Michele G. Sullivan

HALIFAX, N.S. — Emergency physicians don't miss many clinically significant findings on computerized axial tomography scans of the head.

Neuroradiologists agreed with the CT interpretations made by emergency department physicians almost all of the time, Dr. Abdullah Al-Reesi reported in a poster presented at the 11th International Conference on Emergency Medicine.

Dr. Al-Reesi, of the University of Ottawa, reviewed 442 consecutive CT head scans done in an emergency department over a 5-month period, comparing the interpretations done by both groups of physicians.

Indications for CT were head injury, headache, seizure, confusion, decreased consciousness, cerebrovascular accident, transient ischemic attack, and dizziness.

ED physicians missed three clinically significant lesions: two nontraumatic and one traumatic subarachnoid hemorrhages. They also missed six clinically nonsignificant findings, which included one small (less than 5 mm) cerebral contusion, three cases of fluid in the sinuses, one small lacunar infarct, and one patchy hypodensity later identified as a multiple sclerosis lesion. A patient with an intraventricular hemorrhage was discharged home. Once the error was recognized, he was referred for emergency neurosurgical consult.

HALIFAX, N.S. — Emergency physicians don't miss many clinically significant findings on computerized axial tomography scans of the head.

Neuroradiologists agreed with the CT interpretations made by emergency department physicians almost all of the time, Dr. Abdullah Al-Reesi reported in a poster presented at the 11th International Conference on Emergency Medicine.

Dr. Al-Reesi, of the University of Ottawa, reviewed 442 consecutive CT head scans done in an emergency department over a 5-month period, comparing the interpretations done by both groups of physicians.

Indications for CT were head injury, headache, seizure, confusion, decreased consciousness, cerebrovascular accident, transient ischemic attack, and dizziness.

ED physicians missed three clinically significant lesions: two nontraumatic and one traumatic subarachnoid hemorrhages. They also missed six clinically nonsignificant findings, which included one small (less than 5 mm) cerebral contusion, three cases of fluid in the sinuses, one small lacunar infarct, and one patchy hypodensity later identified as a multiple sclerosis lesion. A patient with an intraventricular hemorrhage was discharged home. Once the error was recognized, he was referred for emergency neurosurgical consult.

HALIFAX, N.S. — Emergency physicians don't miss many clinically significant findings on computerized axial tomography scans of the head.

Neuroradiologists agreed with the CT interpretations made by emergency department physicians almost all of the time, Dr. Abdullah Al-Reesi reported in a poster presented at the 11th International Conference on Emergency Medicine.

Dr. Al-Reesi, of the University of Ottawa, reviewed 442 consecutive CT head scans done in an emergency department over a 5-month period, comparing the interpretations done by both groups of physicians.

Indications for CT were head injury, headache, seizure, confusion, decreased consciousness, cerebrovascular accident, transient ischemic attack, and dizziness.

ED physicians missed three clinically significant lesions: two nontraumatic and one traumatic subarachnoid hemorrhages. They also missed six clinically nonsignificant findings, which included one small (less than 5 mm) cerebral contusion, three cases of fluid in the sinuses, one small lacunar infarct, and one patchy hypodensity later identified as a multiple sclerosis lesion. A patient with an intraventricular hemorrhage was discharged home. Once the error was recognized, he was referred for emergency neurosurgical consult.

PITTSBURGH — Anticoagulant therapy is appropriate for children with arterial ischemic stroke, since the rate of intracranial hemorrhage in treated patients is low, Dr. Adam Kirton said in a poster presented at the annual meeting of the Child Neurology Society.

“Our study suggests that intracranial hemorrhage in children with arterial stroke treated with anticoagulation is infrequent and usually very mild in severity,” Dr. Kirton said in an interview.

“The findings add important safety data to support current consensus guidelines recommending the use of anticoagulation in children with stroke.”

His study, carried out in collaboration with the thrombosis program at the Hospital for Sick Children in Toronto, included 126 children younger than 18 years who were treated with anticoagulation therapy for acute arterial ischemic stroke.

Sixteen patients (13%) experienced intracranial hemorrhage, said Dr. Kirton, of the Children's Stroke Program at the Hospital for Sick Children in Toronto. All of the bleeds occurred within 24 days of the stroke diagnosis, with a mean time to bleed of 11 days (range 2–24 days). “This suggests a fixed period of vulnerability,” Dr. Kirton said.

Most of the bleeds (10) were asymptomatic. In the six symptomatic bleeds, symptoms were irritability (three), headache and vomiting (one), loss of consciousness (one), and dysarthria (one).

Treatment regimens in patients with bleeding included low-molecularweight heparin (five patients); unfractionated heparin (four); warfarin alone (one); warfarin plus low-molecular-weight heparin (two); warfarin plus unfractionated heparin (two); low-molecular- weight heparin plus aspirin (one); and unfractionated heparin plus aspirin (one).

Three of the children with bleeds died—two from cardiac causes and one who had preexisting promyelocytic leukemia.

Congenital heart disease significantly increased the risk of an intracranial bleed on anticoagulant therapy.

Bleeds occurred in 26% of the 38 children with congenital heart disease, but in only 7% of those without it.

A larger study of intracranial bleeding in pediatric stroke comparing treated with untreated patients will help confirm the spontaneous occurrence of bleeding and further support the safety of this important therapy.

PITTSBURGH — Anticoagulant therapy is appropriate for children with arterial ischemic stroke, since the rate of intracranial hemorrhage in treated patients is low, Dr. Adam Kirton said in a poster presented at the annual meeting of the Child Neurology Society.

“Our study suggests that intracranial hemorrhage in children with arterial stroke treated with anticoagulation is infrequent and usually very mild in severity,” Dr. Kirton said in an interview.

“The findings add important safety data to support current consensus guidelines recommending the use of anticoagulation in children with stroke.”

His study, carried out in collaboration with the thrombosis program at the Hospital for Sick Children in Toronto, included 126 children younger than 18 years who were treated with anticoagulation therapy for acute arterial ischemic stroke.

Sixteen patients (13%) experienced intracranial hemorrhage, said Dr. Kirton, of the Children's Stroke Program at the Hospital for Sick Children in Toronto. All of the bleeds occurred within 24 days of the stroke diagnosis, with a mean time to bleed of 11 days (range 2–24 days). “This suggests a fixed period of vulnerability,” Dr. Kirton said.

Most of the bleeds (10) were asymptomatic. In the six symptomatic bleeds, symptoms were irritability (three), headache and vomiting (one), loss of consciousness (one), and dysarthria (one).

Treatment regimens in patients with bleeding included low-molecularweight heparin (five patients); unfractionated heparin (four); warfarin alone (one); warfarin plus low-molecular-weight heparin (two); warfarin plus unfractionated heparin (two); low-molecular- weight heparin plus aspirin (one); and unfractionated heparin plus aspirin (one).

Three of the children with bleeds died—two from cardiac causes and one who had preexisting promyelocytic leukemia.

Congenital heart disease significantly increased the risk of an intracranial bleed on anticoagulant therapy.

Bleeds occurred in 26% of the 38 children with congenital heart disease, but in only 7% of those without it.

A larger study of intracranial bleeding in pediatric stroke comparing treated with untreated patients will help confirm the spontaneous occurrence of bleeding and further support the safety of this important therapy.

PITTSBURGH — Anticoagulant therapy is appropriate for children with arterial ischemic stroke, since the rate of intracranial hemorrhage in treated patients is low, Dr. Adam Kirton said in a poster presented at the annual meeting of the Child Neurology Society.

“Our study suggests that intracranial hemorrhage in children with arterial stroke treated with anticoagulation is infrequent and usually very mild in severity,” Dr. Kirton said in an interview.

“The findings add important safety data to support current consensus guidelines recommending the use of anticoagulation in children with stroke.”

His study, carried out in collaboration with the thrombosis program at the Hospital for Sick Children in Toronto, included 126 children younger than 18 years who were treated with anticoagulation therapy for acute arterial ischemic stroke.

Sixteen patients (13%) experienced intracranial hemorrhage, said Dr. Kirton, of the Children's Stroke Program at the Hospital for Sick Children in Toronto. All of the bleeds occurred within 24 days of the stroke diagnosis, with a mean time to bleed of 11 days (range 2–24 days). “This suggests a fixed period of vulnerability,” Dr. Kirton said.

