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Team of 50 cared for Ebola patient
Texas Health Presbyterian Hospital secured an entire 24-bed intensive care unit to care for Thomas Eric Duncan, the Liberian man who succumbed to Ebola on Wednesday and has been the first and only person to be diagnosed with the virus in the United States.
In a statement on Thursday, the Dallas hospital said that it dedicated a team of more than 50 people to the care of Mr. Duncan. Before his condition deteriorated, he had requested not to be resuscitated.
Mr. Duncan was also the first person to receive the investigational antiviral drug Brincidofovir. ZMapp has not been available since August 12, and his blood type was not compatible with available serum donors, the hospital said.
Also on Wednesday, a sheriff’s deputy who had been inside Mr. Duncan’s residence began showing some symptoms and was quickly isolated. His test results came back negative, Texas health officials reported Thursday.
Federal officials stepped up their efforts on Wednesday by announcing entry screening at five airports that receive the majority of travelers from the three affected West African countries.
“The most important place to take care of screening is at the point of departure,” said Health & Human Services Secretary Sylvia Burwell at a news conference on Thursday.
“Next step is having a system that can handle any case that we have. We’ve had one case, and there may be other cases, and we have to recognized that as a nation,” she said.
“We know how to contain [the virus], and that is detect, contact tracing, isolation, and treatment,” said Ms. Burwell, who has been involved in at least one meeting a day on Ebola since end of July.
At a World Bank conference on Thursday, Director of the Centers for Disease Control and Prevention Thomas Frieden compared the Ebola outbreak to the AIDS epidemic and said that more trained staff, laboratories, and infection control are needed in the three affected countries to prevent the virus from spreading.
So far there have been more than 8,000 Ebola cases, including 3,865 deaths, the majority of which have been in Guinea, Liberia, and Sierra Leone.
A trial for an Ebola vaccine has begun in Mali, according to an NBC news report.
The House Democrats, meanwhile, are urging the Labor, Health and Human Services, and Education Appropriation Subcommittee to convene a hearing on “emergent public health threats” posed by Ebola and enterovirus D68.
“Since Congress left Washington last month – the earliest we have recessed in over 50 years – the Ebola virus has found its way onto American soil and enterovirus D68 has reached almost every state and is linked to the deaths of multiple children. The House Appropriations Committee has not heard publicly from the CDC or the NIH since March, and we need to independently assess their response to these critical public health crises,” they wrote to the subcommittee chairman, Jack Kingston.
The first case of human-to-human transmission of the Ebola virus outside of Africa was confirmed earlier this week in Spain, and there have been other unconfirmed reports in Europe. The World Health Organization is not recommending any travel or trade restrictions by countries, except for confirmed or suspected cases.
--Alicia Ault contributed to this report.
Texas Health Presbyterian Hospital secured an entire 24-bed intensive care unit to care for Thomas Eric Duncan, the Liberian man who succumbed to Ebola on Wednesday and has been the first and only person to be diagnosed with the virus in the United States.
In a statement on Thursday, the Dallas hospital said that it dedicated a team of more than 50 people to the care of Mr. Duncan. Before his condition deteriorated, he had requested not to be resuscitated.
Mr. Duncan was also the first person to receive the investigational antiviral drug Brincidofovir. ZMapp has not been available since August 12, and his blood type was not compatible with available serum donors, the hospital said.
Also on Wednesday, a sheriff’s deputy who had been inside Mr. Duncan’s residence began showing some symptoms and was quickly isolated. His test results came back negative, Texas health officials reported Thursday.
Federal officials stepped up their efforts on Wednesday by announcing entry screening at five airports that receive the majority of travelers from the three affected West African countries.
“The most important place to take care of screening is at the point of departure,” said Health & Human Services Secretary Sylvia Burwell at a news conference on Thursday.
“Next step is having a system that can handle any case that we have. We’ve had one case, and there may be other cases, and we have to recognized that as a nation,” she said.
“We know how to contain [the virus], and that is detect, contact tracing, isolation, and treatment,” said Ms. Burwell, who has been involved in at least one meeting a day on Ebola since end of July.
At a World Bank conference on Thursday, Director of the Centers for Disease Control and Prevention Thomas Frieden compared the Ebola outbreak to the AIDS epidemic and said that more trained staff, laboratories, and infection control are needed in the three affected countries to prevent the virus from spreading.
So far there have been more than 8,000 Ebola cases, including 3,865 deaths, the majority of which have been in Guinea, Liberia, and Sierra Leone.
A trial for an Ebola vaccine has begun in Mali, according to an NBC news report.
The House Democrats, meanwhile, are urging the Labor, Health and Human Services, and Education Appropriation Subcommittee to convene a hearing on “emergent public health threats” posed by Ebola and enterovirus D68.
“Since Congress left Washington last month – the earliest we have recessed in over 50 years – the Ebola virus has found its way onto American soil and enterovirus D68 has reached almost every state and is linked to the deaths of multiple children. The House Appropriations Committee has not heard publicly from the CDC or the NIH since March, and we need to independently assess their response to these critical public health crises,” they wrote to the subcommittee chairman, Jack Kingston.
The first case of human-to-human transmission of the Ebola virus outside of Africa was confirmed earlier this week in Spain, and there have been other unconfirmed reports in Europe. The World Health Organization is not recommending any travel or trade restrictions by countries, except for confirmed or suspected cases.
--Alicia Ault contributed to this report.
Texas Health Presbyterian Hospital secured an entire 24-bed intensive care unit to care for Thomas Eric Duncan, the Liberian man who succumbed to Ebola on Wednesday and has been the first and only person to be diagnosed with the virus in the United States.
In a statement on Thursday, the Dallas hospital said that it dedicated a team of more than 50 people to the care of Mr. Duncan. Before his condition deteriorated, he had requested not to be resuscitated.
Mr. Duncan was also the first person to receive the investigational antiviral drug Brincidofovir. ZMapp has not been available since August 12, and his blood type was not compatible with available serum donors, the hospital said.
Also on Wednesday, a sheriff’s deputy who had been inside Mr. Duncan’s residence began showing some symptoms and was quickly isolated. His test results came back negative, Texas health officials reported Thursday.
Federal officials stepped up their efforts on Wednesday by announcing entry screening at five airports that receive the majority of travelers from the three affected West African countries.
“The most important place to take care of screening is at the point of departure,” said Health & Human Services Secretary Sylvia Burwell at a news conference on Thursday.
“Next step is having a system that can handle any case that we have. We’ve had one case, and there may be other cases, and we have to recognized that as a nation,” she said.
“We know how to contain [the virus], and that is detect, contact tracing, isolation, and treatment,” said Ms. Burwell, who has been involved in at least one meeting a day on Ebola since end of July.
