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Wellness tips: How to build on failure
Converge 2021 session
Fall Down Seven Get Up Eight: Making Your Setbacks Count: Strategic Risk Taking, Maintaining Resilience, and Finding Success
Presenters
Marisha Burden, MD, and Flora Kisuule, MD, MPH, SFHM
Session summary
The speakers at this Converge session, in the “Wellness and Resilience” track, covered four major topics: strategic risk-taking, wrestling with failure, embracing constraints, and embracing institutional chaos. First, they began by relating a personal story about failure and discussed how reframing failure could help you learn how to “fail forward.” They outlined how building upon failures can lead to many benefits, such as gaining personal strength, gaining perspective, and seeing new possibilities. They also introduced three roadblocks to failing forward: Personalization, Pervasiveness, and Permanence.
Next, the speakers lead the attendees through an exercise called The Nine Dot Problem, the purpose of which was to illustrate how thinking outside the box can help you find solutions that you cannot otherwise see. They also discussed how thinking inside the box could have its own advantages in that it teaches us to embrace our limitations, which can open up our creativity. They expounded upon this by showing a TED talk about finding liberation in constraints. The speakers wrapped up the session relating the tale of David and Goliath, and explained how David used his own unique advantages to gain power over a seemingly insurmountable problem.
Key takeaways
- Failing forward helps you continue to push ahead and grow, and perspective can help you fail forward.
- When failing, beware the Three Ps.
- Reframe constraints and be sure to think both inside and outside of the box – embrace limitations as a way to inspire new thinking.
- When facing something bigger than you, play to your own advantages in order to succeed.
Ms. Panek is hospital medicine division administrator at the Johns Hopkins Bayview Medical Center, Baltimore.
Converge 2021 session
Fall Down Seven Get Up Eight: Making Your Setbacks Count: Strategic Risk Taking, Maintaining Resilience, and Finding Success
Presenters
Marisha Burden, MD, and Flora Kisuule, MD, MPH, SFHM
Session summary
The speakers at this Converge session, in the “Wellness and Resilience” track, covered four major topics: strategic risk-taking, wrestling with failure, embracing constraints, and embracing institutional chaos. First, they began by relating a personal story about failure and discussed how reframing failure could help you learn how to “fail forward.” They outlined how building upon failures can lead to many benefits, such as gaining personal strength, gaining perspective, and seeing new possibilities. They also introduced three roadblocks to failing forward: Personalization, Pervasiveness, and Permanence.
Next, the speakers lead the attendees through an exercise called The Nine Dot Problem, the purpose of which was to illustrate how thinking outside the box can help you find solutions that you cannot otherwise see. They also discussed how thinking inside the box could have its own advantages in that it teaches us to embrace our limitations, which can open up our creativity. They expounded upon this by showing a TED talk about finding liberation in constraints. The speakers wrapped up the session relating the tale of David and Goliath, and explained how David used his own unique advantages to gain power over a seemingly insurmountable problem.
Key takeaways
- Failing forward helps you continue to push ahead and grow, and perspective can help you fail forward.
- When failing, beware the Three Ps.
- Reframe constraints and be sure to think both inside and outside of the box – embrace limitations as a way to inspire new thinking.
- When facing something bigger than you, play to your own advantages in order to succeed.
Ms. Panek is hospital medicine division administrator at the Johns Hopkins Bayview Medical Center, Baltimore.
Converge 2021 session
Fall Down Seven Get Up Eight: Making Your Setbacks Count: Strategic Risk Taking, Maintaining Resilience, and Finding Success
Presenters
Marisha Burden, MD, and Flora Kisuule, MD, MPH, SFHM
Session summary
The speakers at this Converge session, in the “Wellness and Resilience” track, covered four major topics: strategic risk-taking, wrestling with failure, embracing constraints, and embracing institutional chaos. First, they began by relating a personal story about failure and discussed how reframing failure could help you learn how to “fail forward.” They outlined how building upon failures can lead to many benefits, such as gaining personal strength, gaining perspective, and seeing new possibilities. They also introduced three roadblocks to failing forward: Personalization, Pervasiveness, and Permanence.
Next, the speakers lead the attendees through an exercise called The Nine Dot Problem, the purpose of which was to illustrate how thinking outside the box can help you find solutions that you cannot otherwise see. They also discussed how thinking inside the box could have its own advantages in that it teaches us to embrace our limitations, which can open up our creativity. They expounded upon this by showing a TED talk about finding liberation in constraints. The speakers wrapped up the session relating the tale of David and Goliath, and explained how David used his own unique advantages to gain power over a seemingly insurmountable problem.
Key takeaways
- Failing forward helps you continue to push ahead and grow, and perspective can help you fail forward.
- When failing, beware the Three Ps.
- Reframe constraints and be sure to think both inside and outside of the box – embrace limitations as a way to inspire new thinking.
- When facing something bigger than you, play to your own advantages in order to succeed.
Ms. Panek is hospital medicine division administrator at the Johns Hopkins Bayview Medical Center, Baltimore.
FROM SHM CONVERGE 2021
Look beyond liver biopsy for NAFLD diagnosis
Nonalcoholic fatty liver disease (NAFLD) was present in approximately two-thirds of patients who did not undergo a liver biopsy. These patients were more likely to be non-White and older, as well as have normal ALT levels, which shows potential gaps in knowledge about this population.
Data from studies of patients diagnosed with NAFLD that require biopsy among their inclusion criteria may be subject to selection and detection bias, wrote A. Sidney Barritt, MD, of the University of North Carolina at Chapel Hill, and colleagues. The researchers sought to compare characteristics of patients with NAFLD who were diagnosed using clinical criteria and those diagnosed via liver biopsy.