Most of the bleeds (10) were asymptomatic. In the six symptomatic bleeds, symptoms were irritability (three), headache and vomiting (one), loss of consciousness (one), and dysarthria (one).

Treatment regimens in patients with bleeding included low-molecularweight heparin (five patients); unfractionated heparin (four); warfarin alone (one); warfarin plus low-molecular-weight heparin (two); warfarin plus unfractionated heparin (two); low-molecular- weight heparin plus aspirin (one); and unfractionated heparin plus aspirin (one).

Three of the children with bleeds died—two from cardiac causes and one who had preexisting promyelocytic leukemia.

Congenital heart disease significantly increased the risk of an intracranial bleed on anticoagulant therapy.

Bleeds occurred in 26% of the 38 children with congenital heart disease, but in only 7% of those without it.

A larger study of intracranial bleeding in pediatric stroke comparing treated with untreated patients will help confirm the spontaneous occurrence of bleeding and further support the safety of this important therapy.

Officials in charge of disclosing financial interests in research agree that disclosure is important, but are confused about how to do so effectively and appropriately, Kevin P. Weinfurt, Ph.D., and his colleagues reported.

Their survey of 42 such officials revealed widely varying opinions on when disclosure should be made, the financial limits that should trigger it, and how much information to share with prospective research subjects, said Dr. Weinfurt of the department of psychiatry at Duke University, Durham, N.C., and his coinvestigators.

“Part of their struggle relates to a lack of clarity regarding the ultimate goals of disclosure,” the researchers wrote. “There is also a lack of systematic data regarding how potential research participants can and will use such information in their decision-making” (J. Law Med. Ethics 2006;34:581–91).

The study was based on detailed personal interviews with 8 investigators, 23 review board chairs, and 14 conflict of interest committee chairs. The survey was designed to elicit respondents' understandings of how disclosure is done at their institutions and their thoughts on the importance of disclosure, including its risks and benefits to the institution and research subjects.

More than half of those interviewed agreed that disclosure should occur under all circumstances; the rest said disclosure would depend on the degree of the financial relationship. The most commonly expressed reason for disclosing a financial relationship was to facilitate better-informed decision making for potential subjects.

About 80% of respondents said the disclosure should include the name of the funding source. But some wanted to reveal whether funding came from a nonprofit organization, pharmaceutical company, or government body, for instance.

Conflict of interest committee chairs were most likely to want to share amount of financial interest (93%), while investigators were least likely (63%). Those who expressed concern about disclosing the amount felt that level of detail could become cumbersome or confusing in the informed consent statement, and that research subjects might overestimate the impact that particular amounts might actually have on research outcomes. There was no consensus on what amount should trigger disclosure—the lower limit ranged from $1 to $50,000.

There was general agreement that the nature of the relationship should be disclosed, but no agreement about whether the disclosure should explain the possible impact of those relationships. Again, concern about overcomplicating the consent statement semed to be at the root of these issues. Some respondents said the disclosure should include an explanation of how an unscrupulous investigator might alter the research results.

Some respondents said their consent form highlights the information in bold type, while others place it strategically in the document. Many also emphasized that the informed consent process should include discussion. “Our data suggest that it will be difficult to achieve agreement on the issue of substantial understanding of financial interests,” the researchers concluded. “Before we can resolve what counts as substantial understanding, there must be agreement about what risks are important for potential research participants to understand.”

Officials in charge of disclosing financial interests in research agree that disclosure is important, but are confused about how to do so effectively and appropriately, Kevin P. Weinfurt, Ph.D., and his colleagues reported.

Their survey of 42 such officials revealed widely varying opinions on when disclosure should be made, the financial limits that should trigger it, and how much information to share with prospective research subjects, said Dr. Weinfurt of the department of psychiatry at Duke University, Durham, N.C., and his coinvestigators.

“Part of their struggle relates to a lack of clarity regarding the ultimate goals of disclosure,” the researchers wrote. “There is also a lack of systematic data regarding how potential research participants can and will use such information in their decision-making” (J. Law Med. Ethics 2006;34:581–91).

The study was based on detailed personal interviews with 8 investigators, 23 review board chairs, and 14 conflict of interest committee chairs. The survey was designed to elicit respondents' understandings of how disclosure is done at their institutions and their thoughts on the importance of disclosure, including its risks and benefits to the institution and research subjects.

More than half of those interviewed agreed that disclosure should occur under all circumstances; the rest said disclosure would depend on the degree of the financial relationship. The most commonly expressed reason for disclosing a financial relationship was to facilitate better-informed decision making for potential subjects.

About 80% of respondents said the disclosure should include the name of the funding source. But some wanted to reveal whether funding came from a nonprofit organization, pharmaceutical company, or government body, for instance.

Conflict of interest committee chairs were most likely to want to share amount of financial interest (93%), while investigators were least likely (63%). Those who expressed concern about disclosing the amount felt that level of detail could become cumbersome or confusing in the informed consent statement, and that research subjects might overestimate the impact that particular amounts might actually have on research outcomes. There was no consensus on what amount should trigger disclosure—the lower limit ranged from $1 to $50,000.

There was general agreement that the nature of the relationship should be disclosed, but no agreement about whether the disclosure should explain the possible impact of those relationships. Again, concern about overcomplicating the consent statement semed to be at the root of these issues. Some respondents said the disclosure should include an explanation of how an unscrupulous investigator might alter the research results.

Some respondents said their consent form highlights the information in bold type, while others place it strategically in the document. Many also emphasized that the informed consent process should include discussion. “Our data suggest that it will be difficult to achieve agreement on the issue of substantial understanding of financial interests,” the researchers concluded. “Before we can resolve what counts as substantial understanding, there must be agreement about what risks are important for potential research participants to understand.”

Officials in charge of disclosing financial interests in research agree that disclosure is important, but are confused about how to do so effectively and appropriately, Kevin P. Weinfurt, Ph.D., and his colleagues reported.

Their survey of 42 such officials revealed widely varying opinions on when disclosure should be made, the financial limits that should trigger it, and how much information to share with prospective research subjects, said Dr. Weinfurt of the department of psychiatry at Duke University, Durham, N.C., and his coinvestigators.

“Part of their struggle relates to a lack of clarity regarding the ultimate goals of disclosure,” the researchers wrote. “There is also a lack of systematic data regarding how potential research participants can and will use such information in their decision-making” (J. Law Med. Ethics 2006;34:581–91).

The study was based on detailed personal interviews with 8 investigators, 23 review board chairs, and 14 conflict of interest committee chairs. The survey was designed to elicit respondents' understandings of how disclosure is done at their institutions and their thoughts on the importance of disclosure, including its risks and benefits to the institution and research subjects.

More than half of those interviewed agreed that disclosure should occur under all circumstances; the rest said disclosure would depend on the degree of the financial relationship. The most commonly expressed reason for disclosing a financial relationship was to facilitate better-informed decision making for potential subjects.

About 80% of respondents said the disclosure should include the name of the funding source. But some wanted to reveal whether funding came from a nonprofit organization, pharmaceutical company, or government body, for instance.

Conflict of interest committee chairs were most likely to want to share amount of financial interest (93%), while investigators were least likely (63%). Those who expressed concern about disclosing the amount felt that level of detail could become cumbersome or confusing in the informed consent statement, and that research subjects might overestimate the impact that particular amounts might actually have on research outcomes. There was no consensus on what amount should trigger disclosure—the lower limit ranged from $1 to $50,000.

There was general agreement that the nature of the relationship should be disclosed, but no agreement about whether the disclosure should explain the possible impact of those relationships. Again, concern about overcomplicating the consent statement semed to be at the root of these issues. Some respondents said the disclosure should include an explanation of how an unscrupulous investigator might alter the research results.

Some respondents said their consent form highlights the information in bold type, while others place it strategically in the document. Many also emphasized that the informed consent process should include discussion. “Our data suggest that it will be difficult to achieve agreement on the issue of substantial understanding of financial interests,” the researchers concluded. “Before we can resolve what counts as substantial understanding, there must be agreement about what risks are important for potential research participants to understand.”

Stem cell transplantation may be an option for patients whose lives are threatened by medically refractory vasculitis, Dr. Thomas Daikeler and his colleagues have reported.