At a World Bank conference on Thursday, Director of the Centers for Disease Control and Prevention Thomas Frieden compared the Ebola outbreak to the AIDS epidemic and said that more trained staff, laboratories, and infection control are needed in the three affected countries to prevent the virus from spreading.
So far there have been more than 8,000 Ebola cases, including 3,865 deaths, the majority of which have been in Guinea, Liberia, and Sierra Leone.
A trial for an Ebola vaccine has begun in Mali, according to an NBC news report.
The House Democrats, meanwhile, are urging the Labor, Health and Human Services, and Education Appropriation Subcommittee to convene a hearing on “emergent public health threats” posed by Ebola and enterovirus D68.
“Since Congress left Washington last month – the earliest we have recessed in over 50 years – the Ebola virus has found its way onto American soil and enterovirus D68 has reached almost every state and is linked to the deaths of multiple children. The House Appropriations Committee has not heard publicly from the CDC or the NIH since March, and we need to independently assess their response to these critical public health crises,” they wrote to the subcommittee chairman, Jack Kingston.
The first case of human-to-human transmission of the Ebola virus outside of Africa was confirmed earlier this week in Spain, and there have been other unconfirmed reports in Europe. The World Health Organization is not recommending any travel or trade restrictions by countries, except for confirmed or suspected cases.
--Alicia Ault contributed to this report.
AUDIO: CDC Expert – What Clinicians Need to Know About Enterovirus D68
Enterovirus D68, which has been spreading rapidly across the nation causing mild to severe respiratory illnesses, is now under investigation for a possible link to several cases of paralysis in children.
On Sept. 26, the Centers for Disease Control and Prevention issued an alert about the investigation and encouraged clinicians to report any cases of acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter.
In an interview Sept. 30, Dr. Daniel Feikin, the epidemiology branch chief at the division of viral diseases at the CDC, shared what’s known so far about EV-D68, talked about the ongoing investigation into the link with pediatric paralysis cases, and provided clinical advice to clinicians.
Enterovirus D68, which has been spreading rapidly across the nation causing mild to severe respiratory illnesses, is now under investigation for a possible link to several cases of paralysis in children.
On Sept. 26, the Centers for Disease Control and Prevention issued an alert about the investigation and encouraged clinicians to report any cases of acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter.
In an interview Sept. 30, Dr. Daniel Feikin, the epidemiology branch chief at the division of viral diseases at the CDC, shared what’s known so far about EV-D68, talked about the ongoing investigation into the link with pediatric paralysis cases, and provided clinical advice to clinicians.
Enterovirus D68, which has been spreading rapidly across the nation causing mild to severe respiratory illnesses, is now under investigation for a possible link to several cases of paralysis in children.
On Sept. 26, the Centers for Disease Control and Prevention issued an alert about the investigation and encouraged clinicians to report any cases of acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter.
In an interview Sept. 30, Dr. Daniel Feikin, the epidemiology branch chief at the division of viral diseases at the CDC, shared what’s known so far about EV-D68, talked about the ongoing investigation into the link with pediatric paralysis cases, and provided clinical advice to clinicians.
AUDIO: CDC expert – What physicians need to know about enterovirus D68
Enterovirus D68, which has been spreading rapidly across the nation causing mild to severe respiratory illnesses, is now under investigation for a possible link to several cases of paralysis in children.
On Sept. 26, the Centers for Disease Control and Prevention issued an alert about the investigation and encouraged physicians to report any cases of acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter.
In an interview Sept. 30, Dr. Daniel Feikin, the epidemiology branch chief at the division of viral diseases at the CDC, shared what’s known so far about EV-D68, talked about the ongoing investigation into the link with pediatric paralysis cases, and provided clinical advice to physicians.
On Twitter @naseemmiller
Enterovirus D68, which has been spreading rapidly across the nation causing mild to severe respiratory illnesses, is now under investigation for a possible link to several cases of paralysis in children.
On Sept. 26, the Centers for Disease Control and Prevention issued an alert about the investigation and encouraged physicians to report any cases of acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter.
In an interview Sept. 30, Dr. Daniel Feikin, the epidemiology branch chief at the division of viral diseases at the CDC, shared what’s known so far about EV-D68, talked about the ongoing investigation into the link with pediatric paralysis cases, and provided clinical advice to physicians.
On Twitter @naseemmiller
Enterovirus D68, which has been spreading rapidly across the nation causing mild to severe respiratory illnesses, is now under investigation for a possible link to several cases of paralysis in children.
On Sept. 26, the Centers for Disease Control and Prevention issued an alert about the investigation and encouraged physicians to report any cases of acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter.
In an interview Sept. 30, Dr. Daniel Feikin, the epidemiology branch chief at the division of viral diseases at the CDC, shared what’s known so far about EV-D68, talked about the ongoing investigation into the link with pediatric paralysis cases, and provided clinical advice to physicians.
On Twitter @naseemmiller
Beating heart could power batteryless pacemaker
BARCELONA – Swiss researchers have modified an automatic wristwatch, attached it to a pig’s heart, and successfully harvested more than enough energy from this constantly beating muscle to create the first batteryless pacemaker of its kind.
The feasibility study was presented at the annual congress of the European Society of Cardiology, and Dr. Sylvia G. Priori of NYU Langone Medical Center, New York, said that it “could revolutionize how the devices are made.”
Batteries take up almost half of the space in today’s pacemakers, said Adrian Zurbuchen, an engineer at the University of Bern, Switzerland, who presented the study. In addition, they have to be replaced, which increases costs and the risk of complications.
Meanwhile, automatic watches, which have a history trailing back to the 18th century, have proven effective in harvesting the power of motion to keep the clock running. So what happens if this motion comes from the beating heart to power a pacemaker?
To find the answer, the research team modified a commercially available automatic wristwatch, and after performing a sternotomy in domestic pigs, they sutured it to the myocardium on the anteroapical part of the left ventricle.
The system includes an electric circuit that transforms the energy and powers a custom-made pacemaker, and epicardial leads that deliver the electrical stimuli to the heart.
The group successfully tested the system in vivo and performed batteryless pacing at 130 beats per minute, Mr. Zurbuchen reported. The device generated a mean output power of 52 microwatts, which is nearly five times more than the power required by a modern pacemaker, he said.
Researchers are now looking into less invasive ways of implanting the device, which has not been commercialized.
Dr. Priori and Mr. Zurbuchen had no disclosures.
On Twitter @naseemmiller
BARCELONA – Swiss researchers have modified an automatic wristwatch, attached it to a pig’s heart, and successfully harvested more than enough energy from this constantly beating muscle to create the first batteryless pacemaker of its kind.
The feasibility study was presented at the annual congress of the European Society of Cardiology, and Dr. Sylvia G. Priori of NYU Langone Medical Center, New York, said that it “could revolutionize how the devices are made.”
