User login
Disrupted sleep tied to alexithymia
a pair of studies shows.
Alexithymia is a condition characterized by difficulty identifying and expressing one’s emotions. “The mechanism by which alexithymia confers risk of disrupted sleep remains unclear, [but] suggestions include increased nocturnal arousal as a result of poor verbalization of emotions and increased light sleep,” wrote Jennifer Murphy, citing previous research.
The researchers found associations between total alexithymia scores and reduced sleep quality (P less than .001). They also found a significant association between the TAS-20 subscales and reduced sleep quality (all P less than .006).
In the second study, in which 73 men and women participated, Ms. Murphy and her associates sought to determine whether the association found in the first study was tied to depression or anxiety. Participants went online and completed three questionnaires: the TAS-20; the PSQI; and the Depression, Anxiety, & Stress Scale, or DASS-21, in a randomized order. Higher scores on the DASS-21 correlate with greater levels of depression, anxiety, and stress. None of the questionnaires asked about any aspects of sleep.
Ms. Murphy said in an interview that although it might be too early to make a clear clinical recommendation, the results suggest that “clinicians should be aware of the possibility of sleep problems characterized by heightened alexithymia and more generally in those with alexithymia.”
Whilst further research is needed to confirm the direction of causality between disrupted sleep and alexithymia and how these subjective sleep reports in alexithymia map onto objectively measured sleep problems, these data suggest a link that is independent of depression and anxiety, she said.
Meanwhile, other researchers report that alexithymia is becoming more clinically relevant. Rising rates of alexithymia are being reported in psychiatric conditions such as autism, eating disorders, schizophrenia, and alcohol and substance abuse. The condition is also seen in neurologic conditions such as multiple sclerosis and traumatic brain injury (Neuropsychologica. 2018;11:229-40).
Ms. Murphy and her associates cited several limitations of their research. One is that they did not control for factors that affect sleep quality and alexithymia such as body composition. They also cited reports of discrepancies between objective and subjective measures – such as those made by self-report – and the relatively small sample sizes.
The research was supported by the Economic and Social Research Council and the Baily Thomas Charitable Trust. No conflicts of interest were reported.
SOURCE: Murphy J et al. Pers Individ Dif. 2018 Mar 27;129:175-8.
a pair of studies shows.
Alexithymia is a condition characterized by difficulty identifying and expressing one’s emotions. “The mechanism by which alexithymia confers risk of disrupted sleep remains unclear, [but] suggestions include increased nocturnal arousal as a result of poor verbalization of emotions and increased light sleep,” wrote Jennifer Murphy, citing previous research.
The researchers found associations between total alexithymia scores and reduced sleep quality (P less than .001). They also found a significant association between the TAS-20 subscales and reduced sleep quality (all P less than .006).
In the second study, in which 73 men and women participated, Ms. Murphy and her associates sought to determine whether the association found in the first study was tied to depression or anxiety. Participants went online and completed three questionnaires: the TAS-20; the PSQI; and the Depression, Anxiety, & Stress Scale, or DASS-21, in a randomized order. Higher scores on the DASS-21 correlate with greater levels of depression, anxiety, and stress. None of the questionnaires asked about any aspects of sleep.
Ms. Murphy said in an interview that although it might be too early to make a clear clinical recommendation, the results suggest that “clinicians should be aware of the possibility of sleep problems characterized by heightened alexithymia and more generally in those with alexithymia.”
Whilst further research is needed to confirm the direction of causality between disrupted sleep and alexithymia and how these subjective sleep reports in alexithymia map onto objectively measured sleep problems, these data suggest a link that is independent of depression and anxiety, she said.
Meanwhile, other researchers report that alexithymia is becoming more clinically relevant. Rising rates of alexithymia are being reported in psychiatric conditions such as autism, eating disorders, schizophrenia, and alcohol and substance abuse. The condition is also seen in neurologic conditions such as multiple sclerosis and traumatic brain injury (Neuropsychologica. 2018;11:229-40).
Ms. Murphy and her associates cited several limitations of their research. One is that they did not control for factors that affect sleep quality and alexithymia such as body composition. They also cited reports of discrepancies between objective and subjective measures – such as those made by self-report – and the relatively small sample sizes.
The research was supported by the Economic and Social Research Council and the Baily Thomas Charitable Trust. No conflicts of interest were reported.
SOURCE: Murphy J et al. Pers Individ Dif. 2018 Mar 27;129:175-8.
a pair of studies shows.
Alexithymia is a condition characterized by difficulty identifying and expressing one’s emotions. “The mechanism by which alexithymia confers risk of disrupted sleep remains unclear, [but] suggestions include increased nocturnal arousal as a result of poor verbalization of emotions and increased light sleep,” wrote Jennifer Murphy, citing previous research.
The researchers found associations between total alexithymia scores and reduced sleep quality (P less than .001). They also found a significant association between the TAS-20 subscales and reduced sleep quality (all P less than .006).
In the second study, in which 73 men and women participated, Ms. Murphy and her associates sought to determine whether the association found in the first study was tied to depression or anxiety. Participants went online and completed three questionnaires: the TAS-20; the PSQI; and the Depression, Anxiety, & Stress Scale, or DASS-21, in a randomized order. Higher scores on the DASS-21 correlate with greater levels of depression, anxiety, and stress. None of the questionnaires asked about any aspects of sleep.
Ms. Murphy said in an interview that although it might be too early to make a clear clinical recommendation, the results suggest that “clinicians should be aware of the possibility of sleep problems characterized by heightened alexithymia and more generally in those with alexithymia.”
Whilst further research is needed to confirm the direction of causality between disrupted sleep and alexithymia and how these subjective sleep reports in alexithymia map onto objectively measured sleep problems, these data suggest a link that is independent of depression and anxiety, she said.
Meanwhile, other researchers report that alexithymia is becoming more clinically relevant. Rising rates of alexithymia are being reported in psychiatric conditions such as autism, eating disorders, schizophrenia, and alcohol and substance abuse. The condition is also seen in neurologic conditions such as multiple sclerosis and traumatic brain injury (Neuropsychologica. 2018;11:229-40).
Ms. Murphy and her associates cited several limitations of their research. One is that they did not control for factors that affect sleep quality and alexithymia such as body composition. They also cited reports of discrepancies between objective and subjective measures – such as those made by self-report – and the relatively small sample sizes.
The research was supported by the Economic and Social Research Council and the Baily Thomas Charitable Trust. No conflicts of interest were reported.
SOURCE: Murphy J et al. Pers Individ Dif. 2018 Mar 27;129:175-8.
FROM PERSONALITY AND INDIVIDUAL DIFFERENCES
Transcatheter valves underperform for native aortic regurgitation
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
AT THE 2018 CRT MEETING
Key clinical point:
Major finding: With newer-generation THV, rates of incorrect positioning (9%), persistent regurgitation (4%), and 30-day mortality (8%) remain unacceptably high.
Data source: A registry data analysis.
Disclosures: Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
Source: Dvir D. CRT 2018.
Hurricane relief and patient care
In October 2017, in support of the Federal Emergency Management Agency’s response to assist the Governor and people of Puerto Rico, three Department of Defense (DOD) military hospital platforms were deployed; one each, by the US Army, Navy, and Air Force. They arrived on the island at different times with predominantly wartime surgical capabilities and augmented the Federal Emergency Management Agency (FEMA), US Public Health Service, National Guard, and Puerto Rico Department of Health efforts. My perspective is that of patient care and transport between the Centro Medico hospital complex in San Juan, the larger regional hospitals, the Veterans Administration hospital, the DOD response, FEMA Disaster Medical Assistance Teams (DMAT), and FEMA Federal Medical Shelters about 4 to 6 weeks after Hurricanes Maria and Irma struck. Based upon this experience, I would like to offer the following.
Pre-Disaster: All clinicians have a few patients that teeter “on the edge.” When basic services go away, these patients fall over that edge and become inpatients. Establish a list of patients who require oxygen and devices such as vests, cough-assist, or ventilation. If evacuation before the disaster is possible, those patients need to leave. If they refuse, or are unable to leave, they need to be able to supply their own generated power for a prolonged period of time, as batteries will run out prior to power restoration. They must be able to use oxygen concentrators, as tank re-supply may not be readily available. By law, FEMA cannot give generators to individuals, so individuals must prepare for themselves. In a hurricane-prone area where seasonal risk can be established, planning medication refills at the beginning of the season or giving a larger than normal supply may prove useful. In an area prone to sudden disaster, such as earthquake or tornado, then counseling patients to request refills at least 2 weeks early may be adequate.
Post-Disaster: The most reliable form of communication will be text. You likely already have text contacts for your staff and family members; add other providers, responders, planners, pharmacists, and oxygen suppliers to your text contacts. While you may wish to share a text point of contact with patients, understand that your ability to actually help during the initial disaster will likely be limited. Identify possible language translation needs and possible translators among your staff and/or friends as telephone services will be limited or absent following the disaster. Finally, identify your local emergency response planners on Facebook, Twitter, or other social media feeds. This will allow you to direct others to these sites for accurate information after the disaster.
Responder Recommendations: A single social media post can DESTROY your plans and hamper your efforts. Advertise a single contact point and an information resource (eg, bulletin board, webpage) early and often. Publicly and accurately declare the means by which people will access health care and health-care services, such as medications, dialysis, and oxygen. There will be nongovernment organizations (NGOs), friends, and other well-meaning individuals who will try to assist people in need through unconventional channels. Yet, by requesting assistance through nonroutine channels, those efforts tend to delay assistance, cause confusion, and/or squander resources. Continue to direct those requests through the established response channels, ie, the local 911 equivalent.
Plan to use cellular texts to communicate. While satellite telephones are great in concept, in execution, they are difficult to utilize when transmitting complex medical information. If you have an expansive budget, there are now devices available that allow for Iridium satellite-based text communications that require batteries but not intact cellular towers.
Facilities with electricity, water, oxygen, medications, laboratory testing, and CT scanners need to be identified and advertised within the responder community. If FEMA is involved, these resources will be identified and updated on a routine basis. The information will be distributed to their DMAT teams. Those DMAT teams will be distributed throughout the response area. Additionally, if the resources and budgeting are approved, then FEMA will also help re-establish medical transport, as well as Federal Medical Shelters (FMS). The FMS can temporarily house patients who can perform basic activities of daily living but require power, oxygen, or medication administration. For those patients in need of medications without insurance, FEMA may activate medication assistance through the Emergency Prescription Assistance Program. This will allow up to 30 days of medication to be distributed at no cost to the individual through participating pharmacies.
External responders will obviously need to pair with local providers/professionals who can navigate the system and, if necessary, can translate medical terms and care plans. Additionally, external responders will be targets for individuals looking to obtain resources for secondary gain or profit. Establishing a plan or consistently redirecting people to the appropriate resources for those needs may limit the inevitable damage these individuals will cause. Additionally, understand that the efficiencies of the modern society will be gone, and tasks will take much longer than expected. Even if you can communicate by text, the transporting of patients, delivering supplies, meeting with groups, and assessing sites will take far longer than you are used to when none of the stoplights are functional or if gasoline is in limited supply.
Finally, there will be patients for whom no solution, short of an intact, well-resourced medical system, exists—those with severe congenital issues, patients with advanced dementia, patients with advanced cancer, and those with multiple-antibiotic-resistant osteomyelitis are a few of the patients that this response encountered. If transport out of the area is unavailable, NGOs and other charities may be the best, and at times, the only resource for these patients. During this response, I observed NGO and charities helping individual patients and their families with their power, shelter, and medical needs that could not be legally provided by federal government response.
While I hope you may never need to use them, preparations for evacuation, medication, power, and communications before a potential disaster occurs will prove helpful to your patients. After the disaster, consistent and simple communications to the public will be necessary to limit the damage from the social media rumor mill. Working within the organized response framework and leveraging local knowledge and targeted NGO involvement will maximize the effect of your efforts.
In October 2017, in support of the Federal Emergency Management Agency’s response to assist the Governor and people of Puerto Rico, three Department of Defense (DOD) military hospital platforms were deployed; one each, by the US Army, Navy, and Air Force. They arrived on the island at different times with predominantly wartime surgical capabilities and augmented the Federal Emergency Management Agency (FEMA), US Public Health Service, National Guard, and Puerto Rico Department of Health efforts. My perspective is that of patient care and transport between the Centro Medico hospital complex in San Juan, the larger regional hospitals, the Veterans Administration hospital, the DOD response, FEMA Disaster Medical Assistance Teams (DMAT), and FEMA Federal Medical Shelters about 4 to 6 weeks after Hurricanes Maria and Irma struck. Based upon this experience, I would like to offer the following.
Pre-Disaster: All clinicians have a few patients that teeter “on the edge.” When basic services go away, these patients fall over that edge and become inpatients. Establish a list of patients who require oxygen and devices such as vests, cough-assist, or ventilation. If evacuation before the disaster is possible, those patients need to leave. If they refuse, or are unable to leave, they need to be able to supply their own generated power for a prolonged period of time, as batteries will run out prior to power restoration. They must be able to use oxygen concentrators, as tank re-supply may not be readily available. By law, FEMA cannot give generators to individuals, so individuals must prepare for themselves. In a hurricane-prone area where seasonal risk can be established, planning medication refills at the beginning of the season or giving a larger than normal supply may prove useful. In an area prone to sudden disaster, such as earthquake or tornado, then counseling patients to request refills at least 2 weeks early may be adequate.
Post-Disaster: The most reliable form of communication will be text. You likely already have text contacts for your staff and family members; add other providers, responders, planners, pharmacists, and oxygen suppliers to your text contacts. While you may wish to share a text point of contact with patients, understand that your ability to actually help during the initial disaster will likely be limited. Identify possible language translation needs and possible translators among your staff and/or friends as telephone services will be limited or absent following the disaster. Finally, identify your local emergency response planners on Facebook, Twitter, or other social media feeds. This will allow you to direct others to these sites for accurate information after the disaster.
