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Violence in the workplace: The hidden dangers of a medical career
On Oct. 4, staff, patients, and medical students at my institution received word that a fatal shooting had occurred inside the campus hospital. For staff, this was a painful event compounding the already stressful pandemic times, while for students, it was a harsh introduction to the emerging dangers of practicing medicine.
Sure, . Unfortunately, acts of violence targeting health care workers occur at surprisingly high rates.
Reports following the shooting indicated that the gunman had a personal conflict with a coworker, and thankfully, larger numbers of people had not been targeted. While this may seem like a one-off incident, any shooting inside a hospital is a serious matter. Hospitals should be places of healing. Yes, they are inevitably places of suffering as well, but this pain should never be human-inflicted.
Health care workers are widely admired in the community, and increasingly so due to their sacrifices during the COVID-19 pandemic. Even though there is more attention to our health care spaces, the epidemic of occupational violence against our country’s health care workers has gone largely unrecognized, and this danger has only worsened since the onset of the pandemic.
Acts of violence against health care workers not only include fatal shootings or stabbings but may also include physical or verbal aggressions by frustrated patients and visitors. It is likely that students entering the health care field will encounter such danger during their careers.
Health care workers have four times the likelihood of being assaulted on the job, compared with those working in private industry. The World Health Organization reports that 38% of health workers can expect to experience physical violence at some point in their careers, while verbal threatening was reportedly even more common. It is plausible that the true rate of violence surpasses these rates, as reporting them is entirely voluntary.
In fact, the American Journal of Managed Care reported in 2019 that 75% of workplace assaults occur in health care, yet only 30% of nurses and 26% of emergency department physicians report such experiences.
Anecdotally, many of my own physician mentors have shared stories of troubling or threatening situations they have faced throughout their careers. These types of situations can be difficult to avoid, as providers are trained and naturally inclined to empathize with their patients and help as much as possible, making it difficult to turn away potentially violent individuals.
Since the start of the COVID-19 pandemic, as the public became more fatigued, incidents of violence rose. Facing staffing shortages, visitor restrictions, and high-acuity patients, health care workers found it increasingly difficult to manage large caseloads. High levels of stress were affecting not only patients, who were facing some of the toughest times of their lives, but also staff, who experienced rising demands.
Meanwhile, gun violence in our country has profoundly increased during the pandemic, creating an unstable backdrop to this tension.
Obviously, acts of violence against health care workers are unacceptable. Such events can pose real physical harms to providers, possibly resulting in irreversible injury, health problems, or even death. Additionally, they can yield long-term psychological harms, increase burnout, and impact job satisfaction.
Health care providers already make huge personal sacrifices to pursue their profession, and this threat of violence is an additional burden they unfortunately face.
In addition to the direct harm to employees, violence also has broader systemic detriments to patient outcomes and health care economics. Acts of violence against health care workers can lower the quality of care provided to patients – either directly, by virtue of being present during such dangerous situations, or indirectly, as stressed or burned-out providers may understandably be unable to provide optimal care. Rates of avoidable errors naturally rise in the presence of such stressors.
Unfortunately, regulations protecting health care workers from violence are sparse, and hospitals are not currently required to implement prevention plans for workplace violence. There are certainly some common-sense changes that institutions have begun implementing, including the use of metal detectors upon entry or the increased presence of security staff, but generally, it is questionable whether these measures alone can fully eliminate violence.
The first step in addressing this unacceptably common issue is to boost awareness and brainstorm creative solutions. Health care workers and medical students should at least be made aware of this widely prevalent threat, and safety training can be implemented to parallel that of our nation’s other schools, which have unfortunately faced a similar plight for decades.
However, similar to most issues in medicine, prevention is certainly the best strategy. By highlighting the unbelievably prevalent nature of this issue, along with its severe human and financial costs, hopefully we can draw the attention of policymakers to catalyze lasting change with a preventative focus.
The Thomas Jefferson University community responded to this tragic event with a message of resilience, offering mental health services, increasing its law enforcement presence, and promising to revisit physical security measures. This all-too-familiar pattern has been seen with previous acts of violence, but it has not yet yielded a true solution. Yet there’s not too much more an individual hospital can do without broader systemic change.
We must improve our awareness and understanding of the deep-rooted factors underlying this public health crisis and adapt how we communicate about them to achieve real progress.
Yash Shah is a first-year medical student at Thomas Jefferson University in Philadelphia. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
On Oct. 4, staff, patients, and medical students at my institution received word that a fatal shooting had occurred inside the campus hospital. For staff, this was a painful event compounding the already stressful pandemic times, while for students, it was a harsh introduction to the emerging dangers of practicing medicine.
Sure, . Unfortunately, acts of violence targeting health care workers occur at surprisingly high rates.
Reports following the shooting indicated that the gunman had a personal conflict with a coworker, and thankfully, larger numbers of people had not been targeted. While this may seem like a one-off incident, any shooting inside a hospital is a serious matter. Hospitals should be places of healing. Yes, they are inevitably places of suffering as well, but this pain should never be human-inflicted.
Health care workers are widely admired in the community, and increasingly so due to their sacrifices during the COVID-19 pandemic. Even though there is more attention to our health care spaces, the epidemic of occupational violence against our country’s health care workers has gone largely unrecognized, and this danger has only worsened since the onset of the pandemic.
Acts of violence against health care workers not only include fatal shootings or stabbings but may also include physical or verbal aggressions by frustrated patients and visitors. It is likely that students entering the health care field will encounter such danger during their careers.
Health care workers have four times the likelihood of being assaulted on the job, compared with those working in private industry. The World Health Organization reports that 38% of health workers can expect to experience physical violence at some point in their careers, while verbal threatening was reportedly even more common. It is plausible that the true rate of violence surpasses these rates, as reporting them is entirely voluntary.
In fact, the American Journal of Managed Care reported in 2019 that 75% of workplace assaults occur in health care, yet only 30% of nurses and 26% of emergency department physicians report such experiences.
Anecdotally, many of my own physician mentors have shared stories of troubling or threatening situations they have faced throughout their careers. These types of situations can be difficult to avoid, as providers are trained and naturally inclined to empathize with their patients and help as much as possible, making it difficult to turn away potentially violent individuals.
Since the start of the COVID-19 pandemic, as the public became more fatigued, incidents of violence rose. Facing staffing shortages, visitor restrictions, and high-acuity patients, health care workers found it increasingly difficult to manage large caseloads. High levels of stress were affecting not only patients, who were facing some of the toughest times of their lives, but also staff, who experienced rising demands.
Meanwhile, gun violence in our country has profoundly increased during the pandemic, creating an unstable backdrop to this tension.
Obviously, acts of violence against health care workers are unacceptable. Such events can pose real physical harms to providers, possibly resulting in irreversible injury, health problems, or even death. Additionally, they can yield long-term psychological harms, increase burnout, and impact job satisfaction.
Health care providers already make huge personal sacrifices to pursue their profession, and this threat of violence is an additional burden they unfortunately face.
In addition to the direct harm to employees, violence also has broader systemic detriments to patient outcomes and health care economics. Acts of violence against health care workers can lower the quality of care provided to patients – either directly, by virtue of being present during such dangerous situations, or indirectly, as stressed or burned-out providers may understandably be unable to provide optimal care. Rates of avoidable errors naturally rise in the presence of such stressors.
Unfortunately, regulations protecting health care workers from violence are sparse, and hospitals are not currently required to implement prevention plans for workplace violence. There are certainly some common-sense changes that institutions have begun implementing, including the use of metal detectors upon entry or the increased presence of security staff, but generally, it is questionable whether these measures alone can fully eliminate violence.
The first step in addressing this unacceptably common issue is to boost awareness and brainstorm creative solutions. Health care workers and medical students should at least be made aware of this widely prevalent threat, and safety training can be implemented to parallel that of our nation’s other schools, which have unfortunately faced a similar plight for decades.
However, similar to most issues in medicine, prevention is certainly the best strategy. By highlighting the unbelievably prevalent nature of this issue, along with its severe human and financial costs, hopefully we can draw the attention of policymakers to catalyze lasting change with a preventative focus.
The Thomas Jefferson University community responded to this tragic event with a message of resilience, offering mental health services, increasing its law enforcement presence, and promising to revisit physical security measures. This all-too-familiar pattern has been seen with previous acts of violence, but it has not yet yielded a true solution. Yet there’s not too much more an individual hospital can do without broader systemic change.
We must improve our awareness and understanding of the deep-rooted factors underlying this public health crisis and adapt how we communicate about them to achieve real progress.
Yash Shah is a first-year medical student at Thomas Jefferson University in Philadelphia. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
On Oct. 4, staff, patients, and medical students at my institution received word that a fatal shooting had occurred inside the campus hospital. For staff, this was a painful event compounding the already stressful pandemic times, while for students, it was a harsh introduction to the emerging dangers of practicing medicine.
Sure, . Unfortunately, acts of violence targeting health care workers occur at surprisingly high rates.
Reports following the shooting indicated that the gunman had a personal conflict with a coworker, and thankfully, larger numbers of people had not been targeted. While this may seem like a one-off incident, any shooting inside a hospital is a serious matter. Hospitals should be places of healing. Yes, they are inevitably places of suffering as well, but this pain should never be human-inflicted.
Health care workers are widely admired in the community, and increasingly so due to their sacrifices during the COVID-19 pandemic. Even though there is more attention to our health care spaces, the epidemic of occupational violence against our country’s health care workers has gone largely unrecognized, and this danger has only worsened since the onset of the pandemic.
Acts of violence against health care workers not only include fatal shootings or stabbings but may also include physical or verbal aggressions by frustrated patients and visitors. It is likely that students entering the health care field will encounter such danger during their careers.
Health care workers have four times the likelihood of being assaulted on the job, compared with those working in private industry. The World Health Organization reports that 38% of health workers can expect to experience physical violence at some point in their careers, while verbal threatening was reportedly even more common. It is plausible that the true rate of violence surpasses these rates, as reporting them is entirely voluntary.
In fact, the American Journal of Managed Care reported in 2019 that 75% of workplace assaults occur in health care, yet only 30% of nurses and 26% of emergency department physicians report such experiences.
Anecdotally, many of my own physician mentors have shared stories of troubling or threatening situations they have faced throughout their careers. These types of situations can be difficult to avoid, as providers are trained and naturally inclined to empathize with their patients and help as much as possible, making it difficult to turn away potentially violent individuals.
Since the start of the COVID-19 pandemic, as the public became more fatigued, incidents of violence rose. Facing staffing shortages, visitor restrictions, and high-acuity patients, health care workers found it increasingly difficult to manage large caseloads. High levels of stress were affecting not only patients, who were facing some of the toughest times of their lives, but also staff, who experienced rising demands.
Meanwhile, gun violence in our country has profoundly increased during the pandemic, creating an unstable backdrop to this tension.
Obviously, acts of violence against health care workers are unacceptable. Such events can pose real physical harms to providers, possibly resulting in irreversible injury, health problems, or even death. Additionally, they can yield long-term psychological harms, increase burnout, and impact job satisfaction.
Health care providers already make huge personal sacrifices to pursue their profession, and this threat of violence is an additional burden they unfortunately face.
In addition to the direct harm to employees, violence also has broader systemic detriments to patient outcomes and health care economics. Acts of violence against health care workers can lower the quality of care provided to patients – either directly, by virtue of being present during such dangerous situations, or indirectly, as stressed or burned-out providers may understandably be unable to provide optimal care. Rates of avoidable errors naturally rise in the presence of such stressors.
Unfortunately, regulations protecting health care workers from violence are sparse, and hospitals are not currently required to implement prevention plans for workplace violence. There are certainly some common-sense changes that institutions have begun implementing, including the use of metal detectors upon entry or the increased presence of security staff, but generally, it is questionable whether these measures alone can fully eliminate violence.
The first step in addressing this unacceptably common issue is to boost awareness and brainstorm creative solutions. Health care workers and medical students should at least be made aware of this widely prevalent threat, and safety training can be implemented to parallel that of our nation’s other schools, which have unfortunately faced a similar plight for decades.