Batteries take up almost half of the space in today’s pacemakers, said Adrian Zurbuchen, an engineer at the University of Bern, Switzerland, who presented the study. In addition, they have to be replaced, which increases costs and the risk of complications.
Meanwhile, automatic watches, which have a history trailing back to the 18th century, have proven effective in harvesting the power of motion to keep the clock running. So what happens if this motion comes from the beating heart to power a pacemaker?
To find the answer, the research team modified a commercially available automatic wristwatch, and after performing a sternotomy in domestic pigs, they sutured it to the myocardium on the anteroapical part of the left ventricle.
The system includes an electric circuit that transforms the energy and powers a custom-made pacemaker, and epicardial leads that deliver the electrical stimuli to the heart.
The group successfully tested the system in vivo and performed batteryless pacing at 130 beats per minute, Mr. Zurbuchen reported. The device generated a mean output power of 52 microwatts, which is nearly five times more than the power required by a modern pacemaker, he said.
Researchers are now looking into less invasive ways of implanting the device, which has not been commercialized.
Dr. Priori and Mr. Zurbuchen had no disclosures.
On Twitter @naseemmiller
BARCELONA – Swiss researchers have modified an automatic wristwatch, attached it to a pig’s heart, and successfully harvested more than enough energy from this constantly beating muscle to create the first batteryless pacemaker of its kind.
The feasibility study was presented at the annual congress of the European Society of Cardiology, and Dr. Sylvia G. Priori of NYU Langone Medical Center, New York, said that it “could revolutionize how the devices are made.”
Batteries take up almost half of the space in today’s pacemakers, said Adrian Zurbuchen, an engineer at the University of Bern, Switzerland, who presented the study. In addition, they have to be replaced, which increases costs and the risk of complications.
Meanwhile, automatic watches, which have a history trailing back to the 18th century, have proven effective in harvesting the power of motion to keep the clock running. So what happens if this motion comes from the beating heart to power a pacemaker?
To find the answer, the research team modified a commercially available automatic wristwatch, and after performing a sternotomy in domestic pigs, they sutured it to the myocardium on the anteroapical part of the left ventricle.
The system includes an electric circuit that transforms the energy and powers a custom-made pacemaker, and epicardial leads that deliver the electrical stimuli to the heart.
The group successfully tested the system in vivo and performed batteryless pacing at 130 beats per minute, Mr. Zurbuchen reported. The device generated a mean output power of 52 microwatts, which is nearly five times more than the power required by a modern pacemaker, he said.
Researchers are now looking into less invasive ways of implanting the device, which has not been commercialized.
Dr. Priori and Mr. Zurbuchen had no disclosures.
On Twitter @naseemmiller
AT THE ESC CONGRESS 2014
Key clinical point: The heartbeat can be harvested to power a medical device such as a pacemaker.
Major finding: A modified automatic wristwatch successfully powered a batteryless pacemaker in pigs.
Data source: In vivo study in pigs.
Disclosures: Dr. Priori and Mr. Zurbuchen had no disclosures.
VIDEO: Future direction for AADE and diabetes education
ORLANDO – The field of diabetes education is evolving, especially as health reform is slowly changing the country’s health care landscape.
Deborah Greenwood, Ph.D., the 2014 president-elect for American Association of Diabetes Educators, talked with us during the AADE annual meeting about how the organization is assessing the changes and what it has planned.
On Twitter @naseemmiller
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – The field of diabetes education is evolving, especially as health reform is slowly changing the country’s health care landscape.
Deborah Greenwood, Ph.D., the 2014 president-elect for American Association of Diabetes Educators, talked with us during the AADE annual meeting about how the organization is assessing the changes and what it has planned.
On Twitter @naseemmiller
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – The field of diabetes education is evolving, especially as health reform is slowly changing the country’s health care landscape.
Deborah Greenwood, Ph.D., the 2014 president-elect for American Association of Diabetes Educators, talked with us during the AADE annual meeting about how the organization is assessing the changes and what it has planned.
On Twitter @naseemmiller
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT AADE 2014
VIDEO: Lifestyle improvements prevented cognitive decline in at-risk elderly
COPENHAGEN – When older adults who were at risk of Alzheimer’s disease adopted more healthful lifestyles, including diet and exercise, their cognitive performance improved, according to findings from a 2-year randomized, controlled trial.
The study is yet more proof that "it’s never too late to adopt a healthful lifestyle," said Dr. Ralph A. Nixon, chair of the Alzheimer’s Association Medical and Scientific Advisory Council.
The multimodal intervention study, called the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), added nutritional guidance, physical exercise, cognitive training, and vascular risk factor management to the treatment of half of 1,260 participants who were between ages 60 and 77 years. The other half of participants received regular health advice.
To their surprise, researchers achieved their primary outcome – improvement in cognitive performance – within 2 years. In fact, the benefit was significant in all cognitive domains, including memory, executive function, and psychomotor speed, compared with the control group.
Only 11% of the participants dropped out. There were no serious adverse events.
This is the first long-term study to assess the impact of simultaneous improvement of several lifestyle factors on elderly cognition, the investigators said. The researchers are now conducting cost analysis, and they plan to follow the patients for 7 years to assess the longer-term effect of the interventions.
The findings demonstrate that multidomain intervention is feasible and can reduce the risk of cognitive impairment among the at-risk elderly population, said the study’s lead investigator, Dr. Miia Kivipelto. She hopes that this proof-of-concept study becomes a model for future programs in this group.
In a video interview, Dr. Kivipelto, a professor at the Karolinska Institute in Stockholm, discusses the study’s findings and its implications for clinical practice.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
COPENHAGEN – When older adults who were at risk of Alzheimer’s disease adopted more healthful lifestyles, including diet and exercise, their cognitive performance improved, according to findings from a 2-year randomized, controlled trial.
The study is yet more proof that "it’s never too late to adopt a healthful lifestyle," said Dr. Ralph A. Nixon, chair of the Alzheimer’s Association Medical and Scientific Advisory Council.
The multimodal intervention study, called the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), added nutritional guidance, physical exercise, cognitive training, and vascular risk factor management to the treatment of half of 1,260 participants who were between ages 60 and 77 years. The other half of participants received regular health advice.
To their surprise, researchers achieved their primary outcome – improvement in cognitive performance – within 2 years. In fact, the benefit was significant in all cognitive domains, including memory, executive function, and psychomotor speed, compared with the control group.
Only 11% of the participants dropped out. There were no serious adverse events.
This is the first long-term study to assess the impact of simultaneous improvement of several lifestyle factors on elderly cognition, the investigators said. The researchers are now conducting cost analysis, and they plan to follow the patients for 7 years to assess the longer-term effect of the interventions.
The findings demonstrate that multidomain intervention is feasible and can reduce the risk of cognitive impairment among the at-risk elderly population, said the study’s lead investigator, Dr. Miia Kivipelto. She hopes that this proof-of-concept study becomes a model for future programs in this group.