Responder Recommendations: A single social media post can DESTROY your plans and hamper your efforts. Advertise a single contact point and an information resource (eg, bulletin board, webpage) early and often. Publicly and accurately declare the means by which people will access health care and health-care services, such as medications, dialysis, and oxygen. There will be nongovernment organizations (NGOs), friends, and other well-meaning individuals who will try to assist people in need through unconventional channels. Yet, by requesting assistance through nonroutine channels, those efforts tend to delay assistance, cause confusion, and/or squander resources. Continue to direct those requests through the established response channels, ie, the local 911 equivalent.
Plan to use cellular texts to communicate. While satellite telephones are great in concept, in execution, they are difficult to utilize when transmitting complex medical information. If you have an expansive budget, there are now devices available that allow for Iridium satellite-based text communications that require batteries but not intact cellular towers.
Facilities with electricity, water, oxygen, medications, laboratory testing, and CT scanners need to be identified and advertised within the responder community. If FEMA is involved, these resources will be identified and updated on a routine basis. The information will be distributed to their DMAT teams. Those DMAT teams will be distributed throughout the response area. Additionally, if the resources and budgeting are approved, then FEMA will also help re-establish medical transport, as well as Federal Medical Shelters (FMS). The FMS can temporarily house patients who can perform basic activities of daily living but require power, oxygen, or medication administration. For those patients in need of medications without insurance, FEMA may activate medication assistance through the Emergency Prescription Assistance Program. This will allow up to 30 days of medication to be distributed at no cost to the individual through participating pharmacies.
External responders will obviously need to pair with local providers/professionals who can navigate the system and, if necessary, can translate medical terms and care plans. Additionally, external responders will be targets for individuals looking to obtain resources for secondary gain or profit. Establishing a plan or consistently redirecting people to the appropriate resources for those needs may limit the inevitable damage these individuals will cause. Additionally, understand that the efficiencies of the modern society will be gone, and tasks will take much longer than expected. Even if you can communicate by text, the transporting of patients, delivering supplies, meeting with groups, and assessing sites will take far longer than you are used to when none of the stoplights are functional or if gasoline is in limited supply.
Finally, there will be patients for whom no solution, short of an intact, well-resourced medical system, exists—those with severe congenital issues, patients with advanced dementia, patients with advanced cancer, and those with multiple-antibiotic-resistant osteomyelitis are a few of the patients that this response encountered. If transport out of the area is unavailable, NGOs and other charities may be the best, and at times, the only resource for these patients. During this response, I observed NGO and charities helping individual patients and their families with their power, shelter, and medical needs that could not be legally provided by federal government response.
While I hope you may never need to use them, preparations for evacuation, medication, power, and communications before a potential disaster occurs will prove helpful to your patients. After the disaster, consistent and simple communications to the public will be necessary to limit the damage from the social media rumor mill. Working within the organized response framework and leveraging local knowledge and targeted NGO involvement will maximize the effect of your efforts.
In October 2017, in support of the Federal Emergency Management Agency’s response to assist the Governor and people of Puerto Rico, three Department of Defense (DOD) military hospital platforms were deployed; one each, by the US Army, Navy, and Air Force. They arrived on the island at different times with predominantly wartime surgical capabilities and augmented the Federal Emergency Management Agency (FEMA), US Public Health Service, National Guard, and Puerto Rico Department of Health efforts. My perspective is that of patient care and transport between the Centro Medico hospital complex in San Juan, the larger regional hospitals, the Veterans Administration hospital, the DOD response, FEMA Disaster Medical Assistance Teams (DMAT), and FEMA Federal Medical Shelters about 4 to 6 weeks after Hurricanes Maria and Irma struck. Based upon this experience, I would like to offer the following.
Pre-Disaster: All clinicians have a few patients that teeter “on the edge.” When basic services go away, these patients fall over that edge and become inpatients. Establish a list of patients who require oxygen and devices such as vests, cough-assist, or ventilation. If evacuation before the disaster is possible, those patients need to leave. If they refuse, or are unable to leave, they need to be able to supply their own generated power for a prolonged period of time, as batteries will run out prior to power restoration. They must be able to use oxygen concentrators, as tank re-supply may not be readily available. By law, FEMA cannot give generators to individuals, so individuals must prepare for themselves. In a hurricane-prone area where seasonal risk can be established, planning medication refills at the beginning of the season or giving a larger than normal supply may prove useful. In an area prone to sudden disaster, such as earthquake or tornado, then counseling patients to request refills at least 2 weeks early may be adequate.
Post-Disaster: The most reliable form of communication will be text. You likely already have text contacts for your staff and family members; add other providers, responders, planners, pharmacists, and oxygen suppliers to your text contacts. While you may wish to share a text point of contact with patients, understand that your ability to actually help during the initial disaster will likely be limited. Identify possible language translation needs and possible translators among your staff and/or friends as telephone services will be limited or absent following the disaster. Finally, identify your local emergency response planners on Facebook, Twitter, or other social media feeds. This will allow you to direct others to these sites for accurate information after the disaster.
Responder Recommendations: A single social media post can DESTROY your plans and hamper your efforts. Advertise a single contact point and an information resource (eg, bulletin board, webpage) early and often. Publicly and accurately declare the means by which people will access health care and health-care services, such as medications, dialysis, and oxygen. There will be nongovernment organizations (NGOs), friends, and other well-meaning individuals who will try to assist people in need through unconventional channels. Yet, by requesting assistance through nonroutine channels, those efforts tend to delay assistance, cause confusion, and/or squander resources. Continue to direct those requests through the established response channels, ie, the local 911 equivalent.
Plan to use cellular texts to communicate. While satellite telephones are great in concept, in execution, they are difficult to utilize when transmitting complex medical information. If you have an expansive budget, there are now devices available that allow for Iridium satellite-based text communications that require batteries but not intact cellular towers.
Facilities with electricity, water, oxygen, medications, laboratory testing, and CT scanners need to be identified and advertised within the responder community. If FEMA is involved, these resources will be identified and updated on a routine basis. The information will be distributed to their DMAT teams. Those DMAT teams will be distributed throughout the response area. Additionally, if the resources and budgeting are approved, then FEMA will also help re-establish medical transport, as well as Federal Medical Shelters (FMS). The FMS can temporarily house patients who can perform basic activities of daily living but require power, oxygen, or medication administration. For those patients in need of medications without insurance, FEMA may activate medication assistance through the Emergency Prescription Assistance Program. This will allow up to 30 days of medication to be distributed at no cost to the individual through participating pharmacies.
External responders will obviously need to pair with local providers/professionals who can navigate the system and, if necessary, can translate medical terms and care plans. Additionally, external responders will be targets for individuals looking to obtain resources for secondary gain or profit. Establishing a plan or consistently redirecting people to the appropriate resources for those needs may limit the inevitable damage these individuals will cause. Additionally, understand that the efficiencies of the modern society will be gone, and tasks will take much longer than expected. Even if you can communicate by text, the transporting of patients, delivering supplies, meeting with groups, and assessing sites will take far longer than you are used to when none of the stoplights are functional or if gasoline is in limited supply.
Finally, there will be patients for whom no solution, short of an intact, well-resourced medical system, exists—those with severe congenital issues, patients with advanced dementia, patients with advanced cancer, and those with multiple-antibiotic-resistant osteomyelitis are a few of the patients that this response encountered. If transport out of the area is unavailable, NGOs and other charities may be the best, and at times, the only resource for these patients. During this response, I observed NGO and charities helping individual patients and their families with their power, shelter, and medical needs that could not be legally provided by federal government response.
While I hope you may never need to use them, preparations for evacuation, medication, power, and communications before a potential disaster occurs will prove helpful to your patients. After the disaster, consistent and simple communications to the public will be necessary to limit the damage from the social media rumor mill. Working within the organized response framework and leveraging local knowledge and targeted NGO involvement will maximize the effect of your efforts.
Five things to do around the convention center at CHEST 2018
Planning to attend CHEST 2018? We know you’re always on the go, so we’ve come up with a few quick things to do in San Antonio without having to go more than a few blocks outside of the convention center.
Whataburger
While some may be hardcore In-N-Out fans, there’s another well known burger joint in Texas with a location that happens to be next to the convention center on E Commerce St. Head on over to Whataburger and experience what the company calls a “bigger, better burger.”
San Antonio Riverwalk
Want to experience the San Antonio, Texas atmosphere but don’t have time for a long excursion? The Henry B. Gonzalez Convention Center is a few steps away from the Riverwalk, which winds throughout the city. Off of the northwest corner of the convention center, take a stroll and experience the picturesque beauty of the San Antonio river, the restaurants, and the bright colorful surroundings.
La Villita Historic Arts Village
Interested in art? Interested in architecture? La Villita, located on the west side of the convention center on S Alamo St, is on the US government’s National Register of Historic Places as a Historic District. Take a look at different architectural styles, like adobe, early Victorian, and Texas vernacular limestone buildings. You’ll find markers throughout La Villita with information about each building’s history. You’ll also find local artists, custom art, and unique dining options.
Tower of the Americas
Exit the south end of the convention center to go to the Tower of the Americas for a spectacular view of the city. This 750-foot tall tower has an observation deck, revolving restaurant with panoramic views, a stationary bar, and a 4D theater adventure ride great for the whole family. This is a great stop for lunch, dinner, or a nice afternoon activity.
The Alamo
Lastly, if you have an hour to spare, take a tour of the Alamo that commemorates the 1836 siege and battle. There are free and ticketed activities, including audio or guided tours (ticketed) or history talks, visiting the Alamo Church, exhibitions, and more! Don’t forget to stop at the gift shop for a souvenir or two to take home.
Planning to attend CHEST 2018? We know you’re always on the go, so we’ve come up with a few quick things to do in San Antonio without having to go more than a few blocks outside of the convention center.
Whataburger
While some may be hardcore In-N-Out fans, there’s another well known burger joint in Texas with a location that happens to be next to the convention center on E Commerce St. Head on over to Whataburger and experience what the company calls a “bigger, better burger.”
San Antonio Riverwalk
Want to experience the San Antonio, Texas atmosphere but don’t have time for a long excursion? The Henry B. Gonzalez Convention Center is a few steps away from the Riverwalk, which winds throughout the city. Off of the northwest corner of the convention center, take a stroll and experience the picturesque beauty of the San Antonio river, the restaurants, and the bright colorful surroundings.
La Villita Historic Arts Village
Interested in art? Interested in architecture? La Villita, located on the west side of the convention center on S Alamo St, is on the US government’s National Register of Historic Places as a Historic District. Take a look at different architectural styles, like adobe, early Victorian, and Texas vernacular limestone buildings. You’ll find markers throughout La Villita with information about each building’s history. You’ll also find local artists, custom art, and unique dining options.
Tower of the Americas
Exit the south end of the convention center to go to the Tower of the Americas for a spectacular view of the city. This 750-foot tall tower has an observation deck, revolving restaurant with panoramic views, a stationary bar, and a 4D theater adventure ride great for the whole family. This is a great stop for lunch, dinner, or a nice afternoon activity.
The Alamo
Lastly, if you have an hour to spare, take a tour of the Alamo that commemorates the 1836 siege and battle. There are free and ticketed activities, including audio or guided tours (ticketed) or history talks, visiting the Alamo Church, exhibitions, and more! Don’t forget to stop at the gift shop for a souvenir or two to take home.
Planning to attend CHEST 2018? We know you’re always on the go, so we’ve come up with a few quick things to do in San Antonio without having to go more than a few blocks outside of the convention center.
Whataburger
While some may be hardcore In-N-Out fans, there’s another well known burger joint in Texas with a location that happens to be next to the convention center on E Commerce St. Head on over to Whataburger and experience what the company calls a “bigger, better burger.”
San Antonio Riverwalk
Want to experience the San Antonio, Texas atmosphere but don’t have time for a long excursion? The Henry B. Gonzalez Convention Center is a few steps away from the Riverwalk, which winds throughout the city. Off of the northwest corner of the convention center, take a stroll and experience the picturesque beauty of the San Antonio river, the restaurants, and the bright colorful surroundings.
La Villita Historic Arts Village
Interested in art? Interested in architecture? La Villita, located on the west side of the convention center on S Alamo St, is on the US government’s National Register of Historic Places as a Historic District. Take a look at different architectural styles, like adobe, early Victorian, and Texas vernacular limestone buildings. You’ll find markers throughout La Villita with information about each building’s history. You’ll also find local artists, custom art, and unique dining options.
Tower of the Americas
Exit the south end of the convention center to go to the Tower of the Americas for a spectacular view of the city. This 750-foot tall tower has an observation deck, revolving restaurant with panoramic views, a stationary bar, and a 4D theater adventure ride great for the whole family. This is a great stop for lunch, dinner, or a nice afternoon activity.
The Alamo
Lastly, if you have an hour to spare, take a tour of the Alamo that commemorates the 1836 siege and battle. There are free and ticketed activities, including audio or guided tours (ticketed) or history talks, visiting the Alamo Church, exhibitions, and more! Don’t forget to stop at the gift shop for a souvenir or two to take home.
Medical marijuana’s ‘Catch-22’: Federal limits on research hinder patients’ relief
By the time Ann Marie Owen turned to marijuana to treat her pain, she was struggling to walk and talk. She also hallucinated.
For 4 years, her doctor prescribed the 61-year-old a wide range of opioids for her transverse myelitis, a debilitating disease that caused pain, muscle weakness, and paralysis.
The drugs not only failed to ease her symptoms, they also hooked her.
When her home state of New York legalized marijuana for the treatment of select medical ailments, Ms. Owens decided it was time to swap pills for pot. But her doctors refused to help.
“Even though medical marijuana is legal, none of my doctors were willing to talk to me about it,” she said. “They just kept telling me to take opioids.”
While 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Ms. Owen who use marijuana and the doctors who treat them are caught in the middle of a conflict in federal and state laws – a predicament that is only worsened by thin scientific data.
Because the federal government classifies marijuana a Schedule 1 drug – by definition a substance with no currently accepted medical use and a high potential for abuse – research on marijuana or its active ingredients is highly restricted and even discouraged in some cases.
Underscoring the federal government’s position, Health & Human Services Secretary Alex Azar recently pronounced that there was “no such thing as medical marijuana.”
Scientists say that stance prevents them from conducting the high-quality research required for Food and Drug Administration approval, even as some early research indicates marijuana might be a promising alternative to opioids or other medicines.