However, similar to most issues in medicine, prevention is certainly the best strategy. By highlighting the unbelievably prevalent nature of this issue, along with its severe human and financial costs, hopefully we can draw the attention of policymakers to catalyze lasting change with a preventative focus.
The Thomas Jefferson University community responded to this tragic event with a message of resilience, offering mental health services, increasing its law enforcement presence, and promising to revisit physical security measures. This all-too-familiar pattern has been seen with previous acts of violence, but it has not yet yielded a true solution. Yet there’s not too much more an individual hospital can do without broader systemic change.
We must improve our awareness and understanding of the deep-rooted factors underlying this public health crisis and adapt how we communicate about them to achieve real progress.
Yash Shah is a first-year medical student at Thomas Jefferson University in Philadelphia. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Former APA president suspended by Columbia for ‘racist’ tweet
The university had not confirmed the suspension to this news organization by press time, but a letter from the school’s leadership notifying staff of the suspension was posted on Twitter the morning of Feb. 23 by addiction psychiatrist Jeremy Kidd, MD, who is a colleague of Dr. Lieberman’s at Columbia.
The suspension comes in the wake of Dr. Lieberman’s Feb. 21 tweet that drew immediate backlash by Twitter users who characterized it as racist and misogynist.
Dr. Lieberman, a former president of the American Psychiatric Association, reportedly deleted the tweet and his entire Twitter account soon after, according to NewsOne.
However, the tweet was captured by others, including Jack Turban, MD, a child psychiatry fellow at Stanford University. In Turban’s retweet, Dr. Lieberman commented on a tweet about a black model, noting, “whether a work of art or a freak of nature she’s a beautiful sight to behold.”
The response on Twitter was swift. “My ancestors would roll over in their graves if I refrained from commentary on how anti-Blackness shows up in ‘compliments,’” tweeted Jessica Isom, MD, MPH, a psychiatrist at Yale University.
Dr. Turban speculated that there will be no consequences for Dr. Lieberman, adding in his tweet, “He will continue to make the hiring decisions (including for faculty candidates who are women of color).”
Apology letter?
David Pagliaccio, a research scientist at the New York State Psychiatric Institute, posted what appeared to be an apology letter from Dr. Lieberman, although it could not be verified by this news organization.
In it, Dr. Lieberman was quoted as saying, “Yesterday, I tweeted from my personal account a message that was racist and sexist,” adding that prejudices he didn’t know he had held had been exposed, “and I’m deeply ashamed and very sorry.”
“I’ve hurt many, and I am beginning to understand the work ahead to make needed personal changes and over time to regain your trust,” Dr. Lieberman added.
Dr. Kidd called the suspension “absolutely the right move.” He added in his tweet that it “is only the beginning of what Columbia must do to heal & earn the trust our patients & trainees place in us every day.”
This news organization’s queries to Columbia University and to Dr. Lieberman were not returned by press time.
Dr. Lieberman is also director of the New York State Psychiatric Institute, was an advisory board member for Medscape Psychiatry and a frequent columnist for Medscape Medical News (sister organizations of MDedge.com), and was a consultant for Clinical Psychiatry.
A version of this article first appeared on Medscape.com.
The university had not confirmed the suspension to this news organization by press time, but a letter from the school’s leadership notifying staff of the suspension was posted on Twitter the morning of Feb. 23 by addiction psychiatrist Jeremy Kidd, MD, who is a colleague of Dr. Lieberman’s at Columbia.
The suspension comes in the wake of Dr. Lieberman’s Feb. 21 tweet that drew immediate backlash by Twitter users who characterized it as racist and misogynist.
Dr. Lieberman, a former president of the American Psychiatric Association, reportedly deleted the tweet and his entire Twitter account soon after, according to NewsOne.
However, the tweet was captured by others, including Jack Turban, MD, a child psychiatry fellow at Stanford University. In Turban’s retweet, Dr. Lieberman commented on a tweet about a black model, noting, “whether a work of art or a freak of nature she’s a beautiful sight to behold.”
The response on Twitter was swift. “My ancestors would roll over in their graves if I refrained from commentary on how anti-Blackness shows up in ‘compliments,’” tweeted Jessica Isom, MD, MPH, a psychiatrist at Yale University.
Dr. Turban speculated that there will be no consequences for Dr. Lieberman, adding in his tweet, “He will continue to make the hiring decisions (including for faculty candidates who are women of color).”
Apology letter?
David Pagliaccio, a research scientist at the New York State Psychiatric Institute, posted what appeared to be an apology letter from Dr. Lieberman, although it could not be verified by this news organization.
In it, Dr. Lieberman was quoted as saying, “Yesterday, I tweeted from my personal account a message that was racist and sexist,” adding that prejudices he didn’t know he had held had been exposed, “and I’m deeply ashamed and very sorry.”
“I’ve hurt many, and I am beginning to understand the work ahead to make needed personal changes and over time to regain your trust,” Dr. Lieberman added.
Dr. Kidd called the suspension “absolutely the right move.” He added in his tweet that it “is only the beginning of what Columbia must do to heal & earn the trust our patients & trainees place in us every day.”
This news organization’s queries to Columbia University and to Dr. Lieberman were not returned by press time.
Dr. Lieberman is also director of the New York State Psychiatric Institute, was an advisory board member for Medscape Psychiatry and a frequent columnist for Medscape Medical News (sister organizations of MDedge.com), and was a consultant for Clinical Psychiatry.
A version of this article first appeared on Medscape.com.
The university had not confirmed the suspension to this news organization by press time, but a letter from the school’s leadership notifying staff of the suspension was posted on Twitter the morning of Feb. 23 by addiction psychiatrist Jeremy Kidd, MD, who is a colleague of Dr. Lieberman’s at Columbia.
The suspension comes in the wake of Dr. Lieberman’s Feb. 21 tweet that drew immediate backlash by Twitter users who characterized it as racist and misogynist.
Dr. Lieberman, a former president of the American Psychiatric Association, reportedly deleted the tweet and his entire Twitter account soon after, according to NewsOne.
However, the tweet was captured by others, including Jack Turban, MD, a child psychiatry fellow at Stanford University. In Turban’s retweet, Dr. Lieberman commented on a tweet about a black model, noting, “whether a work of art or a freak of nature she’s a beautiful sight to behold.”
The response on Twitter was swift. “My ancestors would roll over in their graves if I refrained from commentary on how anti-Blackness shows up in ‘compliments,’” tweeted Jessica Isom, MD, MPH, a psychiatrist at Yale University.
Dr. Turban speculated that there will be no consequences for Dr. Lieberman, adding in his tweet, “He will continue to make the hiring decisions (including for faculty candidates who are women of color).”
Apology letter?
David Pagliaccio, a research scientist at the New York State Psychiatric Institute, posted what appeared to be an apology letter from Dr. Lieberman, although it could not be verified by this news organization.
In it, Dr. Lieberman was quoted as saying, “Yesterday, I tweeted from my personal account a message that was racist and sexist,” adding that prejudices he didn’t know he had held had been exposed, “and I’m deeply ashamed and very sorry.”
“I’ve hurt many, and I am beginning to understand the work ahead to make needed personal changes and over time to regain your trust,” Dr. Lieberman added.
Dr. Kidd called the suspension “absolutely the right move.” He added in his tweet that it “is only the beginning of what Columbia must do to heal & earn the trust our patients & trainees place in us every day.”
This news organization’s queries to Columbia University and to Dr. Lieberman were not returned by press time.
Dr. Lieberman is also director of the New York State Psychiatric Institute, was an advisory board member for Medscape Psychiatry and a frequent columnist for Medscape Medical News (sister organizations of MDedge.com), and was a consultant for Clinical Psychiatry.
A version of this article first appeared on Medscape.com.
Your heart doesn’t like peas any more than you do
Big Vegetable has lied to us all
Hear this, children of the world: Your parents have betrayed you. They tell you day in and day out that vegetables are necessary, that they’re healthy, that you need them, but it is not the truth. Behind their foul taste is nothing but empty lies.
Okay, before we get a full-blown child rebellion on our hands, let’s reel things in. Eating vegetables has many benefits, and will help prevent many nasty medical conditions, such as diabetes or cancer. However, cardiovascular disease is not among them.
For their study published in Frontiers in Nutrition, researchers analyzed the diet, lifestyle, and medical history of nearly 400,000 U.K. adults over a 5-year period, finding that 4.5% developed heart disease and that the average adult consumed about 5 tablespoons of vegetables per day. Those who consumed the most vegetables had a reduction in heart disease incidence of about 15%, compared with those who ate the least.
Hang on, you’re thinking, we just said that vegetables didn’t prevent cardiovascular disease. But the data show otherwise! Ah, but the data are unadjusted. Once the researchers took socioeconomic status, information level, and general lifestyle into account, that benefit disappeared almost completely. The benefit seems to come not from the vegetables themselves, but from being able to afford better food and medical care in general.
The researchers were quick to note the other benefits of eating vegetables, and that people should probably keep eating those five servings a day. But we’re onto you, scientists. You can’t fool us with your vegetable-based lies. Unless we’re talking about pizza. Pizza is the best vegetable.
The good old days of surgery?
Modern surgical instruments, techniques, and technological innovations are amazing. It’s hard to imagine what surgery was like before laparoscopes came along, or x-ray machines, or even anesthesia. But those days weren’t really that long ago. Modern anesthesia, after all, dates back to just 1846. We’ve got socks almost that old.
But suppose we go back even further … say 5,300 years. Older than the oldest sock. Scientists studying a funerary chamber in Burgos, Spain, which was built in the 4th millennium B.C., have come across what looks like “the first known radical mastoidectomy in the history of humankind,” Sonia Díaz-Navarro of the University of Valladolid (Spain) and associates wrote in Scientific Reports.
One of the skulls they uncovered shows signs of trepanation. “Despite the [evidence] of cut marks, it is difficult to conclude the type of tool used to remove the bone tissue, most likely a sharp instrument with a circular movement,” they investigators said.
What is clear, though, is that the patient survived the surgery, because there is evidence of bone regeneration at the surgical sites. Sites? “Based on the differences in bone remodelling between the two temporals, it appears that the procedure was first conducted on the right ear, due to an ear pathology sufficiently alarming to require an intervention, which this prehistoric woman survived,” they explained.
The same procedure was then performed on the left ear, “but whether this was performed shortly after the right ear, or several months or even years later can’t be concluded from the existing evidence,” IFL Science reported.
Located nearby was a small section of tree bark with some scratches on it. That, ladies and gentlemen, was the first prior authorization form.
I hate that song, with reason
Do you have a favorite song? You may have a million reasons for loving that song. And past research can tell you why. But it’s only in a recent study that researchers were able to tell you why you dislike a song. And you know the song we’re talking about.
Dislike breaks down into three major categories of rationale: subject-related reasons (how the song makes you feel emotionally and/or physically), object-related reasons (the lyrics or composition), and social reasons (do you relate to this?). Researchers at the Max Planck Institute for Empirical Aesthetics in Frankfurt, Germany, interviewed 21 participants and asked them to come up with a prepared list of music that they disliked and why they didn’t like it. And there was a lot that they didn’t like: 277 dislikes worth, to be exact.
“The most often mentioned type of dislike was musical style, followed by artist and genre,” senior author Julia Merrill explained on Eurekalert. Just over 40% of those rationales for not liking the music just had to do with the music itself, but 85% involved the music combined with one of the other categories.
Social reasoning played a big part in dislike. If the listener didn’t feel like a part of the target in-group for the music or the music didn’t have the same social values as those of the listener, it had an impact on dislike, they said.
But our dislike of certain types of music doesn’t just separate us from people in a negative way. Looking at the dislike of certain types of music helps us define our terms of having good taste, the researchers explained. Saying that one type of music is better than another can bring us closer with like-minded people and becomes a piece of how we identify ourselves. Cue the music snobs.
So if you can blast Barry Manilow but can’t bring yourself to play the Rolling Stones, there’s a reason for that. And if you love Aretha Franklin but not Frank Sinatra, there’s a reason for that, too. It’s all very personal. Just as music is meant to be.