In a study published in Hepatology Communications, the researchers reviewed data from TARGET-NASH, a longitudinal, observational cohort study designed to follow patients with NAFLD in clinical practice to provide data on the effectiveness of treatments.
“TARGET-NASH represents a large cohort of NAFLD patients from multiple sites and can provide us with real world information on progression of disease in patients with NAFLD and particular risk factors that may be clinically relevant,” Zachary Henry, MD, MS, of the division of gastroenterology & hepatology at the University of Virginia Health System in Charlottesville, said in an interview. “This is one of the first studies from this database, and as time goes on, we will see more large-population data like this to answer specific questions for NAFLD patient.”
Surprising findings
The researchers included 3,474 patients aged 18 years and older who were enrolled in the TARGET-NASH study between Aug. 1, 2016, and March 4, 2019. The study participants were classified according to severity of liver disease: nonalcoholic fatty liver (30%), nonalcoholic steatohepatitis (37%), and NAFLD cirrhosis (33%).
A total of 766 patients were diagnosed with NASH based on clinical criteria without biopsy, and all met the criteria for abnormal ALT and steatosis based on imaging. In addition, these patients had at least one secondary diagnostic criteria: body mass index greater than 30 kg/m2 (74%), type 2 diabetes (42%), and dyslipidemia (54%). Significant independent predictors of liver biopsy included younger age, White race, female gender, diabetes, and elevated levels of ALT.
Elevated ALT increased the odds of liver biopsy by 14% per 10-point rise, according to the study. A machine learning model showed that non-White patients with ALT less than 69 IU/mL had a 6% chance of liver biopsy. By comparison, White patients had a 21% chance of biopsy with ALT between 29 IU/mL and 69 IU/mL that dropped to 10% if the ALT was less than 29 IU/mL.
However, ALT remains a “suboptimal surrogate” for disease severity, the researchers noted. “How a normal ALT is defined and how a normal ALT range may vary across different laboratories may play a role in its utility as a diagnostic tool as well.”
Dr. Henry was surprised by this finding: “With the advent of noninvasive measures of fibrosis, such as the NAFLD fibrosis score, Fibrosis-4, and transient elastography, I thought these would have a more significant role in that decision as opposed to ALT levels.”
Notably, mental health diagnoses accounted for nearly half (49%) of comorbid conditions, followed by cardiovascular disease (19%), and osteoarthritis (10%). The prevalence of these conditions emphasizes the challenges of managing patients with NAFLD with diet and exercise alone because mental and physical problems may impede progress, the researchers wrote.
The study findings were limited by several factors including the inability to determine health care provider intent, as well as undocumented factors related to patients and providers that might influence a biopsy decision, such as assessment of disease severity, the researchers noted. In addition, they noted that the mostly White study population treated in specialty settings might not generalize to other populations or primary care.
However, the findings are strengthened by the large study population and real-world setting, the researchers emphasized. “These data provide context for the selection bias that may be present in many registries and randomized, controlled trials of therapies for NAFLD, where biopsy is required for inclusion,” and show potential knowledge gaps about the patient population less likely to undergo biopsy.
Knowledge gaps and implications
The study is important because of the need to identify patient factors that predict histologic versus clinical diagnosis of NAFLD as the number of patient registries and clinical trials for NAFLD increase, Bubu Banini, MD, of Yale University, New Haven, Conn., said in an interview. “This information helps to elucidate selection and ascertainment bias and place findings from NAFLD registries and clinical trials into context.”
Dr. Banini said that some of the findings were to be expected, while others were not.
“Historically, males and non-Whites are less likely to participate in registries and clinical trials, compared to females and Whites. However, I was surprised to find that these discrepancies further paralleled the likelihood of undergoing liver biopsy even among those who chose to participate. In addition, while mental health disorders (such as anxiety and depression) are a fairly prevalent comorbidity in patients with NAFLD, I was surprised to find that NAFLD patients with mental health disorders were more likely to undergo liver biopsy compared to those without these disorders. I would have expected the reverse,” he noted.
“These findings highlight the gaps in knowledge regarding the impact of demographic and psychosocial factors on choice and assess to care among patients with NAFLD, and the need for further studies to address these gaps,” she emphasized.
“A number of [studies] such as TARGET-NASH are doing away with the requirement for liver biopsy for participation; hence, it is less likely that selection bias related to liver biopsy would be a problem in these [studies] if clinical diagnosis is considered as a surrogate for histological diagnosis,” Dr. Banini added.
“On the contrary, many NAFLD clinical trials require liver biopsy for inclusion.” As nicely demonstrated in the current study, “this inclusion criterion may introduce selection bias,” she said. “Awareness of potential biases would hopefully inform the design and recruitment strategy for registries and clinical trials in order to overcome these issues.”
“I think the results of this study may actually point to a larger issue within medicine in general, which is a difference in care provided to minority communities,” Dr. Henry said. “Whether this is intentional, related to unconscious bias on the part of providers, or related to a significant mistrust between minority communities and their health care providers is unclear but certainly needs to be addressed.”
He noted that the purpose of TARGET-NASH is to enroll all patients with NAFLD regardless of biopsy. “Over time, as we have more data on these patients, we will have a better understanding of both diagnostic and therapeutic decisions in patients with NAFLD.”
The study was supported by Target RWE, sponsor of the TARGET-NASH study. TARGET-NASH is a collaboration of academic and community investigators and the pharmaceutical industry. Lead author Dr. Barritt had no financial conflicts to disclose, but many study coauthors disclosed relationships with multiple pharmaceutical companies, including those involved in the TARGET-NASH study. Dr. Banini currently serves on the NASH advisory board for Boehringer Ingelheim. Dr. Henry reported no disclosures, although his institution is one of the enrollment sites for TARGET-NASH.