Patients and physicians, meanwhile, lack guidance when making decisions about medical treatment for an array of serious conditions.
“We have the federal government and the state governments driving a hundred miles an hour in the opposite direction when they should be coming together to obtain more scientific data,” said Orrin Devinsky, MD, who is researching the effects of cannabidiol, an active ingredient of marijuana, on epilepsy. “It’s like saying in 1960, ‘We’re not going to the moon because no one agrees how to get there.’ ”
The problem stems partly from the fact that the federal government’s restrictive marijuana research policies have not been overhauled in more than 40 years, researchers say.
Only one federal government contractor grows marijuana for federally funded research. Researchers complain the pot grown by the contractor at the University of Mississippi is inadequate for high-quality studies.
The marijuana, which comes in a micronized powder form, is less potent than the pot offered at dispensaries, researchers say. It also differs from other products offered at dispensaries, such as so-called edibles, which are eaten like snacks. The difference makes it difficult to compare the real-life effects of the marijuana compounds.
Researchers also face time-consuming and costly hurdles in completing the complicated federal application process for using marijuana in long-term clinical trials.
“It’s public policy before science,” said Chinazo Cunningham, MD, a primary care doctor who is the lead investigator on one of the few federally funded studies exploring marijuana as a treatment for pain. “The federal government’s policies really make it much more difficult.”
Dr. Cunningham, who received a 5-year, $3.8 million federal grant, will not be administering marijuana directly to participants. Instead, she will follow 250 HIV-positive and HIV-negative adults with chronic pain who use opioids and have been certified to get medical marijuana from a dispensary.
“It’s a Catch-22,” said Dr. Cunningham, who is with the Albert Einstein College of Medicine, New York. “We’re going to be looking at all of these issues – age, disease, level of pain – but when we’re done, there’s the danger that people are going to say ‘Oh, it’s anecdotal’ or that it’s inherently flawed because it’s not a randomized trial.’’
Without clear answers, hospitals, doctors, and patients are left to their own devices, which can result in poor treatment and needless suffering.
Hospitals and other medical facilities have to decide what to do with newly hospitalized patients who normally take medical marijuana at home.
Some have a “don’t ask, don’t tell” approach, said Dr. Devinsky, who sometimes advises his patients to use it. Others ban its use and substitute opioids or other prescriptions.
Young adults, for instance, have had to stop taking cannabidiol compounds for their epilepsy because they’re in federally funded group homes, said Dr. Devinsky, the director of New York University’s Langone Comprehensive Epilepsy Center.
“These kids end up getting seizures again,” he said. “This whole situation has created a hodgepodge of insanity.”
The Trump administration, however, has resisted policy changes.
Last year, the Drug Enforcement Administration had been gearing up to allow facilities other than the University of Mississippi to grow pot for research. But after the DEA received 26 applications from other growers, Attorney General Jeff Sessions halted the initiative.
The Department of Veterans Affairs also recently announced it would not fund studies of using marijuana compounds to treat ailments such as pain.
The DEA and HHS have cited concerns about medical supervision, addiction, and a lack of “well-controlled studies proving efficacy.”
Patients, meanwhile, forge ahead.
While experts say they don’t know exactly how many older Americans rely on marijuana for medicinal purposes, the number of Americans aged 65 years and older who say they are using the drug skyrocketed 250% from 2006 to 2013.
Some patients turn to friends, patient advocacy groups, or online support groups for information.
Ms. Owen, for one, kept searching for a doctor and eventually found a neurologist willing to certify her to use marijuana and advise her on what to take.
“It’s saved my life,” said the retired university administrative assistant who credited marijuana for weaning her off opioids. “It not only helps my pain, but I can think, walk, and talk again.”
Mary Jo, a Minnesotan, was afraid of being identified as a medical marijuana user, even though she now helps friends navigate the process and it’s legal in her home state.
“There’s still a stigma,” said Mary Jo, who found it effective for treating her pain from a nerve condition. “Nobody helps you figure it out, so you kind of play around with it on your own.”
Still, doctors and scientists worry about the implications of such experimentation.
In a sweeping report last year, the National Academies of Sciences, Engineering and Medicine called on the federal government to support better research, decrying the “lack of definitive evidence on using medical marijuana.”
The national academies’ committee reviewed more than 10,000 scientific abstracts related to the topic. It made 100 conclusions based on its review, including finding evidence that marijuana relieves pain and chemotherapy-induced nausea. But it found “inadequate information” to support or refute effects on Parkinson’s disease.
Yet those who find that medical marijuana helps them can become fierce advocates no matter what their doctors say.
Caryl Barrett, a 54-year-old who lives in Georgia, said she decided to travel out of state to Colorado to treat her pain from her transverse myelitis and the autoimmune disease neurosarcoidosis.
“I realized it worked and I decided to bring it back with me,” she said. “I broke federal law.”
Georgia, meanwhile, permitted limited medicinal use of marijuana but did not set up dispensaries. As a result, patients resort to ordering it online or driving to another state to get it.
The conflict in the law makes her uneasy. But Ms. Barrett, who had been on opioids for a decade, said she feels so strongly about it working that “if someone wants to arrest me, bring it on.”
Others experience mixed results.
Melodie Beckham, who had metastatic lung cancer, tried medical marijuana for 13 days in a clinical trial at Connecticut Hospice before deciding to quit.
“She was hopeful that it would help her relax and just kind of enjoy those days,” said her daughter, Laura Beckham.
Instead, it seemed to make her mother, who died in July at age 69, “a little more agitated or more paranoid.”
The marijuana “didn’t seem effective,” nor did it keep her mother from hitting her pain pump to get extra doses of an opioid, her daughter said.
The researchers running the trial at Connecticut Hospice spent 2 years getting necessary approvals from the FDA, the National Institute on Drug Abuse (NIDA), and the DEA.
Since May, the trial has enrolled only 7 of the 66 patients it plans to sign up because many patients were too sick, too close to death, or simply couldn’t swallow the pills. So far, the trial has shown “mixed results,” said James Prota, director of pharmacy for the hospice.
Researchers point out they are still exploring the basics when it comes to marijuana’s effects on older adults or the terminally ill.
“We just have no data on how many older adults are using medical marijuana, what they are using it for, and most importantly, what are the outcomes,” said Brian Kaskie, an associate professor at the University of Iowa’s College of Public Health in Iowa City. “It’s all anecdotal.”
Mr. Kaskie, who specializes in public policy and the aging, received grants from the state of Colorado and the Chicago-based Retirement Research Foundation to survey the use of medical marijuana by older Americans.
In many quarters, there’s a growing appetite for solid information, he said.
“When I first started this, my colleagues joked we were going to find all the aging hippies who listen to the Grateful Dead,” said Mr. Kaskie, who has been studying medicinal marijuana for years. “Now, they’re starting to realize this is a legitimate area of research.”
Twenty researchers received marijuana from the federal program last year, which was more than any previous year since 2010, according to NIDA statistics.
In a recent funding announcement, the National Institutes of Health requested grant applications to study the effects of marijuana and other drugs on older adults and pain. NIH, however, continues to funnel much of its funding into studying the adverse effects of marijuana, researchers said.
Although NIH acknowledged in one of the announcements that some research supports “possible benefits” of marijuana, it emphasized “there have not been adequate large controlled trials to support these claims.”
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
By the time Ann Marie Owen turned to marijuana to treat her pain, she was struggling to walk and talk. She also hallucinated.
For 4 years, her doctor prescribed the 61-year-old a wide range of opioids for her transverse myelitis, a debilitating disease that caused pain, muscle weakness, and paralysis.
The drugs not only failed to ease her symptoms, they also hooked her.
When her home state of New York legalized marijuana for the treatment of select medical ailments, Ms. Owens decided it was time to swap pills for pot. But her doctors refused to help.
“Even though medical marijuana is legal, none of my doctors were willing to talk to me about it,” she said. “They just kept telling me to take opioids.”
While 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Ms. Owen who use marijuana and the doctors who treat them are caught in the middle of a conflict in federal and state laws – a predicament that is only worsened by thin scientific data.
Because the federal government classifies marijuana a Schedule 1 drug – by definition a substance with no currently accepted medical use and a high potential for abuse – research on marijuana or its active ingredients is highly restricted and even discouraged in some cases.
Underscoring the federal government’s position, Health & Human Services Secretary Alex Azar recently pronounced that there was “no such thing as medical marijuana.”
Scientists say that stance prevents them from conducting the high-quality research required for Food and Drug Administration approval, even as some early research indicates marijuana might be a promising alternative to opioids or other medicines.
Patients and physicians, meanwhile, lack guidance when making decisions about medical treatment for an array of serious conditions.
“We have the federal government and the state governments driving a hundred miles an hour in the opposite direction when they should be coming together to obtain more scientific data,” said Orrin Devinsky, MD, who is researching the effects of cannabidiol, an active ingredient of marijuana, on epilepsy. “It’s like saying in 1960, ‘We’re not going to the moon because no one agrees how to get there.’ ”
The problem stems partly from the fact that the federal government’s restrictive marijuana research policies have not been overhauled in more than 40 years, researchers say.
Only one federal government contractor grows marijuana for federally funded research. Researchers complain the pot grown by the contractor at the University of Mississippi is inadequate for high-quality studies.
The marijuana, which comes in a micronized powder form, is less potent than the pot offered at dispensaries, researchers say. It also differs from other products offered at dispensaries, such as so-called edibles, which are eaten like snacks. The difference makes it difficult to compare the real-life effects of the marijuana compounds.
Researchers also face time-consuming and costly hurdles in completing the complicated federal application process for using marijuana in long-term clinical trials.
“It’s public policy before science,” said Chinazo Cunningham, MD, a primary care doctor who is the lead investigator on one of the few federally funded studies exploring marijuana as a treatment for pain. “The federal government’s policies really make it much more difficult.”
Dr. Cunningham, who received a 5-year, $3.8 million federal grant, will not be administering marijuana directly to participants. Instead, she will follow 250 HIV-positive and HIV-negative adults with chronic pain who use opioids and have been certified to get medical marijuana from a dispensary.
“It’s a Catch-22,” said Dr. Cunningham, who is with the Albert Einstein College of Medicine, New York. “We’re going to be looking at all of these issues – age, disease, level of pain – but when we’re done, there’s the danger that people are going to say ‘Oh, it’s anecdotal’ or that it’s inherently flawed because it’s not a randomized trial.’’
Without clear answers, hospitals, doctors, and patients are left to their own devices, which can result in poor treatment and needless suffering.
Hospitals and other medical facilities have to decide what to do with newly hospitalized patients who normally take medical marijuana at home.
Some have a “don’t ask, don’t tell” approach, said Dr. Devinsky, who sometimes advises his patients to use it. Others ban its use and substitute opioids or other prescriptions.
Young adults, for instance, have had to stop taking cannabidiol compounds for their epilepsy because they’re in federally funded group homes, said Dr. Devinsky, the director of New York University’s Langone Comprehensive Epilepsy Center.
“These kids end up getting seizures again,” he said. “This whole situation has created a hodgepodge of insanity.”
The Trump administration, however, has resisted policy changes.
Last year, the Drug Enforcement Administration had been gearing up to allow facilities other than the University of Mississippi to grow pot for research. But after the DEA received 26 applications from other growers, Attorney General Jeff Sessions halted the initiative.
The Department of Veterans Affairs also recently announced it would not fund studies of using marijuana compounds to treat ailments such as pain.
The DEA and HHS have cited concerns about medical supervision, addiction, and a lack of “well-controlled studies proving efficacy.”
Patients, meanwhile, forge ahead.
While experts say they don’t know exactly how many older Americans rely on marijuana for medicinal purposes, the number of Americans aged 65 years and older who say they are using the drug skyrocketed 250% from 2006 to 2013.
Some patients turn to friends, patient advocacy groups, or online support groups for information.
Ms. Owen, for one, kept searching for a doctor and eventually found a neurologist willing to certify her to use marijuana and advise her on what to take.
“It’s saved my life,” said the retired university administrative assistant who credited marijuana for weaning her off opioids. “It not only helps my pain, but I can think, walk, and talk again.”
Mary Jo, a Minnesotan, was afraid of being identified as a medical marijuana user, even though she now helps friends navigate the process and it’s legal in her home state.
“There’s still a stigma,” said Mary Jo, who found it effective for treating her pain from a nerve condition. “Nobody helps you figure it out, so you kind of play around with it on your own.”
Still, doctors and scientists worry about the implications of such experimentation.
In a sweeping report last year, the National Academies of Sciences, Engineering and Medicine called on the federal government to support better research, decrying the “lack of definitive evidence on using medical marijuana.”
The national academies’ committee reviewed more than 10,000 scientific abstracts related to the topic. It made 100 conclusions based on its review, including finding evidence that marijuana relieves pain and chemotherapy-induced nausea. But it found “inadequate information” to support or refute effects on Parkinson’s disease.
Yet those who find that medical marijuana helps them can become fierce advocates no matter what their doctors say.
Caryl Barrett, a 54-year-old who lives in Georgia, said she decided to travel out of state to Colorado to treat her pain from her transverse myelitis and the autoimmune disease neurosarcoidosis.
“I realized it worked and I decided to bring it back with me,” she said. “I broke federal law.”
Georgia, meanwhile, permitted limited medicinal use of marijuana but did not set up dispensaries. As a result, patients resort to ordering it online or driving to another state to get it.
The conflict in the law makes her uneasy. But Ms. Barrett, who had been on opioids for a decade, said she feels so strongly about it working that “if someone wants to arrest me, bring it on.”
Others experience mixed results.
Melodie Beckham, who had metastatic lung cancer, tried medical marijuana for 13 days in a clinical trial at Connecticut Hospice before deciding to quit.
“She was hopeful that it would help her relax and just kind of enjoy those days,” said her daughter, Laura Beckham.
Instead, it seemed to make her mother, who died in July at age 69, “a little more agitated or more paranoid.”
The marijuana “didn’t seem effective,” nor did it keep her mother from hitting her pain pump to get extra doses of an opioid, her daughter said.
The researchers running the trial at Connecticut Hospice spent 2 years getting necessary approvals from the FDA, the National Institute on Drug Abuse (NIDA), and the DEA.
