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Does PREDICT accurately estimate breast cancer survival?

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The PREDICT score does not seem to be particularly accurate when it comes to estimating overall survival (OS) in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 targeted therapies. This is the conclusion of an international study published in the journal npj Breast Cancer. The work was supervised by Matteo Lambertini, MD, PhD, an oncologist at the IRCCS San Martino Polyclinic Hospital in Genoa, Italy.

As the authors explain, “PREDICT is a publicly available online tool that helps to predict the individual prognosis of patients with early breast cancer and to show the impact of adjuvant treatments administered after breast cancer surgery.” The tool uses traditional clinical-pathological factors. The authors also point out that the original version of this tool was validated in several datasets of patients with breast cancer. In 2011, it was updated to include HER2 status.

The investigators noted that, although the use of PREDICT is recommended to aid decision-making in the adjuvant setting, its prognostic role in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 therapies – even trastuzumab-based ones – remains unclear.

Therefore, they decided to analyze PREDICT’s prognostic performance using data extracted from the ALTTO trial, the largest adjuvant study ever conducted in the field of HER2-positive early breast cancer. That trial “represented a unique opportunity to investigate the reliability and prognostic performance of PREDICT in women with HER2-positive disease,” according to the investigators. They went on to specify that ALTTO evaluated adjuvant lapatinib plus trastuzumab vs. trastuzumab alone in 8,381 patients – 2,794 of whom were included in their own analysis.

What the analysis found was that, overall, PREDICT underestimated 5-year OS by 6.7%. The observed 5-year OS was 94.7%, and the predicted 5-year OS was 88.0%.

“The underestimation was consistent across all subgroups, including those according to the type of anti-HER2 therapy. The highest absolute differences were observed for patients with hormone receptor–negative disease, nodal involvement, and large tumor size (13.0%, 15.8%, and 15.3%, respectively),” they wrote. Furthermore, they reported that “the suboptimal performance of this prognostic tool was observed irrespective of type of anti-HER2 treatment, type of chemotherapy regimen, age of the patients at the time of diagnosis, central hormone receptor status, pathological nodal status, and pathological tumor size.”

To potentially explain the reasons for the underestimation of patients’ OS, the authors questioned whether the population used to validate PREDICT accurately mirrored the real-world population of patients with HER2-positive disease treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies. “Moreover, the current standard of care for early breast cancer is even superior to the treatment received by many patients in the ALTTO study. … As such, the discordance between OS estimated by PREDICT and the current real-world OS is expected to be even higher. Therefore,” the researchers concluded, “our results suggest that the current version of PREDICT should be used with caution for prognostication in HER2-positive early breast cancer patients treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy.

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The PREDICT score does not seem to be particularly accurate when it comes to estimating overall survival (OS) in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 targeted therapies. This is the conclusion of an international study published in the journal npj Breast Cancer. The work was supervised by Matteo Lambertini, MD, PhD, an oncologist at the IRCCS San Martino Polyclinic Hospital in Genoa, Italy.

As the authors explain, “PREDICT is a publicly available online tool that helps to predict the individual prognosis of patients with early breast cancer and to show the impact of adjuvant treatments administered after breast cancer surgery.” The tool uses traditional clinical-pathological factors. The authors also point out that the original version of this tool was validated in several datasets of patients with breast cancer. In 2011, it was updated to include HER2 status.

The investigators noted that, although the use of PREDICT is recommended to aid decision-making in the adjuvant setting, its prognostic role in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 therapies – even trastuzumab-based ones – remains unclear.

Therefore, they decided to analyze PREDICT’s prognostic performance using data extracted from the ALTTO trial, the largest adjuvant study ever conducted in the field of HER2-positive early breast cancer. That trial “represented a unique opportunity to investigate the reliability and prognostic performance of PREDICT in women with HER2-positive disease,” according to the investigators. They went on to specify that ALTTO evaluated adjuvant lapatinib plus trastuzumab vs. trastuzumab alone in 8,381 patients – 2,794 of whom were included in their own analysis.

What the analysis found was that, overall, PREDICT underestimated 5-year OS by 6.7%. The observed 5-year OS was 94.7%, and the predicted 5-year OS was 88.0%.

“The underestimation was consistent across all subgroups, including those according to the type of anti-HER2 therapy. The highest absolute differences were observed for patients with hormone receptor–negative disease, nodal involvement, and large tumor size (13.0%, 15.8%, and 15.3%, respectively),” they wrote. Furthermore, they reported that “the suboptimal performance of this prognostic tool was observed irrespective of type of anti-HER2 treatment, type of chemotherapy regimen, age of the patients at the time of diagnosis, central hormone receptor status, pathological nodal status, and pathological tumor size.”

To potentially explain the reasons for the underestimation of patients’ OS, the authors questioned whether the population used to validate PREDICT accurately mirrored the real-world population of patients with HER2-positive disease treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies. “Moreover, the current standard of care for early breast cancer is even superior to the treatment received by many patients in the ALTTO study. … As such, the discordance between OS estimated by PREDICT and the current real-world OS is expected to be even higher. Therefore,” the researchers concluded, “our results suggest that the current version of PREDICT should be used with caution for prognostication in HER2-positive early breast cancer patients treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy.

 

The PREDICT score does not seem to be particularly accurate when it comes to estimating overall survival (OS) in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 targeted therapies. This is the conclusion of an international study published in the journal npj Breast Cancer. The work was supervised by Matteo Lambertini, MD, PhD, an oncologist at the IRCCS San Martino Polyclinic Hospital in Genoa, Italy.

As the authors explain, “PREDICT is a publicly available online tool that helps to predict the individual prognosis of patients with early breast cancer and to show the impact of adjuvant treatments administered after breast cancer surgery.” The tool uses traditional clinical-pathological factors. The authors also point out that the original version of this tool was validated in several datasets of patients with breast cancer. In 2011, it was updated to include HER2 status.

The investigators noted that, although the use of PREDICT is recommended to aid decision-making in the adjuvant setting, its prognostic role in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 therapies – even trastuzumab-based ones – remains unclear.

Therefore, they decided to analyze PREDICT’s prognostic performance using data extracted from the ALTTO trial, the largest adjuvant study ever conducted in the field of HER2-positive early breast cancer. That trial “represented a unique opportunity to investigate the reliability and prognostic performance of PREDICT in women with HER2-positive disease,” according to the investigators. They went on to specify that ALTTO evaluated adjuvant lapatinib plus trastuzumab vs. trastuzumab alone in 8,381 patients – 2,794 of whom were included in their own analysis.

What the analysis found was that, overall, PREDICT underestimated 5-year OS by 6.7%. The observed 5-year OS was 94.7%, and the predicted 5-year OS was 88.0%.

“The underestimation was consistent across all subgroups, including those according to the type of anti-HER2 therapy. The highest absolute differences were observed for patients with hormone receptor–negative disease, nodal involvement, and large tumor size (13.0%, 15.8%, and 15.3%, respectively),” they wrote. Furthermore, they reported that “the suboptimal performance of this prognostic tool was observed irrespective of type of anti-HER2 treatment, type of chemotherapy regimen, age of the patients at the time of diagnosis, central hormone receptor status, pathological nodal status, and pathological tumor size.”

To potentially explain the reasons for the underestimation of patients’ OS, the authors questioned whether the population used to validate PREDICT accurately mirrored the real-world population of patients with HER2-positive disease treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies. “Moreover, the current standard of care for early breast cancer is even superior to the treatment received by many patients in the ALTTO study. … As such, the discordance between OS estimated by PREDICT and the current real-world OS is expected to be even higher. Therefore,” the researchers concluded, “our results suggest that the current version of PREDICT should be used with caution for prognostication in HER2-positive early breast cancer patients treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy.

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FROM NPJ BREAST CANCER

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No-shows

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Tue, 08/16/2022 - 12:28

Of all the headaches inherent in a private medical practice, few are more frustrating than patients who make appointments and then fail to keep them.

No-shows are a problem for all physicians, but especially for dermatologists. In one study, the no-show rate in dermatology offices averaged 10% – almost double the average for all medical offices.

Dr. Joseph S. Eastern

The problem has become so pervasive that many physicians are now charging a fee for missed appointments. I have never been a fan of such fees for a variety of reasons, starting with the anger and bad will that they engender; but also, in my experience, they seldom accomplish their intended goal of changing the behavior.

That’s because fees imply some sort of conscious decision made by a patient to miss an appointment, but studies show that this is rarely the case. Some patients cite transportation issues or childcare obligations. One Canadian study found that nearly a quarter of patients who missed an appointment felt too sick to keep it. Another reason is lack of insurance coverage. Studies have shown that the no-show rate is far higher when the patient is paying out-of-pocket for the visit.

Patients who don’t show up for appointments tend to be younger and poorer, and live farther away from the office than those who attend consistently. Some patients may be unaware that they need to cancel, while others report that they don’t feel obliged to keep appointments because they feel disrespected by the system. One person posted on a medical forum, “Everyone’s time is valuable. When the doctor makes me wait, there are consequences too. Why are there two standards in the situation?”

The most common reason for missed appointments, however, according to multiple studies, is that patients simply forget that they have one. One reason for that is a lag between appointment and visit. Many dermatologists are booked well in advance; by the time the appointment arrives, some patients’ complaints will have resolved spontaneously, while other patients will have found another office willing to see them sooner.

Another big reason is the absence of a strong physician-patient relationship. Perhaps the patient sees a different doctor or physician assistant at each visit and doesn’t feel a particular bond with any of them. Some patients may perceive a lack of concern on the part of the physician. And others may suffer from poor communication; for example, patients frequently become frustrated that a chronic condition has not resolved, when it has not been clearly explained to them that such problems cannot be expected to resolve rapidly or completely.

Whatever the reasons, no-shows are an economic and medicolegal liability. It is worth the considerable effort it often takes to minimize them.



Research suggests that no-show rates can be reduced by providing more same-day or next-day appointments. One large-scale analysis of national data found that same-day appointments accounted for just 2% of no-shows, while appointments booked 15 days or more in advance accounted for nearly a third of them. Canadian studies have likewise found the risk of no-shows increases the further in advance clinics book patients.

Deal with simple forgetfulness by calling your patients the day before to remind them of their appointments. Reasonably priced phone software is available from a variety of vendors to automate this process. Or hire a teenager to do it after school each day.

Whenever possible, use cellphone numbers for reminder calls. Patients often aren’t home during the day, and many don’t listen to their messages when they come in. And patients who have moved will often have a new home phone number, but their cellphone number will be the same.

Decrease the wait for new appointments. Keep some slots open each week for new patients, who will often “shop around” for a faster appointment while they’re waiting for an appointment they already have elsewhere.

But above all, seek to maximize the strength of your physician-patient relationships. Try not to shuttle patients between different physicians or PAs, and make it clear that you are genuinely concerned about their health. Impress upon them the crucial role they play in their own care, which includes keeping all their appointments.

In our office, significant no-shows (for example, a patient with a melanoma who misses a follow-up visit) receive a phone call and a certified letter, and their records go into a special file for close follow-up by the nursing staff.

If you choose to go the missed-appointment-fee route, be sure to post notices in your office and on your website clearly delineating your policy. Emphasize that it is not a service fee, and cannot be billed to insurance.

All missed appointments should be documented in the patient’s record; it’s important clinical and medicolegal information. And habitual no-shows should be dismissed from your practice. You cannot afford them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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Of all the headaches inherent in a private medical practice, few are more frustrating than patients who make appointments and then fail to keep them.

No-shows are a problem for all physicians, but especially for dermatologists. In one study, the no-show rate in dermatology offices averaged 10% – almost double the average for all medical offices.

Dr. Joseph S. Eastern

The problem has become so pervasive that many physicians are now charging a fee for missed appointments. I have never been a fan of such fees for a variety of reasons, starting with the anger and bad will that they engender; but also, in my experience, they seldom accomplish their intended goal of changing the behavior.

That’s because fees imply some sort of conscious decision made by a patient to miss an appointment, but studies show that this is rarely the case. Some patients cite transportation issues or childcare obligations. One Canadian study found that nearly a quarter of patients who missed an appointment felt too sick to keep it. Another reason is lack of insurance coverage. Studies have shown that the no-show rate is far higher when the patient is paying out-of-pocket for the visit.

Patients who don’t show up for appointments tend to be younger and poorer, and live farther away from the office than those who attend consistently. Some patients may be unaware that they need to cancel, while others report that they don’t feel obliged to keep appointments because they feel disrespected by the system. One person posted on a medical forum, “Everyone’s time is valuable. When the doctor makes me wait, there are consequences too. Why are there two standards in the situation?”

The most common reason for missed appointments, however, according to multiple studies, is that patients simply forget that they have one. One reason for that is a lag between appointment and visit. Many dermatologists are booked well in advance; by the time the appointment arrives, some patients’ complaints will have resolved spontaneously, while other patients will have found another office willing to see them sooner.

Another big reason is the absence of a strong physician-patient relationship. Perhaps the patient sees a different doctor or physician assistant at each visit and doesn’t feel a particular bond with any of them. Some patients may perceive a lack of concern on the part of the physician. And others may suffer from poor communication; for example, patients frequently become frustrated that a chronic condition has not resolved, when it has not been clearly explained to them that such problems cannot be expected to resolve rapidly or completely.

Whatever the reasons, no-shows are an economic and medicolegal liability. It is worth the considerable effort it often takes to minimize them.



Research suggests that no-show rates can be reduced by providing more same-day or next-day appointments. One large-scale analysis of national data found that same-day appointments accounted for just 2% of no-shows, while appointments booked 15 days or more in advance accounted for nearly a third of them. Canadian studies have likewise found the risk of no-shows increases the further in advance clinics book patients.

Deal with simple forgetfulness by calling your patients the day before to remind them of their appointments. Reasonably priced phone software is available from a variety of vendors to automate this process. Or hire a teenager to do it after school each day.

Whenever possible, use cellphone numbers for reminder calls. Patients often aren’t home during the day, and many don’t listen to their messages when they come in. And patients who have moved will often have a new home phone number, but their cellphone number will be the same.

Decrease the wait for new appointments. Keep some slots open each week for new patients, who will often “shop around” for a faster appointment while they’re waiting for an appointment they already have elsewhere.

But above all, seek to maximize the strength of your physician-patient relationships. Try not to shuttle patients between different physicians or PAs, and make it clear that you are genuinely concerned about their health. Impress upon them the crucial role they play in their own care, which includes keeping all their appointments.

In our office, significant no-shows (for example, a patient with a melanoma who misses a follow-up visit) receive a phone call and a certified letter, and their records go into a special file for close follow-up by the nursing staff.

If you choose to go the missed-appointment-fee route, be sure to post notices in your office and on your website clearly delineating your policy. Emphasize that it is not a service fee, and cannot be billed to insurance.

All missed appointments should be documented in the patient’s record; it’s important clinical and medicolegal information. And habitual no-shows should be dismissed from your practice. You cannot afford them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Of all the headaches inherent in a private medical practice, few are more frustrating than patients who make appointments and then fail to keep them.

No-shows are a problem for all physicians, but especially for dermatologists. In one study, the no-show rate in dermatology offices averaged 10% – almost double the average for all medical offices.

Dr. Joseph S. Eastern

The problem has become so pervasive that many physicians are now charging a fee for missed appointments. I have never been a fan of such fees for a variety of reasons, starting with the anger and bad will that they engender; but also, in my experience, they seldom accomplish their intended goal of changing the behavior.

That’s because fees imply some sort of conscious decision made by a patient to miss an appointment, but studies show that this is rarely the case. Some patients cite transportation issues or childcare obligations. One Canadian study found that nearly a quarter of patients who missed an appointment felt too sick to keep it. Another reason is lack of insurance coverage. Studies have shown that the no-show rate is far higher when the patient is paying out-of-pocket for the visit.