Big Vegetable has lied to us all
Hear this, children of the world: Your parents have betrayed you. They tell you day in and day out that vegetables are necessary, that they’re healthy, that you need them, but it is not the truth. Behind their foul taste is nothing but empty lies.
Okay, before we get a full-blown child rebellion on our hands, let’s reel things in. Eating vegetables has many benefits, and will help prevent many nasty medical conditions, such as diabetes or cancer. However, cardiovascular disease is not among them.
For their study published in Frontiers in Nutrition, researchers analyzed the diet, lifestyle, and medical history of nearly 400,000 U.K. adults over a 5-year period, finding that 4.5% developed heart disease and that the average adult consumed about 5 tablespoons of vegetables per day. Those who consumed the most vegetables had a reduction in heart disease incidence of about 15%, compared with those who ate the least.
Hang on, you’re thinking, we just said that vegetables didn’t prevent cardiovascular disease. But the data show otherwise! Ah, but the data are unadjusted. Once the researchers took socioeconomic status, information level, and general lifestyle into account, that benefit disappeared almost completely. The benefit seems to come not from the vegetables themselves, but from being able to afford better food and medical care in general.
The researchers were quick to note the other benefits of eating vegetables, and that people should probably keep eating those five servings a day. But we’re onto you, scientists. You can’t fool us with your vegetable-based lies. Unless we’re talking about pizza. Pizza is the best vegetable.
The good old days of surgery?
Modern surgical instruments, techniques, and technological innovations are amazing. It’s hard to imagine what surgery was like before laparoscopes came along, or x-ray machines, or even anesthesia. But those days weren’t really that long ago. Modern anesthesia, after all, dates back to just 1846. We’ve got socks almost that old.
But suppose we go back even further … say 5,300 years. Older than the oldest sock. Scientists studying a funerary chamber in Burgos, Spain, which was built in the 4th millennium B.C., have come across what looks like “the first known radical mastoidectomy in the history of humankind,” Sonia Díaz-Navarro of the University of Valladolid (Spain) and associates wrote in Scientific Reports.
One of the skulls they uncovered shows signs of trepanation. “Despite the [evidence] of cut marks, it is difficult to conclude the type of tool used to remove the bone tissue, most likely a sharp instrument with a circular movement,” they investigators said.
What is clear, though, is that the patient survived the surgery, because there is evidence of bone regeneration at the surgical sites. Sites? “Based on the differences in bone remodelling between the two temporals, it appears that the procedure was first conducted on the right ear, due to an ear pathology sufficiently alarming to require an intervention, which this prehistoric woman survived,” they explained.
The same procedure was then performed on the left ear, “but whether this was performed shortly after the right ear, or several months or even years later can’t be concluded from the existing evidence,” IFL Science reported.
Located nearby was a small section of tree bark with some scratches on it. That, ladies and gentlemen, was the first prior authorization form.
I hate that song, with reason
Do you have a favorite song? You may have a million reasons for loving that song. And past research can tell you why. But it’s only in a recent study that researchers were able to tell you why you dislike a song. And you know the song we’re talking about.
Dislike breaks down into three major categories of rationale: subject-related reasons (how the song makes you feel emotionally and/or physically), object-related reasons (the lyrics or composition), and social reasons (do you relate to this?). Researchers at the Max Planck Institute for Empirical Aesthetics in Frankfurt, Germany, interviewed 21 participants and asked them to come up with a prepared list of music that they disliked and why they didn’t like it. And there was a lot that they didn’t like: 277 dislikes worth, to be exact.
“The most often mentioned type of dislike was musical style, followed by artist and genre,” senior author Julia Merrill explained on Eurekalert. Just over 40% of those rationales for not liking the music just had to do with the music itself, but 85% involved the music combined with one of the other categories.
Social reasoning played a big part in dislike. If the listener didn’t feel like a part of the target in-group for the music or the music didn’t have the same social values as those of the listener, it had an impact on dislike, they said.
But our dislike of certain types of music doesn’t just separate us from people in a negative way. Looking at the dislike of certain types of music helps us define our terms of having good taste, the researchers explained. Saying that one type of music is better than another can bring us closer with like-minded people and becomes a piece of how we identify ourselves. Cue the music snobs.
So if you can blast Barry Manilow but can’t bring yourself to play the Rolling Stones, there’s a reason for that. And if you love Aretha Franklin but not Frank Sinatra, there’s a reason for that, too. It’s all very personal. Just as music is meant to be.
Big Vegetable has lied to us all
Hear this, children of the world: Your parents have betrayed you. They tell you day in and day out that vegetables are necessary, that they’re healthy, that you need them, but it is not the truth. Behind their foul taste is nothing but empty lies.
Okay, before we get a full-blown child rebellion on our hands, let’s reel things in. Eating vegetables has many benefits, and will help prevent many nasty medical conditions, such as diabetes or cancer. However, cardiovascular disease is not among them.
For their study published in Frontiers in Nutrition, researchers analyzed the diet, lifestyle, and medical history of nearly 400,000 U.K. adults over a 5-year period, finding that 4.5% developed heart disease and that the average adult consumed about 5 tablespoons of vegetables per day. Those who consumed the most vegetables had a reduction in heart disease incidence of about 15%, compared with those who ate the least.
Hang on, you’re thinking, we just said that vegetables didn’t prevent cardiovascular disease. But the data show otherwise! Ah, but the data are unadjusted. Once the researchers took socioeconomic status, information level, and general lifestyle into account, that benefit disappeared almost completely. The benefit seems to come not from the vegetables themselves, but from being able to afford better food and medical care in general.
The researchers were quick to note the other benefits of eating vegetables, and that people should probably keep eating those five servings a day. But we’re onto you, scientists. You can’t fool us with your vegetable-based lies. Unless we’re talking about pizza. Pizza is the best vegetable.
The good old days of surgery?
Modern surgical instruments, techniques, and technological innovations are amazing. It’s hard to imagine what surgery was like before laparoscopes came along, or x-ray machines, or even anesthesia. But those days weren’t really that long ago. Modern anesthesia, after all, dates back to just 1846. We’ve got socks almost that old.
But suppose we go back even further … say 5,300 years. Older than the oldest sock. Scientists studying a funerary chamber in Burgos, Spain, which was built in the 4th millennium B.C., have come across what looks like “the first known radical mastoidectomy in the history of humankind,” Sonia Díaz-Navarro of the University of Valladolid (Spain) and associates wrote in Scientific Reports.
One of the skulls they uncovered shows signs of trepanation. “Despite the [evidence] of cut marks, it is difficult to conclude the type of tool used to remove the bone tissue, most likely a sharp instrument with a circular movement,” they investigators said.
What is clear, though, is that the patient survived the surgery, because there is evidence of bone regeneration at the surgical sites. Sites? “Based on the differences in bone remodelling between the two temporals, it appears that the procedure was first conducted on the right ear, due to an ear pathology sufficiently alarming to require an intervention, which this prehistoric woman survived,” they explained.
The same procedure was then performed on the left ear, “but whether this was performed shortly after the right ear, or several months or even years later can’t be concluded from the existing evidence,” IFL Science reported.
Located nearby was a small section of tree bark with some scratches on it. That, ladies and gentlemen, was the first prior authorization form.
I hate that song, with reason
Do you have a favorite song? You may have a million reasons for loving that song. And past research can tell you why. But it’s only in a recent study that researchers were able to tell you why you dislike a song. And you know the song we’re talking about.
Dislike breaks down into three major categories of rationale: subject-related reasons (how the song makes you feel emotionally and/or physically), object-related reasons (the lyrics or composition), and social reasons (do you relate to this?). Researchers at the Max Planck Institute for Empirical Aesthetics in Frankfurt, Germany, interviewed 21 participants and asked them to come up with a prepared list of music that they disliked and why they didn’t like it. And there was a lot that they didn’t like: 277 dislikes worth, to be exact.
“The most often mentioned type of dislike was musical style, followed by artist and genre,” senior author Julia Merrill explained on Eurekalert. Just over 40% of those rationales for not liking the music just had to do with the music itself, but 85% involved the music combined with one of the other categories.
Social reasoning played a big part in dislike. If the listener didn’t feel like a part of the target in-group for the music or the music didn’t have the same social values as those of the listener, it had an impact on dislike, they said.
But our dislike of certain types of music doesn’t just separate us from people in a negative way. Looking at the dislike of certain types of music helps us define our terms of having good taste, the researchers explained. Saying that one type of music is better than another can bring us closer with like-minded people and becomes a piece of how we identify ourselves. Cue the music snobs.
So if you can blast Barry Manilow but can’t bring yourself to play the Rolling Stones, there’s a reason for that. And if you love Aretha Franklin but not Frank Sinatra, there’s a reason for that, too. It’s all very personal. Just as music is meant to be.
Spironolactone not linked to increased cancer risk in systematic review and meta-analysis
covering seven observational studies and a total population of over 4.5 million people.
The data, published in JAMA Dermatology, are “reassuring,” the authors reported, considering that the spironolactone label carries a Food and Drug Administration warning regarding possible tumorigenicity, which is based on animal studies of doses up to 150-fold greater than doses used for humans. The drug’s antiandrogenic properties have driven its off-label use as a treatment for acne, hidradenitis, androgenetic alopecia, and hirsutism.
Spironolactone, a synthetic 17-lactone steroid, is approved for the treatment of heart failure, edema and ascites, hypertension, and primary hyperaldosteronism. Off label, it is also frequently used in gender-affirming care and is included in Endocrine Society guidelines as part of hormonal regimens for transgender women, the authors noted.
The seven eligible studies looked at the occurrence of cancer in men and women who had any exposure to the drug, regardless of the primary indication. Sample sizes ranged from 18,035 to 2.3 million, and the mean age across all studies was 62.6-72 years.
The researchers synthesized the studies, mostly of European individuals, using random effects meta-analysis and found no statistically significant association between spironolactone use and risk of breast cancer (risk ratio, 1.04; 95% confidence interval, 0.86-1.22). Three of the seven studies investigated breast cancer.
There was also no significant association between spironolactone use and risk of ovarian cancer (two studies), bladder cancer (three studies), kidney cancer (two studies), gastric cancer (two studies), or esophageal cancer (two studies).
For prostate cancer, investigated in four studies, use of the drug was associated with decreased risk (RR, 0.79, 95% CI, 0.68-0.90).
Kanthi Bommareddy, MD, of the University of Miami and coauthors concluded that all studies were at low risk of bias after appraising each one using a scale that looks at selection bias, confounding bias, and detection and outcome bias.
In dermatology, the results should “help us to take a collective sigh of relief,” said Julie C. Harper, MD, of the Dermatology and Skin Care Center of Birmingham, Ala., who was asked to comment on the study. The drug has been “safe and effective in our clinics and it is affordable and accessible to our patients,” she said, but with the FDA’s warning and the drug’s antiandrogen capacity, “there has been concern that we might be putting our patients at increased risk of breast cancer [in particular].”
The pooling of seven large studies together and the finding of no substantive increased risk of cancer “gives us evidence and comfort that spironolactone does not increase the risk of cancer in our dermatology patients,” said Dr. Harper, a past president of the American Acne & Rosacea Society.
“With every passing year,” she noted, “dermatologists are prescribing more and more spironolactone for acne, hidradenitis, androgenetic alopecia, and hirsutism.”
Four of the seven studies stratified analyses by sex, and in those without stratification by sex, women accounted for 17.2%-54.4% of the samples.
The studies had long follow-up periods of 5-20 years, but certainty of the evidence was low and since many of the studies included mostly older individuals, “they may not generalize to younger populations, such as those treated with spironolactone for acne,” the investigators wrote.
The authors also noted they were unable to look for dose-dependent associations between spironolactone and cancer risk, and that confidence intervals for rarer cancers like ovarian cancer were wide. “We cannot entirely exclude the potential for a meaningful increase in cancer risk,” and future studies are needed, in populations that include younger patients and those with acne or hirsutism.