Nonalcoholic fatty liver disease (NAFLD) was present in approximately two-thirds of patients who did not undergo a liver biopsy. These patients were more likely to be non-White and older, as well as have normal ALT levels, which shows potential gaps in knowledge about this population.
Data from studies of patients diagnosed with NAFLD that require biopsy among their inclusion criteria may be subject to selection and detection bias, wrote A. Sidney Barritt, MD, of the University of North Carolina at Chapel Hill, and colleagues. The researchers sought to compare characteristics of patients with NAFLD who were diagnosed using clinical criteria and those diagnosed via liver biopsy.
In a study published in Hepatology Communications, the researchers reviewed data from TARGET-NASH, a longitudinal, observational cohort study designed to follow patients with NAFLD in clinical practice to provide data on the effectiveness of treatments.
“TARGET-NASH represents a large cohort of NAFLD patients from multiple sites and can provide us with real world information on progression of disease in patients with NAFLD and particular risk factors that may be clinically relevant,” Zachary Henry, MD, MS, of the division of gastroenterology & hepatology at the University of Virginia Health System in Charlottesville, said in an interview. “This is one of the first studies from this database, and as time goes on, we will see more large-population data like this to answer specific questions for NAFLD patient.”
Surprising findings
The researchers included 3,474 patients aged 18 years and older who were enrolled in the TARGET-NASH study between Aug. 1, 2016, and March 4, 2019. The study participants were classified according to severity of liver disease: nonalcoholic fatty liver (30%), nonalcoholic steatohepatitis (37%), and NAFLD cirrhosis (33%).
A total of 766 patients were diagnosed with NASH based on clinical criteria without biopsy, and all met the criteria for abnormal ALT and steatosis based on imaging. In addition, these patients had at least one secondary diagnostic criteria: body mass index greater than 30 kg/m2 (74%), type 2 diabetes (42%), and dyslipidemia (54%). Significant independent predictors of liver biopsy included younger age, White race, female gender, diabetes, and elevated levels of ALT.
Elevated ALT increased the odds of liver biopsy by 14% per 10-point rise, according to the study. A machine learning model showed that non-White patients with ALT less than 69 IU/mL had a 6% chance of liver biopsy. By comparison, White patients had a 21% chance of biopsy with ALT between 29 IU/mL and 69 IU/mL that dropped to 10% if the ALT was less than 29 IU/mL.
However, ALT remains a “suboptimal surrogate” for disease severity, the researchers noted. “How a normal ALT is defined and how a normal ALT range may vary across different laboratories may play a role in its utility as a diagnostic tool as well.”
Dr. Henry was surprised by this finding: “With the advent of noninvasive measures of fibrosis, such as the NAFLD fibrosis score, Fibrosis-4, and transient elastography, I thought these would have a more significant role in that decision as opposed to ALT levels.”
Notably, mental health diagnoses accounted for nearly half (49%) of comorbid conditions, followed by cardiovascular disease (19%), and osteoarthritis (10%). The prevalence of these conditions emphasizes the challenges of managing patients with NAFLD with diet and exercise alone because mental and physical problems may impede progress, the researchers wrote.
The study findings were limited by several factors including the inability to determine health care provider intent, as well as undocumented factors related to patients and providers that might influence a biopsy decision, such as assessment of disease severity, the researchers noted. In addition, they noted that the mostly White study population treated in specialty settings might not generalize to other populations or primary care.
However, the findings are strengthened by the large study population and real-world setting, the researchers emphasized. “These data provide context for the selection bias that may be present in many registries and randomized, controlled trials of therapies for NAFLD, where biopsy is required for inclusion,” and show potential knowledge gaps about the patient population less likely to undergo biopsy.
Knowledge gaps and implications
The study is important because of the need to identify patient factors that predict histologic versus clinical diagnosis of NAFLD as the number of patient registries and clinical trials for NAFLD increase, Bubu Banini, MD, of Yale University, New Haven, Conn., said in an interview. “This information helps to elucidate selection and ascertainment bias and place findings from NAFLD registries and clinical trials into context.”
Dr. Banini said that some of the findings were to be expected, while others were not.
“Historically, males and non-Whites are less likely to participate in registries and clinical trials, compared to females and Whites. However, I was surprised to find that these discrepancies further paralleled the likelihood of undergoing liver biopsy even among those who chose to participate. In addition, while mental health disorders (such as anxiety and depression) are a fairly prevalent comorbidity in patients with NAFLD, I was surprised to find that NAFLD patients with mental health disorders were more likely to undergo liver biopsy compared to those without these disorders. I would have expected the reverse,” he noted.
“These findings highlight the gaps in knowledge regarding the impact of demographic and psychosocial factors on choice and assess to care among patients with NAFLD, and the need for further studies to address these gaps,” she emphasized.
“A number of [studies] such as TARGET-NASH are doing away with the requirement for liver biopsy for participation; hence, it is less likely that selection bias related to liver biopsy would be a problem in these [studies] if clinical diagnosis is considered as a surrogate for histological diagnosis,” Dr. Banini added.
“On the contrary, many NAFLD clinical trials require liver biopsy for inclusion.” As nicely demonstrated in the current study, “this inclusion criterion may introduce selection bias,” she said. “Awareness of potential biases would hopefully inform the design and recruitment strategy for registries and clinical trials in order to overcome these issues.”
“I think the results of this study may actually point to a larger issue within medicine in general, which is a difference in care provided to minority communities,” Dr. Henry said. “Whether this is intentional, related to unconscious bias on the part of providers, or related to a significant mistrust between minority communities and their health care providers is unclear but certainly needs to be addressed.”