Patients who don’t show up for appointments tend to be younger and poorer, and live farther away from the office than those who attend consistently. Some patients may be unaware that they need to cancel, while others report that they don’t feel obliged to keep appointments because they feel disrespected by the system. One person posted on a medical forum, “Everyone’s time is valuable. When the doctor makes me wait, there are consequences too. Why are there two standards in the situation?”

The most common reason for missed appointments, however, according to multiple studies, is that patients simply forget that they have one. One reason for that is a lag between appointment and visit. Many dermatologists are booked well in advance; by the time the appointment arrives, some patients’ complaints will have resolved spontaneously, while other patients will have found another office willing to see them sooner.

Another big reason is the absence of a strong physician-patient relationship. Perhaps the patient sees a different doctor or physician assistant at each visit and doesn’t feel a particular bond with any of them. Some patients may perceive a lack of concern on the part of the physician. And others may suffer from poor communication; for example, patients frequently become frustrated that a chronic condition has not resolved, when it has not been clearly explained to them that such problems cannot be expected to resolve rapidly or completely.

Whatever the reasons, no-shows are an economic and medicolegal liability. It is worth the considerable effort it often takes to minimize them.



Research suggests that no-show rates can be reduced by providing more same-day or next-day appointments. One large-scale analysis of national data found that same-day appointments accounted for just 2% of no-shows, while appointments booked 15 days or more in advance accounted for nearly a third of them. Canadian studies have likewise found the risk of no-shows increases the further in advance clinics book patients.

Deal with simple forgetfulness by calling your patients the day before to remind them of their appointments. Reasonably priced phone software is available from a variety of vendors to automate this process. Or hire a teenager to do it after school each day.

Whenever possible, use cellphone numbers for reminder calls. Patients often aren’t home during the day, and many don’t listen to their messages when they come in. And patients who have moved will often have a new home phone number, but their cellphone number will be the same.

Decrease the wait for new appointments. Keep some slots open each week for new patients, who will often “shop around” for a faster appointment while they’re waiting for an appointment they already have elsewhere.

But above all, seek to maximize the strength of your physician-patient relationships. Try not to shuttle patients between different physicians or PAs, and make it clear that you are genuinely concerned about their health. Impress upon them the crucial role they play in their own care, which includes keeping all their appointments.

In our office, significant no-shows (for example, a patient with a melanoma who misses a follow-up visit) receive a phone call and a certified letter, and their records go into a special file for close follow-up by the nursing staff.

If you choose to go the missed-appointment-fee route, be sure to post notices in your office and on your website clearly delineating your policy. Emphasize that it is not a service fee, and cannot be billed to insurance.

All missed appointments should be documented in the patient’s record; it’s important clinical and medicolegal information. And habitual no-shows should be dismissed from your practice. You cannot afford them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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Mindfulness ‘changes the biology’ of pain

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Wed, 08/17/2022 - 09:52

New research provides novel insight into how mindfulness alters pain-related activity in the brain, in findings that point to more targeted pain management.

In a randomized trial, more than 100 healthy individuals were assigned to an 8-week mindfulness-based stress reduction (MBSR) program, a health improvement program (HEP) of the same length, or a waiting list.

Scanning participants’ brains during a heat-based stimulus pain task showed those who completed the MBSR had a reduction in a brain signature linked to the sensory intensity of pain.

Dr. Joseph Wielgosz


“Our finding supports the idea that for new practitioners, mindfulness training directly affects how sensory signals from the body are converted into a brain response,” lead investigator Joseph Wielgosz, PhD, of the Center for Healthy Minds, University of Wisconsin–Madison, said in a release.

Further analysis in long-term meditation practitioners showed the total time spent on intensive retreats was associated with neural changes associated with the perceived stress of pain.

“Just like an experienced athlete plays a sport differently than a first-timer, experienced mindfulness practitioners seem to use their mental ‘muscles’ differently in response to pain than first-time meditators,” Dr. Wielgosz noted.

The findings were published online in the American Journal of Psychiatry.

A complex condition

Dr. Wielgosz told this news organization that pain is “complex,” with multiple stages and several phases between the time signals are sent from pain receptors and the experience of pain.

“The way that mindfulness affects pain processing has more to do with the way the brain interprets pain signals.”

The investigators note that understanding the neurocognitive mechanisms underlying the efficacy of nonpharmacologic pain interventions is a “high-priority objective for improving pain treatment.”

Evidence from brief laboratory interventions and cross-sectional studies suggests that mindfulness training is associated with alterations in both sensory processing and cognitive-emotional regulatory networks, the investigators note.

“However, no such study has yet been conducted on a standardized, full-length, and widely used clinical intervention, such as MBSR,” they add.
 

Thermal pain task

The randomized, active-control trial included 115 healthy, meditation-naive individuals (61.7% women; average age, 48.3 years). Just over half (58%) had a graduate degree and their mean score on the Hollingshead index was 58.3, indicting a higher socioeconomic status.

All were randomly assigned to an 8-week MBSR course, an 8-week HEP course as an active control group, or a waiting-list control group with no intervention.

The MBSR involved instruction and practice in continuous focused attention on the breath, bodily sensations, and mental content while in seated postures, walking, and doing yoga.

The HEP matched the MBSR in terms of its length, structure, and nonspecific therapeutic elements, which included a supportive group atmosphere, expert instruction, and positive expectancy for benefit.

To examine the interventions’ effect on the pain experience, participants underwent a pain task in which they had 20 thermal stimuli applied to the inside of the left wrist for 12 seconds, including 8 seconds at peak temperature.

The stimuli were separated by a distractor task and intervals for cued anticipation, recovery, and subjective ratings of intensity and unpleasantness on a scale of 0-20.

During the task, participants underwent MRI to assess the neurologic pain signature (NPS) and the stimulus intensity independent pain signature-1 (SIIPS-1) within the brain.

The NPS is activated by various types of pain stimuli, while responding minimally or not at all to “emotionally evocative stimuli” relating to pain or to placebo treatment, the researchers note.

In contrast, the SIIPS-1 is activated in response to aspects of pain unrelated to the stimulus itself. It incorporates a “broader range of cognitive and emotional modulatory circuits,” including those related to expectancy and cognitive processes to modulate the pain experience.
 

 

 

Neural signatures

Results showed that in all groups, age was significantly negatively associated with both NPS (P = .001) and SIIPS-1 response (P < .001), although not subjective pain reports, and was subsequently included in all analyses of neural signatures.

Persons in the MBSR group had a significant decrease in the NPS, compared with those in the HEP group (P = .05), and from pre- to postintervention assessments (P = .023).

Those in the MBSR group also had “marginal” decreases in the NPS vs. the waiting list group (P = .096), and in the SIIPS-1 relative to both the HEP (P = .089) and waiting list groups (P = .087).

In subjective pain ratings, the MBSR group showed a marginal decrease, compared with the waiting list group (P = .078), and from the pre- to postintervention assessments (= .028).

The HEP group also had marginal decreases in pain unpleasantness vs. the waiting list group (P = .043), and from the pre- to postintervention assessments for pain intensity (P = .046) and unpleasantness (P = .007).

The researchers also assessed 30 long-term meditators who had undertaken at least 3 years of formal experience with meditation, including participating in multiple intensive retreats and ongoing daily practice, and compared them with meditation-naive individuals.

Long-term meditators reported significantly less pain intensity and unpleasantness than those who had not undergone the training (P < .001).

In addition, a higher number of practice hours during a retreat was linked to a greater reduction in pain ratings. This association remained even after adjustment for gender and respiration rate.

However, the number of daily practice hours was not significantly associated with pain ratings among long-term meditators.

Although there were no average differences in neural signature responses between long-term meditators and individuals who were naive to the technique, there was an inverse relationship between hours on retreat and SIIPS-1 response (P = .027).
 

‘We’re seeing the biology change’

Commenting for this news organization, Fadel Zeidan, PhD, associate professor of anesthesiology, University of California, San Diego, said that in attenuating the experience of pain, mindfulness engages “very novel” mechanisms.

Dr. Fadel Zeidan

However, the “most remarkable thing about this study” is that the pain effect occurred when the participants were not meditating, “which gives rise to the notion that mental training is just like physical training,” said Dr. Zeidan, who was not involved with the research.

He noted that the notion was not appreciated previously, “because we weren’t able to see the changes,” as they were based on self-report alone.

However, combining those reports with brain imaging and other objective methods means that “we’re actually seeing the biology change,” Dr. Zeidan said.

He added that mindfulness is different from other techniques for modulating the pain experience, because it is self-facilitated.

“People can learn this technique, ideally, for free online. They can learn the recipe, and it’s one of the only techniques out there that can be used immediately to assuage one’s own pain,” he said.

“There’s nothing else out there on this planet that could immediately reduce one’s own pain. You have to wait 45 minutes for Tylenol, distraction can only work for so long, and you can’t really placebo yourself,” Dr. Zeidan added.

The study was funded by a National Center for Complementary and Alternative Medicine grant, National Institute of Mental Health grants, a Fetzer Institute grant, and a John Templeton Foundation grant, as well as a core grant to the Waisman Center from the National Institute of Child Health and Human Development to Albee Messing. Dr. Wielgosz and Dr. Zeidan have reported no relevant financial relationships. Disclosures for the coinvestigators are listed in the original article.

A version of this article first appeared on Medscape.com.

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New research provides novel insight into how mindfulness alters pain-related activity in the brain, in findings that point to more targeted pain management.

In a randomized trial, more than 100 healthy individuals were assigned to an 8-week mindfulness-based stress reduction (MBSR) program, a health improvement program (HEP) of the same length, or a waiting list.

Scanning participants’ brains during a heat-based stimulus pain task showed those who completed the MBSR had a reduction in a brain signature linked to the sensory intensity of pain.

Dr. Joseph Wielgosz


“Our finding supports the idea that for new practitioners, mindfulness training directly affects how sensory signals from the body are converted into a brain response,” lead investigator Joseph Wielgosz, PhD, of the Center for Healthy Minds, University of Wisconsin–Madison, said in a release.

Further analysis in long-term meditation practitioners showed the total time spent on intensive retreats was associated with neural changes associated with the perceived stress of pain.

“Just like an experienced athlete plays a sport differently than a first-timer, experienced mindfulness practitioners seem to use their mental ‘muscles’ differently in response to pain than first-time meditators,” Dr. Wielgosz noted.

The findings were published online in the American Journal of Psychiatry.

A complex condition

Dr. Wielgosz told this news organization that pain is “complex,” with multiple stages and several phases between the time signals are sent from pain receptors and the experience of pain.

“The way that mindfulness affects pain processing has more to do with the way the brain interprets pain signals.”

The investigators note that understanding the neurocognitive mechanisms underlying the efficacy of nonpharmacologic pain interventions is a “high-priority objective for improving pain treatment.”

Evidence from brief laboratory interventions and cross-sectional studies suggests that mindfulness training is associated with alterations in both sensory processing and cognitive-emotional regulatory networks, the investigators note.

“However, no such study has yet been conducted on a standardized, full-length, and widely used clinical intervention, such as MBSR,” they add.
 

Thermal pain task

The randomized, active-control trial included 115 healthy, meditation-naive individuals (61.7% women; average age, 48.3 years). Just over half (58%) had a graduate degree and their mean score on the Hollingshead index was 58.3, indicting a higher socioeconomic status.

All were randomly assigned to an 8-week MBSR course, an 8-week HEP course as an active control group, or a waiting-list control group with no intervention.

The MBSR involved instruction and practice in continuous focused attention on the breath, bodily sensations, and mental content while in seated postures, walking, and doing yoga.

The HEP matched the MBSR in terms of its length, structure, and nonspecific therapeutic elements, which included a supportive group atmosphere, expert instruction, and positive expectancy for benefit.

To examine the interventions’ effect on the pain experience, participants underwent a pain task in which they had 20 thermal stimuli applied to the inside of the left wrist for 12 seconds, including 8 seconds at peak temperature.

The stimuli were separated by a distractor task and intervals for cued anticipation, recovery, and subjective ratings of intensity and unpleasantness on a scale of 0-20.

During the task, participants underwent MRI to assess the neurologic pain signature (NPS) and the stimulus intensity independent pain signature-1 (SIIPS-1) within the brain.

The NPS is activated by various types of pain stimuli, while responding minimally or not at all to “emotionally evocative stimuli” relating to pain or to placebo treatment, the researchers note.

In contrast, the SIIPS-1 is activated in response to aspects of pain unrelated to the stimulus itself. It incorporates a “broader range of cognitive and emotional modulatory circuits,” including those related to expectancy and cognitive processes to modulate the pain experience.
 

 

 

Neural signatures

Results showed that in all groups, age was significantly negatively associated with both NPS (P = .001) and SIIPS-1 response (P < .001), although not subjective pain reports, and was subsequently included in all analyses of neural signatures.

Persons in the MBSR group had a significant decrease in the NPS, compared with those in the HEP group (P = .05), and from pre- to postintervention assessments (P = .023).

Those in the MBSR group also had “marginal” decreases in the NPS vs. the waiting list group (P = .096), and in the SIIPS-1 relative to both the HEP (P = .089) and waiting list groups (P = .087).

In subjective pain ratings, the MBSR group showed a marginal decrease, compared with the waiting list group (P = .078), and from the pre- to postintervention assessments (= .028).

The HEP group also had marginal decreases in pain unpleasantness vs. the waiting list group (P = .043), and from the pre- to postintervention assessments for pain intensity (P = .046) and unpleasantness (P = .007).

The researchers also assessed 30 long-term meditators who had undertaken at least 3 years of formal experience with meditation, including participating in multiple intensive retreats and ongoing daily practice, and compared them with meditation-naive individuals.

Long-term meditators reported significantly less pain intensity and unpleasantness than those who had not undergone the training (P < .001).

In addition, a higher number of practice hours during a retreat was linked to a greater reduction in pain ratings. This association remained even after adjustment for gender and respiration rate.

However, the number of daily practice hours was not significantly associated with pain ratings among long-term meditators.

Although there were no average differences in neural signature responses between long-term meditators and individuals who were naive to the technique, there was an inverse relationship between hours on retreat and SIIPS-1 response (P = .027).
 

‘We’re seeing the biology change’

Commenting for this news organization, Fadel Zeidan, PhD, associate professor of anesthesiology, University of California, San Diego, said that in attenuating the experience of pain, mindfulness engages “very novel” mechanisms.

Dr. Fadel Zeidan

However, the “most remarkable thing about this study” is that the pain effect occurred when the participants were not meditating, “which gives rise to the notion that mental training is just like physical training,” said Dr. Zeidan, who was not involved with the research.

He noted that the notion was not appreciated previously, “because we weren’t able to see the changes,” as they were based on self-report alone.

However, combining those reports with brain imaging and other objective methods means that “we’re actually seeing the biology change,” Dr. Zeidan said.

He added that mindfulness is different from other techniques for modulating the pain experience, because it is self-facilitated.

“People can learn this technique, ideally, for free online. They can learn the recipe, and it’s one of the only techniques out there that can be used immediately to assuage one’s own pain,” he said.

“There’s nothing else out there on this planet that could immediately reduce one’s own pain. You have to wait 45 minutes for Tylenol, distraction can only work for so long, and you can’t really placebo yourself,” Dr. Zeidan added.

The study was funded by a National Center for Complementary and Alternative Medicine grant, National Institute of Mental Health grants, a Fetzer Institute grant, and a John Templeton Foundation grant, as well as a core grant to the Waisman Center from the National Institute of Child Health and Human Development to Albee Messing. Dr. Wielgosz and Dr. Zeidan have reported no relevant financial relationships. Disclosures for the coinvestigators are listed in the original article.