Since May, the trial has enrolled only 7 of the 66 patients it plans to sign up because many patients were too sick, too close to death, or simply couldn’t swallow the pills. So far, the trial has shown “mixed results,” said James Prota, director of pharmacy for the hospice.
Researchers point out they are still exploring the basics when it comes to marijuana’s effects on older adults or the terminally ill.
“We just have no data on how many older adults are using medical marijuana, what they are using it for, and most importantly, what are the outcomes,” said Brian Kaskie, an associate professor at the University of Iowa’s College of Public Health in Iowa City. “It’s all anecdotal.”
Mr. Kaskie, who specializes in public policy and the aging, received grants from the state of Colorado and the Chicago-based Retirement Research Foundation to survey the use of medical marijuana by older Americans.
In many quarters, there’s a growing appetite for solid information, he said.
“When I first started this, my colleagues joked we were going to find all the aging hippies who listen to the Grateful Dead,” said Mr. Kaskie, who has been studying medicinal marijuana for years. “Now, they’re starting to realize this is a legitimate area of research.”
Twenty researchers received marijuana from the federal program last year, which was more than any previous year since 2010, according to NIDA statistics.
In a recent funding announcement, the National Institutes of Health requested grant applications to study the effects of marijuana and other drugs on older adults and pain. NIH, however, continues to funnel much of its funding into studying the adverse effects of marijuana, researchers said.
Although NIH acknowledged in one of the announcements that some research supports “possible benefits” of marijuana, it emphasized “there have not been adequate large controlled trials to support these claims.”
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
By the time Ann Marie Owen turned to marijuana to treat her pain, she was struggling to walk and talk. She also hallucinated.
For 4 years, her doctor prescribed the 61-year-old a wide range of opioids for her transverse myelitis, a debilitating disease that caused pain, muscle weakness, and paralysis.
The drugs not only failed to ease her symptoms, they also hooked her.
When her home state of New York legalized marijuana for the treatment of select medical ailments, Ms. Owens decided it was time to swap pills for pot. But her doctors refused to help.
“Even though medical marijuana is legal, none of my doctors were willing to talk to me about it,” she said. “They just kept telling me to take opioids.”
While 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Ms. Owen who use marijuana and the doctors who treat them are caught in the middle of a conflict in federal and state laws – a predicament that is only worsened by thin scientific data.
Because the federal government classifies marijuana a Schedule 1 drug – by definition a substance with no currently accepted medical use and a high potential for abuse – research on marijuana or its active ingredients is highly restricted and even discouraged in some cases.
Underscoring the federal government’s position, Health & Human Services Secretary Alex Azar recently pronounced that there was “no such thing as medical marijuana.”
Scientists say that stance prevents them from conducting the high-quality research required for Food and Drug Administration approval, even as some early research indicates marijuana might be a promising alternative to opioids or other medicines.
Patients and physicians, meanwhile, lack guidance when making decisions about medical treatment for an array of serious conditions.
“We have the federal government and the state governments driving a hundred miles an hour in the opposite direction when they should be coming together to obtain more scientific data,” said Orrin Devinsky, MD, who is researching the effects of cannabidiol, an active ingredient of marijuana, on epilepsy. “It’s like saying in 1960, ‘We’re not going to the moon because no one agrees how to get there.’ ”
The problem stems partly from the fact that the federal government’s restrictive marijuana research policies have not been overhauled in more than 40 years, researchers say.
Only one federal government contractor grows marijuana for federally funded research. Researchers complain the pot grown by the contractor at the University of Mississippi is inadequate for high-quality studies.
The marijuana, which comes in a micronized powder form, is less potent than the pot offered at dispensaries, researchers say. It also differs from other products offered at dispensaries, such as so-called edibles, which are eaten like snacks. The difference makes it difficult to compare the real-life effects of the marijuana compounds.
Researchers also face time-consuming and costly hurdles in completing the complicated federal application process for using marijuana in long-term clinical trials.
“It’s public policy before science,” said Chinazo Cunningham, MD, a primary care doctor who is the lead investigator on one of the few federally funded studies exploring marijuana as a treatment for pain. “The federal government’s policies really make it much more difficult.”
Dr. Cunningham, who received a 5-year, $3.8 million federal grant, will not be administering marijuana directly to participants. Instead, she will follow 250 HIV-positive and HIV-negative adults with chronic pain who use opioids and have been certified to get medical marijuana from a dispensary.
“It’s a Catch-22,” said Dr. Cunningham, who is with the Albert Einstein College of Medicine, New York. “We’re going to be looking at all of these issues – age, disease, level of pain – but when we’re done, there’s the danger that people are going to say ‘Oh, it’s anecdotal’ or that it’s inherently flawed because it’s not a randomized trial.’’
Without clear answers, hospitals, doctors, and patients are left to their own devices, which can result in poor treatment and needless suffering.
Hospitals and other medical facilities have to decide what to do with newly hospitalized patients who normally take medical marijuana at home.
Some have a “don’t ask, don’t tell” approach, said Dr. Devinsky, who sometimes advises his patients to use it. Others ban its use and substitute opioids or other prescriptions.
Young adults, for instance, have had to stop taking cannabidiol compounds for their epilepsy because they’re in federally funded group homes, said Dr. Devinsky, the director of New York University’s Langone Comprehensive Epilepsy Center.
“These kids end up getting seizures again,” he said. “This whole situation has created a hodgepodge of insanity.”
The Trump administration, however, has resisted policy changes.
Last year, the Drug Enforcement Administration had been gearing up to allow facilities other than the University of Mississippi to grow pot for research. But after the DEA received 26 applications from other growers, Attorney General Jeff Sessions halted the initiative.
The Department of Veterans Affairs also recently announced it would not fund studies of using marijuana compounds to treat ailments such as pain.
The DEA and HHS have cited concerns about medical supervision, addiction, and a lack of “well-controlled studies proving efficacy.”
Patients, meanwhile, forge ahead.
While experts say they don’t know exactly how many older Americans rely on marijuana for medicinal purposes, the number of Americans aged 65 years and older who say they are using the drug skyrocketed 250% from 2006 to 2013.
Some patients turn to friends, patient advocacy groups, or online support groups for information.
Ms. Owen, for one, kept searching for a doctor and eventually found a neurologist willing to certify her to use marijuana and advise her on what to take.
“It’s saved my life,” said the retired university administrative assistant who credited marijuana for weaning her off opioids. “It not only helps my pain, but I can think, walk, and talk again.”
Mary Jo, a Minnesotan, was afraid of being identified as a medical marijuana user, even though she now helps friends navigate the process and it’s legal in her home state.
“There’s still a stigma,” said Mary Jo, who found it effective for treating her pain from a nerve condition. “Nobody helps you figure it out, so you kind of play around with it on your own.”
Still, doctors and scientists worry about the implications of such experimentation.
In a sweeping report last year, the National Academies of Sciences, Engineering and Medicine called on the federal government to support better research, decrying the “lack of definitive evidence on using medical marijuana.”
The national academies’ committee reviewed more than 10,000 scientific abstracts related to the topic. It made 100 conclusions based on its review, including finding evidence that marijuana relieves pain and chemotherapy-induced nausea. But it found “inadequate information” to support or refute effects on Parkinson’s disease.
Yet those who find that medical marijuana helps them can become fierce advocates no matter what their doctors say.
Caryl Barrett, a 54-year-old who lives in Georgia, said she decided to travel out of state to Colorado to treat her pain from her transverse myelitis and the autoimmune disease neurosarcoidosis.
“I realized it worked and I decided to bring it back with me,” she said. “I broke federal law.”
Georgia, meanwhile, permitted limited medicinal use of marijuana but did not set up dispensaries. As a result, patients resort to ordering it online or driving to another state to get it.
The conflict in the law makes her uneasy. But Ms. Barrett, who had been on opioids for a decade, said she feels so strongly about it working that “if someone wants to arrest me, bring it on.”
Others experience mixed results.
Melodie Beckham, who had metastatic lung cancer, tried medical marijuana for 13 days in a clinical trial at Connecticut Hospice before deciding to quit.
“She was hopeful that it would help her relax and just kind of enjoy those days,” said her daughter, Laura Beckham.
Instead, it seemed to make her mother, who died in July at age 69, “a little more agitated or more paranoid.”
The marijuana “didn’t seem effective,” nor did it keep her mother from hitting her pain pump to get extra doses of an opioid, her daughter said.
The researchers running the trial at Connecticut Hospice spent 2 years getting necessary approvals from the FDA, the National Institute on Drug Abuse (NIDA), and the DEA.
Since May, the trial has enrolled only 7 of the 66 patients it plans to sign up because many patients were too sick, too close to death, or simply couldn’t swallow the pills. So far, the trial has shown “mixed results,” said James Prota, director of pharmacy for the hospice.
Researchers point out they are still exploring the basics when it comes to marijuana’s effects on older adults or the terminally ill.
“We just have no data on how many older adults are using medical marijuana, what they are using it for, and most importantly, what are the outcomes,” said Brian Kaskie, an associate professor at the University of Iowa’s College of Public Health in Iowa City. “It’s all anecdotal.”
Mr. Kaskie, who specializes in public policy and the aging, received grants from the state of Colorado and the Chicago-based Retirement Research Foundation to survey the use of medical marijuana by older Americans.
In many quarters, there’s a growing appetite for solid information, he said.
“When I first started this, my colleagues joked we were going to find all the aging hippies who listen to the Grateful Dead,” said Mr. Kaskie, who has been studying medicinal marijuana for years. “Now, they’re starting to realize this is a legitimate area of research.”
Twenty researchers received marijuana from the federal program last year, which was more than any previous year since 2010, according to NIDA statistics.
In a recent funding announcement, the National Institutes of Health requested grant applications to study the effects of marijuana and other drugs on older adults and pain. NIH, however, continues to funnel much of its funding into studying the adverse effects of marijuana, researchers said.
Although NIH acknowledged in one of the announcements that some research supports “possible benefits” of marijuana, it emphasized “there have not been adequate large controlled trials to support these claims.”
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
CDC: Marijuana use may spur industries to rethink current policies
according to a report from the Centers for Disease Control and Prevention.
As legal recreational marijuana use continues to expand across the United States, marijuana has been shown to inhibit certain motor skills, which has made it crucial for employers to have a better understanding how best to approach safety training, according to the study published in the Morbidity and Mortality Weekly Report.
“We have been looking at some of the behavioral risk factors associated with marijuana legalization and were interested in the data broken down by industry and occupation, which could help employers make decisions on any kind of safety and drug use policies in the workplace,” lead author Roberta Smith, RN, occupational health program manager at the Colorado Department of Public Health and Environment, said in a interview. “This doesn’t necessarily imply any impairment on the job, but these data will reinforce current policies and encourage employers to go back and see how their work places operate and make sure their employees are good to staff.”
To examine current marijuana use by working adults and the industries and occupations in which they are employed, the Colorado Department of Public Health and Environment analyzed data from the state’s Behavioral Risk Factor Surveillance System regarding current marijuana use (at least 1 day during the preceding 30 days) among 10,169 persons who had responded to the current marijuana use question.
Participants were over the age of 21 years old and were either employed at the time of the survey or had been unemployed for less than a year.
In the overall population, 14.6% reported using marijuana, with higher prevalence in men (17.2%) and those 18-25 years old (29.6%).
By industry, accommodation and food service workers reported the highest rate of use at 30.1%, followed by those in the arts, entertainment, and recreation industry with 28.3%.
While the highest percentage of reported users came from food services and entertainment, safety-sensitive jobs like construction saw rates as high as 20% when not adjusted for age, according to investigators,
Ms. Smith and her colleagues found use varied across safety-sensitive industries, with high rates in construction (19.7%), waste management (18.8%), and manufacturing (16.3%) that were above the total population prevalence. Meanwhile, mining, health care, and transportation were all 10% or lower, which may be because of more regular drug testing.
“It might be reassuring that our health care professionals are on the lower end of use,” said Ms. Smith. “Having worked in a medical facility, I know drug policies for workers are clear and employees are aware of drug testing and when it will occur.”
While the health care industry reported low usage, 15.8% of health care support management workers, such as x-ray technicians, reported marijuana use.
When adjusted for age, the prevalence among workers in certain industries – such as food services, arts, and construction industry – saw significant decreases, which lead investigators to conclude younger employees would be a key target for more marijuana-related drug-use policies.
Ms. Smith and her colleagues recognized the population used may not be a full representation of all Colorado employees and that missing data regarding how often individuals used marijuana within 30 days could offer different considerations for workplace impairment.
Investigators also noted the data may have been influenced by self-reported bias or recording errors by survey takers.
Moving forward, Ms. Smith and her colleagues are interested in how this data might shift as more states conduct their own research and as marijuana policy changes.
This report was funded by the CDC, and investigators report no relevant financial disclosures.
SOURCE: Smith R et al. MMWR. 2018 Apr 13;67(14):409-13.
according to a report from the Centers for Disease Control and Prevention.
As legal recreational marijuana use continues to expand across the United States, marijuana has been shown to inhibit certain motor skills, which has made it crucial for employers to have a better understanding how best to approach safety training, according to the study published in the Morbidity and Mortality Weekly Report.
“We have been looking at some of the behavioral risk factors associated with marijuana legalization and were interested in the data broken down by industry and occupation, which could help employers make decisions on any kind of safety and drug use policies in the workplace,” lead author Roberta Smith, RN, occupational health program manager at the Colorado Department of Public Health and Environment, said in a interview. “This doesn’t necessarily imply any impairment on the job, but these data will reinforce current policies and encourage employers to go back and see how their work places operate and make sure their employees are good to staff.”
To examine current marijuana use by working adults and the industries and occupations in which they are employed, the Colorado Department of Public Health and Environment analyzed data from the state’s Behavioral Risk Factor Surveillance System regarding current marijuana use (at least 1 day during the preceding 30 days) among 10,169 persons who had responded to the current marijuana use question.
Participants were over the age of 21 years old and were either employed at the time of the survey or had been unemployed for less than a year.
In the overall population, 14.6% reported using marijuana, with higher prevalence in men (17.2%) and those 18-25 years old (29.6%).