He noted that the purpose of TARGET-NASH is to enroll all patients with NAFLD regardless of biopsy. “Over time, as we have more data on these patients, we will have a better understanding of both diagnostic and therapeutic decisions in patients with NAFLD.”
The study was supported by Target RWE, sponsor of the TARGET-NASH study. TARGET-NASH is a collaboration of academic and community investigators and the pharmaceutical industry. Lead author Dr. Barritt had no financial conflicts to disclose, but many study coauthors disclosed relationships with multiple pharmaceutical companies, including those involved in the TARGET-NASH study. Dr. Banini currently serves on the NASH advisory board for Boehringer Ingelheim. Dr. Henry reported no disclosures, although his institution is one of the enrollment sites for TARGET-NASH.
Nonalcoholic fatty liver disease (NAFLD) was present in approximately two-thirds of patients who did not undergo a liver biopsy. These patients were more likely to be non-White and older, as well as have normal ALT levels, which shows potential gaps in knowledge about this population.
Data from studies of patients diagnosed with NAFLD that require biopsy among their inclusion criteria may be subject to selection and detection bias, wrote A. Sidney Barritt, MD, of the University of North Carolina at Chapel Hill, and colleagues. The researchers sought to compare characteristics of patients with NAFLD who were diagnosed using clinical criteria and those diagnosed via liver biopsy.
In a study published in Hepatology Communications, the researchers reviewed data from TARGET-NASH, a longitudinal, observational cohort study designed to follow patients with NAFLD in clinical practice to provide data on the effectiveness of treatments.
“TARGET-NASH represents a large cohort of NAFLD patients from multiple sites and can provide us with real world information on progression of disease in patients with NAFLD and particular risk factors that may be clinically relevant,” Zachary Henry, MD, MS, of the division of gastroenterology & hepatology at the University of Virginia Health System in Charlottesville, said in an interview. “This is one of the first studies from this database, and as time goes on, we will see more large-population data like this to answer specific questions for NAFLD patient.”
Surprising findings
The researchers included 3,474 patients aged 18 years and older who were enrolled in the TARGET-NASH study between Aug. 1, 2016, and March 4, 2019. The study participants were classified according to severity of liver disease: nonalcoholic fatty liver (30%), nonalcoholic steatohepatitis (37%), and NAFLD cirrhosis (33%).
A total of 766 patients were diagnosed with NASH based on clinical criteria without biopsy, and all met the criteria for abnormal ALT and steatosis based on imaging. In addition, these patients had at least one secondary diagnostic criteria: body mass index greater than 30 kg/m2 (74%), type 2 diabetes (42%), and dyslipidemia (54%). Significant independent predictors of liver biopsy included younger age, White race, female gender, diabetes, and elevated levels of ALT.
Elevated ALT increased the odds of liver biopsy by 14% per 10-point rise, according to the study. A machine learning model showed that non-White patients with ALT less than 69 IU/mL had a 6% chance of liver biopsy. By comparison, White patients had a 21% chance of biopsy with ALT between 29 IU/mL and 69 IU/mL that dropped to 10% if the ALT was less than 29 IU/mL.
However, ALT remains a “suboptimal surrogate” for disease severity, the researchers noted. “How a normal ALT is defined and how a normal ALT range may vary across different laboratories may play a role in its utility as a diagnostic tool as well.”
Dr. Henry was surprised by this finding: “With the advent of noninvasive measures of fibrosis, such as the NAFLD fibrosis score, Fibrosis-4, and transient elastography, I thought these would have a more significant role in that decision as opposed to ALT levels.”
Notably, mental health diagnoses accounted for nearly half (49%) of comorbid conditions, followed by cardiovascular disease (19%), and osteoarthritis (10%). The prevalence of these conditions emphasizes the challenges of managing patients with NAFLD with diet and exercise alone because mental and physical problems may impede progress, the researchers wrote.
The study findings were limited by several factors including the inability to determine health care provider intent, as well as undocumented factors related to patients and providers that might influence a biopsy decision, such as assessment of disease severity, the researchers noted. In addition, they noted that the mostly White study population treated in specialty settings might not generalize to other populations or primary care.
However, the findings are strengthened by the large study population and real-world setting, the researchers emphasized. “These data provide context for the selection bias that may be present in many registries and randomized, controlled trials of therapies for NAFLD, where biopsy is required for inclusion,” and show potential knowledge gaps about the patient population less likely to undergo biopsy.
Knowledge gaps and implications
The study is important because of the need to identify patient factors that predict histologic versus clinical diagnosis of NAFLD as the number of patient registries and clinical trials for NAFLD increase, Bubu Banini, MD, of Yale University, New Haven, Conn., said in an interview. “This information helps to elucidate selection and ascertainment bias and place findings from NAFLD registries and clinical trials into context.”
Dr. Banini said that some of the findings were to be expected, while others were not.
“Historically, males and non-Whites are less likely to participate in registries and clinical trials, compared to females and Whites. However, I was surprised to find that these discrepancies further paralleled the likelihood of undergoing liver biopsy even among those who chose to participate. In addition, while mental health disorders (such as anxiety and depression) are a fairly prevalent comorbidity in patients with NAFLD, I was surprised to find that NAFLD patients with mental health disorders were more likely to undergo liver biopsy compared to those without these disorders. I would have expected the reverse,” he noted.
“These findings highlight the gaps in knowledge regarding the impact of demographic and psychosocial factors on choice and assess to care among patients with NAFLD, and the need for further studies to address these gaps,” she emphasized.