In a video interview, Dr. Kivipelto, a professor at the Karolinska Institute in Stockholm, discusses the study’s findings and its implications for clinical practice.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
COPENHAGEN – When older adults who were at risk of Alzheimer’s disease adopted more healthful lifestyles, including diet and exercise, their cognitive performance improved, according to findings from a 2-year randomized, controlled trial.
The study is yet more proof that "it’s never too late to adopt a healthful lifestyle," said Dr. Ralph A. Nixon, chair of the Alzheimer’s Association Medical and Scientific Advisory Council.
The multimodal intervention study, called the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), added nutritional guidance, physical exercise, cognitive training, and vascular risk factor management to the treatment of half of 1,260 participants who were between ages 60 and 77 years. The other half of participants received regular health advice.
To their surprise, researchers achieved their primary outcome – improvement in cognitive performance – within 2 years. In fact, the benefit was significant in all cognitive domains, including memory, executive function, and psychomotor speed, compared with the control group.
Only 11% of the participants dropped out. There were no serious adverse events.
This is the first long-term study to assess the impact of simultaneous improvement of several lifestyle factors on elderly cognition, the investigators said. The researchers are now conducting cost analysis, and they plan to follow the patients for 7 years to assess the longer-term effect of the interventions.
The findings demonstrate that multidomain intervention is feasible and can reduce the risk of cognitive impairment among the at-risk elderly population, said the study’s lead investigator, Dr. Miia Kivipelto. She hopes that this proof-of-concept study becomes a model for future programs in this group.
In a video interview, Dr. Kivipelto, a professor at the Karolinska Institute in Stockholm, discusses the study’s findings and its implications for clinical practice.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
AT AAIC 2014
FDA clears marketing of robotic exoskeleton for at-home use
The Food and Drug Administration has cleared the marketing of the ReWalk Personal System, thereby for the first time enabling individuals with lower-body paralysis because of a spinal cord injury to use a wearable motorized exoskeleton at home.
The robotic device consists of a fitted, metal brace worn over the legs and part of the upper body and is controlled by a wireless remote. It accommodates individuals with heights from 5’3" to 6’3" and weighs up to 220 pounds.
ReWalk costs $69,500 and is currently not covered by insurance, although company officials are in talks with insurance companies, according to a spokesperson. The company also says that the potential medical benefits of using the device will offset the cost by reducing hospitalization and some medications.
ReWalk Personal System is not the only motorized exoskeleton available in the United States, but so far, ReWalk, along with similar (but different) exoskeleton systems such as Ekso Bionics, have been mainly used in rehabilitation facilities and Veterans Affairs hospitals.
"Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility," Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a written statement. "Along with physical therapy, training, and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities."
Individuals with paraplegia due to spinal cord injuries at level T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra), can use the device when accompanied by a specially trained caregiver, according to the FDA.
People with spinal cord injury at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) can also use the device, but only in rehab facilities, according to the FDA. The device is not for sports or climbing stairs.
Consumers and their caregivers, who could be a spouse or home health aid, must successfully complete a training program designed by ReWalk at a rehabilitation center or a VA hospital. Physicians evaluate the individual’s skill level based on training before writing a prescription for the device.
But, according to the FDA, prior to being trained to use ReWalk:
• Patients should be able to stand using an assistive standing device (e.g., standing frame), and their hands and shoulders should be able to support crutches or a walker.
• Patients should not use the device if they have a history of severe neurologic injuries other than spinal cord injury, or have severe spasticity, significant contractures, unstable spine, unhealed limb fractures, or pelvic fractures.
• Patients should also not use the device if they have severe concurrent medical diseases such as infection, circulatory conditions, heart or lung conditions, or pressure sores.
The ReWalk Personal System consists of motors that help with movement of hips, knees, and ankles, enabling people to sit, stand, turn and walk, with assistance from a trained person. The device has a tilt sensor, and its computer and power supply are contained in a backpack. Patients use crutches, and they control the device with a wireless remote control worn on the wrist. The device weighs 46 pounds, but the user feels mostly the weight of the backpack, which is about 5 pounds, according to the company.
"The person walks the system, the system does not walk them," Dr. Amit Goffer, the Israeli inventor of ReWalk who became quadriplegic after an ATV accident in 1997, said in a company news release. "The users are in control – when they want to sit, they sit, when then want to stand and walk, they do so."
The device, manufactured by Argo Medical Technologies, has been in use in Europe, Israel, and other countries. The rehab version of ReWalk became available internationally in 2011, while sales of the personal system began in 2012.
It is not clear when another brand of exoskeletons will be cleared for marketing by the FDA. "We’re excited that the FDA has opened this gateway and look forward to seeing how the market reacts," said a spokesperson for Ekso Bionics, noting that the company is currently focused on the rehabilitation market, but some individuals use the device at home with a physical therapist and in clinical studies conducted by the company.
The ReWalk personal system was reviewed through FDA’s de novo classification process, used for novel, first-of-its-kind medical devices that are low to moderate risk. The agency cleared the device after reviewing its durability, hardware, software, and battery system, in addition to assessing clinical data from a 30-subject study and a 16-patient observational study.
The company reports that "Study data of the ReWalk system indicate potential improvements in cardiovascular health, loss of fat tissue, building of lean muscle mass, and improved bowel function. Feedback from ReWalk users supports these potential benefits and others, such as better pain management, fewer medications, and potentially reduced hospitalizations."
The device’s manufacturer is required to complete a postmarket clinical study to collect data on adverse events related to device use and to assess the adequacy of its training program, according to the FDA.
On Twitter @naseemmiller
The Food and Drug Administration has cleared the marketing of the ReWalk Personal System, thereby for the first time enabling individuals with lower-body paralysis because of a spinal cord injury to use a wearable motorized exoskeleton at home.
The robotic device consists of a fitted, metal brace worn over the legs and part of the upper body and is controlled by a wireless remote. It accommodates individuals with heights from 5’3" to 6’3" and weighs up to 220 pounds.
ReWalk costs $69,500 and is currently not covered by insurance, although company officials are in talks with insurance companies, according to a spokesperson. The company also says that the potential medical benefits of using the device will offset the cost by reducing hospitalization and some medications.
ReWalk Personal System is not the only motorized exoskeleton available in the United States, but so far, ReWalk, along with similar (but different) exoskeleton systems such as Ekso Bionics, have been mainly used in rehabilitation facilities and Veterans Affairs hospitals.
"Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility," Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a written statement. "Along with physical therapy, training, and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities."
Individuals with paraplegia due to spinal cord injuries at level T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra), can use the device when accompanied by a specially trained caregiver, according to the FDA.
People with spinal cord injury at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) can also use the device, but only in rehab facilities, according to the FDA. The device is not for sports or climbing stairs.
