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Children and COVID-19: 7 million cases and still counting
Total COVID-19 cases in children surpassed the 7-million mark as new cases rose slightly after the previous week’s decline, according to the American Academy of Pediatrics and the Children’s Hospital Association.
, the AAP and CHA said in their weekly COVID-19 report. New cases had dropped the previous week after 3 straight weeks of increases since late October.
The Centers for Disease Control and Prevention puts the total number of child COVID-19 cases at 6.2 million, but both estimates are based on all-age totals – 40 million for the CDC and 41 million for the AAP/CHA – that are well short of the CDC’s latest cumulative figure, which is now just over 49 million, so the actual figures are undoubtedly higher.
Meanwhile, the 1-month anniversary of 5- to 11-year-olds’ vaccine eligibility brought many completions: 923,000 received their second dose during the week ending Dec. 6, compared with 405,000 the previous week. About 16.9% (4.9 million) of children aged 5-11 have gotten at least one dose of the COVID-19 vaccine thus far, of whom almost 1.5 million children (5.1% of the age group) are now fully vaccinated, the CDC said on its COVID-19 Data Tracker.
The pace of vaccinations, however, is much lower for older children. Weekly numbers for all COVID-19 vaccinations, both first and second doses, dropped from 84,000 (Nov. 23-29) to 70,000 (Nov. 30 to Dec. 6), for those aged 12-17 years. In that group, 61.6% have received at least one dose and 51.8% are fully vaccinated, the CDC said.
The pace of vaccinations varies for younger children as well, when geography is considered. The AAP analyzed the CDC’s data and found that 42% of all 5- to 11-year-olds in Vermont had received at least one dose as of Dec. 1, followed by Massachusetts (33%), Maine (30%), and Rhode Island (28%). At the other end of the vaccination scale are Alabama, Louisiana, Mississippi, and West Virginia, all with 4%, the AAP reported.
As the United States puts 7 million children infected with COVID-19 in its rear view mirror, another milestone is looming ahead: The CDC’s current count of deaths in children is 974.
Total COVID-19 cases in children surpassed the 7-million mark as new cases rose slightly after the previous week’s decline, according to the American Academy of Pediatrics and the Children’s Hospital Association.
, the AAP and CHA said in their weekly COVID-19 report. New cases had dropped the previous week after 3 straight weeks of increases since late October.
The Centers for Disease Control and Prevention puts the total number of child COVID-19 cases at 6.2 million, but both estimates are based on all-age totals – 40 million for the CDC and 41 million for the AAP/CHA – that are well short of the CDC’s latest cumulative figure, which is now just over 49 million, so the actual figures are undoubtedly higher.
Meanwhile, the 1-month anniversary of 5- to 11-year-olds’ vaccine eligibility brought many completions: 923,000 received their second dose during the week ending Dec. 6, compared with 405,000 the previous week. About 16.9% (4.9 million) of children aged 5-11 have gotten at least one dose of the COVID-19 vaccine thus far, of whom almost 1.5 million children (5.1% of the age group) are now fully vaccinated, the CDC said on its COVID-19 Data Tracker.
The pace of vaccinations, however, is much lower for older children. Weekly numbers for all COVID-19 vaccinations, both first and second doses, dropped from 84,000 (Nov. 23-29) to 70,000 (Nov. 30 to Dec. 6), for those aged 12-17 years. In that group, 61.6% have received at least one dose and 51.8% are fully vaccinated, the CDC said.
The pace of vaccinations varies for younger children as well, when geography is considered. The AAP analyzed the CDC’s data and found that 42% of all 5- to 11-year-olds in Vermont had received at least one dose as of Dec. 1, followed by Massachusetts (33%), Maine (30%), and Rhode Island (28%). At the other end of the vaccination scale are Alabama, Louisiana, Mississippi, and West Virginia, all with 4%, the AAP reported.
As the United States puts 7 million children infected with COVID-19 in its rear view mirror, another milestone is looming ahead: The CDC’s current count of deaths in children is 974.
Total COVID-19 cases in children surpassed the 7-million mark as new cases rose slightly after the previous week’s decline, according to the American Academy of Pediatrics and the Children’s Hospital Association.
, the AAP and CHA said in their weekly COVID-19 report. New cases had dropped the previous week after 3 straight weeks of increases since late October.
The Centers for Disease Control and Prevention puts the total number of child COVID-19 cases at 6.2 million, but both estimates are based on all-age totals – 40 million for the CDC and 41 million for the AAP/CHA – that are well short of the CDC’s latest cumulative figure, which is now just over 49 million, so the actual figures are undoubtedly higher.
Meanwhile, the 1-month anniversary of 5- to 11-year-olds’ vaccine eligibility brought many completions: 923,000 received their second dose during the week ending Dec. 6, compared with 405,000 the previous week. About 16.9% (4.9 million) of children aged 5-11 have gotten at least one dose of the COVID-19 vaccine thus far, of whom almost 1.5 million children (5.1% of the age group) are now fully vaccinated, the CDC said on its COVID-19 Data Tracker.
The pace of vaccinations, however, is much lower for older children. Weekly numbers for all COVID-19 vaccinations, both first and second doses, dropped from 84,000 (Nov. 23-29) to 70,000 (Nov. 30 to Dec. 6), for those aged 12-17 years. In that group, 61.6% have received at least one dose and 51.8% are fully vaccinated, the CDC said.
The pace of vaccinations varies for younger children as well, when geography is considered. The AAP analyzed the CDC’s data and found that 42% of all 5- to 11-year-olds in Vermont had received at least one dose as of Dec. 1, followed by Massachusetts (33%), Maine (30%), and Rhode Island (28%). At the other end of the vaccination scale are Alabama, Louisiana, Mississippi, and West Virginia, all with 4%, the AAP reported.
As the United States puts 7 million children infected with COVID-19 in its rear view mirror, another milestone is looming ahead: The CDC’s current count of deaths in children is 974.
Specialists think it’s up to the PCP to recommend flu vaccines. But many patients don’t see a PCP every year
A new survey from the National Foundation for Infectious Diseases shows that, despite the recommendation that patients who have chronic illnesses receive annual flu vaccines, only 45% of these patients do get them. People with chronic diseases are at increased risk for serious flu-related complications, including hospitalization and death.
The survey looked at physicians’ practices toward flu vaccination and communication between health care providers (HCP) and their adult patients with chronic health conditions.
Overall, less than a third of HCPs (31%) said they recommend annual flu vaccination to all of their patients with chronic health conditions. There were some surprising differences between subspecialists. For example, 72% of patients with a heart problem who saw a cardiologist said that physician recommended the flu vaccine. The recommendation rate dropped to 32% of lung patients seeing a pulmonary physician and only 10% of people with diabetes who saw an endocrinologist.
There is quite a large gap between what physicians and patients say about their interactions. Fully 77% of HCPs who recommend annual flu vaccination say they tell patients when they are at higher risk of complications from influenza. Yet only 48% of patients say they have been given such information.
Although it is critically important information for patients to learn, their risk of influenza is often missing from the discussion. For example, patients with heart disease are six times more likely to have a heart attack within 7 days of flu infection. People with diabetes are six times more likely to be hospitalized from flu and three times more likely to die. Similarly, those with asthma or chronic obstructive pulmonary disorder are at a much higher risk of complications.
One problem is that Yet only 65% of patients with one of these chronic illnesses report seeing their primary care physician at least annually.
Much of the disparity between the patient’s perception of what they were told and the physician’s is “how the ‘recommendation’ is actually made,” William Schaffner, MD, NFID’s medical director and professor of medicine at Vanderbilt University, Nashville, Tenn., told this news organization. Dr. Schaffner offered the following example: At the end of the visit, the doctor might say: “It’s that time of the year again – you want to think about getting your flu shot.”
“The doctor thinks they’ve recommended that, but the doctor really has opened the door for you to think about it and leave [yourself] unvaccinated.”
Dr. Schaffner’s alternative? Tell the patient: “‘You’ll get your flu vaccine on the way out. Tom or Sally will give it to you.’ That’s a very different kind of recommendation. And it’s a much greater assurance of providing the vaccine.”
Another major problem, Dr. Schaffner said, is that many specialists “don’t think of vaccination as something that’s included with their routine care” even though they do direct much of the patient’s care. He said that physicians should be more “directive” in their care and that immunizations should be better integrated into routine practice.
Jody Lanard, MD, a retired risk communication consultant who spent many years working with the World Health Organization on disease outbreak communications, said in an interview that this disconnect between physician and patient reports “was really jarring. And it’s actionable!”
She offered several practical suggestions. For one, she said, “the messaging to the specialists has to be very, very empathic. We know you’re already overburdened. And here we’re asking you to do something that you think of as somebody else’s job.” But if your patient gets flu, then your job as the cardiologist or endocrinologist will become more complicated and time-consuming. So getting the patients vaccinated will be a good investment and will make your job easier.
Because of the disparity in patient and physician reports, Dr. Lanard suggested implementing a “feedback mechanism where they [the health care providers] give out the prescription, and then the office calls [the patient] to see if they’ve gotten the shot or not. Because that way it will help correct the mismatch between them thinking that they told the patient and the patient not hearing it.”
Asked about why there might be a big gap between what physicians report they said and what patients heard, Dr. Lanard explained that “physicians often communicate in [a manner] sort of like a checklist. And the patients are focused on one or two things that are high in their minds. And the physician was mentioning some things that are on a separate topic that are not on a patient’s list and it goes right past them.”
Dr. Lanard recommended brief storytelling instead of checklists. For example: “I’ve been treating your diabetes for 10 years. During this last flu season, several of my diabetic patients had a really hard time when they caught the flu. So now I’m trying harder to remember to remind you to get your flu shots.”
She urged HCPs to “make it more personal ... but it can still be scripted in advance as part of something that [you’re] remembering to do during the check.” She added that their professional associations may be able to send them suggested language they can adapt.
Finally, Dr. Lanard cautioned about vaccine myths. “The word myth is so insulting. It’s basically a word that sends the signal that you’re an idiot.”
She advised specialists to avoid the word “myth,” which will make the person defensive. Instead, say something like, “A lot of people, even some of my own family members, think the flu vaccine gives you the flu. ... But it doesn’t. And then you go into the reality.”
Dr. Lanard suggested that specialists implement the follow-up calls and close the feedback loop, saying: “If they did the survey a few years later, I bet that gap would narrow.”
Dr. Schaffner and Dr. Lanard disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new survey from the National Foundation for Infectious Diseases shows that, despite the recommendation that patients who have chronic illnesses receive annual flu vaccines, only 45% of these patients do get them. People with chronic diseases are at increased risk for serious flu-related complications, including hospitalization and death.
The survey looked at physicians’ practices toward flu vaccination and communication between health care providers (HCP) and their adult patients with chronic health conditions.
Overall, less than a third of HCPs (31%) said they recommend annual flu vaccination to all of their patients with chronic health conditions. There were some surprising differences between subspecialists. For example, 72% of patients with a heart problem who saw a cardiologist said that physician recommended the flu vaccine. The recommendation rate dropped to 32% of lung patients seeing a pulmonary physician and only 10% of people with diabetes who saw an endocrinologist.
There is quite a large gap between what physicians and patients say about their interactions. Fully 77% of HCPs who recommend annual flu vaccination say they tell patients when they are at higher risk of complications from influenza. Yet only 48% of patients say they have been given such information.
Although it is critically important information for patients to learn, their risk of influenza is often missing from the discussion. For example, patients with heart disease are six times more likely to have a heart attack within 7 days of flu infection. People with diabetes are six times more likely to be hospitalized from flu and three times more likely to die. Similarly, those with asthma or chronic obstructive pulmonary disorder are at a much higher risk of complications.
One problem is that Yet only 65% of patients with one of these chronic illnesses report seeing their primary care physician at least annually.
Much of the disparity between the patient’s perception of what they were told and the physician’s is “how the ‘recommendation’ is actually made,” William Schaffner, MD, NFID’s medical director and professor of medicine at Vanderbilt University, Nashville, Tenn., told this news organization. Dr. Schaffner offered the following example: At the end of the visit, the doctor might say: “It’s that time of the year again – you want to think about getting your flu shot.”
“The doctor thinks they’ve recommended that, but the doctor really has opened the door for you to think about it and leave [yourself] unvaccinated.”
Dr. Schaffner’s alternative? Tell the patient: “‘You’ll get your flu vaccine on the way out. Tom or Sally will give it to you.’ That’s a very different kind of recommendation. And it’s a much greater assurance of providing the vaccine.”
Another major problem, Dr. Schaffner said, is that many specialists “don’t think of vaccination as something that’s included with their routine care” even though they do direct much of the patient’s care. He said that physicians should be more “directive” in their care and that immunizations should be better integrated into routine practice.
Jody Lanard, MD, a retired risk communication consultant who spent many years working with the World Health Organization on disease outbreak communications, said in an interview that this disconnect between physician and patient reports “was really jarring. And it’s actionable!”
She offered several practical suggestions. For one, she said, “the messaging to the specialists has to be very, very empathic. We know you’re already overburdened. And here we’re asking you to do something that you think of as somebody else’s job.” But if your patient gets flu, then your job as the cardiologist or endocrinologist will become more complicated and time-consuming. So getting the patients vaccinated will be a good investment and will make your job easier.
Because of the disparity in patient and physician reports, Dr. Lanard suggested implementing a “feedback mechanism where they [the health care providers] give out the prescription, and then the office calls [the patient] to see if they’ve gotten the shot or not. Because that way it will help correct the mismatch between them thinking that they told the patient and the patient not hearing it.”