“A number of [studies] such as TARGET-NASH are doing away with the requirement for liver biopsy for participation; hence, it is less likely that selection bias related to liver biopsy would be a problem in these [studies] if clinical diagnosis is considered as a surrogate for histological diagnosis,” Dr. Banini added.
“On the contrary, many NAFLD clinical trials require liver biopsy for inclusion.” As nicely demonstrated in the current study, “this inclusion criterion may introduce selection bias,” she said. “Awareness of potential biases would hopefully inform the design and recruitment strategy for registries and clinical trials in order to overcome these issues.”
“I think the results of this study may actually point to a larger issue within medicine in general, which is a difference in care provided to minority communities,” Dr. Henry said. “Whether this is intentional, related to unconscious bias on the part of providers, or related to a significant mistrust between minority communities and their health care providers is unclear but certainly needs to be addressed.”
He noted that the purpose of TARGET-NASH is to enroll all patients with NAFLD regardless of biopsy. “Over time, as we have more data on these patients, we will have a better understanding of both diagnostic and therapeutic decisions in patients with NAFLD.”
The study was supported by Target RWE, sponsor of the TARGET-NASH study. TARGET-NASH is a collaboration of academic and community investigators and the pharmaceutical industry. Lead author Dr. Barritt had no financial conflicts to disclose, but many study coauthors disclosed relationships with multiple pharmaceutical companies, including those involved in the TARGET-NASH study. Dr. Banini currently serves on the NASH advisory board for Boehringer Ingelheim. Dr. Henry reported no disclosures, although his institution is one of the enrollment sites for TARGET-NASH.
FROM HEPATOLOGY COMMUNICATIONS
Endoscopic device could expand treatment for GERD, reduce PPI use
In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) – performed with the novel GERD-X device – improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like it is a quick, easy-to-use procedure,” Gyanprakash A. Ketwaroo, MD, MSc, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Dr. Ketwaroo was not involved in the study.
“Even though the objective measures were not as good as perhaps you had hoped, the subjective outcomes were good. [And] it seems that it may have more of a long-term benefit, compared to some of the other endoscopic procedures. But that wasn’t a [primary] outcome of the study, and we still need more long-term studies to figure that out,” he added.
The research, led by Rakesh Kalapala, MD, DNB, and D. Nageshwar Reddy, MD, FACG, of the Asian Institute of Gastroenterology, Hyderabad, India, appeared in Gut.
The fact that the EFTP procedure is relatively simple could reduce cost and ease the learning curve, which in turn could broaden accessibility if more gastroenterologists are trained on it.
“There are not many gastroenterologists who offer endoscopic approaches to GERD therapy, so increasing that cohort [could] potentially have a huge impact given the number of patients who have GERD in this country, and especially given the rising and persistent concern over long-term use of PPIs,” said Dr. Ketwaroo.
Addressing the drawbacks of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there are concerns that long-term use could increase the risk of acute and chronic kidney disease, hypomagnesaemia, Clostridioides difficile infection, and osteoporotic fractures. Surgical antireflux interventions are effective but may lead to dysphagia, bloating, and diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. While the preponderance of published evidence supports the Esophyx device (EndoGastric Solutions), which has a 70% efficacy rate and few adverse events in one analysis, it requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in patients with PPI dependence who refuse surgery; however, the majority of the endoscopic devices are cumbersome to use and robust data on their long-term efficacy are lacking,” Dr. Kalapala and colleagues noted in their new paper.
In 2014, the German company G-Surg introduced a novel endoscopic plication device called GERD-X. A prospective, single-arm study had shown efficacy in both patients taking PPIs and those with refractory GERD.
A closer look at the device
To bolster that evidence, Dr. Kalapala and colleagues conducted this new single-center, randomized, sham-controlled trial with 70 enrollees with PPI-dependent GERD, of which 70% had nonerosive reflux disease (mean DeMeester score, 18.9). The median participant age was 36 years, and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved at least a 50% improvement in GERD health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the sham group (P < .001). The median percentage improvement in GERD-HRQL score was higher in the treatment group at 6 months (81.4% vs. 8.0%; P < .001) and at 12 months (92.3% vs. 9.1%; P < .001). Similar improvements were seen at 6 months and 12 months in heartburn symptom score (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; P < .001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; P < .001 for both). At 12 months, 62.8% of the treatment group no longer took PPIs, compared with 11.4% of the sham group (P < .001).
Objective measures of improvement were more modest. The treatment arm trended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The median percentage of time with esophageal pH below 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also noted trends toward fewer reflux events in 24 hours in the treatment group at 6 months (P = .072) and 12 months (P = .051).
The treatment group had fewer non–acid reflux episodes at 12 months versus baseline (P = .038), but there was no difference in the median number of acid reflux episodes in 24 hours.
“Our study found endoscopic full-thickness fundoplication, using a novel device, was safe and significantly improved GERD-related quality of life and severity of reflux symptoms at short and long terms, compared with a sham procedure,” wrote the authors.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” they concluded.
The authors of the study disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
This article was updated May 6, 2021.
In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) – performed with the novel GERD-X device – improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like it is a quick, easy-to-use procedure,” Gyanprakash A. Ketwaroo, MD, MSc, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Dr. Ketwaroo was not involved in the study.
“Even though the objective measures were not as good as perhaps you had hoped, the subjective outcomes were good. [And] it seems that it may have more of a long-term benefit, compared to some of the other endoscopic procedures. But that wasn’t a [primary] outcome of the study, and we still need more long-term studies to figure that out,” he added.
The research, led by Rakesh Kalapala, MD, DNB, and D. Nageshwar Reddy, MD, FACG, of the Asian Institute of Gastroenterology, Hyderabad, India, appeared in Gut.