Consumers and their caregivers, who could be a spouse or home health aid, must successfully complete a training program designed by ReWalk at a rehabilitation center or a VA hospital. Physicians evaluate the individual’s skill level based on training before writing a prescription for the device.
But, according to the FDA, prior to being trained to use ReWalk:
• Patients should be able to stand using an assistive standing device (e.g., standing frame), and their hands and shoulders should be able to support crutches or a walker.
• Patients should not use the device if they have a history of severe neurologic injuries other than spinal cord injury, or have severe spasticity, significant contractures, unstable spine, unhealed limb fractures, or pelvic fractures.
• Patients should also not use the device if they have severe concurrent medical diseases such as infection, circulatory conditions, heart or lung conditions, or pressure sores.
The ReWalk Personal System consists of motors that help with movement of hips, knees, and ankles, enabling people to sit, stand, turn and walk, with assistance from a trained person. The device has a tilt sensor, and its computer and power supply are contained in a backpack. Patients use crutches, and they control the device with a wireless remote control worn on the wrist. The device weighs 46 pounds, but the user feels mostly the weight of the backpack, which is about 5 pounds, according to the company.
"The person walks the system, the system does not walk them," Dr. Amit Goffer, the Israeli inventor of ReWalk who became quadriplegic after an ATV accident in 1997, said in a company news release. "The users are in control – when they want to sit, they sit, when then want to stand and walk, they do so."
The device, manufactured by Argo Medical Technologies, has been in use in Europe, Israel, and other countries. The rehab version of ReWalk became available internationally in 2011, while sales of the personal system began in 2012.
It is not clear when another brand of exoskeletons will be cleared for marketing by the FDA. "We’re excited that the FDA has opened this gateway and look forward to seeing how the market reacts," said a spokesperson for Ekso Bionics, noting that the company is currently focused on the rehabilitation market, but some individuals use the device at home with a physical therapist and in clinical studies conducted by the company.
The ReWalk personal system was reviewed through FDA’s de novo classification process, used for novel, first-of-its-kind medical devices that are low to moderate risk. The agency cleared the device after reviewing its durability, hardware, software, and battery system, in addition to assessing clinical data from a 30-subject study and a 16-patient observational study.
The company reports that "Study data of the ReWalk system indicate potential improvements in cardiovascular health, loss of fat tissue, building of lean muscle mass, and improved bowel function. Feedback from ReWalk users supports these potential benefits and others, such as better pain management, fewer medications, and potentially reduced hospitalizations."
The device’s manufacturer is required to complete a postmarket clinical study to collect data on adverse events related to device use and to assess the adequacy of its training program, according to the FDA.
On Twitter @naseemmiller
The Food and Drug Administration has cleared the marketing of the ReWalk Personal System, thereby for the first time enabling individuals with lower-body paralysis because of a spinal cord injury to use a wearable motorized exoskeleton at home.
The robotic device consists of a fitted, metal brace worn over the legs and part of the upper body and is controlled by a wireless remote. It accommodates individuals with heights from 5’3" to 6’3" and weighs up to 220 pounds.
ReWalk costs $69,500 and is currently not covered by insurance, although company officials are in talks with insurance companies, according to a spokesperson. The company also says that the potential medical benefits of using the device will offset the cost by reducing hospitalization and some medications.
ReWalk Personal System is not the only motorized exoskeleton available in the United States, but so far, ReWalk, along with similar (but different) exoskeleton systems such as Ekso Bionics, have been mainly used in rehabilitation facilities and Veterans Affairs hospitals.
"Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility," Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a written statement. "Along with physical therapy, training, and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities."
Individuals with paraplegia due to spinal cord injuries at level T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra), can use the device when accompanied by a specially trained caregiver, according to the FDA.
People with spinal cord injury at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) can also use the device, but only in rehab facilities, according to the FDA. The device is not for sports or climbing stairs.
Consumers and their caregivers, who could be a spouse or home health aid, must successfully complete a training program designed by ReWalk at a rehabilitation center or a VA hospital. Physicians evaluate the individual’s skill level based on training before writing a prescription for the device.
But, according to the FDA, prior to being trained to use ReWalk:
• Patients should be able to stand using an assistive standing device (e.g., standing frame), and their hands and shoulders should be able to support crutches or a walker.
• Patients should not use the device if they have a history of severe neurologic injuries other than spinal cord injury, or have severe spasticity, significant contractures, unstable spine, unhealed limb fractures, or pelvic fractures.
• Patients should also not use the device if they have severe concurrent medical diseases such as infection, circulatory conditions, heart or lung conditions, or pressure sores.
The ReWalk Personal System consists of motors that help with movement of hips, knees, and ankles, enabling people to sit, stand, turn and walk, with assistance from a trained person. The device has a tilt sensor, and its computer and power supply are contained in a backpack. Patients use crutches, and they control the device with a wireless remote control worn on the wrist. The device weighs 46 pounds, but the user feels mostly the weight of the backpack, which is about 5 pounds, according to the company.
"The person walks the system, the system does not walk them," Dr. Amit Goffer, the Israeli inventor of ReWalk who became quadriplegic after an ATV accident in 1997, said in a company news release. "The users are in control – when they want to sit, they sit, when then want to stand and walk, they do so."
The device, manufactured by Argo Medical Technologies, has been in use in Europe, Israel, and other countries. The rehab version of ReWalk became available internationally in 2011, while sales of the personal system began in 2012.
It is not clear when another brand of exoskeletons will be cleared for marketing by the FDA. "We’re excited that the FDA has opened this gateway and look forward to seeing how the market reacts," said a spokesperson for Ekso Bionics, noting that the company is currently focused on the rehabilitation market, but some individuals use the device at home with a physical therapist and in clinical studies conducted by the company.
The ReWalk personal system was reviewed through FDA’s de novo classification process, used for novel, first-of-its-kind medical devices that are low to moderate risk. The agency cleared the device after reviewing its durability, hardware, software, and battery system, in addition to assessing clinical data from a 30-subject study and a 16-patient observational study.
The company reports that "Study data of the ReWalk system indicate potential improvements in cardiovascular health, loss of fat tissue, building of lean muscle mass, and improved bowel function. Feedback from ReWalk users supports these potential benefits and others, such as better pain management, fewer medications, and potentially reduced hospitalizations."
The device’s manufacturer is required to complete a postmarket clinical study to collect data on adverse events related to device use and to assess the adequacy of its training program, according to the FDA.
On Twitter @naseemmiller
Education improved impaired hypoglycemia awareness
CHICAGO – Patients with type 1 diabetes who had impaired awareness of hypoglycemia and were provided with education and support, had equal biochemical outcomes whether they were on insulin pump therapy or daily injections.
Researchers also found that the outcomes were equal for patients whether they were on conventional or real-time glucose monitoring.