Asked about why there might be a big gap between what physicians report they said and what patients heard, Dr. Lanard explained that “physicians often communicate in [a manner] sort of like a checklist. And the patients are focused on one or two things that are high in their minds. And the physician was mentioning some things that are on a separate topic that are not on a patient’s list and it goes right past them.”
Dr. Lanard recommended brief storytelling instead of checklists. For example: “I’ve been treating your diabetes for 10 years. During this last flu season, several of my diabetic patients had a really hard time when they caught the flu. So now I’m trying harder to remember to remind you to get your flu shots.”
She urged HCPs to “make it more personal ... but it can still be scripted in advance as part of something that [you’re] remembering to do during the check.” She added that their professional associations may be able to send them suggested language they can adapt.
Finally, Dr. Lanard cautioned about vaccine myths. “The word myth is so insulting. It’s basically a word that sends the signal that you’re an idiot.”
She advised specialists to avoid the word “myth,” which will make the person defensive. Instead, say something like, “A lot of people, even some of my own family members, think the flu vaccine gives you the flu. ... But it doesn’t. And then you go into the reality.”
Dr. Lanard suggested that specialists implement the follow-up calls and close the feedback loop, saying: “If they did the survey a few years later, I bet that gap would narrow.”
Dr. Schaffner and Dr. Lanard disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new survey from the National Foundation for Infectious Diseases shows that, despite the recommendation that patients who have chronic illnesses receive annual flu vaccines, only 45% of these patients do get them. People with chronic diseases are at increased risk for serious flu-related complications, including hospitalization and death.
The survey looked at physicians’ practices toward flu vaccination and communication between health care providers (HCP) and their adult patients with chronic health conditions.
Overall, less than a third of HCPs (31%) said they recommend annual flu vaccination to all of their patients with chronic health conditions. There were some surprising differences between subspecialists. For example, 72% of patients with a heart problem who saw a cardiologist said that physician recommended the flu vaccine. The recommendation rate dropped to 32% of lung patients seeing a pulmonary physician and only 10% of people with diabetes who saw an endocrinologist.
There is quite a large gap between what physicians and patients say about their interactions. Fully 77% of HCPs who recommend annual flu vaccination say they tell patients when they are at higher risk of complications from influenza. Yet only 48% of patients say they have been given such information.
Although it is critically important information for patients to learn, their risk of influenza is often missing from the discussion. For example, patients with heart disease are six times more likely to have a heart attack within 7 days of flu infection. People with diabetes are six times more likely to be hospitalized from flu and three times more likely to die. Similarly, those with asthma or chronic obstructive pulmonary disorder are at a much higher risk of complications.
One problem is that Yet only 65% of patients with one of these chronic illnesses report seeing their primary care physician at least annually.
Much of the disparity between the patient’s perception of what they were told and the physician’s is “how the ‘recommendation’ is actually made,” William Schaffner, MD, NFID’s medical director and professor of medicine at Vanderbilt University, Nashville, Tenn., told this news organization. Dr. Schaffner offered the following example: At the end of the visit, the doctor might say: “It’s that time of the year again – you want to think about getting your flu shot.”
“The doctor thinks they’ve recommended that, but the doctor really has opened the door for you to think about it and leave [yourself] unvaccinated.”
Dr. Schaffner’s alternative? Tell the patient: “‘You’ll get your flu vaccine on the way out. Tom or Sally will give it to you.’ That’s a very different kind of recommendation. And it’s a much greater assurance of providing the vaccine.”
Another major problem, Dr. Schaffner said, is that many specialists “don’t think of vaccination as something that’s included with their routine care” even though they do direct much of the patient’s care. He said that physicians should be more “directive” in their care and that immunizations should be better integrated into routine practice.
Jody Lanard, MD, a retired risk communication consultant who spent many years working with the World Health Organization on disease outbreak communications, said in an interview that this disconnect between physician and patient reports “was really jarring. And it’s actionable!”
She offered several practical suggestions. For one, she said, “the messaging to the specialists has to be very, very empathic. We know you’re already overburdened. And here we’re asking you to do something that you think of as somebody else’s job.” But if your patient gets flu, then your job as the cardiologist or endocrinologist will become more complicated and time-consuming. So getting the patients vaccinated will be a good investment and will make your job easier.
Because of the disparity in patient and physician reports, Dr. Lanard suggested implementing a “feedback mechanism where they [the health care providers] give out the prescription, and then the office calls [the patient] to see if they’ve gotten the shot or not. Because that way it will help correct the mismatch between them thinking that they told the patient and the patient not hearing it.”
Asked about why there might be a big gap between what physicians report they said and what patients heard, Dr. Lanard explained that “physicians often communicate in [a manner] sort of like a checklist. And the patients are focused on one or two things that are high in their minds. And the physician was mentioning some things that are on a separate topic that are not on a patient’s list and it goes right past them.”
Dr. Lanard recommended brief storytelling instead of checklists. For example: “I’ve been treating your diabetes for 10 years. During this last flu season, several of my diabetic patients had a really hard time when they caught the flu. So now I’m trying harder to remember to remind you to get your flu shots.”
She urged HCPs to “make it more personal ... but it can still be scripted in advance as part of something that [you’re] remembering to do during the check.” She added that their professional associations may be able to send them suggested language they can adapt.
Finally, Dr. Lanard cautioned about vaccine myths. “The word myth is so insulting. It’s basically a word that sends the signal that you’re an idiot.”
She advised specialists to avoid the word “myth,” which will make the person defensive. Instead, say something like, “A lot of people, even some of my own family members, think the flu vaccine gives you the flu. ... But it doesn’t. And then you go into the reality.”
Dr. Lanard suggested that specialists implement the follow-up calls and close the feedback loop, saying: “If they did the survey a few years later, I bet that gap would narrow.”
Dr. Schaffner and Dr. Lanard disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Online reviews most important factor in choosing a doctor: Survey
from Press Ganey, a provider of patient satisfaction surveys. According to the data, this online information is more important to consumers in selecting a physician than another doctor’s referral and is more than twice as important when choosing a primary care physician.
In fact, 83% of respondents said they went online to read reviews of a physician after receiving a referral from another provider.
The online research trend reflects not only the increased familiarity of all generations with the internet but also the growing consumerization of health care, Thomas Jeffrey, president of the Sullivan/Luallin Group, a patient experience consulting firm, told this news organization.
“According to patient satisfaction surveys, people are becoming health care consumers more than in the past,” he noted. “Historically, we didn’t look at health care as a consumer product. But, with high deductibles and copays, doctor visits can represent a pretty significant out-of-pocket expense. As it begins to hit folks’ pocketbooks, they become more savvy shoppers.”
Digital preferences for providers were gaining “positive momentum” even before the COVID-19 pandemic, but the crisis “drove upticks in some consumer digital behaviors,” the Press Ganey report pointed out.
Mr. Jeffrey agreed, noting that this finding matches what Sullivan/Luallin has discovered in its research. “I think the pandemic pushed people to engage more online,” he said. “The highest net promoter score [likelihood to recommend in market surveys] for a pharmacy is the Amazon pharmacy, which is an online-based delivery service. Then you have telehealth visits, which are more convenient in many ways.”
How patients search online
In choosing a new primary care doctor, 51.1% go on the web first, 23.8% seek a referral from another health care provider, and 4.4% get information from an insurer or a benefits manager, according to the survey.
The factors that matter most to consumers when they pick any provider, in order, are online ratings and reviews of the physician, referral from a current doctor, ratings and reviews of the facility, and the quality and completeness of a doctor’s profile on a website or online directory. The doctor’s online presence and the quality of their website are also important.
According to Press Ganey, search engines like Google are the most used digital resources, with 65.4% of consumers employing them to find a doctor. However, consumers now use an average of 2.7 sites in their search. The leading destinations are a hospital or a clinic site, WebMD, Healthgrades, and Facebook. (This news organization is owned by WebMD.)
Compared with 2019, the report said, there has been a 22.8% decline in the use of search engines for seeking a doctor and a 53.7% increase in the use of health care review sites such as Healthgrades and Vitals.
When reading provider reviews, consumers look for more recent reviews and want the reviews to be “authentic and informative.” They also value the star ratings. About 84%of respondents said they wouldn’t book an appointment with a referred provider that had a rating of less than four stars.
Overall, the top reasons why people are deterred from making an appointment are difficulty contacting the office, the poor quality of online reviews, and an average online rating of less than four stars.
The vast majority of respondents (77%) said they believe internet reviews reflect their own experience with a provider organization, and only 2.6% said the reviews were inaccurate. Another finding of the survey indicates that this attention of patients to reviews of their own provider doesn’t represent idle curiosity: About 57% of Baby Boomers and 45% of millennials/Gen Z’ers said they’d written online reviews of a doctor or a hospital.
Factors in patient loyalty
The Press Ganey survey asked which of several factors, besides excellent care, patients weighed when giving a five-star review to a health care provider.
Quality of customer service was rated first by 70.8% of respondents, followed by cleanliness of facilities (67.5%), communication (63.4%), the provider’s bedside manner (63%), ease of appointment booking (58.8%), ease of patient intake/registration (52.3%), quality and accuracy of information (40.1%), availability of telehealth services (21.7%), and waiting room amenities (21.8%).
The report explained that “quality of customer service” means “demeanor, attentiveness, and helpfulness of staff and practitioners.” “Communication” refers to things like follow-up appointment reminders and annual checkup reminders.
According to Mr. Jeffrey, these factors were considered more important than a doctor’s bedside manner because of the team care approach in most physician offices. “We see a lot more folks derive their notion of quality from continuity of care. And if they feel the physician they love is being supported by a less than competent team, that can impact significantly their sense of the quality of care,” he said.
Online appointment booking is a must
To win over the online consumer, Press Ganey emphasized, practices should ensure that provider listings are accurate and complete. In addition, offering online appointment booking can avoid the top challenge in making a new appointment, which is getting through to the office.
Mr. Jeffrey concurred, although he notes that practices have to be careful about how they enable patients to select appointment slots online. He suggests that an appointment request form on a patient portal first ask what the purpose of the visit is and that it offer five or so options. If the request fits into a routine visit category, the provider’s calendar pops up and the patient can select a convenient time slot. If it’s something else, an appointment scheduler calls the patient back.
“There needs to be greater access to standard appointments online,” he said. “While privacy is an issue, you can use the patient portal that most EHRs have to provide online booking. If you want to succeed going forward, that’s going to be a major plus.”
Of course, to do any of this, including reading provider reviews, a consumer needs a good internet connection and a mobile or desktop device. While broadband internet access is still not available in some communities, the breakdown of the survey respondents by demographics shows that low-income people were included.
Mr. Jeffrey doesn’t believe that a lack of internet access or digital devices prevents many Americans from going online today. “Even in poor communities, most people have internet access through their smartphones. Even baby boomers are familiar with smartphones. I haven’t seen internet access be a big barrier for low-income households, because they all have access to phones.”
A version of this article first appeared on Medscape.com.
from Press Ganey, a provider of patient satisfaction surveys. According to the data, this online information is more important to consumers in selecting a physician than another doctor’s referral and is more than twice as important when choosing a primary care physician.
In fact, 83% of respondents said they went online to read reviews of a physician after receiving a referral from another provider.
The online research trend reflects not only the increased familiarity of all generations with the internet but also the growing consumerization of health care, Thomas Jeffrey, president of the Sullivan/Luallin Group, a patient experience consulting firm, told this news organization.
“According to patient satisfaction surveys, people are becoming health care consumers more than in the past,” he noted. “Historically, we didn’t look at health care as a consumer product. But, with high deductibles and copays, doctor visits can represent a pretty significant out-of-pocket expense. As it begins to hit folks’ pocketbooks, they become more savvy shoppers.”
Digital preferences for providers were gaining “positive momentum” even before the COVID-19 pandemic, but the crisis “drove upticks in some consumer digital behaviors,” the Press Ganey report pointed out.
Mr. Jeffrey agreed, noting that this finding matches what Sullivan/Luallin has discovered in its research. “I think the pandemic pushed people to engage more online,” he said. “The highest net promoter score [likelihood to recommend in market surveys] for a pharmacy is the Amazon pharmacy, which is an online-based delivery service. Then you have telehealth visits, which are more convenient in many ways.”
How patients search online
In choosing a new primary care doctor, 51.1% go on the web first, 23.8% seek a referral from another health care provider, and 4.4% get information from an insurer or a benefits manager, according to the survey.
The factors that matter most to consumers when they pick any provider, in order, are online ratings and reviews of the physician, referral from a current doctor, ratings and reviews of the facility, and the quality and completeness of a doctor’s profile on a website or online directory. The doctor’s online presence and the quality of their website are also important.
According to Press Ganey, search engines like Google are the most used digital resources, with 65.4% of consumers employing them to find a doctor. However, consumers now use an average of 2.7 sites in their search. The leading destinations are a hospital or a clinic site, WebMD, Healthgrades, and Facebook. (This news organization is owned by WebMD.)
Compared with 2019, the report said, there has been a 22.8% decline in the use of search engines for seeking a doctor and a 53.7% increase in the use of health care review sites such as Healthgrades and Vitals.
When reading provider reviews, consumers look for more recent reviews and want the reviews to be “authentic and informative.” They also value the star ratings. About 84%of respondents said they wouldn’t book an appointment with a referred provider that had a rating of less than four stars.