By industry, accommodation and food service workers reported the highest rate of use at 30.1%, followed by those in the arts, entertainment, and recreation industry with 28.3%.
While the highest percentage of reported users came from food services and entertainment, safety-sensitive jobs like construction saw rates as high as 20% when not adjusted for age, according to investigators,
Ms. Smith and her colleagues found use varied across safety-sensitive industries, with high rates in construction (19.7%), waste management (18.8%), and manufacturing (16.3%) that were above the total population prevalence. Meanwhile, mining, health care, and transportation were all 10% or lower, which may be because of more regular drug testing.
“It might be reassuring that our health care professionals are on the lower end of use,” said Ms. Smith. “Having worked in a medical facility, I know drug policies for workers are clear and employees are aware of drug testing and when it will occur.”
While the health care industry reported low usage, 15.8% of health care support management workers, such as x-ray technicians, reported marijuana use.
When adjusted for age, the prevalence among workers in certain industries – such as food services, arts, and construction industry – saw significant decreases, which lead investigators to conclude younger employees would be a key target for more marijuana-related drug-use policies.
Ms. Smith and her colleagues recognized the population used may not be a full representation of all Colorado employees and that missing data regarding how often individuals used marijuana within 30 days could offer different considerations for workplace impairment.
Investigators also noted the data may have been influenced by self-reported bias or recording errors by survey takers.
Moving forward, Ms. Smith and her colleagues are interested in how this data might shift as more states conduct their own research and as marijuana policy changes.
This report was funded by the CDC, and investigators report no relevant financial disclosures.
SOURCE: Smith R et al. MMWR. 2018 Apr 13;67(14):409-13.
according to a report from the Centers for Disease Control and Prevention.
As legal recreational marijuana use continues to expand across the United States, marijuana has been shown to inhibit certain motor skills, which has made it crucial for employers to have a better understanding how best to approach safety training, according to the study published in the Morbidity and Mortality Weekly Report.
“We have been looking at some of the behavioral risk factors associated with marijuana legalization and were interested in the data broken down by industry and occupation, which could help employers make decisions on any kind of safety and drug use policies in the workplace,” lead author Roberta Smith, RN, occupational health program manager at the Colorado Department of Public Health and Environment, said in a interview. “This doesn’t necessarily imply any impairment on the job, but these data will reinforce current policies and encourage employers to go back and see how their work places operate and make sure their employees are good to staff.”
To examine current marijuana use by working adults and the industries and occupations in which they are employed, the Colorado Department of Public Health and Environment analyzed data from the state’s Behavioral Risk Factor Surveillance System regarding current marijuana use (at least 1 day during the preceding 30 days) among 10,169 persons who had responded to the current marijuana use question.
Participants were over the age of 21 years old and were either employed at the time of the survey or had been unemployed for less than a year.
In the overall population, 14.6% reported using marijuana, with higher prevalence in men (17.2%) and those 18-25 years old (29.6%).
By industry, accommodation and food service workers reported the highest rate of use at 30.1%, followed by those in the arts, entertainment, and recreation industry with 28.3%.
While the highest percentage of reported users came from food services and entertainment, safety-sensitive jobs like construction saw rates as high as 20% when not adjusted for age, according to investigators,
Ms. Smith and her colleagues found use varied across safety-sensitive industries, with high rates in construction (19.7%), waste management (18.8%), and manufacturing (16.3%) that were above the total population prevalence. Meanwhile, mining, health care, and transportation were all 10% or lower, which may be because of more regular drug testing.
“It might be reassuring that our health care professionals are on the lower end of use,” said Ms. Smith. “Having worked in a medical facility, I know drug policies for workers are clear and employees are aware of drug testing and when it will occur.”
While the health care industry reported low usage, 15.8% of health care support management workers, such as x-ray technicians, reported marijuana use.
When adjusted for age, the prevalence among workers in certain industries – such as food services, arts, and construction industry – saw significant decreases, which lead investigators to conclude younger employees would be a key target for more marijuana-related drug-use policies.
Ms. Smith and her colleagues recognized the population used may not be a full representation of all Colorado employees and that missing data regarding how often individuals used marijuana within 30 days could offer different considerations for workplace impairment.
Investigators also noted the data may have been influenced by self-reported bias or recording errors by survey takers.
Moving forward, Ms. Smith and her colleagues are interested in how this data might shift as more states conduct their own research and as marijuana policy changes.
This report was funded by the CDC, and investigators report no relevant financial disclosures.
SOURCE: Smith R et al. MMWR. 2018 Apr 13;67(14):409-13.
FROM MMWR
New lung cancer screening guideline from CHEST
An update to CHEST’s lung cancer screening guideline, Screening for Lung Cancer: CHEST Guideline and Expert Panel Report, has just been published online in the journal CHEST®. This update was made possible by the hard work of my co-authors and the amazing support of the CHEST staff.
Our goal was to update the evidence base for the benefit, harms, and implementation of low-radiation dose chest CT screening, then use this evidence base to produce meaningful and usable recommendations. The process for developing the guideline followed the rigorous methodological standards of CHEST in which the evidence was gathered from a systematic literature review, and the overall quality of the body of evidence was assessed using the GRADE approach. Recommendations were developed and graded based on this assessment.
There are a few aspects of the new guidelines to highlight. First, we have updated some of the core recommendations; second, we have developed new recommendations related to the implementation of high-quality screening; and third, the CHEST approach to guideline development has evolved to allow us to provide recommendations in which the evidence allows and statements based on experience and expert consensus in which it does not. Through this process, we developed six graded recommendations and nine ungraded consensus-based statements.
In this update, a few changes to the core recommendations about who should be screened are worthy to note:
- We have recommended an increase to the upper age of the screen-eligible cohort from 74 to 77, in line with CMS coverage and reflecting the oldest age of participants in the National Lung Screening Trial at the end of the screening period.
- We have directly addressed the cohort of individuals who are at high risk for having/developing lung cancer based on clinical risk prediction calculators but do not meet the current eligibility criteria. We recommended that this cohort should not be routinely screened given the greater potential for this cohort to have comorbid conditions that would influence morbidity from the evaluation and treatment of screen-detected findings and death from any cause. We did, however, state that there will be individuals within the cohort deemed to be at high risk for lung cancer from a clinical risk prediction calculator who are healthy enough to benefit from lung cancer screening and that low-radiation dose CT screening could be considered in these individuals.
- We recommended against low-radiation dose CT screening in cohorts at low risk of developing lung cancer and in individuals with comorbidities that adversely influence their ability to tolerate the evaluation of screen-detected findings, tolerate treatment of an early stage screen-detected lung cancer, or that substantially limit their life expectancy.
- We also highlighted that screening is reserved for patients without symptoms that could be caused by the presence of lung cancer, stressing that all symptomatic patients should receive an appropriate diagnostic evaluation.
Our remaining recommendation and statements are focused on aspects of screening implementation that influence the balance of benefit and harms of screening and lend to an approach to screening that respects patient values. An extensive literature review, followed by a recommendation or statement, is provided to guide programs in the following areas:
- the choice of nodule size to define what constitutes a positive test;
- maximizing compliance with annual screening exams;
- developing a comprehensive approach to lung nodule management;
- minimizing overtreatment of potentially indolent lung cancers;
- the provision of evidence-based tobacco cessation treatment;
- providing effective counseling and shared decision-making visits prior to the low-radiation dose CT scan;
- how to perform the low-radiation dose CT scan;
- structured reporting of the exam results, management of non-nodule findings on the low radiation dose CT; and
- the development of data collection and reporting tools that are capable of assisting with quality improvement initiatives.
Throughout the recommendations and statements, we have tried to be sensitive to the variety of acceptable approaches to screening program organization, ranging from program structures that are entirely decentralized (test ordering, counseling, and management of the findings by the referring provider) to those that are entirely centralized (test ordering, counseling, and management of the findings by the screening program).
Though we have attempted to comprehensively evaluate the literature and balance available evidence with pragmatism and the needs of our patients, we recognize that well-intentioned and informed experts can have different opinions about aspects of our guidelines. This highlights the need for further research to guide the screening community. Most will agree that it is time to increase access to high- quality lung cancer screening programs across the country. We hope that the updated CHEST lung cancer screening guidelines can help catalyze this.
Coinciding with the publication of the guideline, CHEST has developed new e-learning modules on the benefits and harms of CT screening for lung cancer. The modules are based on the CHEST 2018 educational session on the Screening for Lung Cancer Guidelines. The modules are available at chestnet.org/lungcancerscreening.
An update to CHEST’s lung cancer screening guideline, Screening for Lung Cancer: CHEST Guideline and Expert Panel Report, has just been published online in the journal CHEST®. This update was made possible by the hard work of my co-authors and the amazing support of the CHEST staff.
Our goal was to update the evidence base for the benefit, harms, and implementation of low-radiation dose chest CT screening, then use this evidence base to produce meaningful and usable recommendations. The process for developing the guideline followed the rigorous methodological standards of CHEST in which the evidence was gathered from a systematic literature review, and the overall quality of the body of evidence was assessed using the GRADE approach. Recommendations were developed and graded based on this assessment.
There are a few aspects of the new guidelines to highlight. First, we have updated some of the core recommendations; second, we have developed new recommendations related to the implementation of high-quality screening; and third, the CHEST approach to guideline development has evolved to allow us to provide recommendations in which the evidence allows and statements based on experience and expert consensus in which it does not. Through this process, we developed six graded recommendations and nine ungraded consensus-based statements.
In this update, a few changes to the core recommendations about who should be screened are worthy to note:
- We have recommended an increase to the upper age of the screen-eligible cohort from 74 to 77, in line with CMS coverage and reflecting the oldest age of participants in the National Lung Screening Trial at the end of the screening period.
- We have directly addressed the cohort of individuals who are at high risk for having/developing lung cancer based on clinical risk prediction calculators but do not meet the current eligibility criteria. We recommended that this cohort should not be routinely screened given the greater potential for this cohort to have comorbid conditions that would influence morbidity from the evaluation and treatment of screen-detected findings and death from any cause. We did, however, state that there will be individuals within the cohort deemed to be at high risk for lung cancer from a clinical risk prediction calculator who are healthy enough to benefit from lung cancer screening and that low-radiation dose CT screening could be considered in these individuals.
- We recommended against low-radiation dose CT screening in cohorts at low risk of developing lung cancer and in individuals with comorbidities that adversely influence their ability to tolerate the evaluation of screen-detected findings, tolerate treatment of an early stage screen-detected lung cancer, or that substantially limit their life expectancy.
- We also highlighted that screening is reserved for patients without symptoms that could be caused by the presence of lung cancer, stressing that all symptomatic patients should receive an appropriate diagnostic evaluation.
Our remaining recommendation and statements are focused on aspects of screening implementation that influence the balance of benefit and harms of screening and lend to an approach to screening that respects patient values. An extensive literature review, followed by a recommendation or statement, is provided to guide programs in the following areas:
- the choice of nodule size to define what constitutes a positive test;
- maximizing compliance with annual screening exams;
- developing a comprehensive approach to lung nodule management;
- minimizing overtreatment of potentially indolent lung cancers;
- the provision of evidence-based tobacco cessation treatment;
- providing effective counseling and shared decision-making visits prior to the low-radiation dose CT scan;
- how to perform the low-radiation dose CT scan;
- structured reporting of the exam results, management of non-nodule findings on the low radiation dose CT; and
- the development of data collection and reporting tools that are capable of assisting with quality improvement initiatives.
Throughout the recommendations and statements, we have tried to be sensitive to the variety of acceptable approaches to screening program organization, ranging from program structures that are entirely decentralized (test ordering, counseling, and management of the findings by the referring provider) to those that are entirely centralized (test ordering, counseling, and management of the findings by the screening program).
Though we have attempted to comprehensively evaluate the literature and balance available evidence with pragmatism and the needs of our patients, we recognize that well-intentioned and informed experts can have different opinions about aspects of our guidelines. This highlights the need for further research to guide the screening community. Most will agree that it is time to increase access to high- quality lung cancer screening programs across the country. We hope that the updated CHEST lung cancer screening guidelines can help catalyze this.
Coinciding with the publication of the guideline, CHEST has developed new e-learning modules on the benefits and harms of CT screening for lung cancer. The modules are based on the CHEST 2018 educational session on the Screening for Lung Cancer Guidelines. The modules are available at chestnet.org/lungcancerscreening.
An update to CHEST’s lung cancer screening guideline, Screening for Lung Cancer: CHEST Guideline and Expert Panel Report, has just been published online in the journal CHEST®. This update was made possible by the hard work of my co-authors and the amazing support of the CHEST staff.
Our goal was to update the evidence base for the benefit, harms, and implementation of low-radiation dose chest CT screening, then use this evidence base to produce meaningful and usable recommendations. The process for developing the guideline followed the rigorous methodological standards of CHEST in which the evidence was gathered from a systematic literature review, and the overall quality of the body of evidence was assessed using the GRADE approach. Recommendations were developed and graded based on this assessment.
There are a few aspects of the new guidelines to highlight. First, we have updated some of the core recommendations; second, we have developed new recommendations related to the implementation of high-quality screening; and third, the CHEST approach to guideline development has evolved to allow us to provide recommendations in which the evidence allows and statements based on experience and expert consensus in which it does not. Through this process, we developed six graded recommendations and nine ungraded consensus-based statements.
In this update, a few changes to the core recommendations about who should be screened are worthy to note:
- We have recommended an increase to the upper age of the screen-eligible cohort from 74 to 77, in line with CMS coverage and reflecting the oldest age of participants in the National Lung Screening Trial at the end of the screening period.
- We have directly addressed the cohort of individuals who are at high risk for having/developing lung cancer based on clinical risk prediction calculators but do not meet the current eligibility criteria. We recommended that this cohort should not be routinely screened given the greater potential for this cohort to have comorbid conditions that would influence morbidity from the evaluation and treatment of screen-detected findings and death from any cause. We did, however, state that there will be individuals within the cohort deemed to be at high risk for lung cancer from a clinical risk prediction calculator who are healthy enough to benefit from lung cancer screening and that low-radiation dose CT screening could be considered in these individuals.