The fact that the EFTP procedure is relatively simple could reduce cost and ease the learning curve, which in turn could broaden accessibility if more gastroenterologists are trained on it.
“There are not many gastroenterologists who offer endoscopic approaches to GERD therapy, so increasing that cohort [could] potentially have a huge impact given the number of patients who have GERD in this country, and especially given the rising and persistent concern over long-term use of PPIs,” said Dr. Ketwaroo.
Addressing the drawbacks of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there are concerns that long-term use could increase the risk of acute and chronic kidney disease, hypomagnesaemia, Clostridioides difficile infection, and osteoporotic fractures. Surgical antireflux interventions are effective but may lead to dysphagia, bloating, and diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. While the preponderance of published evidence supports the Esophyx device (EndoGastric Solutions), which has a 70% efficacy rate and few adverse events in one analysis, it requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in patients with PPI dependence who refuse surgery; however, the majority of the endoscopic devices are cumbersome to use and robust data on their long-term efficacy are lacking,” Dr. Kalapala and colleagues noted in their new paper.
In 2014, the German company G-Surg introduced a novel endoscopic plication device called GERD-X. A prospective, single-arm study had shown efficacy in both patients taking PPIs and those with refractory GERD.
A closer look at the device
To bolster that evidence, Dr. Kalapala and colleagues conducted this new single-center, randomized, sham-controlled trial with 70 enrollees with PPI-dependent GERD, of which 70% had nonerosive reflux disease (mean DeMeester score, 18.9). The median participant age was 36 years, and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved at least a 50% improvement in GERD health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the sham group (P < .001). The median percentage improvement in GERD-HRQL score was higher in the treatment group at 6 months (81.4% vs. 8.0%; P < .001) and at 12 months (92.3% vs. 9.1%; P < .001). Similar improvements were seen at 6 months and 12 months in heartburn symptom score (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; P < .001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; P < .001 for both). At 12 months, 62.8% of the treatment group no longer took PPIs, compared with 11.4% of the sham group (P < .001).
Objective measures of improvement were more modest. The treatment arm trended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The median percentage of time with esophageal pH below 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also noted trends toward fewer reflux events in 24 hours in the treatment group at 6 months (P = .072) and 12 months (P = .051).
The treatment group had fewer non–acid reflux episodes at 12 months versus baseline (P = .038), but there was no difference in the median number of acid reflux episodes in 24 hours.
“Our study found endoscopic full-thickness fundoplication, using a novel device, was safe and significantly improved GERD-related quality of life and severity of reflux symptoms at short and long terms, compared with a sham procedure,” wrote the authors.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” they concluded.
The authors of the study disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
This article was updated May 6, 2021.
In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) – performed with the novel GERD-X device – improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like it is a quick, easy-to-use procedure,” Gyanprakash A. Ketwaroo, MD, MSc, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Dr. Ketwaroo was not involved in the study.
“Even though the objective measures were not as good as perhaps you had hoped, the subjective outcomes were good. [And] it seems that it may have more of a long-term benefit, compared to some of the other endoscopic procedures. But that wasn’t a [primary] outcome of the study, and we still need more long-term studies to figure that out,” he added.
The research, led by Rakesh Kalapala, MD, DNB, and D. Nageshwar Reddy, MD, FACG, of the Asian Institute of Gastroenterology, Hyderabad, India, appeared in Gut.
The fact that the EFTP procedure is relatively simple could reduce cost and ease the learning curve, which in turn could broaden accessibility if more gastroenterologists are trained on it.
“There are not many gastroenterologists who offer endoscopic approaches to GERD therapy, so increasing that cohort [could] potentially have a huge impact given the number of patients who have GERD in this country, and especially given the rising and persistent concern over long-term use of PPIs,” said Dr. Ketwaroo.
Addressing the drawbacks of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there are concerns that long-term use could increase the risk of acute and chronic kidney disease, hypomagnesaemia, Clostridioides difficile infection, and osteoporotic fractures. Surgical antireflux interventions are effective but may lead to dysphagia, bloating, and diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. While the preponderance of published evidence supports the Esophyx device (EndoGastric Solutions), which has a 70% efficacy rate and few adverse events in one analysis, it requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in patients with PPI dependence who refuse surgery; however, the majority of the endoscopic devices are cumbersome to use and robust data on their long-term efficacy are lacking,” Dr. Kalapala and colleagues noted in their new paper.
In 2014, the German company G-Surg introduced a novel endoscopic plication device called GERD-X. A prospective, single-arm study had shown efficacy in both patients taking PPIs and those with refractory GERD.
A closer look at the device
To bolster that evidence, Dr. Kalapala and colleagues conducted this new single-center, randomized, sham-controlled trial with 70 enrollees with PPI-dependent GERD, of which 70% had nonerosive reflux disease (mean DeMeester score, 18.9). The median participant age was 36 years, and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved at least a 50% improvement in GERD health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the sham group (P < .001). The median percentage improvement in GERD-HRQL score was higher in the treatment group at 6 months (81.4% vs. 8.0%; P < .001) and at 12 months (92.3% vs. 9.1%; P < .001). Similar improvements were seen at 6 months and 12 months in heartburn symptom score (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; P < .001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; P < .001 for both). At 12 months, 62.8% of the treatment group no longer took PPIs, compared with 11.4% of the sham group (P < .001).
Objective measures of improvement were more modest. The treatment arm trended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The median percentage of time with esophageal pH below 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also noted trends toward fewer reflux events in 24 hours in the treatment group at 6 months (P = .072) and 12 months (P = .051).