Overall, the top reasons why people are deterred from making an appointment are difficulty contacting the office, the poor quality of online reviews, and an average online rating of less than four stars.
The vast majority of respondents (77%) said they believe internet reviews reflect their own experience with a provider organization, and only 2.6% said the reviews were inaccurate. Another finding of the survey indicates that this attention of patients to reviews of their own provider doesn’t represent idle curiosity: About 57% of Baby Boomers and 45% of millennials/Gen Z’ers said they’d written online reviews of a doctor or a hospital.
Factors in patient loyalty
The Press Ganey survey asked which of several factors, besides excellent care, patients weighed when giving a five-star review to a health care provider.
Quality of customer service was rated first by 70.8% of respondents, followed by cleanliness of facilities (67.5%), communication (63.4%), the provider’s bedside manner (63%), ease of appointment booking (58.8%), ease of patient intake/registration (52.3%), quality and accuracy of information (40.1%), availability of telehealth services (21.7%), and waiting room amenities (21.8%).
The report explained that “quality of customer service” means “demeanor, attentiveness, and helpfulness of staff and practitioners.” “Communication” refers to things like follow-up appointment reminders and annual checkup reminders.
According to Mr. Jeffrey, these factors were considered more important than a doctor’s bedside manner because of the team care approach in most physician offices. “We see a lot more folks derive their notion of quality from continuity of care. And if they feel the physician they love is being supported by a less than competent team, that can impact significantly their sense of the quality of care,” he said.
Online appointment booking is a must
To win over the online consumer, Press Ganey emphasized, practices should ensure that provider listings are accurate and complete. In addition, offering online appointment booking can avoid the top challenge in making a new appointment, which is getting through to the office.
Mr. Jeffrey concurred, although he notes that practices have to be careful about how they enable patients to select appointment slots online. He suggests that an appointment request form on a patient portal first ask what the purpose of the visit is and that it offer five or so options. If the request fits into a routine visit category, the provider’s calendar pops up and the patient can select a convenient time slot. If it’s something else, an appointment scheduler calls the patient back.
“There needs to be greater access to standard appointments online,” he said. “While privacy is an issue, you can use the patient portal that most EHRs have to provide online booking. If you want to succeed going forward, that’s going to be a major plus.”
Of course, to do any of this, including reading provider reviews, a consumer needs a good internet connection and a mobile or desktop device. While broadband internet access is still not available in some communities, the breakdown of the survey respondents by demographics shows that low-income people were included.
Mr. Jeffrey doesn’t believe that a lack of internet access or digital devices prevents many Americans from going online today. “Even in poor communities, most people have internet access through their smartphones. Even baby boomers are familiar with smartphones. I haven’t seen internet access be a big barrier for low-income households, because they all have access to phones.”
A version of this article first appeared on Medscape.com.
from Press Ganey, a provider of patient satisfaction surveys. According to the data, this online information is more important to consumers in selecting a physician than another doctor’s referral and is more than twice as important when choosing a primary care physician.
In fact, 83% of respondents said they went online to read reviews of a physician after receiving a referral from another provider.
The online research trend reflects not only the increased familiarity of all generations with the internet but also the growing consumerization of health care, Thomas Jeffrey, president of the Sullivan/Luallin Group, a patient experience consulting firm, told this news organization.
“According to patient satisfaction surveys, people are becoming health care consumers more than in the past,” he noted. “Historically, we didn’t look at health care as a consumer product. But, with high deductibles and copays, doctor visits can represent a pretty significant out-of-pocket expense. As it begins to hit folks’ pocketbooks, they become more savvy shoppers.”
Digital preferences for providers were gaining “positive momentum” even before the COVID-19 pandemic, but the crisis “drove upticks in some consumer digital behaviors,” the Press Ganey report pointed out.
Mr. Jeffrey agreed, noting that this finding matches what Sullivan/Luallin has discovered in its research. “I think the pandemic pushed people to engage more online,” he said. “The highest net promoter score [likelihood to recommend in market surveys] for a pharmacy is the Amazon pharmacy, which is an online-based delivery service. Then you have telehealth visits, which are more convenient in many ways.”
How patients search online
In choosing a new primary care doctor, 51.1% go on the web first, 23.8% seek a referral from another health care provider, and 4.4% get information from an insurer or a benefits manager, according to the survey.
The factors that matter most to consumers when they pick any provider, in order, are online ratings and reviews of the physician, referral from a current doctor, ratings and reviews of the facility, and the quality and completeness of a doctor’s profile on a website or online directory. The doctor’s online presence and the quality of their website are also important.
According to Press Ganey, search engines like Google are the most used digital resources, with 65.4% of consumers employing them to find a doctor. However, consumers now use an average of 2.7 sites in their search. The leading destinations are a hospital or a clinic site, WebMD, Healthgrades, and Facebook. (This news organization is owned by WebMD.)
Compared with 2019, the report said, there has been a 22.8% decline in the use of search engines for seeking a doctor and a 53.7% increase in the use of health care review sites such as Healthgrades and Vitals.
When reading provider reviews, consumers look for more recent reviews and want the reviews to be “authentic and informative.” They also value the star ratings. About 84%of respondents said they wouldn’t book an appointment with a referred provider that had a rating of less than four stars.
Overall, the top reasons why people are deterred from making an appointment are difficulty contacting the office, the poor quality of online reviews, and an average online rating of less than four stars.
The vast majority of respondents (77%) said they believe internet reviews reflect their own experience with a provider organization, and only 2.6% said the reviews were inaccurate. Another finding of the survey indicates that this attention of patients to reviews of their own provider doesn’t represent idle curiosity: About 57% of Baby Boomers and 45% of millennials/Gen Z’ers said they’d written online reviews of a doctor or a hospital.
Factors in patient loyalty
The Press Ganey survey asked which of several factors, besides excellent care, patients weighed when giving a five-star review to a health care provider.
Quality of customer service was rated first by 70.8% of respondents, followed by cleanliness of facilities (67.5%), communication (63.4%), the provider’s bedside manner (63%), ease of appointment booking (58.8%), ease of patient intake/registration (52.3%), quality and accuracy of information (40.1%), availability of telehealth services (21.7%), and waiting room amenities (21.8%).
The report explained that “quality of customer service” means “demeanor, attentiveness, and helpfulness of staff and practitioners.” “Communication” refers to things like follow-up appointment reminders and annual checkup reminders.
According to Mr. Jeffrey, these factors were considered more important than a doctor’s bedside manner because of the team care approach in most physician offices. “We see a lot more folks derive their notion of quality from continuity of care. And if they feel the physician they love is being supported by a less than competent team, that can impact significantly their sense of the quality of care,” he said.
Online appointment booking is a must
To win over the online consumer, Press Ganey emphasized, practices should ensure that provider listings are accurate and complete. In addition, offering online appointment booking can avoid the top challenge in making a new appointment, which is getting through to the office.
Mr. Jeffrey concurred, although he notes that practices have to be careful about how they enable patients to select appointment slots online. He suggests that an appointment request form on a patient portal first ask what the purpose of the visit is and that it offer five or so options. If the request fits into a routine visit category, the provider’s calendar pops up and the patient can select a convenient time slot. If it’s something else, an appointment scheduler calls the patient back.
“There needs to be greater access to standard appointments online,” he said. “While privacy is an issue, you can use the patient portal that most EHRs have to provide online booking. If you want to succeed going forward, that’s going to be a major plus.”
Of course, to do any of this, including reading provider reviews, a consumer needs a good internet connection and a mobile or desktop device. While broadband internet access is still not available in some communities, the breakdown of the survey respondents by demographics shows that low-income people were included.
Mr. Jeffrey doesn’t believe that a lack of internet access or digital devices prevents many Americans from going online today. “Even in poor communities, most people have internet access through their smartphones. Even baby boomers are familiar with smartphones. I haven’t seen internet access be a big barrier for low-income households, because they all have access to phones.”
A version of this article first appeared on Medscape.com.
Apixaban outmatches rivaroxaban for VTE in study
Recurrent venous thromboembolism (VTE) – a composite of pulmonary embolism and deep vein thrombosis – was the primary effectiveness outcome in the retrospective analysis of new-user data from almost 40,000 patients, which was published in Annals of Internal Medicine. Safety was evaluated through a composite of intracranial and gastrointestinal bleeding.
After a median follow-up of 102 days in the apixaban group and 105 days in the rivaroxaban group, apixaban demonstrated superiority for both primary outcomes.
These real-world findings may guide selection of initial anticoagulant therapy, reported lead author Ghadeer K. Dawwas, PhD, MSc, MBA, of the University of Pennsylvania, Philadelphia, and colleagues.
“Randomized clinical trials comparing apixaban with rivaroxaban in patients with VTE are under way (for example, COBRRA (NCT03266783),” the investigators wrote. “Until the results from these trials become available (The estimated completion date for COBRRA is December 2023.), observational studies that use existing data can provide evidence on the effectiveness and safety of these alternatives to inform clinical practice.”
In the new research, apixaban was associated with a 23% lower rate of recurrent VTE (hazard ratio, 0.77; 95% confidence interval, 0.69-0.87), including a 15% lower rate of deep vein thrombosis and a 41% lower rate of pulmonary embolism. Apixaban was associated with 40% fewer bleeding events (HR, 0.60; 95% CI, 0.53-0.69]), including a 40% lower rate of GI bleeding and a 46% lower rate of intracranial bleeding.
The study involved 37,236 patients with VTE, all of whom were diagnosed in at least one inpatient encounter and initiated direct oral anticoagulant (DOAC) therapy within 30 days, according to Optum’s deidentified Clinformatics Data Mart Database. Patients were evenly split into apixaban and rivaroxaban groups, with 18,618 individuals in each. Propensity score matching was used to minimize differences in baseline characteristics.
Apixaban was associated with an absolute reduction in recurrent VTE of 0.6% and 1.1% over 2 and 6 months, respectively, as well as reductions in bleeding of 1.1% and 1.5% over the same respective time periods.
The investigators noted that these findings were maintained in various sensitivity and subgroup analyses, including a model in which patients with VTE who had transient risk factors were compared with VTE patients exhibiting chronic risk factors.
“These findings suggest that apixaban has superior effectiveness and safety, compared with rivaroxaban and may provide guidance to clinicians and patients regarding selection of an anticoagulant for treatment of VTE,” Dr. Dawwas and colleagues concluded.
Study may have missed some nuance in possible outcomes, according to vascular surgeon
Thomas Wakefield, MD, a vascular surgeon and a professor of surgery at the University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, generally agreed with the investigators’ conclusion, although he noted that DOAC selection may also be influenced by other considerations.
“The results of this study suggest that, when choosing an agent for an individual patient, apixaban does appear to have an advantage over rivaroxaban related to recurrent VTE and bleeding,” Dr. Wakefield said in an interview. “One must keep in mind that these are not the only factors that are considered when choosing an agent and these are not the only two DOACs available. For example, rivaroxaban is given once per day while apixaban is given twice per day, and rivaroxaban has been shown to be successful in the treatment of other thrombotic disorders.”
Dr. Wakefield also pointed out that the study may have missed some nuance in possible outcomes.
“The current study looked at severe outcomes that resulted in inpatient hospitalization, so the generalization to strictly outpatient treatment and less severe outcomes cannot be inferred,” he said.
Damon E. Houghton, MD, of the department of medicine and a consultant in the department of vascular medicine and hematology at Mayo Clinic, Rochester, Minn., called the study a “very nice analysis,” highlighting the large sample size.
“The results are not a reason to abandon rivaroxaban altogether, but do suggest that, when otherwise appropriate for a patient, apixaban should be the first choice,” Dr. Houghton said in a written comment. “Hopefully this analysis will encourage more payers to create financial incentives that facilitate the use of apixaban in more patients.”
Randomized trial needed, says hematologist
Colleen Edwards, MD, of the departments of medicine, hematology, and medical oncology, at the Icahn School of Medicine at Mount Sinai, New York, had a more guarded view of the findings than Dr. Wakefield and Dr. Houghton.
“[The investigators] certainly seem to be doing a lot of statistical gymnastics in this paper,” Dr. Edwards said in an interview. “They used all kinds of surrogates in place of real data that you would get from a randomized trial.”
For example, Dr. Edwards noted the use of prescription refills as a surrogate for medication adherence, and emphasized that inpatient observational data may not reflect outpatient therapy.
“Inpatients are constantly missing their medicines all the time,” she said. “They’re holding it for procedures, they’re NPO, they’re off the floor, so they missed their medicine. So it’s just a very different patient population than the outpatient population, which is where venous thromboembolism is treated now, by and large.”
Although Dr. Edwards suggested that the findings might guide treatment selection “a little bit,” she noted that insurance constraints and costs play a greater role, and ultimately concluded that a randomized trial is needed to materially alter clinical decision-making.
“I think we really have to wait for randomized trial before we abandon our other choices,” she said.
The investigators disclosed relationships with Merck, Celgene, UCB, and others. Dr. Wakefield reported awaiting disclosures. Dr. Houghton and Dr. Edwards reported no relevant conflicts of interest.
Recurrent venous thromboembolism (VTE) – a composite of pulmonary embolism and deep vein thrombosis – was the primary effectiveness outcome in the retrospective analysis of new-user data from almost 40,000 patients, which was published in Annals of Internal Medicine. Safety was evaluated through a composite of intracranial and gastrointestinal bleeding.
