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Will this trial help solve chronic back pain?
Chronic pain, and back pain in particular, is among the most frequent concerns for patients in the primary care setting. Roughly 8% of adults in the United States say they suffer from chronic low back pain, and many of them say the pain is significant enough to impair their ability to move, work, and otherwise enjoy life. All this, despite decades of research and countless millions in funding to find the optimal approach to treating chronic pain.
As the United States crawls out of the opioid epidemic, a group of pain specialists is hoping to identify effective, personalized approaches to managing back pain. Daniel Clauw, MD, professor of anesthesiology, internal medicine, and psychiatry at the University of Michigan, Ann Arbor, is helping lead the BEST trial. With projected enrollment of nearly 800 patients, BEST will be the largest federally funded clinical trial of interventions to treat chronic low back pain.
In an interview, The interview has been edited for length and clarity.
What are your thoughts on the current state of primary care physicians’ understanding and management of pain?
Primary care physicians need a lot of help in demystifying the diagnosis and treatment of any kind of pain, but back pain is a really good place to start. When it comes to back pain, most primary care physicians are not any more knowledgeable than a layperson.
What has the opioid debacle-cum-tragedy taught you about pain management, particular as regards people with chronic pain?
I don’t feel opioids should ever be used to treat chronic low back pain. The few long-term studies that have been performed using opioids for longer than 3 months suggest that they often make pain worse rather than just failing to make pain better – and we know they are associated with a significantly increased all-cause mortality with increased deaths from myocardial infarction, accidents, and suicides, in addition to overdose.
Given how many patients experience back pain, how did we come to the point at which primary care physicians are so ill equipped?
We’ve had terrible pain curricula in medical schools. To give you an example: I’m one of the leading pain experts in the world and I’m not allowed to teach our medical students their pain curriculum. The students learn about neurophysiology and the anatomy of the nerves, not what’s relevant in pain.
This is notorious in medical school: Curricula are almost impossible to modify and change. So it starts with poor training in medical school. And then, regardless of what education they do or don’t get in medical school, a lot of their education about pain management is through our residencies – mainly in inpatient settings, where you’re really seeing the management of acute pain and not the management of chronic pain.
People get more accustomed to managing acute pain, where opioids are a reasonable option. It’s just that when you start managing subacute or chronic pain, opioids don’t work as well.
The other big problem is that historically, most people trained in medicine think that if you have pain in your elbow, there’s got to be something wrong in your elbow. This third mechanism of pain, central sensitization – or nociplastic pain – the kind of pain that we see in fibromyalgia, headache, and low back pain, where the pain is coming from the brain – that’s confusing to people. People can have pain without any damage or inflammation to that region of the body.
Physicians are trained that if there’s pain, there’s something wrong and we have to do surgery or there’s been some trauma. Most chronic pain is none of that. There’s a big disconnect between how people are trained, and then when they go out and are seeing a tremendous number of people with chronic pain.
What are the different types of pain, and how should they inform clinicians’ understanding about what approaches might work for managing their patients in pain?
The way the central nervous system responds to pain is analogous to the loudness of an electric guitar. You can make an electric guitar louder either by strumming the strings harder or by turning up the amplifier. For many people with fibromyalgia, low back pain, and endometriosis, for example, the problem is really more that the amplifier is turned up too high rather than its being that the guitar is strummed too strongly. That kind of pain where the pain is not due to anatomic damage or inflammation is particularly flummoxing for providers.
Can you explain the design of the new study?
It’s a 13-site study looking at four treatments: enhanced self-care, cognitive-behavioral therapy, physical therapy, and duloxetine. It’s a big precision medicine trial, trying to take everything we’ve learned and putting it all into one big study.
We’re using a SMART design, which randomizes people to two of those treatments, unless they are very much improved from the first treatment. To be eligible for the trial, you have to be able to be randomized to three of the four treatments, and people can’t choose which of the four they get.
We give them one of those treatments for 12 weeks, and at the end of 12 weeks we make the call – “Did you respond or not respond?” – and then we go back to the phenotypic data we collected at the beginning of that trial and say, “What information at baseline that we collected predicts that someone is going to respond better to duloxetine or worse to duloxetine?” And then we create the phenotype that responds best to each of those four treatments.
None of our treatments works so well that someone doesn’t end up getting randomized to a second treatment. About 85% of people so far need a second treatment because they still have enough pain that they want more relief. But the nice thing about that is we’ve already done all the functional brain imaging and all these really expensive and time-consuming things.
We’re hoping to have around 700-800 people total in this trial, which means that around 170 people will get randomized to each of the four initial treatments. No one’s ever done a study that has functional brain imaging and all these other things in it with more than 80 or 100 people. The scale of this is totally unprecedented.
Given that the individual therapies don’t appear to be all that successful on their own, what is your goal?
The primary aim is to match the phenotypic characteristics of a patient with chronic low back pain with treatment response to each of these four treatments. So at the end, we can give clinicians information on which of the patients is going to respond to physical therapy, for instance.
Right now, about one out of three people respond to most treatments for pain. We think by doing a trial like this, we can take treatments that work in one out of three people and make them work in one out of two or two out of three people just by using them in the right people.
How do you differentiate between these types of pain in your study?
We phenotype people by asking them a number of questions. We also do brain imaging, look at their back with MRI, test biomechanics, and then give them four different treatments that we know work in groups of people with low back pain.
We think one of the first parts of the phenotype is, do they have pain just in their back? Or do they have pain in their back plus a lot of other body regions? Because the more body regions that people have pain in, the more likely it is that this is an amplifier problem rather than a guitar problem.
Treatments like physical therapy, surgery, and injections are going to work better for people in whom the pain is a guitar problem rather than an amplifier problem. And drugs like duloxetine, which works in the brain, and cognitive-behavioral therapy are going to work a lot better in the people with pain in multiple sites besides the back.
To pick up on your metaphor, do any symptoms help clinicians differentiate between the guitar and the amplifier?
Sleep problems, fatigue, memory problems, and mood problems are common in patients with chronic pain and are more common with amplifier pain. Because again, those are all central nervous system problems. And so we see that the people that have anxiety, depression, and a lot of distress are more likely to have this kind of pain.
Does medical imaging help?
There’s a terrible relationship between what you see on an MRI of the back and whether someone has pain or how severe the pain is going to be. There’s always going to be individuals that have a lot of anatomic damage who don’t have any pain because they happen to be on the other end of the continuum from fibromyalgia; they’re actually pain-insensitive people.
What are your thoughts about ketamine as a possible treatment for chronic pain?
I have a mentee who’s doing a ketamine trial. We’re doing psilocybin trials in patients with fibromyalgia. Ketamine is such a dirty drug; it has so many different mechanisms of action. It does have some psychedelic effects, but it also is an NMDA blocker. It really has so many different effects.
I think it’s being thrown around like water in settings where we don’t yet know it to be efficacious. Even the data in treatment-refractory depression are pretty weak, but we’re so desperate to do something for those patients. If you’re trying to harness the psychedelic properties of ketamine, I think there’s other psychedelics that are a lot more interesting, which is why we’re using psilocybin for a subset of patients. Most of us in the pain field think that the psychedelics will work best for the people with chronic pain who have a lot of comorbid psychiatric illness, especially the ones with a lot of trauma. These drugs will allow us therapeutically to get at a lot of these patients with the side-by-side psychotherapy that’s being done as people are getting care in the medicalized setting.
Dr. Clauw reported conflicts of interest with Pfizer, Tonix, Theravance, Zynerba, Samumed, Aptinyx, Daiichi Sankyo, Intec, Regeneron, Teva, Lundbeck, Virios, and Cerephex.
A version of this article first appeared on Medscape.com.
Chronic pain, and back pain in particular, is among the most frequent concerns for patients in the primary care setting. Roughly 8% of adults in the United States say they suffer from chronic low back pain, and many of them say the pain is significant enough to impair their ability to move, work, and otherwise enjoy life. All this, despite decades of research and countless millions in funding to find the optimal approach to treating chronic pain.
As the United States crawls out of the opioid epidemic, a group of pain specialists is hoping to identify effective, personalized approaches to managing back pain. Daniel Clauw, MD, professor of anesthesiology, internal medicine, and psychiatry at the University of Michigan, Ann Arbor, is helping lead the BEST trial. With projected enrollment of nearly 800 patients, BEST will be the largest federally funded clinical trial of interventions to treat chronic low back pain.
In an interview, The interview has been edited for length and clarity.
What are your thoughts on the current state of primary care physicians’ understanding and management of pain?
Primary care physicians need a lot of help in demystifying the diagnosis and treatment of any kind of pain, but back pain is a really good place to start. When it comes to back pain, most primary care physicians are not any more knowledgeable than a layperson.
What has the opioid debacle-cum-tragedy taught you about pain management, particular as regards people with chronic pain?
I don’t feel opioids should ever be used to treat chronic low back pain. The few long-term studies that have been performed using opioids for longer than 3 months suggest that they often make pain worse rather than just failing to make pain better – and we know they are associated with a significantly increased all-cause mortality with increased deaths from myocardial infarction, accidents, and suicides, in addition to overdose.
Given how many patients experience back pain, how did we come to the point at which primary care physicians are so ill equipped?
We’ve had terrible pain curricula in medical schools. To give you an example: I’m one of the leading pain experts in the world and I’m not allowed to teach our medical students their pain curriculum. The students learn about neurophysiology and the anatomy of the nerves, not what’s relevant in pain.
This is notorious in medical school: Curricula are almost impossible to modify and change. So it starts with poor training in medical school. And then, regardless of what education they do or don’t get in medical school, a lot of their education about pain management is through our residencies – mainly in inpatient settings, where you’re really seeing the management of acute pain and not the management of chronic pain.
People get more accustomed to managing acute pain, where opioids are a reasonable option. It’s just that when you start managing subacute or chronic pain, opioids don’t work as well.
The other big problem is that historically, most people trained in medicine think that if you have pain in your elbow, there’s got to be something wrong in your elbow. This third mechanism of pain, central sensitization – or nociplastic pain – the kind of pain that we see in fibromyalgia, headache, and low back pain, where the pain is coming from the brain – that’s confusing to people. People can have pain without any damage or inflammation to that region of the body.
Physicians are trained that if there’s pain, there’s something wrong and we have to do surgery or there’s been some trauma. Most chronic pain is none of that. There’s a big disconnect between how people are trained, and then when they go out and are seeing a tremendous number of people with chronic pain.
What are the different types of pain, and how should they inform clinicians’ understanding about what approaches might work for managing their patients in pain?
The way the central nervous system responds to pain is analogous to the loudness of an electric guitar. You can make an electric guitar louder either by strumming the strings harder or by turning up the amplifier. For many people with fibromyalgia, low back pain, and endometriosis, for example, the problem is really more that the amplifier is turned up too high rather than its being that the guitar is strummed too strongly. That kind of pain where the pain is not due to anatomic damage or inflammation is particularly flummoxing for providers.
Can you explain the design of the new study?
It’s a 13-site study looking at four treatments: enhanced self-care, cognitive-behavioral therapy, physical therapy, and duloxetine. It’s a big precision medicine trial, trying to take everything we’ve learned and putting it all into one big study.
We’re using a SMART design, which randomizes people to two of those treatments, unless they are very much improved from the first treatment. To be eligible for the trial, you have to be able to be randomized to three of the four treatments, and people can’t choose which of the four they get.
We give them one of those treatments for 12 weeks, and at the end of 12 weeks we make the call – “Did you respond or not respond?” – and then we go back to the phenotypic data we collected at the beginning of that trial and say, “What information at baseline that we collected predicts that someone is going to respond better to duloxetine or worse to duloxetine?” And then we create the phenotype that responds best to each of those four treatments.