- We recommended against low-radiation dose CT screening in cohorts at low risk of developing lung cancer and in individuals with comorbidities that adversely influence their ability to tolerate the evaluation of screen-detected findings, tolerate treatment of an early stage screen-detected lung cancer, or that substantially limit their life expectancy.
- We also highlighted that screening is reserved for patients without symptoms that could be caused by the presence of lung cancer, stressing that all symptomatic patients should receive an appropriate diagnostic evaluation.
Our remaining recommendation and statements are focused on aspects of screening implementation that influence the balance of benefit and harms of screening and lend to an approach to screening that respects patient values. An extensive literature review, followed by a recommendation or statement, is provided to guide programs in the following areas:
- the choice of nodule size to define what constitutes a positive test;
- maximizing compliance with annual screening exams;
- developing a comprehensive approach to lung nodule management;
- minimizing overtreatment of potentially indolent lung cancers;
- the provision of evidence-based tobacco cessation treatment;
- providing effective counseling and shared decision-making visits prior to the low-radiation dose CT scan;
- how to perform the low-radiation dose CT scan;
- structured reporting of the exam results, management of non-nodule findings on the low radiation dose CT; and
- the development of data collection and reporting tools that are capable of assisting with quality improvement initiatives.
Throughout the recommendations and statements, we have tried to be sensitive to the variety of acceptable approaches to screening program organization, ranging from program structures that are entirely decentralized (test ordering, counseling, and management of the findings by the referring provider) to those that are entirely centralized (test ordering, counseling, and management of the findings by the screening program).
Though we have attempted to comprehensively evaluate the literature and balance available evidence with pragmatism and the needs of our patients, we recognize that well-intentioned and informed experts can have different opinions about aspects of our guidelines. This highlights the need for further research to guide the screening community. Most will agree that it is time to increase access to high- quality lung cancer screening programs across the country. We hope that the updated CHEST lung cancer screening guidelines can help catalyze this.
Coinciding with the publication of the guideline, CHEST has developed new e-learning modules on the benefits and harms of CT screening for lung cancer. The modules are based on the CHEST 2018 educational session on the Screening for Lung Cancer Guidelines. The modules are available at chestnet.org/lungcancerscreening.
Life after angiotensin II
Hypotension is an often-underestimated adversary. Even brief periods of intraoperative mean arterial pressure (MAP) <65 mm Hg increase the odds of both myocardial ischemia and acute kidney injury in the postoperative period. The threshold may be even higher in the postoperative critically ill population (Khanna, et al. Crit Care Med. 2018;46(1):71). Hypotension that is refractory to high-dose vasopressors is associated with an all-cause mortality of 50% to 80%.
The vasopressor toolbox centers around escalating doses of catecholamines with or without the addition of vasopressin. High-dose catecholamines, albeit a frequent choice, is associated with adverse cardiac events (Schmittinger, et al. Intensive Care Med. 2012;38[6]:950) and is an independent predictor of ICU mortality (Sviri, et al. J Crit Care. 2014;29[1]:157).
The evidence behind angiotensin II
Angiotensin II (AT II) is a naturally occurring hormone in the renin-angiotensin-aldosterone (RAA) system that modulates blood pressure through direct arterial vasoconstriction and direct stimulation of the kidneys and adrenal cortex to release vasopressin and aldosterone, respectively.
Positive results from the recent phase 3 trial for AT II have offered hope that this agent would add the needed balance to the current scarcity of vasopressor options (Khanna, et al. N Engl J Med. 2017;377[5]:419). AT II would provide the missing piece in the jigsaw that would allow the intensivist to manage refractory hypotension, while keeping a multimodal vasopressor dosing regimen within therapeutic limits.
Irvine Page and coworkers are credited with most of the initial work on AT II, which they did nearly 70 years ago. Anecdotal use in humans has been reported since the early 1960s (Del Greco, et al. JAMA 1961;178:994). After a prolonged period of quiescence, the Angiotensin II in High-Output Shock (ATHOS) pilot study, which was done in 2014 as a single-center “proof of concept” study of 20 patients, reinvigorated clinical enthusiasm for this agent (Chawla, et al. Crit Care. 2014;18[5]:534). ATHOS demonstrated the effectiveness of AT II at decreasing norepinephrine (NE) requirements of patients in vasodilatory shock (mean NE dose in AT II group 7.4 ug/min vs 27.6 ug/min in placebo, P=.06). These promising results were followed by ATHOS-3, a phase 3, double-blind, multicenter randomized controlled trial of stable human synthetic AT II. This trial was conducted under a special protocol assessment agreement with the US Food and Drug Administration (FDA). A total of 344 patients with predefined criteria for vasodilatory shock were randomized to AT II or placebo as the intention-to-treat population. The primary end-point was a response in MAP by hour 3 of AT II initiation; response was defined as either a MAP rise to 75 mm Hg or an increase in MAP ≥ 10 mm Hg. The primary end-point was reached more frequently in the AT II group than in the placebo group (69.9% AT II vs 23.4% placebo, OR 7.95, 95% CI 4.76-13.3, P<.001). The AT II group had significantly lower cardiovascular sequential organ failure assessment (SOFA) scores at 48 hours and achieved a consistent decrease in background vasopressor doses. Post-hoc data analysis found that the highest benefit was in patients who were AT II deficient (high ratio of AT I:AT II) (Wunderink, et al. Intensive Care Med Exp. 2017;5(Suppl 2):44). The patients who were AT II depleted and received placebo had a higher hazard ratio of death (HR 1.77, 95% CI 1.10-2.85, P=.019), while those who were AT II depleted and received AT II had a decreased risk of mortality (HR 0.64, 95% CI 0.41-1.00, P=.047). The data suggest not only that AT II levels may be predictive of mortality in vasodilatory shock but also that exogenous AT II administration may favorably modulate mortality in this population. Further, a subset data analysis of severely ill patients (APACHE II scores > 30) showed that those who received AT II and standard vasopressors had a significantly lower 28-day mortality compared with patients who only received standard vasopressors (Szerlip, et al. Crit Care Med. 2018;46[1]:3). Considering that the endothelial cells in the lungs and kidneys are locations where AT I is hydrolyzed by angiotensin-converting enzyme (ACE) into AT II, patients receiving ACE-inhibitors and individuals with pulmonary or renal disease are at greatest risk for AT II deficiency. As such, the use of AT II in the extra-corporeal membrane oxygenation (ECMO), post cardiopulmonary bypass, acute respiratory distress syndrome (ARDS), and renal failure populations are of future interest.
Is there a downside?
Appropriate caution is necessary when interpreting these outcomes. One criticism that ATHOS-3 received was the use of a MAP goal of 75 mm Hg, a higher value than currently recommended by clinical guidelines, in the first 3 hours of AT II administration. Because this was a phase 3 trial, both the safety and efficacy of the drug were examined. These goals are difficult to accomplish if simultaneously manipulating other variables. Therefore, to isolate the effects of drug efficacy and safety, a higher MAP goal (75 mm Hg) was established to minimize any effect from varying background vasopressor doses during the first 3 hours of the study.
Furthermore, ATHOS-3 did find an increase in venous and arterial thromboembolic events in patients who received AT II (13% AT II vs 5% placebo). Previously, a systematic review of over 30,000 patients did not report this increased thromboembolic risk (Busse, et al. Crit Care. 2017;21[1]:324). According to the package insert, all patients receiving AT II should receive appropriate thromboembolic prophylaxis if medically indicated.
Where does AT II fit in our algorithm for resuscitation and the vasopressor toolbox?
Data from Wunderink et al indicate a potential mortality benefit in populations who are AT II depleted. However, we can only infer who these patients may be, as no commonly available assay can measure AT I and AT II levels. ATHOS and ATHOS-3 used AT II late during resuscitation, as did the Expanded Access Program (EAP) of the FDA, which gave physicians preliminary access to AT II while it was undergoing FDA review. Using similar inclusion criteria as ATHOS-3, the EAP did not permit patients to receive AT II until doses greater than or equal to 0.2 ug/kg/min of NE-equivalents were reached. In a recently published case report, AT II was successfully used in a patient with septic shock secondary to a colonic perforation (Chow, et al. Accepted for e-publication: A&A Practice. April 2018.). This individual was in vasodilatory shock despite standard resuscitation, 0.48 ug/kg/min of NE, and 0.04 units/min of vasopressin. Methylene blue and hydroxocobalamin had failed to relieve the vasoplegia, and only after the initiation of AT II at 40 ng/kg/min, the patient could be relieved of vasopressors and survived to be discharged from the hospital. In our opinion, best clinical practices would allow for an early multimodal vasopressor regimen that should include AT II at the earliest sign of rapid clinical decline (Jentzer, et al. Chest. 2018. Jan 9. pii: S0012-3692(18)30072-2. doi: 10.1016/j.chest.2017.12.021. [Epub ahead of print]).
Angiotensin II was recently approved by the FDA in December 2017 and is now available on the market for management of vasodilatory shock. This will undoubtedly have a profound impact on the way clinicians treat vasodilatory shock. Previously, we were confined to agents such methylene blue and hydroxocobalamin to rescue patients from profound vasoplegia. However, none of these agents are supported by robust evidence from randomized control trials.
Now, we can openly welcome a new challenger to the campaign, a new hue to the palette of vasopressor colors. This new class of vasopressor makes complete physiological sense and will provide an invaluable tool in our daily battle against sepsis and vasodilatory shock.
Dr. Chow is Assistant Professor, Division of Critical Care Medicine, Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD; Dr. Khana is Assistant Professor of Anesthesiology, Staff Intensivist, Vice-Chief for Research, Center for Critical Care, Department of Outcomes Research & General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH
Editor’s note
For decades, our options to treat patients with profound vasoplegia have been limited to high-dose catecholamines and vasopressin. Clinicians are often faced with the need to initiate multiple catecholamine agents knowing that these drugs stimulate similar receptors. The recent ATHOS-3 trial introduces AT II as a new option for the management of patients with refractory vasodilatory shock. This drug has a distinct mechanism of action that complements the effect of other vasopressors. Moreover, recent data suggest that this new agent is most beneficial in patients who are AT II deficient. Just like cancer therapies have evolved to precision medicine, will we perhaps face the need to better understand and promptly identify patients with AT II deficiency? For now, we have a new player on our vasopressor team.
Angel Coz, MD, FCCP
Section Editor
Hypotension is an often-underestimated adversary. Even brief periods of intraoperative mean arterial pressure (MAP) <65 mm Hg increase the odds of both myocardial ischemia and acute kidney injury in the postoperative period. The threshold may be even higher in the postoperative critically ill population (Khanna, et al. Crit Care Med. 2018;46(1):71). Hypotension that is refractory to high-dose vasopressors is associated with an all-cause mortality of 50% to 80%.
The vasopressor toolbox centers around escalating doses of catecholamines with or without the addition of vasopressin. High-dose catecholamines, albeit a frequent choice, is associated with adverse cardiac events (Schmittinger, et al. Intensive Care Med. 2012;38[6]:950) and is an independent predictor of ICU mortality (Sviri, et al. J Crit Care. 2014;29[1]:157).
The evidence behind angiotensin II
Angiotensin II (AT II) is a naturally occurring hormone in the renin-angiotensin-aldosterone (RAA) system that modulates blood pressure through direct arterial vasoconstriction and direct stimulation of the kidneys and adrenal cortex to release vasopressin and aldosterone, respectively.
Positive results from the recent phase 3 trial for AT II have offered hope that this agent would add the needed balance to the current scarcity of vasopressor options (Khanna, et al. N Engl J Med. 2017;377[5]:419). AT II would provide the missing piece in the jigsaw that would allow the intensivist to manage refractory hypotension, while keeping a multimodal vasopressor dosing regimen within therapeutic limits.
Irvine Page and coworkers are credited with most of the initial work on AT II, which they did nearly 70 years ago. Anecdotal use in humans has been reported since the early 1960s (Del Greco, et al. JAMA 1961;178:994). After a prolonged period of quiescence, the Angiotensin II in High-Output Shock (ATHOS) pilot study, which was done in 2014 as a single-center “proof of concept” study of 20 patients, reinvigorated clinical enthusiasm for this agent (Chawla, et al. Crit Care. 2014;18[5]:534). ATHOS demonstrated the effectiveness of AT II at decreasing norepinephrine (NE) requirements of patients in vasodilatory shock (mean NE dose in AT II group 7.4 ug/min vs 27.6 ug/min in placebo, P=.06). These promising results were followed by ATHOS-3, a phase 3, double-blind, multicenter randomized controlled trial of stable human synthetic AT II. This trial was conducted under a special protocol assessment agreement with the US Food and Drug Administration (FDA). A total of 344 patients with predefined criteria for vasodilatory shock were randomized to AT II or placebo as the intention-to-treat population. The primary end-point was a response in MAP by hour 3 of AT II initiation; response was defined as either a MAP rise to 75 mm Hg or an increase in MAP ≥ 10 mm Hg. The primary end-point was reached more frequently in the AT II group than in the placebo group (69.9% AT II vs 23.4% placebo, OR 7.95, 95% CI 4.76-13.3, P<.001). The AT II group had significantly lower cardiovascular sequential organ failure assessment (SOFA) scores at 48 hours and achieved a consistent decrease in background vasopressor doses. Post-hoc data analysis found that the highest benefit was in patients who were AT II deficient (high ratio of AT I:AT II) (Wunderink, et al. Intensive Care Med Exp. 2017;5(Suppl 2):44). The patients who were AT II depleted and received placebo had a higher hazard ratio of death (HR 1.77, 95% CI 1.10-2.85, P=.019), while those who were AT II depleted and received AT II had a decreased risk of mortality (HR 0.64, 95% CI 0.41-1.00, P=.047). The data suggest not only that AT II levels may be predictive of mortality in vasodilatory shock but also that exogenous AT II administration may favorably modulate mortality in this population. Further, a subset data analysis of severely ill patients (APACHE II scores > 30) showed that those who received AT II and standard vasopressors had a significantly lower 28-day mortality compared with patients who only received standard vasopressors (Szerlip, et al. Crit Care Med. 2018;46[1]:3). Considering that the endothelial cells in the lungs and kidneys are locations where AT I is hydrolyzed by angiotensin-converting enzyme (ACE) into AT II, patients receiving ACE-inhibitors and individuals with pulmonary or renal disease are at greatest risk for AT II deficiency. As such, the use of AT II in the extra-corporeal membrane oxygenation (ECMO), post cardiopulmonary bypass, acute respiratory distress syndrome (ARDS), and renal failure populations are of future interest.