A version of this article first appeared on Medscape.com.

New research provides novel insight into how mindfulness alters pain-related activity in the brain, in findings that point to more targeted pain management.

In a randomized trial, more than 100 healthy individuals were assigned to an 8-week mindfulness-based stress reduction (MBSR) program, a health improvement program (HEP) of the same length, or a waiting list.

Scanning participants’ brains during a heat-based stimulus pain task showed those who completed the MBSR had a reduction in a brain signature linked to the sensory intensity of pain.

Dr. Joseph Wielgosz


“Our finding supports the idea that for new practitioners, mindfulness training directly affects how sensory signals from the body are converted into a brain response,” lead investigator Joseph Wielgosz, PhD, of the Center for Healthy Minds, University of Wisconsin–Madison, said in a release.

Further analysis in long-term meditation practitioners showed the total time spent on intensive retreats was associated with neural changes associated with the perceived stress of pain.

“Just like an experienced athlete plays a sport differently than a first-timer, experienced mindfulness practitioners seem to use their mental ‘muscles’ differently in response to pain than first-time meditators,” Dr. Wielgosz noted.

The findings were published online in the American Journal of Psychiatry.

A complex condition

Dr. Wielgosz told this news organization that pain is “complex,” with multiple stages and several phases between the time signals are sent from pain receptors and the experience of pain.

“The way that mindfulness affects pain processing has more to do with the way the brain interprets pain signals.”

The investigators note that understanding the neurocognitive mechanisms underlying the efficacy of nonpharmacologic pain interventions is a “high-priority objective for improving pain treatment.”

Evidence from brief laboratory interventions and cross-sectional studies suggests that mindfulness training is associated with alterations in both sensory processing and cognitive-emotional regulatory networks, the investigators note.

“However, no such study has yet been conducted on a standardized, full-length, and widely used clinical intervention, such as MBSR,” they add.
 

Thermal pain task

The randomized, active-control trial included 115 healthy, meditation-naive individuals (61.7% women; average age, 48.3 years). Just over half (58%) had a graduate degree and their mean score on the Hollingshead index was 58.3, indicting a higher socioeconomic status.

All were randomly assigned to an 8-week MBSR course, an 8-week HEP course as an active control group, or a waiting-list control group with no intervention.

The MBSR involved instruction and practice in continuous focused attention on the breath, bodily sensations, and mental content while in seated postures, walking, and doing yoga.

The HEP matched the MBSR in terms of its length, structure, and nonspecific therapeutic elements, which included a supportive group atmosphere, expert instruction, and positive expectancy for benefit.

To examine the interventions’ effect on the pain experience, participants underwent a pain task in which they had 20 thermal stimuli applied to the inside of the left wrist for 12 seconds, including 8 seconds at peak temperature.

The stimuli were separated by a distractor task and intervals for cued anticipation, recovery, and subjective ratings of intensity and unpleasantness on a scale of 0-20.

During the task, participants underwent MRI to assess the neurologic pain signature (NPS) and the stimulus intensity independent pain signature-1 (SIIPS-1) within the brain.

The NPS is activated by various types of pain stimuli, while responding minimally or not at all to “emotionally evocative stimuli” relating to pain or to placebo treatment, the researchers note.

In contrast, the SIIPS-1 is activated in response to aspects of pain unrelated to the stimulus itself. It incorporates a “broader range of cognitive and emotional modulatory circuits,” including those related to expectancy and cognitive processes to modulate the pain experience.
 

 

 

Neural signatures

Results showed that in all groups, age was significantly negatively associated with both NPS (P = .001) and SIIPS-1 response (P < .001), although not subjective pain reports, and was subsequently included in all analyses of neural signatures.

Persons in the MBSR group had a significant decrease in the NPS, compared with those in the HEP group (P = .05), and from pre- to postintervention assessments (P = .023).

Those in the MBSR group also had “marginal” decreases in the NPS vs. the waiting list group (P = .096), and in the SIIPS-1 relative to both the HEP (P = .089) and waiting list groups (P = .087).

In subjective pain ratings, the MBSR group showed a marginal decrease, compared with the waiting list group (P = .078), and from the pre- to postintervention assessments (= .028).

The HEP group also had marginal decreases in pain unpleasantness vs. the waiting list group (P = .043), and from the pre- to postintervention assessments for pain intensity (P = .046) and unpleasantness (P = .007).

The researchers also assessed 30 long-term meditators who had undertaken at least 3 years of formal experience with meditation, including participating in multiple intensive retreats and ongoing daily practice, and compared them with meditation-naive individuals.

Long-term meditators reported significantly less pain intensity and unpleasantness than those who had not undergone the training (P < .001).

In addition, a higher number of practice hours during a retreat was linked to a greater reduction in pain ratings. This association remained even after adjustment for gender and respiration rate.

However, the number of daily practice hours was not significantly associated with pain ratings among long-term meditators.

Although there were no average differences in neural signature responses between long-term meditators and individuals who were naive to the technique, there was an inverse relationship between hours on retreat and SIIPS-1 response (P = .027).
 

‘We’re seeing the biology change’

Commenting for this news organization, Fadel Zeidan, PhD, associate professor of anesthesiology, University of California, San Diego, said that in attenuating the experience of pain, mindfulness engages “very novel” mechanisms.

Dr. Fadel Zeidan

However, the “most remarkable thing about this study” is that the pain effect occurred when the participants were not meditating, “which gives rise to the notion that mental training is just like physical training,” said Dr. Zeidan, who was not involved with the research.

He noted that the notion was not appreciated previously, “because we weren’t able to see the changes,” as they were based on self-report alone.

However, combining those reports with brain imaging and other objective methods means that “we’re actually seeing the biology change,” Dr. Zeidan said.

He added that mindfulness is different from other techniques for modulating the pain experience, because it is self-facilitated.

“People can learn this technique, ideally, for free online. They can learn the recipe, and it’s one of the only techniques out there that can be used immediately to assuage one’s own pain,” he said.

“There’s nothing else out there on this planet that could immediately reduce one’s own pain. You have to wait 45 minutes for Tylenol, distraction can only work for so long, and you can’t really placebo yourself,” Dr. Zeidan added.

The study was funded by a National Center for Complementary and Alternative Medicine grant, National Institute of Mental Health grants, a Fetzer Institute grant, and a John Templeton Foundation grant, as well as a core grant to the Waisman Center from the National Institute of Child Health and Human Development to Albee Messing. Dr. Wielgosz and Dr. Zeidan have reported no relevant financial relationships. Disclosures for the coinvestigators are listed in the original article.

A version of this article first appeared on Medscape.com.

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Patients who won’t pay: What’s your recourse?

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Tue, 08/16/2022 - 10:38

You may have noticed that collecting patient payments has been tough this year. Owing to the pandemic, job loss, and the possible loss of health insurance, patients have had more difficulty managing copays, coinsurance, and deductibles, not to mention other out-of-pocket health care charges.

“Many of our patients have lost their jobs or have had their hours cut back, and as a result, they are struggling to make ends meet,” said Ahmad Chaudhry, MD, a cardiothoracic surgeon in Lexington, Ky. “However, we cannot continue to provide care if our patients do not pay their bills.”

This news organization asked physicians what they do when their patients don’t pay. About 43% said that they continue to treat them and develop a payment plan; 13% send their bill to collections; 12% continue their care and write off their balance, and 25% choose other actions. Only 8% of physicians drop patients if they don’t pay.

Because you need to pay your own bills, what can you do about nonpaying patients?
 

Start with price transparency

In the past, patients never knew what their lab work or a chest EKG would cost because it wasn’t listed anywhere, and it was usually more than expected. Because of new legislation concerning health care price transparency, hospitals, health plans, and insurers must pony up with the actual fees, making them transparent to patients. Physician practices should follow suit and keep prices transparent too. Patients are more likely to pay their bills when prepared for the expense.

Patients with insurance often don’t know what they’ll be paying for their visit or their tests because they don’t know how much insurance will cover and what will be left for them to pay. Also, they may not know if they’ve met their deductible yet so they’re unsure whether insurance will even kick in. And patients without insurance still need to know what their costs will be upfront.

According to 10 insights from the Primary Care Consumer Choice Survey, 74% of health care consumers were willing to pay a $50 out-of-pocket charge to know the cost of their primary care visit.
 

Provide payment plans

Many patients have always needed payment plans. It’s one thing to post a sign at check-in telling patients that all monies are due at the time of service, but it’s another reality for a patient who can’t fork over the $250 charge they just unexpectedly spent in your office.

Discover Financial Services recently ran a survey, with results presented in the press release Americans are Delaying Non-Emergency Medical Care in Higher Numbers than Last Year, and found that many Americans with medical debt are delaying nonemergency medical care. For example, they put off seeing a specialist (52%), seeing a doctor for sickness (41%), and undergoing treatment plans recommended by their doctor (31%). 

Turning an account over to collections should be a last resort. In addition, agencies typically charge 30%-40% of the total collected off the top.

Though collecting that amount is better than nothing, using a collection agency may have unexpected consequences. For instance, you’re trusting the agency you hire to collect to represent you and act on your practice’s behalf. If they’re rude or their tactics are harsh in the eyes of the patient or their relatives, it’s your reputation that is on the line.

Rather than use a collection agency, you could collect the payments yourself. When a patient fails to pay within about 3 months, begin mailing statements from the office, followed by firm but generous phone calls trying to collect. Industry estimates put the average cost of sending an invoice, including staff labor, printing, and postage, at about $35 per mailer. Some practices combat the added costs by offering a 20% prompt-pay discount. Offering payment plans is another option that helps garner eventual payment. Plus, practices should direct patients to third-party lenders such as CareCredit for larger bills.

On occasion, some small practices may allow a swap, such as allowing a patient to provide a service such as plumbing, electrical, or painting in exchange for working off the bill. Though it’s not ideal when it comes to finances, you may find it can work in a pinch for a cash-strapped patient. Make sure to keep records of what bills the patient’s work goes toward.

It often helps to incentivize your billing staff to follow up regularly, with various suggestions and tactics, to get patients to pay their bills. The incentive amount you offer will probably be less than if you had to use a collection agency.
 

 

 

Have a payment policy

Because your practice’s primary job is caring for patients’ physical and emotional needs, payment collection without coming off as insensitive can be tricky. “We understand these are difficult times for everyone, and we are doing our best to work with our patients,” said Dr. Chaudhry. Having a written payment policy can help build the bridge. A policy lets patients know what they can expect and can help prevent surprises over what occurs in the event of nonpayment. Your written policy should include:

  • When payment is due.
  • How the practice handles copays and deductibles.
  • What forms of payment are accepted.
  • Your policy regarding nonpayment.

Why patients don’t pay

A 2021 Healthcare Consumer Experience Study from Cedar found that medical bills are a source of anxiety and frustration for most patients, affecting their financial experience. More than half of the respondents said that paying a medical bill is stressful. Complicating matters, many health care practices rely on outdated payment systems, which may not provide patients with a clear view of what they owe and how to pay it.

The study found that 53% of respondents find understanding their plan’s coverage and benefits stressful, and 37% of patients won’t pay their bill if they can’t understand it.

People may think the patient is trying to get out of paying, which, of course, is sometimes true, but most of the time they want to pay, concluded the study. Most patients need a better explanation, communication, and accurate accounting of their out-of-pocket costs.
 

What can doctors do?

If you’re a physician who regularly sees patients who have problems paying their bills, you can take a few steps to minimize the financial impact on your practice:

  • Bill the patient’s insurance directly to ensure you receive at least partial payment.
  • Keep adequate records of services in case you need to pursue legal action.
  • “Be understanding and flexible when it comes to payment arrangements, as this can often be the difference between getting paid and not getting paid at all,” said Dr. Chaudhry.

Distance yourself

When discussing payment policies, physicians should try to distance themselves from the actual collection process as much as possible. Well-meaning physicians often tell patients things like they can “figure something out “ financially or “work them in” during a scheduling conflict, but that often undermines the authority and credibility of the practice’s office staff. Plus, it teaches patients they can get their way if they work on the doctor’s soft spot – something you don’t want to encourage.

By following some of these measures, you can help ensure that your practice continues to thrive despite the challenges posed by nonpaying patients.

A version of this article first appeared on Medscape.com.

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You may have noticed that collecting patient payments has been tough this year. Owing to the pandemic, job loss, and the possible loss of health insurance, patients have had more difficulty managing copays, coinsurance, and deductibles, not to mention other out-of-pocket health care charges.

“Many of our patients have lost their jobs or have had their hours cut back, and as a result, they are struggling to make ends meet,” said Ahmad Chaudhry, MD, a cardiothoracic surgeon in Lexington, Ky. “However, we cannot continue to provide care if our patients do not pay their bills.”

This news organization asked physicians what they do when their patients don’t pay. About 43% said that they continue to treat them and develop a payment plan; 13% send their bill to collections; 12% continue their care and write off their balance, and 25% choose other actions. Only 8% of physicians drop patients if they don’t pay.

Because you need to pay your own bills, what can you do about nonpaying patients?
 

Start with price transparency

In the past, patients never knew what their lab work or a chest EKG would cost because it wasn’t listed anywhere, and it was usually more than expected. Because of new legislation concerning health care price transparency, hospitals, health plans, and insurers must pony up with the actual fees, making them transparent to patients. Physician practices should follow suit and keep prices transparent too. Patients are more likely to pay their bills when prepared for the expense.

Patients with insurance often don’t know what they’ll be paying for their visit or their tests because they don’t know how much insurance will cover and what will be left for them to pay. Also, they may not know if they’ve met their deductible yet so they’re unsure whether insurance will even kick in. And patients without insurance still need to know what their costs will be upfront.

According to 10 insights from the Primary Care Consumer Choice Survey, 74% of health care consumers were willing to pay a $50 out-of-pocket charge to know the cost of their primary care visit.
 

Provide payment plans

Many patients have always needed payment plans. It’s one thing to post a sign at check-in telling patients that all monies are due at the time of service, but it’s another reality for a patient who can’t fork over the $250 charge they just unexpectedly spent in your office.

Discover Financial Services recently ran a survey, with results presented in the press release Americans are Delaying Non-Emergency Medical Care in Higher Numbers than Last Year, and found that many Americans with medical debt are delaying nonemergency medical care. For example, they put off seeing a specialist (52%), seeing a doctor for sickness (41%), and undergoing treatment plans recommended by their doctor (31%). 

Turning an account over to collections should be a last resort. In addition, agencies typically charge 30%-40% of the total collected off the top.

Though collecting that amount is better than nothing, using a collection agency may have unexpected consequences. For instance, you’re trusting the agency you hire to collect to represent you and act on your practice’s behalf. If they’re rude or their tactics are harsh in the eyes of the patient or their relatives, it’s your reputation that is on the line.

Rather than use a collection agency, you could collect the payments yourself. When a patient fails to pay within about 3 months, begin mailing statements from the office, followed by firm but generous phone calls trying to collect. Industry estimates put the average cost of sending an invoice, including staff labor, printing, and postage, at about $35 per mailer. Some practices combat the added costs by offering a 20% prompt-pay discount. Offering payment plans is another option that helps garner eventual payment. Plus, practices should direct patients to third-party lenders such as CareCredit for larger bills.

On occasion, some small practices may allow a swap, such as allowing a patient to provide a service such as plumbing, electrical, or painting in exchange for working off the bill. Though it’s not ideal when it comes to finances, you may find it can work in a pinch for a cash-strapped patient. Make sure to keep records of what bills the patient’s work goes toward.