None of our treatments works so well that someone doesn’t end up getting randomized to a second treatment. About 85% of people so far need a second treatment because they still have enough pain that they want more relief. But the nice thing about that is we’ve already done all the functional brain imaging and all these really expensive and time-consuming things.
We’re hoping to have around 700-800 people total in this trial, which means that around 170 people will get randomized to each of the four initial treatments. No one’s ever done a study that has functional brain imaging and all these other things in it with more than 80 or 100 people. The scale of this is totally unprecedented.
Given that the individual therapies don’t appear to be all that successful on their own, what is your goal?
The primary aim is to match the phenotypic characteristics of a patient with chronic low back pain with treatment response to each of these four treatments. So at the end, we can give clinicians information on which of the patients is going to respond to physical therapy, for instance.
Right now, about one out of three people respond to most treatments for pain. We think by doing a trial like this, we can take treatments that work in one out of three people and make them work in one out of two or two out of three people just by using them in the right people.
How do you differentiate between these types of pain in your study?
We phenotype people by asking them a number of questions. We also do brain imaging, look at their back with MRI, test biomechanics, and then give them four different treatments that we know work in groups of people with low back pain.
We think one of the first parts of the phenotype is, do they have pain just in their back? Or do they have pain in their back plus a lot of other body regions? Because the more body regions that people have pain in, the more likely it is that this is an amplifier problem rather than a guitar problem.
Treatments like physical therapy, surgery, and injections are going to work better for people in whom the pain is a guitar problem rather than an amplifier problem. And drugs like duloxetine, which works in the brain, and cognitive-behavioral therapy are going to work a lot better in the people with pain in multiple sites besides the back.
To pick up on your metaphor, do any symptoms help clinicians differentiate between the guitar and the amplifier?
Sleep problems, fatigue, memory problems, and mood problems are common in patients with chronic pain and are more common with amplifier pain. Because again, those are all central nervous system problems. And so we see that the people that have anxiety, depression, and a lot of distress are more likely to have this kind of pain.
Does medical imaging help?
There’s a terrible relationship between what you see on an MRI of the back and whether someone has pain or how severe the pain is going to be. There’s always going to be individuals that have a lot of anatomic damage who don’t have any pain because they happen to be on the other end of the continuum from fibromyalgia; they’re actually pain-insensitive people.
What are your thoughts about ketamine as a possible treatment for chronic pain?
I have a mentee who’s doing a ketamine trial. We’re doing psilocybin trials in patients with fibromyalgia. Ketamine is such a dirty drug; it has so many different mechanisms of action. It does have some psychedelic effects, but it also is an NMDA blocker. It really has so many different effects.
I think it’s being thrown around like water in settings where we don’t yet know it to be efficacious. Even the data in treatment-refractory depression are pretty weak, but we’re so desperate to do something for those patients. If you’re trying to harness the psychedelic properties of ketamine, I think there’s other psychedelics that are a lot more interesting, which is why we’re using psilocybin for a subset of patients. Most of us in the pain field think that the psychedelics will work best for the people with chronic pain who have a lot of comorbid psychiatric illness, especially the ones with a lot of trauma. These drugs will allow us therapeutically to get at a lot of these patients with the side-by-side psychotherapy that’s being done as people are getting care in the medicalized setting.
Dr. Clauw reported conflicts of interest with Pfizer, Tonix, Theravance, Zynerba, Samumed, Aptinyx, Daiichi Sankyo, Intec, Regeneron, Teva, Lundbeck, Virios, and Cerephex.
A version of this article first appeared on Medscape.com.
Chronic pain, and back pain in particular, is among the most frequent concerns for patients in the primary care setting. Roughly 8% of adults in the United States say they suffer from chronic low back pain, and many of them say the pain is significant enough to impair their ability to move, work, and otherwise enjoy life. All this, despite decades of research and countless millions in funding to find the optimal approach to treating chronic pain.
As the United States crawls out of the opioid epidemic, a group of pain specialists is hoping to identify effective, personalized approaches to managing back pain. Daniel Clauw, MD, professor of anesthesiology, internal medicine, and psychiatry at the University of Michigan, Ann Arbor, is helping lead the BEST trial. With projected enrollment of nearly 800 patients, BEST will be the largest federally funded clinical trial of interventions to treat chronic low back pain.
In an interview, The interview has been edited for length and clarity.
What are your thoughts on the current state of primary care physicians’ understanding and management of pain?
Primary care physicians need a lot of help in demystifying the diagnosis and treatment of any kind of pain, but back pain is a really good place to start. When it comes to back pain, most primary care physicians are not any more knowledgeable than a layperson.
What has the opioid debacle-cum-tragedy taught you about pain management, particular as regards people with chronic pain?
I don’t feel opioids should ever be used to treat chronic low back pain. The few long-term studies that have been performed using opioids for longer than 3 months suggest that they often make pain worse rather than just failing to make pain better – and we know they are associated with a significantly increased all-cause mortality with increased deaths from myocardial infarction, accidents, and suicides, in addition to overdose.
Given how many patients experience back pain, how did we come to the point at which primary care physicians are so ill equipped?
We’ve had terrible pain curricula in medical schools. To give you an example: I’m one of the leading pain experts in the world and I’m not allowed to teach our medical students their pain curriculum. The students learn about neurophysiology and the anatomy of the nerves, not what’s relevant in pain.
This is notorious in medical school: Curricula are almost impossible to modify and change. So it starts with poor training in medical school. And then, regardless of what education they do or don’t get in medical school, a lot of their education about pain management is through our residencies – mainly in inpatient settings, where you’re really seeing the management of acute pain and not the management of chronic pain.
People get more accustomed to managing acute pain, where opioids are a reasonable option. It’s just that when you start managing subacute or chronic pain, opioids don’t work as well.
The other big problem is that historically, most people trained in medicine think that if you have pain in your elbow, there’s got to be something wrong in your elbow. This third mechanism of pain, central sensitization – or nociplastic pain – the kind of pain that we see in fibromyalgia, headache, and low back pain, where the pain is coming from the brain – that’s confusing to people. People can have pain without any damage or inflammation to that region of the body.
Physicians are trained that if there’s pain, there’s something wrong and we have to do surgery or there’s been some trauma. Most chronic pain is none of that. There’s a big disconnect between how people are trained, and then when they go out and are seeing a tremendous number of people with chronic pain.
What are the different types of pain, and how should they inform clinicians’ understanding about what approaches might work for managing their patients in pain?
The way the central nervous system responds to pain is analogous to the loudness of an electric guitar. You can make an electric guitar louder either by strumming the strings harder or by turning up the amplifier. For many people with fibromyalgia, low back pain, and endometriosis, for example, the problem is really more that the amplifier is turned up too high rather than its being that the guitar is strummed too strongly. That kind of pain where the pain is not due to anatomic damage or inflammation is particularly flummoxing for providers.
Can you explain the design of the new study?
It’s a 13-site study looking at four treatments: enhanced self-care, cognitive-behavioral therapy, physical therapy, and duloxetine. It’s a big precision medicine trial, trying to take everything we’ve learned and putting it all into one big study.
We’re using a SMART design, which randomizes people to two of those treatments, unless they are very much improved from the first treatment. To be eligible for the trial, you have to be able to be randomized to three of the four treatments, and people can’t choose which of the four they get.
We give them one of those treatments for 12 weeks, and at the end of 12 weeks we make the call – “Did you respond or not respond?” – and then we go back to the phenotypic data we collected at the beginning of that trial and say, “What information at baseline that we collected predicts that someone is going to respond better to duloxetine or worse to duloxetine?” And then we create the phenotype that responds best to each of those four treatments.
None of our treatments works so well that someone doesn’t end up getting randomized to a second treatment. About 85% of people so far need a second treatment because they still have enough pain that they want more relief. But the nice thing about that is we’ve already done all the functional brain imaging and all these really expensive and time-consuming things.
We’re hoping to have around 700-800 people total in this trial, which means that around 170 people will get randomized to each of the four initial treatments. No one’s ever done a study that has functional brain imaging and all these other things in it with more than 80 or 100 people. The scale of this is totally unprecedented.
Given that the individual therapies don’t appear to be all that successful on their own, what is your goal?
The primary aim is to match the phenotypic characteristics of a patient with chronic low back pain with treatment response to each of these four treatments. So at the end, we can give clinicians information on which of the patients is going to respond to physical therapy, for instance.
Right now, about one out of three people respond to most treatments for pain. We think by doing a trial like this, we can take treatments that work in one out of three people and make them work in one out of two or two out of three people just by using them in the right people.
How do you differentiate between these types of pain in your study?
We phenotype people by asking them a number of questions. We also do brain imaging, look at their back with MRI, test biomechanics, and then give them four different treatments that we know work in groups of people with low back pain.
We think one of the first parts of the phenotype is, do they have pain just in their back? Or do they have pain in their back plus a lot of other body regions? Because the more body regions that people have pain in, the more likely it is that this is an amplifier problem rather than a guitar problem.
Treatments like physical therapy, surgery, and injections are going to work better for people in whom the pain is a guitar problem rather than an amplifier problem. And drugs like duloxetine, which works in the brain, and cognitive-behavioral therapy are going to work a lot better in the people with pain in multiple sites besides the back.
To pick up on your metaphor, do any symptoms help clinicians differentiate between the guitar and the amplifier?
Sleep problems, fatigue, memory problems, and mood problems are common in patients with chronic pain and are more common with amplifier pain. Because again, those are all central nervous system problems. And so we see that the people that have anxiety, depression, and a lot of distress are more likely to have this kind of pain.
Does medical imaging help?
There’s a terrible relationship between what you see on an MRI of the back and whether someone has pain or how severe the pain is going to be. There’s always going to be individuals that have a lot of anatomic damage who don’t have any pain because they happen to be on the other end of the continuum from fibromyalgia; they’re actually pain-insensitive people.
What are your thoughts about ketamine as a possible treatment for chronic pain?
I have a mentee who’s doing a ketamine trial. We’re doing psilocybin trials in patients with fibromyalgia. Ketamine is such a dirty drug; it has so many different mechanisms of action. It does have some psychedelic effects, but it also is an NMDA blocker. It really has so many different effects.
I think it’s being thrown around like water in settings where we don’t yet know it to be efficacious. Even the data in treatment-refractory depression are pretty weak, but we’re so desperate to do something for those patients. If you’re trying to harness the psychedelic properties of ketamine, I think there’s other psychedelics that are a lot more interesting, which is why we’re using psilocybin for a subset of patients. Most of us in the pain field think that the psychedelics will work best for the people with chronic pain who have a lot of comorbid psychiatric illness, especially the ones with a lot of trauma. These drugs will allow us therapeutically to get at a lot of these patients with the side-by-side psychotherapy that’s being done as people are getting care in the medicalized setting.
Dr. Clauw reported conflicts of interest with Pfizer, Tonix, Theravance, Zynerba, Samumed, Aptinyx, Daiichi Sankyo, Intec, Regeneron, Teva, Lundbeck, Virios, and Cerephex.
A version of this article first appeared on Medscape.com.
Oxycodone tied to persistent use only after vaginal delivery
“In the last decade in Ontario, oxycodone surpassed codeine as the most commonly prescribed opioid postpartum for pain control,” Jonathan Zipursky, MD, PhD, of Sunnybrook Health Sciences Centre, ICES, Toronto, and the University of Toronto, said in an interview. “This likely had to do with concerns with codeine use during breastfeeding, many of which are unsubstantiated.
“We hypothesized that use of oxycodone would be associated with an increased risk of persistent postpartum opioid use,” he said. “However, we did not find this.”
Instead, other factors, such as the quantity of opioids initially prescribed, were probably more important risks, he said.
The team also was “a bit surprised” that oxycodone was associated with an increased risk of persistent use only among those who had a vaginal delivery, Dr. Zipursky added.