After a median follow-up of 102 days in the apixaban group and 105 days in the rivaroxaban group, apixaban demonstrated superiority for both primary outcomes.
These real-world findings may guide selection of initial anticoagulant therapy, reported lead author Ghadeer K. Dawwas, PhD, MSc, MBA, of the University of Pennsylvania, Philadelphia, and colleagues.
“Randomized clinical trials comparing apixaban with rivaroxaban in patients with VTE are under way (for example, COBRRA (NCT03266783),” the investigators wrote. “Until the results from these trials become available (The estimated completion date for COBRRA is December 2023.), observational studies that use existing data can provide evidence on the effectiveness and safety of these alternatives to inform clinical practice.”
In the new research, apixaban was associated with a 23% lower rate of recurrent VTE (hazard ratio, 0.77; 95% confidence interval, 0.69-0.87), including a 15% lower rate of deep vein thrombosis and a 41% lower rate of pulmonary embolism. Apixaban was associated with 40% fewer bleeding events (HR, 0.60; 95% CI, 0.53-0.69]), including a 40% lower rate of GI bleeding and a 46% lower rate of intracranial bleeding.
The study involved 37,236 patients with VTE, all of whom were diagnosed in at least one inpatient encounter and initiated direct oral anticoagulant (DOAC) therapy within 30 days, according to Optum’s deidentified Clinformatics Data Mart Database. Patients were evenly split into apixaban and rivaroxaban groups, with 18,618 individuals in each. Propensity score matching was used to minimize differences in baseline characteristics.
Apixaban was associated with an absolute reduction in recurrent VTE of 0.6% and 1.1% over 2 and 6 months, respectively, as well as reductions in bleeding of 1.1% and 1.5% over the same respective time periods.
The investigators noted that these findings were maintained in various sensitivity and subgroup analyses, including a model in which patients with VTE who had transient risk factors were compared with VTE patients exhibiting chronic risk factors.
“These findings suggest that apixaban has superior effectiveness and safety, compared with rivaroxaban and may provide guidance to clinicians and patients regarding selection of an anticoagulant for treatment of VTE,” Dr. Dawwas and colleagues concluded.
Study may have missed some nuance in possible outcomes, according to vascular surgeon
Thomas Wakefield, MD, a vascular surgeon and a professor of surgery at the University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, generally agreed with the investigators’ conclusion, although he noted that DOAC selection may also be influenced by other considerations.
“The results of this study suggest that, when choosing an agent for an individual patient, apixaban does appear to have an advantage over rivaroxaban related to recurrent VTE and bleeding,” Dr. Wakefield said in an interview. “One must keep in mind that these are not the only factors that are considered when choosing an agent and these are not the only two DOACs available. For example, rivaroxaban is given once per day while apixaban is given twice per day, and rivaroxaban has been shown to be successful in the treatment of other thrombotic disorders.”
Dr. Wakefield also pointed out that the study may have missed some nuance in possible outcomes.
“The current study looked at severe outcomes that resulted in inpatient hospitalization, so the generalization to strictly outpatient treatment and less severe outcomes cannot be inferred,” he said.
Damon E. Houghton, MD, of the department of medicine and a consultant in the department of vascular medicine and hematology at Mayo Clinic, Rochester, Minn., called the study a “very nice analysis,” highlighting the large sample size.
“The results are not a reason to abandon rivaroxaban altogether, but do suggest that, when otherwise appropriate for a patient, apixaban should be the first choice,” Dr. Houghton said in a written comment. “Hopefully this analysis will encourage more payers to create financial incentives that facilitate the use of apixaban in more patients.”
Randomized trial needed, says hematologist
Colleen Edwards, MD, of the departments of medicine, hematology, and medical oncology, at the Icahn School of Medicine at Mount Sinai, New York, had a more guarded view of the findings than Dr. Wakefield and Dr. Houghton.
“[The investigators] certainly seem to be doing a lot of statistical gymnastics in this paper,” Dr. Edwards said in an interview. “They used all kinds of surrogates in place of real data that you would get from a randomized trial.”
For example, Dr. Edwards noted the use of prescription refills as a surrogate for medication adherence, and emphasized that inpatient observational data may not reflect outpatient therapy.
“Inpatients are constantly missing their medicines all the time,” she said. “They’re holding it for procedures, they’re NPO, they’re off the floor, so they missed their medicine. So it’s just a very different patient population than the outpatient population, which is where venous thromboembolism is treated now, by and large.”
Although Dr. Edwards suggested that the findings might guide treatment selection “a little bit,” she noted that insurance constraints and costs play a greater role, and ultimately concluded that a randomized trial is needed to materially alter clinical decision-making.
“I think we really have to wait for randomized trial before we abandon our other choices,” she said.
The investigators disclosed relationships with Merck, Celgene, UCB, and others. Dr. Wakefield reported awaiting disclosures. Dr. Houghton and Dr. Edwards reported no relevant conflicts of interest.
Recurrent venous thromboembolism (VTE) – a composite of pulmonary embolism and deep vein thrombosis – was the primary effectiveness outcome in the retrospective analysis of new-user data from almost 40,000 patients, which was published in Annals of Internal Medicine. Safety was evaluated through a composite of intracranial and gastrointestinal bleeding.
After a median follow-up of 102 days in the apixaban group and 105 days in the rivaroxaban group, apixaban demonstrated superiority for both primary outcomes.
These real-world findings may guide selection of initial anticoagulant therapy, reported lead author Ghadeer K. Dawwas, PhD, MSc, MBA, of the University of Pennsylvania, Philadelphia, and colleagues.
“Randomized clinical trials comparing apixaban with rivaroxaban in patients with VTE are under way (for example, COBRRA (NCT03266783),” the investigators wrote. “Until the results from these trials become available (The estimated completion date for COBRRA is December 2023.), observational studies that use existing data can provide evidence on the effectiveness and safety of these alternatives to inform clinical practice.”
In the new research, apixaban was associated with a 23% lower rate of recurrent VTE (hazard ratio, 0.77; 95% confidence interval, 0.69-0.87), including a 15% lower rate of deep vein thrombosis and a 41% lower rate of pulmonary embolism. Apixaban was associated with 40% fewer bleeding events (HR, 0.60; 95% CI, 0.53-0.69]), including a 40% lower rate of GI bleeding and a 46% lower rate of intracranial bleeding.
The study involved 37,236 patients with VTE, all of whom were diagnosed in at least one inpatient encounter and initiated direct oral anticoagulant (DOAC) therapy within 30 days, according to Optum’s deidentified Clinformatics Data Mart Database. Patients were evenly split into apixaban and rivaroxaban groups, with 18,618 individuals in each. Propensity score matching was used to minimize differences in baseline characteristics.
Apixaban was associated with an absolute reduction in recurrent VTE of 0.6% and 1.1% over 2 and 6 months, respectively, as well as reductions in bleeding of 1.1% and 1.5% over the same respective time periods.
The investigators noted that these findings were maintained in various sensitivity and subgroup analyses, including a model in which patients with VTE who had transient risk factors were compared with VTE patients exhibiting chronic risk factors.
“These findings suggest that apixaban has superior effectiveness and safety, compared with rivaroxaban and may provide guidance to clinicians and patients regarding selection of an anticoagulant for treatment of VTE,” Dr. Dawwas and colleagues concluded.
Study may have missed some nuance in possible outcomes, according to vascular surgeon
Thomas Wakefield, MD, a vascular surgeon and a professor of surgery at the University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, generally agreed with the investigators’ conclusion, although he noted that DOAC selection may also be influenced by other considerations.
“The results of this study suggest that, when choosing an agent for an individual patient, apixaban does appear to have an advantage over rivaroxaban related to recurrent VTE and bleeding,” Dr. Wakefield said in an interview. “One must keep in mind that these are not the only factors that are considered when choosing an agent and these are not the only two DOACs available. For example, rivaroxaban is given once per day while apixaban is given twice per day, and rivaroxaban has been shown to be successful in the treatment of other thrombotic disorders.”
Dr. Wakefield also pointed out that the study may have missed some nuance in possible outcomes.
“The current study looked at severe outcomes that resulted in inpatient hospitalization, so the generalization to strictly outpatient treatment and less severe outcomes cannot be inferred,” he said.
Damon E. Houghton, MD, of the department of medicine and a consultant in the department of vascular medicine and hematology at Mayo Clinic, Rochester, Minn., called the study a “very nice analysis,” highlighting the large sample size.
“The results are not a reason to abandon rivaroxaban altogether, but do suggest that, when otherwise appropriate for a patient, apixaban should be the first choice,” Dr. Houghton said in a written comment. “Hopefully this analysis will encourage more payers to create financial incentives that facilitate the use of apixaban in more patients.”
Randomized trial needed, says hematologist
Colleen Edwards, MD, of the departments of medicine, hematology, and medical oncology, at the Icahn School of Medicine at Mount Sinai, New York, had a more guarded view of the findings than Dr. Wakefield and Dr. Houghton.
“[The investigators] certainly seem to be doing a lot of statistical gymnastics in this paper,” Dr. Edwards said in an interview. “They used all kinds of surrogates in place of real data that you would get from a randomized trial.”
For example, Dr. Edwards noted the use of prescription refills as a surrogate for medication adherence, and emphasized that inpatient observational data may not reflect outpatient therapy.
“Inpatients are constantly missing their medicines all the time,” she said. “They’re holding it for procedures, they’re NPO, they’re off the floor, so they missed their medicine. So it’s just a very different patient population than the outpatient population, which is where venous thromboembolism is treated now, by and large.”
Although Dr. Edwards suggested that the findings might guide treatment selection “a little bit,” she noted that insurance constraints and costs play a greater role, and ultimately concluded that a randomized trial is needed to materially alter clinical decision-making.
“I think we really have to wait for randomized trial before we abandon our other choices,” she said.
The investigators disclosed relationships with Merck, Celgene, UCB, and others. Dr. Wakefield reported awaiting disclosures. Dr. Houghton and Dr. Edwards reported no relevant conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
Care via video teleconferencing can be as effective as in-person for some conditions
This was a finding of a new study published in Annals of Internal Medicine involving a review of literature on video teleconferencing (VTC) visits, which was authored by Jordan Albritton, PhD, MPH and his colleagues.
The authors found generally comparable patient outcomes as well as no differences in health care use, patient satisfaction, and quality of life when visits conducted using VTC were compared with usual care.
While VTC may work best for monitoring patients with chronic conditions, it can also be effective for acute care, said Dr. Albritton, who is a research public health analyst at RTI International in Research Triangle Park, N.C., in an interview.
The investigators analyzed 20 randomized controlled trials of at least 50 patients and acceptable risk of bias in which VTC was used either for main or adjunct care delivery. Published from 2013 to 2019, these studies looked at care for diabetes and pain management, as well as some respiratory, neurologic, and cardiovascular conditions. Studies comparing VTC with usual care that did not involve any added in-person care were more likely to favor the VTC group, the investigators found.
“We excluded conditions such as substance use disorders, maternal care, and weight management for which there was sufficient prior evidence of the benefit of VTC,” Dr. Albritton said in an interview. “But I don’t think our results would have been substantially different if we had included these other diseases. We found general evidence in the literature that VTC is effective for a broader range of conditions.”
In some cases, such as if changes in a patient’s condition triggered an automatic virtual visit, the author said he thinks VTC may lead to even greater effectiveness.
“The doctor and patient could figure out on the spot what’s going on and perhaps change the medication,” Dr. Albritton explained.
In general agreement is Julia L. Frydman, MD, assistant professor in the Brookdale Department of Geriatric and Palliative Medicine at Icahn School of Medicine at Mount Sinai in New York, who was not involved in the RTI research.
“Telemedicine has promise across many medical subspecialties, and what we need now are more studies to understand the perspectives of patients, caregivers, and clinicians as well as the impact of telemedicine on health outcomes and healthcare utilization.”
In acknowledgment of their utility, video visits are on the rise in the United States. A 2020 survey found that 22% of patients and 80% of physicians reported having participated in a video visit, three times the rate of the previous year. The authors noted that policy changes enacted to support telehealth strategies during the pandemic are expected to remain in place, and although patients are returning to in-person care, the virtual visit market will likely continue growing.
Increased telemedicine use by older adults
“We’ve seen an exciting expansion of telemedicine use among older adults, and we need to focus on continuing to meet their needs,” Dr. Frydman said.
In a recent study of televisits during the pandemic, Dr. Frydman’s group found a fivefold greater uptake of remote consultations by seniors – from 5% to 25%. Although in-person visits were far more common among older adults.
A specific advantage of video-based over audio-only telehealth, noted Dr. Albritton, is that physicians can directly observe patients in their home environment. Sharing that view is Deepa Iyengar, MBBS/MD,MPH, professor of family medicine at McGovern Medical School at The University of Texas Health Science Center at Houston, where, she said, “the pandemic has put VTC use into overdrive.”
According to Dr. Iyengar, who was not involved in the RTI research, the video component definitely represents value-added over phone calls. “You can pick up visual cues on video that you might not see if the patient came in and you can see what the home environment is like – whether there are a lot of loose rugs on the floor or broken or missing light bulbs,” she said in an interview.
‘VTC is here to stay’
In other parts of the country, doctors are finding virtual care useful – and more common. “VTC is here to stay, for sure – the horse is out of the barn,” said Cheryl L. Wilkes, MD, an internist at Northwestern Medicine and assistant professor of medicine at Northwestern University in Chicago. “The RTI study shows no harm from VTC and also shows it may even improve clinical outcomes.”