It often helps to incentivize your billing staff to follow up regularly, with various suggestions and tactics, to get patients to pay their bills. The incentive amount you offer will probably be less than if you had to use a collection agency.
 

 

 

Have a payment policy

Because your practice’s primary job is caring for patients’ physical and emotional needs, payment collection without coming off as insensitive can be tricky. “We understand these are difficult times for everyone, and we are doing our best to work with our patients,” said Dr. Chaudhry. Having a written payment policy can help build the bridge. A policy lets patients know what they can expect and can help prevent surprises over what occurs in the event of nonpayment. Your written policy should include:

  • When payment is due.
  • How the practice handles copays and deductibles.
  • What forms of payment are accepted.
  • Your policy regarding nonpayment.

Why patients don’t pay

A 2021 Healthcare Consumer Experience Study from Cedar found that medical bills are a source of anxiety and frustration for most patients, affecting their financial experience. More than half of the respondents said that paying a medical bill is stressful. Complicating matters, many health care practices rely on outdated payment systems, which may not provide patients with a clear view of what they owe and how to pay it.

The study found that 53% of respondents find understanding their plan’s coverage and benefits stressful, and 37% of patients won’t pay their bill if they can’t understand it.

People may think the patient is trying to get out of paying, which, of course, is sometimes true, but most of the time they want to pay, concluded the study. Most patients need a better explanation, communication, and accurate accounting of their out-of-pocket costs.
 

What can doctors do?

If you’re a physician who regularly sees patients who have problems paying their bills, you can take a few steps to minimize the financial impact on your practice:

  • Bill the patient’s insurance directly to ensure you receive at least partial payment.
  • Keep adequate records of services in case you need to pursue legal action.
  • “Be understanding and flexible when it comes to payment arrangements, as this can often be the difference between getting paid and not getting paid at all,” said Dr. Chaudhry.

Distance yourself

When discussing payment policies, physicians should try to distance themselves from the actual collection process as much as possible. Well-meaning physicians often tell patients things like they can “figure something out “ financially or “work them in” during a scheduling conflict, but that often undermines the authority and credibility of the practice’s office staff. Plus, it teaches patients they can get their way if they work on the doctor’s soft spot – something you don’t want to encourage.

By following some of these measures, you can help ensure that your practice continues to thrive despite the challenges posed by nonpaying patients.

A version of this article first appeared on Medscape.com.

You may have noticed that collecting patient payments has been tough this year. Owing to the pandemic, job loss, and the possible loss of health insurance, patients have had more difficulty managing copays, coinsurance, and deductibles, not to mention other out-of-pocket health care charges.

“Many of our patients have lost their jobs or have had their hours cut back, and as a result, they are struggling to make ends meet,” said Ahmad Chaudhry, MD, a cardiothoracic surgeon in Lexington, Ky. “However, we cannot continue to provide care if our patients do not pay their bills.”

This news organization asked physicians what they do when their patients don’t pay. About 43% said that they continue to treat them and develop a payment plan; 13% send their bill to collections; 12% continue their care and write off their balance, and 25% choose other actions. Only 8% of physicians drop patients if they don’t pay.

Because you need to pay your own bills, what can you do about nonpaying patients?
 

Start with price transparency

In the past, patients never knew what their lab work or a chest EKG would cost because it wasn’t listed anywhere, and it was usually more than expected. Because of new legislation concerning health care price transparency, hospitals, health plans, and insurers must pony up with the actual fees, making them transparent to patients. Physician practices should follow suit and keep prices transparent too. Patients are more likely to pay their bills when prepared for the expense.

Patients with insurance often don’t know what they’ll be paying for their visit or their tests because they don’t know how much insurance will cover and what will be left for them to pay. Also, they may not know if they’ve met their deductible yet so they’re unsure whether insurance will even kick in. And patients without insurance still need to know what their costs will be upfront.

According to 10 insights from the Primary Care Consumer Choice Survey, 74% of health care consumers were willing to pay a $50 out-of-pocket charge to know the cost of their primary care visit.
 

Provide payment plans

Many patients have always needed payment plans. It’s one thing to post a sign at check-in telling patients that all monies are due at the time of service, but it’s another reality for a patient who can’t fork over the $250 charge they just unexpectedly spent in your office.

Discover Financial Services recently ran a survey, with results presented in the press release Americans are Delaying Non-Emergency Medical Care in Higher Numbers than Last Year, and found that many Americans with medical debt are delaying nonemergency medical care. For example, they put off seeing a specialist (52%), seeing a doctor for sickness (41%), and undergoing treatment plans recommended by their doctor (31%). 

Turning an account over to collections should be a last resort. In addition, agencies typically charge 30%-40% of the total collected off the top.

Though collecting that amount is better than nothing, using a collection agency may have unexpected consequences. For instance, you’re trusting the agency you hire to collect to represent you and act on your practice’s behalf. If they’re rude or their tactics are harsh in the eyes of the patient or their relatives, it’s your reputation that is on the line.

Rather than use a collection agency, you could collect the payments yourself. When a patient fails to pay within about 3 months, begin mailing statements from the office, followed by firm but generous phone calls trying to collect. Industry estimates put the average cost of sending an invoice, including staff labor, printing, and postage, at about $35 per mailer. Some practices combat the added costs by offering a 20% prompt-pay discount. Offering payment plans is another option that helps garner eventual payment. Plus, practices should direct patients to third-party lenders such as CareCredit for larger bills.

On occasion, some small practices may allow a swap, such as allowing a patient to provide a service such as plumbing, electrical, or painting in exchange for working off the bill. Though it’s not ideal when it comes to finances, you may find it can work in a pinch for a cash-strapped patient. Make sure to keep records of what bills the patient’s work goes toward.

It often helps to incentivize your billing staff to follow up regularly, with various suggestions and tactics, to get patients to pay their bills. The incentive amount you offer will probably be less than if you had to use a collection agency.
 

 

 

Have a payment policy

Because your practice’s primary job is caring for patients’ physical and emotional needs, payment collection without coming off as insensitive can be tricky. “We understand these are difficult times for everyone, and we are doing our best to work with our patients,” said Dr. Chaudhry. Having a written payment policy can help build the bridge. A policy lets patients know what they can expect and can help prevent surprises over what occurs in the event of nonpayment. Your written policy should include:

  • When payment is due.
  • How the practice handles copays and deductibles.
  • What forms of payment are accepted.
  • Your policy regarding nonpayment.

Why patients don’t pay

A 2021 Healthcare Consumer Experience Study from Cedar found that medical bills are a source of anxiety and frustration for most patients, affecting their financial experience. More than half of the respondents said that paying a medical bill is stressful. Complicating matters, many health care practices rely on outdated payment systems, which may not provide patients with a clear view of what they owe and how to pay it.

The study found that 53% of respondents find understanding their plan’s coverage and benefits stressful, and 37% of patients won’t pay their bill if they can’t understand it.

People may think the patient is trying to get out of paying, which, of course, is sometimes true, but most of the time they want to pay, concluded the study. Most patients need a better explanation, communication, and accurate accounting of their out-of-pocket costs.
 

What can doctors do?

If you’re a physician who regularly sees patients who have problems paying their bills, you can take a few steps to minimize the financial impact on your practice:

  • Bill the patient’s insurance directly to ensure you receive at least partial payment.
  • Keep adequate records of services in case you need to pursue legal action.
  • “Be understanding and flexible when it comes to payment arrangements, as this can often be the difference between getting paid and not getting paid at all,” said Dr. Chaudhry.

Distance yourself

When discussing payment policies, physicians should try to distance themselves from the actual collection process as much as possible. Well-meaning physicians often tell patients things like they can “figure something out “ financially or “work them in” during a scheduling conflict, but that often undermines the authority and credibility of the practice’s office staff. Plus, it teaches patients they can get their way if they work on the doctor’s soft spot – something you don’t want to encourage.

By following some of these measures, you can help ensure that your practice continues to thrive despite the challenges posed by nonpaying patients.

A version of this article first appeared on Medscape.com.

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Poor sleep raises risk for fatty liver disease

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Changed
Tue, 08/16/2022 - 16:00

 

Sleep behaviors, both individually and combined, are associated with an increased risk of developing metabolic dysfunction–associated fatty liver disease (MAFLD), according to a Chinese analysis that suggests the effect may be independent of obesity.

Yan Liu, PhD, from the School of Public Health at Sun Yat-sen University in Guangzhou, China, and colleagues studied data on over 5,000 individuals who self-reported sleep behaviors and underwent liver ultrasound.

Late bedtimes, snoring, and prolonged daytime napping were significantly associated with MAFLD, increasing the risk by 37%, 59%, and 17%, respectively, whereas people with both poor nighttime sleep and prolonged daytime napping had the “highest risk for developing fatty liver disease,” said Dr. Liu in a press release.

In contrast, having any of six healthy sleep behaviors decreased the risk by 16% each, and even a “moderate improvement in sleep quality was related to a 29% reduction in the risk for fatty liver disease,” he added.

The research, published online in the Journal of Clinical Endocrinology & Metabolism, also indicated that obesity accounted for only one fifth of the effect of sleep quality on MAFLD risk.

Rise in unhealthy lifestyles leads to increase in MALFD

The authors write that MAFLD is the “leading chronic liver disease worldwide,” affecting around a quarter of the adult population, and may lead to end-stage liver diseases and extrahepatic complications, thus “posing a major health and economic burden.”

Moreover, the disease prevalence is “soaring at an unanticipated rate,” increasing from 18% to 29% in China over the past decade, because of a “rapid rise in unhealthy lifestyles,” the authors note.

Sleep disturbance is increasingly prevalent, “and an emerging contributor to multiple metabolic disorders,” with insomnia and habitual snoring, for example, positively correlated with hypertension, impaired glucose metabolism, and dyslipidemia, report the authors.

However, whether sleep quality, which includes “several metabolic-related sleep behaviors,” constitutes an independent risk for MAFLD “over and above” the effect of obesity remains unclear.

To investigate further, the researchers examined data from the baseline survey of the community-based, prospective South China Cohort study, which was conducted in four regions of Southern China and involved 5,430 individuals aged 30-79 years.

Between March 2018 and October 2019, the participants self-reported sleep behaviors on the Pittsburgh Sleep Quality Index questionnaire and underwent ultrasound examination of the liver.

MAFLD was diagnosed in those with hepatic steatosis and one of the following:

  • Overweight/obesity, defined by this study as a body mass index greater than or equal to 23 kg/m2.
  • Presence of diabetes.
  • Evidence of metabolic dysregulation.

After excluding patients with insufficient data, and those with a history of liver cirrhosis, hepatectomy, or liver cancer, among others, the team included 5,011 individuals with an average age of 64 years and a mean body mass index of 24.31 kg/m2. Forty percent were male.

Obesity was present in 13% of participants, whereas 15% had diabetes, 58% hypertension, and 35% metabolic syndrome.

MAFLD was diagnosed in 28% of the study population. They were older, more likely to be female with a higher education, and had a higher prevalence of preexisting metabolic disorders and worse metabolic profiles, than those without the disease.

Turning to the associations between sleep and the risk of MAFLD, the researchers say that “in contrast to previous reports, neither shorter nor longer sleep duration was found to be associated with the risk for MAFLD.”

However, after adjusting for demographics, lifestyles, medication, and preexisting metabolic comorbidities including hypertension, diabetes, and obesity, they found that the risk of MAFLD was significantly associated with late bedtime (defined as after 10 p.m.), at an odds ratio of 1.37 (P < .05).

MAFLD was also linked to snoring, at an odds ratio of 1.59, and to daytime napping for longer than 30 minutes, at an odds ratio of 1.17 (P < .05 for both).

When the team compared low-risk and high-risk sleep factors, they found that participants who had an early bedtime, slept 7-8 hours per night, never or rarely had insomnia or snoring, had infrequent daytime sleepiness, and daytime napping of half-hour or less had an odds ratio for MAFLD vs. other participants of 0.64 (P < .05).

Combining those factors into a healthy sleep score, the team found that each additional increase of healthy sleep score was associated with a fully adjusted odds ratio for MAFLD of 0.84 (P < .05).

In contrast, individuals with poor nocturnal sleep patterns and prolonged daytime napping had a higher risk for developing MAFLD, compared with those with a healthy nocturnal sleep pattern and daytime napping of half-hour or less, at an odds ratio of 2.38 (P < .05).

Further analysis indicated that individuals with a sedentary lifestyle and central obesity had a higher risk of MAFLD, but that the presence of obesity accounted for only 20.8% of the total effect of sleep quality on the risk of MAFLD.

“Taken together, our results suggests that obesity only partially mediates the effect of overall sleep quality on MAFLD,” the authors write.

“Given that large proportions of subjects suffering from poor sleep quality are underdiagnosed and undertreated, our study calls for more research into this field and strategies to improve sleep quality,” Dr. Liu said.

The study was supported by the “National Key R&D Program” of China, the Fundamental Research Funds for the Central Universities (Sun Yat-sen University), Natural Science Foundation of Guangdong Province, the Key Project of Medicine Discipline of Guangzhou, and Basic Research Project of Key Laboratory of Guangzhou.

The authors report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Sleep behaviors, both individually and combined, are associated with an increased risk of developing metabolic dysfunction–associated fatty liver disease (MAFLD), according to a Chinese analysis that suggests the effect may be independent of obesity.

Yan Liu, PhD, from the School of Public Health at Sun Yat-sen University in Guangzhou, China, and colleagues studied data on over 5,000 individuals who self-reported sleep behaviors and underwent liver ultrasound.

Late bedtimes, snoring, and prolonged daytime napping were significantly associated with MAFLD, increasing the risk by 37%, 59%, and 17%, respectively, whereas people with both poor nighttime sleep and prolonged daytime napping had the “highest risk for developing fatty liver disease,” said Dr. Liu in a press release.

In contrast, having any of six healthy sleep behaviors decreased the risk by 16% each, and even a “moderate improvement in sleep quality was related to a 29% reduction in the risk for fatty liver disease,” he added.

The research, published online in the Journal of Clinical Endocrinology & Metabolism, also indicated that obesity accounted for only one fifth of the effect of sleep quality on MAFLD risk.

Rise in unhealthy lifestyles leads to increase in MALFD

The authors write that MAFLD is the “leading chronic liver disease worldwide,” affecting around a quarter of the adult population, and may lead to end-stage liver diseases and extrahepatic complications, thus “posing a major health and economic burden.”

Moreover, the disease prevalence is “soaring at an unanticipated rate,” increasing from 18% to 29% in China over the past decade, because of a “rapid rise in unhealthy lifestyles,” the authors note.

Sleep disturbance is increasingly prevalent, “and an emerging contributor to multiple metabolic disorders,” with insomnia and habitual snoring, for example, positively correlated with hypertension, impaired glucose metabolism, and dyslipidemia, report the authors.

However, whether sleep quality, which includes “several metabolic-related sleep behaviors,” constitutes an independent risk for MAFLD “over and above” the effect of obesity remains unclear.

To investigate further, the researchers examined data from the baseline survey of the community-based, prospective South China Cohort study, which was conducted in four regions of Southern China and involved 5,430 individuals aged 30-79 years.

Between March 2018 and October 2019, the participants self-reported sleep behaviors on the Pittsburgh Sleep Quality Index questionnaire and underwent ultrasound examination of the liver.

MAFLD was diagnosed in those with hepatic steatosis and one of the following:

  • Overweight/obesity, defined by this study as a body mass index greater than or equal to 23 kg/m2.
  • Presence of diabetes.
  • Evidence of metabolic dysregulation.

After excluding patients with insufficient data, and those with a history of liver cirrhosis, hepatectomy, or liver cancer, among others, the team included 5,011 individuals with an average age of 64 years and a mean body mass index of 24.31 kg/m2. Forty percent were male.