“Receipt of an opioid prescription after vaginal delivery is uncommon in Ontario. People who fill prescriptions for potent opioids, such as oxycodone, after vaginal delivery may have underlying characteristics that predispose them to chronic opioid use,” he suggested. “Some of these factors we were unable to assess using our data.”
The study was published online in the Canadian Medical Association Journal.
Oxycodone okay
The investigators analyzed data from 70,607 people (median age, 32) who filled an opioid prescription within 7 days of discharge from the hospital between 2012 and 2020. Two-thirds (69.8%) received oxycodone and one-third received (30.2%) codeine.
The median gestational age at delivery was 39 weeks, and 80% of participants had a cesarean delivery. The median opioid prescription duration was 3 days. The median opioid content per prescription was 150 morphine milligram equivalents (MMEs) among those prescribed oxycodone and 135 MMEs for codeine.
The main outcome was persistent opioid use. This was defined as one or more additional prescriptions for an opioid within 90 days of the first postpartum prescription and one or more additional prescriptions in the 91-365 days after.
Oxycodone receipt was not associated with persistent opioid use, compared with codeine (relative risk, 1.04).
However, in a secondary analysis by mode of delivery, an association was seen between a prescription for oxycodone and persistent use after vaginal (RR, 1.63), but not after cesarean (RR, 0.85), delivery.
Dr. Zipursky noted that the quantity of opioids prescribed in the initial postpartum prescription “is likely a more important modifiable risk factor for new persistent opioid use, rather than the type of opioid prescribed.”
For example, a prescription containing more than 225 MMEs (equivalent to about 30 tablets of 5 mg oxycodone and to 50 tablets of 30 mg codeine) was associated with a roughly twofold increased risk of persistent use, compared with less than 112.5 MMEs after both vaginal (odds ratio, 2.51) and cesarean (OR, 1.78) delivery.
Furthermore, a prescription duration of more than 7 days was also associated with a roughly twofold increased risk of persistent use, compared with a duration of 1-3 days after both vaginal (OR, 2.43) and cesarean (OR, 1.52) delivery.
Most risk factors for persistent opioid use – a history of mental illness, substance use disorder, and more maternal comorbidities (aggregated diagnosis groups > 10) – were consistent across modes of delivery.
“Awareness of modifiable factors associated with new, persistent opioid use may help clinicians tailor opioid prescribing while ensuring adequate analgesia after delivery,” Dr. Zipursky suggested.
Less is more
In a comment, Elaine Duryea, MD, assistant professor in the department of obstetrics and gynecology at UT Southwestern Medical Center and medical director of the Maternal-Fetal Medicine Clinic at Parkland Health and Hospital System, both in Dallas, said, “It is likely exposure to any opioid, rather than a specific opioid, that can promote continued use – that is, past the medically indicated period.”
Dr. Duryea was principal investigator of a study, published in the American Journal of Obstetrics and Gynecology, that showed a multimodal regimen that included scheduled nonsteroidal anti-inflammatory drugs and acetaminophen, with opioids used as needed, resulted in a decrease in opioid use while adequately controlling pain after cesarean delivery.
“It is important to understand how to appropriately tailor the amount of opioid given to patients at the time of hospital discharge after cesarean in order to treat pain effectively but not send patients home with more opioids than [are] really needed,” she said.
It is also important to “individualize prescribing practices and maximize the use of non-opioid medication to treat postpartum and postoperative pain. Opioids should be a last resort for breakthrough pain, not first-line therapy,” Dr. Duryea concluded.
The study was funded by a Canadian Institutes of Health Research project grant. Dr. Zipursky has received payments from private law firms for medicolegal opinions on the safety and effectiveness of analgesics, including opioids.
A version of this article first appeared on Medscape.com.
“In the last decade in Ontario, oxycodone surpassed codeine as the most commonly prescribed opioid postpartum for pain control,” Jonathan Zipursky, MD, PhD, of Sunnybrook Health Sciences Centre, ICES, Toronto, and the University of Toronto, said in an interview. “This likely had to do with concerns with codeine use during breastfeeding, many of which are unsubstantiated.
“We hypothesized that use of oxycodone would be associated with an increased risk of persistent postpartum opioid use,” he said. “However, we did not find this.”
Instead, other factors, such as the quantity of opioids initially prescribed, were probably more important risks, he said.
The team also was “a bit surprised” that oxycodone was associated with an increased risk of persistent use only among those who had a vaginal delivery, Dr. Zipursky added.
“Receipt of an opioid prescription after vaginal delivery is uncommon in Ontario. People who fill prescriptions for potent opioids, such as oxycodone, after vaginal delivery may have underlying characteristics that predispose them to chronic opioid use,” he suggested. “Some of these factors we were unable to assess using our data.”
The study was published online in the Canadian Medical Association Journal.
Oxycodone okay
The investigators analyzed data from 70,607 people (median age, 32) who filled an opioid prescription within 7 days of discharge from the hospital between 2012 and 2020. Two-thirds (69.8%) received oxycodone and one-third received (30.2%) codeine.
The median gestational age at delivery was 39 weeks, and 80% of participants had a cesarean delivery. The median opioid prescription duration was 3 days. The median opioid content per prescription was 150 morphine milligram equivalents (MMEs) among those prescribed oxycodone and 135 MMEs for codeine.
The main outcome was persistent opioid use. This was defined as one or more additional prescriptions for an opioid within 90 days of the first postpartum prescription and one or more additional prescriptions in the 91-365 days after.
Oxycodone receipt was not associated with persistent opioid use, compared with codeine (relative risk, 1.04).
However, in a secondary analysis by mode of delivery, an association was seen between a prescription for oxycodone and persistent use after vaginal (RR, 1.63), but not after cesarean (RR, 0.85), delivery.
Dr. Zipursky noted that the quantity of opioids prescribed in the initial postpartum prescription “is likely a more important modifiable risk factor for new persistent opioid use, rather than the type of opioid prescribed.”
For example, a prescription containing more than 225 MMEs (equivalent to about 30 tablets of 5 mg oxycodone and to 50 tablets of 30 mg codeine) was associated with a roughly twofold increased risk of persistent use, compared with less than 112.5 MMEs after both vaginal (odds ratio, 2.51) and cesarean (OR, 1.78) delivery.
Furthermore, a prescription duration of more than 7 days was also associated with a roughly twofold increased risk of persistent use, compared with a duration of 1-3 days after both vaginal (OR, 2.43) and cesarean (OR, 1.52) delivery.
Most risk factors for persistent opioid use – a history of mental illness, substance use disorder, and more maternal comorbidities (aggregated diagnosis groups > 10) – were consistent across modes of delivery.
“Awareness of modifiable factors associated with new, persistent opioid use may help clinicians tailor opioid prescribing while ensuring adequate analgesia after delivery,” Dr. Zipursky suggested.
Less is more
In a comment, Elaine Duryea, MD, assistant professor in the department of obstetrics and gynecology at UT Southwestern Medical Center and medical director of the Maternal-Fetal Medicine Clinic at Parkland Health and Hospital System, both in Dallas, said, “It is likely exposure to any opioid, rather than a specific opioid, that can promote continued use – that is, past the medically indicated period.”
Dr. Duryea was principal investigator of a study, published in the American Journal of Obstetrics and Gynecology, that showed a multimodal regimen that included scheduled nonsteroidal anti-inflammatory drugs and acetaminophen, with opioids used as needed, resulted in a decrease in opioid use while adequately controlling pain after cesarean delivery.
“It is important to understand how to appropriately tailor the amount of opioid given to patients at the time of hospital discharge after cesarean in order to treat pain effectively but not send patients home with more opioids than [are] really needed,” she said.
It is also important to “individualize prescribing practices and maximize the use of non-opioid medication to treat postpartum and postoperative pain. Opioids should be a last resort for breakthrough pain, not first-line therapy,” Dr. Duryea concluded.
The study was funded by a Canadian Institutes of Health Research project grant. Dr. Zipursky has received payments from private law firms for medicolegal opinions on the safety and effectiveness of analgesics, including opioids.
A version of this article first appeared on Medscape.com.
“In the last decade in Ontario, oxycodone surpassed codeine as the most commonly prescribed opioid postpartum for pain control,” Jonathan Zipursky, MD, PhD, of Sunnybrook Health Sciences Centre, ICES, Toronto, and the University of Toronto, said in an interview. “This likely had to do with concerns with codeine use during breastfeeding, many of which are unsubstantiated.
“We hypothesized that use of oxycodone would be associated with an increased risk of persistent postpartum opioid use,” he said. “However, we did not find this.”
Instead, other factors, such as the quantity of opioids initially prescribed, were probably more important risks, he said.
The team also was “a bit surprised” that oxycodone was associated with an increased risk of persistent use only among those who had a vaginal delivery, Dr. Zipursky added.
“Receipt of an opioid prescription after vaginal delivery is uncommon in Ontario. People who fill prescriptions for potent opioids, such as oxycodone, after vaginal delivery may have underlying characteristics that predispose them to chronic opioid use,” he suggested. “Some of these factors we were unable to assess using our data.”
The study was published online in the Canadian Medical Association Journal.
Oxycodone okay
The investigators analyzed data from 70,607 people (median age, 32) who filled an opioid prescription within 7 days of discharge from the hospital between 2012 and 2020. Two-thirds (69.8%) received oxycodone and one-third received (30.2%) codeine.
The median gestational age at delivery was 39 weeks, and 80% of participants had a cesarean delivery. The median opioid prescription duration was 3 days. The median opioid content per prescription was 150 morphine milligram equivalents (MMEs) among those prescribed oxycodone and 135 MMEs for codeine.
The main outcome was persistent opioid use. This was defined as one or more additional prescriptions for an opioid within 90 days of the first postpartum prescription and one or more additional prescriptions in the 91-365 days after.
Oxycodone receipt was not associated with persistent opioid use, compared with codeine (relative risk, 1.04).
However, in a secondary analysis by mode of delivery, an association was seen between a prescription for oxycodone and persistent use after vaginal (RR, 1.63), but not after cesarean (RR, 0.85), delivery.
Dr. Zipursky noted that the quantity of opioids prescribed in the initial postpartum prescription “is likely a more important modifiable risk factor for new persistent opioid use, rather than the type of opioid prescribed.”
For example, a prescription containing more than 225 MMEs (equivalent to about 30 tablets of 5 mg oxycodone and to 50 tablets of 30 mg codeine) was associated with a roughly twofold increased risk of persistent use, compared with less than 112.5 MMEs after both vaginal (odds ratio, 2.51) and cesarean (OR, 1.78) delivery.
Furthermore, a prescription duration of more than 7 days was also associated with a roughly twofold increased risk of persistent use, compared with a duration of 1-3 days after both vaginal (OR, 2.43) and cesarean (OR, 1.52) delivery.
Most risk factors for persistent opioid use – a history of mental illness, substance use disorder, and more maternal comorbidities (aggregated diagnosis groups > 10) – were consistent across modes of delivery.
“Awareness of modifiable factors associated with new, persistent opioid use may help clinicians tailor opioid prescribing while ensuring adequate analgesia after delivery,” Dr. Zipursky suggested.
Less is more
In a comment, Elaine Duryea, MD, assistant professor in the department of obstetrics and gynecology at UT Southwestern Medical Center and medical director of the Maternal-Fetal Medicine Clinic at Parkland Health and Hospital System, both in Dallas, said, “It is likely exposure to any opioid, rather than a specific opioid, that can promote continued use – that is, past the medically indicated period.”
Dr. Duryea was principal investigator of a study, published in the American Journal of Obstetrics and Gynecology, that showed a multimodal regimen that included scheduled nonsteroidal anti-inflammatory drugs and acetaminophen, with opioids used as needed, resulted in a decrease in opioid use while adequately controlling pain after cesarean delivery.