Up to 20% of vasculitis patients don't respond to conventionally dosed immunosuppression, Dr. Daikeler said in an interview. Options for these patients are very limited, he said. However, his review of 20 patients who received the transplants showed that 93% responded positively, with 7 achieving sustained complete remission (Ann. Rheum. Dis. 2006 Sept. 1 [Epub doi:10.1136/ard.2006.056630]).

Dr. Daikeler, of the University of Basel, Switzerland, reviewed outcomes in 15 patients included in the European League Against Rheumatism (EULAR) database or the PROMISE international medical database, and 5 additional patients identified through a Medline search.

The report focused on the details of the 15 EULAR/PROMISE patients. Their median age was 37 years (age range 10–57 years). Four had cryoglobulinemia, three had Behçet's syndrome, three had Wegener's granulomatosis, and the others had Churg-Strauss angiitis, Takayasu's arteritis, polychondritis, and a polyarteritis nodosa. All patients had active disease and had failed intensive immunosuppressive therapy, including cytostatic drugs. Most of them (14) had an autologous stem cell transplant first; 1 had an allogeneic transplant first.

At the time of the analysis, the median follow-up for all patients was 44 months (range 16–84 months). The response rate was 93%. Overall, seven responded partially and needed maintenance immunosuppression for minor disease, seven patients were in complete remission, and one patient showed stable disease.

Three patients died. One patient with partial response relapsed 24 months after allogenic transplant and died of died of graft-versus-host disease; a second patient who achieved complete response of his underlying polyarteritis nodosa died of lung cancer 2 years after autologous transplant; the third patient showed no response to therapy and died of right ventricular failure due to severe preexisting pulmonary hypertension 26 months after the initial transplant.

Among the 14 patients who received an autologous transplant, there were 2 relapses—one at 2 months and one at 24 months post transplant. One of these patients then received an allogeneic stem cell transplant and relapsed again 2 years later with headache and aphthous disease. However, the patient was successfully treated with four cycles of rituximab and cyclophosphamide.

The second relapsed patient received another autologous transplant 24 months after the first one. This was followed by another relapse 4 months later, and then an allogeneic transplant, which led to partial remission lasting for 24 months. Six patients in the group experienced neutropenic fever, and two others had reactivation of cytomegalic and Epstein-Barr virus. One patient experienced transient pancytopenia and transient cardiotoxicity.

Among the five patients identified in the Medline search, the following outcomes occurred: complete remission 18 months after transplant in a patient with polyarteritis nodosa; cessation of all disease activity, no medication necessary, for a 4-year-old with intestinal Behçet's syndrome; cessation of all immunosuppressive therapy 18 months after transplant for a patient with Takayasu's arteritis; cessation of disease activity, no medication necessary, for a child with small-vessel vasculitis; complete remission 16 months after transplant for patient with Wegener's granulomatosis.

Since the graft-versus-host disease is an issue only with allogeneic transplants, Dr. Daikeler suggested that autologous transplants for these patients be evaluated in larger clinical trials.

Stem cell transplantation may be an option for patients whose lives are threatened by medically refractory vasculitis, Dr. Thomas Daikeler and his colleagues have reported.

Up to 20% of vasculitis patients don't respond to conventionally dosed immunosuppression, Dr. Daikeler said in an interview. Options for these patients are very limited, he said. However, his review of 20 patients who received the transplants showed that 93% responded positively, with 7 achieving sustained complete remission (Ann. Rheum. Dis. 2006 Sept. 1 [Epub doi:10.1136/ard.2006.056630]).

Dr. Daikeler, of the University of Basel, Switzerland, reviewed outcomes in 15 patients included in the European League Against Rheumatism (EULAR) database or the PROMISE international medical database, and 5 additional patients identified through a Medline search.

The report focused on the details of the 15 EULAR/PROMISE patients. Their median age was 37 years (age range 10–57 years). Four had cryoglobulinemia, three had Behçet's syndrome, three had Wegener's granulomatosis, and the others had Churg-Strauss angiitis, Takayasu's arteritis, polychondritis, and a polyarteritis nodosa. All patients had active disease and had failed intensive immunosuppressive therapy, including cytostatic drugs. Most of them (14) had an autologous stem cell transplant first; 1 had an allogeneic transplant first.

At the time of the analysis, the median follow-up for all patients was 44 months (range 16–84 months). The response rate was 93%. Overall, seven responded partially and needed maintenance immunosuppression for minor disease, seven patients were in complete remission, and one patient showed stable disease.

Three patients died. One patient with partial response relapsed 24 months after allogenic transplant and died of died of graft-versus-host disease; a second patient who achieved complete response of his underlying polyarteritis nodosa died of lung cancer 2 years after autologous transplant; the third patient showed no response to therapy and died of right ventricular failure due to severe preexisting pulmonary hypertension 26 months after the initial transplant.

Among the 14 patients who received an autologous transplant, there were 2 relapses—one at 2 months and one at 24 months post transplant. One of these patients then received an allogeneic stem cell transplant and relapsed again 2 years later with headache and aphthous disease. However, the patient was successfully treated with four cycles of rituximab and cyclophosphamide.

The second relapsed patient received another autologous transplant 24 months after the first one. This was followed by another relapse 4 months later, and then an allogeneic transplant, which led to partial remission lasting for 24 months. Six patients in the group experienced neutropenic fever, and two others had reactivation of cytomegalic and Epstein-Barr virus. One patient experienced transient pancytopenia and transient cardiotoxicity.

Among the five patients identified in the Medline search, the following outcomes occurred: complete remission 18 months after transplant in a patient with polyarteritis nodosa; cessation of all disease activity, no medication necessary, for a 4-year-old with intestinal Behçet's syndrome; cessation of all immunosuppressive therapy 18 months after transplant for a patient with Takayasu's arteritis; cessation of disease activity, no medication necessary, for a child with small-vessel vasculitis; complete remission 16 months after transplant for patient with Wegener's granulomatosis.

Since the graft-versus-host disease is an issue only with allogeneic transplants, Dr. Daikeler suggested that autologous transplants for these patients be evaluated in larger clinical trials.

Stem cell transplantation may be an option for patients whose lives are threatened by medically refractory vasculitis, Dr. Thomas Daikeler and his colleagues have reported.

Up to 20% of vasculitis patients don't respond to conventionally dosed immunosuppression, Dr. Daikeler said in an interview. Options for these patients are very limited, he said. However, his review of 20 patients who received the transplants showed that 93% responded positively, with 7 achieving sustained complete remission (Ann. Rheum. Dis. 2006 Sept. 1 [Epub doi:10.1136/ard.2006.056630]).

Dr. Daikeler, of the University of Basel, Switzerland, reviewed outcomes in 15 patients included in the European League Against Rheumatism (EULAR) database or the PROMISE international medical database, and 5 additional patients identified through a Medline search.

The report focused on the details of the 15 EULAR/PROMISE patients. Their median age was 37 years (age range 10–57 years). Four had cryoglobulinemia, three had Behçet's syndrome, three had Wegener's granulomatosis, and the others had Churg-Strauss angiitis, Takayasu's arteritis, polychondritis, and a polyarteritis nodosa. All patients had active disease and had failed intensive immunosuppressive therapy, including cytostatic drugs. Most of them (14) had an autologous stem cell transplant first; 1 had an allogeneic transplant first.

At the time of the analysis, the median follow-up for all patients was 44 months (range 16–84 months). The response rate was 93%. Overall, seven responded partially and needed maintenance immunosuppression for minor disease, seven patients were in complete remission, and one patient showed stable disease.

Three patients died. One patient with partial response relapsed 24 months after allogenic transplant and died of died of graft-versus-host disease; a second patient who achieved complete response of his underlying polyarteritis nodosa died of lung cancer 2 years after autologous transplant; the third patient showed no response to therapy and died of right ventricular failure due to severe preexisting pulmonary hypertension 26 months after the initial transplant.

Among the 14 patients who received an autologous transplant, there were 2 relapses—one at 2 months and one at 24 months post transplant. One of these patients then received an allogeneic stem cell transplant and relapsed again 2 years later with headache and aphthous disease. However, the patient was successfully treated with four cycles of rituximab and cyclophosphamide.