Obesity was present in 13% of participants, whereas 15% had diabetes, 58% hypertension, and 35% metabolic syndrome.

MAFLD was diagnosed in 28% of the study population. They were older, more likely to be female with a higher education, and had a higher prevalence of preexisting metabolic disorders and worse metabolic profiles, than those without the disease.

Turning to the associations between sleep and the risk of MAFLD, the researchers say that “in contrast to previous reports, neither shorter nor longer sleep duration was found to be associated with the risk for MAFLD.”

However, after adjusting for demographics, lifestyles, medication, and preexisting metabolic comorbidities including hypertension, diabetes, and obesity, they found that the risk of MAFLD was significantly associated with late bedtime (defined as after 10 p.m.), at an odds ratio of 1.37 (P < .05).

MAFLD was also linked to snoring, at an odds ratio of 1.59, and to daytime napping for longer than 30 minutes, at an odds ratio of 1.17 (P < .05 for both).

When the team compared low-risk and high-risk sleep factors, they found that participants who had an early bedtime, slept 7-8 hours per night, never or rarely had insomnia or snoring, had infrequent daytime sleepiness, and daytime napping of half-hour or less had an odds ratio for MAFLD vs. other participants of 0.64 (P < .05).

Combining those factors into a healthy sleep score, the team found that each additional increase of healthy sleep score was associated with a fully adjusted odds ratio for MAFLD of 0.84 (P < .05).

In contrast, individuals with poor nocturnal sleep patterns and prolonged daytime napping had a higher risk for developing MAFLD, compared with those with a healthy nocturnal sleep pattern and daytime napping of half-hour or less, at an odds ratio of 2.38 (P < .05).

Further analysis indicated that individuals with a sedentary lifestyle and central obesity had a higher risk of MAFLD, but that the presence of obesity accounted for only 20.8% of the total effect of sleep quality on the risk of MAFLD.

“Taken together, our results suggests that obesity only partially mediates the effect of overall sleep quality on MAFLD,” the authors write.

“Given that large proportions of subjects suffering from poor sleep quality are underdiagnosed and undertreated, our study calls for more research into this field and strategies to improve sleep quality,” Dr. Liu said.

The study was supported by the “National Key R&D Program” of China, the Fundamental Research Funds for the Central Universities (Sun Yat-sen University), Natural Science Foundation of Guangdong Province, the Key Project of Medicine Discipline of Guangzhou, and Basic Research Project of Key Laboratory of Guangzhou.

The authors report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

Sleep behaviors, both individually and combined, are associated with an increased risk of developing metabolic dysfunction–associated fatty liver disease (MAFLD), according to a Chinese analysis that suggests the effect may be independent of obesity.

Yan Liu, PhD, from the School of Public Health at Sun Yat-sen University in Guangzhou, China, and colleagues studied data on over 5,000 individuals who self-reported sleep behaviors and underwent liver ultrasound.

Late bedtimes, snoring, and prolonged daytime napping were significantly associated with MAFLD, increasing the risk by 37%, 59%, and 17%, respectively, whereas people with both poor nighttime sleep and prolonged daytime napping had the “highest risk for developing fatty liver disease,” said Dr. Liu in a press release.

In contrast, having any of six healthy sleep behaviors decreased the risk by 16% each, and even a “moderate improvement in sleep quality was related to a 29% reduction in the risk for fatty liver disease,” he added.

The research, published online in the Journal of Clinical Endocrinology & Metabolism, also indicated that obesity accounted for only one fifth of the effect of sleep quality on MAFLD risk.

Rise in unhealthy lifestyles leads to increase in MALFD

The authors write that MAFLD is the “leading chronic liver disease worldwide,” affecting around a quarter of the adult population, and may lead to end-stage liver diseases and extrahepatic complications, thus “posing a major health and economic burden.”

Moreover, the disease prevalence is “soaring at an unanticipated rate,” increasing from 18% to 29% in China over the past decade, because of a “rapid rise in unhealthy lifestyles,” the authors note.

Sleep disturbance is increasingly prevalent, “and an emerging contributor to multiple metabolic disorders,” with insomnia and habitual snoring, for example, positively correlated with hypertension, impaired glucose metabolism, and dyslipidemia, report the authors.

However, whether sleep quality, which includes “several metabolic-related sleep behaviors,” constitutes an independent risk for MAFLD “over and above” the effect of obesity remains unclear.

To investigate further, the researchers examined data from the baseline survey of the community-based, prospective South China Cohort study, which was conducted in four regions of Southern China and involved 5,430 individuals aged 30-79 years.

Between March 2018 and October 2019, the participants self-reported sleep behaviors on the Pittsburgh Sleep Quality Index questionnaire and underwent ultrasound examination of the liver.

MAFLD was diagnosed in those with hepatic steatosis and one of the following:

  • Overweight/obesity, defined by this study as a body mass index greater than or equal to 23 kg/m2.
  • Presence of diabetes.
  • Evidence of metabolic dysregulation.

After excluding patients with insufficient data, and those with a history of liver cirrhosis, hepatectomy, or liver cancer, among others, the team included 5,011 individuals with an average age of 64 years and a mean body mass index of 24.31 kg/m2. Forty percent were male.

Obesity was present in 13% of participants, whereas 15% had diabetes, 58% hypertension, and 35% metabolic syndrome.

MAFLD was diagnosed in 28% of the study population. They were older, more likely to be female with a higher education, and had a higher prevalence of preexisting metabolic disorders and worse metabolic profiles, than those without the disease.

Turning to the associations between sleep and the risk of MAFLD, the researchers say that “in contrast to previous reports, neither shorter nor longer sleep duration was found to be associated with the risk for MAFLD.”

However, after adjusting for demographics, lifestyles, medication, and preexisting metabolic comorbidities including hypertension, diabetes, and obesity, they found that the risk of MAFLD was significantly associated with late bedtime (defined as after 10 p.m.), at an odds ratio of 1.37 (P < .05).

MAFLD was also linked to snoring, at an odds ratio of 1.59, and to daytime napping for longer than 30 minutes, at an odds ratio of 1.17 (P < .05 for both).

When the team compared low-risk and high-risk sleep factors, they found that participants who had an early bedtime, slept 7-8 hours per night, never or rarely had insomnia or snoring, had infrequent daytime sleepiness, and daytime napping of half-hour or less had an odds ratio for MAFLD vs. other participants of 0.64 (P < .05).

Combining those factors into a healthy sleep score, the team found that each additional increase of healthy sleep score was associated with a fully adjusted odds ratio for MAFLD of 0.84 (P < .05).

In contrast, individuals with poor nocturnal sleep patterns and prolonged daytime napping had a higher risk for developing MAFLD, compared with those with a healthy nocturnal sleep pattern and daytime napping of half-hour or less, at an odds ratio of 2.38 (P < .05).

Further analysis indicated that individuals with a sedentary lifestyle and central obesity had a higher risk of MAFLD, but that the presence of obesity accounted for only 20.8% of the total effect of sleep quality on the risk of MAFLD.

“Taken together, our results suggests that obesity only partially mediates the effect of overall sleep quality on MAFLD,” the authors write.

“Given that large proportions of subjects suffering from poor sleep quality are underdiagnosed and undertreated, our study calls for more research into this field and strategies to improve sleep quality,” Dr. Liu said.

The study was supported by the “National Key R&D Program” of China, the Fundamental Research Funds for the Central Universities (Sun Yat-sen University), Natural Science Foundation of Guangdong Province, the Key Project of Medicine Discipline of Guangzhou, and Basic Research Project of Key Laboratory of Guangzhou.

The authors report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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FROM JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

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Polio: The unwanted sequel

Article Type
Changed
Mon, 08/15/2022 - 15:45

Summer, since 1975, is traditionally a time for the BIG blockbusters to hit theaters. Some are new, others are sequels in successful franchises. Some anticipated, some not as much.

And, in summer 2022, we have the least-wanted sequel in modern history – Polio II: The Return.

Of course, this sequel isn’t in the theaters (unless the concessions staff isn’t washing their hands), definitely isn’t funny, and could potentially cost a lot more money than the latest Marvel Cinematic Universe flick.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

Personally and professionally, I’m in the middle generation on the disease. I’m young enough that I never had to worry about catching it or having afflicted classmates. But, as a doctor, I’m old enough to still see the consequences. Like most neurologists, I have a handful of patients who had childhood polio, and still deal with the chronic weakness (and consequent pain and orthopedic issues it brings). Signing off on braces and other mobility aids for them is still commonplace.

One of my attendings in residency was the renowned Parkinson’s disease expert Abraham Lieberman. On rounds it was impossible not to notice his marked limp, a consequence of childhood polio, and he’d tell us what it was like, being a 6-year-old boy and dealing with the disease. You learn as much from hearing firsthand experiences as you do from textbooks.

And now the virus is showing up again. A few victims, a lot of virions circulating in waste water, but it shouldn’t be there at all.

We aren’t in the era when schoolchildren died or were crippled by it. Elementary school kids today don’t see classmates catch polio and never return to school, or see their grieving parents.

To take 1 year: More than 3,000 American children died of polio in 1952, and more than 21,000 were left with lifelong paralysis – many of them still among us.

When you think of an iron lung, you think of polio.

Those were the casualties in a war to save future generations from this, along with smallpox and other horrors.

But today, that war is mostly forgotten. And now scientific evidence is drowned out by whatever’s on Facebook and the hard-earned miracle of vaccination is ignored in favor of a nonmedical “social influencer” on YouTube.

So polio is back. The majority of the population likely has nothing to worry about. But there may be segments that are hit hard, and when they are they will never accept the obvious reasons why. It will be part of a cover-up, or a conspiracy, or whatever the guy on Parler told them it was.

As doctors, we’re in the middle. We have to give patients the best recommendations we can, based on learning, evidence, and experience, but at the same time have to recognize their autonomy. I’m not following someone around to make sure they get vaccinated, or take the medication I prescribed.

But we’re also the ones who can be held legally responsible for bad outcomes, regardless of the actual facts of the matter. On the flip side, you don’t hear about someone suing a Facebook “influencer” for doling out inaccurate, potentially fatal, medical advice.

So cracks appear in herd immunity, and leaks will happen.

A few generations of neurologists, including mine, have completed training without considering polio in a differential diagnosis. It would, of course, get bandied about in grand rounds or at the conference table, but none of us really took it seriously. To us residents it was more of historical note. “Gone with the Wind” and the “Wizard of Oz” both came out in 1939, and while we all knew of them, none of us were going to be watching them at the theaters.

Unlike them, though, polio is trying make it back to prime time. It’s a sequel nobody wanted.

But here it is.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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Summer, since 1975, is traditionally a time for the BIG blockbusters to hit theaters. Some are new, others are sequels in successful franchises. Some anticipated, some not as much.

And, in summer 2022, we have the least-wanted sequel in modern history – Polio II: The Return.

Of course, this sequel isn’t in the theaters (unless the concessions staff isn’t washing their hands), definitely isn’t funny, and could potentially cost a lot more money than the latest Marvel Cinematic Universe flick.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

Personally and professionally, I’m in the middle generation on the disease. I’m young enough that I never had to worry about catching it or having afflicted classmates. But, as a doctor, I’m old enough to still see the consequences. Like most neurologists, I have a handful of patients who had childhood polio, and still deal with the chronic weakness (and consequent pain and orthopedic issues it brings). Signing off on braces and other mobility aids for them is still commonplace.

One of my attendings in residency was the renowned Parkinson’s disease expert Abraham Lieberman. On rounds it was impossible not to notice his marked limp, a consequence of childhood polio, and he’d tell us what it was like, being a 6-year-old boy and dealing with the disease. You learn as much from hearing firsthand experiences as you do from textbooks.

And now the virus is showing up again. A few victims, a lot of virions circulating in waste water, but it shouldn’t be there at all.

We aren’t in the era when schoolchildren died or were crippled by it. Elementary school kids today don’t see classmates catch polio and never return to school, or see their grieving parents.

To take 1 year: More than 3,000 American children died of polio in 1952, and more than 21,000 were left with lifelong paralysis – many of them still among us.

When you think of an iron lung, you think of polio.

Those were the casualties in a war to save future generations from this, along with smallpox and other horrors.

But today, that war is mostly forgotten. And now scientific evidence is drowned out by whatever’s on Facebook and the hard-earned miracle of vaccination is ignored in favor of a nonmedical “social influencer” on YouTube.

So polio is back. The majority of the population likely has nothing to worry about. But there may be segments that are hit hard, and when they are they will never accept the obvious reasons why. It will be part of a cover-up, or a conspiracy, or whatever the guy on Parler told them it was.

As doctors, we’re in the middle. We have to give patients the best recommendations we can, based on learning, evidence, and experience, but at the same time have to recognize their autonomy. I’m not following someone around to make sure they get vaccinated, or take the medication I prescribed.

But we’re also the ones who can be held legally responsible for bad outcomes, regardless of the actual facts of the matter. On the flip side, you don’t hear about someone suing a Facebook “influencer” for doling out inaccurate, potentially fatal, medical advice.

So cracks appear in herd immunity, and leaks will happen.

A few generations of neurologists, including mine, have completed training without considering polio in a differential diagnosis. It would, of course, get bandied about in grand rounds or at the conference table, but none of us really took it seriously. To us residents it was more of historical note. “Gone with the Wind” and the “Wizard of Oz” both came out in 1939, and while we all knew of them, none of us were going to be watching them at the theaters.

Unlike them, though, polio is trying make it back to prime time. It’s a sequel nobody wanted.

But here it is.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Summer, since 1975, is traditionally a time for the BIG blockbusters to hit theaters. Some are new, others are sequels in successful franchises. Some anticipated, some not as much.

And, in summer 2022, we have the least-wanted sequel in modern history – Polio II: The Return.

Of course, this sequel isn’t in the theaters (unless the concessions staff isn’t washing their hands), definitely isn’t funny, and could potentially cost a lot more money than the latest Marvel Cinematic Universe flick.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

Personally and professionally, I’m in the middle generation on the disease. I’m young enough that I never had to worry about catching it or having afflicted classmates. But, as a doctor, I’m old enough to still see the consequences. Like most neurologists, I have a handful of patients who had childhood polio, and still deal with the chronic weakness (and consequent pain and orthopedic issues it brings). Signing off on braces and other mobility aids for them is still commonplace.

One of my attendings in residency was the renowned Parkinson’s disease expert Abraham Lieberman. On rounds it was impossible not to notice his marked limp, a consequence of childhood polio, and he’d tell us what it was like, being a 6-year-old boy and dealing with the disease. You learn as much from hearing firsthand experiences as you do from textbooks.

And now the virus is showing up again. A few victims, a lot of virions circulating in waste water, but it shouldn’t be there at all.

We aren’t in the era when schoolchildren died or were crippled by it. Elementary school kids today don’t see classmates catch polio and never return to school, or see their grieving parents.

To take 1 year: More than 3,000 American children died of polio in 1952, and more than 21,000 were left with lifelong paralysis – many of them still among us.

When you think of an iron lung, you think of polio.

Those were the casualties in a war to save future generations from this, along with smallpox and other horrors.

But today, that war is mostly forgotten. And now scientific evidence is drowned out by whatever’s on Facebook and the hard-earned miracle of vaccination is ignored in favor of a nonmedical “social influencer” on YouTube.

So polio is back. The majority of the population likely has nothing to worry about. But there may be segments that are hit hard, and when they are they will never accept the obvious reasons why. It will be part of a cover-up, or a conspiracy, or whatever the guy on Parler told them it was.

As doctors, we’re in the middle. We have to give patients the best recommendations we can, based on learning, evidence, and experience, but at the same time have to recognize their autonomy. I’m not following someone around to make sure they get vaccinated, or take the medication I prescribed.