“It is important to understand how to appropriately tailor the amount of opioid given to patients at the time of hospital discharge after cesarean in order to treat pain effectively but not send patients home with more opioids than [are] really needed,” she said.
It is also important to “individualize prescribing practices and maximize the use of non-opioid medication to treat postpartum and postoperative pain. Opioids should be a last resort for breakthrough pain, not first-line therapy,” Dr. Duryea concluded.
The study was funded by a Canadian Institutes of Health Research project grant. Dr. Zipursky has received payments from private law firms for medicolegal opinions on the safety and effectiveness of analgesics, including opioids.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN MEDICAL ASSOCIATION JOURNAL
Could your practice be more profitable if you outsource?
Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.
Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.
The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.
“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.
When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.
For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
What functions lend themselves to outsourcing?
Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.
Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.
Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.
The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.
“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”
Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
What medical practices benefit most from outsourcing?
All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”
Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.
Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”
Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
The pros and cons of outsourcing
Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”
“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”
When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.
However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.
“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”
Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”
He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”
Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
Offshore outsourcing
Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.
The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.
However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.
“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
How to select the right company
Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”
“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”
Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.
Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”
Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
Working with outsource service providers
Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.
Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.
Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”
“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
Will outsourcing expand in the future?
Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.
Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”
Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”
A version of this article first appeared on Medscape.com.
Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.
Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.
The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.
“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.
When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.
For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
What functions lend themselves to outsourcing?
Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.
Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.
Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.
The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.
“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”
Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
What medical practices benefit most from outsourcing?
All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”
Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.
Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”
Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
The pros and cons of outsourcing
Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”
“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”
When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.
However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.
“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”
Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”
He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”
Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
Offshore outsourcing
Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.
The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.
However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.
“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
How to select the right company
Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”
“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”
Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.
Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”
Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
Working with outsource service providers
Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.
Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.
Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”
“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
Will outsourcing expand in the future?
Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.
Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”
Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”
A version of this article first appeared on Medscape.com.
Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.
Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.
The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.
“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.
When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.
For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
What functions lend themselves to outsourcing?
Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.
Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.
Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.
The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.
“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”
Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
What medical practices benefit most from outsourcing?
All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”
Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.
Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”
Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
The pros and cons of outsourcing
Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”
“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”
When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.
However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.
“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”
Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”
He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”
Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
Offshore outsourcing
Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.
The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.
However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.
“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
How to select the right company
Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”
“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”
Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.
Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”
Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
Working with outsource service providers
Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.
Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.
Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”
“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
Will outsourcing expand in the future?
Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.
Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”
Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”
A version of this article first appeared on Medscape.com.
Reassuring data on stimulants for ADHD in kids and later substance abuse
“Throughout rigorous analyses, and after accounting for more than 70 variables in this longitudinal sample of children with ADHD taking stimulants, we did not find an association with later substance use,” lead investigator Brooke Molina, PhD, director of the youth and family research program at the University of Pittsburgh, said in an interview.
The findings were published online in JAMA Psychiatry.
Protective effect?
Owing to symptoms of impulsivity inherent to ADHD, the disorder itself carries a risk for elevated substance use, the investigators note.
They speculate that this may be why some previous research suggests prescription stimulants reduce the risk of subsequent substance use disorder. However, other studies have found no such protective link.
To shed more light on the issue, the investigators used data from the Multimodal Treatment Study of ADHD, a multicenter, 14-month randomized clinical trial of medication and behavioral therapy for children with ADHD. However, for the purposes of the present study, investigators focused only on stimulant use in children.
At the time of recruitment, the children were aged 7-9 and had been diagnosed with ADHD between 1994 and 1996.
Investigators assessed the participants prior to randomization, at months 3 and 9, and at the end of treatment. They were then followed for 16 years and were assessed at years 2, 3, 6, 8, 10, 12, 14, and 16 until a mean age of 25.
During 12-, 14-, and 16-year follow-up, participants completed a questionnaire on their use of alcohol, marijuana, cigarettes, and several illicit and prescription drugs.
Investigators collected information on participants’ stimulant treatment via the Services for Children and Adolescents Parent Interview until they reached age 18. After that, participants reported their own stimulant treatment.
A total of 579 participants were included in the analysis. Of these, 61% were White, 20% were Black, and 8% were Hispanic.
Decline in stimulant use over time
The analysis showed that stimulant use declined “precipitously” over time – from 60% at the 2- and 3-year assessments to an average of 7% during early adulthood.
The investigators also found that for some participants, substance use increased steadily through adolescence and remained stable through early adulthood. For instance, 36.5% of the adolescents in the total cohort reported smoking tobacco daily, and 29.6% reported using marijuana every week.
In addition, approximately 21% of the participants indulged in heavy drinking at least once a week, and 6% reported “other” substance use, which included sedative misuse, heroin, inhalants, hallucinogens, or other substances taken to “get high.”
After accounting for developmental trends in substance use in the sample through adolescence into early adulthood with several rigorous statistical models, the researchers found no association between current or prior stimulant treatment and cigarette, marijuana, alcohol, or other substance use, with one exception.
While cumulative stimulant treatment was associated with increased heavy drinking, the effect size of this association was small. Each additional year of cumulative stimulant use was estimated to increase participants’ likelihood of any binge drinking/drunkenness vs. none in the past year by 4% (95% confidence interval, 0.01-0.08; P =.03).
When the investigators used a causal analytic method to account for age and other time-varying characteristics, including household income, behavior problems, and parental support, there was no evidence that current (B range, –0.62-0.34) or prior stimulant treatment (B range, –0.06-0.70) or their interaction (B range, –0.49-0.86) was associated with substance use in adulthood.
Dr. Molina noted that although participants were recruited from multiple sites, the sample may not be generalizable because children and parents who present for an intensive treatment study such as this are not necessarily representative of the general ADHD population.
Reassuring findings
In a comment, Julie Schweitzer, PhD, professor of psychiatry and behavioral sciences at the University of California, Davis, said she hopes the study findings will quell the stigma surrounding stimulant use by children with ADHD.
“Parents’ fears that stimulant use will lead to a substance use disorder inhibits them from bringing their children for an ADHD evaluation, thus reducing the likelihood that they will receive timely treatment,” Dr. Schweitzer said.
“While stimulant medication is the first-line treatment most often recommended for most persons with ADHD, by not following through on evaluations, parents also miss the opportunity to learn about nonpharmacological strategies that might also be helpful to help cope with ADHD symptoms and its potential co-occurring challenges,” she added.
Dr. Schweitzer also noted that many parents hope their children will outgrow the symptoms without realizing that by not obtaining an evaluation and treatment for their child, there is an associated cost, including less than optimal academic performance, social relationships, and emotional health.
The Multimodal Treatment Study of Children with ADHD was a National Institute of Mental Health cooperative agreement randomized clinical trial, continued under an NIMH contract as a follow-up study and under a National Institute on Drug Abuse contract followed by a data analysis grant. Dr. Molina reported grants from the NIMH and the National Institute on Drug Abuse during the conduct of the study.
A version of this article first appeared on Medscape.com.
“Throughout rigorous analyses, and after accounting for more than 70 variables in this longitudinal sample of children with ADHD taking stimulants, we did not find an association with later substance use,” lead investigator Brooke Molina, PhD, director of the youth and family research program at the University of Pittsburgh, said in an interview.
The findings were published online in JAMA Psychiatry.
Protective effect?
Owing to symptoms of impulsivity inherent to ADHD, the disorder itself carries a risk for elevated substance use, the investigators note.
They speculate that this may be why some previous research suggests prescription stimulants reduce the risk of subsequent substance use disorder. However, other studies have found no such protective link.
To shed more light on the issue, the investigators used data from the Multimodal Treatment Study of ADHD, a multicenter, 14-month randomized clinical trial of medication and behavioral therapy for children with ADHD. However, for the purposes of the present study, investigators focused only on stimulant use in children.
At the time of recruitment, the children were aged 7-9 and had been diagnosed with ADHD between 1994 and 1996.
Investigators assessed the participants prior to randomization, at months 3 and 9, and at the end of treatment. They were then followed for 16 years and were assessed at years 2, 3, 6, 8, 10, 12, 14, and 16 until a mean age of 25.
During 12-, 14-, and 16-year follow-up, participants completed a questionnaire on their use of alcohol, marijuana, cigarettes, and several illicit and prescription drugs.
Investigators collected information on participants’ stimulant treatment via the Services for Children and Adolescents Parent Interview until they reached age 18. After that, participants reported their own stimulant treatment.
A total of 579 participants were included in the analysis. Of these, 61% were White, 20% were Black, and 8% were Hispanic.
Decline in stimulant use over time
The analysis showed that stimulant use declined “precipitously” over time – from 60% at the 2- and 3-year assessments to an average of 7% during early adulthood.
The investigators also found that for some participants, substance use increased steadily through adolescence and remained stable through early adulthood. For instance, 36.5% of the adolescents in the total cohort reported smoking tobacco daily, and 29.6% reported using marijuana every week.
In addition, approximately 21% of the participants indulged in heavy drinking at least once a week, and 6% reported “other” substance use, which included sedative misuse, heroin, inhalants, hallucinogens, or other substances taken to “get high.”
After accounting for developmental trends in substance use in the sample through adolescence into early adulthood with several rigorous statistical models, the researchers found no association between current or prior stimulant treatment and cigarette, marijuana, alcohol, or other substance use, with one exception.
While cumulative stimulant treatment was associated with increased heavy drinking, the effect size of this association was small. Each additional year of cumulative stimulant use was estimated to increase participants’ likelihood of any binge drinking/drunkenness vs. none in the past year by 4% (95% confidence interval, 0.01-0.08; P =.03).
When the investigators used a causal analytic method to account for age and other time-varying characteristics, including household income, behavior problems, and parental support, there was no evidence that current (B range, –0.62-0.34) or prior stimulant treatment (B range, –0.06-0.70) or their interaction (B range, –0.49-0.86) was associated with substance use in adulthood.
Dr. Molina noted that although participants were recruited from multiple sites, the sample may not be generalizable because children and parents who present for an intensive treatment study such as this are not necessarily representative of the general ADHD population.
Reassuring findings
In a comment, Julie Schweitzer, PhD, professor of psychiatry and behavioral sciences at the University of California, Davis, said she hopes the study findings will quell the stigma surrounding stimulant use by children with ADHD.
“Parents’ fears that stimulant use will lead to a substance use disorder inhibits them from bringing their children for an ADHD evaluation, thus reducing the likelihood that they will receive timely treatment,” Dr. Schweitzer said.
“While stimulant medication is the first-line treatment most often recommended for most persons with ADHD, by not following through on evaluations, parents also miss the opportunity to learn about nonpharmacological strategies that might also be helpful to help cope with ADHD symptoms and its potential co-occurring challenges,” she added.
Dr. Schweitzer also noted that many parents hope their children will outgrow the symptoms without realizing that by not obtaining an evaluation and treatment for their child, there is an associated cost, including less than optimal academic performance, social relationships, and emotional health.
The Multimodal Treatment Study of Children with ADHD was a National Institute of Mental Health cooperative agreement randomized clinical trial, continued under an NIMH contract as a follow-up study and under a National Institute on Drug Abuse contract followed by a data analysis grant. Dr. Molina reported grants from the NIMH and the National Institute on Drug Abuse during the conduct of the study.
A version of this article first appeared on Medscape.com.
“Throughout rigorous analyses, and after accounting for more than 70 variables in this longitudinal sample of children with ADHD taking stimulants, we did not find an association with later substance use,” lead investigator Brooke Molina, PhD, director of the youth and family research program at the University of Pittsburgh, said in an interview.
The findings were published online in JAMA Psychiatry.
Protective effect?
Owing to symptoms of impulsivity inherent to ADHD, the disorder itself carries a risk for elevated substance use, the investigators note.