Video visits can also save patients high parking fees at clinics and spare the sick or elderly from having to hire caregivers to bring them into the office or from having to walk blocks in dangerous weather conditions, she added. “And I can do a virtual visit on the fly or at night when a relative or caregiver is home from work to be there with the patient.”
In addition to being beneficial for following up with patients with chronic diseases such as hypertension or diabetes, VTC may be able to replace some visits that have traditionally required hands-on care, said Dr. Wilkes.
She said she knows a cardiologist who has refined a process whereby a patient – say, one who may have edema – is asked to perform a maneuver via VTC and then display the result to the doctor: The doctor says, “put your leg up and press on it hard for 10 seconds and then show me what it looks like,” according to Dr. Wilkes.
The key now is to identify the best persons across specialties from neurology to rheumatology to videotape ways they’ve created to help their patients participate virtually in consults traditionally done at the office, Dr. Wilkes noted.
But some conditions will always require palpation and the use of a stethoscope, according Dr. Iyengar.
“If someone has an ulcer, I have to be able to feel it,” she said.
And while some maternity care can be given virtually – for instance, if a mother-to be develops a bad cold – hands-on obstetrical care to check the position and health of the baby obviously has to be done in person. “So VTC is definitely going to be a welcome addition but not a replacement,” Dr. Iyengar said.
Gaps in research on VTC visits
Many questions remain regarding the overall usefulness of VTC visits for certain patient groups, according to the authors.
They highlighted, for example, the dearth of data on subgroups or on underserved and vulnerable populations, with no head-to-head studies identified in their review. In addition, they found no studies examining VTC versus usual care for patients with concurrent conditions or on its effect on health equity and disparities.
“It’s now our job to understand the ongoing barriers to telemedicine access, including the digital divide and the usability of telemedicine platforms, and design interventions that overcome them,” Dr. Frydman said. “At the same time, we need to make sure we’re understanding and respecting the preferences of older adults in terms of how they access health care.”
This study was supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Albritton is employed by RTI International, the contractor responsible for conducting the research and developing the manuscript. Several coauthors disclosed support from or contracts with PCORI. One coauthor’s spouse holds stock in private health companies. Dr. Frydman, Dr. Iyengar, and Dr. Wilkes disclosed no competing interests relevant to their comments.
This was a finding of a new study published in Annals of Internal Medicine involving a review of literature on video teleconferencing (VTC) visits, which was authored by Jordan Albritton, PhD, MPH and his colleagues.
The authors found generally comparable patient outcomes as well as no differences in health care use, patient satisfaction, and quality of life when visits conducted using VTC were compared with usual care.
While VTC may work best for monitoring patients with chronic conditions, it can also be effective for acute care, said Dr. Albritton, who is a research public health analyst at RTI International in Research Triangle Park, N.C., in an interview.
The investigators analyzed 20 randomized controlled trials of at least 50 patients and acceptable risk of bias in which VTC was used either for main or adjunct care delivery. Published from 2013 to 2019, these studies looked at care for diabetes and pain management, as well as some respiratory, neurologic, and cardiovascular conditions. Studies comparing VTC with usual care that did not involve any added in-person care were more likely to favor the VTC group, the investigators found.
“We excluded conditions such as substance use disorders, maternal care, and weight management for which there was sufficient prior evidence of the benefit of VTC,” Dr. Albritton said in an interview. “But I don’t think our results would have been substantially different if we had included these other diseases. We found general evidence in the literature that VTC is effective for a broader range of conditions.”
In some cases, such as if changes in a patient’s condition triggered an automatic virtual visit, the author said he thinks VTC may lead to even greater effectiveness.
“The doctor and patient could figure out on the spot what’s going on and perhaps change the medication,” Dr. Albritton explained.
In general agreement is Julia L. Frydman, MD, assistant professor in the Brookdale Department of Geriatric and Palliative Medicine at Icahn School of Medicine at Mount Sinai in New York, who was not involved in the RTI research.
“Telemedicine has promise across many medical subspecialties, and what we need now are more studies to understand the perspectives of patients, caregivers, and clinicians as well as the impact of telemedicine on health outcomes and healthcare utilization.”
In acknowledgment of their utility, video visits are on the rise in the United States. A 2020 survey found that 22% of patients and 80% of physicians reported having participated in a video visit, three times the rate of the previous year. The authors noted that policy changes enacted to support telehealth strategies during the pandemic are expected to remain in place, and although patients are returning to in-person care, the virtual visit market will likely continue growing.
Increased telemedicine use by older adults
“We’ve seen an exciting expansion of telemedicine use among older adults, and we need to focus on continuing to meet their needs,” Dr. Frydman said.
In a recent study of televisits during the pandemic, Dr. Frydman’s group found a fivefold greater uptake of remote consultations by seniors – from 5% to 25%. Although in-person visits were far more common among older adults.
A specific advantage of video-based over audio-only telehealth, noted Dr. Albritton, is that physicians can directly observe patients in their home environment. Sharing that view is Deepa Iyengar, MBBS/MD,MPH, professor of family medicine at McGovern Medical School at The University of Texas Health Science Center at Houston, where, she said, “the pandemic has put VTC use into overdrive.”
According to Dr. Iyengar, who was not involved in the RTI research, the video component definitely represents value-added over phone calls. “You can pick up visual cues on video that you might not see if the patient came in and you can see what the home environment is like – whether there are a lot of loose rugs on the floor or broken or missing light bulbs,” she said in an interview.
‘VTC is here to stay’
In other parts of the country, doctors are finding virtual care useful – and more common. “VTC is here to stay, for sure – the horse is out of the barn,” said Cheryl L. Wilkes, MD, an internist at Northwestern Medicine and assistant professor of medicine at Northwestern University in Chicago. “The RTI study shows no harm from VTC and also shows it may even improve clinical outcomes.”
Video visits can also save patients high parking fees at clinics and spare the sick or elderly from having to hire caregivers to bring them into the office or from having to walk blocks in dangerous weather conditions, she added. “And I can do a virtual visit on the fly or at night when a relative or caregiver is home from work to be there with the patient.”
In addition to being beneficial for following up with patients with chronic diseases such as hypertension or diabetes, VTC may be able to replace some visits that have traditionally required hands-on care, said Dr. Wilkes.
She said she knows a cardiologist who has refined a process whereby a patient – say, one who may have edema – is asked to perform a maneuver via VTC and then display the result to the doctor: The doctor says, “put your leg up and press on it hard for 10 seconds and then show me what it looks like,” according to Dr. Wilkes.
The key now is to identify the best persons across specialties from neurology to rheumatology to videotape ways they’ve created to help their patients participate virtually in consults traditionally done at the office, Dr. Wilkes noted.
But some conditions will always require palpation and the use of a stethoscope, according Dr. Iyengar.
“If someone has an ulcer, I have to be able to feel it,” she said.
And while some maternity care can be given virtually – for instance, if a mother-to be develops a bad cold – hands-on obstetrical care to check the position and health of the baby obviously has to be done in person. “So VTC is definitely going to be a welcome addition but not a replacement,” Dr. Iyengar said.
Gaps in research on VTC visits
Many questions remain regarding the overall usefulness of VTC visits for certain patient groups, according to the authors.
They highlighted, for example, the dearth of data on subgroups or on underserved and vulnerable populations, with no head-to-head studies identified in their review. In addition, they found no studies examining VTC versus usual care for patients with concurrent conditions or on its effect on health equity and disparities.
“It’s now our job to understand the ongoing barriers to telemedicine access, including the digital divide and the usability of telemedicine platforms, and design interventions that overcome them,” Dr. Frydman said. “At the same time, we need to make sure we’re understanding and respecting the preferences of older adults in terms of how they access health care.”
This study was supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Albritton is employed by RTI International, the contractor responsible for conducting the research and developing the manuscript. Several coauthors disclosed support from or contracts with PCORI. One coauthor’s spouse holds stock in private health companies. Dr. Frydman, Dr. Iyengar, and Dr. Wilkes disclosed no competing interests relevant to their comments.
This was a finding of a new study published in Annals of Internal Medicine involving a review of literature on video teleconferencing (VTC) visits, which was authored by Jordan Albritton, PhD, MPH and his colleagues.
The authors found generally comparable patient outcomes as well as no differences in health care use, patient satisfaction, and quality of life when visits conducted using VTC were compared with usual care.
While VTC may work best for monitoring patients with chronic conditions, it can also be effective for acute care, said Dr. Albritton, who is a research public health analyst at RTI International in Research Triangle Park, N.C., in an interview.
The investigators analyzed 20 randomized controlled trials of at least 50 patients and acceptable risk of bias in which VTC was used either for main or adjunct care delivery. Published from 2013 to 2019, these studies looked at care for diabetes and pain management, as well as some respiratory, neurologic, and cardiovascular conditions. Studies comparing VTC with usual care that did not involve any added in-person care were more likely to favor the VTC group, the investigators found.
“We excluded conditions such as substance use disorders, maternal care, and weight management for which there was sufficient prior evidence of the benefit of VTC,” Dr. Albritton said in an interview. “But I don’t think our results would have been substantially different if we had included these other diseases. We found general evidence in the literature that VTC is effective for a broader range of conditions.”
In some cases, such as if changes in a patient’s condition triggered an automatic virtual visit, the author said he thinks VTC may lead to even greater effectiveness.
“The doctor and patient could figure out on the spot what’s going on and perhaps change the medication,” Dr. Albritton explained.
In general agreement is Julia L. Frydman, MD, assistant professor in the Brookdale Department of Geriatric and Palliative Medicine at Icahn School of Medicine at Mount Sinai in New York, who was not involved in the RTI research.
“Telemedicine has promise across many medical subspecialties, and what we need now are more studies to understand the perspectives of patients, caregivers, and clinicians as well as the impact of telemedicine on health outcomes and healthcare utilization.”
In acknowledgment of their utility, video visits are on the rise in the United States. A 2020 survey found that 22% of patients and 80% of physicians reported having participated in a video visit, three times the rate of the previous year. The authors noted that policy changes enacted to support telehealth strategies during the pandemic are expected to remain in place, and although patients are returning to in-person care, the virtual visit market will likely continue growing.
Increased telemedicine use by older adults
“We’ve seen an exciting expansion of telemedicine use among older adults, and we need to focus on continuing to meet their needs,” Dr. Frydman said.
In a recent study of televisits during the pandemic, Dr. Frydman’s group found a fivefold greater uptake of remote consultations by seniors – from 5% to 25%. Although in-person visits were far more common among older adults.
A specific advantage of video-based over audio-only telehealth, noted Dr. Albritton, is that physicians can directly observe patients in their home environment. Sharing that view is Deepa Iyengar, MBBS/MD,MPH, professor of family medicine at McGovern Medical School at The University of Texas Health Science Center at Houston, where, she said, “the pandemic has put VTC use into overdrive.”
According to Dr. Iyengar, who was not involved in the RTI research, the video component definitely represents value-added over phone calls. “You can pick up visual cues on video that you might not see if the patient came in and you can see what the home environment is like – whether there are a lot of loose rugs on the floor or broken or missing light bulbs,” she said in an interview.
‘VTC is here to stay’
In other parts of the country, doctors are finding virtual care useful – and more common. “VTC is here to stay, for sure – the horse is out of the barn,” said Cheryl L. Wilkes, MD, an internist at Northwestern Medicine and assistant professor of medicine at Northwestern University in Chicago. “The RTI study shows no harm from VTC and also shows it may even improve clinical outcomes.”
Video visits can also save patients high parking fees at clinics and spare the sick or elderly from having to hire caregivers to bring them into the office or from having to walk blocks in dangerous weather conditions, she added. “And I can do a virtual visit on the fly or at night when a relative or caregiver is home from work to be there with the patient.”
In addition to being beneficial for following up with patients with chronic diseases such as hypertension or diabetes, VTC may be able to replace some visits that have traditionally required hands-on care, said Dr. Wilkes.
She said she knows a cardiologist who has refined a process whereby a patient – say, one who may have edema – is asked to perform a maneuver via VTC and then display the result to the doctor: The doctor says, “put your leg up and press on it hard for 10 seconds and then show me what it looks like,” according to Dr. Wilkes.
The key now is to identify the best persons across specialties from neurology to rheumatology to videotape ways they’ve created to help their patients participate virtually in consults traditionally done at the office, Dr. Wilkes noted.
But some conditions will always require palpation and the use of a stethoscope, according Dr. Iyengar.
“If someone has an ulcer, I have to be able to feel it,” she said.
And while some maternity care can be given virtually – for instance, if a mother-to be develops a bad cold – hands-on obstetrical care to check the position and health of the baby obviously has to be done in person. “So VTC is definitely going to be a welcome addition but not a replacement,” Dr. Iyengar said.
Gaps in research on VTC visits
Many questions remain regarding the overall usefulness of VTC visits for certain patient groups, according to the authors.
They highlighted, for example, the dearth of data on subgroups or on underserved and vulnerable populations, with no head-to-head studies identified in their review. In addition, they found no studies examining VTC versus usual care for patients with concurrent conditions or on its effect on health equity and disparities.
“It’s now our job to understand the ongoing barriers to telemedicine access, including the digital divide and the usability of telemedicine platforms, and design interventions that overcome them,” Dr. Frydman said. “At the same time, we need to make sure we’re understanding and respecting the preferences of older adults in terms of how they access health care.”
