity of Parkinson’s disease or physician diagnostic accuracy. "As with any epidemiological study, unknown medical, social, economic, or cultural factors may remain that have influenced the observed health care patterns," she noted. "Also, seeking neurologist care may be more likely in those who are health conscious and may correlate with other behaviors which would improve well-being, clinical course, or survival, such as medication use and exercise."

Dr. Willis said she had no relevant financial disclosures.

HONOLULU – Women and minorities with Parkinson’s disease obtained care from a neurologist less often than did white men, in a large national analysis of Medicare data.

In addition, Parkinson’s patients who received care from a neurologist had significant improvement in certain clinical outcomes as well as better overall survival compared with patients who received care from physicians in other specialties.

"Neurological disorders are common," Dr. Allison Wright Willis said at the annual meeting of the American Academy of Neurology. "However, medical students and new physicians report feeling least secure in their ability to diagnose and manage neurologic disease. Unfortunately, primary care training programs may not be able to provide sufficient training in the management of complicated neurodegenerative diseases such as Parkinson’s disease."

Dr. Willis of the department of neurology at Washington University in St. Louis and her associates set out to determine if treatment of Parkinson’s patients by a neurologist is associated with improved selected health outcomes, including hip fracture, skilled nursing facility placement, and survival. They evaluated more than 138,000 incident cases of Parkinson’s disease from Medicare beneficiaries with outpatient or carrier file claims for Parkinson’s disease in 2002.

For the period of 2002-2008, Dr. Willis and her colleagues used a Cox proportional hazards model to compare survival in patients with Parkinson’s disease who were treated by either a neurologist or primary care physician. They included the variables of race, age, sex, comorbidity index, socioeconomic deprivation score, and physician specialty.

Dr. Willis reported that only 57% of newly diagnosed Parkinson’s patients saw a neurologist at any time during the 48-month period in which neurologist encounter rates were calculated. Men and whites had the highest specialist treatment rates. Women and blacks both had 23% lower odds of receiving neurologist care than did men and whites, after adjustment for covariates.

Investigation of race and gender pairs revealed that white women, black men, black women, Hispanic women, and Asian women all had significantly lower odds, compared with white men, of receiving care from a neurologist after adjustment for age, comorbidity, and economic disparity. A sensitivity analysis performed using 469,000 prevalent cases of Parkinson’s disease yielded similar findings.

In a subgroup analysis of nearly 130,000 Parkinson’s patients without incident stroke or transient ischemic attack, patients cared for by a neurologist had 21% lower odds of being placed in a skilled nursing home, compared with patients treated by primary care physicians. Treatment by a neurologist also was associated with 14% lower odds of hip fracture than was treatment by primary care physicians.

The odds of survival over a 6-year period was 23% greater when patients received care from a neurologist rather than a primary care physician, with the greatest increase in survival seen in white men, white women, and black men.

"Should these results be confirmed using individual-level data, measures to lessen these disparities are vital," Dr. Willis commented. "Furthermore, by demonstrating that neurologist treatment improves Parkinson’s disease outcomes, our data highlight the need for health policy measures that support neurology practice and neurological education. However, the finding that fewer women and nonwhites received neurologist care may have broader implications for health care disparity and medical education."

She went on to point out that in addition to what she described as "the clear social and policy implications of our research, these data are important to Parkinson’s researchers. Parkinson’s disease epidemiological studies and clinical trials typically rely on speciality centers or neurologist practices for case identification and recruitment. Our data suggest that this may produce a significant referral bias, [which is] critical when attempting to perform gene or environmental risk studies, and may result in a distortion of the Parkinson’s disease risk literature or possibly confound clinical trial results. Additionally, the exclusive use of speciality center populations for recruitment may propagate a treatment bias resulting in fewer women and fewer minorities receiving state-of-the-art care."

Dr. Willis acknowledged certain limitations of the study, including the fact that the Medicare data set analyzed does not provide information on severity of Parkinson’s disease or physician diagnostic accuracy. "As with any epidemiological study, unknown medical, social, economic, or cultural factors may remain that have influenced the observed health care patterns," she noted. "Also, seeking neurologist care may be more likely in those who are health conscious and may correlate with other behaviors which would improve well-being, clinical course, or survival, such as medication use and exercise."