They speculate that this may be why some previous research suggests prescription stimulants reduce the risk of subsequent substance use disorder. However, other studies have found no such protective link.
To shed more light on the issue, the investigators used data from the Multimodal Treatment Study of ADHD, a multicenter, 14-month randomized clinical trial of medication and behavioral therapy for children with ADHD. However, for the purposes of the present study, investigators focused only on stimulant use in children.
At the time of recruitment, the children were aged 7-9 and had been diagnosed with ADHD between 1994 and 1996.
Investigators assessed the participants prior to randomization, at months 3 and 9, and at the end of treatment. They were then followed for 16 years and were assessed at years 2, 3, 6, 8, 10, 12, 14, and 16 until a mean age of 25.
During 12-, 14-, and 16-year follow-up, participants completed a questionnaire on their use of alcohol, marijuana, cigarettes, and several illicit and prescription drugs.
Investigators collected information on participants’ stimulant treatment via the Services for Children and Adolescents Parent Interview until they reached age 18. After that, participants reported their own stimulant treatment.
A total of 579 participants were included in the analysis. Of these, 61% were White, 20% were Black, and 8% were Hispanic.
Decline in stimulant use over time
The analysis showed that stimulant use declined “precipitously” over time – from 60% at the 2- and 3-year assessments to an average of 7% during early adulthood.
The investigators also found that for some participants, substance use increased steadily through adolescence and remained stable through early adulthood. For instance, 36.5% of the adolescents in the total cohort reported smoking tobacco daily, and 29.6% reported using marijuana every week.
In addition, approximately 21% of the participants indulged in heavy drinking at least once a week, and 6% reported “other” substance use, which included sedative misuse, heroin, inhalants, hallucinogens, or other substances taken to “get high.”
After accounting for developmental trends in substance use in the sample through adolescence into early adulthood with several rigorous statistical models, the researchers found no association between current or prior stimulant treatment and cigarette, marijuana, alcohol, or other substance use, with one exception.
While cumulative stimulant treatment was associated with increased heavy drinking, the effect size of this association was small. Each additional year of cumulative stimulant use was estimated to increase participants’ likelihood of any binge drinking/drunkenness vs. none in the past year by 4% (95% confidence interval, 0.01-0.08; P =.03).
When the investigators used a causal analytic method to account for age and other time-varying characteristics, including household income, behavior problems, and parental support, there was no evidence that current (B range, –0.62-0.34) or prior stimulant treatment (B range, –0.06-0.70) or their interaction (B range, –0.49-0.86) was associated with substance use in adulthood.
Dr. Molina noted that although participants were recruited from multiple sites, the sample may not be generalizable because children and parents who present for an intensive treatment study such as this are not necessarily representative of the general ADHD population.
Reassuring findings
In a comment, Julie Schweitzer, PhD, professor of psychiatry and behavioral sciences at the University of California, Davis, said she hopes the study findings will quell the stigma surrounding stimulant use by children with ADHD.
“Parents’ fears that stimulant use will lead to a substance use disorder inhibits them from bringing their children for an ADHD evaluation, thus reducing the likelihood that they will receive timely treatment,” Dr. Schweitzer said.
“While stimulant medication is the first-line treatment most often recommended for most persons with ADHD, by not following through on evaluations, parents also miss the opportunity to learn about nonpharmacological strategies that might also be helpful to help cope with ADHD symptoms and its potential co-occurring challenges,” she added.
Dr. Schweitzer also noted that many parents hope their children will outgrow the symptoms without realizing that by not obtaining an evaluation and treatment for their child, there is an associated cost, including less than optimal academic performance, social relationships, and emotional health.
The Multimodal Treatment Study of Children with ADHD was a National Institute of Mental Health cooperative agreement randomized clinical trial, continued under an NIMH contract as a follow-up study and under a National Institute on Drug Abuse contract followed by a data analysis grant. Dr. Molina reported grants from the NIMH and the National Institute on Drug Abuse during the conduct of the study.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Psilocybin shows early promise for anorexia nervosa
The psychedelic psilocybin may have a role in the treatment of anorexia nervosa (AN), an eating disorder that is notoriously difficult and costly to treat.
Stephanie Knatz Peck, PhD, and colleagues with the eating disorders treatment & research center, University of California San Diego, write that the “robust response” in a subset of women after a single dose of psilocybin is “notable,” given that currently available treatments for adult anorexia result in only modest improvements in symptoms and often focus on weight and nutritional rehabilitation without adequately addressing underlying psychopathology.
However, given this was a small, phase 1, open-label feasibility study, these effects are “preliminary and inconclusive,” they caution.
The study was published online in Nature Medicine.
Meaningful experience
The 10 women in the study met DSM-5 criteria for AN or partial remission of AN. They were between age 18 and 40 years with a mean body mass index (BMI) of 19.7 kg/m2.
Following the single 25-mg dose of psilocybin, no clinically significant changes were observed in ECG, vital signs, laboratory values, or suicidality.
All adverse events were mild and mirrored typical psilocybin-associated symptoms such as transient headache, nausea, and fatigue.
Psilocybin was associated with reduced levels of anxiety and preoccupations surrounding food, eating, and body shape at the 1-month follow-up.
Weight concerns decreased significantly at the 1-month (P = .036, Cohen’s d = .78) and 3-month (P = .04, d = .78) follow-up, with a medium to large effect.
Shape concerns significantly decreased at 1-month follow-up (P = .036, d = .78) but were no longer significant at 3-month follow-up (P = .081, d = .62).
Four of the 10 women (40%) had clinically significant reductions in eating disorder scores at 3 months, which qualified for remission from eating-disorder psychopathology.
However, the researchers caution that the effects on eating disorder psychopathology were “highly variable.”
On average, changes in BMI were not significant during the 3 months following psilocybin treatment. However, five women had an increase in BMI at 3 months, ranging from 0.4 to 1.2 kg/m2.
Overall, the psilocybin experience was regarded as meaningful by participants; 80% endorsed the experience as one of the top five most meaningful of life; 90% endorsed feeling more positive about life endeavors; and 70% reported experiencing a shift in personal identity and overall quality of life.
The vast majority of women (90%) felt that one dosing session was not enough.
The fact that the treatment was regarded as beneficial by most women and that there were no dropouts are “promising signs of engagement,” given that dropout rates for currently available AN treatments tend to be high, the researchers note.
They urge caution in interpreting the results considering they were based on a small sample size and did not include a placebo group. They note that larger, adequately powered, randomized controlled trials are needed to draw any conclusions about the role of psilocybin for anorexia nervosa.
Encouraging data
The coauthors of a Nature Medicine News & Views commentary say this “encouraging” phase 1 trial “underscores the necessity for more research into classic psychedelics to address the urgent need for effective treatments” for AN.
Outside experts also weighed in on the study in a statement from the U.K.-based nonprofit Science Media Centre.
Alexandra Pike, DPhil, MSc, with University of York, England, noted that this study is “a first step in showing that psilocybin may be a safe treatment for those with anorexia nervosa, but we cannot conclude from this work that it will be effective in this chronic, complex illness.”
Trevor Steward, MD, with University of Melbourne, noted that psilocybin therapy has provided “glimmers of hope in other mental health disorders, notably by providing evidence that it can improve anxiety, cognitive flexibility, and self-acceptance for some people. These are all features of anorexia nervosa and the rationale for exploring psilocybin therapy as an option in the case of anorexia is strong.”
Dr. Steward also noted that the field is only beginning to “scratch the surface in terms of understanding how psilocybin impacts the brain. Dedicated funding to exploring how it specifically acts to target anorexia nervosa symptoms is crucial to advancing this important avenue of research.
“As there are no approved medications available specifically for anorexia nervosa treatment, psilocybin therapy may prove to be a promising option, though additional research is needed to test this,” Dr. Steward said.
The study used an investigational synthetic formulation of psilocybin (COMP360 psilocybin) developed by COMPASS Pathways, which funded the study. Two coauthors have financial and scientific relationships with COMPASS Pathways. The commentary authors and Dr. Steward report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The psychedelic psilocybin may have a role in the treatment of anorexia nervosa (AN), an eating disorder that is notoriously difficult and costly to treat.
Stephanie Knatz Peck, PhD, and colleagues with the eating disorders treatment & research center, University of California San Diego, write that the “robust response” in a subset of women after a single dose of psilocybin is “notable,” given that currently available treatments for adult anorexia result in only modest improvements in symptoms and often focus on weight and nutritional rehabilitation without adequately addressing underlying psychopathology.
However, given this was a small, phase 1, open-label feasibility study, these effects are “preliminary and inconclusive,” they caution.
The study was published online in Nature Medicine.
Meaningful experience
The 10 women in the study met DSM-5 criteria for AN or partial remission of AN. They were between age 18 and 40 years with a mean body mass index (BMI) of 19.7 kg/m2.
Following the single 25-mg dose of psilocybin, no clinically significant changes were observed in ECG, vital signs, laboratory values, or suicidality.
All adverse events were mild and mirrored typical psilocybin-associated symptoms such as transient headache, nausea, and fatigue.
Psilocybin was associated with reduced levels of anxiety and preoccupations surrounding food, eating, and body shape at the 1-month follow-up.
Weight concerns decreased significantly at the 1-month (P = .036, Cohen’s d = .78) and 3-month (P = .04, d = .78) follow-up, with a medium to large effect.
Shape concerns significantly decreased at 1-month follow-up (P = .036, d = .78) but were no longer significant at 3-month follow-up (P = .081, d = .62).
Four of the 10 women (40%) had clinically significant reductions in eating disorder scores at 3 months, which qualified for remission from eating-disorder psychopathology.
However, the researchers caution that the effects on eating disorder psychopathology were “highly variable.”
On average, changes in BMI were not significant during the 3 months following psilocybin treatment. However, five women had an increase in BMI at 3 months, ranging from 0.4 to 1.2 kg/m2.
Overall, the psilocybin experience was regarded as meaningful by participants; 80% endorsed the experience as one of the top five most meaningful of life; 90% endorsed feeling more positive about life endeavors; and 70% reported experiencing a shift in personal identity and overall quality of life.
The vast majority of women (90%) felt that one dosing session was not enough.
The fact that the treatment was regarded as beneficial by most women and that there were no dropouts are “promising signs of engagement,” given that dropout rates for currently available AN treatments tend to be high, the researchers note.
They urge caution in interpreting the results considering they were based on a small sample size and did not include a placebo group. They note that larger, adequately powered, randomized controlled trials are needed to draw any conclusions about the role of psilocybin for anorexia nervosa.
Encouraging data
The coauthors of a Nature Medicine News & Views commentary say this “encouraging” phase 1 trial “underscores the necessity for more research into classic psychedelics to address the urgent need for effective treatments” for AN.
Outside experts also weighed in on the study in a statement from the U.K.-based nonprofit Science Media Centre.
Alexandra Pike, DPhil, MSc, with University of York, England, noted that this study is “a first step in showing that psilocybin may be a safe treatment for those with anorexia nervosa, but we cannot conclude from this work that it will be effective in this chronic, complex illness.”
Trevor Steward, MD, with University of Melbourne, noted that psilocybin therapy has provided “glimmers of hope in other mental health disorders, notably by providing evidence that it can improve anxiety, cognitive flexibility, and self-acceptance for some people. These are all features of anorexia nervosa and the rationale for exploring psilocybin therapy as an option in the case of anorexia is strong.”
Dr. Steward also noted that the field is only beginning to “scratch the surface in terms of understanding how psilocybin impacts the brain. Dedicated funding to exploring how it specifically acts to target anorexia nervosa symptoms is crucial to advancing this important avenue of research.
“As there are no approved medications available specifically for anorexia nervosa treatment, psilocybin therapy may prove to be a promising option, though additional research is needed to test this,” Dr. Steward said.