This study was supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Albritton is employed by RTI International, the contractor responsible for conducting the research and developing the manuscript. Several coauthors disclosed support from or contracts with PCORI. One coauthor’s spouse holds stock in private health companies. Dr. Frydman, Dr. Iyengar, and Dr. Wilkes disclosed no competing interests relevant to their comments.
FROM ANNALS OF INTERNAL MEDICINE
Is it time to change the definition of ‘fully vaccinated’?
As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming,
It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.
At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.
The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.
Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.
“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.
But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”
Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.
“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.
New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.
What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.
“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”
Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.
Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.
Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.
Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.
But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.
Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming,
It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.
At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.
The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.
Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.
“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.
But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”
Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.
“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.
New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.
What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.
“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”
Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.
Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.
Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.
Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.
But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.
Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming,
It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.
At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.
The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.
Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.
“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.
But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”
Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.
“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.
New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.
What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.
“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”
Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.
Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.
Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.
Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.
But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.
Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Seven legal risks of promoting unproven COVID-19 treatments
The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.
Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.
The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.
Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. This can have serious legal consequences.
The crux of the issue
This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.
On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:
“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”
What are the legal consequences?
Medical malpractice
The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.
The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.
By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.
In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.
In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
Professional licensing action
Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.
This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.
In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.
The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.
The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.
Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.
Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.
In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
Peer review and affected privileges
Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.
The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
Criminal charges
Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.
Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
Breach of contract
Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.
Reputation/credibility damage and the attendant consequences
In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.
Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.
In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
Violation of the COVID-19 Consumer Protection Act of 2020
For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.
The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.
Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”
After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.
In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
Conclusion
It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.
Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.
The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.
Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.
The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.
Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. This can have serious legal consequences.
The crux of the issue
This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.
On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:
“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”
What are the legal consequences?
Medical malpractice
The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.
The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.
By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.
In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.
In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
Professional licensing action
Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.
This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.
In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.
The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.
The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.
Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.
Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.
In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
Peer review and affected privileges
Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.
The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
Criminal charges
Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.
Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
Breach of contract
Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.
Reputation/credibility damage and the attendant consequences
In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.
Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.
In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
Violation of the COVID-19 Consumer Protection Act of 2020
For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.
The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.
Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”
After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.
In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
Conclusion
It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.
Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.
The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.
Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.
The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.
Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. This can have serious legal consequences.
The crux of the issue
This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.
On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:
“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”
What are the legal consequences?
Medical malpractice
The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.
The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.
By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.
In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.
In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
Professional licensing action
Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.
This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.
In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.
The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.
The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.
Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.
Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.
In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
Peer review and affected privileges
Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.
The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
Criminal charges
Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.
Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
Breach of contract
Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.
Reputation/credibility damage and the attendant consequences
In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.
Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.
In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
Violation of the COVID-19 Consumer Protection Act of 2020
For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.
The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.
Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”
After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.
In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
Conclusion
It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.
Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.
OSA linked to white-matter hyperintensities
Individuals diagnosed with obstructive sleep apnea (OSA) have higher volumes of white-matter hyperintensities (WMHs), according to a new analysis of data from the SHIP-Trend-0 cohort in Western Pomerania, Germany, which is part of the Study of Health In Pomerania. The association was true for individual measures of OSA, including apnea-hypopnea index (AHI) and oxygen desaturation index (ODI).
WMHs are often seen on MRI in older people and in patients with stroke or dementia, and they may be an indicator of cerebral small-vessel disease. They are linked to greater risk of abnormal gait, worsening balance, depression, cognitive decline, dementia, stroke, and death. Suggested mechanisms for harms from WMHs include ischemia, hypoxia, hypoperfusion, inflammation, and demyelination.
WMHs have been linked to vascular risk factors like smoking, diabetes, and hypertension. Brain pathology studies have found loss of myelin, axonal loss, and scarring close to WMHs.
Although a few studies have looked for associations between WMHs and OSA, they have yielded inconsistent results. The new work employed highly standardized data collection and more complete covariate adjustment. The results, published in JAMA Network Open, suggest a novel, and potentially treatable, pathological WMH mechanism, according to the authors.
“This is an important study. It has strong methodology. The automated analysis of WMH in a large population-based cohort helps to eliminate several biases that can occur in this type of assessment. The data analysis was massive, with adequate control of all potential confounders and testing for interactions. This generated robust results,” said Diego Z. Carvalho, MD, who was asked to comment on the findings. Dr. Carvalho is an assistant professor of neurology at the Center for Sleep Medicine at the Mayo Clinic, Rochester, Minn.
Worse apnea, worse hyperintensity
“The association varies according to the degree of apnea severity, so mild OSA is probably not associated with increased WMH, while severe OSA is mostly likely driving most of the associations,” said Dr. Carvalho.
If a causal mechanism were to be proven, it would “bring a stronger call for treatment of severe OSA patients, particularly those with increased risk for small-vessel disease, [such as] patients with metabolic syndrome. Likewise, patients with severe OSA would be the best candidates for therapeutic trials with [continuous positive airway pressure] with or without possible adjunctive neuroprotective treatment for halting or slowing down WMH progression,” said Dr. Carvalho.
Stuart McCarter, MD, who is an instructor of neurology at the Center for Sleep Medicine at the Mayo Clinic, Rochester, Minn., also found the results interesting but pointed out that much more work needs to be done. “While they found a relationship between OSA as well as OSA severity and WMH despite adjusting for other known confounders, it is unlikely that it is as simple as OSA is the main causal factor for WMH, given the complex relationship between OSA, hypertension, and metabolic syndrome. However, this data does highlight the importance of considering OSA in addition to other more traditional risk factors when considering modifiable risk factors for brain aging,” said Dr. McCarter. The study cohort was mostly of White European ancestry, so more work also needs to be done in other racial groups.
The study underlines the importance of screening among individuals with cognitive impairment. “If OSA represents a modifiable risk factor for WMH and associated cognitive decline, then it would represent one of the few potentially treatable etiologies, or at least contributors of cognitive impairment,” said Dr. McCarter.
The SHIP-Trend-0 cohort is drawn from adults in Western Pomerania. The researchers analyzed data from 529 patients who had WMH and for whom intracranial volume data were available. Each member of the cohort also underwent polysomnography.
Based on AHI criteria, 24% of the overall sample had mild OSA, 10% had moderate OSA, and 6% had severe OSA.
After adjustment for sex, age, intracranial volume, and body weight, WMH volume was associated with AHI (beta = 0.024; P < .001) and ODI (beta = 0.033; P < .001). WMH counts were also associated with AHI (beta = 0.008; P = .01) and ODI (beta = 0.011; P = .02).
The effect size increased with greater OSA severity, as measured by AHI for both WMH volume (beta = 0.312, 0.480, and 1.255 for mild, moderate, and severe OSA, respectively) and WMH count (beta = 0.129, 0.107, and 0.419). The ODI regression models showed similar associations for WMH volume (beta = 0.426, 1.030, and 1.130) and WMH count (beta = 0.141, 0.315, and 0.538).
Dr. Carvalho and Dr. McCarter disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Individuals diagnosed with obstructive sleep apnea (OSA) have higher volumes of white-matter hyperintensities (WMHs), according to a new analysis of data from the SHIP-Trend-0 cohort in Western Pomerania, Germany, which is part of the Study of Health In Pomerania. The association was true for individual measures of OSA, including apnea-hypopnea index (AHI) and oxygen desaturation index (ODI).
WMHs are often seen on MRI in older people and in patients with stroke or dementia, and they may be an indicator of cerebral small-vessel disease. They are linked to greater risk of abnormal gait, worsening balance, depression, cognitive decline, dementia, stroke, and death. Suggested mechanisms for harms from WMHs include ischemia, hypoxia, hypoperfusion, inflammation, and demyelination.
WMHs have been linked to vascular risk factors like smoking, diabetes, and hypertension. Brain pathology studies have found loss of myelin, axonal loss, and scarring close to WMHs.
Although a few studies have looked for associations between WMHs and OSA, they have yielded inconsistent results. The new work employed highly standardized data collection and more complete covariate adjustment. The results, published in JAMA Network Open, suggest a novel, and potentially treatable, pathological WMH mechanism, according to the authors.
“This is an important study. It has strong methodology. The automated analysis of WMH in a large population-based cohort helps to eliminate several biases that can occur in this type of assessment. The data analysis was massive, with adequate control of all potential confounders and testing for interactions. This generated robust results,” said Diego Z. Carvalho, MD, who was asked to comment on the findings. Dr. Carvalho is an assistant professor of neurology at the Center for Sleep Medicine at the Mayo Clinic, Rochester, Minn.
Worse apnea, worse hyperintensity
“The association varies according to the degree of apnea severity, so mild OSA is probably not associated with increased WMH, while severe OSA is mostly likely driving most of the associations,” said Dr. Carvalho.
If a causal mechanism were to be proven, it would “bring a stronger call for treatment of severe OSA patients, particularly those with increased risk for small-vessel disease, [such as] patients with metabolic syndrome. Likewise, patients with severe OSA would be the best candidates for therapeutic trials with [continuous positive airway pressure] with or without possible adjunctive neuroprotective treatment for halting or slowing down WMH progression,” said Dr. Carvalho.
Stuart McCarter, MD, who is an instructor of neurology at the Center for Sleep Medicine at the Mayo Clinic, Rochester, Minn., also found the results interesting but pointed out that much more work needs to be done. “While they found a relationship between OSA as well as OSA severity and WMH despite adjusting for other known confounders, it is unlikely that it is as simple as OSA is the main causal factor for WMH, given the complex relationship between OSA, hypertension, and metabolic syndrome. However, this data does highlight the importance of considering OSA in addition to other more traditional risk factors when considering modifiable risk factors for brain aging,” said Dr. McCarter. The study cohort was mostly of White European ancestry, so more work also needs to be done in other racial groups.
The study underlines the importance of screening among individuals with cognitive impairment. “If OSA represents a modifiable risk factor for WMH and associated cognitive decline, then it would represent one of the few potentially treatable etiologies, or at least contributors of cognitive impairment,” said Dr. McCarter.
The SHIP-Trend-0 cohort is drawn from adults in Western Pomerania. The researchers analyzed data from 529 patients who had WMH and for whom intracranial volume data were available. Each member of the cohort also underwent polysomnography.
Based on AHI criteria, 24% of the overall sample had mild OSA, 10% had moderate OSA, and 6% had severe OSA.
After adjustment for sex, age, intracranial volume, and body weight, WMH volume was associated with AHI (beta = 0.024; P < .001) and ODI (beta = 0.033; P < .001). WMH counts were also associated with AHI (beta = 0.008; P = .01) and ODI (beta = 0.011; P = .02).
The effect size increased with greater OSA severity, as measured by AHI for both WMH volume (beta = 0.312, 0.480, and 1.255 for mild, moderate, and severe OSA, respectively) and WMH count (beta = 0.129, 0.107, and 0.419). The ODI regression models showed similar associations for WMH volume (beta = 0.426, 1.030, and 1.130) and WMH count (beta = 0.141, 0.315, and 0.538).
Dr. Carvalho and Dr. McCarter disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Individuals diagnosed with obstructive sleep apnea (OSA) have higher volumes of white-matter hyperintensities (WMHs), according to a new analysis of data from the SHIP-Trend-0 cohort in Western Pomerania, Germany, which is part of the Study of Health In Pomerania. The association was true for individual measures of OSA, including apnea-hypopnea index (AHI) and oxygen desaturation index (ODI).
WMHs are often seen on MRI in older people and in patients with stroke or dementia, and they may be an indicator of cerebral small-vessel disease. They are linked to greater risk of abnormal gait, worsening balance, depression, cognitive decline, dementia, stroke, and death. Suggested mechanisms for harms from WMHs include ischemia, hypoxia, hypoperfusion, inflammation, and demyelination.
WMHs have been linked to vascular risk factors like smoking, diabetes, and hypertension. Brain pathology studies have found loss of myelin, axonal loss, and scarring close to WMHs.
Although a few studies have looked for associations between WMHs and OSA, they have yielded inconsistent results. The new work employed highly standardized data collection and more complete covariate adjustment. The results, published in JAMA Network Open, suggest a novel, and potentially treatable, pathological WMH mechanism, according to the authors.
“This is an important study. It has strong methodology. The automated analysis of WMH in a large population-based cohort helps to eliminate several biases that can occur in this type of assessment. The data analysis was massive, with adequate control of all potential confounders and testing for interactions. This generated robust results,” said Diego Z. Carvalho, MD, who was asked to comment on the findings. Dr. Carvalho is an assistant professor of neurology at the Center for Sleep Medicine at the Mayo Clinic, Rochester, Minn.
Worse apnea, worse hyperintensity
“The association varies according to the degree of apnea severity, so mild OSA is probably not associated with increased WMH, while severe OSA is mostly likely driving most of the associations,” said Dr. Carvalho.
If a causal mechanism were to be proven, it would “bring a stronger call for treatment of severe OSA patients, particularly those with increased risk for small-vessel disease, [such as] patients with metabolic syndrome. Likewise, patients with severe OSA would be the best candidates for therapeutic trials with [continuous positive airway pressure] with or without possible adjunctive neuroprotective treatment for halting or slowing down WMH progression,” said Dr. Carvalho.
Stuart McCarter, MD, who is an instructor of neurology at the Center for Sleep Medicine at the Mayo Clinic, Rochester, Minn., also found the results interesting but pointed out that much more work needs to be done. “While they found a relationship between OSA as well as OSA severity and WMH despite adjusting for other known confounders, it is unlikely that it is as simple as OSA is the main causal factor for WMH, given the complex relationship between OSA, hypertension, and metabolic syndrome. However, this data does highlight the importance of considering OSA in addition to other more traditional risk factors when considering modifiable risk factors for brain aging,” said Dr. McCarter. The study cohort was mostly of White European ancestry, so more work also needs to be done in other racial groups.