Impaired awareness of hypoglycemia, or IAH, affects roughly 20% of adults with type 1 diabetes. Also, severe hypoglycemia is six times more likely in these adults, said Dr. Stuart A. Little of Newcastle upon Tyne, England, who presented the results of Hypo COMPaSS, a 24-week, randomized controlled trial of 96 participants, at the annual scientific sessions of the American Diabetes Association.
"Sometimes patients with impaired awareness say that they don’t even feel it, and they think it’s okay," said Marjorie Cypress, Ph.D., the 2013 president-elect of ADA’s health care and education committee. "They need to learn that it’s not okay, that they’re not getting those warning signs, but they’re losing glucose from their brain."
Most of the participants in the trial were women (63%), their mean age was 49 years, their diabetes duration was about 29 years, and their mean HbA1c level was 66 mmol/mol, or about 8.2%.
Dr. Little and his colleagues randomized the 96 participants to a multiple daily injection (MDI) group (50 patients) and an insulin pump therapy (CSII) group (46). In the MDI group, 24 patients did not have real-time (RT) continuous glucose monitoring, and 26 did. And in the CSII group, 24 patients had no RT, and 22 did.
The primary endpoint of the study was the difference in 24-week Gold score, with an 80% power to detect a Gold score difference of 1.1 on a 7-point Likert scale.
Secondary endpoints included overall glycemic control and patient-reported outcomes.
All patients received equal support and had a treatment goal of rigorous avoidance of biochemical hypoglycemia without relaxation of overall hemoglobin A1c. They all had Gold scores of at least 4, indicating IAH.
Within 4 weeks, the patients’ biochemical hypoglycemia was reduced significantly, from 3.7% to 1.7% of the time, from 53 minutes/day to under half an hour. The reduction was maintained throughout the study.
The median Gold score also showed a statistically significant reduction by week 24 among all participants, dropping from 5 at baseline to 4 at the end of the study period.
There was also a dramatic reduction in severe hypoglycemic events, said Dr. Little. While 92% of the patients were affected by the condition the year before the study, and 77% were affected 6 months before the trial, only 19% were affected during the trial.
Fear of hypoglycemia was significantly reduced and treatment satisfaction improved among all participants. The mean HbA1c did not change throughout the study among the participants.
When the investigators compared the MDI and CSII groups, the Gold score and severe hypoglycemia were not significantly different, nor were the HbA1c levels or insulin units. And although the fear of hypoglycemia did not differ significantly between the two groups, the treatment satisfaction was significantly higher in the CSII group.
Comparing the patients based on real-time glucose monitoring or self-monitoring showed no statistically significant difference in Gold score, severe hypoglycemia, HbA1c levels, or insulin units. There were also no significant differences in fear of hypoglycemia and treatment satisfaction.
"The bottom line is, if you give people education about hypoglycemia, they do better. We’ve seen this before in other studies. Teach people, and they can avoid hypoglycemia," said Dr. Cypress.
Dr. Little and Dr. Cypress had no disclosures.
nmiller@frontlinemedcom.com
On Twitter @NaseemSMiller
CHICAGO – Patients with type 1 diabetes who had impaired awareness of hypoglycemia and were provided with education and support, had equal biochemical outcomes whether they were on insulin pump therapy or daily injections.
Researchers also found that the outcomes were equal for patients whether they were on conventional or real-time glucose monitoring.
Impaired awareness of hypoglycemia, or IAH, affects roughly 20% of adults with type 1 diabetes. Also, severe hypoglycemia is six times more likely in these adults, said Dr. Stuart A. Little of Newcastle upon Tyne, England, who presented the results of Hypo COMPaSS, a 24-week, randomized controlled trial of 96 participants, at the annual scientific sessions of the American Diabetes Association.
"Sometimes patients with impaired awareness say that they don’t even feel it, and they think it’s okay," said Marjorie Cypress, Ph.D., the 2013 president-elect of ADA’s health care and education committee. "They need to learn that it’s not okay, that they’re not getting those warning signs, but they’re losing glucose from their brain."
Most of the participants in the trial were women (63%), their mean age was 49 years, their diabetes duration was about 29 years, and their mean HbA1c level was 66 mmol/mol, or about 8.2%.
Dr. Little and his colleagues randomized the 96 participants to a multiple daily injection (MDI) group (50 patients) and an insulin pump therapy (CSII) group (46). In the MDI group, 24 patients did not have real-time (RT) continuous glucose monitoring, and 26 did. And in the CSII group, 24 patients had no RT, and 22 did.
The primary endpoint of the study was the difference in 24-week Gold score, with an 80% power to detect a Gold score difference of 1.1 on a 7-point Likert scale.
Secondary endpoints included overall glycemic control and patient-reported outcomes.
All patients received equal support and had a treatment goal of rigorous avoidance of biochemical hypoglycemia without relaxation of overall hemoglobin A1c. They all had Gold scores of at least 4, indicating IAH.
Within 4 weeks, the patients’ biochemical hypoglycemia was reduced significantly, from 3.7% to 1.7% of the time, from 53 minutes/day to under half an hour. The reduction was maintained throughout the study.
The median Gold score also showed a statistically significant reduction by week 24 among all participants, dropping from 5 at baseline to 4 at the end of the study period.
There was also a dramatic reduction in severe hypoglycemic events, said Dr. Little. While 92% of the patients were affected by the condition the year before the study, and 77% were affected 6 months before the trial, only 19% were affected during the trial.
Fear of hypoglycemia was significantly reduced and treatment satisfaction improved among all participants. The mean HbA1c did not change throughout the study among the participants.
When the investigators compared the MDI and CSII groups, the Gold score and severe hypoglycemia were not significantly different, nor were the HbA1c levels or insulin units. And although the fear of hypoglycemia did not differ significantly between the two groups, the treatment satisfaction was significantly higher in the CSII group.
Comparing the patients based on real-time glucose monitoring or self-monitoring showed no statistically significant difference in Gold score, severe hypoglycemia, HbA1c levels, or insulin units. There were also no significant differences in fear of hypoglycemia and treatment satisfaction.
"The bottom line is, if you give people education about hypoglycemia, they do better. We’ve seen this before in other studies. Teach people, and they can avoid hypoglycemia," said Dr. Cypress.
Dr. Little and Dr. Cypress had no disclosures.
nmiller@frontlinemedcom.com
On Twitter @NaseemSMiller
CHICAGO – Patients with type 1 diabetes who had impaired awareness of hypoglycemia and were provided with education and support, had equal biochemical outcomes whether they were on insulin pump therapy or daily injections.
Researchers also found that the outcomes were equal for patients whether they were on conventional or real-time glucose monitoring.
Impaired awareness of hypoglycemia, or IAH, affects roughly 20% of adults with type 1 diabetes. Also, severe hypoglycemia is six times more likely in these adults, said Dr. Stuart A. Little of Newcastle upon Tyne, England, who presented the results of Hypo COMPaSS, a 24-week, randomized controlled trial of 96 participants, at the annual scientific sessions of the American Diabetes Association.