The second relapsed patient received another autologous transplant 24 months after the first one. This was followed by another relapse 4 months later, and then an allogeneic transplant, which led to partial remission lasting for 24 months. Six patients in the group experienced neutropenic fever, and two others had reactivation of cytomegalic and Epstein-Barr virus. One patient experienced transient pancytopenia and transient cardiotoxicity.

Among the five patients identified in the Medline search, the following outcomes occurred: complete remission 18 months after transplant in a patient with polyarteritis nodosa; cessation of all disease activity, no medication necessary, for a 4-year-old with intestinal Behçet's syndrome; cessation of all immunosuppressive therapy 18 months after transplant for a patient with Takayasu's arteritis; cessation of disease activity, no medication necessary, for a child with small-vessel vasculitis; complete remission 16 months after transplant for patient with Wegener's granulomatosis.

Since the graft-versus-host disease is an issue only with allogeneic transplants, Dr. Daikeler suggested that autologous transplants for these patients be evaluated in larger clinical trials.

Officials in charge of disclosing financial interests in research agree that disclosure is important, but are confused about how to do so effectively and appropriately, Kevin P. Weinfurt, Ph.D., and his colleagues reported.

Their survey of 42 such officials revealed widely varying opinions on when disclosure should be made, the financial limits that should trigger it, and how much information to share with prospective research subjects, said Dr. Weinfurt of the department of psychiatry at Duke University, Durham, N.C., and his coinvestigators.

“Part of their struggle relates to a lack of clarity regarding the ultimate goals of disclosure,” the researchers wrote. “There is also a lack of systematic data regarding how potential research participants can and will use such information in their decision-making” (J. Law Med. Ethics 2006;34:581–91).

The study was based on detailed personal interviews with eight investigators, 23 review board chairs, and 14 conflict of interest committee chairs. The survey was designed to elicit respondents' understandings of how disclosure is done at their institutions and their thoughts on the importance of disclosure, including its risks and benefits to the institution and research subjects.

More than half of those interviewed agreed that disclosure should occur under all circumstances; the rest said disclosure would depend on the degree of the financial relationship. The most commonly expressed reason for disclosing a financial relationship was to facilitate better-informed decision making for potential subjects. Other reasons included trust and transparency issues, reducing liability risk, and managing public perception of the institution.

About 80% of respondents said the disclosure should include the name of the funding source. But some said the name of the company or organization wasn't as important as a description—whether it was a nonprofit organization, pharmaceutical company, or government body, for instance.

They also differed on whether the amount of financial interest should be disclosed. Conflict of interest committee chairs were most likely to want to share this information (93%), while investigators were least likely (63%). Those who expressed concern about disclosing the amount felt that level of detail could become cumbersome or confusing in the informed consent statement, and that research subjects might overestimate the impact that particular amounts might actually have on research outcomes. There was no consensus on what amount should trigger disclosure—the lower limit ranged from $1 to $50,000.

There was general agreement that the nature of the relationship should be disclosed, but no agreement about whether the disclosure should explain the possible impact of those relationships. Again, concern about overcomplicating the consent statement semed to be at the root of these issues. Some respondents said the disclosure should include an explanation of how an unscrupulous investigator might alter the research results. Most respondents dismissed the idea that disclosure could lower enrollment. There was little sympathy among the group for researchers who complained that full disclosure was an invasion of their financial privacy.

There was also concern about how to best highlight disclosure information without overemphasizing its importance or potential risk to a study's integrity. Some respondents said their consent form highlights the information in bold type, while others place it strategically in the document—at the very beginning, for example. Many also emphasized that the informed consent process should include a discussion of conflict of interest, not just a read-through of the document.

Officials in charge of disclosing financial interests in research agree that disclosure is important, but are confused about how to do so effectively and appropriately, Kevin P. Weinfurt, Ph.D., and his colleagues reported.

Their survey of 42 such officials revealed widely varying opinions on when disclosure should be made, the financial limits that should trigger it, and how much information to share with prospective research subjects, said Dr. Weinfurt of the department of psychiatry at Duke University, Durham, N.C., and his coinvestigators.

“Part of their struggle relates to a lack of clarity regarding the ultimate goals of disclosure,” the researchers wrote. “There is also a lack of systematic data regarding how potential research participants can and will use such information in their decision-making” (J. Law Med. Ethics 2006;34:581–91).

The study was based on detailed personal interviews with eight investigators, 23 review board chairs, and 14 conflict of interest committee chairs. The survey was designed to elicit respondents' understandings of how disclosure is done at their institutions and their thoughts on the importance of disclosure, including its risks and benefits to the institution and research subjects.

More than half of those interviewed agreed that disclosure should occur under all circumstances; the rest said disclosure would depend on the degree of the financial relationship. The most commonly expressed reason for disclosing a financial relationship was to facilitate better-informed decision making for potential subjects. Other reasons included trust and transparency issues, reducing liability risk, and managing public perception of the institution.

About 80% of respondents said the disclosure should include the name of the funding source. But some said the name of the company or organization wasn't as important as a description—whether it was a nonprofit organization, pharmaceutical company, or government body, for instance.

They also differed on whether the amount of financial interest should be disclosed. Conflict of interest committee chairs were most likely to want to share this information (93%), while investigators were least likely (63%). Those who expressed concern about disclosing the amount felt that level of detail could become cumbersome or confusing in the informed consent statement, and that research subjects might overestimate the impact that particular amounts might actually have on research outcomes. There was no consensus on what amount should trigger disclosure—the lower limit ranged from $1 to $50,000.

There was general agreement that the nature of the relationship should be disclosed, but no agreement about whether the disclosure should explain the possible impact of those relationships. Again, concern about overcomplicating the consent statement semed to be at the root of these issues. Some respondents said the disclosure should include an explanation of how an unscrupulous investigator might alter the research results. Most respondents dismissed the idea that disclosure could lower enrollment. There was little sympathy among the group for researchers who complained that full disclosure was an invasion of their financial privacy.

There was also concern about how to best highlight disclosure information without overemphasizing its importance or potential risk to a study's integrity. Some respondents said their consent form highlights the information in bold type, while others place it strategically in the document—at the very beginning, for example. Many also emphasized that the informed consent process should include a discussion of conflict of interest, not just a read-through of the document.

Officials in charge of disclosing financial interests in research agree that disclosure is important, but are confused about how to do so effectively and appropriately, Kevin P. Weinfurt, Ph.D., and his colleagues reported.

Their survey of 42 such officials revealed widely varying opinions on when disclosure should be made, the financial limits that should trigger it, and how much information to share with prospective research subjects, said Dr. Weinfurt of the department of psychiatry at Duke University, Durham, N.C., and his coinvestigators.

“Part of their struggle relates to a lack of clarity regarding the ultimate goals of disclosure,” the researchers wrote. “There is also a lack of systematic data regarding how potential research participants can and will use such information in their decision-making” (J. Law Med. Ethics 2006;34:581–91).

The study was based on detailed personal interviews with eight investigators, 23 review board chairs, and 14 conflict of interest committee chairs. The survey was designed to elicit respondents' understandings of how disclosure is done at their institutions and their thoughts on the importance of disclosure, including its risks and benefits to the institution and research subjects.

More than half of those interviewed agreed that disclosure should occur under all circumstances; the rest said disclosure would depend on the degree of the financial relationship. The most commonly expressed reason for disclosing a financial relationship was to facilitate better-informed decision making for potential subjects. Other reasons included trust and transparency issues, reducing liability risk, and managing public perception of the institution.

About 80% of respondents said the disclosure should include the name of the funding source. But some said the name of the company or organization wasn't as important as a description—whether it was a nonprofit organization, pharmaceutical company, or government body, for instance.

They also differed on whether the amount of financial interest should be disclosed. Conflict of interest committee chairs were most likely to want to share this information (93%), while investigators were least likely (63%). Those who expressed concern about disclosing the amount felt that level of detail could become cumbersome or confusing in the informed consent statement, and that research subjects might overestimate the impact that particular amounts might actually have on research outcomes. There was no consensus on what amount should trigger disclosure—the lower limit ranged from $1 to $50,000.