But we’re also the ones who can be held legally responsible for bad outcomes, regardless of the actual facts of the matter. On the flip side, you don’t hear about someone suing a Facebook “influencer” for doling out inaccurate, potentially fatal, medical advice.

So cracks appear in herd immunity, and leaks will happen.

A few generations of neurologists, including mine, have completed training without considering polio in a differential diagnosis. It would, of course, get bandied about in grand rounds or at the conference table, but none of us really took it seriously. To us residents it was more of historical note. “Gone with the Wind” and the “Wizard of Oz” both came out in 1939, and while we all knew of them, none of us were going to be watching them at the theaters.

Unlike them, though, polio is trying make it back to prime time. It’s a sequel nobody wanted.

But here it is.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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Active shooter drills may be harming children, but doctors offer help

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Tue, 08/16/2022 - 08:46

Gun attacks in classrooms across the nation have led principals and other school leaders to implement “active shooter” drills to try to increase the safety of their students and faculty.

The drills can range from staging lockdowns and sheltering in place to quasi dramas with mock shooters roaming the halls. Although the goals of these training exercises are important, equally important are the potential negative effects of drills on students’ mental health, according to doctors with expertise in pediatrics and mental health.

Dr. Peter L. Loper Jr.

“Dramatic simulation of an active shooter event at school would be expected to provoke the same stress response as the real thing,” said Peter L. Loper Jr., MD, a pediatrician and psychiatrist, in an interview. “While ensuring their physical safety is very important, we must be intentional about making sure that we are not doing so at the expense of their psychosocial or emotional safety.”

“Children may not be able to differentiate a dramatic drill from a real event,” emphasized Dr. Loper, of the neuropsychiatry and behavioral science departments at the University of South Carolina, Columbia. “The parts of the brain responsible for our flight-fight-or-freeze response would interpret both simulated and real events identically and produce the same neurohormonal stress-response.”

Indeed, a study published in the journal Humanities & Social Sciences Communications suggested children experienced mental health problems related to participating in active shooter drills. In the large study, a team of statisticians from the Georgia Institute of Technology found that students reported a 42% increase in stress and anxiety and a 38.7% increase in depression during the 90 days following active shooter drills, compared with the 90 days before the drills.

The authors of this study, including Mai ElSherief, PhD, drew these conclusions after analyzing 54 million social media posts before and after drills in 114 schools across 33 states. The researchers analyzed the language of the social media posts by teachers, parents, and students and found increased use of the words hope, love, home, school, kids, community, support, and help after the drills. The researchers considered posting with these terms in the aftermath of the drills to be indicative of having high anxiety.

They included examples of how high stress, anxiety, and depression manifested in specific posts from parents in their report. The following is an example of a poster expressing high anxiety and stress: “are we really gonna normalize school shooter drills?! holy sh* there has to be a real way to avoid these tragedies. sh*t like this cannot be normalized. teachers injured after being shot with plastic pellets ‘execution style’ in active shooter drill.”

The authors also shared this post to serve as an example of a person who seems depressed: “and now we are revisiting the trauma on our kids, forcing them to act out school drills monthly. i don’t get why gen x parents buy into this concept wholeheartedly. things need to change.”

The published material did not include posts from students, but the researchers’ analysis of the content of posts overall showed increased concerns for health and increased concerns about death during the period after drills, compared with before drills.

The authors also conducted focus groups in communities in which drills occurred, and many teachers and parents reported anecdotal evidence of children who were nervous long after the drills were over, with some showing extreme reactions such as panic over a standard fire alarm at school. Overall, the results show that school shooter drills can negatively affect school communities over prolonged periods of time, they concluded.

According to a statement from the American Academy of Pediatrics, “there is a need to be cautious about the potential psychological risks and other unintended consequences of directly involving children in live exercises and drills.”

“These risks and consequences are especially a concern when children are deceived and led to believe there is an actual attack and not a drill,” wrote David Schonfeld, MD, the lead author of the statement on Participation of Children and Adolescents in Live Crisis Drills and Exercises, and colleagues.
 

 

 

Managing the fallout

Physicians can help students experiencing mental health problems from these drills, according to doctors interviewed for this piece.

It’s important for providers to know that stress will show up differently in children than in adults, said Chelsea Younghans, MD, a psychiatrist and military officer in Bethesda, Md., in an interview.

“They may see children with headaches, stomach aches, or nonspecific complaints. They may also see children who have not had difficulty with sleep present with nightmares or bed wetting,” she added.

For teens and preteens, validated tools such as the Child PTSD Symptom Scale (CPSS-5) and Child and Adolescent Trauma Screen (CATS) to assess PTSD in youth, may help serve as a starting point for a conversation between providers and their older child population, she noted.

Children who exhibit avoidance or withdrawal behaviors including consistent school refusal, an increase in reassurance-seeking behaviors, or somatic symptoms like vague abdominal pain or headaches that prevent school attendance after participating in a drill, may need more robust mental health services, Dr. Loper noted.

Dr. Schonfeld, who is also director of the National Center for School Crisis and Bereavement at Children’s Hospital Los Angeles, called for health care providers to be available to help children process traumatic reactions to these exercises.

Agreeing with Dr. Schonfeld, Dr. Younghans said: “It is vital to debrief with students and staff after drills, making sure that students have a safe space and ample time to speak with trusted staff. As children will undoubtedly have questions and concerns, creating open lines of communication will help alleviate any traumatic effect these drills may have.”
 

Communicating with various stakeholders

Experts also gave recommendations for how clinicians communicate with leaders in their area’s school districts and other members of their communities about these training exercises.

“For primary care providers, it is important to establish meaningful relationships within your community and patient population as much as possible,” Dr. Younghans said. “Having a good relationship with the local schools and being part of the conversation can help increase school and community awareness on the impact these drills can have on students and staff,” she added.

For those pediatricians or other health care providers who serve as consultants to schools, Dr. Schonfeld advised they ask about policies related to exercises and drills, such as what are the limits to what children might be exposed to in a drill, and what requirements there might be at the local and state level in terms of frequency and what the drills will and will not involve.

He also noted that clinicians should encourage school leaders to consider the fact that kids may have personal histories of trauma that are completely unknown to the school when they design these exercises.

School staff and health care providers should explain the nature and reasons for drills, invite family members to express concerns, and make accommodations if necessary for some children to participate in drills in a more limited way, noted Dr. Schonfeld, who is also clinical professor of pediatrics at the University of Southern California, Los Angeles.

“I think health care providers should work with legislators, so that if they require a drill, it must be done in a way that is physically and emotionally safe,” he added.
 

 

 

Executing better drills for students’ mental health

Experts also advised on ways to execute these drills that will be least damaging to students.

The AAP statement on Participation of Children and Adolescents in Live Crisis Drills and Exercises, for example, advocates eliminating high-intensity drills, prohibiting deception in drills, and providing accommodations based on children’s vulnerabilities.

Dr. Schonfeld also emphasized, in an interview, that training for an attack need not be extremely realistic to be effective.

“When you are preparing for a crisis, the drills and exercises are for children to practice and develop mastery over something they don’t know how to do fully yet,” said Dr. Schonfeld.

Citing a suggestion from a 2020 report conducted by Everytown for Gun Safety on keeping schools safe from gun violence, Dr. Younghans said, “Schools should be in clear communication with communities and families regarding when drills will be happening,” and advised ensuring that the explanation of drills is developmentally appropriate to the age of the children participating.

The report also recommends conducting drills that do not simulate an actual incident, combining drills with trauma-informed approaches to address students’ well-being during and for a sustained period after the drills, and tracking data on the efficacy and effects of drills.

Dr. Loper suggested ways that clinicians and parents can help navigate the tricky territory of school safety drills.

In his view, they should not be random or unexpected, and anticipatory guidance should be given regarding any visual or auditory stimuli, such as flashing lights or sirens, alarms, or announcements.

“A preventive approach should be utilized to ensure that any child who is experiencing extreme drill-distress be excused from any future disaster drills to prevent retraumatization,” Dr. Loper said.

Physicians interviewed for this piece also provided tips on how to talk about these events with children in a way that is beneficial to their mental health.

“What we want to do is [have a] calm discussion [with kids] about what we are doing and why we are doing it” and guide them through the movements, Dr. Schonfeld said.

When teaching children how to respond to an emergency, some elements of uncertainty need to be discussed. Children need to anticipate “what you might do if you are not in the classroom if something occurs, such as being in the bathroom, or out at recess,” he continued.

Dr. Younghans recommended that parents and staff schedule time to prepare children for the drill and practice in advance, and that behavioral health providers, counselors, and/or primary care providers should be involved in the planning and execution of the drill.

The Georgia Tech study was supported through a grant from Everytown for Gun Safety.

The study authors and experts interviewed for this piece had no financial conflicts to disclose.

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Gun attacks in classrooms across the nation have led principals and other school leaders to implement “active shooter” drills to try to increase the safety of their students and faculty.

The drills can range from staging lockdowns and sheltering in place to quasi dramas with mock shooters roaming the halls. Although the goals of these training exercises are important, equally important are the potential negative effects of drills on students’ mental health, according to doctors with expertise in pediatrics and mental health.

Dr. Peter L. Loper Jr.

“Dramatic simulation of an active shooter event at school would be expected to provoke the same stress response as the real thing,” said Peter L. Loper Jr., MD, a pediatrician and psychiatrist, in an interview. “While ensuring their physical safety is very important, we must be intentional about making sure that we are not doing so at the expense of their psychosocial or emotional safety.”

“Children may not be able to differentiate a dramatic drill from a real event,” emphasized Dr. Loper, of the neuropsychiatry and behavioral science departments at the University of South Carolina, Columbia. “The parts of the brain responsible for our flight-fight-or-freeze response would interpret both simulated and real events identically and produce the same neurohormonal stress-response.”

Indeed, a study published in the journal Humanities & Social Sciences Communications suggested children experienced mental health problems related to participating in active shooter drills. In the large study, a team of statisticians from the Georgia Institute of Technology found that students reported a 42% increase in stress and anxiety and a 38.7% increase in depression during the 90 days following active shooter drills, compared with the 90 days before the drills.

The authors of this study, including Mai ElSherief, PhD, drew these conclusions after analyzing 54 million social media posts before and after drills in 114 schools across 33 states. The researchers analyzed the language of the social media posts by teachers, parents, and students and found increased use of the words hope, love, home, school, kids, community, support, and help after the drills. The researchers considered posting with these terms in the aftermath of the drills to be indicative of having high anxiety.

They included examples of how high stress, anxiety, and depression manifested in specific posts from parents in their report. The following is an example of a poster expressing high anxiety and stress: “are we really gonna normalize school shooter drills?! holy sh* there has to be a real way to avoid these tragedies. sh*t like this cannot be normalized. teachers injured after being shot with plastic pellets ‘execution style’ in active shooter drill.”

The authors also shared this post to serve as an example of a person who seems depressed: “and now we are revisiting the trauma on our kids, forcing them to act out school drills monthly. i don’t get why gen x parents buy into this concept wholeheartedly. things need to change.”

The published material did not include posts from students, but the researchers’ analysis of the content of posts overall showed increased concerns for health and increased concerns about death during the period after drills, compared with before drills.

The authors also conducted focus groups in communities in which drills occurred, and many teachers and parents reported anecdotal evidence of children who were nervous long after the drills were over, with some showing extreme reactions such as panic over a standard fire alarm at school. Overall, the results show that school shooter drills can negatively affect school communities over prolonged periods of time, they concluded.

According to a statement from the American Academy of Pediatrics, “there is a need to be cautious about the potential psychological risks and other unintended consequences of directly involving children in live exercises and drills.”

“These risks and consequences are especially a concern when children are deceived and led to believe there is an actual attack and not a drill,” wrote David Schonfeld, MD, the lead author of the statement on Participation of Children and Adolescents in Live Crisis Drills and Exercises, and colleagues.
 

 

 

Managing the fallout

Physicians can help students experiencing mental health problems from these drills, according to doctors interviewed for this piece.

It’s important for providers to know that stress will show up differently in children than in adults, said Chelsea Younghans, MD, a psychiatrist and military officer in Bethesda, Md., in an interview.

“They may see children with headaches, stomach aches, or nonspecific complaints. They may also see children who have not had difficulty with sleep present with nightmares or bed wetting,” she added.

For teens and preteens, validated tools such as the Child PTSD Symptom Scale (CPSS-5) and Child and Adolescent Trauma Screen (CATS) to assess PTSD in youth, may help serve as a starting point for a conversation between providers and their older child population, she noted.

Children who exhibit avoidance or withdrawal behaviors including consistent school refusal, an increase in reassurance-seeking behaviors, or somatic symptoms like vague abdominal pain or headaches that prevent school attendance after participating in a drill, may need more robust mental health services, Dr. Loper noted.

Dr. Schonfeld, who is also director of the National Center for School Crisis and Bereavement at Children’s Hospital Los Angeles, called for health care providers to be available to help children process traumatic reactions to these exercises.

Agreeing with Dr. Schonfeld, Dr. Younghans said: “It is vital to debrief with students and staff after drills, making sure that students have a safe space and ample time to speak with trusted staff. As children will undoubtedly have questions and concerns, creating open lines of communication will help alleviate any traumatic effect these drills may have.”
 

Communicating with various stakeholders

Experts also gave recommendations for how clinicians communicate with leaders in their area’s school districts and other members of their communities about these training exercises.

“For primary care providers, it is important to establish meaningful relationships within your community and patient population as much as possible,” Dr. Younghans said. “Having a good relationship with the local schools and being part of the conversation can help increase school and community awareness on the impact these drills can have on students and staff,” she added.

For those pediatricians or other health care providers who serve as consultants to schools, Dr. Schonfeld advised they ask about policies related to exercises and drills, such as what are the limits to what children might be exposed to in a drill, and what requirements there might be at the local and state level in terms of frequency and what the drills will and will not involve.

He also noted that clinicians should encourage school leaders to consider the fact that kids may have personal histories of trauma that are completely unknown to the school when they design these exercises.

School staff and health care providers should explain the nature and reasons for drills, invite family members to express concerns, and make accommodations if necessary for some children to participate in drills in a more limited way, noted Dr. Schonfeld, who is also clinical professor of pediatrics at the University of Southern California, Los Angeles.

“I think health care providers should work with legislators, so that if they require a drill, it must be done in a way that is physically and emotionally safe,” he added.
 

 

 

Executing better drills for students’ mental health

Experts also advised on ways to execute these drills that will be least damaging to students.

The AAP statement on Participation of Children and Adolescents in Live Crisis Drills and Exercises, for example, advocates eliminating high-intensity drills, prohibiting deception in drills, and providing accommodations based on children’s vulnerabilities.

Dr. Schonfeld also emphasized, in an interview, that training for an attack need not be extremely realistic to be effective.

“When you are preparing for a crisis, the drills and exercises are for children to practice and develop mastery over something they don’t know how to do fully yet,” said Dr. Schonfeld.

Citing a suggestion from a 2020 report conducted by Everytown for Gun Safety on keeping schools safe from gun violence, Dr. Younghans said, “Schools should be in clear communication with communities and families regarding when drills will be happening,” and advised ensuring that the explanation of drills is developmentally appropriate to the age of the children participating.

The report also recommends conducting drills that do not simulate an actual incident, combining drills with trauma-informed approaches to address students’ well-being during and for a sustained period after the drills, and tracking data on the efficacy and effects of drills.

Dr. Loper suggested ways that clinicians and parents can help navigate the tricky territory of school safety drills.

In his view, they should not be random or unexpected, and anticipatory guidance should be given regarding any visual or auditory stimuli, such as flashing lights or sirens, alarms, or announcements.