Dr. Willis said she had no relevant financial disclosures.

HONOLULU – Women and minorities with Parkinson’s disease obtained care from a neurologist less often than did white men, in a large national analysis of Medicare data.

In addition, Parkinson’s patients who received care from a neurologist had significant improvement in certain clinical outcomes as well as better overall survival compared with patients who received care from physicians in other specialties.

"Neurological disorders are common," Dr. Allison Wright Willis said at the annual meeting of the American Academy of Neurology. "However, medical students and new physicians report feeling least secure in their ability to diagnose and manage neurologic disease. Unfortunately, primary care training programs may not be able to provide sufficient training in the management of complicated neurodegenerative diseases such as Parkinson’s disease."

Dr. Willis of the department of neurology at Washington University in St. Louis and her associates set out to determine if treatment of Parkinson’s patients by a neurologist is associated with improved selected health outcomes, including hip fracture, skilled nursing facility placement, and survival. They evaluated more than 138,000 incident cases of Parkinson’s disease from Medicare beneficiaries with outpatient or carrier file claims for Parkinson’s disease in 2002.

For the period of 2002-2008, Dr. Willis and her colleagues used a Cox proportional hazards model to compare survival in patients with Parkinson’s disease who were treated by either a neurologist or primary care physician. They included the variables of race, age, sex, comorbidity index, socioeconomic deprivation score, and physician specialty.

Dr. Willis reported that only 57% of newly diagnosed Parkinson’s patients saw a neurologist at any time during the 48-month period in which neurologist encounter rates were calculated. Men and whites had the highest specialist treatment rates. Women and blacks both had 23% lower odds of receiving neurologist care than did men and whites, after adjustment for covariates.

Investigation of race and gender pairs revealed that white women, black men, black women, Hispanic women, and Asian women all had significantly lower odds, compared with white men, of receiving care from a neurologist after adjustment for age, comorbidity, and economic disparity. A sensitivity analysis performed using 469,000 prevalent cases of Parkinson’s disease yielded similar findings.

In a subgroup analysis of nearly 130,000 Parkinson’s patients without incident stroke or transient ischemic attack, patients cared for by a neurologist had 21% lower odds of being placed in a skilled nursing home, compared with patients treated by primary care physicians. Treatment by a neurologist also was associated with 14% lower odds of hip fracture than was treatment by primary care physicians.

The odds of survival over a 6-year period was 23% greater when patients received care from a neurologist rather than a primary care physician, with the greatest increase in survival seen in white men, white women, and black men.

"Should these results be confirmed using individual-level data, measures to lessen these disparities are vital," Dr. Willis commented. "Furthermore, by demonstrating that neurologist treatment improves Parkinson’s disease outcomes, our data highlight the need for health policy measures that support neurology practice and neurological education. However, the finding that fewer women and nonwhites received neurologist care may have broader implications for health care disparity and medical education."

She went on to point out that in addition to what she described as "the clear social and policy implications of our research, these data are important to Parkinson’s researchers. Parkinson’s disease epidemiological studies and clinical trials typically rely on speciality centers or neurologist practices for case identification and recruitment. Our data suggest that this may produce a significant referral bias, [which is] critical when attempting to perform gene or environmental risk studies, and may result in a distortion of the Parkinson’s disease risk literature or possibly confound clinical trial results. Additionally, the exclusive use of speciality center populations for recruitment may propagate a treatment bias resulting in fewer women and fewer minorities receiving state-of-the-art care."

Dr. Willis acknowledged certain limitations of the study, including the fact that the Medicare data set analyzed does not provide information on severity of Parkinson’s disease or physician diagnostic accuracy. "As with any epidemiological study, unknown medical, social, economic, or cultural factors may remain that have influenced the observed health care patterns," she noted. "Also, seeking neurologist care may be more likely in those who are health conscious and may correlate with other behaviors which would improve well-being, clinical course, or survival, such as medication use and exercise."

Dr. Willis said she had no relevant financial disclosures.