There was general agreement that the nature of the relationship should be disclosed, but no agreement about whether the disclosure should explain the possible impact of those relationships. Again, concern about overcomplicating the consent statement semed to be at the root of these issues. Some respondents said the disclosure should include an explanation of how an unscrupulous investigator might alter the research results. Most respondents dismissed the idea that disclosure could lower enrollment. There was little sympathy among the group for researchers who complained that full disclosure was an invasion of their financial privacy.

There was also concern about how to best highlight disclosure information without overemphasizing its importance or potential risk to a study's integrity. Some respondents said their consent form highlights the information in bold type, while others place it strategically in the document—at the very beginning, for example. Many also emphasized that the informed consent process should include a discussion of conflict of interest, not just a read-through of the document.

For high school football players, the best defense against concussions is a good offense—and that means a well-fitted football helmet, according to Dr. Eugene Hong.

But many high school athletes don't receive a proper helmet fitting, which can put them at increased risk for concussion during play, said Dr. Hong of Drexel University, Philadelphia, in an interview.

Certified athletic trainers specially trained in gear fitting are most qualified to perform that task, Dr. Hong said. But his survey of 289 high schools in Pennsylvania and New Jersey showed that although 90% of schools have a certified athletic trainer available, only 44% of those schools use the trainer to fit helmets. Coaches or other individuals (including parents) do the fitting the rest of the time and make mistakes up to 25% of the time.

The overall concussion rate in Dr. Hong's survey was 3.5%, and it wasn't significantly different between players fit by trainers and those fit by coaches or others. However, Dr. Hong said, athletic trainers were fitting helmets a little better than coaches were, with significant differences in 3 of 10 recommended fitting techniques.

The three most commonly missed fitting techniques among coaches were not having the facemask 2 inches from the nose (25.5%), not positioning the helmet 1 inch above the eyebrows (17.5%), and not having the chin straps equidistant from each other (17.5%).

Parents and student athletes should be reminded at the preparticipation physicial examination of the importance of properly fit gear, Dr. Hong said.

Proper follow-up with conservative return-to-play decisions are vitally important for athletes recovering from a concussion, he added. Receiving a second blow to the head before a previous concussion has completely resolved can lead to second-impact syndrome, a usually fatal brain swelling.

Dr. Hong presented his data at the American College of Sports Medicine's annual meeting; the study will be published in the journal Medicine and Science in Sports and Exercise.

For high school football players, the best defense against concussions is a good offense—and that means a well-fitted football helmet, according to Dr. Eugene Hong.

But many high school athletes don't receive a proper helmet fitting, which can put them at increased risk for concussion during play, said Dr. Hong of Drexel University, Philadelphia, in an interview.

Certified athletic trainers specially trained in gear fitting are most qualified to perform that task, Dr. Hong said. But his survey of 289 high schools in Pennsylvania and New Jersey showed that although 90% of schools have a certified athletic trainer available, only 44% of those schools use the trainer to fit helmets. Coaches or other individuals (including parents) do the fitting the rest of the time and make mistakes up to 25% of the time.

The overall concussion rate in Dr. Hong's survey was 3.5%, and it wasn't significantly different between players fit by trainers and those fit by coaches or others. However, Dr. Hong said, athletic trainers were fitting helmets a little better than coaches were, with significant differences in 3 of 10 recommended fitting techniques.

The three most commonly missed fitting techniques among coaches were not having the facemask 2 inches from the nose (25.5%), not positioning the helmet 1 inch above the eyebrows (17.5%), and not having the chin straps equidistant from each other (17.5%).

Parents and student athletes should be reminded at the preparticipation physicial examination of the importance of properly fit gear, Dr. Hong said.

Proper follow-up with conservative return-to-play decisions are vitally important for athletes recovering from a concussion, he added. Receiving a second blow to the head before a previous concussion has completely resolved can lead to second-impact syndrome, a usually fatal brain swelling.

Dr. Hong presented his data at the American College of Sports Medicine's annual meeting; the study will be published in the journal Medicine and Science in Sports and Exercise.

For high school football players, the best defense against concussions is a good offense—and that means a well-fitted football helmet, according to Dr. Eugene Hong.

But many high school athletes don't receive a proper helmet fitting, which can put them at increased risk for concussion during play, said Dr. Hong of Drexel University, Philadelphia, in an interview.

Certified athletic trainers specially trained in gear fitting are most qualified to perform that task, Dr. Hong said. But his survey of 289 high schools in Pennsylvania and New Jersey showed that although 90% of schools have a certified athletic trainer available, only 44% of those schools use the trainer to fit helmets. Coaches or other individuals (including parents) do the fitting the rest of the time and make mistakes up to 25% of the time.

The overall concussion rate in Dr. Hong's survey was 3.5%, and it wasn't significantly different between players fit by trainers and those fit by coaches or others. However, Dr. Hong said, athletic trainers were fitting helmets a little better than coaches were, with significant differences in 3 of 10 recommended fitting techniques.

The three most commonly missed fitting techniques among coaches were not having the facemask 2 inches from the nose (25.5%), not positioning the helmet 1 inch above the eyebrows (17.5%), and not having the chin straps equidistant from each other (17.5%).

Parents and student athletes should be reminded at the preparticipation physicial examination of the importance of properly fit gear, Dr. Hong said.

Proper follow-up with conservative return-to-play decisions are vitally important for athletes recovering from a concussion, he added. Receiving a second blow to the head before a previous concussion has completely resolved can lead to second-impact syndrome, a usually fatal brain swelling.

Dr. Hong presented his data at the American College of Sports Medicine's annual meeting; the study will be published in the journal Medicine and Science in Sports and Exercise.

SAN FRANCISCO – Breast cancer patients who cope using spirituality are most likely to report personal growth resulting from their illness, Valerie Bussell, Ph.D., reported in a poster at the annual meeting of the Society of Behavioral Medicine.

“Positive things do come out of trauma,” she said in an interview. “Two years after their chemotherapy, these women are able to look back on it as something good that happened to change them.”

Her 2-year prospective study of coping in these women highlights the importance of a holistic approach to cancer treatment, she noted. “We are social and spiritual beings as well as physical,” said Dr. Bussell, a social psychologist at Houston Baptist University, Texas.

She surveyed 53 women (mean age of 51 years) who were undergoing adjuvant chemotherapy for breast cancer. The survey assessed the women's type of coping (emotional, problem-based, or spiritual/religious) and levels of distress, including depression, anxiety, perceived stress, and fatigue.

Dr. Bussell surveyed survivors of the same group 2 years later, looking for the same symptoms of distress and ways of coping, but also looking at how they reported any posttraumatic personal growth. She found that only spiritual coping was positively associated with reports of personal growth.

SAN FRANCISCO – Breast cancer patients who cope using spirituality are most likely to report personal growth resulting from their illness, Valerie Bussell, Ph.D., reported in a poster at the annual meeting of the Society of Behavioral Medicine.

“Positive things do come out of trauma,” she said in an interview. “Two years after their chemotherapy, these women are able to look back on it as something good that happened to change them.”

Her 2-year prospective study of coping in these women highlights the importance of a holistic approach to cancer treatment, she noted. “We are social and spiritual beings as well as physical,” said Dr. Bussell, a social psychologist at Houston Baptist University, Texas.

She surveyed 53 women (mean age of 51 years) who were undergoing adjuvant chemotherapy for breast cancer. The survey assessed the women's type of coping (emotional, problem-based, or spiritual/religious) and levels of distress, including depression, anxiety, perceived stress, and fatigue.

Dr. Bussell surveyed survivors of the same group 2 years later, looking for the same symptoms of distress and ways of coping, but also looking at how they reported any posttraumatic personal growth. She found that only spiritual coping was positively associated with reports of personal growth.

SAN FRANCISCO – Breast cancer patients who cope using spirituality are most likely to report personal growth resulting from their illness, Valerie Bussell, Ph.D., reported in a poster at the annual meeting of the Society of Behavioral Medicine.

“Positive things do come out of trauma,” she said in an interview. “Two years after their chemotherapy, these women are able to look back on it as something good that happened to change them.”

Her 2-year prospective study of coping in these women highlights the importance of a holistic approach to cancer treatment, she noted. “We are social and spiritual beings as well as physical,” said Dr. Bussell, a social psychologist at Houston Baptist University, Texas.