The study underlines the importance of screening among individuals with cognitive impairment. “If OSA represents a modifiable risk factor for WMH and associated cognitive decline, then it would represent one of the few potentially treatable etiologies, or at least contributors of cognitive impairment,” said Dr. McCarter.
The SHIP-Trend-0 cohort is drawn from adults in Western Pomerania. The researchers analyzed data from 529 patients who had WMH and for whom intracranial volume data were available. Each member of the cohort also underwent polysomnography.
Based on AHI criteria, 24% of the overall sample had mild OSA, 10% had moderate OSA, and 6% had severe OSA.
After adjustment for sex, age, intracranial volume, and body weight, WMH volume was associated with AHI (beta = 0.024; P < .001) and ODI (beta = 0.033; P < .001). WMH counts were also associated with AHI (beta = 0.008; P = .01) and ODI (beta = 0.011; P = .02).
The effect size increased with greater OSA severity, as measured by AHI for both WMH volume (beta = 0.312, 0.480, and 1.255 for mild, moderate, and severe OSA, respectively) and WMH count (beta = 0.129, 0.107, and 0.419). The ODI regression models showed similar associations for WMH volume (beta = 0.426, 1.030, and 1.130) and WMH count (beta = 0.141, 0.315, and 0.538).
Dr. Carvalho and Dr. McCarter disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sleep disorders and cancer: It’s complicated
Sleep apnea and other types of sleep disorders appear to elevate the risk for some types of cancer, specifically prostate cancer, more so than others. But the overall risk can be highly variable, and some sleep problems were found to be associated with a lower risk for cancer and cancer-related death, an analysis of a large observational cohort study of cardiovascular patients found.
Results of the analysis were published online in the journal Cancer Epidemiology. Investigators analyzed the presence of sleep apnea and insomnia and cancer risk in more than 8,500 patients in the Cardiovascular Health Study (CHS). “The fact that we observed certain sleep problems, like apneas, to be associated with elevated risk of some cancers but not others reflects the fact that cancer is a heterogeneous disease,” senior author Amanda Phipps, PhD, said in an interview. Dr. Phipps is an associate professor of epidemiology at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle.
Variable cancer links
The researchers assessed sleep problems in two groups in the CHS: an incident cancer group of 3,930 patients and a cancer mortality group of 4,580 patients. Within those respective groups, the investigators identified 885 first-incident cancers and 804 cancer deaths with a median follow-up of 12 and 14 years. The average age of the study population was 73 years, and 57% were women.
Sleep apnea symptoms (SAS) were associated with a lower risk for incident cancers – a 16% lower baseline risk and a 24% lower time-dependent risk. The study showed no association between cancer incidence and daytime sleepiness and apneas.
However, there was a significantly elevated risk relationship between sleep problems and prostate cancer. A time-dependent analysis of apnea showed more than double the risk (hazard ratio, 2.34), and baseline snoring carried a 69% greater risk. There was also a dose-response relationship for baseline cumulative SAS, compared with not having symptoms: an HR of 1.30 for one symptom, and 2.22 for two or more symptoms.
Risks for lymphatic or hematopoietic cancers were also associated with baseline daytime sleepiness (HR, 1.81), but not with insomnia (HR, 0.54).
With regard to cancer mortality, the study found no relationship between sleep problems and cancer death. In fact, it found an overall inverse relationship with snoring (time-dependent HR, 0.73; cumulative average HR, 0.67) and baseline apnea (HR, 0.69). Likewise, patients reporting SAS had lower risks than those having no SAS: an HR of 0.90 for one symptom and 0.75 for multiple symptoms. No relationships were found between any insomnia symptom and cancer death.
“We know the pathways that lead to prostate cancer can be very different than the pathways that lead to colorectal cancer,” Dr. Phipps said. “What we don’t yet understand is why these associations differ or what mechanisms are responsible for these cancer site-specific associations.”
Need for sleep assessment
The findings don’t change much for how clinicians should evaluate cancer risks in patients with sleep problems, Dr. Phipps said. “Other studies have clearly demonstrated the implications that sleep apnea has for a variety of other important health conditions – such as cardiovascular disease – so there are already plenty of good reasons for clinicians to ask their patients about their sleep and to connect patients with resources for the diagnosis and treatment of sleep apnea,” she added. “This study provides another possible reason.”
These findings provide context for future studies of the relationship between sleep problems and cancer. “But, given that sleep is something we all do and given that sleep problems are so pervasive, it’s important that we keep trying to better understand this relationship,” Dr. Phipps said.
“My hope is that future cancer studies will build in more detailed, longitudinal information on sleep patterns to help us fill current gaps in knowledge.”
Dr. Phipps has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sleep apnea and other types of sleep disorders appear to elevate the risk for some types of cancer, specifically prostate cancer, more so than others. But the overall risk can be highly variable, and some sleep problems were found to be associated with a lower risk for cancer and cancer-related death, an analysis of a large observational cohort study of cardiovascular patients found.
Results of the analysis were published online in the journal Cancer Epidemiology. Investigators analyzed the presence of sleep apnea and insomnia and cancer risk in more than 8,500 patients in the Cardiovascular Health Study (CHS). “The fact that we observed certain sleep problems, like apneas, to be associated with elevated risk of some cancers but not others reflects the fact that cancer is a heterogeneous disease,” senior author Amanda Phipps, PhD, said in an interview. Dr. Phipps is an associate professor of epidemiology at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle.
Variable cancer links
The researchers assessed sleep problems in two groups in the CHS: an incident cancer group of 3,930 patients and a cancer mortality group of 4,580 patients. Within those respective groups, the investigators identified 885 first-incident cancers and 804 cancer deaths with a median follow-up of 12 and 14 years. The average age of the study population was 73 years, and 57% were women.
Sleep apnea symptoms (SAS) were associated with a lower risk for incident cancers – a 16% lower baseline risk and a 24% lower time-dependent risk. The study showed no association between cancer incidence and daytime sleepiness and apneas.
However, there was a significantly elevated risk relationship between sleep problems and prostate cancer. A time-dependent analysis of apnea showed more than double the risk (hazard ratio, 2.34), and baseline snoring carried a 69% greater risk. There was also a dose-response relationship for baseline cumulative SAS, compared with not having symptoms: an HR of 1.30 for one symptom, and 2.22 for two or more symptoms.
Risks for lymphatic or hematopoietic cancers were also associated with baseline daytime sleepiness (HR, 1.81), but not with insomnia (HR, 0.54).
With regard to cancer mortality, the study found no relationship between sleep problems and cancer death. In fact, it found an overall inverse relationship with snoring (time-dependent HR, 0.73; cumulative average HR, 0.67) and baseline apnea (HR, 0.69). Likewise, patients reporting SAS had lower risks than those having no SAS: an HR of 0.90 for one symptom and 0.75 for multiple symptoms. No relationships were found between any insomnia symptom and cancer death.
“We know the pathways that lead to prostate cancer can be very different than the pathways that lead to colorectal cancer,” Dr. Phipps said. “What we don’t yet understand is why these associations differ or what mechanisms are responsible for these cancer site-specific associations.”
Need for sleep assessment
The findings don’t change much for how clinicians should evaluate cancer risks in patients with sleep problems, Dr. Phipps said. “Other studies have clearly demonstrated the implications that sleep apnea has for a variety of other important health conditions – such as cardiovascular disease – so there are already plenty of good reasons for clinicians to ask their patients about their sleep and to connect patients with resources for the diagnosis and treatment of sleep apnea,” she added. “This study provides another possible reason.”
These findings provide context for future studies of the relationship between sleep problems and cancer. “But, given that sleep is something we all do and given that sleep problems are so pervasive, it’s important that we keep trying to better understand this relationship,” Dr. Phipps said.
“My hope is that future cancer studies will build in more detailed, longitudinal information on sleep patterns to help us fill current gaps in knowledge.”
Dr. Phipps has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sleep apnea and other types of sleep disorders appear to elevate the risk for some types of cancer, specifically prostate cancer, more so than others. But the overall risk can be highly variable, and some sleep problems were found to be associated with a lower risk for cancer and cancer-related death, an analysis of a large observational cohort study of cardiovascular patients found.
Results of the analysis were published online in the journal Cancer Epidemiology. Investigators analyzed the presence of sleep apnea and insomnia and cancer risk in more than 8,500 patients in the Cardiovascular Health Study (CHS). “The fact that we observed certain sleep problems, like apneas, to be associated with elevated risk of some cancers but not others reflects the fact that cancer is a heterogeneous disease,” senior author Amanda Phipps, PhD, said in an interview. Dr. Phipps is an associate professor of epidemiology at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle.
Variable cancer links
The researchers assessed sleep problems in two groups in the CHS: an incident cancer group of 3,930 patients and a cancer mortality group of 4,580 patients. Within those respective groups, the investigators identified 885 first-incident cancers and 804 cancer deaths with a median follow-up of 12 and 14 years. The average age of the study population was 73 years, and 57% were women.
Sleep apnea symptoms (SAS) were associated with a lower risk for incident cancers – a 16% lower baseline risk and a 24% lower time-dependent risk. The study showed no association between cancer incidence and daytime sleepiness and apneas.
However, there was a significantly elevated risk relationship between sleep problems and prostate cancer. A time-dependent analysis of apnea showed more than double the risk (hazard ratio, 2.34), and baseline snoring carried a 69% greater risk. There was also a dose-response relationship for baseline cumulative SAS, compared with not having symptoms: an HR of 1.30 for one symptom, and 2.22 for two or more symptoms.
Risks for lymphatic or hematopoietic cancers were also associated with baseline daytime sleepiness (HR, 1.81), but not with insomnia (HR, 0.54).
With regard to cancer mortality, the study found no relationship between sleep problems and cancer death. In fact, it found an overall inverse relationship with snoring (time-dependent HR, 0.73; cumulative average HR, 0.67) and baseline apnea (HR, 0.69). Likewise, patients reporting SAS had lower risks than those having no SAS: an HR of 0.90 for one symptom and 0.75 for multiple symptoms. No relationships were found between any insomnia symptom and cancer death.
“We know the pathways that lead to prostate cancer can be very different than the pathways that lead to colorectal cancer,” Dr. Phipps said. “What we don’t yet understand is why these associations differ or what mechanisms are responsible for these cancer site-specific associations.”
Need for sleep assessment
The findings don’t change much for how clinicians should evaluate cancer risks in patients with sleep problems, Dr. Phipps said. “Other studies have clearly demonstrated the implications that sleep apnea has for a variety of other important health conditions – such as cardiovascular disease – so there are already plenty of good reasons for clinicians to ask their patients about their sleep and to connect patients with resources for the diagnosis and treatment of sleep apnea,” she added. “This study provides another possible reason.”
These findings provide context for future studies of the relationship between sleep problems and cancer. “But, given that sleep is something we all do and given that sleep problems are so pervasive, it’s important that we keep trying to better understand this relationship,” Dr. Phipps said.
“My hope is that future cancer studies will build in more detailed, longitudinal information on sleep patterns to help us fill current gaps in knowledge.”
Dr. Phipps has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CANCER EPIDEMIOLOGY
Clinical Edge Journal Scan Commentary: CAP December 2021
The virtual elimination of Haemophilus influenzae type B as a respiratory pathogen, recognition of Mycoplasma pneumoniae as a common cause of pneumonia in older children and young adults, and atypical pathogens in elderly adults have recently changed our selection of initial empiric antimicrobial therapy for lower respiratory tract infections in some patients. It is increasingly important to use such information since narrow-spectrum antibiotics for empiric therapy of moderately severe community acquired pneumonia (CAP) should be standard therapy.1 On the other hand, the addition of doxycycline to a beta-lactam antibiotic has recently been shown to improve outcomes of CAP in elderly adults.2 Along with advanced age, male gender is also a risk factor for treatment failure of moderately severe CAP,3 so should be taken into consideration in management decisions.
If a patient with mild CAP does not respond to initial antibacterial therapy, the most likely explanation is a viral cause. Other bacterial causes might also be considered, such as Staphylococcus aureus, multi-resistant pneumococcus, coliforms, ampicillin-resistant H. influenzae, fungi, or anaerobes depending on clinical and laboratory factors.
New, rapid diagnostic tests are also useful in making clinical decisions and are particularly important for children who are unable to produce sputum for examination and whose small airways limit use of bronchoscopy. Recent studies have shown that heparin-binding protein (HBP) predicts disease progression in children with severe CAP, directing the physician to do further testing of microbiologic etiology.4
Treatment of pneumonia is usually empiric. If Chlamydia pneumoniae or M. pneumoniae is suspected as the responsible pathogen, azithromycin should be used as primary therapy. Quinolones or tetracycline-based antibiotics can be considered when macrolides are not tolerated. In children with community-acquired pneumonia (CAP) discharged from emergency departments or inpatient wards, findings from a trial including 814 children > 6 months old with CAP found that a lower dose and shorter course of amoxicillin was not inferior compared to higher doses and longer courses. The children were randomly assigned 1:1 after hospital discharge to receive one of the 4 possible combinations of amoxicillin dose (35-50 or 70-90 mg/kg) and duration (3 or 7 days). The results indicated that further outpatient treatment with amoxicillin at the lower dose was not inferior to a higher dose, and a 3-day treatment course was not inferior to a 7-day treatment course.5
Pneumococcal urinary antigen testing (PUAT) has recently been shown to direct narrow spectrum antibiotic therapy when positive in children or allow earlier de-escalation from broad spectrum antibiotics.6
When Staphylococcus aureus is suspected, methicillin resistance (MRSA) must be considered. Vancomycin has been standard therapy for this pathogen unless clindamycin susceptibility is documented. A recent study showed that the newer cephalosporin, ceftaroline, used as monotherapy or in combination with a macrolide or quinolone resulted in a lower hospital mortality rate than standard therapy with vancomycin or combination antibiotics.7
Other data used to determine probable causes of CAP include associated clinical signs and symptoms, chest x-ray findings, and diagnostic laboratory tests. Sputum is rarely produced by children during episodes of pneumonia, so the usual common step in the management of adult severe pneumonias, Gram stain examination of sputum is eliminated.