Dr. Bommareddy reported no disclosures. Other coauthors reported grants from the National Cancer Institute outside the submitted work, and personal fees as a Cancer Prevention and Research Institute of Texas Scholar in Cancer Research. There was no funding reported for the study. Dr. Harper said she had no disclosures.
covering seven observational studies and a total population of over 4.5 million people.
The data, published in JAMA Dermatology, are “reassuring,” the authors reported, considering that the spironolactone label carries a Food and Drug Administration warning regarding possible tumorigenicity, which is based on animal studies of doses up to 150-fold greater than doses used for humans. The drug’s antiandrogenic properties have driven its off-label use as a treatment for acne, hidradenitis, androgenetic alopecia, and hirsutism.
Spironolactone, a synthetic 17-lactone steroid, is approved for the treatment of heart failure, edema and ascites, hypertension, and primary hyperaldosteronism. Off label, it is also frequently used in gender-affirming care and is included in Endocrine Society guidelines as part of hormonal regimens for transgender women, the authors noted.
The seven eligible studies looked at the occurrence of cancer in men and women who had any exposure to the drug, regardless of the primary indication. Sample sizes ranged from 18,035 to 2.3 million, and the mean age across all studies was 62.6-72 years.
The researchers synthesized the studies, mostly of European individuals, using random effects meta-analysis and found no statistically significant association between spironolactone use and risk of breast cancer (risk ratio, 1.04; 95% confidence interval, 0.86-1.22). Three of the seven studies investigated breast cancer.
There was also no significant association between spironolactone use and risk of ovarian cancer (two studies), bladder cancer (three studies), kidney cancer (two studies), gastric cancer (two studies), or esophageal cancer (two studies).
For prostate cancer, investigated in four studies, use of the drug was associated with decreased risk (RR, 0.79, 95% CI, 0.68-0.90).
Kanthi Bommareddy, MD, of the University of Miami and coauthors concluded that all studies were at low risk of bias after appraising each one using a scale that looks at selection bias, confounding bias, and detection and outcome bias.
In dermatology, the results should “help us to take a collective sigh of relief,” said Julie C. Harper, MD, of the Dermatology and Skin Care Center of Birmingham, Ala., who was asked to comment on the study. The drug has been “safe and effective in our clinics and it is affordable and accessible to our patients,” she said, but with the FDA’s warning and the drug’s antiandrogen capacity, “there has been concern that we might be putting our patients at increased risk of breast cancer [in particular].”
The pooling of seven large studies together and the finding of no substantive increased risk of cancer “gives us evidence and comfort that spironolactone does not increase the risk of cancer in our dermatology patients,” said Dr. Harper, a past president of the American Acne & Rosacea Society.
“With every passing year,” she noted, “dermatologists are prescribing more and more spironolactone for acne, hidradenitis, androgenetic alopecia, and hirsutism.”
Four of the seven studies stratified analyses by sex, and in those without stratification by sex, women accounted for 17.2%-54.4% of the samples.
The studies had long follow-up periods of 5-20 years, but certainty of the evidence was low and since many of the studies included mostly older individuals, “they may not generalize to younger populations, such as those treated with spironolactone for acne,” the investigators wrote.
The authors also noted they were unable to look for dose-dependent associations between spironolactone and cancer risk, and that confidence intervals for rarer cancers like ovarian cancer were wide. “We cannot entirely exclude the potential for a meaningful increase in cancer risk,” and future studies are needed, in populations that include younger patients and those with acne or hirsutism.
Dr. Bommareddy reported no disclosures. Other coauthors reported grants from the National Cancer Institute outside the submitted work, and personal fees as a Cancer Prevention and Research Institute of Texas Scholar in Cancer Research. There was no funding reported for the study. Dr. Harper said she had no disclosures.
covering seven observational studies and a total population of over 4.5 million people.
The data, published in JAMA Dermatology, are “reassuring,” the authors reported, considering that the spironolactone label carries a Food and Drug Administration warning regarding possible tumorigenicity, which is based on animal studies of doses up to 150-fold greater than doses used for humans. The drug’s antiandrogenic properties have driven its off-label use as a treatment for acne, hidradenitis, androgenetic alopecia, and hirsutism.
Spironolactone, a synthetic 17-lactone steroid, is approved for the treatment of heart failure, edema and ascites, hypertension, and primary hyperaldosteronism. Off label, it is also frequently used in gender-affirming care and is included in Endocrine Society guidelines as part of hormonal regimens for transgender women, the authors noted.
The seven eligible studies looked at the occurrence of cancer in men and women who had any exposure to the drug, regardless of the primary indication. Sample sizes ranged from 18,035 to 2.3 million, and the mean age across all studies was 62.6-72 years.
The researchers synthesized the studies, mostly of European individuals, using random effects meta-analysis and found no statistically significant association between spironolactone use and risk of breast cancer (risk ratio, 1.04; 95% confidence interval, 0.86-1.22). Three of the seven studies investigated breast cancer.
There was also no significant association between spironolactone use and risk of ovarian cancer (two studies), bladder cancer (three studies), kidney cancer (two studies), gastric cancer (two studies), or esophageal cancer (two studies).
For prostate cancer, investigated in four studies, use of the drug was associated with decreased risk (RR, 0.79, 95% CI, 0.68-0.90).
Kanthi Bommareddy, MD, of the University of Miami and coauthors concluded that all studies were at low risk of bias after appraising each one using a scale that looks at selection bias, confounding bias, and detection and outcome bias.
In dermatology, the results should “help us to take a collective sigh of relief,” said Julie C. Harper, MD, of the Dermatology and Skin Care Center of Birmingham, Ala., who was asked to comment on the study. The drug has been “safe and effective in our clinics and it is affordable and accessible to our patients,” she said, but with the FDA’s warning and the drug’s antiandrogen capacity, “there has been concern that we might be putting our patients at increased risk of breast cancer [in particular].”
The pooling of seven large studies together and the finding of no substantive increased risk of cancer “gives us evidence and comfort that spironolactone does not increase the risk of cancer in our dermatology patients,” said Dr. Harper, a past president of the American Acne & Rosacea Society.
“With every passing year,” she noted, “dermatologists are prescribing more and more spironolactone for acne, hidradenitis, androgenetic alopecia, and hirsutism.”
Four of the seven studies stratified analyses by sex, and in those without stratification by sex, women accounted for 17.2%-54.4% of the samples.
The studies had long follow-up periods of 5-20 years, but certainty of the evidence was low and since many of the studies included mostly older individuals, “they may not generalize to younger populations, such as those treated with spironolactone for acne,” the investigators wrote.
The authors also noted they were unable to look for dose-dependent associations between spironolactone and cancer risk, and that confidence intervals for rarer cancers like ovarian cancer were wide. “We cannot entirely exclude the potential for a meaningful increase in cancer risk,” and future studies are needed, in populations that include younger patients and those with acne or hirsutism.
Dr. Bommareddy reported no disclosures. Other coauthors reported grants from the National Cancer Institute outside the submitted work, and personal fees as a Cancer Prevention and Research Institute of Texas Scholar in Cancer Research. There was no funding reported for the study. Dr. Harper said she had no disclosures.
FROM JAMA DERMATOLOGY
Infectious disease pop quiz: Clinical challenge #15 for the ObGyn
What is the most appropriate treatment for a pregnant woman who is moderately to severely ill with COVID-19 infection?
Continue to the answer...
Moderately to severely ill pregnant women with COVID-19 infection should be hospitalized and treated with supplementary oxygen, remdesivir, and dexamethasone. Other possible therapies include inhaled nitric oxide, baricitinib (a Janus kinase inhibitor), and tocilizumab (an anti-interleukin 6 receptor antibody). (RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, et al. Dexamethasone in hospitalized patients with COVID-19. N Engl J Med. 2021;384:693-704. Kalil AC, Patterson TF, Mehta AK, et al; ACTT-2 Study Group. Baricitinib plus remdesivir for hospitalized adults with COVID-19. N Engl J Med. 2021;384:795-807. Berlin DA, Gulick RM, Martinez FJ, et al. Severe COVID-19. N Engl J Med. 2020;383;2451-2460.)
- Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
- Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.
Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.
The authors report no financial relationships relevant to this article.
Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.
Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.
The authors report no financial relationships relevant to this article.
Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.
Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.
The authors report no financial relationships relevant to this article.
What is the most appropriate treatment for a pregnant woman who is moderately to severely ill with COVID-19 infection?
Continue to the answer...
Moderately to severely ill pregnant women with COVID-19 infection should be hospitalized and treated with supplementary oxygen, remdesivir, and dexamethasone. Other possible therapies include inhaled nitric oxide, baricitinib (a Janus kinase inhibitor), and tocilizumab (an anti-interleukin 6 receptor antibody). (RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, et al. Dexamethasone in hospitalized patients with COVID-19. N Engl J Med. 2021;384:693-704. Kalil AC, Patterson TF, Mehta AK, et al; ACTT-2 Study Group. Baricitinib plus remdesivir for hospitalized adults with COVID-19. N Engl J Med. 2021;384:795-807. Berlin DA, Gulick RM, Martinez FJ, et al. Severe COVID-19. N Engl J Med. 2020;383;2451-2460.)
What is the most appropriate treatment for a pregnant woman who is moderately to severely ill with COVID-19 infection?
Continue to the answer...
Moderately to severely ill pregnant women with COVID-19 infection should be hospitalized and treated with supplementary oxygen, remdesivir, and dexamethasone. Other possible therapies include inhaled nitric oxide, baricitinib (a Janus kinase inhibitor), and tocilizumab (an anti-interleukin 6 receptor antibody). (RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, et al. Dexamethasone in hospitalized patients with COVID-19. N Engl J Med. 2021;384:693-704. Kalil AC, Patterson TF, Mehta AK, et al; ACTT-2 Study Group. Baricitinib plus remdesivir for hospitalized adults with COVID-19. N Engl J Med. 2021;384:795-807. Berlin DA, Gulick RM, Martinez FJ, et al. Severe COVID-19. N Engl J Med. 2020;383;2451-2460.)
- Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
- Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
- Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
- Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
When your medical error harmed a patient and you’re wracked with guilt
Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.
“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.
“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”
To err may be human, but in a health care setting, the harm can be catastrophic. that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”
Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
Are doctors really ‘second victims?’
Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.
But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.
“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”
That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.
“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.
Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
Emotional first aid
Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.
An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.
Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.
This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.
The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.
“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
Wisdom through adversity
While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.
In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.
Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.
“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
Acceptance and compassion
Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.
Sometimes, doctors say, the path forward starts with acceptance.
Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.
Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”
Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”
A version of this article first appeared on Medscape.com.
Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.
“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.
“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”
To err may be human, but in a health care setting, the harm can be catastrophic. that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”
Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
Are doctors really ‘second victims?’
Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.
But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.
“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”
That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.
“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.
Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
Emotional first aid
Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.
An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.
Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.
This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.
The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.
“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
Wisdom through adversity
While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.
In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.
Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.
“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
Acceptance and compassion
Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.
Sometimes, doctors say, the path forward starts with acceptance.
Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.
Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”
Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”
A version of this article first appeared on Medscape.com.
Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.
“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.
“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”
To err may be human, but in a health care setting, the harm can be catastrophic. that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”
Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
Are doctors really ‘second victims?’
Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.
But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.
“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”
That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.
“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.
Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
Emotional first aid
Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.
An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.
Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.
This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.
The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.
“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
Wisdom through adversity
While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.
In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.
Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.
“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
Acceptance and compassion
Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.
Sometimes, doctors say, the path forward starts with acceptance.
Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.
Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”
Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”
A version of this article first appeared on Medscape.com.
ACIP issues adult vaccination schedule 2022
by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).
The Clinical Guideline on the “Recommended Adult Immunization Schedule, United States, 2022” appears online Feb. 17 in Annals of Internal Medicine and in the CDC’s Morbidity and Mortality Weekly Report.
The document features changes to the zoster, pneumococcal, and hepatitis B vaccines. COVID-19 vaccinations are now included in the notes section of the schedule and can be co-administered with other vaccines, according to ACIP.
The 2022 schedule is particularly important because the pandemic has caused many adults to fall behind in routine vaccinations, according to lead author Neil Murthy, MD, MPH, MSJ, of the CDC’s immunization services division, National Center for Immunization and Respiratory Diseases, and colleagues.