She surveyed 53 women (mean age of 51 years) who were undergoing adjuvant chemotherapy for breast cancer. The survey assessed the women's type of coping (emotional, problem-based, or spiritual/religious) and levels of distress, including depression, anxiety, perceived stress, and fatigue.

Dr. Bussell surveyed survivors of the same group 2 years later, looking for the same symptoms of distress and ways of coping, but also looking at how they reported any posttraumatic personal growth. She found that only spiritual coping was positively associated with reports of personal growth.

MADRID – Prescriptions for atypical antipsychotics have not decreased significantly among elderly patients with dementia, despite the black box warning of an increased risk of death associated with the drugs, Henry Riordan, Ph.D., said at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Overall, prescribing has declined only 2.4%, even though the number of new prescriptions issued has decreased by 37%, Dr. Riordan said at the meeting presented by the Alzheimer's Association. This pattern probably reflects physicians' perceptions that the clinical benefits of the drugs outweigh their well-documented risks for older dementia patients with serious behavioral issues.

More than 80% of Alzheimer's patients will eventually develop psychotic symptoms, said Dr. Riordan, vice president and global head of medical and scientific affairs for I3 Research in Basking Ridge, N.J.

“These are the issues that typically result in institutionalization and take a big chunk out of these patients' quality of life,” he said in an interview.

The problem lands patients, families, and physicians on the horns of a very sharp dilemma. “Withholding the drugs is dangerous, especially when you are dealing with behavior that can be either self-injurious or harmful to caregivers,” Dr. Riordan said, but the risks of atypical antipsychotics were well documented years before the Food and Drug Administration's warning.

Fifteen of the 17 randomized atypical antipsychotic trials the FDA reviewed found a significantly increased risk of death–usually cardiovascular or infectious–among elderly, demented patients taking the drugs, compared with placebo. The resultant black box warning highlighted the danger and reiterated that the drugs are not approved for the treatment of patients with dementia-related psychosis.

To estimate the impact of the black box warning on prescribing patterns, Dr. Riordan examined claims data from a large U.S. health plan, for 10 months before and 10 months after the 2005 warning was issued. The database included 900,000 people older than 65 years of age; 20,515 had a diagnosis of dementia. Of those, 5,000 were taking at least one atypical antipsychotic before the black box warning. Ten months after the warning, 4,883 people were still taking the drugs. New prescriptions had decreased significantly, however, declining from 3,423 to 2,148. “This probably tells us that if you were on the drug, you stayed on it, but that physicians might have been looking at something else for patients with new symptoms.”

A supporting pattern emerged when Dr. Riordan broke down the data by age: Prescriptions decreased more among patients younger than 81 (5%) than they did among older patients (0.73%). “Here we're probably seeing a risk-benefit ratio that's perceived as different for older people,” Dr. Riordan said. “If someone has been on it with good efficacy, it would probably just be continued. But the physician's thought process might be very different for someone younger, in the earlier stages of the disease.”

Six drugs were used in the study: aripiprazole (Abilify), clozapine (Clozaril), ziprasidone (Geodon), risperidone (Risperdal), quetiapine (Seroquel), and olanzapine (Zyprexa). Among the six drugs, only two showed significant pre- and postwarning prescribing changes.

Prescriptions for quetiapine increased significantly, while those for olanzapine decreased significantly. “It could be that quetiapine is being used more now for its sedative effect in sleep difficulty, and clozapine less due to its issues with increasing cardiovascular risk factors.”

Dr. Riordan now is investigating whether the decrease in new prescriptions caused any similar increases in prescriptions for alternative treatments, like mood stabilizers or antianxiolytics.

Unfortunately, he said, there is no evidence to suggest that anything other than the atypical antipsychotic agents is effective in treating the psychotic symptoms of dementia.

“We really need something new that is both safe and effective, and until we get that, people will continue to wrestle with these very difficult decisions,” Dr. Riordan said.

MADRID – Prescriptions for atypical antipsychotics have not decreased significantly among elderly patients with dementia, despite the black box warning of an increased risk of death associated with the drugs, Henry Riordan, Ph.D., said at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Overall, prescribing has declined only 2.4%, even though the number of new prescriptions issued has decreased by 37%, Dr. Riordan said at the meeting presented by the Alzheimer's Association. This pattern probably reflects physicians' perceptions that the clinical benefits of the drugs outweigh their well-documented risks for older dementia patients with serious behavioral issues.

More than 80% of Alzheimer's patients will eventually develop psychotic symptoms, said Dr. Riordan, vice president and global head of medical and scientific affairs for I3 Research in Basking Ridge, N.J.

“These are the issues that typically result in institutionalization and take a big chunk out of these patients' quality of life,” he said in an interview.

The problem lands patients, families, and physicians on the horns of a very sharp dilemma. “Withholding the drugs is dangerous, especially when you are dealing with behavior that can be either self-injurious or harmful to caregivers,” Dr. Riordan said, but the risks of atypical antipsychotics were well documented years before the Food and Drug Administration's warning.

Fifteen of the 17 randomized atypical antipsychotic trials the FDA reviewed found a significantly increased risk of death–usually cardiovascular or infectious–among elderly, demented patients taking the drugs, compared with placebo. The resultant black box warning highlighted the danger and reiterated that the drugs are not approved for the treatment of patients with dementia-related psychosis.

To estimate the impact of the black box warning on prescribing patterns, Dr. Riordan examined claims data from a large U.S. health plan, for 10 months before and 10 months after the 2005 warning was issued. The database included 900,000 people older than 65 years of age; 20,515 had a diagnosis of dementia. Of those, 5,000 were taking at least one atypical antipsychotic before the black box warning. Ten months after the warning, 4,883 people were still taking the drugs. New prescriptions had decreased significantly, however, declining from 3,423 to 2,148. “This probably tells us that if you were on the drug, you stayed on it, but that physicians might have been looking at something else for patients with new symptoms.”

A supporting pattern emerged when Dr. Riordan broke down the data by age: Prescriptions decreased more among patients younger than 81 (5%) than they did among older patients (0.73%). “Here we're probably seeing a risk-benefit ratio that's perceived as different for older people,” Dr. Riordan said. “If someone has been on it with good efficacy, it would probably just be continued. But the physician's thought process might be very different for someone younger, in the earlier stages of the disease.”

Six drugs were used in the study: aripiprazole (Abilify), clozapine (Clozaril), ziprasidone (Geodon), risperidone (Risperdal), quetiapine (Seroquel), and olanzapine (Zyprexa). Among the six drugs, only two showed significant pre- and postwarning prescribing changes.

Prescriptions for quetiapine increased significantly, while those for olanzapine decreased significantly. “It could be that quetiapine is being used more now for its sedative effect in sleep difficulty, and clozapine less due to its issues with increasing cardiovascular risk factors.”

Dr. Riordan now is investigating whether the decrease in new prescriptions caused any similar increases in prescriptions for alternative treatments, like mood stabilizers or antianxiolytics.

Unfortunately, he said, there is no evidence to suggest that anything other than the atypical antipsychotic agents is effective in treating the psychotic symptoms of dementia.

“We really need something new that is both safe and effective, and until we get that, people will continue to wrestle with these very difficult decisions,” Dr. Riordan said.

MADRID – Prescriptions for atypical antipsychotics have not decreased significantly among elderly patients with dementia, despite the black box warning of an increased risk of death associated with the drugs, Henry Riordan, Ph.D., said at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Overall, prescribing has declined only 2.4%, even though the number of new prescriptions issued has decreased by 37%, Dr. Riordan said at the meeting presented by the Alzheimer's Association. This pattern probably reflects physicians' perceptions that the clinical benefits of the drugs outweigh their well-documented risks for older dementia patients with serious behavioral issues.

More than 80% of Alzheimer's patients will eventually develop psychotic symptoms, said Dr. Riordan, vice president and global head of medical and scientific affairs for I3 Research in Basking Ridge, N.J.

“These are the issues that typically result in institutionalization and take a big chunk out of these patients' quality of life,” he said in an interview.

The problem lands patients, families, and physicians on the horns of a very sharp dilemma. “Withholding the drugs is dangerous, especially when you are dealing with behavior that can be either self-injurious or harmful to caregivers,” Dr. Riordan said, but the risks of atypical antipsychotics were well documented years before the Food and Drug Administration's warning.