The study used an investigational synthetic formulation of psilocybin (COMP360 psilocybin) developed by COMPASS Pathways, which funded the study. Two coauthors have financial and scientific relationships with COMPASS Pathways. The commentary authors and Dr. Steward report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The psychedelic psilocybin may have a role in the treatment of anorexia nervosa (AN), an eating disorder that is notoriously difficult and costly to treat.
Stephanie Knatz Peck, PhD, and colleagues with the eating disorders treatment & research center, University of California San Diego, write that the “robust response” in a subset of women after a single dose of psilocybin is “notable,” given that currently available treatments for adult anorexia result in only modest improvements in symptoms and often focus on weight and nutritional rehabilitation without adequately addressing underlying psychopathology.
However, given this was a small, phase 1, open-label feasibility study, these effects are “preliminary and inconclusive,” they caution.
The study was published online in Nature Medicine.
Meaningful experience
The 10 women in the study met DSM-5 criteria for AN or partial remission of AN. They were between age 18 and 40 years with a mean body mass index (BMI) of 19.7 kg/m2.
Following the single 25-mg dose of psilocybin, no clinically significant changes were observed in ECG, vital signs, laboratory values, or suicidality.
All adverse events were mild and mirrored typical psilocybin-associated symptoms such as transient headache, nausea, and fatigue.
Psilocybin was associated with reduced levels of anxiety and preoccupations surrounding food, eating, and body shape at the 1-month follow-up.
Weight concerns decreased significantly at the 1-month (P = .036, Cohen’s d = .78) and 3-month (P = .04, d = .78) follow-up, with a medium to large effect.
Shape concerns significantly decreased at 1-month follow-up (P = .036, d = .78) but were no longer significant at 3-month follow-up (P = .081, d = .62).
Four of the 10 women (40%) had clinically significant reductions in eating disorder scores at 3 months, which qualified for remission from eating-disorder psychopathology.
However, the researchers caution that the effects on eating disorder psychopathology were “highly variable.”
On average, changes in BMI were not significant during the 3 months following psilocybin treatment. However, five women had an increase in BMI at 3 months, ranging from 0.4 to 1.2 kg/m2.
Overall, the psilocybin experience was regarded as meaningful by participants; 80% endorsed the experience as one of the top five most meaningful of life; 90% endorsed feeling more positive about life endeavors; and 70% reported experiencing a shift in personal identity and overall quality of life.
The vast majority of women (90%) felt that one dosing session was not enough.
The fact that the treatment was regarded as beneficial by most women and that there were no dropouts are “promising signs of engagement,” given that dropout rates for currently available AN treatments tend to be high, the researchers note.
They urge caution in interpreting the results considering they were based on a small sample size and did not include a placebo group. They note that larger, adequately powered, randomized controlled trials are needed to draw any conclusions about the role of psilocybin for anorexia nervosa.
Encouraging data
The coauthors of a Nature Medicine News & Views commentary say this “encouraging” phase 1 trial “underscores the necessity for more research into classic psychedelics to address the urgent need for effective treatments” for AN.
Outside experts also weighed in on the study in a statement from the U.K.-based nonprofit Science Media Centre.
Alexandra Pike, DPhil, MSc, with University of York, England, noted that this study is “a first step in showing that psilocybin may be a safe treatment for those with anorexia nervosa, but we cannot conclude from this work that it will be effective in this chronic, complex illness.”
Trevor Steward, MD, with University of Melbourne, noted that psilocybin therapy has provided “glimmers of hope in other mental health disorders, notably by providing evidence that it can improve anxiety, cognitive flexibility, and self-acceptance for some people. These are all features of anorexia nervosa and the rationale for exploring psilocybin therapy as an option in the case of anorexia is strong.”
Dr. Steward also noted that the field is only beginning to “scratch the surface in terms of understanding how psilocybin impacts the brain. Dedicated funding to exploring how it specifically acts to target anorexia nervosa symptoms is crucial to advancing this important avenue of research.
“As there are no approved medications available specifically for anorexia nervosa treatment, psilocybin therapy may prove to be a promising option, though additional research is needed to test this,” Dr. Steward said.
The study used an investigational synthetic formulation of psilocybin (COMP360 psilocybin) developed by COMPASS Pathways, which funded the study. Two coauthors have financial and scientific relationships with COMPASS Pathways. The commentary authors and Dr. Steward report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NATURE MEDICINE
Fast-acting postpartum depression drug is effective
The Food and Drug Administration is considering approving a postpartum depression medication that can start working rapidly – in as little as 3 days. Promising results for the drug, zuranolone, were published recently in The American Journal of Psychiatry.
Approximately 17% of women are affected by postpartum depression (PPD) during pregnancy or after birth, study authors noted. The condition often results in reduced breastfeeding, poor maternal-infant bonding, and hindering behavioral, emotional and brain development of the baby. Severe PPD can lead to suicide of the mother, which accounts for 20% of all postpartum deaths, they wrote.
The study included 196 people who had given birth in the past year, and were between the ages of 18 and 45 years old. Participants had major depression that began in the 3rd trimester of pregnancy or during the first 4 weeks of the postpartum period. Among participants, 22% were Black and 38% were Hispanic.
The average time it took for symptoms to significantly decline was 9 days. Most people who saw improvements had them continue for the entire 45-day follow-up period. The most common side effects were drowsiness, dizziness, and sleepiness.
Currently, PPD treatment includes taking antidepressants, which can take up to 12 weeks to work.
Researchers noted that the limitations of the study were that it only included women with severe PPD, and that women with a history of bipolar or psychotic disorders were excluded. Women in the study were not allowed to breastfeed, so the effect of zuranolone on lactation is unknown, they wrote.
A February news release from drugmaker Biogen indicated the FDA may decide whether to approve the medicine by Aug. 5.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration is considering approving a postpartum depression medication that can start working rapidly – in as little as 3 days. Promising results for the drug, zuranolone, were published recently in The American Journal of Psychiatry.
Approximately 17% of women are affected by postpartum depression (PPD) during pregnancy or after birth, study authors noted. The condition often results in reduced breastfeeding, poor maternal-infant bonding, and hindering behavioral, emotional and brain development of the baby. Severe PPD can lead to suicide of the mother, which accounts for 20% of all postpartum deaths, they wrote.
The study included 196 people who had given birth in the past year, and were between the ages of 18 and 45 years old. Participants had major depression that began in the 3rd trimester of pregnancy or during the first 4 weeks of the postpartum period. Among participants, 22% were Black and 38% were Hispanic.
The average time it took for symptoms to significantly decline was 9 days. Most people who saw improvements had them continue for the entire 45-day follow-up period. The most common side effects were drowsiness, dizziness, and sleepiness.
Currently, PPD treatment includes taking antidepressants, which can take up to 12 weeks to work.
Researchers noted that the limitations of the study were that it only included women with severe PPD, and that women with a history of bipolar or psychotic disorders were excluded. Women in the study were not allowed to breastfeed, so the effect of zuranolone on lactation is unknown, they wrote.
A February news release from drugmaker Biogen indicated the FDA may decide whether to approve the medicine by Aug. 5.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration is considering approving a postpartum depression medication that can start working rapidly – in as little as 3 days. Promising results for the drug, zuranolone, were published recently in The American Journal of Psychiatry.
Approximately 17% of women are affected by postpartum depression (PPD) during pregnancy or after birth, study authors noted. The condition often results in reduced breastfeeding, poor maternal-infant bonding, and hindering behavioral, emotional and brain development of the baby. Severe PPD can lead to suicide of the mother, which accounts for 20% of all postpartum deaths, they wrote.
The study included 196 people who had given birth in the past year, and were between the ages of 18 and 45 years old. Participants had major depression that began in the 3rd trimester of pregnancy or during the first 4 weeks of the postpartum period. Among participants, 22% were Black and 38% were Hispanic.
The average time it took for symptoms to significantly decline was 9 days. Most people who saw improvements had them continue for the entire 45-day follow-up period. The most common side effects were drowsiness, dizziness, and sleepiness.
Currently, PPD treatment includes taking antidepressants, which can take up to 12 weeks to work.
Researchers noted that the limitations of the study were that it only included women with severe PPD, and that women with a history of bipolar or psychotic disorders were excluded. Women in the study were not allowed to breastfeed, so the effect of zuranolone on lactation is unknown, they wrote.
A February news release from drugmaker Biogen indicated the FDA may decide whether to approve the medicine by Aug. 5.
A version of this article first appeared on WebMD.com.
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Hospital guards snoop through patient records, cost hospital $240K
Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.
The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.
As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
Is such snooping common?
The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.
“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”
In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.
Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.
“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”
“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”
Yakima Valley Memorial Hospital did not return a message seeking comment.
According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
Common reasons employees snoop
The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.
“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”
In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.
“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
Privacy breaches fuel lawsuits
Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.
A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.
Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.
“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”
Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.
Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.
Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
How can practices stop snooping?
A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.
“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.
Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.
Training is also a critical component, adds Mr. Sims.
“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”
Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.
Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.
“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”
The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.
“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”
A version of this article first appeared on Medscape.com.
Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.
The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.
As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
Is such snooping common?
The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.
“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”
In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.
Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.
“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”
“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”
Yakima Valley Memorial Hospital did not return a message seeking comment.
According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
Common reasons employees snoop
The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.
“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”
In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.
“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
Privacy breaches fuel lawsuits
Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.
A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.
Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.
“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”
Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.
Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.
Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
How can practices stop snooping?
A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.
“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.
Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.
Training is also a critical component, adds Mr. Sims.
“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”
Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.
Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.
“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”
The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.
“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”
A version of this article first appeared on Medscape.com.
Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.
The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.
As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
Is such snooping common?
The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.
“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”
In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.
Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.
“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”
“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”
Yakima Valley Memorial Hospital did not return a message seeking comment.
According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
Common reasons employees snoop
The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.
“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”
In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.
“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
Privacy breaches fuel lawsuits
Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.
A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.
Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.
“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”
Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.
Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.
Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
How can practices stop snooping?
A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.
“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.
Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.
Training is also a critical component, adds Mr. Sims.
“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”
Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.
Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.
“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”
The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.
“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”
A version of this article first appeared on Medscape.com.
Women increasingly dying of alcohol-related causes
The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.
“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.
Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”
Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men.
“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:
- 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
- 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said.
- 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.
The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year.
Explaining the increase
“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.
Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.
The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
Other findings on women, alcohol
Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men.
A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.
Expert perspectives
Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.
“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.”
In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually.
While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.
However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.”
Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies.
Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”
Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.
A version of this article first appeared on WebMD.com.
The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.
“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.
Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”
Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men.
“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:
- 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
- 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said.
- 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.
The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year.
Explaining the increase
“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.
Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.
The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
Other findings on women, alcohol
Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men.
A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.
Expert perspectives
Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.
“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.”
In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually.
While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.
However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.”
Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies.
Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”
Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.
A version of this article first appeared on WebMD.com.
The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.
“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.
Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”
Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men.
“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:
- 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
- 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said.
- 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.
The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year.
Explaining the increase
“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.
Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.
The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
Other findings on women, alcohol
Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men.
A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.
Expert perspectives
Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.
“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.”
In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually.
While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.
However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.”
Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies.
Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”
Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.
A version of this article first appeared on WebMD.com.
FROM JAMA NETWORK OPEN
Concussion may not affect IQ in children
data suggest.
In a multicenter study of almost 900 children with concussion or orthopedic injury, differences between groups in full-scale IQ (Cohen’s d = 0.13) and matrix reasoning scores (d = 0.16) were small.
“We draw the inference that IQ scores are unchanged, in the sense that they’re not different from [those of] kids with other types of injuries that don’t involve the brain,” said study author Keith Owen Yeates, PhD, Ronald and Irene Ward Chair in Pediatric Brain Injury and a professor of psychology at the University of Calgary (Alta.).
The study was published in Pediatrics.