“Providers should administer all due and overdue vaccines according to the routine immunization schedule during the same visit,” the group wrote. “In addition, providers should implement strategies to catch up all patients on any overdue vaccines.”
Among other changes appearing in the 2022 recommendations:
- A new step 4 in the form of an appendix lists all the contraindications and precautions for each vaccine.
- The zoster vaccine now is recommended for use in everyone aged 19 years and older who are or will be immunodeficient or immunosuppressed through disease or therapy. The new purple color bar reflects ACIP’s new two-dose series regimen for immunocompromised adults aged 19 to 49.
- The simplified pneumococcal recommendation includes guidance on using the new PCV15 and PCV20 vaccines.
- The hepatitis B recommendation has been made more inclusive, with vaccination recommended for all adults aged 19 to 59. The Special Situations section in the Notes outlines the risk-based recommendations for the hepatitis B vaccine in adults aged 60 and older. The schedule has been harmonized with the 2022 Child and Adolescent Immunization Schedule.
A welcome change
Sandra A. Fryhofer, MD, a member of the ACIP Combined Immunization Work Group, said the new pneumococcal recommendation is a particularly welcome change.
“The old recommendation was complicated and confusing. The new one is much more straightforward,” Dr. Fryhofer, an internist in Atlanta, said in an interview. Now there are only two options: a two-vaccine series of PCV15 (Vaxneuvance), in combination with the already familiar PPSV23 polysaccharide vaccine (Pneumovax 23), and a single dose of the new PCV20, Prevnar 20.
“Some work group members favored a universal age-based recommendation starting at 50 instead of 65,” Fryhofer said. “This would provide more opportunities to vaccinate adults but could lead to waning immunity later in life when risk of disease is higher.”
Although none of the updates is likely to stir controversy, discussion among ACIP members was particularly lively around hepatitis B vaccination, Dr. Fryhofer said. This vaccine has historically been recommended based on risk and has had poor uptake, while age-based vaccine recommendations generally have greater uptake.
“ACIP approved hepatitis B vaccine universally for those up to age 60, but for those 60 and older, the recommendation remains risk-based with a loophole: Anyone 60 and older who wants it can get it,” she told this news organization. “Some of the risk indications for hepatitis B vaccination may be uncomfortable or embarrassing to disclose, especially for older patients. The loophole takes care of that, but patients may have to ask for the vaccine.”
As usual, the graphics have been fine-tuned for greater accuracy and readability. “You can print a color copy to have in the exam room or at your workspace or give it a bookmark and check it online,” Dr. Fryhofer said. “It’s a great resource to have at your fingertips.”
Dr. Fryhofer has made a series of videos explaining ACIP’s approval process, the use of the schedule, and changes to vaccines including influenza. These can be accessed on the American College of Physicians website.
The authors of the recommendations stress that physicians should pay careful attention to the notes section for each vaccine, as these details clarify who needs what vaccine, when, and at what dose.
Co-author Henry Bernstein, DO, reported that he is the editor of Current Opinion in Pediatrics Office Pediatrics Series and received a presentation honorarium from the Florida chapter of the American Academy of Pediatrics. Co-author Kevin Ault, MD, reported having received a grant from the National Cancer Institute, consulting fees from PathoVax, and payments supporting attending meetings and/or travel from the American College of Obstetricians and Gynecologists.
A version of this article first appeared on Medscape.com.
by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).
The Clinical Guideline on the “Recommended Adult Immunization Schedule, United States, 2022” appears online Feb. 17 in Annals of Internal Medicine and in the CDC’s Morbidity and Mortality Weekly Report.
The document features changes to the zoster, pneumococcal, and hepatitis B vaccines. COVID-19 vaccinations are now included in the notes section of the schedule and can be co-administered with other vaccines, according to ACIP.
The 2022 schedule is particularly important because the pandemic has caused many adults to fall behind in routine vaccinations, according to lead author Neil Murthy, MD, MPH, MSJ, of the CDC’s immunization services division, National Center for Immunization and Respiratory Diseases, and colleagues.
“Providers should administer all due and overdue vaccines according to the routine immunization schedule during the same visit,” the group wrote. “In addition, providers should implement strategies to catch up all patients on any overdue vaccines.”
Among other changes appearing in the 2022 recommendations:
- A new step 4 in the form of an appendix lists all the contraindications and precautions for each vaccine.
- The zoster vaccine now is recommended for use in everyone aged 19 years and older who are or will be immunodeficient or immunosuppressed through disease or therapy. The new purple color bar reflects ACIP’s new two-dose series regimen for immunocompromised adults aged 19 to 49.
- The simplified pneumococcal recommendation includes guidance on using the new PCV15 and PCV20 vaccines.
- The hepatitis B recommendation has been made more inclusive, with vaccination recommended for all adults aged 19 to 59. The Special Situations section in the Notes outlines the risk-based recommendations for the hepatitis B vaccine in adults aged 60 and older. The schedule has been harmonized with the 2022 Child and Adolescent Immunization Schedule.
A welcome change
Sandra A. Fryhofer, MD, a member of the ACIP Combined Immunization Work Group, said the new pneumococcal recommendation is a particularly welcome change.
“The old recommendation was complicated and confusing. The new one is much more straightforward,” Dr. Fryhofer, an internist in Atlanta, said in an interview. Now there are only two options: a two-vaccine series of PCV15 (Vaxneuvance), in combination with the already familiar PPSV23 polysaccharide vaccine (Pneumovax 23), and a single dose of the new PCV20, Prevnar 20.
“Some work group members favored a universal age-based recommendation starting at 50 instead of 65,” Fryhofer said. “This would provide more opportunities to vaccinate adults but could lead to waning immunity later in life when risk of disease is higher.”
Although none of the updates is likely to stir controversy, discussion among ACIP members was particularly lively around hepatitis B vaccination, Dr. Fryhofer said. This vaccine has historically been recommended based on risk and has had poor uptake, while age-based vaccine recommendations generally have greater uptake.
“ACIP approved hepatitis B vaccine universally for those up to age 60, but for those 60 and older, the recommendation remains risk-based with a loophole: Anyone 60 and older who wants it can get it,” she told this news organization. “Some of the risk indications for hepatitis B vaccination may be uncomfortable or embarrassing to disclose, especially for older patients. The loophole takes care of that, but patients may have to ask for the vaccine.”
As usual, the graphics have been fine-tuned for greater accuracy and readability. “You can print a color copy to have in the exam room or at your workspace or give it a bookmark and check it online,” Dr. Fryhofer said. “It’s a great resource to have at your fingertips.”
Dr. Fryhofer has made a series of videos explaining ACIP’s approval process, the use of the schedule, and changes to vaccines including influenza. These can be accessed on the American College of Physicians website.
The authors of the recommendations stress that physicians should pay careful attention to the notes section for each vaccine, as these details clarify who needs what vaccine, when, and at what dose.
Co-author Henry Bernstein, DO, reported that he is the editor of Current Opinion in Pediatrics Office Pediatrics Series and received a presentation honorarium from the Florida chapter of the American Academy of Pediatrics. Co-author Kevin Ault, MD, reported having received a grant from the National Cancer Institute, consulting fees from PathoVax, and payments supporting attending meetings and/or travel from the American College of Obstetricians and Gynecologists.
A version of this article first appeared on Medscape.com.
by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).
The Clinical Guideline on the “Recommended Adult Immunization Schedule, United States, 2022” appears online Feb. 17 in Annals of Internal Medicine and in the CDC’s Morbidity and Mortality Weekly Report.
The document features changes to the zoster, pneumococcal, and hepatitis B vaccines. COVID-19 vaccinations are now included in the notes section of the schedule and can be co-administered with other vaccines, according to ACIP.
The 2022 schedule is particularly important because the pandemic has caused many adults to fall behind in routine vaccinations, according to lead author Neil Murthy, MD, MPH, MSJ, of the CDC’s immunization services division, National Center for Immunization and Respiratory Diseases, and colleagues.
“Providers should administer all due and overdue vaccines according to the routine immunization schedule during the same visit,” the group wrote. “In addition, providers should implement strategies to catch up all patients on any overdue vaccines.”
Among other changes appearing in the 2022 recommendations:
- A new step 4 in the form of an appendix lists all the contraindications and precautions for each vaccine.
- The zoster vaccine now is recommended for use in everyone aged 19 years and older who are or will be immunodeficient or immunosuppressed through disease or therapy. The new purple color bar reflects ACIP’s new two-dose series regimen for immunocompromised adults aged 19 to 49.
- The simplified pneumococcal recommendation includes guidance on using the new PCV15 and PCV20 vaccines.
- The hepatitis B recommendation has been made more inclusive, with vaccination recommended for all adults aged 19 to 59. The Special Situations section in the Notes outlines the risk-based recommendations for the hepatitis B vaccine in adults aged 60 and older. The schedule has been harmonized with the 2022 Child and Adolescent Immunization Schedule.
A welcome change
Sandra A. Fryhofer, MD, a member of the ACIP Combined Immunization Work Group, said the new pneumococcal recommendation is a particularly welcome change.
“The old recommendation was complicated and confusing. The new one is much more straightforward,” Dr. Fryhofer, an internist in Atlanta, said in an interview. Now there are only two options: a two-vaccine series of PCV15 (Vaxneuvance), in combination with the already familiar PPSV23 polysaccharide vaccine (Pneumovax 23), and a single dose of the new PCV20, Prevnar 20.
“Some work group members favored a universal age-based recommendation starting at 50 instead of 65,” Fryhofer said. “This would provide more opportunities to vaccinate adults but could lead to waning immunity later in life when risk of disease is higher.”
Although none of the updates is likely to stir controversy, discussion among ACIP members was particularly lively around hepatitis B vaccination, Dr. Fryhofer said. This vaccine has historically been recommended based on risk and has had poor uptake, while age-based vaccine recommendations generally have greater uptake.
“ACIP approved hepatitis B vaccine universally for those up to age 60, but for those 60 and older, the recommendation remains risk-based with a loophole: Anyone 60 and older who wants it can get it,” she told this news organization. “Some of the risk indications for hepatitis B vaccination may be uncomfortable or embarrassing to disclose, especially for older patients. The loophole takes care of that, but patients may have to ask for the vaccine.”
As usual, the graphics have been fine-tuned for greater accuracy and readability. “You can print a color copy to have in the exam room or at your workspace or give it a bookmark and check it online,” Dr. Fryhofer said. “It’s a great resource to have at your fingertips.”
Dr. Fryhofer has made a series of videos explaining ACIP’s approval process, the use of the schedule, and changes to vaccines including influenza. These can be accessed on the American College of Physicians website.
The authors of the recommendations stress that physicians should pay careful attention to the notes section for each vaccine, as these details clarify who needs what vaccine, when, and at what dose.
Co-author Henry Bernstein, DO, reported that he is the editor of Current Opinion in Pediatrics Office Pediatrics Series and received a presentation honorarium from the Florida chapter of the American Academy of Pediatrics. Co-author Kevin Ault, MD, reported having received a grant from the National Cancer Institute, consulting fees from PathoVax, and payments supporting attending meetings and/or travel from the American College of Obstetricians and Gynecologists.
A version of this article first appeared on Medscape.com.
Diversity among oncologists has not kept pace with the U.S. population
in these fields, according to a cross-sectional study of data from the Association of American Medical Colleges.
“Creating and maintaining a diverse health care workforce is a priority to help combat societal inequities and health disparities, particularly in light of the evolving demographic characteristics of the general U.S. population,” wrote authors who were led by Sophia C. Kamran, MD, a radiation oncologist with Massachusetts General Hospital, Boston.
The study, which was published Dec. 9 in JAMA Oncology, surveyed full-time U.S.-based faculty in radiation and medical oncology departments from 1970 through 2019.
Improved patient satisfaction, compliance, and outcomes have been documented when a health care workforce better reflects the demographic traits of those whom it serves, Dr. Kamran and associates wrote.