Is there a downside?
Appropriate caution is necessary when interpreting these outcomes. One criticism that ATHOS-3 received was the use of a MAP goal of 75 mm Hg, a higher value than currently recommended by clinical guidelines, in the first 3 hours of AT II administration. Because this was a phase 3 trial, both the safety and efficacy of the drug were examined. These goals are difficult to accomplish if simultaneously manipulating other variables. Therefore, to isolate the effects of drug efficacy and safety, a higher MAP goal (75 mm Hg) was established to minimize any effect from varying background vasopressor doses during the first 3 hours of the study.
Furthermore, ATHOS-3 did find an increase in venous and arterial thromboembolic events in patients who received AT II (13% AT II vs 5% placebo). Previously, a systematic review of over 30,000 patients did not report this increased thromboembolic risk (Busse, et al. Crit Care. 2017;21[1]:324). According to the package insert, all patients receiving AT II should receive appropriate thromboembolic prophylaxis if medically indicated.
Where does AT II fit in our algorithm for resuscitation and the vasopressor toolbox?
Data from Wunderink et al indicate a potential mortality benefit in populations who are AT II depleted. However, we can only infer who these patients may be, as no commonly available assay can measure AT I and AT II levels. ATHOS and ATHOS-3 used AT II late during resuscitation, as did the Expanded Access Program (EAP) of the FDA, which gave physicians preliminary access to AT II while it was undergoing FDA review. Using similar inclusion criteria as ATHOS-3, the EAP did not permit patients to receive AT II until doses greater than or equal to 0.2 ug/kg/min of NE-equivalents were reached. In a recently published case report, AT II was successfully used in a patient with septic shock secondary to a colonic perforation (Chow, et al. Accepted for e-publication: A&A Practice. April 2018.). This individual was in vasodilatory shock despite standard resuscitation, 0.48 ug/kg/min of NE, and 0.04 units/min of vasopressin. Methylene blue and hydroxocobalamin had failed to relieve the vasoplegia, and only after the initiation of AT II at 40 ng/kg/min, the patient could be relieved of vasopressors and survived to be discharged from the hospital. In our opinion, best clinical practices would allow for an early multimodal vasopressor regimen that should include AT II at the earliest sign of rapid clinical decline (Jentzer, et al. Chest. 2018. Jan 9. pii: S0012-3692(18)30072-2. doi: 10.1016/j.chest.2017.12.021. [Epub ahead of print]).
Angiotensin II was recently approved by the FDA in December 2017 and is now available on the market for management of vasodilatory shock. This will undoubtedly have a profound impact on the way clinicians treat vasodilatory shock. Previously, we were confined to agents such methylene blue and hydroxocobalamin to rescue patients from profound vasoplegia. However, none of these agents are supported by robust evidence from randomized control trials.
Now, we can openly welcome a new challenger to the campaign, a new hue to the palette of vasopressor colors. This new class of vasopressor makes complete physiological sense and will provide an invaluable tool in our daily battle against sepsis and vasodilatory shock.
Dr. Chow is Assistant Professor, Division of Critical Care Medicine, Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD; Dr. Khana is Assistant Professor of Anesthesiology, Staff Intensivist, Vice-Chief for Research, Center for Critical Care, Department of Outcomes Research & General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH
Editor’s note
For decades, our options to treat patients with profound vasoplegia have been limited to high-dose catecholamines and vasopressin. Clinicians are often faced with the need to initiate multiple catecholamine agents knowing that these drugs stimulate similar receptors. The recent ATHOS-3 trial introduces AT II as a new option for the management of patients with refractory vasodilatory shock. This drug has a distinct mechanism of action that complements the effect of other vasopressors. Moreover, recent data suggest that this new agent is most beneficial in patients who are AT II deficient. Just like cancer therapies have evolved to precision medicine, will we perhaps face the need to better understand and promptly identify patients with AT II deficiency? For now, we have a new player on our vasopressor team.
Angel Coz, MD, FCCP
Section Editor
Hypotension is an often-underestimated adversary. Even brief periods of intraoperative mean arterial pressure (MAP) <65 mm Hg increase the odds of both myocardial ischemia and acute kidney injury in the postoperative period. The threshold may be even higher in the postoperative critically ill population (Khanna, et al. Crit Care Med. 2018;46(1):71). Hypotension that is refractory to high-dose vasopressors is associated with an all-cause mortality of 50% to 80%.
The vasopressor toolbox centers around escalating doses of catecholamines with or without the addition of vasopressin. High-dose catecholamines, albeit a frequent choice, is associated with adverse cardiac events (Schmittinger, et al. Intensive Care Med. 2012;38[6]:950) and is an independent predictor of ICU mortality (Sviri, et al. J Crit Care. 2014;29[1]:157).
The evidence behind angiotensin II
Angiotensin II (AT II) is a naturally occurring hormone in the renin-angiotensin-aldosterone (RAA) system that modulates blood pressure through direct arterial vasoconstriction and direct stimulation of the kidneys and adrenal cortex to release vasopressin and aldosterone, respectively.
Positive results from the recent phase 3 trial for AT II have offered hope that this agent would add the needed balance to the current scarcity of vasopressor options (Khanna, et al. N Engl J Med. 2017;377[5]:419). AT II would provide the missing piece in the jigsaw that would allow the intensivist to manage refractory hypotension, while keeping a multimodal vasopressor dosing regimen within therapeutic limits.
Irvine Page and coworkers are credited with most of the initial work on AT II, which they did nearly 70 years ago. Anecdotal use in humans has been reported since the early 1960s (Del Greco, et al. JAMA 1961;178:994). After a prolonged period of quiescence, the Angiotensin II in High-Output Shock (ATHOS) pilot study, which was done in 2014 as a single-center “proof of concept” study of 20 patients, reinvigorated clinical enthusiasm for this agent (Chawla, et al. Crit Care. 2014;18[5]:534). ATHOS demonstrated the effectiveness of AT II at decreasing norepinephrine (NE) requirements of patients in vasodilatory shock (mean NE dose in AT II group 7.4 ug/min vs 27.6 ug/min in placebo, P=.06). These promising results were followed by ATHOS-3, a phase 3, double-blind, multicenter randomized controlled trial of stable human synthetic AT II. This trial was conducted under a special protocol assessment agreement with the US Food and Drug Administration (FDA). A total of 344 patients with predefined criteria for vasodilatory shock were randomized to AT II or placebo as the intention-to-treat population. The primary end-point was a response in MAP by hour 3 of AT II initiation; response was defined as either a MAP rise to 75 mm Hg or an increase in MAP ≥ 10 mm Hg. The primary end-point was reached more frequently in the AT II group than in the placebo group (69.9% AT II vs 23.4% placebo, OR 7.95, 95% CI 4.76-13.3, P<.001). The AT II group had significantly lower cardiovascular sequential organ failure assessment (SOFA) scores at 48 hours and achieved a consistent decrease in background vasopressor doses. Post-hoc data analysis found that the highest benefit was in patients who were AT II deficient (high ratio of AT I:AT II) (Wunderink, et al. Intensive Care Med Exp. 2017;5(Suppl 2):44). The patients who were AT II depleted and received placebo had a higher hazard ratio of death (HR 1.77, 95% CI 1.10-2.85, P=.019), while those who were AT II depleted and received AT II had a decreased risk of mortality (HR 0.64, 95% CI 0.41-1.00, P=.047). The data suggest not only that AT II levels may be predictive of mortality in vasodilatory shock but also that exogenous AT II administration may favorably modulate mortality in this population. Further, a subset data analysis of severely ill patients (APACHE II scores > 30) showed that those who received AT II and standard vasopressors had a significantly lower 28-day mortality compared with patients who only received standard vasopressors (Szerlip, et al. Crit Care Med. 2018;46[1]:3). Considering that the endothelial cells in the lungs and kidneys are locations where AT I is hydrolyzed by angiotensin-converting enzyme (ACE) into AT II, patients receiving ACE-inhibitors and individuals with pulmonary or renal disease are at greatest risk for AT II deficiency. As such, the use of AT II in the extra-corporeal membrane oxygenation (ECMO), post cardiopulmonary bypass, acute respiratory distress syndrome (ARDS), and renal failure populations are of future interest.
Is there a downside?
Appropriate caution is necessary when interpreting these outcomes. One criticism that ATHOS-3 received was the use of a MAP goal of 75 mm Hg, a higher value than currently recommended by clinical guidelines, in the first 3 hours of AT II administration. Because this was a phase 3 trial, both the safety and efficacy of the drug were examined. These goals are difficult to accomplish if simultaneously manipulating other variables. Therefore, to isolate the effects of drug efficacy and safety, a higher MAP goal (75 mm Hg) was established to minimize any effect from varying background vasopressor doses during the first 3 hours of the study.
Furthermore, ATHOS-3 did find an increase in venous and arterial thromboembolic events in patients who received AT II (13% AT II vs 5% placebo). Previously, a systematic review of over 30,000 patients did not report this increased thromboembolic risk (Busse, et al. Crit Care. 2017;21[1]:324). According to the package insert, all patients receiving AT II should receive appropriate thromboembolic prophylaxis if medically indicated.
Where does AT II fit in our algorithm for resuscitation and the vasopressor toolbox?
Data from Wunderink et al indicate a potential mortality benefit in populations who are AT II depleted. However, we can only infer who these patients may be, as no commonly available assay can measure AT I and AT II levels. ATHOS and ATHOS-3 used AT II late during resuscitation, as did the Expanded Access Program (EAP) of the FDA, which gave physicians preliminary access to AT II while it was undergoing FDA review. Using similar inclusion criteria as ATHOS-3, the EAP did not permit patients to receive AT II until doses greater than or equal to 0.2 ug/kg/min of NE-equivalents were reached. In a recently published case report, AT II was successfully used in a patient with septic shock secondary to a colonic perforation (Chow, et al. Accepted for e-publication: A&A Practice. April 2018.). This individual was in vasodilatory shock despite standard resuscitation, 0.48 ug/kg/min of NE, and 0.04 units/min of vasopressin. Methylene blue and hydroxocobalamin had failed to relieve the vasoplegia, and only after the initiation of AT II at 40 ng/kg/min, the patient could be relieved of vasopressors and survived to be discharged from the hospital. In our opinion, best clinical practices would allow for an early multimodal vasopressor regimen that should include AT II at the earliest sign of rapid clinical decline (Jentzer, et al. Chest. 2018. Jan 9. pii: S0012-3692(18)30072-2. doi: 10.1016/j.chest.2017.12.021. [Epub ahead of print]).
Angiotensin II was recently approved by the FDA in December 2017 and is now available on the market for management of vasodilatory shock. This will undoubtedly have a profound impact on the way clinicians treat vasodilatory shock. Previously, we were confined to agents such methylene blue and hydroxocobalamin to rescue patients from profound vasoplegia. However, none of these agents are supported by robust evidence from randomized control trials.
Now, we can openly welcome a new challenger to the campaign, a new hue to the palette of vasopressor colors. This new class of vasopressor makes complete physiological sense and will provide an invaluable tool in our daily battle against sepsis and vasodilatory shock.
Dr. Chow is Assistant Professor, Division of Critical Care Medicine, Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD; Dr. Khana is Assistant Professor of Anesthesiology, Staff Intensivist, Vice-Chief for Research, Center for Critical Care, Department of Outcomes Research & General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH
Editor’s note
For decades, our options to treat patients with profound vasoplegia have been limited to high-dose catecholamines and vasopressin. Clinicians are often faced with the need to initiate multiple catecholamine agents knowing that these drugs stimulate similar receptors. The recent ATHOS-3 trial introduces AT II as a new option for the management of patients with refractory vasodilatory shock. This drug has a distinct mechanism of action that complements the effect of other vasopressors. Moreover, recent data suggest that this new agent is most beneficial in patients who are AT II deficient. Just like cancer therapies have evolved to precision medicine, will we perhaps face the need to better understand and promptly identify patients with AT II deficiency? For now, we have a new player on our vasopressor team.
Angel Coz, MD, FCCP
Section Editor
Bringing respiratory care to asthma clinics in Guyana
How it all started
The study abroad project was truly a goal and vision that came about after returning to Guyana after approximately 46 years. I was born in Guyana but left as a child and returned later and joined a mission group. In 2015, I began a personal journey of missionary service with the team of Bridge Global Medical Missions (BGMM) in Georgetown, Guyana. I was the first respiratory therapist to join the team.
I remember during the first few days in the hospitals I was told that there was “a lot of wheezing” in the EDs. Treating patients consisted of just administrating short-acting nebulizer treatments, but I remember being very impressed with the ICU at the main public hospital, Georgetown Public Hospital Corporation (GPHC), because they had the ventilators I could use. However, physicians only managed the patients while the nurses were left to monitor the ventilators and equipment, which they did not understand.
At the Linden Hospital in Guyana, the ED was constantly full of the “wheezers,” and the ICU only had ventilators that were basically nonfunctioning due to language barriers or a lack of biomed professionals. One of my fondest memories was fixing two ventilators from China. I could get the ventilators to work and explain the basic modes because in my mind, it was just a ventilator, and they could see the modes. The problem was the language was all in Chinese! So, we all got together: a Cuban doctor, a Cuban biomed, and a nurse with a translation program and, finally, changed the language to English. It was an interesting day!
When we were on our study abroad trip this past January, I was able to place an intubated patient on that same ventilator. After my first visit to Linden Hospital, I addressed a few of my observations with the medical director, and I will never forget his comment. He said, “I thought respiratory would just come do some nebulizer treatments and show us oxygen.”
Study abroad and respiratory care
Then the vision of my project began, because I needed to show him the scope of the practice of a respiratory therapist. I asked Dr. Heyliger-Thomas of BGMM if she could assist me in promoting a study abroad program in Guyana with the Ministry of Health. It was very important for me to bring my students to Guyana for many reasons, the most important being the profession was needed there, and our students would be excellent representatives.