Antibiotics are selected primarily on the basis of age and severity of illness. Duration of therapy is 7 to 10 days for uncomplicated CAP. Once the causative agent is identified by culture or with one of the rapid antigen detection assays, specific therapy may be readily selected.
Treatment of pneumonia is usually empiric but the preference for narrow spectrum antibiotics should be emphasized .1 Amoxicillin for children and a quinolone for adults is the usual therapy.
If a patient with mild CAP does not respond to initial antibacterial therapy, the most likely explanation is a viral cause but for severely ill patients, other bacterial etiologies should also be considered, particularly MRSA where the addition of caftaroline would be considered.7
References
- Schweitzer VA et al. Narrow-spectrum antibiotics for community-acquired pneumonia in Dutch adults (CAP-PACT): a cross-sectional, stepped-wedge, cluster-randomised, non-inferiority, antimicrobial stewardship intervention trial. Lancet Infect Dis. 2021(Oct 7).
- Uddin M et al. Effectiveness of Beta-Lactam plus Doxycycline for Patients Hospitalized with Community-Acquired Pneumonia Clin Infect Dis. 2021;ciab863 (Nov 9).
- Dinh A et al. Factors Associated With Treatment Failure in Moderately Severe Community-Acquired Pneumonia: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021;4(10):e2129566 (Oct 15).
- Huang C et al. Heparin-Binding Protein in Critically Ill Children With Severe Community-Acquired Pneumonia. Front Pediatr. 2021 (Oct 28).
- Bielicki JA et al. Effect of Amoxicillin Dose and Treatment Duration on the Need for Antibiotic Re-treatment in Children With Community-Acquired Pneumonia: The CAP-IT Randomized Clinical Trial. JAMA. 2021;326(17):1713-1724 (Nov 2).
- Greenfield A et al. Impact of Streptococcus pneumoniae Urinary Antigen Testing in Patients with Community-acquired Pneumonia Admitted within a Large Academic Health System. Open Forum Infect Dis. 2021;ofab522 (Oct 22).
- Cilloniz C et al. Impact on in-hospital mortality of ceftaroline versus standard of care in community-acquired pneumonia: a propensity-matched analysis. Eur J Clin Microbiol Infect Dis. 2021 (Nov 12).
The virtual elimination of Haemophilus influenzae type B as a respiratory pathogen, recognition of Mycoplasma pneumoniae as a common cause of pneumonia in older children and young adults, and atypical pathogens in elderly adults have recently changed our selection of initial empiric antimicrobial therapy for lower respiratory tract infections in some patients. It is increasingly important to use such information since narrow-spectrum antibiotics for empiric therapy of moderately severe community acquired pneumonia (CAP) should be standard therapy.1 On the other hand, the addition of doxycycline to a beta-lactam antibiotic has recently been shown to improve outcomes of CAP in elderly adults.2 Along with advanced age, male gender is also a risk factor for treatment failure of moderately severe CAP,3 so should be taken into consideration in management decisions.
If a patient with mild CAP does not respond to initial antibacterial therapy, the most likely explanation is a viral cause. Other bacterial causes might also be considered, such as Staphylococcus aureus, multi-resistant pneumococcus, coliforms, ampicillin-resistant H. influenzae, fungi, or anaerobes depending on clinical and laboratory factors.
New, rapid diagnostic tests are also useful in making clinical decisions and are particularly important for children who are unable to produce sputum for examination and whose small airways limit use of bronchoscopy. Recent studies have shown that heparin-binding protein (HBP) predicts disease progression in children with severe CAP, directing the physician to do further testing of microbiologic etiology.4
Treatment of pneumonia is usually empiric. If Chlamydia pneumoniae or M. pneumoniae is suspected as the responsible pathogen, azithromycin should be used as primary therapy. Quinolones or tetracycline-based antibiotics can be considered when macrolides are not tolerated. In children with community-acquired pneumonia (CAP) discharged from emergency departments or inpatient wards, findings from a trial including 814 children > 6 months old with CAP found that a lower dose and shorter course of amoxicillin was not inferior compared to higher doses and longer courses. The children were randomly assigned 1:1 after hospital discharge to receive one of the 4 possible combinations of amoxicillin dose (35-50 or 70-90 mg/kg) and duration (3 or 7 days). The results indicated that further outpatient treatment with amoxicillin at the lower dose was not inferior to a higher dose, and a 3-day treatment course was not inferior to a 7-day treatment course.5
Pneumococcal urinary antigen testing (PUAT) has recently been shown to direct narrow spectrum antibiotic therapy when positive in children or allow earlier de-escalation from broad spectrum antibiotics.6
When Staphylococcus aureus is suspected, methicillin resistance (MRSA) must be considered. Vancomycin has been standard therapy for this pathogen unless clindamycin susceptibility is documented. A recent study showed that the newer cephalosporin, ceftaroline, used as monotherapy or in combination with a macrolide or quinolone resulted in a lower hospital mortality rate than standard therapy with vancomycin or combination antibiotics.7
Other data used to determine probable causes of CAP include associated clinical signs and symptoms, chest x-ray findings, and diagnostic laboratory tests. Sputum is rarely produced by children during episodes of pneumonia, so the usual common step in the management of adult severe pneumonias, Gram stain examination of sputum is eliminated.
Antibiotics are selected primarily on the basis of age and severity of illness. Duration of therapy is 7 to 10 days for uncomplicated CAP. Once the causative agent is identified by culture or with one of the rapid antigen detection assays, specific therapy may be readily selected.
Treatment of pneumonia is usually empiric but the preference for narrow spectrum antibiotics should be emphasized .1 Amoxicillin for children and a quinolone for adults is the usual therapy.
If a patient with mild CAP does not respond to initial antibacterial therapy, the most likely explanation is a viral cause but for severely ill patients, other bacterial etiologies should also be considered, particularly MRSA where the addition of caftaroline would be considered.7
References
- Schweitzer VA et al. Narrow-spectrum antibiotics for community-acquired pneumonia in Dutch adults (CAP-PACT): a cross-sectional, stepped-wedge, cluster-randomised, non-inferiority, antimicrobial stewardship intervention trial. Lancet Infect Dis. 2021(Oct 7).
- Uddin M et al. Effectiveness of Beta-Lactam plus Doxycycline for Patients Hospitalized with Community-Acquired Pneumonia Clin Infect Dis. 2021;ciab863 (Nov 9).
- Dinh A et al. Factors Associated With Treatment Failure in Moderately Severe Community-Acquired Pneumonia: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021;4(10):e2129566 (Oct 15).
- Huang C et al. Heparin-Binding Protein in Critically Ill Children With Severe Community-Acquired Pneumonia. Front Pediatr. 2021 (Oct 28).
- Bielicki JA et al. Effect of Amoxicillin Dose and Treatment Duration on the Need for Antibiotic Re-treatment in Children With Community-Acquired Pneumonia: The CAP-IT Randomized Clinical Trial. JAMA. 2021;326(17):1713-1724 (Nov 2).
- Greenfield A et al. Impact of Streptococcus pneumoniae Urinary Antigen Testing in Patients with Community-acquired Pneumonia Admitted within a Large Academic Health System. Open Forum Infect Dis. 2021;ofab522 (Oct 22).
- Cilloniz C et al. Impact on in-hospital mortality of ceftaroline versus standard of care in community-acquired pneumonia: a propensity-matched analysis. Eur J Clin Microbiol Infect Dis. 2021 (Nov 12).
The virtual elimination of Haemophilus influenzae type B as a respiratory pathogen, recognition of Mycoplasma pneumoniae as a common cause of pneumonia in older children and young adults, and atypical pathogens in elderly adults have recently changed our selection of initial empiric antimicrobial therapy for lower respiratory tract infections in some patients. It is increasingly important to use such information since narrow-spectrum antibiotics for empiric therapy of moderately severe community acquired pneumonia (CAP) should be standard therapy.1 On the other hand, the addition of doxycycline to a beta-lactam antibiotic has recently been shown to improve outcomes of CAP in elderly adults.2 Along with advanced age, male gender is also a risk factor for treatment failure of moderately severe CAP,3 so should be taken into consideration in management decisions.
If a patient with mild CAP does not respond to initial antibacterial therapy, the most likely explanation is a viral cause. Other bacterial causes might also be considered, such as Staphylococcus aureus, multi-resistant pneumococcus, coliforms, ampicillin-resistant H. influenzae, fungi, or anaerobes depending on clinical and laboratory factors.
New, rapid diagnostic tests are also useful in making clinical decisions and are particularly important for children who are unable to produce sputum for examination and whose small airways limit use of bronchoscopy. Recent studies have shown that heparin-binding protein (HBP) predicts disease progression in children with severe CAP, directing the physician to do further testing of microbiologic etiology.4
Treatment of pneumonia is usually empiric. If Chlamydia pneumoniae or M. pneumoniae is suspected as the responsible pathogen, azithromycin should be used as primary therapy. Quinolones or tetracycline-based antibiotics can be considered when macrolides are not tolerated. In children with community-acquired pneumonia (CAP) discharged from emergency departments or inpatient wards, findings from a trial including 814 children > 6 months old with CAP found that a lower dose and shorter course of amoxicillin was not inferior compared to higher doses and longer courses. The children were randomly assigned 1:1 after hospital discharge to receive one of the 4 possible combinations of amoxicillin dose (35-50 or 70-90 mg/kg) and duration (3 or 7 days). The results indicated that further outpatient treatment with amoxicillin at the lower dose was not inferior to a higher dose, and a 3-day treatment course was not inferior to a 7-day treatment course.5
Pneumococcal urinary antigen testing (PUAT) has recently been shown to direct narrow spectrum antibiotic therapy when positive in children or allow earlier de-escalation from broad spectrum antibiotics.6
When Staphylococcus aureus is suspected, methicillin resistance (MRSA) must be considered. Vancomycin has been standard therapy for this pathogen unless clindamycin susceptibility is documented. A recent study showed that the newer cephalosporin, ceftaroline, used as monotherapy or in combination with a macrolide or quinolone resulted in a lower hospital mortality rate than standard therapy with vancomycin or combination antibiotics.7
Other data used to determine probable causes of CAP include associated clinical signs and symptoms, chest x-ray findings, and diagnostic laboratory tests. Sputum is rarely produced by children during episodes of pneumonia, so the usual common step in the management of adult severe pneumonias, Gram stain examination of sputum is eliminated.
Antibiotics are selected primarily on the basis of age and severity of illness. Duration of therapy is 7 to 10 days for uncomplicated CAP. Once the causative agent is identified by culture or with one of the rapid antigen detection assays, specific therapy may be readily selected.
Treatment of pneumonia is usually empiric but the preference for narrow spectrum antibiotics should be emphasized .1 Amoxicillin for children and a quinolone for adults is the usual therapy.
If a patient with mild CAP does not respond to initial antibacterial therapy, the most likely explanation is a viral cause but for severely ill patients, other bacterial etiologies should also be considered, particularly MRSA where the addition of caftaroline would be considered.7
References
- Schweitzer VA et al. Narrow-spectrum antibiotics for community-acquired pneumonia in Dutch adults (CAP-PACT): a cross-sectional, stepped-wedge, cluster-randomised, non-inferiority, antimicrobial stewardship intervention trial. Lancet Infect Dis. 2021(Oct 7).
- Uddin M et al. Effectiveness of Beta-Lactam plus Doxycycline for Patients Hospitalized with Community-Acquired Pneumonia Clin Infect Dis. 2021;ciab863 (Nov 9).
- Dinh A et al. Factors Associated With Treatment Failure in Moderately Severe Community-Acquired Pneumonia: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021;4(10):e2129566 (Oct 15).
- Huang C et al. Heparin-Binding Protein in Critically Ill Children With Severe Community-Acquired Pneumonia. Front Pediatr. 2021 (Oct 28).
- Bielicki JA et al. Effect of Amoxicillin Dose and Treatment Duration on the Need for Antibiotic Re-treatment in Children With Community-Acquired Pneumonia: The CAP-IT Randomized Clinical Trial. JAMA. 2021;326(17):1713-1724 (Nov 2).
- Greenfield A et al. Impact of Streptococcus pneumoniae Urinary Antigen Testing in Patients with Community-acquired Pneumonia Admitted within a Large Academic Health System. Open Forum Infect Dis. 2021;ofab522 (Oct 22).
- Cilloniz C et al. Impact on in-hospital mortality of ceftaroline versus standard of care in community-acquired pneumonia: a propensity-matched analysis. Eur J Clin Microbiol Infect Dis. 2021 (Nov 12).