A representative sample
The investigators analyzed data from two prospective cohort studies of children who were treated for concussion or mild orthopedic injury at two hospitals in the United States and five in Canada. Participants were aged 8-17 years and were recruited within 24 hours of the index event. Patients in the United States completed IQ and performance validity testing at 3-18 days after injury. Patients in Canada did so at 3 months after injury. The study used the short-form IQ test. The investigators included 866 children in their analysis.
Using linear modeling, Bayesian analysis, and multigroup factor analysis, the researchers found “very small group differences” in full-scale IQ scores between the two groups. Mean IQ was 104.95 for the concussion group and 106.08 for the orthopedic-injury group. Matrix reasoning scores were 52.28 and 53.81 for the concussion and orthopedic-injury groups, respectively.
Vocabulary scores did not differ between the two groups (53.25 for the concussion group and 53.27 for the orthopedic-injury group).
The study population is “pretty representative” from a demographic perspective, although it was predominantly White, said Dr. Yeates. “On the other hand, we did look at socioeconomic status, and that didn’t seem to alter the findings at all.”
The sample size is one of the study’s strengths, said Dr. Yeates. “Having 866 kids is far larger, I think, than just about any other study out there.” Drawing from seven children’s hospitals in North America is another strength. “Previous studies, in addition to having smaller samples, were from a single site and often recruited from a clinic population, not a representative group for a general population of kids with concussion.”
The findings must be interpreted precisely, however. “We don’t have actual preinjury data, so the more precise way of describing the findings is to say they’re not different from kids who are very similar to them demographically, have the same risk factors for injuries, and had a similar experience of a traumatic injury,” said Dr. Yeates. “The IQ scores for both groups are smack dab in the average range.”
Overall, the results are encouraging. “There’s been a lot of bad news in the media and in the science about concussion that worries patients, so it’s nice to be able to provide a little bit of balance,” said Dr. Yeates. “The message I give parents is that most kids recover within 2-4 weeks, and we’re much better now at predicting who’s going to [recover] and who isn’t, and that helps, too, so that we can focus our intervention on kids who are most at risk.”
Some children will have persisting symptoms, but evidence-based treatments are lacking. “I think that’ll be a really important direction for the future,” said Dr. Yeates.
Graduated return
Commenting on the findings, Michael Esser, MD, a pediatric neurologist at Alberta Children’s Hospital, Calgary, and an associate professor in pediatrics at the University of Calgary, said that they can help allay parents’ concerns about concussions. “It can also be of help for clinicians who want to have evidence to reassure families and promote a graduated return to activities. In particular, the study would support the philosophy of a graduated return to school or work, after a brief period of rest, following concussion.” Dr. Esser did not participate in the study.
The research is also noteworthy because it acknowledges that the differences in the design and methodology used in prior studies may explain the apparent disagreement over how concussion may influence cognitive function.
“This is an important message,” said Dr. Esser. “Families struggle with determining the merit of a lot of information due to the myriad of social media comments about concussion and the risk for cognitive impairment. Therefore, it is important that conclusions with a significant implication are evaluated with a variety of approaches.”
The study received funding from the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Yeates disclosed relationships with the American Psychological Association, Guilford Press, and Cambridge University Press. He has received grant funding from the Canadian Institutes of Health Research, the National Institutes of Health, Brain Canada Foundation, and the National Football League Scientific Advisory Board. He also has relationships with the National Institute for Child Health and Human Development, National Institute of Neurologic Disorders and Stroke, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation, and Virginia Tech University. Dr. Esser had no relevant relationships to disclose.
A version of this article appeared on Medscape.com.
data suggest.
In a multicenter study of almost 900 children with concussion or orthopedic injury, differences between groups in full-scale IQ (Cohen’s d = 0.13) and matrix reasoning scores (d = 0.16) were small.
“We draw the inference that IQ scores are unchanged, in the sense that they’re not different from [those of] kids with other types of injuries that don’t involve the brain,” said study author Keith Owen Yeates, PhD, Ronald and Irene Ward Chair in Pediatric Brain Injury and a professor of psychology at the University of Calgary (Alta.).
The study was published in Pediatrics.
A representative sample
The investigators analyzed data from two prospective cohort studies of children who were treated for concussion or mild orthopedic injury at two hospitals in the United States and five in Canada. Participants were aged 8-17 years and were recruited within 24 hours of the index event. Patients in the United States completed IQ and performance validity testing at 3-18 days after injury. Patients in Canada did so at 3 months after injury. The study used the short-form IQ test. The investigators included 866 children in their analysis.
Using linear modeling, Bayesian analysis, and multigroup factor analysis, the researchers found “very small group differences” in full-scale IQ scores between the two groups. Mean IQ was 104.95 for the concussion group and 106.08 for the orthopedic-injury group. Matrix reasoning scores were 52.28 and 53.81 for the concussion and orthopedic-injury groups, respectively.
Vocabulary scores did not differ between the two groups (53.25 for the concussion group and 53.27 for the orthopedic-injury group).
The study population is “pretty representative” from a demographic perspective, although it was predominantly White, said Dr. Yeates. “On the other hand, we did look at socioeconomic status, and that didn’t seem to alter the findings at all.”
The sample size is one of the study’s strengths, said Dr. Yeates. “Having 866 kids is far larger, I think, than just about any other study out there.” Drawing from seven children’s hospitals in North America is another strength. “Previous studies, in addition to having smaller samples, were from a single site and often recruited from a clinic population, not a representative group for a general population of kids with concussion.”
The findings must be interpreted precisely, however. “We don’t have actual preinjury data, so the more precise way of describing the findings is to say they’re not different from kids who are very similar to them demographically, have the same risk factors for injuries, and had a similar experience of a traumatic injury,” said Dr. Yeates. “The IQ scores for both groups are smack dab in the average range.”
Overall, the results are encouraging. “There’s been a lot of bad news in the media and in the science about concussion that worries patients, so it’s nice to be able to provide a little bit of balance,” said Dr. Yeates. “The message I give parents is that most kids recover within 2-4 weeks, and we’re much better now at predicting who’s going to [recover] and who isn’t, and that helps, too, so that we can focus our intervention on kids who are most at risk.”
Some children will have persisting symptoms, but evidence-based treatments are lacking. “I think that’ll be a really important direction for the future,” said Dr. Yeates.
Graduated return
Commenting on the findings, Michael Esser, MD, a pediatric neurologist at Alberta Children’s Hospital, Calgary, and an associate professor in pediatrics at the University of Calgary, said that they can help allay parents’ concerns about concussions. “It can also be of help for clinicians who want to have evidence to reassure families and promote a graduated return to activities. In particular, the study would support the philosophy of a graduated return to school or work, after a brief period of rest, following concussion.” Dr. Esser did not participate in the study.
The research is also noteworthy because it acknowledges that the differences in the design and methodology used in prior studies may explain the apparent disagreement over how concussion may influence cognitive function.
“This is an important message,” said Dr. Esser. “Families struggle with determining the merit of a lot of information due to the myriad of social media comments about concussion and the risk for cognitive impairment. Therefore, it is important that conclusions with a significant implication are evaluated with a variety of approaches.”
The study received funding from the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Yeates disclosed relationships with the American Psychological Association, Guilford Press, and Cambridge University Press. He has received grant funding from the Canadian Institutes of Health Research, the National Institutes of Health, Brain Canada Foundation, and the National Football League Scientific Advisory Board. He also has relationships with the National Institute for Child Health and Human Development, National Institute of Neurologic Disorders and Stroke, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation, and Virginia Tech University. Dr. Esser had no relevant relationships to disclose.
A version of this article appeared on Medscape.com.
data suggest.
In a multicenter study of almost 900 children with concussion or orthopedic injury, differences between groups in full-scale IQ (Cohen’s d = 0.13) and matrix reasoning scores (d = 0.16) were small.
“We draw the inference that IQ scores are unchanged, in the sense that they’re not different from [those of] kids with other types of injuries that don’t involve the brain,” said study author Keith Owen Yeates, PhD, Ronald and Irene Ward Chair in Pediatric Brain Injury and a professor of psychology at the University of Calgary (Alta.).
The study was published in Pediatrics.
A representative sample
The investigators analyzed data from two prospective cohort studies of children who were treated for concussion or mild orthopedic injury at two hospitals in the United States and five in Canada. Participants were aged 8-17 years and were recruited within 24 hours of the index event. Patients in the United States completed IQ and performance validity testing at 3-18 days after injury. Patients in Canada did so at 3 months after injury. The study used the short-form IQ test. The investigators included 866 children in their analysis.
Using linear modeling, Bayesian analysis, and multigroup factor analysis, the researchers found “very small group differences” in full-scale IQ scores between the two groups. Mean IQ was 104.95 for the concussion group and 106.08 for the orthopedic-injury group. Matrix reasoning scores were 52.28 and 53.81 for the concussion and orthopedic-injury groups, respectively.
Vocabulary scores did not differ between the two groups (53.25 for the concussion group and 53.27 for the orthopedic-injury group).
The study population is “pretty representative” from a demographic perspective, although it was predominantly White, said Dr. Yeates. “On the other hand, we did look at socioeconomic status, and that didn’t seem to alter the findings at all.”
The sample size is one of the study’s strengths, said Dr. Yeates. “Having 866 kids is far larger, I think, than just about any other study out there.” Drawing from seven children’s hospitals in North America is another strength. “Previous studies, in addition to having smaller samples, were from a single site and often recruited from a clinic population, not a representative group for a general population of kids with concussion.”
The findings must be interpreted precisely, however. “We don’t have actual preinjury data, so the more precise way of describing the findings is to say they’re not different from kids who are very similar to them demographically, have the same risk factors for injuries, and had a similar experience of a traumatic injury,” said Dr. Yeates. “The IQ scores for both groups are smack dab in the average range.”
Overall, the results are encouraging. “There’s been a lot of bad news in the media and in the science about concussion that worries patients, so it’s nice to be able to provide a little bit of balance,” said Dr. Yeates. “The message I give parents is that most kids recover within 2-4 weeks, and we’re much better now at predicting who’s going to [recover] and who isn’t, and that helps, too, so that we can focus our intervention on kids who are most at risk.”
Some children will have persisting symptoms, but evidence-based treatments are lacking. “I think that’ll be a really important direction for the future,” said Dr. Yeates.
Graduated return
Commenting on the findings, Michael Esser, MD, a pediatric neurologist at Alberta Children’s Hospital, Calgary, and an associate professor in pediatrics at the University of Calgary, said that they can help allay parents’ concerns about concussions. “It can also be of help for clinicians who want to have evidence to reassure families and promote a graduated return to activities. In particular, the study would support the philosophy of a graduated return to school or work, after a brief period of rest, following concussion.” Dr. Esser did not participate in the study.
The research is also noteworthy because it acknowledges that the differences in the design and methodology used in prior studies may explain the apparent disagreement over how concussion may influence cognitive function.
“This is an important message,” said Dr. Esser. “Families struggle with determining the merit of a lot of information due to the myriad of social media comments about concussion and the risk for cognitive impairment. Therefore, it is important that conclusions with a significant implication are evaluated with a variety of approaches.”
The study received funding from the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Yeates disclosed relationships with the American Psychological Association, Guilford Press, and Cambridge University Press. He has received grant funding from the Canadian Institutes of Health Research, the National Institutes of Health, Brain Canada Foundation, and the National Football League Scientific Advisory Board. He also has relationships with the National Institute for Child Health and Human Development, National Institute of Neurologic Disorders and Stroke, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation, and Virginia Tech University. Dr. Esser had no relevant relationships to disclose.
A version of this article appeared on Medscape.com.