“A preventive approach should be utilized to ensure that any child who is experiencing extreme drill-distress be excused from any future disaster drills to prevent retraumatization,” Dr. Loper said.

Physicians interviewed for this piece also provided tips on how to talk about these events with children in a way that is beneficial to their mental health.

“What we want to do is [have a] calm discussion [with kids] about what we are doing and why we are doing it” and guide them through the movements, Dr. Schonfeld said.

When teaching children how to respond to an emergency, some elements of uncertainty need to be discussed. Children need to anticipate “what you might do if you are not in the classroom if something occurs, such as being in the bathroom, or out at recess,” he continued.

Dr. Younghans recommended that parents and staff schedule time to prepare children for the drill and practice in advance, and that behavioral health providers, counselors, and/or primary care providers should be involved in the planning and execution of the drill.

The Georgia Tech study was supported through a grant from Everytown for Gun Safety.

The study authors and experts interviewed for this piece had no financial conflicts to disclose.

Gun attacks in classrooms across the nation have led principals and other school leaders to implement “active shooter” drills to try to increase the safety of their students and faculty.

The drills can range from staging lockdowns and sheltering in place to quasi dramas with mock shooters roaming the halls. Although the goals of these training exercises are important, equally important are the potential negative effects of drills on students’ mental health, according to doctors with expertise in pediatrics and mental health.

Dr. Peter L. Loper Jr.

“Dramatic simulation of an active shooter event at school would be expected to provoke the same stress response as the real thing,” said Peter L. Loper Jr., MD, a pediatrician and psychiatrist, in an interview. “While ensuring their physical safety is very important, we must be intentional about making sure that we are not doing so at the expense of their psychosocial or emotional safety.”

“Children may not be able to differentiate a dramatic drill from a real event,” emphasized Dr. Loper, of the neuropsychiatry and behavioral science departments at the University of South Carolina, Columbia. “The parts of the brain responsible for our flight-fight-or-freeze response would interpret both simulated and real events identically and produce the same neurohormonal stress-response.”

Indeed, a study published in the journal Humanities & Social Sciences Communications suggested children experienced mental health problems related to participating in active shooter drills. In the large study, a team of statisticians from the Georgia Institute of Technology found that students reported a 42% increase in stress and anxiety and a 38.7% increase in depression during the 90 days following active shooter drills, compared with the 90 days before the drills.

The authors of this study, including Mai ElSherief, PhD, drew these conclusions after analyzing 54 million social media posts before and after drills in 114 schools across 33 states. The researchers analyzed the language of the social media posts by teachers, parents, and students and found increased use of the words hope, love, home, school, kids, community, support, and help after the drills. The researchers considered posting with these terms in the aftermath of the drills to be indicative of having high anxiety.

They included examples of how high stress, anxiety, and depression manifested in specific posts from parents in their report. The following is an example of a poster expressing high anxiety and stress: “are we really gonna normalize school shooter drills?! holy sh* there has to be a real way to avoid these tragedies. sh*t like this cannot be normalized. teachers injured after being shot with plastic pellets ‘execution style’ in active shooter drill.”

The authors also shared this post to serve as an example of a person who seems depressed: “and now we are revisiting the trauma on our kids, forcing them to act out school drills monthly. i don’t get why gen x parents buy into this concept wholeheartedly. things need to change.”

The published material did not include posts from students, but the researchers’ analysis of the content of posts overall showed increased concerns for health and increased concerns about death during the period after drills, compared with before drills.

The authors also conducted focus groups in communities in which drills occurred, and many teachers and parents reported anecdotal evidence of children who were nervous long after the drills were over, with some showing extreme reactions such as panic over a standard fire alarm at school. Overall, the results show that school shooter drills can negatively affect school communities over prolonged periods of time, they concluded.

According to a statement from the American Academy of Pediatrics, “there is a need to be cautious about the potential psychological risks and other unintended consequences of directly involving children in live exercises and drills.”

“These risks and consequences are especially a concern when children are deceived and led to believe there is an actual attack and not a drill,” wrote David Schonfeld, MD, the lead author of the statement on Participation of Children and Adolescents in Live Crisis Drills and Exercises, and colleagues.
 

 

 

Managing the fallout

Physicians can help students experiencing mental health problems from these drills, according to doctors interviewed for this piece.

It’s important for providers to know that stress will show up differently in children than in adults, said Chelsea Younghans, MD, a psychiatrist and military officer in Bethesda, Md., in an interview.

“They may see children with headaches, stomach aches, or nonspecific complaints. They may also see children who have not had difficulty with sleep present with nightmares or bed wetting,” she added.

For teens and preteens, validated tools such as the Child PTSD Symptom Scale (CPSS-5) and Child and Adolescent Trauma Screen (CATS) to assess PTSD in youth, may help serve as a starting point for a conversation between providers and their older child population, she noted.

Children who exhibit avoidance or withdrawal behaviors including consistent school refusal, an increase in reassurance-seeking behaviors, or somatic symptoms like vague abdominal pain or headaches that prevent school attendance after participating in a drill, may need more robust mental health services, Dr. Loper noted.

Dr. Schonfeld, who is also director of the National Center for School Crisis and Bereavement at Children’s Hospital Los Angeles, called for health care providers to be available to help children process traumatic reactions to these exercises.

Agreeing with Dr. Schonfeld, Dr. Younghans said: “It is vital to debrief with students and staff after drills, making sure that students have a safe space and ample time to speak with trusted staff. As children will undoubtedly have questions and concerns, creating open lines of communication will help alleviate any traumatic effect these drills may have.”
 

Communicating with various stakeholders

Experts also gave recommendations for how clinicians communicate with leaders in their area’s school districts and other members of their communities about these training exercises.

“For primary care providers, it is important to establish meaningful relationships within your community and patient population as much as possible,” Dr. Younghans said. “Having a good relationship with the local schools and being part of the conversation can help increase school and community awareness on the impact these drills can have on students and staff,” she added.

For those pediatricians or other health care providers who serve as consultants to schools, Dr. Schonfeld advised they ask about policies related to exercises and drills, such as what are the limits to what children might be exposed to in a drill, and what requirements there might be at the local and state level in terms of frequency and what the drills will and will not involve.

He also noted that clinicians should encourage school leaders to consider the fact that kids may have personal histories of trauma that are completely unknown to the school when they design these exercises.

School staff and health care providers should explain the nature and reasons for drills, invite family members to express concerns, and make accommodations if necessary for some children to participate in drills in a more limited way, noted Dr. Schonfeld, who is also clinical professor of pediatrics at the University of Southern California, Los Angeles.

“I think health care providers should work with legislators, so that if they require a drill, it must be done in a way that is physically and emotionally safe,” he added.
 

 

 

Executing better drills for students’ mental health

Experts also advised on ways to execute these drills that will be least damaging to students.

The AAP statement on Participation of Children and Adolescents in Live Crisis Drills and Exercises, for example, advocates eliminating high-intensity drills, prohibiting deception in drills, and providing accommodations based on children’s vulnerabilities.

Dr. Schonfeld also emphasized, in an interview, that training for an attack need not be extremely realistic to be effective.

“When you are preparing for a crisis, the drills and exercises are for children to practice and develop mastery over something they don’t know how to do fully yet,” said Dr. Schonfeld.

Citing a suggestion from a 2020 report conducted by Everytown for Gun Safety on keeping schools safe from gun violence, Dr. Younghans said, “Schools should be in clear communication with communities and families regarding when drills will be happening,” and advised ensuring that the explanation of drills is developmentally appropriate to the age of the children participating.

The report also recommends conducting drills that do not simulate an actual incident, combining drills with trauma-informed approaches to address students’ well-being during and for a sustained period after the drills, and tracking data on the efficacy and effects of drills.

Dr. Loper suggested ways that clinicians and parents can help navigate the tricky territory of school safety drills.

In his view, they should not be random or unexpected, and anticipatory guidance should be given regarding any visual or auditory stimuli, such as flashing lights or sirens, alarms, or announcements.

“A preventive approach should be utilized to ensure that any child who is experiencing extreme drill-distress be excused from any future disaster drills to prevent retraumatization,” Dr. Loper said.

Physicians interviewed for this piece also provided tips on how to talk about these events with children in a way that is beneficial to their mental health.

“What we want to do is [have a] calm discussion [with kids] about what we are doing and why we are doing it” and guide them through the movements, Dr. Schonfeld said.

When teaching children how to respond to an emergency, some elements of uncertainty need to be discussed. Children need to anticipate “what you might do if you are not in the classroom if something occurs, such as being in the bathroom, or out at recess,” he continued.

Dr. Younghans recommended that parents and staff schedule time to prepare children for the drill and practice in advance, and that behavioral health providers, counselors, and/or primary care providers should be involved in the planning and execution of the drill.

The Georgia Tech study was supported through a grant from Everytown for Gun Safety.

The study authors and experts interviewed for this piece had no financial conflicts to disclose.

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Sexual dysfunction, hair loss linked with long COVID

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Mon, 08/15/2022 - 15:09

Hair loss, reduced sex drive, and erectile dysfunction have joined a list of better-known symptoms linked to long COVID in patients who were not hospitalized, according to findings of a large study.

Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.

The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
 

New symptoms

The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.

“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.

They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.

They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.

Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.

“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.

Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.

In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.

More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.

Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.

But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.

A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
 

 

 

Three main clusters of symptoms

Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.

They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.

Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.

She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)

Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.

Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.

“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.

One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.

“Counseling has also become very important for our patients in the pandemic,” she said.

It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.

A version of this article first appeared on WebMD.com.

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Hair loss, reduced sex drive, and erectile dysfunction have joined a list of better-known symptoms linked to long COVID in patients who were not hospitalized, according to findings of a large study.

Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.

The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
 

New symptoms

The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.

“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.

They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.

They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.

Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.

“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.

Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.

In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.

More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.

Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.

But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.

A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
 

 

 

Three main clusters of symptoms

Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.

They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.

Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.

She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)

Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.

Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.

“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.

One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.

“Counseling has also become very important for our patients in the pandemic,” she said.

It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.

A version of this article first appeared on WebMD.com.

Hair loss, reduced sex drive, and erectile dysfunction have joined a list of better-known symptoms linked to long COVID in patients who were not hospitalized, according to findings of a large study.

Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.

The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
 

New symptoms

The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.

“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.

They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.

They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.

Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.

“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.

Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.

In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.

More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.

Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.

But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.

A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
 

 

 

Three main clusters of symptoms

Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.

They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.

Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.

She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)

Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.

Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.

“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.

One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.

“Counseling has also become very important for our patients in the pandemic,” she said.

It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.

A version of this article first appeared on WebMD.com.

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Two deaths from liver failure linked to spinal muscular atrophy drug

Article Type
Changed
Fri, 08/19/2022 - 10:13

Two children taking the gene therapy drug onasemnogene abeparvovec (Zolgensma, Novartis) for spinal muscular atrophy (SMA) have died from acute liver failure, according to a statement issued by the drug›s manufacturer.

The patients were 4 months and 28 months of age and lived in Russia and Kazakhstan. They died 5-6 weeks after infusion with Zolgensma and approximately 1-10 days after the initiation of a corticosteroid taper.

These are the first known fatal cases of acute liver failure associated with the drug, which the company notes was a known side effect included in the product label and in a boxed warning in the United States.

“Following two recent patient fatalities, and in alignment with health authorities, we will be updating the labeling to specify that fatal acute liver failure has been reported,” the statement reads.

“While this is important safety information, it is not a new safety signal,” it adds.
 

Rare genetic disorder

SMA is a rare genetic disorder that affects about 1 in 10,000 newborns. Patients with SMA lack a working copy of the survival motor neuron 1 (SMN1) gene, which encodes a protein called SMN that is critical for the maintenance and function of motor neurons.

Without this protein, motor neurons eventually die, causing debilitating and progressive muscle weakness that affects the ability to walk, eat, and breathe.

Zolgensma, a one-time gene replacement therapy delivered via intravenous infusion, replaces the function of the missing or nonworking SMN1 gene with a new, working copy of the SMN1 gene.

The first gene therapy treatment for SMA, it was approved by the U.S. Food and Drug Administration in 2019 for patients with SMA up to 2 years of age. It is also the most expensive drug in the world, costing about $2.1 million for a one-time treatment.

“We have notified health authorities in all markets where Zolgensma is used, including FDA, and are communicating to relevant healthcare professionals as an additional step in markets where this action is supported by health authorities,” the manufacturer’s statement says.

Studies have suggested that the treatment›s effects persist more than 5 years after infusion.

Clinical trials currently underway by Novartis are studying the drug’s long-term efficacy and safety and its potential use in older patients.

The company is also leading the phase 3 clinical trial STEER to test intrathecal (IT) administration of the drug in patients ages 2-18 years who have type 2 SMA.

That trial began late last year after the FDA lifted a 2-year partial hold on an earlier study. The FDA halted the STRONG trial in 2019, citing concerns from animal studies that IT administration may result in dorsal root ganglia injury. The partial hold was released last fall following positive study results in nonhuman primates.

None of the current trials will be affected by the two deaths reported this week, according to a Novartis spokesperson.

A version of this article first appeared on Medscape.com.

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Two children taking the gene therapy drug onasemnogene abeparvovec (Zolgensma, Novartis) for spinal muscular atrophy (SMA) have died from acute liver failure, according to a statement issued by the drug›s manufacturer.

The patients were 4 months and 28 months of age and lived in Russia and Kazakhstan. They died 5-6 weeks after infusion with Zolgensma and approximately 1-10 days after the initiation of a corticosteroid taper.

These are the first known fatal cases of acute liver failure associated with the drug, which the company notes was a known side effect included in the product label and in a boxed warning in the United States.

“Following two recent patient fatalities, and in alignment with health authorities, we will be updating the labeling to specify that fatal acute liver failure has been reported,” the statement reads.

“While this is important safety information, it is not a new safety signal,” it adds.
 

Rare genetic disorder

SMA is a rare genetic disorder that affects about 1 in 10,000 newborns. Patients with SMA lack a working copy of the survival motor neuron 1 (SMN1) gene, which encodes a protein called SMN that is critical for the maintenance and function of motor neurons.

Without this protein, motor neurons eventually die, causing debilitating and progressive muscle weakness that affects the ability to walk, eat, and breathe.

Zolgensma, a one-time gene replacement therapy delivered via intravenous infusion, replaces the function of the missing or nonworking SMN1 gene with a new, working copy of the SMN1 gene.

The first gene therapy treatment for SMA, it was approved by the U.S. Food and Drug Administration in 2019 for patients with SMA up to 2 years of age. It is also the most expensive drug in the world, costing about $2.1 million for a one-time treatment.

“We have notified health authorities in all markets where Zolgensma is used, including FDA, and are communicating to relevant healthcare professionals as an additional step in markets where this action is supported by health authorities,” the manufacturer’s statement says.

Studies have suggested that the treatment›s effects persist more than 5 years after infusion.

Clinical trials currently underway by Novartis are studying the drug’s long-term efficacy and safety and its potential use in older patients.

The company is also leading the phase 3 clinical trial STEER to test intrathecal (IT) administration of the drug in patients ages 2-18 years who have type 2 SMA.

That trial began late last year after the FDA lifted a 2-year partial hold on an earlier study. The FDA halted the STRONG trial in 2019, citing concerns from animal studies that IT administration may result in dorsal root ganglia injury. The partial hold was released last fall following positive study results in nonhuman primates.

None of the current trials will be affected by the two deaths reported this week, according to a Novartis spokesperson.

A version of this article first appeared on Medscape.com.

Two children taking the gene therapy drug onasemnogene abeparvovec (Zolgensma, Novartis) for spinal muscular atrophy (SMA) have died from acute liver failure, according to a statement issued by the drug›s manufacturer.