The treatment group had fewer non–acid reflux episodes at 12 months versus baseline (P = .038), but there was no difference in the median number of acid reflux episodes in 24 hours.
“Our study found endoscopic full-thickness fundoplication, using a novel device, was safe and significantly improved GERD-related quality of life and severity of reflux symptoms at short and long terms, compared with a sham procedure,” wrote the authors.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” they concluded.
The authors of the study disclosed no external funding. Dr. Ketwaroo has no relevant financial disclosures, although he is on the editorial advisory board for GI & Hepatology News.
This article was updated May 6, 2021.
FROM GUT
Survey offers a snapshot of nationwide COVID-19 discharge practices
Discharge practices for COVID-19 patients vary widely at the nation’s academic medical centers, but there are some areas of strong concordance, especially related to procedures for isolation and mitigating transmission of COVID-19.
In addition, most sites use some form of clinical criteria to determine discharge readiness, S. Ryan Greysen, MD, MHS, SFHM, said on May 5 at SHM Converge, the annual conference of the Society of Hospital Medicine.
Those rank among the key findings from of a survey of 22 academic medical centers conducted by the Hospital Medicine Re-engineering Network (HOMERuN), which was launched in 2011 as a way to advance hospital medicine through rigorous research to improve the care of hospitalized patients.
“When COVID came and changed all of our lives, HOMERuN was well positioned to examine the state of practices in member hospitals, and we set out some key principles,” Dr. Greysen said. “First, we wanted to respect the challenges and needs of sites during this extraordinary time. We wanted to support speed and flexibility from our study design to get results to the front lines as quickly as possible. Therefore, we used lightweight research methods such as cross-sectional surveys, periodic evaluations, and we use the data to support operational needs. We have developed linkages to more granular datasets such as electronic health records, but our focus to date has been mostly on the frontline experience of hospitalists and gathering consensus around clinical practice, especially in the early stages of the pandemic.”
In March and April of 2020, Dr. Greysen and colleagues collected and analyzed any discharge protocols, policies, or other documents from 22 academic medical centers. From this they created a follow-up survey containing 21 different domains that was administered to the same institutions in May and June of 2020. “It’s not meant to be a completely comprehensive list, but these 21 domains were the themes we saw coming out of these discharge practice documents,” explained Dr. Greysen, chief of hospital medicine at the University of Pennsylvania, Philadelphia, which is one of the participating sites.
Next, the researchers used a concordance table to help them keep track of which institution responded in which way for which domain, and they bundled the discharge criteria into five higher order domains: procedures for isolation and mitigating transmission; clinical criteria for discharge; nonclinical/nonisolation issues; discharge to settings other than home, and postdischarge instructions, monitoring, and follow-up.
In the procedures for isolation and mitigating transmission domain, Dr. Greysen reported that the use of isolation guidelines was the area of greatest consensus in the study, with 19 of 22 sites (86%) citing the Centers for Disease Control and Prevention and 7 (32%) also citing state department of health guidance. “Specifically, most sites included the ability to socially isolate at home (until no longer necessary per CDC guidance) as part of the criteria,” he said. Most sites (73%) required use of personal protective equipment (PPE) in transportation from the hospital and 73% gave masks and other PPE for use at home.
Session copresenter Maralyssa A. Bann, MD, a hospitalist at the University of Washington/Harborview Medical Center, Seattle, another participating site, pointed out that the institutions surveyed look to the CDC as being “the single source of truth on discharge practices,” specifically material for health care workers related to discharging COVID-19 patients. “Notable specific recent updates include the recommendation that meeting criteria for discontinuation of Transmission-Based Precautions is not a prerequisite for discharge from a health care facility,” Dr. Bann said. “Also, as of August 2020, use of symptom-based strategy for discontinuation of isolation precautions instead of repeat testing is recommended for most patients. This is a rapidly evolving area.”
Practices in the clinical criteria for discharge domain varied by site. Slightly more than one-quarter of sites (27%) gave little or no guidance by using terms like “use clinical judgment,” while 14% gave very specific detailed algorithms. “Most sites fell in between and gave some parameters, usually along the lines of symptom improvement, temperature, and oxygen requirement, but the criteria were variable,” Dr. Greysen said. “For example, in terms of temperature, many sites said that patients should be afebrile for a specific length of time, 24-72 hours, while other sites simply said afebrile at discharge.” Meanwhile, the following criteria for discharge were addressed by relatively few sites: lab criteria (36%), age (36%), high-risk comorbidities (32%), or ID consultation (18%).
In the nonclinical/nonisolation domain, 73% of sites assessed for level of support available, though this was variably defined. Slightly more than half (55%) specifically assessed activities of daily living or the presence of a caregiver to assist, while 18% reported addressing durable medical equipment such as beds and toilets and access to food or medication supplies in ways that were specific for COVID-19 patients.
In the discharge to settings other than home domain, 77% of sites addressed discharge to skilled nursing facilities, inpatient rehabilitation, or long-term care, although specific requirements were often set by the accepting facilities. In addition, 65% of sites gave specific guidance for patients experiencing unstable housing/homelessness, usually recommending a respite facility or similar, and 59% addressed congregate/shared living spaces such as assisted living facilities. “Often the strictest criteria [two negative COVID tests] were applied to discharge to these types of settings,” he said.
In the postdischarge instructions, monitoring, and follow-up domain, 73% of sites reported providing home monitoring and/or virtual follow-up care. Programs ranged from daily texting via SMS or patient portals, RN phone calls, home pulse oximeters, and/or thermometers. In addition, 55% of sites had created COVID-specific brochures, discharge instructions, and other materials to standardize content such as use of PPE, travel restrictions, social distancing, signs and symptoms to watch out for, and what to do if worsening clinically.