They point to recent increases in the number and urgency of calls for improved diversity in the health care workforce, citing also higher incidence and mortality of new cancer cases among Black, indigenous, and Hispanic populations, compared with their non-Hispanic White counterparts. Prior calls for health care work force diversity have led to some creation of opportunities and pathways for increased representation of women and racial and ethnic minority groups in medicine, and the overall diversity of medical school faculty has been increasing by race and ethnicity and sex.
The change, however, is of lesser magnitude than what has been seen among medical school applicants, students, and graduates, and the gains in medical school faculty diversity have not kept pace with increasing diversity of the U.S. population. It has remained unclear whether corresponding progress has occurred in the composition of radiation oncology and medical oncology departments during the last 5 decades.
Despite lack of diversity, total faculty numbers have increased
Dr. Kamran and associates’ analysis revealed that total faculty numbers increased over time in both radiation oncology and medical oncology, with faculty representation of underrepresented-in-medicine (URM) women proportionally increased by 0.1% per decade in both radiation oncology (95% confidence interval, 0.005%-0.110%; P < . 001 for trend) and medical oncology (95% CI, −0.03% to 0.16%; P = .06 for trend), compared with non–URM women faculty, which increased by 0.4% (95% CI, 0.25%-0.80%) per decade in radiation oncology and 0.7% (95% CI, 0.47%-0.87%) per decade in medical oncology (P < .001 for trend for both). Faculty representation of URM men did not significantly change for radiation oncology (0.03% per decade [95% CI, −0.008% to 0.065%]; P = .09 for trend) or for medical oncology (0.003% per decade [95% CI, −0.13% to 0.14%]; P = .94 for trend).
In both 2009 and 2019, representation of both women and URM individuals for both specialties was less than their representation in the U.S. population. Radiation oncology faculty had the lowest URM representation in 2019 at 5.1%. The number of total URM faculty represented among both medical oncology and radiation oncology remained low for every rank in 2019 (Medical oncology: instructor, 2 of 44 [5%]; assistant professor, 18 of 274 [7%]; associate professor, 13 of 177 [7%]; full professor, 13 of 276 [5%]. Radiation oncology: instructor, 9 of 147 [6%]; assistant professor, 57 of 927 [6%]; associate professor, 20 of 510 [4%]; full professor, 18 of 452 [4%]).
“Our results highlight significant diversity differences along the career ladder in both specialties, with women having lower academic rank than men throughout the study period, and underrepresented [racial and ethnic groups] at every rank,” the authors wrote.
And, although Black, Hispanic, and indigenous people make up about 31% of the U.S. population, their inclusion in the health care workforce trails at all stages in the pipeline, the investigators found.
Diversity among radiation and medical oncologists lags behind that of medical school diversity in general, which has grown through efforts by the Association of American Medical Colleges.
Despite some improvements, the authors suggest the need for more initiatives to retain racial and ethnic minorities in an effort to reflect the diversity of the U.S. cancer population.
“This is a multifactorial issue, with focus not only on increasing diversity of the upstream pipeline but maintaining diversity throughout the entire pipeline, requiring difficult but necessary conversations about racial and ethnic systemic bias, lack of exposure and opportunities, and financial toxicities and pressures, to name a few. Until these factors are further delineated and better addressed, focused and targeted mentorship is key,” the authors wrote.
Small steps can have a collective impact
In a commentary published with the study, Frederick Lansigan, MD, and Charles R. Thomas Jr, MD, both of the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., called for a systemic change in hiring practices.
“Any small steps of change that contribute to supporting the issues highlighted by the Kamran et al. study can have a collective positive impact. A holistic evaluation of [underrepresented] applicants at all stages of education and training is paramount, and joining selection committees is necessary to ensure fair processes. Mentoring programs, leadership courses, and addressing microaggressions and mistreatment may improve retention of [underrepresented] medical school matriculants and trainees in oncology. Cancer centers can build and lead visible and tangible diversity, equity, inclusion, justice, and belonging efforts as we are doing at our institution,” the physicians wrote.
But above all, Dr. Lansigan and Dr. Thomas said that the oncology community needs to agree that intentionally increasing the number of underrepresented physicians in the U.S. workforce is necessary to better address health care inequities.
“We need all hands on deck to reduce structural barriers in early education. We need STEM programs that start in elementary school and offer support through college. Oncologists can mentor these early learners to highlight the positive aspects of a career in oncology, the importance of [underrepresented] physicians in oncology, and the resilience required in caring for those with serious illness, many of whom will come from underserved populations. “Physicians and public health experts themselves who are interested in tackling the discrepancy between [underrepresented] and [non-underrepresented] medical school [students] and oncology trainees need to seek and be elected into positions that can start to balance this equation. If more are willing to acknowledge the structural inequities that exist in the oncology workforce pipeline, we can start to solve the complex equation of structural inequities.”
Dr Lansigan reported being the Interim Associate Dean of Diversity, Equity, and Inclusion at the Geisel School of Medicine and the Principal of Diversity, Equity, and Inclusion for the department of medicine at Dartmouth-Hitchcock Medical Center. No other disclosures were reported.
in these fields, according to a cross-sectional study of data from the Association of American Medical Colleges.
“Creating and maintaining a diverse health care workforce is a priority to help combat societal inequities and health disparities, particularly in light of the evolving demographic characteristics of the general U.S. population,” wrote authors who were led by Sophia C. Kamran, MD, a radiation oncologist with Massachusetts General Hospital, Boston.
The study, which was published Dec. 9 in JAMA Oncology, surveyed full-time U.S.-based faculty in radiation and medical oncology departments from 1970 through 2019.
Improved patient satisfaction, compliance, and outcomes have been documented when a health care workforce better reflects the demographic traits of those whom it serves, Dr. Kamran and associates wrote.
They point to recent increases in the number and urgency of calls for improved diversity in the health care workforce, citing also higher incidence and mortality of new cancer cases among Black, indigenous, and Hispanic populations, compared with their non-Hispanic White counterparts. Prior calls for health care work force diversity have led to some creation of opportunities and pathways for increased representation of women and racial and ethnic minority groups in medicine, and the overall diversity of medical school faculty has been increasing by race and ethnicity and sex.
The change, however, is of lesser magnitude than what has been seen among medical school applicants, students, and graduates, and the gains in medical school faculty diversity have not kept pace with increasing diversity of the U.S. population. It has remained unclear whether corresponding progress has occurred in the composition of radiation oncology and medical oncology departments during the last 5 decades.
Despite lack of diversity, total faculty numbers have increased
Dr. Kamran and associates’ analysis revealed that total faculty numbers increased over time in both radiation oncology and medical oncology, with faculty representation of underrepresented-in-medicine (URM) women proportionally increased by 0.1% per decade in both radiation oncology (95% confidence interval, 0.005%-0.110%; P < . 001 for trend) and medical oncology (95% CI, −0.03% to 0.16%; P = .06 for trend), compared with non–URM women faculty, which increased by 0.4% (95% CI, 0.25%-0.80%) per decade in radiation oncology and 0.7% (95% CI, 0.47%-0.87%) per decade in medical oncology (P < .001 for trend for both). Faculty representation of URM men did not significantly change for radiation oncology (0.03% per decade [95% CI, −0.008% to 0.065%]; P = .09 for trend) or for medical oncology (0.003% per decade [95% CI, −0.13% to 0.14%]; P = .94 for trend).
In both 2009 and 2019, representation of both women and URM individuals for both specialties was less than their representation in the U.S. population. Radiation oncology faculty had the lowest URM representation in 2019 at 5.1%. The number of total URM faculty represented among both medical oncology and radiation oncology remained low for every rank in 2019 (Medical oncology: instructor, 2 of 44 [5%]; assistant professor, 18 of 274 [7%]; associate professor, 13 of 177 [7%]; full professor, 13 of 276 [5%]. Radiation oncology: instructor, 9 of 147 [6%]; assistant professor, 57 of 927 [6%]; associate professor, 20 of 510 [4%]; full professor, 18 of 452 [4%]).
“Our results highlight significant diversity differences along the career ladder in both specialties, with women having lower academic rank than men throughout the study period, and underrepresented [racial and ethnic groups] at every rank,” the authors wrote.
And, although Black, Hispanic, and indigenous people make up about 31% of the U.S. population, their inclusion in the health care workforce trails at all stages in the pipeline, the investigators found.
Diversity among radiation and medical oncologists lags behind that of medical school diversity in general, which has grown through efforts by the Association of American Medical Colleges.
Despite some improvements, the authors suggest the need for more initiatives to retain racial and ethnic minorities in an effort to reflect the diversity of the U.S. cancer population.
“This is a multifactorial issue, with focus not only on increasing diversity of the upstream pipeline but maintaining diversity throughout the entire pipeline, requiring difficult but necessary conversations about racial and ethnic systemic bias, lack of exposure and opportunities, and financial toxicities and pressures, to name a few. Until these factors are further delineated and better addressed, focused and targeted mentorship is key,” the authors wrote.
Small steps can have a collective impact
In a commentary published with the study, Frederick Lansigan, MD, and Charles R. Thomas Jr, MD, both of the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., called for a systemic change in hiring practices.
“Any small steps of change that contribute to supporting the issues highlighted by the Kamran et al. study can have a collective positive impact. A holistic evaluation of [underrepresented] applicants at all stages of education and training is paramount, and joining selection committees is necessary to ensure fair processes. Mentoring programs, leadership courses, and addressing microaggressions and mistreatment may improve retention of [underrepresented] medical school matriculants and trainees in oncology. Cancer centers can build and lead visible and tangible diversity, equity, inclusion, justice, and belonging efforts as we are doing at our institution,” the physicians wrote.
But above all, Dr. Lansigan and Dr. Thomas said that the oncology community needs to agree that intentionally increasing the number of underrepresented physicians in the U.S. workforce is necessary to better address health care inequities.
“We need all hands on deck to reduce structural barriers in early education. We need STEM programs that start in elementary school and offer support through college. Oncologists can mentor these early learners to highlight the positive aspects of a career in oncology, the importance of [underrepresented] physicians in oncology, and the resilience required in caring for those with serious illness, many of whom will come from underserved populations. “Physicians and public health experts themselves who are interested in tackling the discrepancy between [underrepresented] and [non-underrepresented] medical school [students] and oncology trainees need to seek and be elected into positions that can start to balance this equation. If more are willing to acknowledge the structural inequities that exist in the oncology workforce pipeline, we can start to solve the complex equation of structural inequities.”
Dr Lansigan reported being the Interim Associate Dean of Diversity, Equity, and Inclusion at the Geisel School of Medicine and the Principal of Diversity, Equity, and Inclusion for the department of medicine at Dartmouth-Hitchcock Medical Center. No other disclosures were reported.
in these fields, according to a cross-sectional study of data from the Association of American Medical Colleges.
“Creating and maintaining a diverse health care workforce is a priority to help combat societal inequities and health disparities, particularly in light of the evolving demographic characteristics of the general U.S. population,” wrote authors who were led by Sophia C. Kamran, MD, a radiation oncologist with Massachusetts General Hospital, Boston.
The study, which was published Dec. 9 in JAMA Oncology, surveyed full-time U.S.-based faculty in radiation and medical oncology departments from 1970 through 2019.
Improved patient satisfaction, compliance, and outcomes have been documented when a health care workforce better reflects the demographic traits of those whom it serves, Dr. Kamran and associates wrote.
They point to recent increases in the number and urgency of calls for improved diversity in the health care workforce, citing also higher incidence and mortality of new cancer cases among Black, indigenous, and Hispanic populations, compared with their non-Hispanic White counterparts. Prior calls for health care work force diversity have led to some creation of opportunities and pathways for increased representation of women and racial and ethnic minority groups in medicine, and the overall diversity of medical school faculty has been increasing by race and ethnicity and sex.
The change, however, is of lesser magnitude than what has been seen among medical school applicants, students, and graduates, and the gains in medical school faculty diversity have not kept pace with increasing diversity of the U.S. population. It has remained unclear whether corresponding progress has occurred in the composition of radiation oncology and medical oncology departments during the last 5 decades.