Fifteen of the 17 randomized atypical antipsychotic trials the FDA reviewed found a significantly increased risk of death–usually cardiovascular or infectious–among elderly, demented patients taking the drugs, compared with placebo. The resultant black box warning highlighted the danger and reiterated that the drugs are not approved for the treatment of patients with dementia-related psychosis.

To estimate the impact of the black box warning on prescribing patterns, Dr. Riordan examined claims data from a large U.S. health plan, for 10 months before and 10 months after the 2005 warning was issued. The database included 900,000 people older than 65 years of age; 20,515 had a diagnosis of dementia. Of those, 5,000 were taking at least one atypical antipsychotic before the black box warning. Ten months after the warning, 4,883 people were still taking the drugs. New prescriptions had decreased significantly, however, declining from 3,423 to 2,148. “This probably tells us that if you were on the drug, you stayed on it, but that physicians might have been looking at something else for patients with new symptoms.”

A supporting pattern emerged when Dr. Riordan broke down the data by age: Prescriptions decreased more among patients younger than 81 (5%) than they did among older patients (0.73%). “Here we're probably seeing a risk-benefit ratio that's perceived as different for older people,” Dr. Riordan said. “If someone has been on it with good efficacy, it would probably just be continued. But the physician's thought process might be very different for someone younger, in the earlier stages of the disease.”

Six drugs were used in the study: aripiprazole (Abilify), clozapine (Clozaril), ziprasidone (Geodon), risperidone (Risperdal), quetiapine (Seroquel), and olanzapine (Zyprexa). Among the six drugs, only two showed significant pre- and postwarning prescribing changes.

Prescriptions for quetiapine increased significantly, while those for olanzapine decreased significantly. “It could be that quetiapine is being used more now for its sedative effect in sleep difficulty, and clozapine less due to its issues with increasing cardiovascular risk factors.”

Dr. Riordan now is investigating whether the decrease in new prescriptions caused any similar increases in prescriptions for alternative treatments, like mood stabilizers or antianxiolytics.

Unfortunately, he said, there is no evidence to suggest that anything other than the atypical antipsychotic agents is effective in treating the psychotic symptoms of dementia.

“We really need something new that is both safe and effective, and until we get that, people will continue to wrestle with these very difficult decisions,” Dr. Riordan said.

MADRID – Tight control of blood glucose levels may decrease the incidence of dementia and Alzheimer's disease among patients with diabetes, researchers reported at the 10th International Conference on Alzheimer's Disease and Related Disorders.

The findings speak volumes about the need for early implementation of significant lifestyle changes among those at risk for diabetes, especially in light of the ongoing obesity epidemic, said Dr. Ronald Petersen, who moderated a press conference on the studies. “The number of people with Alzheimer's, and the number who will soon get it, is rising dramatically as the baby boomers turn 50, approaching the age of highest risk,” said Dr. Petersen, vice chair of the Alzheimer's Association's Medical and Scientific Advisory Council. “Will this growth be redoubled by the rising tide of obesity and diabetes?”

Glycemic control is crucial in protecting diabetic patients from dementia, said Rachel Whitmer, Ph.D., of Kaiser Permanente, Oakland, Calif. Her population-based study included 22,852 members of Kaiser's Northern California Diabetes Registry surveyed from 1994 to 1996. Their mean age at baseline was 66 years; 66% were white, 10% black, and the rest were Hispanic, Asian, or Native American.

The patients were followed until 2005. By then, 11% had developed new-onset dementias. Hemoglobin A_1c (HbA_1c) was significantly associated with the incidence of dementia. Patients with the highest HbA_1c (15% and higher) were the most likely to develop dementia, with an elevated risk of 78% compared with those whose levels were below 10%. Diabetic patients are advised to keep their HbA_1c below 7%.

Those with HbA_1c levels of 12%–15% were 22% more likely to develop dementia, while those whose levels were between 10% and 11.9% had a 16% increased risk. The increased risks remained significant even after adjusting for age, race, gender, weight, and diabetes treatment.

“This shows us that tight glycemic control continues to be as important as patients' age,” Dr. Whitmer said at the meeting, presented by the Alzheimer's Association. “And it will become more and more important as we experience the epidemic of obesity in the United States.”

MADRID – Tight control of blood glucose levels may decrease the incidence of dementia and Alzheimer's disease among patients with diabetes, researchers reported at the 10th International Conference on Alzheimer's Disease and Related Disorders.

The findings speak volumes about the need for early implementation of significant lifestyle changes among those at risk for diabetes, especially in light of the ongoing obesity epidemic, said Dr. Ronald Petersen, who moderated a press conference on the studies. “The number of people with Alzheimer's, and the number who will soon get it, is rising dramatically as the baby boomers turn 50, approaching the age of highest risk,” said Dr. Petersen, vice chair of the Alzheimer's Association's Medical and Scientific Advisory Council. “Will this growth be redoubled by the rising tide of obesity and diabetes?”

Glycemic control is crucial in protecting diabetic patients from dementia, said Rachel Whitmer, Ph.D., of Kaiser Permanente, Oakland, Calif. Her population-based study included 22,852 members of Kaiser's Northern California Diabetes Registry surveyed from 1994 to 1996. Their mean age at baseline was 66 years; 66% were white, 10% black, and the rest were Hispanic, Asian, or Native American.

The patients were followed until 2005. By then, 11% had developed new-onset dementias. Hemoglobin A_1c (HbA_1c) was significantly associated with the incidence of dementia. Patients with the highest HbA_1c (15% and higher) were the most likely to develop dementia, with an elevated risk of 78% compared with those whose levels were below 10%. Diabetic patients are advised to keep their HbA_1c below 7%.

Those with HbA_1c levels of 12%–15% were 22% more likely to develop dementia, while those whose levels were between 10% and 11.9% had a 16% increased risk. The increased risks remained significant even after adjusting for age, race, gender, weight, and diabetes treatment.

“This shows us that tight glycemic control continues to be as important as patients' age,” Dr. Whitmer said at the meeting, presented by the Alzheimer's Association. “And it will become more and more important as we experience the epidemic of obesity in the United States.”

MADRID – Tight control of blood glucose levels may decrease the incidence of dementia and Alzheimer's disease among patients with diabetes, researchers reported at the 10th International Conference on Alzheimer's Disease and Related Disorders.

The findings speak volumes about the need for early implementation of significant lifestyle changes among those at risk for diabetes, especially in light of the ongoing obesity epidemic, said Dr. Ronald Petersen, who moderated a press conference on the studies. “The number of people with Alzheimer's, and the number who will soon get it, is rising dramatically as the baby boomers turn 50, approaching the age of highest risk,” said Dr. Petersen, vice chair of the Alzheimer's Association's Medical and Scientific Advisory Council. “Will this growth be redoubled by the rising tide of obesity and diabetes?”

Glycemic control is crucial in protecting diabetic patients from dementia, said Rachel Whitmer, Ph.D., of Kaiser Permanente, Oakland, Calif. Her population-based study included 22,852 members of Kaiser's Northern California Diabetes Registry surveyed from 1994 to 1996. Their mean age at baseline was 66 years; 66% were white, 10% black, and the rest were Hispanic, Asian, or Native American.

The patients were followed until 2005. By then, 11% had developed new-onset dementias. Hemoglobin A_1c (HbA_1c) was significantly associated with the incidence of dementia. Patients with the highest HbA_1c (15% and higher) were the most likely to develop dementia, with an elevated risk of 78% compared with those whose levels were below 10%. Diabetic patients are advised to keep their HbA_1c below 7%.

Those with HbA_1c levels of 12%–15% were 22% more likely to develop dementia, while those whose levels were between 10% and 11.9% had a 16% increased risk. The increased risks remained significant even after adjusting for age, race, gender, weight, and diabetes treatment.

“This shows us that tight glycemic control continues to be as important as patients' age,” Dr. Whitmer said at the meeting, presented by the Alzheimer's Association. “And it will become more and more important as we experience the epidemic of obesity in the United States.”

Officials in charge of disclosing financial interests in research agree that disclosure is important, but are confused about how to do so effectively and appropriately, Kevin P. Weinfurt, Ph.D., and his colleagues reported.