FROM PEDIATRICS
Why scratching is so contagious
If you’ve ever felt an urge to scratch after witnessing someone else relieve their own itch, you’re certainly not alone. Itching can be contagious and the phenomenon is so common it doesn’t just affect humans. Now researchers may understand why.
Some background: In a 2007 study led by Zhou-Feng Chen, PhD, professor of anesthesiology, psychiatry, and developmental biology at the Washington University in St. Louis, researchers discovered a specific gene, the GRPR (gastrin-releasing peptide receptor), in the spinal cord and a corresponding neuropeptide, GRP (gastrin-releasing peptide). Together, the GRP system was found to transmit the “itch information” from one’s skin to the spinal cord.
This discovery was further backed by 2017 findings when Dr. Chen and his colleagues closely observed the molecular and neural basis of contagious itch behavior in mice. “We played a video that showed a mouse scratching at a very high frequency to other mice,” said Dr. Chen. “We found that, indeed, the mice who watched the video also scratched.”
To determine the inner workings at play, the researchers used molecular mapping to reveal increased neuronal activity in the suprachiasmatic nucleus (SCN), a bilateral structure found in the hypothalamus of the mouse’s brain. In other words, this part of the mouse’s brain “lit up” when a mouse displayed contagious scratching behavior.
The researchers then decided to take this one step further by manipulating the amount of GRP in the hypothalamus. “When we deleted the GRP in the SCN, the mice stopped imitating the scratch,” Dr. Chen said. “When we injected more GRP into the SCN, the mice started scratching like crazy.”
Now, after more investigating and research published in 2022 in Cell Reports, Dr. Chen and his team suspect contagious itching may have just as much to do with our eyeballs as our skin and spinal cord. Why? The phenomenon begins with a visual component: Someone seeing another person scratching.
The researchers targeted mice’s retinal ganglion cells, a type of light-capturing neuron found near the inner surface of the retina. When those cells were disabled, all scratching stopped.
This recent study argues that a previously undiscovered visual pathway may exist between the retina and the brain – bypassing the visual cortex – to provide more immediate physical reactions to potential adverse situations.
There’s more (and it could be quite relatable to some people): After the mice watched a video of another mouse scratching for half an hour, the researchers measured the mice’s stress hormone levels, finding a significant increase. This suggested that exposure to impulsive, contagious scratching behavior may have caused heightened anxiety in the mice.
said Dr. Chen. “We humans also scratch a lot, sometimes as a way to unconsciously express our internal anxiety.”
The mice may have interpreted the scratching video as a sudden negative change to their environment that they had to prepare for. “Contagious behavior is actually a very efficient way to inform other animals of what’s coming,” Dr. Chen said. “When we see other people running in a panic, there is no time to think. You just run as fast as you can. This is another example of contagious behavior that is in your own interest to survive.”
As a result, Dr. Chen believes it’s fair to infer that contagious behavior, including yawning and emotional contagion, is merely an expression of a fundamental survival mechanism that has evolved over time. “The human being is just an imitation machine. It’s often very difficult for people to act independently or as a minority because you would be working against evolution,” said Dr. Chen.
Scott Ira Krakower, DO, a child and adolescent psychiatrist at Northwell Health in Glen Oaks, N.Y., (and not party to this research), seconds this sentiment. “In regard to the physical benefits of contagion, it acts as a permanent defense and helps build collective immunity,” he said. “The social benefits when it comes to empathy or social media contagion are also important to our development. It helps us understand, adapt, and connect with others.”
Observing how empathy operates as a socially contagious behavior is something Dr. Chen and his colleagues are interested in looking into in the future.
“The definition of empathy is the sharing of emotions,” Dr. Chen said. “Shared feelings are crucial for social bonding and mental health, and for other animals, like mice, this is also the case.” Previous studies have shown that mice do, in fact, experience empathy and share feelings of pain and fear with one another.
There is still much to be explored in the study of contagious behaviors and the components of the brain that are activated during such behavior. Dr. Chen and his team intend to, ahem, scratch that particular itch.
A version of this article first appeared on Medscape.com.
If you’ve ever felt an urge to scratch after witnessing someone else relieve their own itch, you’re certainly not alone. Itching can be contagious and the phenomenon is so common it doesn’t just affect humans. Now researchers may understand why.
Some background: In a 2007 study led by Zhou-Feng Chen, PhD, professor of anesthesiology, psychiatry, and developmental biology at the Washington University in St. Louis, researchers discovered a specific gene, the GRPR (gastrin-releasing peptide receptor), in the spinal cord and a corresponding neuropeptide, GRP (gastrin-releasing peptide). Together, the GRP system was found to transmit the “itch information” from one’s skin to the spinal cord.
This discovery was further backed by 2017 findings when Dr. Chen and his colleagues closely observed the molecular and neural basis of contagious itch behavior in mice. “We played a video that showed a mouse scratching at a very high frequency to other mice,” said Dr. Chen. “We found that, indeed, the mice who watched the video also scratched.”
To determine the inner workings at play, the researchers used molecular mapping to reveal increased neuronal activity in the suprachiasmatic nucleus (SCN), a bilateral structure found in the hypothalamus of the mouse’s brain. In other words, this part of the mouse’s brain “lit up” when a mouse displayed contagious scratching behavior.
The researchers then decided to take this one step further by manipulating the amount of GRP in the hypothalamus. “When we deleted the GRP in the SCN, the mice stopped imitating the scratch,” Dr. Chen said. “When we injected more GRP into the SCN, the mice started scratching like crazy.”
Now, after more investigating and research published in 2022 in Cell Reports, Dr. Chen and his team suspect contagious itching may have just as much to do with our eyeballs as our skin and spinal cord. Why? The phenomenon begins with a visual component: Someone seeing another person scratching.
The researchers targeted mice’s retinal ganglion cells, a type of light-capturing neuron found near the inner surface of the retina. When those cells were disabled, all scratching stopped.
This recent study argues that a previously undiscovered visual pathway may exist between the retina and the brain – bypassing the visual cortex – to provide more immediate physical reactions to potential adverse situations.
There’s more (and it could be quite relatable to some people): After the mice watched a video of another mouse scratching for half an hour, the researchers measured the mice’s stress hormone levels, finding a significant increase. This suggested that exposure to impulsive, contagious scratching behavior may have caused heightened anxiety in the mice.
said Dr. Chen. “We humans also scratch a lot, sometimes as a way to unconsciously express our internal anxiety.”
The mice may have interpreted the scratching video as a sudden negative change to their environment that they had to prepare for. “Contagious behavior is actually a very efficient way to inform other animals of what’s coming,” Dr. Chen said. “When we see other people running in a panic, there is no time to think. You just run as fast as you can. This is another example of contagious behavior that is in your own interest to survive.”
As a result, Dr. Chen believes it’s fair to infer that contagious behavior, including yawning and emotional contagion, is merely an expression of a fundamental survival mechanism that has evolved over time. “The human being is just an imitation machine. It’s often very difficult for people to act independently or as a minority because you would be working against evolution,” said Dr. Chen.
Scott Ira Krakower, DO, a child and adolescent psychiatrist at Northwell Health in Glen Oaks, N.Y., (and not party to this research), seconds this sentiment. “In regard to the physical benefits of contagion, it acts as a permanent defense and helps build collective immunity,” he said. “The social benefits when it comes to empathy or social media contagion are also important to our development. It helps us understand, adapt, and connect with others.”
Observing how empathy operates as a socially contagious behavior is something Dr. Chen and his colleagues are interested in looking into in the future.
“The definition of empathy is the sharing of emotions,” Dr. Chen said. “Shared feelings are crucial for social bonding and mental health, and for other animals, like mice, this is also the case.” Previous studies have shown that mice do, in fact, experience empathy and share feelings of pain and fear with one another.
There is still much to be explored in the study of contagious behaviors and the components of the brain that are activated during such behavior. Dr. Chen and his team intend to, ahem, scratch that particular itch.
A version of this article first appeared on Medscape.com.
If you’ve ever felt an urge to scratch after witnessing someone else relieve their own itch, you’re certainly not alone. Itching can be contagious and the phenomenon is so common it doesn’t just affect humans. Now researchers may understand why.
Some background: In a 2007 study led by Zhou-Feng Chen, PhD, professor of anesthesiology, psychiatry, and developmental biology at the Washington University in St. Louis, researchers discovered a specific gene, the GRPR (gastrin-releasing peptide receptor), in the spinal cord and a corresponding neuropeptide, GRP (gastrin-releasing peptide). Together, the GRP system was found to transmit the “itch information” from one’s skin to the spinal cord.
This discovery was further backed by 2017 findings when Dr. Chen and his colleagues closely observed the molecular and neural basis of contagious itch behavior in mice. “We played a video that showed a mouse scratching at a very high frequency to other mice,” said Dr. Chen. “We found that, indeed, the mice who watched the video also scratched.”
To determine the inner workings at play, the researchers used molecular mapping to reveal increased neuronal activity in the suprachiasmatic nucleus (SCN), a bilateral structure found in the hypothalamus of the mouse’s brain. In other words, this part of the mouse’s brain “lit up” when a mouse displayed contagious scratching behavior.
The researchers then decided to take this one step further by manipulating the amount of GRP in the hypothalamus. “When we deleted the GRP in the SCN, the mice stopped imitating the scratch,” Dr. Chen said. “When we injected more GRP into the SCN, the mice started scratching like crazy.”
Now, after more investigating and research published in 2022 in Cell Reports, Dr. Chen and his team suspect contagious itching may have just as much to do with our eyeballs as our skin and spinal cord. Why? The phenomenon begins with a visual component: Someone seeing another person scratching.
The researchers targeted mice’s retinal ganglion cells, a type of light-capturing neuron found near the inner surface of the retina. When those cells were disabled, all scratching stopped.
This recent study argues that a previously undiscovered visual pathway may exist between the retina and the brain – bypassing the visual cortex – to provide more immediate physical reactions to potential adverse situations.
There’s more (and it could be quite relatable to some people): After the mice watched a video of another mouse scratching for half an hour, the researchers measured the mice’s stress hormone levels, finding a significant increase. This suggested that exposure to impulsive, contagious scratching behavior may have caused heightened anxiety in the mice.
said Dr. Chen. “We humans also scratch a lot, sometimes as a way to unconsciously express our internal anxiety.”
The mice may have interpreted the scratching video as a sudden negative change to their environment that they had to prepare for. “Contagious behavior is actually a very efficient way to inform other animals of what’s coming,” Dr. Chen said. “When we see other people running in a panic, there is no time to think. You just run as fast as you can. This is another example of contagious behavior that is in your own interest to survive.”
As a result, Dr. Chen believes it’s fair to infer that contagious behavior, including yawning and emotional contagion, is merely an expression of a fundamental survival mechanism that has evolved over time. “The human being is just an imitation machine. It’s often very difficult for people to act independently or as a minority because you would be working against evolution,” said Dr. Chen.
Scott Ira Krakower, DO, a child and adolescent psychiatrist at Northwell Health in Glen Oaks, N.Y., (and not party to this research), seconds this sentiment. “In regard to the physical benefits of contagion, it acts as a permanent defense and helps build collective immunity,” he said. “The social benefits when it comes to empathy or social media contagion are also important to our development. It helps us understand, adapt, and connect with others.”
Observing how empathy operates as a socially contagious behavior is something Dr. Chen and his colleagues are interested in looking into in the future.
“The definition of empathy is the sharing of emotions,” Dr. Chen said. “Shared feelings are crucial for social bonding and mental health, and for other animals, like mice, this is also the case.” Previous studies have shown that mice do, in fact, experience empathy and share feelings of pain and fear with one another.
There is still much to be explored in the study of contagious behaviors and the components of the brain that are activated during such behavior. Dr. Chen and his team intend to, ahem, scratch that particular itch.
A version of this article first appeared on Medscape.com.
FROM CELL REPORTS