Despite lack of diversity, total faculty numbers have increased
Dr. Kamran and associates’ analysis revealed that total faculty numbers increased over time in both radiation oncology and medical oncology, with faculty representation of underrepresented-in-medicine (URM) women proportionally increased by 0.1% per decade in both radiation oncology (95% confidence interval, 0.005%-0.110%; P < . 001 for trend) and medical oncology (95% CI, −0.03% to 0.16%; P = .06 for trend), compared with non–URM women faculty, which increased by 0.4% (95% CI, 0.25%-0.80%) per decade in radiation oncology and 0.7% (95% CI, 0.47%-0.87%) per decade in medical oncology (P < .001 for trend for both). Faculty representation of URM men did not significantly change for radiation oncology (0.03% per decade [95% CI, −0.008% to 0.065%]; P = .09 for trend) or for medical oncology (0.003% per decade [95% CI, −0.13% to 0.14%]; P = .94 for trend).
In both 2009 and 2019, representation of both women and URM individuals for both specialties was less than their representation in the U.S. population. Radiation oncology faculty had the lowest URM representation in 2019 at 5.1%. The number of total URM faculty represented among both medical oncology and radiation oncology remained low for every rank in 2019 (Medical oncology: instructor, 2 of 44 [5%]; assistant professor, 18 of 274 [7%]; associate professor, 13 of 177 [7%]; full professor, 13 of 276 [5%]. Radiation oncology: instructor, 9 of 147 [6%]; assistant professor, 57 of 927 [6%]; associate professor, 20 of 510 [4%]; full professor, 18 of 452 [4%]).
“Our results highlight significant diversity differences along the career ladder in both specialties, with women having lower academic rank than men throughout the study period, and underrepresented [racial and ethnic groups] at every rank,” the authors wrote.
And, although Black, Hispanic, and indigenous people make up about 31% of the U.S. population, their inclusion in the health care workforce trails at all stages in the pipeline, the investigators found.
Diversity among radiation and medical oncologists lags behind that of medical school diversity in general, which has grown through efforts by the Association of American Medical Colleges.
Despite some improvements, the authors suggest the need for more initiatives to retain racial and ethnic minorities in an effort to reflect the diversity of the U.S. cancer population.
“This is a multifactorial issue, with focus not only on increasing diversity of the upstream pipeline but maintaining diversity throughout the entire pipeline, requiring difficult but necessary conversations about racial and ethnic systemic bias, lack of exposure and opportunities, and financial toxicities and pressures, to name a few. Until these factors are further delineated and better addressed, focused and targeted mentorship is key,” the authors wrote.
Small steps can have a collective impact
In a commentary published with the study, Frederick Lansigan, MD, and Charles R. Thomas Jr, MD, both of the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., called for a systemic change in hiring practices.
“Any small steps of change that contribute to supporting the issues highlighted by the Kamran et al. study can have a collective positive impact. A holistic evaluation of [underrepresented] applicants at all stages of education and training is paramount, and joining selection committees is necessary to ensure fair processes. Mentoring programs, leadership courses, and addressing microaggressions and mistreatment may improve retention of [underrepresented] medical school matriculants and trainees in oncology. Cancer centers can build and lead visible and tangible diversity, equity, inclusion, justice, and belonging efforts as we are doing at our institution,” the physicians wrote.
But above all, Dr. Lansigan and Dr. Thomas said that the oncology community needs to agree that intentionally increasing the number of underrepresented physicians in the U.S. workforce is necessary to better address health care inequities.
“We need all hands on deck to reduce structural barriers in early education. We need STEM programs that start in elementary school and offer support through college. Oncologists can mentor these early learners to highlight the positive aspects of a career in oncology, the importance of [underrepresented] physicians in oncology, and the resilience required in caring for those with serious illness, many of whom will come from underserved populations. “Physicians and public health experts themselves who are interested in tackling the discrepancy between [underrepresented] and [non-underrepresented] medical school [students] and oncology trainees need to seek and be elected into positions that can start to balance this equation. If more are willing to acknowledge the structural inequities that exist in the oncology workforce pipeline, we can start to solve the complex equation of structural inequities.”
Dr Lansigan reported being the Interim Associate Dean of Diversity, Equity, and Inclusion at the Geisel School of Medicine and the Principal of Diversity, Equity, and Inclusion for the department of medicine at Dartmouth-Hitchcock Medical Center. No other disclosures were reported.
FROM JAMA ONCOLOGY
Biden’s FDA chief nominee narrowly wins Senate confirmation
On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.
The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.
In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.
Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”
“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”
This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.
But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.
On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.
“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”
Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.
There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.
Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.
The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
Support of medical community
The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.
“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”
Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.
A version of this article first appeared on Medscape.com.
On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.
The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.
In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.
Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”
“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”
This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.
But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.
On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.
“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”
Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.
There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.
Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.
The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
Support of medical community
The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.
“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”
Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.
A version of this article first appeared on Medscape.com.
On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.
The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.
In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.
Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”
“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”
This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.
But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.
On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.
“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”
Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.
There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.
Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.
The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
Support of medical community
The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.
“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”
Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.
A version of this article first appeared on Medscape.com.
Why is vitamin D hype so impervious to evidence?
The vitamin D story exudes teaching points: It offers a master class in critical appraisal, connecting the concepts of biologic plausibility, flawed surrogate markers, confounded observational studies, and slews of randomized controlled trials (RCTs) showing no benefits on health outcomes.
Yet despite the utter lack of benefit seen in trials, the hype continues. And the pandemic has only enhanced this hype as an onslaught of papers have reported the association of low vitamin D levels and COVID-19 disease.
My questions are simple: Why doesn’t the evidence persuade people? How many nonsignificant trials do we need before researchers stop studying vitamin D, doctors stop (routinely) measuring levels, and patients stop wasting money on the unhelpful supplement? What are the implications for this lack of persuasion?
Before exploring these questions, I want to set out that symptomatic vitamin deficiencies of any sort ought to be corrected.
Biologic plausibility and the pull of observational studies
It has long been known that vitamin D is crucial for bone health and that it can be produced in the skin with sun exposure. In the last decade, however, experts note that nearly every tissue and cell in our body has a vitamin D receptor. It then follows that if this many cells in the body can activate vitamin D, it must be vital for cardiovascular health, immune function, cancer prevention: basically, everything health related.
Oodles of observational studies have found that low serum levels of vitamin D correlate with higher mortality from all causes, cancer, cardiovascular disease, and now even COVID-19. Yet no matter the amount of statistical adjustment in these studies, we cannot know whether these associations are due to true causality.
The major issue is confounding: That is, people with low vitamin D levels have other conditions or diseases that lead to higher rates of ill health. Consider a patient with obesity, arthritis, and cognitive decline; this person is unlikely to do much exercise in the sun and may have low vitamin D levels. The low vitamin D level is simply a marker of overall poor health.
The randomized controlled trials tell a clear story
There are hundreds of vitamin D RCTs. The results simplify into one sentence: Vitamin D supplements do not improve health outcomes.
Here is a short summary of some recent studies.
VITAL, a massive (N > 25,000) RCT with 5 years of follow-up, compared vitamin D supplements to placebo and found no differences in the primary endpoints of cancer or cardiac events. Rates of death from any cause were nearly identical. Crucially, in subgroup analyses, the effects did not vary according to vitamin D levels at baseline.
The D-Health investigators randomly assigned more than 21,000 adults to vitamin D or placebo and after 5.7 years of follow-up reported no differences in the primary endpoint of overall mortality. There also were no differences in cardiovascular disease mortality.
Then you have the Mendelian randomized studies, which some have called nature’s RCT. These studies take advantage of the fact that some people are born with gene variations that predispose to low vitamin D levels. More than 60 Mendelian randomization studies have evaluated the consequences of lifelong genetically lowered vitamin D levels on various outcomes; most of these have found null effects.
Then there are the meta-analyses and systematic reviews. I loved the conclusion of this review of systematic reviews from the BMJ (emphasis mine):
“Despite a few hundred systematic reviews and meta-analyses, highly convincing evidence of a clear role of vitamin D does not exist for any outcome, but associations with a selection of outcomes are probable.”
The failure to persuade
My original plan was to emphasize the power of the RCT. Despite strong associations of low vitamin D levels with poor outcomes, the trials show no benefit to treatment. This strongly suggests (or nearly proves) that low vitamin D levels are akin to premature ventricular complexes after myocardial infarction: a marker for risk but not a target for therapy.
But I now see the more important issue as why scientists, funders, clinicians, and patients are not persuaded by clear evidence. Every day in clinic I see patients on vitamin D supplements; the journals keep publishing vitamin D studies. The proponents of vitamin D remain positive. And lately there is outsized attention and hope that vitamin D will mitigate SARS-CoV2 infection – based only on observational data.
You might argue against this point by saying vitamin D is natural and relatively innocuous, so who cares?
I offer three rebuttals to that point: Opportunity costs, distraction, and the insidious danger of poor critical appraisal skills. If you are burning money on vitamin D research, there is less available to study other important issues. If a patient is distracted by low vitamin D levels, she may pay less attention to her high body mass index or hypertension. And on the matter of critical appraisal, trust in medicine requires clinicians to be competent in critical appraisal. And these days, what could be more important than trust in medical professionals?
One major reason for the failure of persuasion of evidence is spin – or language that distracts from the primary endpoint. Here are two (of many) examples:
A meta-analysis of 50 vitamin D trials set out to study mortality. The authors found no significant difference in that primary endpoint. But the second sentence in their conclusion was that vitamin D supplements reduced the risk for cancer deaths by 15%. That’s a secondary endpoint in a study with nonsignificance in the primary endpoint. That is spin. This meta-analysis was completed before the Australian D-Health trial found that cancer deaths were 15% higher in the vitamin D arm, a difference that did not reach statistical significance.
The following example is worse: The authors of the VITAL trial, which found that vitamin D supplements had no effect on the primary endpoint of invasive cancer or cardiovascular disease, published a secondary analysis of the trial looking at a different endpoint: A composite incidence of metastatic and fatal invasive total cancer. They reported a 0.4% lower rate for the vitamin D group, a difference that barely made statistical significance at a P value of .04.
But everyone knows the dangers of reanalyzing data with a new endpoint after you have seen the data. What’s more, even if this were a reasonable post hoc analysis, the results are neither clinically meaningful nor statistically robust. Yet the fatally flawed paper has been viewed 60,000 times and picked up by 48 news outlets.
Another way to distract from nonsignificant primary outcomes is to nitpick the trials. The vitamin D dose wasn’t high enough, for instance. This might persuade me if there were one or two vitamin D trials, but there are hundreds of trials and meta-analyses, and their results are consistently null.
Conclusion: No, it is not hopeless
A nihilist would argue that fighting spin is futile. They would say you can’t fight incentives and business models. The incentive structure to publish is strong, and the journals and media know vitamin D studies garner attention – which is their currency.
I am not a nihilist and believe strongly that we must continue to teach critical appraisal and numerical literacy.
In fact, I would speculate that decades of poor critical appraisal by the medical profession have fostered outsized hope and created erroneous norms.
Imagine a counter-factual world in which clinicians have taught society that the human body is unlike an engine that can be repaired by fixing one part (i.e., the vitamin D level), that magic bullets (insulin) are rare, that most treatments fail, or that you can’t rely on association studies to prove efficacy.
In this world, people would be immune from spin and hype.
The norm would be that pills, supplements, and procedures are not what delivers good health. What delivers health is an amalgam of good luck, healthy habits, and lots of time spent outside playing in the sun.
Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
The vitamin D story exudes teaching points: It offers a master class in critical appraisal, connecting the concepts of biologic plausibility, flawed surrogate markers, confounded observational studies, and slews of randomized controlled trials (RCTs) showing no benefits on health outcomes.
Yet despite the utter lack of benefit seen in trials, the hype continues. And the pandemic has only enhanced this hype as an onslaught of papers have reported the association of low vitamin D levels and COVID-19 disease.
My questions are simple: Why doesn’t the evidence persuade people? How many nonsignificant trials do we need before researchers stop studying vitamin D, doctors stop (routinely) measuring levels, and patients stop wasting money on the unhelpful supplement? What are the implications for this lack of persuasion?
Before exploring these questions, I want to set out that symptomatic vitamin deficiencies of any sort ought to be corrected.