Their survey of 42 such officials revealed widely varying opinions on when disclosure should be made, the financial limits that should trigger it, and how much information to share with prospective research subjects, said Dr. Weinfurt of the department of psychiatry at Duke University, Durham, N.C., and his coinvestigators.

“Part of their struggle relates to a lack of clarity regarding the ultimate goals of disclosure,” they wrote. “There is also a lack of systematic data regarding how potential research participants can and will use such information in their decision-making” (J. Law Med. Ethics 2006;34:581–91).

The study was based on detailed personal interviews with 8 investigators, 23 review board chairs, and 14 conflict of interest committee chairs. The survey was designed to elicit respondents' understandings of how disclosure is done at their institutions and their thoughts on the importance of disclosure, including its risks and benefits for the institution and for research subjects.

More than half of those interviewed agreed that disclosure should occur under all circumstances; the rest said disclosure would depend on the degree of the financial relationship. The most commonly expressed reason for disclosing a financial relationship was to facilitate better-informed decision making for potential subjects. Other reasons included trust and transparency issues, reducing liability risk, and managing public perception of the institution.

About 80% of respondents said the disclosure should include the name of the funding source. But some said the name of the company or organization wasn't as important as a description—whether it was a nonprofit organization, pharmaceutical firm, or government body, for instance.

They also differed on whether the amount of financial interest should be disclosed. Conflict of interest committee chairs were most likely to want to share this information (93%), while investigators were least likely (63%). Those who expressed concern about disclosing the amount felt that such detail could become cumbersome or confusing in the informed consent statement, and that research subjects might overestimate the impact that particular amounts might actually have on research outcomes. There was no consensus on what amount should trigger disclosure—the lower limit ranged from $1 to $50,000.

There was general agreement that the nature of the relationship should be disclosed, but no agreement about whether the disclosure should explain the possible impact of those relationships. Again, concern about overcomplicating the consent statement semed to be at the root of these issues. Some respondents said the disclosure should include an explanation of how an unscrupulous investigator might alter the research results.

Most respondents dismissed the idea that disclosure could lower enrollment. There was little sympathy among the group for researchers who complained that full disclosure was an invasion of their financial privacy.

There was also concern about how to best highlight disclosure information without overemphasizing its importance or potential risk to a study's integrity. Some respondents said their consent form highlights the information in bold type, while others place it strategically in the document—at the very beginning, for example. Many also emphasized that the informed consent process should include a discussion of conflict of interest, not just a read-through of the document.

“Our data suggest that it will be difficult to achieve agreement on the issue of substantial understanding of financial interests,” the researchers concluded. “Before we can resolve what counts as substantial understanding, there must be agreement about what risks are important for potential research participants to understand.”

Officials in charge of disclosing financial interests in research agree that disclosure is important, but are confused about how to do so effectively and appropriately, Kevin P. Weinfurt, Ph.D., and his colleagues reported.

Their survey of 42 such officials revealed widely varying opinions on when disclosure should be made, the financial limits that should trigger it, and how much information to share with prospective research subjects, said Dr. Weinfurt of the department of psychiatry at Duke University, Durham, N.C., and his coinvestigators.

“Part of their struggle relates to a lack of clarity regarding the ultimate goals of disclosure,” they wrote. “There is also a lack of systematic data regarding how potential research participants can and will use such information in their decision-making” (J. Law Med. Ethics 2006;34:581–91).

The study was based on detailed personal interviews with 8 investigators, 23 review board chairs, and 14 conflict of interest committee chairs. The survey was designed to elicit respondents' understandings of how disclosure is done at their institutions and their thoughts on the importance of disclosure, including its risks and benefits for the institution and for research subjects.

More than half of those interviewed agreed that disclosure should occur under all circumstances; the rest said disclosure would depend on the degree of the financial relationship. The most commonly expressed reason for disclosing a financial relationship was to facilitate better-informed decision making for potential subjects. Other reasons included trust and transparency issues, reducing liability risk, and managing public perception of the institution.

About 80% of respondents said the disclosure should include the name of the funding source. But some said the name of the company or organization wasn't as important as a description—whether it was a nonprofit organization, pharmaceutical firm, or government body, for instance.

They also differed on whether the amount of financial interest should be disclosed. Conflict of interest committee chairs were most likely to want to share this information (93%), while investigators were least likely (63%). Those who expressed concern about disclosing the amount felt that such detail could become cumbersome or confusing in the informed consent statement, and that research subjects might overestimate the impact that particular amounts might actually have on research outcomes. There was no consensus on what amount should trigger disclosure—the lower limit ranged from $1 to $50,000.

There was general agreement that the nature of the relationship should be disclosed, but no agreement about whether the disclosure should explain the possible impact of those relationships. Again, concern about overcomplicating the consent statement semed to be at the root of these issues. Some respondents said the disclosure should include an explanation of how an unscrupulous investigator might alter the research results.

Most respondents dismissed the idea that disclosure could lower enrollment. There was little sympathy among the group for researchers who complained that full disclosure was an invasion of their financial privacy.

There was also concern about how to best highlight disclosure information without overemphasizing its importance or potential risk to a study's integrity. Some respondents said their consent form highlights the information in bold type, while others place it strategically in the document—at the very beginning, for example. Many also emphasized that the informed consent process should include a discussion of conflict of interest, not just a read-through of the document.

“Our data suggest that it will be difficult to achieve agreement on the issue of substantial understanding of financial interests,” the researchers concluded. “Before we can resolve what counts as substantial understanding, there must be agreement about what risks are important for potential research participants to understand.”

Officials in charge of disclosing financial interests in research agree that disclosure is important, but are confused about how to do so effectively and appropriately, Kevin P. Weinfurt, Ph.D., and his colleagues reported.

Their survey of 42 such officials revealed widely varying opinions on when disclosure should be made, the financial limits that should trigger it, and how much information to share with prospective research subjects, said Dr. Weinfurt of the department of psychiatry at Duke University, Durham, N.C., and his coinvestigators.

“Part of their struggle relates to a lack of clarity regarding the ultimate goals of disclosure,” they wrote. “There is also a lack of systematic data regarding how potential research participants can and will use such information in their decision-making” (J. Law Med. Ethics 2006;34:581–91).

The study was based on detailed personal interviews with 8 investigators, 23 review board chairs, and 14 conflict of interest committee chairs. The survey was designed to elicit respondents' understandings of how disclosure is done at their institutions and their thoughts on the importance of disclosure, including its risks and benefits for the institution and for research subjects.

More than half of those interviewed agreed that disclosure should occur under all circumstances; the rest said disclosure would depend on the degree of the financial relationship. The most commonly expressed reason for disclosing a financial relationship was to facilitate better-informed decision making for potential subjects. Other reasons included trust and transparency issues, reducing liability risk, and managing public perception of the institution.

About 80% of respondents said the disclosure should include the name of the funding source. But some said the name of the company or organization wasn't as important as a description—whether it was a nonprofit organization, pharmaceutical firm, or government body, for instance.

They also differed on whether the amount of financial interest should be disclosed. Conflict of interest committee chairs were most likely to want to share this information (93%), while investigators were least likely (63%). Those who expressed concern about disclosing the amount felt that such detail could become cumbersome or confusing in the informed consent statement, and that research subjects might overestimate the impact that particular amounts might actually have on research outcomes. There was no consensus on what amount should trigger disclosure—the lower limit ranged from $1 to $50,000.

There was general agreement that the nature of the relationship should be disclosed, but no agreement about whether the disclosure should explain the possible impact of those relationships. Again, concern about overcomplicating the consent statement semed to be at the root of these issues. Some respondents said the disclosure should include an explanation of how an unscrupulous investigator might alter the research results.

Most respondents dismissed the idea that disclosure could lower enrollment. There was little sympathy among the group for researchers who complained that full disclosure was an invasion of their financial privacy.

There was also concern about how to best highlight disclosure information without overemphasizing its importance or potential risk to a study's integrity. Some respondents said their consent form highlights the information in bold type, while others place it strategically in the document—at the very beginning, for example. Many also emphasized that the informed consent process should include a discussion of conflict of interest, not just a read-through of the document.

“Our data suggest that it will be difficult to achieve agreement on the issue of substantial understanding of financial interests,” the researchers concluded. “Before we can resolve what counts as substantial understanding, there must be agreement about what risks are important for potential research participants to understand.”