In 2015, the study “Introduction of spirometry into clinical practice in Georgetown, Guyana: quality and diagnostic outcomes” highlighted increased physician referral to the country’s only COPD/asthma clinic. I wanted to promote the importance of study abroad and international mission work, especially when promoting the care of asthma and the pulmonary patient, which I believe we did. The main project during study abroad was to test the school-aged children in Linden, thereby showing that there was undiagnosed asthma.
The 2 days that we were in Linden brought the largest sign-up for their clinic. When we did our screening at Mackenzie High School, we were able to utilize the portable spirometers and printer purchased by the CHEST Foundation community service grant. We are still collecting data, but the one thing that was revealed was the difficulty in obtaining medication for the treatment of asthma and COPD in some areas.
This project was also a learning experience for our students in many ways: in how they performed their interviews, how the culture affected the way their patients answered their questionnaires, and even how they performed on the tests. The value to the student and the individual of working within a different culture, far away from the norms of North America, allows them to appreciate their patients, the work they do, and their interprofessional team in a whole new light.
I want this experience to have an impact on each student’s life. You are a teacher, an instructor, a mentor, professor, and much more when traveling with 10 students. The most satisfying moment is the transformation you see in them. They are no longer timid and unsure of themselves; they have greater confidence in their abilities and a deeper understanding of the needs of a patient. They finally understand the importance of culture as it pertains to health care.
The effect of the CHEST Foundation grant
Applying for the CHEST Foundation community service grant was the largest grant I had ever attempted. Having a support system behind you is the most important piece of advice I can give to future grant applicants. I could not have completed my grant without our grant team at Texas State University. They truly had my back; and close to the deadline when it seemed insurmountable, they helped push me through it. The other piece of advice is to have a true vision and stick to that vision. The most difficult part of my project was the budget, prioritizing the things or people that I needed. Honestly, I needed help here, because for me, I needed everything. I had to make choices and leave some things out. I focused on what the actual need was for the many.
My ultimate goal for Guyana is to promote and show the need for respiratory care professionals to have that education offered at the University of Guyana as part of its allied health program and assist those in the application to the International Fellowship Program of the American Association of Respiratory Care—there has never been a fellow from Guyana. I believe that Guyana will have the resources, and with assistance, could achieve the goal. My vision and goal started in 2016, and I want to achieve it in the next 10 years.
I would like to thank all the CHEST Foundation donors from the bottom of my heart. This project was real and, as a CHEST member myself, it encourages me to be a better donor. Thank you—for it was and is much appreciated. Finally, I would like to express my thanks to my Co-Assistant Program Director, Holly Wise (Mass Communications) and Amber Hazelett, RRT (RC assistant), and the BGMM team for their entire support throughout the study abroad journey.
(This article was previous published in CHEST Thought Leaders.)
This grant is supported in full by the CHEST Foundation. Donors like you make grants like this possible. Thank you for your generosity and passion for community service and moving the needle forward on improving patient outcomes. To support community service initiatives, and the next generation of lung health champions, please go to foundation.chestnet.org/donate
How it all started
The study abroad project was truly a goal and vision that came about after returning to Guyana after approximately 46 years. I was born in Guyana but left as a child and returned later and joined a mission group. In 2015, I began a personal journey of missionary service with the team of Bridge Global Medical Missions (BGMM) in Georgetown, Guyana. I was the first respiratory therapist to join the team.
I remember during the first few days in the hospitals I was told that there was “a lot of wheezing” in the EDs. Treating patients consisted of just administrating short-acting nebulizer treatments, but I remember being very impressed with the ICU at the main public hospital, Georgetown Public Hospital Corporation (GPHC), because they had the ventilators I could use. However, physicians only managed the patients while the nurses were left to monitor the ventilators and equipment, which they did not understand.
At the Linden Hospital in Guyana, the ED was constantly full of the “wheezers,” and the ICU only had ventilators that were basically nonfunctioning due to language barriers or a lack of biomed professionals. One of my fondest memories was fixing two ventilators from China. I could get the ventilators to work and explain the basic modes because in my mind, it was just a ventilator, and they could see the modes. The problem was the language was all in Chinese! So, we all got together: a Cuban doctor, a Cuban biomed, and a nurse with a translation program and, finally, changed the language to English. It was an interesting day!
When we were on our study abroad trip this past January, I was able to place an intubated patient on that same ventilator. After my first visit to Linden Hospital, I addressed a few of my observations with the medical director, and I will never forget his comment. He said, “I thought respiratory would just come do some nebulizer treatments and show us oxygen.”
Study abroad and respiratory care
Then the vision of my project began, because I needed to show him the scope of the practice of a respiratory therapist. I asked Dr. Heyliger-Thomas of BGMM if she could assist me in promoting a study abroad program in Guyana with the Ministry of Health. It was very important for me to bring my students to Guyana for many reasons, the most important being the profession was needed there, and our students would be excellent representatives.
In 2015, the study “Introduction of spirometry into clinical practice in Georgetown, Guyana: quality and diagnostic outcomes” highlighted increased physician referral to the country’s only COPD/asthma clinic. I wanted to promote the importance of study abroad and international mission work, especially when promoting the care of asthma and the pulmonary patient, which I believe we did. The main project during study abroad was to test the school-aged children in Linden, thereby showing that there was undiagnosed asthma.
The 2 days that we were in Linden brought the largest sign-up for their clinic. When we did our screening at Mackenzie High School, we were able to utilize the portable spirometers and printer purchased by the CHEST Foundation community service grant. We are still collecting data, but the one thing that was revealed was the difficulty in obtaining medication for the treatment of asthma and COPD in some areas.
This project was also a learning experience for our students in many ways: in how they performed their interviews, how the culture affected the way their patients answered their questionnaires, and even how they performed on the tests. The value to the student and the individual of working within a different culture, far away from the norms of North America, allows them to appreciate their patients, the work they do, and their interprofessional team in a whole new light.
I want this experience to have an impact on each student’s life. You are a teacher, an instructor, a mentor, professor, and much more when traveling with 10 students. The most satisfying moment is the transformation you see in them. They are no longer timid and unsure of themselves; they have greater confidence in their abilities and a deeper understanding of the needs of a patient. They finally understand the importance of culture as it pertains to health care.
The effect of the CHEST Foundation grant
Applying for the CHEST Foundation community service grant was the largest grant I had ever attempted. Having a support system behind you is the most important piece of advice I can give to future grant applicants. I could not have completed my grant without our grant team at Texas State University. They truly had my back; and close to the deadline when it seemed insurmountable, they helped push me through it. The other piece of advice is to have a true vision and stick to that vision. The most difficult part of my project was the budget, prioritizing the things or people that I needed. Honestly, I needed help here, because for me, I needed everything. I had to make choices and leave some things out. I focused on what the actual need was for the many.
My ultimate goal for Guyana is to promote and show the need for respiratory care professionals to have that education offered at the University of Guyana as part of its allied health program and assist those in the application to the International Fellowship Program of the American Association of Respiratory Care—there has never been a fellow from Guyana. I believe that Guyana will have the resources, and with assistance, could achieve the goal. My vision and goal started in 2016, and I want to achieve it in the next 10 years.
I would like to thank all the CHEST Foundation donors from the bottom of my heart. This project was real and, as a CHEST member myself, it encourages me to be a better donor. Thank you—for it was and is much appreciated. Finally, I would like to express my thanks to my Co-Assistant Program Director, Holly Wise (Mass Communications) and Amber Hazelett, RRT (RC assistant), and the BGMM team for their entire support throughout the study abroad journey.
(This article was previous published in CHEST Thought Leaders.)
This grant is supported in full by the CHEST Foundation. Donors like you make grants like this possible. Thank you for your generosity and passion for community service and moving the needle forward on improving patient outcomes. To support community service initiatives, and the next generation of lung health champions, please go to foundation.chestnet.org/donate
How it all started
The study abroad project was truly a goal and vision that came about after returning to Guyana after approximately 46 years. I was born in Guyana but left as a child and returned later and joined a mission group. In 2015, I began a personal journey of missionary service with the team of Bridge Global Medical Missions (BGMM) in Georgetown, Guyana. I was the first respiratory therapist to join the team.
I remember during the first few days in the hospitals I was told that there was “a lot of wheezing” in the EDs. Treating patients consisted of just administrating short-acting nebulizer treatments, but I remember being very impressed with the ICU at the main public hospital, Georgetown Public Hospital Corporation (GPHC), because they had the ventilators I could use. However, physicians only managed the patients while the nurses were left to monitor the ventilators and equipment, which they did not understand.
At the Linden Hospital in Guyana, the ED was constantly full of the “wheezers,” and the ICU only had ventilators that were basically nonfunctioning due to language barriers or a lack of biomed professionals. One of my fondest memories was fixing two ventilators from China. I could get the ventilators to work and explain the basic modes because in my mind, it was just a ventilator, and they could see the modes. The problem was the language was all in Chinese! So, we all got together: a Cuban doctor, a Cuban biomed, and a nurse with a translation program and, finally, changed the language to English. It was an interesting day!
When we were on our study abroad trip this past January, I was able to place an intubated patient on that same ventilator. After my first visit to Linden Hospital, I addressed a few of my observations with the medical director, and I will never forget his comment. He said, “I thought respiratory would just come do some nebulizer treatments and show us oxygen.”
Study abroad and respiratory care
Then the vision of my project began, because I needed to show him the scope of the practice of a respiratory therapist. I asked Dr. Heyliger-Thomas of BGMM if she could assist me in promoting a study abroad program in Guyana with the Ministry of Health. It was very important for me to bring my students to Guyana for many reasons, the most important being the profession was needed there, and our students would be excellent representatives.
In 2015, the study “Introduction of spirometry into clinical practice in Georgetown, Guyana: quality and diagnostic outcomes” highlighted increased physician referral to the country’s only COPD/asthma clinic. I wanted to promote the importance of study abroad and international mission work, especially when promoting the care of asthma and the pulmonary patient, which I believe we did. The main project during study abroad was to test the school-aged children in Linden, thereby showing that there was undiagnosed asthma.
The 2 days that we were in Linden brought the largest sign-up for their clinic. When we did our screening at Mackenzie High School, we were able to utilize the portable spirometers and printer purchased by the CHEST Foundation community service grant. We are still collecting data, but the one thing that was revealed was the difficulty in obtaining medication for the treatment of asthma and COPD in some areas.
This project was also a learning experience for our students in many ways: in how they performed their interviews, how the culture affected the way their patients answered their questionnaires, and even how they performed on the tests. The value to the student and the individual of working within a different culture, far away from the norms of North America, allows them to appreciate their patients, the work they do, and their interprofessional team in a whole new light.
I want this experience to have an impact on each student’s life. You are a teacher, an instructor, a mentor, professor, and much more when traveling with 10 students. The most satisfying moment is the transformation you see in them. They are no longer timid and unsure of themselves; they have greater confidence in their abilities and a deeper understanding of the needs of a patient. They finally understand the importance of culture as it pertains to health care.
The effect of the CHEST Foundation grant
Applying for the CHEST Foundation community service grant was the largest grant I had ever attempted. Having a support system behind you is the most important piece of advice I can give to future grant applicants. I could not have completed my grant without our grant team at Texas State University. They truly had my back; and close to the deadline when it seemed insurmountable, they helped push me through it. The other piece of advice is to have a true vision and stick to that vision. The most difficult part of my project was the budget, prioritizing the things or people that I needed. Honestly, I needed help here, because for me, I needed everything. I had to make choices and leave some things out. I focused on what the actual need was for the many.
My ultimate goal for Guyana is to promote and show the need for respiratory care professionals to have that education offered at the University of Guyana as part of its allied health program and assist those in the application to the International Fellowship Program of the American Association of Respiratory Care—there has never been a fellow from Guyana. I believe that Guyana will have the resources, and with assistance, could achieve the goal. My vision and goal started in 2016, and I want to achieve it in the next 10 years.
I would like to thank all the CHEST Foundation donors from the bottom of my heart. This project was real and, as a CHEST member myself, it encourages me to be a better donor. Thank you—for it was and is much appreciated. Finally, I would like to express my thanks to my Co-Assistant Program Director, Holly Wise (Mass Communications) and Amber Hazelett, RRT (RC assistant), and the BGMM team for their entire support throughout the study abroad journey.
(This article was previous published in CHEST Thought Leaders.)
This grant is supported in full by the CHEST Foundation. Donors like you make grants like this possible. Thank you for your generosity and passion for community service and moving the needle forward on improving patient outcomes. To support community service initiatives, and the next generation of lung health champions, please go to foundation.chestnet.org/donate
FDA to host meeting about sleep apnea devices
You are invited to attend this open meeting on April 16, held at the FDA White Oak Campus in Silver Spring, Md. (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596147.htm). The FDA is soliciting ideas or opinions about criteria or processes for FDA review of medical devices to diagnose or treat sleep apnea. CHEST is represented by Dr. Neil Freedman ([email protected]) and Dr. Barbara Phillips ([email protected]) who also welcome your input by email prior to the meeting. Home testing, “apps,” and the criteria to diagnose sleep apnea and/or its resolution are among the topics to be discussed.
You are invited to attend this open meeting on April 16, held at the FDA White Oak Campus in Silver Spring, Md. (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596147.htm). The FDA is soliciting ideas or opinions about criteria or processes for FDA review of medical devices to diagnose or treat sleep apnea. CHEST is represented by Dr. Neil Freedman ([email protected]) and Dr. Barbara Phillips ([email protected]) who also welcome your input by email prior to the meeting. Home testing, “apps,” and the criteria to diagnose sleep apnea and/or its resolution are among the topics to be discussed.
You are invited to attend this open meeting on April 16, held at the FDA White Oak Campus in Silver Spring, Md. (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596147.htm). The FDA is soliciting ideas or opinions about criteria or processes for FDA review of medical devices to diagnose or treat sleep apnea. CHEST is represented by Dr. Neil Freedman ([email protected]) and Dr. Barbara Phillips ([email protected]) who also welcome your input by email prior to the meeting. Home testing, “apps,” and the criteria to diagnose sleep apnea and/or its resolution are among the topics to be discussed.