Biologic plausibility and the pull of observational studies
It has long been known that vitamin D is crucial for bone health and that it can be produced in the skin with sun exposure. In the last decade, however, experts note that nearly every tissue and cell in our body has a vitamin D receptor. It then follows that if this many cells in the body can activate vitamin D, it must be vital for cardiovascular health, immune function, cancer prevention: basically, everything health related.
Oodles of observational studies have found that low serum levels of vitamin D correlate with higher mortality from all causes, cancer, cardiovascular disease, and now even COVID-19. Yet no matter the amount of statistical adjustment in these studies, we cannot know whether these associations are due to true causality.
The major issue is confounding: That is, people with low vitamin D levels have other conditions or diseases that lead to higher rates of ill health. Consider a patient with obesity, arthritis, and cognitive decline; this person is unlikely to do much exercise in the sun and may have low vitamin D levels. The low vitamin D level is simply a marker of overall poor health.
The randomized controlled trials tell a clear story
There are hundreds of vitamin D RCTs. The results simplify into one sentence: Vitamin D supplements do not improve health outcomes.
Here is a short summary of some recent studies.
VITAL, a massive (N > 25,000) RCT with 5 years of follow-up, compared vitamin D supplements to placebo and found no differences in the primary endpoints of cancer or cardiac events. Rates of death from any cause were nearly identical. Crucially, in subgroup analyses, the effects did not vary according to vitamin D levels at baseline.
The D-Health investigators randomly assigned more than 21,000 adults to vitamin D or placebo and after 5.7 years of follow-up reported no differences in the primary endpoint of overall mortality. There also were no differences in cardiovascular disease mortality.
Then you have the Mendelian randomized studies, which some have called nature’s RCT. These studies take advantage of the fact that some people are born with gene variations that predispose to low vitamin D levels. More than 60 Mendelian randomization studies have evaluated the consequences of lifelong genetically lowered vitamin D levels on various outcomes; most of these have found null effects.
Then there are the meta-analyses and systematic reviews. I loved the conclusion of this review of systematic reviews from the BMJ (emphasis mine):
“Despite a few hundred systematic reviews and meta-analyses, highly convincing evidence of a clear role of vitamin D does not exist for any outcome, but associations with a selection of outcomes are probable.”
The failure to persuade
My original plan was to emphasize the power of the RCT. Despite strong associations of low vitamin D levels with poor outcomes, the trials show no benefit to treatment. This strongly suggests (or nearly proves) that low vitamin D levels are akin to premature ventricular complexes after myocardial infarction: a marker for risk but not a target for therapy.
But I now see the more important issue as why scientists, funders, clinicians, and patients are not persuaded by clear evidence. Every day in clinic I see patients on vitamin D supplements; the journals keep publishing vitamin D studies. The proponents of vitamin D remain positive. And lately there is outsized attention and hope that vitamin D will mitigate SARS-CoV2 infection – based only on observational data.
You might argue against this point by saying vitamin D is natural and relatively innocuous, so who cares?
I offer three rebuttals to that point: Opportunity costs, distraction, and the insidious danger of poor critical appraisal skills. If you are burning money on vitamin D research, there is less available to study other important issues. If a patient is distracted by low vitamin D levels, she may pay less attention to her high body mass index or hypertension. And on the matter of critical appraisal, trust in medicine requires clinicians to be competent in critical appraisal. And these days, what could be more important than trust in medical professionals?
One major reason for the failure of persuasion of evidence is spin – or language that distracts from the primary endpoint. Here are two (of many) examples:
A meta-analysis of 50 vitamin D trials set out to study mortality. The authors found no significant difference in that primary endpoint. But the second sentence in their conclusion was that vitamin D supplements reduced the risk for cancer deaths by 15%. That’s a secondary endpoint in a study with nonsignificance in the primary endpoint. That is spin. This meta-analysis was completed before the Australian D-Health trial found that cancer deaths were 15% higher in the vitamin D arm, a difference that did not reach statistical significance.
The following example is worse: The authors of the VITAL trial, which found that vitamin D supplements had no effect on the primary endpoint of invasive cancer or cardiovascular disease, published a secondary analysis of the trial looking at a different endpoint: A composite incidence of metastatic and fatal invasive total cancer. They reported a 0.4% lower rate for the vitamin D group, a difference that barely made statistical significance at a P value of .04.
But everyone knows the dangers of reanalyzing data with a new endpoint after you have seen the data. What’s more, even if this were a reasonable post hoc analysis, the results are neither clinically meaningful nor statistically robust. Yet the fatally flawed paper has been viewed 60,000 times and picked up by 48 news outlets.
Another way to distract from nonsignificant primary outcomes is to nitpick the trials. The vitamin D dose wasn’t high enough, for instance. This might persuade me if there were one or two vitamin D trials, but there are hundreds of trials and meta-analyses, and their results are consistently null.
Conclusion: No, it is not hopeless
A nihilist would argue that fighting spin is futile. They would say you can’t fight incentives and business models. The incentive structure to publish is strong, and the journals and media know vitamin D studies garner attention – which is their currency.
I am not a nihilist and believe strongly that we must continue to teach critical appraisal and numerical literacy.
In fact, I would speculate that decades of poor critical appraisal by the medical profession have fostered outsized hope and created erroneous norms.
Imagine a counter-factual world in which clinicians have taught society that the human body is unlike an engine that can be repaired by fixing one part (i.e., the vitamin D level), that magic bullets (insulin) are rare, that most treatments fail, or that you can’t rely on association studies to prove efficacy.
In this world, people would be immune from spin and hype.
The norm would be that pills, supplements, and procedures are not what delivers good health. What delivers health is an amalgam of good luck, healthy habits, and lots of time spent outside playing in the sun.
Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
The vitamin D story exudes teaching points: It offers a master class in critical appraisal, connecting the concepts of biologic plausibility, flawed surrogate markers, confounded observational studies, and slews of randomized controlled trials (RCTs) showing no benefits on health outcomes.
Yet despite the utter lack of benefit seen in trials, the hype continues. And the pandemic has only enhanced this hype as an onslaught of papers have reported the association of low vitamin D levels and COVID-19 disease.
My questions are simple: Why doesn’t the evidence persuade people? How many nonsignificant trials do we need before researchers stop studying vitamin D, doctors stop (routinely) measuring levels, and patients stop wasting money on the unhelpful supplement? What are the implications for this lack of persuasion?
Before exploring these questions, I want to set out that symptomatic vitamin deficiencies of any sort ought to be corrected.
Biologic plausibility and the pull of observational studies
It has long been known that vitamin D is crucial for bone health and that it can be produced in the skin with sun exposure. In the last decade, however, experts note that nearly every tissue and cell in our body has a vitamin D receptor. It then follows that if this many cells in the body can activate vitamin D, it must be vital for cardiovascular health, immune function, cancer prevention: basically, everything health related.
Oodles of observational studies have found that low serum levels of vitamin D correlate with higher mortality from all causes, cancer, cardiovascular disease, and now even COVID-19. Yet no matter the amount of statistical adjustment in these studies, we cannot know whether these associations are due to true causality.
The major issue is confounding: That is, people with low vitamin D levels have other conditions or diseases that lead to higher rates of ill health. Consider a patient with obesity, arthritis, and cognitive decline; this person is unlikely to do much exercise in the sun and may have low vitamin D levels. The low vitamin D level is simply a marker of overall poor health.
The randomized controlled trials tell a clear story
There are hundreds of vitamin D RCTs. The results simplify into one sentence: Vitamin D supplements do not improve health outcomes.
Here is a short summary of some recent studies.
VITAL, a massive (N > 25,000) RCT with 5 years of follow-up, compared vitamin D supplements to placebo and found no differences in the primary endpoints of cancer or cardiac events. Rates of death from any cause were nearly identical. Crucially, in subgroup analyses, the effects did not vary according to vitamin D levels at baseline.
The D-Health investigators randomly assigned more than 21,000 adults to vitamin D or placebo and after 5.7 years of follow-up reported no differences in the primary endpoint of overall mortality. There also were no differences in cardiovascular disease mortality.
Then you have the Mendelian randomized studies, which some have called nature’s RCT. These studies take advantage of the fact that some people are born with gene variations that predispose to low vitamin D levels. More than 60 Mendelian randomization studies have evaluated the consequences of lifelong genetically lowered vitamin D levels on various outcomes; most of these have found null effects.
Then there are the meta-analyses and systematic reviews. I loved the conclusion of this review of systematic reviews from the BMJ (emphasis mine):
“Despite a few hundred systematic reviews and meta-analyses, highly convincing evidence of a clear role of vitamin D does not exist for any outcome, but associations with a selection of outcomes are probable.”
The failure to persuade
My original plan was to emphasize the power of the RCT. Despite strong associations of low vitamin D levels with poor outcomes, the trials show no benefit to treatment. This strongly suggests (or nearly proves) that low vitamin D levels are akin to premature ventricular complexes after myocardial infarction: a marker for risk but not a target for therapy.
But I now see the more important issue as why scientists, funders, clinicians, and patients are not persuaded by clear evidence. Every day in clinic I see patients on vitamin D supplements; the journals keep publishing vitamin D studies. The proponents of vitamin D remain positive. And lately there is outsized attention and hope that vitamin D will mitigate SARS-CoV2 infection – based only on observational data.
You might argue against this point by saying vitamin D is natural and relatively innocuous, so who cares?
I offer three rebuttals to that point: Opportunity costs, distraction, and the insidious danger of poor critical appraisal skills. If you are burning money on vitamin D research, there is less available to study other important issues. If a patient is distracted by low vitamin D levels, she may pay less attention to her high body mass index or hypertension. And on the matter of critical appraisal, trust in medicine requires clinicians to be competent in critical appraisal. And these days, what could be more important than trust in medical professionals?
One major reason for the failure of persuasion of evidence is spin – or language that distracts from the primary endpoint. Here are two (of many) examples:
A meta-analysis of 50 vitamin D trials set out to study mortality. The authors found no significant difference in that primary endpoint. But the second sentence in their conclusion was that vitamin D supplements reduced the risk for cancer deaths by 15%. That’s a secondary endpoint in a study with nonsignificance in the primary endpoint. That is spin. This meta-analysis was completed before the Australian D-Health trial found that cancer deaths were 15% higher in the vitamin D arm, a difference that did not reach statistical significance.
The following example is worse: The authors of the VITAL trial, which found that vitamin D supplements had no effect on the primary endpoint of invasive cancer or cardiovascular disease, published a secondary analysis of the trial looking at a different endpoint: A composite incidence of metastatic and fatal invasive total cancer. They reported a 0.4% lower rate for the vitamin D group, a difference that barely made statistical significance at a P value of .04.
But everyone knows the dangers of reanalyzing data with a new endpoint after you have seen the data. What’s more, even if this were a reasonable post hoc analysis, the results are neither clinically meaningful nor statistically robust. Yet the fatally flawed paper has been viewed 60,000 times and picked up by 48 news outlets.
Another way to distract from nonsignificant primary outcomes is to nitpick the trials. The vitamin D dose wasn’t high enough, for instance. This might persuade me if there were one or two vitamin D trials, but there are hundreds of trials and meta-analyses, and their results are consistently null.
Conclusion: No, it is not hopeless
A nihilist would argue that fighting spin is futile. They would say you can’t fight incentives and business models. The incentive structure to publish is strong, and the journals and media know vitamin D studies garner attention – which is their currency.
I am not a nihilist and believe strongly that we must continue to teach critical appraisal and numerical literacy.
In fact, I would speculate that decades of poor critical appraisal by the medical profession have fostered outsized hope and created erroneous norms.
Imagine a counter-factual world in which clinicians have taught society that the human body is unlike an engine that can be repaired by fixing one part (i.e., the vitamin D level), that magic bullets (insulin) are rare, that most treatments fail, or that you can’t rely on association studies to prove efficacy.
In this world, people would be immune from spin and hype.
The norm would be that pills, supplements, and procedures are not what delivers good health. What delivers health is an amalgam of good luck, healthy habits, and lots of time spent outside playing in the sun.
Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