"Sometimes patients with impaired awareness say that they don’t even feel it, and they think it’s okay," said Marjorie Cypress, Ph.D., the 2013 president-elect of ADA’s health care and education committee. "They need to learn that it’s not okay, that they’re not getting those warning signs, but they’re losing glucose from their brain."
Most of the participants in the trial were women (63%), their mean age was 49 years, their diabetes duration was about 29 years, and their mean HbA1c level was 66 mmol/mol, or about 8.2%.
Dr. Little and his colleagues randomized the 96 participants to a multiple daily injection (MDI) group (50 patients) and an insulin pump therapy (CSII) group (46). In the MDI group, 24 patients did not have real-time (RT) continuous glucose monitoring, and 26 did. And in the CSII group, 24 patients had no RT, and 22 did.
The primary endpoint of the study was the difference in 24-week Gold score, with an 80% power to detect a Gold score difference of 1.1 on a 7-point Likert scale.
Secondary endpoints included overall glycemic control and patient-reported outcomes.
All patients received equal support and had a treatment goal of rigorous avoidance of biochemical hypoglycemia without relaxation of overall hemoglobin A1c. They all had Gold scores of at least 4, indicating IAH.
Within 4 weeks, the patients’ biochemical hypoglycemia was reduced significantly, from 3.7% to 1.7% of the time, from 53 minutes/day to under half an hour. The reduction was maintained throughout the study.
The median Gold score also showed a statistically significant reduction by week 24 among all participants, dropping from 5 at baseline to 4 at the end of the study period.
There was also a dramatic reduction in severe hypoglycemic events, said Dr. Little. While 92% of the patients were affected by the condition the year before the study, and 77% were affected 6 months before the trial, only 19% were affected during the trial.
Fear of hypoglycemia was significantly reduced and treatment satisfaction improved among all participants. The mean HbA1c did not change throughout the study among the participants.
When the investigators compared the MDI and CSII groups, the Gold score and severe hypoglycemia were not significantly different, nor were the HbA1c levels or insulin units. And although the fear of hypoglycemia did not differ significantly between the two groups, the treatment satisfaction was significantly higher in the CSII group.
Comparing the patients based on real-time glucose monitoring or self-monitoring showed no statistically significant difference in Gold score, severe hypoglycemia, HbA1c levels, or insulin units. There were also no significant differences in fear of hypoglycemia and treatment satisfaction.
"The bottom line is, if you give people education about hypoglycemia, they do better. We’ve seen this before in other studies. Teach people, and they can avoid hypoglycemia," said Dr. Cypress.
Dr. Little and Dr. Cypress had no disclosures.
nmiller@frontlinemedcom.com
On Twitter @NaseemSMiller
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Storify: News & opinion on AMA's decision to consider obesity a disease
EULAR Takes on Systemic Steroids' Risks
A multidisciplinary EULAR task force has developed for the first time recommendations for the management of medium- to high-dose systemic glucocorticoid therapy in rheumatic diseases at the annual European Congress of Rheumatology.
"High doses are very important because systemic glucocorticoids work rapidly and are most effective, but there is very little known about adverse events and incidence," said Dr. Nurten Duru said in an interview. "There are many studies; however, the adverse events are not systematically assessed. The studies have not focused on the adverse events; they have involved investigation of efficacy."
"We expect to see adverse events at high doses but the question is how to handle these, and how to take the co-morbidities into consideration. This is difficult without data. The best we have is expert opinion and they advise vigilance for these adverse events."
The recommendations focus on patient education and informing general practitioners, preventive measures for osteoporosis, optimal glucocorticoid (GC) starting dosages, risk-benefit ratio of GC treatment, GC sparing therapy, screening for co morbidity, and monitoring for adverse events, according to Dr. Duru, a rheumatologist at University Medical Center Utrecht, the Netherlands.
To develop the recommendations the task force conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library, and the strength of recommendations was given according to available evidence, clinical expertise and patient preference. However, "robust evidence was often lacking and items in need for further research were defined," the task force noted.
The task force comprised eight rheumatologists, one endocrinologist, one rheumatologist/epidemiologist, four patients, and two research fellows from seven European countries. "Each participant contributed 10 propositions describing key clinical points concerning the safe use of medium to high dose GCs. The final recommendations were developed using a Delphi consensus approach and the wording was improved by a native speaker," according to the task force.
"In this EULAR task force patients participated. The most important issue from the patient point of view was their concern with side effects such as alopecia," she said.
Dr. Duru said the next steps maybe developing a patient-friendly version of the recommendations in different languages, or a website where physicians could search for information about glucocorticoids.
The recommendations – in three different categories – are as follows:
Education and prevention
• Explain to patients (and their family and/or caregivers, including general practitioners) the aim of medium-/high-dose GC treatment and the potential risks associated with such therapy.
• Discuss measures to mitigate such risks, including diet, regular exercise, and awareness of wounds.
• Dispense appropriate preventive/therapeutic interventions to patients with or at risk of GC-induced osteoporosis.
• Present appropriate, practical advice to patients and the patients’ treatment teams on how to manage with GC-induced hypothalamic-pituitary-adrenal axis suppression.
• Provide an accessible resource to promote best practice in the use of medium/high dose GCs to general practitioners.
Dosing/risk-benefit
• Consider comorbidities that might predispose patients to adverse effects before starting them on medium-/high dose GC treatment; these include diabetes, glucose intolerance, cardiovascular disease, peptic ulcer disease, chronic infections, severe immunosuppression, (risk factors of) glaucoma, and osteoporosis. Patients with these comorbidities require especially tight control of dosages to manage the risk/benefit ratio.
• Select the appropriate starting dose as the (expected) minimum required to achieve therapeutic response.
• Keep the requirement for continuing on GC treatment under constant review and titrate the dose against therapeutic response and any developing adverse effects.
Monitoring
• Regularly monitor all patients for frequent, clinically significant adverse effects. The minimum set of items to monitor includes diabetes, hypertension, dyslipidemia, weight gain, edema, osteoporosis, (hidden) infections, osteonecrosis, myopathy, eye problems, skin problems, and neuropsychological adverse effects.
The recommendation rejected by the task force is as follows:
• Actively consider GC sparing therapy if long-term medium-/high-dose GC therapy is anticipated to be necessary.
Dr. Duru reported that she has no relevant conflicts of interest.
A multidisciplinary EULAR task force has developed for the first time recommendations for the management of medium- to high-dose systemic glucocorticoid therapy in rheumatic diseases at the annual European Congress of Rheumatology.
"High doses are very important because systemic glucocorticoids work rapidly and are most effective, but there is very little known about adverse events and incidence," said Dr. Nurten Duru said in an interview. "There are many studies; however, the adverse events are not systematically assessed. The studies have not focused on the adverse events; they have involved investigation of efficacy."