The patients were 4 months and 28 months of age and lived in Russia and Kazakhstan. They died 5-6 weeks after infusion with Zolgensma and approximately 1-10 days after the initiation of a corticosteroid taper.

These are the first known fatal cases of acute liver failure associated with the drug, which the company notes was a known side effect included in the product label and in a boxed warning in the United States.

“Following two recent patient fatalities, and in alignment with health authorities, we will be updating the labeling to specify that fatal acute liver failure has been reported,” the statement reads.

“While this is important safety information, it is not a new safety signal,” it adds.
 

Rare genetic disorder

SMA is a rare genetic disorder that affects about 1 in 10,000 newborns. Patients with SMA lack a working copy of the survival motor neuron 1 (SMN1) gene, which encodes a protein called SMN that is critical for the maintenance and function of motor neurons.

Without this protein, motor neurons eventually die, causing debilitating and progressive muscle weakness that affects the ability to walk, eat, and breathe.

Zolgensma, a one-time gene replacement therapy delivered via intravenous infusion, replaces the function of the missing or nonworking SMN1 gene with a new, working copy of the SMN1 gene.

The first gene therapy treatment for SMA, it was approved by the U.S. Food and Drug Administration in 2019 for patients with SMA up to 2 years of age. It is also the most expensive drug in the world, costing about $2.1 million for a one-time treatment.

“We have notified health authorities in all markets where Zolgensma is used, including FDA, and are communicating to relevant healthcare professionals as an additional step in markets where this action is supported by health authorities,” the manufacturer’s statement says.

Studies have suggested that the treatment›s effects persist more than 5 years after infusion.

Clinical trials currently underway by Novartis are studying the drug’s long-term efficacy and safety and its potential use in older patients.

The company is also leading the phase 3 clinical trial STEER to test intrathecal (IT) administration of the drug in patients ages 2-18 years who have type 2 SMA.

That trial began late last year after the FDA lifted a 2-year partial hold on an earlier study. The FDA halted the STRONG trial in 2019, citing concerns from animal studies that IT administration may result in dorsal root ganglia injury. The partial hold was released last fall following positive study results in nonhuman primates.

None of the current trials will be affected by the two deaths reported this week, according to a Novartis spokesperson.

A version of this article first appeared on Medscape.com.

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More evidence salt substitutes lower risk of CVD and death

Article Type
Changed
Wed, 08/17/2022 - 15:17

Dietary salt substitutes not only lower blood pressure but also have a clear impact on hard clinical endpoints, lowering the risk of myocardial infarction (MI), stroke, and death from all causes and cardiovascular disease (CVD), a meta-analysis shows.

jirkaejc/Getty Images

The blood pressure–mediated protective effects of salt substitutes on CVD and death are likely to apply to the roughly 1.28 billion people around the world who have high blood pressure, the researchers say.

“These findings are unlikely to reflect the play of chance and support the adoption of salt substitutes in clinical practice and public health policy as a strategy to reduce dietary sodium intake, increase dietary potassium intake, lower blood pressure, and prevent major cardiovascular events,” they write.

The study was published online  in Heart.
 

Strong support for landmark study

In salt substitutes, a proportion of sodium chloride is replaced with potassium chloride. They are known to help lower blood pressure, but less is known about their impact on hard clinical endpoints, Maoyi Tian, PhD, with Harbin Medical University, China, and the George Institute for Global Health, Sydney, and colleagues note in their article.

In the landmark Salt Substitute and Stroke Study (SSaSS), salt substitutes cut the risk of MI, stroke, and early death, as reported previously by this news organization.

But SSaSS was conducted in China, and it was unclear whether these benefits would apply to people in other parts of the world.

To investigate, Dr. Tian and colleagues pooled data from 21 relevant parallel-group, step-wedge, or cluster randomized controlled trials published through August 2021, with 31,949 participants. The trials were conducted in Europe, the Western Pacific Region, the Americas, and South East Asia and reported the effect of a salt substitute on blood pressure or clinical outcomes.

A meta-analysis of blood pressure data from 19 trials that included 29,528 participants showed that salt substitutes lowered systolic blood pressure (SBP) by 4.61 mm Hg (95% confidence interval, −6.07 to −3.14) and diastolic blood pressure (DBP) by 1.61 mm Hg (95% CI, −2.42 to −0.79).

The proportion of sodium chloride in the salt substitutes varied from 33% to 75%; the proportion of potassium ranged from 25% to 65%.

Each 10% lower proportion of sodium chloride in the salt substitute was associated with a 1.53 mm Hg (95% CI, −3.02 to −0.03; P = .045) greater reduction in SBP and a 0.95 mm Hg (95% CI, −1.78 to −0.12; P = .025) greater reduction in DBP.

Reductions in blood pressure appeared consistent, irrespective of country, age, sex, history of high blood pressure, weight, baseline blood pressure, and baseline levels of urinary sodium and potassium.

Clear benefit on hard outcomes

Pooled data on clinical outcomes from five trials that included 24,306 participants, mostly from the SSaSS, showed clear protective effects of salt substitutes on total mortality (risk ratio, 0.89; 95% CI, 0.85-0.94), CV mortality (RR, 0.87; 95% CI, 0.81-0.94), and CV events (RR, 0.89; 95% CI, 0.85-0.94).

Dr. Tian and colleagues say that “broader population use of salt substitute is supported by the absence of any detectable adverse effect of salt substitutes on hyperkalemia in this review.”

They note, however, that all of the trials took “pragmatic steps to exclude participants at elevated risk of hyperkalemia, seeking to exclude those with chronic kidney disease or using medications that elevate serum potassium.”

Offering perspective on the study, Harlan Krumholz, MD, with Yale New Haven Hospital and Yale School of Medicine, both in New Haven, Conn., said it provides “useful information by bringing together the trial evidence on salt substitutes. The evidence is dominated by the SSaSS, but the others add context.”

Dr. Krumholz said that at this point, he thinks salt substitutes “could be included in recommendations to patients.”

“SSaSS was conducted in villages in China, so that is where the evidence is strongest and most relevant, but this is a low-cost and seemingly safe strategy that could be tried by anyone without contraindications, such as kidney disease or taking a potassium-sparing medication or potassium supplement,” Dr. Krumholz told this news organization.

Johanna Contreras, MD, heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, agrees that in the absence of contraindications, salt substitutes should be recommended.

“Americans put salt on everything and don’t even think about it. The salt substitutes are very helpful,” Dr. Contreras said in an interview.

“People who don’t have high blood pressure should limit salt intake, because what we have seen is that if you have high blood pressure in your family – even if you don’t have high blood pressure in your 20s or 30s – you’re likely to develop high blood pressure,” Dr. Contreras said.

“Therefore, it’s wise early on to start protecting yourself and using low salt and salt substitutes,” she added.

The study had no specific funding. Dr. Tian, Dr. Krumholz, and Dr. Contreras have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Dietary salt substitutes not only lower blood pressure but also have a clear impact on hard clinical endpoints, lowering the risk of myocardial infarction (MI), stroke, and death from all causes and cardiovascular disease (CVD), a meta-analysis shows.

jirkaejc/Getty Images

The blood pressure–mediated protective effects of salt substitutes on CVD and death are likely to apply to the roughly 1.28 billion people around the world who have high blood pressure, the researchers say.

“These findings are unlikely to reflect the play of chance and support the adoption of salt substitutes in clinical practice and public health policy as a strategy to reduce dietary sodium intake, increase dietary potassium intake, lower blood pressure, and prevent major cardiovascular events,” they write.

The study was published online  in Heart.
 

Strong support for landmark study

In salt substitutes, a proportion of sodium chloride is replaced with potassium chloride. They are known to help lower blood pressure, but less is known about their impact on hard clinical endpoints, Maoyi Tian, PhD, with Harbin Medical University, China, and the George Institute for Global Health, Sydney, and colleagues note in their article.

In the landmark Salt Substitute and Stroke Study (SSaSS), salt substitutes cut the risk of MI, stroke, and early death, as reported previously by this news organization.

But SSaSS was conducted in China, and it was unclear whether these benefits would apply to people in other parts of the world.

To investigate, Dr. Tian and colleagues pooled data from 21 relevant parallel-group, step-wedge, or cluster randomized controlled trials published through August 2021, with 31,949 participants. The trials were conducted in Europe, the Western Pacific Region, the Americas, and South East Asia and reported the effect of a salt substitute on blood pressure or clinical outcomes.

A meta-analysis of blood pressure data from 19 trials that included 29,528 participants showed that salt substitutes lowered systolic blood pressure (SBP) by 4.61 mm Hg (95% confidence interval, −6.07 to −3.14) and diastolic blood pressure (DBP) by 1.61 mm Hg (95% CI, −2.42 to −0.79).

The proportion of sodium chloride in the salt substitutes varied from 33% to 75%; the proportion of potassium ranged from 25% to 65%.

Each 10% lower proportion of sodium chloride in the salt substitute was associated with a 1.53 mm Hg (95% CI, −3.02 to −0.03; P = .045) greater reduction in SBP and a 0.95 mm Hg (95% CI, −1.78 to −0.12; P = .025) greater reduction in DBP.

Reductions in blood pressure appeared consistent, irrespective of country, age, sex, history of high blood pressure, weight, baseline blood pressure, and baseline levels of urinary sodium and potassium.

Clear benefit on hard outcomes

Pooled data on clinical outcomes from five trials that included 24,306 participants, mostly from the SSaSS, showed clear protective effects of salt substitutes on total mortality (risk ratio, 0.89; 95% CI, 0.85-0.94), CV mortality (RR, 0.87; 95% CI, 0.81-0.94), and CV events (RR, 0.89; 95% CI, 0.85-0.94).

Dr. Tian and colleagues say that “broader population use of salt substitute is supported by the absence of any detectable adverse effect of salt substitutes on hyperkalemia in this review.”

They note, however, that all of the trials took “pragmatic steps to exclude participants at elevated risk of hyperkalemia, seeking to exclude those with chronic kidney disease or using medications that elevate serum potassium.”

Offering perspective on the study, Harlan Krumholz, MD, with Yale New Haven Hospital and Yale School of Medicine, both in New Haven, Conn., said it provides “useful information by bringing together the trial evidence on salt substitutes. The evidence is dominated by the SSaSS, but the others add context.”

Dr. Krumholz said that at this point, he thinks salt substitutes “could be included in recommendations to patients.”

“SSaSS was conducted in villages in China, so that is where the evidence is strongest and most relevant, but this is a low-cost and seemingly safe strategy that could be tried by anyone without contraindications, such as kidney disease or taking a potassium-sparing medication or potassium supplement,” Dr. Krumholz told this news organization.

Johanna Contreras, MD, heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, agrees that in the absence of contraindications, salt substitutes should be recommended.

“Americans put salt on everything and don’t even think about it. The salt substitutes are very helpful,” Dr. Contreras said in an interview.

“People who don’t have high blood pressure should limit salt intake, because what we have seen is that if you have high blood pressure in your family – even if you don’t have high blood pressure in your 20s or 30s – you’re likely to develop high blood pressure,” Dr. Contreras said.

“Therefore, it’s wise early on to start protecting yourself and using low salt and salt substitutes,” she added.

The study had no specific funding. Dr. Tian, Dr. Krumholz, and Dr. Contreras have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Dietary salt substitutes not only lower blood pressure but also have a clear impact on hard clinical endpoints, lowering the risk of myocardial infarction (MI), stroke, and death from all causes and cardiovascular disease (CVD), a meta-analysis shows.

jirkaejc/Getty Images

The blood pressure–mediated protective effects of salt substitutes on CVD and death are likely to apply to the roughly 1.28 billion people around the world who have high blood pressure, the researchers say.

“These findings are unlikely to reflect the play of chance and support the adoption of salt substitutes in clinical practice and public health policy as a strategy to reduce dietary sodium intake, increase dietary potassium intake, lower blood pressure, and prevent major cardiovascular events,” they write.

The study was published online  in Heart.
 

Strong support for landmark study

In salt substitutes, a proportion of sodium chloride is replaced with potassium chloride. They are known to help lower blood pressure, but less is known about their impact on hard clinical endpoints, Maoyi Tian, PhD, with Harbin Medical University, China, and the George Institute for Global Health, Sydney, and colleagues note in their article.

In the landmark Salt Substitute and Stroke Study (SSaSS), salt substitutes cut the risk of MI, stroke, and early death, as reported previously by this news organization.

But SSaSS was conducted in China, and it was unclear whether these benefits would apply to people in other parts of the world.

To investigate, Dr. Tian and colleagues pooled data from 21 relevant parallel-group, step-wedge, or cluster randomized controlled trials published through August 2021, with 31,949 participants. The trials were conducted in Europe, the Western Pacific Region, the Americas, and South East Asia and reported the effect of a salt substitute on blood pressure or clinical outcomes.

A meta-analysis of blood pressure data from 19 trials that included 29,528 participants showed that salt substitutes lowered systolic blood pressure (SBP) by 4.61 mm Hg (95% confidence interval, −6.07 to −3.14) and diastolic blood pressure (DBP) by 1.61 mm Hg (95% CI, −2.42 to −0.79).

The proportion of sodium chloride in the salt substitutes varied from 33% to 75%; the proportion of potassium ranged from 25% to 65%.

Each 10% lower proportion of sodium chloride in the salt substitute was associated with a 1.53 mm Hg (95% CI, −3.02 to −0.03; P = .045) greater reduction in SBP and a 0.95 mm Hg (95% CI, −1.78 to −0.12; P = .025) greater reduction in DBP.

Reductions in blood pressure appeared consistent, irrespective of country, age, sex, history of high blood pressure, weight, baseline blood pressure, and baseline levels of urinary sodium and potassium.

Clear benefit on hard outcomes

Pooled data on clinical outcomes from five trials that included 24,306 participants, mostly from the SSaSS, showed clear protective effects of salt substitutes on total mortality (risk ratio, 0.89; 95% CI, 0.85-0.94), CV mortality (RR, 0.87; 95% CI, 0.81-0.94), and CV events (RR, 0.89; 95% CI, 0.85-0.94).

Dr. Tian and colleagues say that “broader population use of salt substitute is supported by the absence of any detectable adverse effect of salt substitutes on hyperkalemia in this review.”

They note, however, that all of the trials took “pragmatic steps to exclude participants at elevated risk of hyperkalemia, seeking to exclude those with chronic kidney disease or using medications that elevate serum potassium.”

Offering perspective on the study, Harlan Krumholz, MD, with Yale New Haven Hospital and Yale School of Medicine, both in New Haven, Conn., said it provides “useful information by bringing together the trial evidence on salt substitutes. The evidence is dominated by the SSaSS, but the others add context.”

Dr. Krumholz said that at this point, he thinks salt substitutes “could be included in recommendations to patients.”

“SSaSS was conducted in villages in China, so that is where the evidence is strongest and most relevant, but this is a low-cost and seemingly safe strategy that could be tried by anyone without contraindications, such as kidney disease or taking a potassium-sparing medication or potassium supplement,” Dr. Krumholz told this news organization.

Johanna Contreras, MD, heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, agrees that in the absence of contraindications, salt substitutes should be recommended.

“Americans put salt on everything and don’t even think about it. The salt substitutes are very helpful,” Dr. Contreras said in an interview.

“People who don’t have high blood pressure should limit salt intake, because what we have seen is that if you have high blood pressure in your family – even if you don’t have high blood pressure in your 20s or 30s – you’re likely to develop high blood pressure,” Dr. Contreras said.

“Therefore, it’s wise early on to start protecting yourself and using low salt and salt substitutes,” she added.

The study had no specific funding. Dr. Tian, Dr. Krumholz, and Dr. Contreras have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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