"We expect to see adverse events at high doses but the question is how to handle these, and how to take the co-morbidities into consideration. This is difficult without data. The best we have is expert opinion and they advise vigilance for these adverse events."
The recommendations focus on patient education and informing general practitioners, preventive measures for osteoporosis, optimal glucocorticoid (GC) starting dosages, risk-benefit ratio of GC treatment, GC sparing therapy, screening for co morbidity, and monitoring for adverse events, according to Dr. Duru, a rheumatologist at University Medical Center Utrecht, the Netherlands.
To develop the recommendations the task force conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library, and the strength of recommendations was given according to available evidence, clinical expertise and patient preference. However, "robust evidence was often lacking and items in need for further research were defined," the task force noted.
The task force comprised eight rheumatologists, one endocrinologist, one rheumatologist/epidemiologist, four patients, and two research fellows from seven European countries. "Each participant contributed 10 propositions describing key clinical points concerning the safe use of medium to high dose GCs. The final recommendations were developed using a Delphi consensus approach and the wording was improved by a native speaker," according to the task force.
"In this EULAR task force patients participated. The most important issue from the patient point of view was their concern with side effects such as alopecia," she said.
Dr. Duru said the next steps maybe developing a patient-friendly version of the recommendations in different languages, or a website where physicians could search for information about glucocorticoids.
The recommendations – in three different categories – are as follows:
Education and prevention
• Explain to patients (and their family and/or caregivers, including general practitioners) the aim of medium-/high-dose GC treatment and the potential risks associated with such therapy.
• Discuss measures to mitigate such risks, including diet, regular exercise, and awareness of wounds.
• Dispense appropriate preventive/therapeutic interventions to patients with or at risk of GC-induced osteoporosis.
• Present appropriate, practical advice to patients and the patients’ treatment teams on how to manage with GC-induced hypothalamic-pituitary-adrenal axis suppression.
• Provide an accessible resource to promote best practice in the use of medium/high dose GCs to general practitioners.
Dosing/risk-benefit
• Consider comorbidities that might predispose patients to adverse effects before starting them on medium-/high dose GC treatment; these include diabetes, glucose intolerance, cardiovascular disease, peptic ulcer disease, chronic infections, severe immunosuppression, (risk factors of) glaucoma, and osteoporosis. Patients with these comorbidities require especially tight control of dosages to manage the risk/benefit ratio.
• Select the appropriate starting dose as the (expected) minimum required to achieve therapeutic response.
• Keep the requirement for continuing on GC treatment under constant review and titrate the dose against therapeutic response and any developing adverse effects.
Monitoring
• Regularly monitor all patients for frequent, clinically significant adverse effects. The minimum set of items to monitor includes diabetes, hypertension, dyslipidemia, weight gain, edema, osteoporosis, (hidden) infections, osteonecrosis, myopathy, eye problems, skin problems, and neuropsychological adverse effects.
The recommendation rejected by the task force is as follows:
• Actively consider GC sparing therapy if long-term medium-/high-dose GC therapy is anticipated to be necessary.
Dr. Duru reported that she has no relevant conflicts of interest.
A multidisciplinary EULAR task force has developed for the first time recommendations for the management of medium- to high-dose systemic glucocorticoid therapy in rheumatic diseases at the annual European Congress of Rheumatology.
"High doses are very important because systemic glucocorticoids work rapidly and are most effective, but there is very little known about adverse events and incidence," said Dr. Nurten Duru said in an interview. "There are many studies; however, the adverse events are not systematically assessed. The studies have not focused on the adverse events; they have involved investigation of efficacy."
"We expect to see adverse events at high doses but the question is how to handle these, and how to take the co-morbidities into consideration. This is difficult without data. The best we have is expert opinion and they advise vigilance for these adverse events."
The recommendations focus on patient education and informing general practitioners, preventive measures for osteoporosis, optimal glucocorticoid (GC) starting dosages, risk-benefit ratio of GC treatment, GC sparing therapy, screening for co morbidity, and monitoring for adverse events, according to Dr. Duru, a rheumatologist at University Medical Center Utrecht, the Netherlands.
To develop the recommendations the task force conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library, and the strength of recommendations was given according to available evidence, clinical expertise and patient preference. However, "robust evidence was often lacking and items in need for further research were defined," the task force noted.
The task force comprised eight rheumatologists, one endocrinologist, one rheumatologist/epidemiologist, four patients, and two research fellows from seven European countries. "Each participant contributed 10 propositions describing key clinical points concerning the safe use of medium to high dose GCs. The final recommendations were developed using a Delphi consensus approach and the wording was improved by a native speaker," according to the task force.
"In this EULAR task force patients participated. The most important issue from the patient point of view was their concern with side effects such as alopecia," she said.
Dr. Duru said the next steps maybe developing a patient-friendly version of the recommendations in different languages, or a website where physicians could search for information about glucocorticoids.
The recommendations – in three different categories – are as follows:
Education and prevention
• Explain to patients (and their family and/or caregivers, including general practitioners) the aim of medium-/high-dose GC treatment and the potential risks associated with such therapy.
• Discuss measures to mitigate such risks, including diet, regular exercise, and awareness of wounds.
• Dispense appropriate preventive/therapeutic interventions to patients with or at risk of GC-induced osteoporosis.
• Present appropriate, practical advice to patients and the patients’ treatment teams on how to manage with GC-induced hypothalamic-pituitary-adrenal axis suppression.
• Provide an accessible resource to promote best practice in the use of medium/high dose GCs to general practitioners.
Dosing/risk-benefit
• Consider comorbidities that might predispose patients to adverse effects before starting them on medium-/high dose GC treatment; these include diabetes, glucose intolerance, cardiovascular disease, peptic ulcer disease, chronic infections, severe immunosuppression, (risk factors of) glaucoma, and osteoporosis. Patients with these comorbidities require especially tight control of dosages to manage the risk/benefit ratio.
• Select the appropriate starting dose as the (expected) minimum required to achieve therapeutic response.
• Keep the requirement for continuing on GC treatment under constant review and titrate the dose against therapeutic response and any developing adverse effects.
Monitoring
• Regularly monitor all patients for frequent, clinically significant adverse effects. The minimum set of items to monitor includes diabetes, hypertension, dyslipidemia, weight gain, edema, osteoporosis, (hidden) infections, osteonecrosis, myopathy, eye problems, skin problems, and neuropsychological adverse effects.
The recommendation rejected by the task force is as follows:
• Actively consider GC sparing therapy if long-term medium-/high-dose GC therapy is anticipated to be necessary.
Dr. Duru reported that she has no relevant conflicts of interest.
FROM THE ANNUAL EUROPEAN CONGRESS OF RHEUMATOLOGY