Dr. Bann predicted future trends on the heels of the HOMERuN survey, including the development of more evidence and consensus related to discharge criteria. “Clarity is needed specifically around hypoxemia at rest/on ambulation, as well as more flexible criteria for oxygen supplementation,” she said. “We also think there will be a considerable amount of growth in posthospitalization monitoring and support, in particular home-based and virtual/remote monitoring.”
HOMERuN is supported by the Gordon and Betty Moore Foundation, the AAMC, the Patient-Centered Outcomes Research Institute, the Clinical Data Research Networks, the Patient-Powered Research Networks, and Agency for Healthcare Research and Quality. Dr. Greysen and Dr. Bann reported having no financial disclosures.
Discharge practices for COVID-19 patients vary widely at the nation’s academic medical centers, but there are some areas of strong concordance, especially related to procedures for isolation and mitigating transmission of COVID-19.
In addition, most sites use some form of clinical criteria to determine discharge readiness, S. Ryan Greysen, MD, MHS, SFHM, said on May 5 at SHM Converge, the annual conference of the Society of Hospital Medicine.
Those rank among the key findings from of a survey of 22 academic medical centers conducted by the Hospital Medicine Re-engineering Network (HOMERuN), which was launched in 2011 as a way to advance hospital medicine through rigorous research to improve the care of hospitalized patients.
“When COVID came and changed all of our lives, HOMERuN was well positioned to examine the state of practices in member hospitals, and we set out some key principles,” Dr. Greysen said. “First, we wanted to respect the challenges and needs of sites during this extraordinary time. We wanted to support speed and flexibility from our study design to get results to the front lines as quickly as possible. Therefore, we used lightweight research methods such as cross-sectional surveys, periodic evaluations, and we use the data to support operational needs. We have developed linkages to more granular datasets such as electronic health records, but our focus to date has been mostly on the frontline experience of hospitalists and gathering consensus around clinical practice, especially in the early stages of the pandemic.”
In March and April of 2020, Dr. Greysen and colleagues collected and analyzed any discharge protocols, policies, or other documents from 22 academic medical centers. From this they created a follow-up survey containing 21 different domains that was administered to the same institutions in May and June of 2020. “It’s not meant to be a completely comprehensive list, but these 21 domains were the themes we saw coming out of these discharge practice documents,” explained Dr. Greysen, chief of hospital medicine at the University of Pennsylvania, Philadelphia, which is one of the participating sites.
Next, the researchers used a concordance table to help them keep track of which institution responded in which way for which domain, and they bundled the discharge criteria into five higher order domains: procedures for isolation and mitigating transmission; clinical criteria for discharge; nonclinical/nonisolation issues; discharge to settings other than home, and postdischarge instructions, monitoring, and follow-up.
In the procedures for isolation and mitigating transmission domain, Dr. Greysen reported that the use of isolation guidelines was the area of greatest consensus in the study, with 19 of 22 sites (86%) citing the Centers for Disease Control and Prevention and 7 (32%) also citing state department of health guidance. “Specifically, most sites included the ability to socially isolate at home (until no longer necessary per CDC guidance) as part of the criteria,” he said. Most sites (73%) required use of personal protective equipment (PPE) in transportation from the hospital and 73% gave masks and other PPE for use at home.
Session copresenter Maralyssa A. Bann, MD, a hospitalist at the University of Washington/Harborview Medical Center, Seattle, another participating site, pointed out that the institutions surveyed look to the CDC as being “the single source of truth on discharge practices,” specifically material for health care workers related to discharging COVID-19 patients. “Notable specific recent updates include the recommendation that meeting criteria for discontinuation of Transmission-Based Precautions is not a prerequisite for discharge from a health care facility,” Dr. Bann said. “Also, as of August 2020, use of symptom-based strategy for discontinuation of isolation precautions instead of repeat testing is recommended for most patients. This is a rapidly evolving area.”
Practices in the clinical criteria for discharge domain varied by site. Slightly more than one-quarter of sites (27%) gave little or no guidance by using terms like “use clinical judgment,” while 14% gave very specific detailed algorithms. “Most sites fell in between and gave some parameters, usually along the lines of symptom improvement, temperature, and oxygen requirement, but the criteria were variable,” Dr. Greysen said. “For example, in terms of temperature, many sites said that patients should be afebrile for a specific length of time, 24-72 hours, while other sites simply said afebrile at discharge.” Meanwhile, the following criteria for discharge were addressed by relatively few sites: lab criteria (36%), age (36%), high-risk comorbidities (32%), or ID consultation (18%).
In the nonclinical/nonisolation domain, 73% of sites assessed for level of support available, though this was variably defined. Slightly more than half (55%) specifically assessed activities of daily living or the presence of a caregiver to assist, while 18% reported addressing durable medical equipment such as beds and toilets and access to food or medication supplies in ways that were specific for COVID-19 patients.
In the discharge to settings other than home domain, 77% of sites addressed discharge to skilled nursing facilities, inpatient rehabilitation, or long-term care, although specific requirements were often set by the accepting facilities. In addition, 65% of sites gave specific guidance for patients experiencing unstable housing/homelessness, usually recommending a respite facility or similar, and 59% addressed congregate/shared living spaces such as assisted living facilities. “Often the strictest criteria [two negative COVID tests] were applied to discharge to these types of settings,” he said.
In the postdischarge instructions, monitoring, and follow-up domain, 73% of sites reported providing home monitoring and/or virtual follow-up care. Programs ranged from daily texting via SMS or patient portals, RN phone calls, home pulse oximeters, and/or thermometers. In addition, 55% of sites had created COVID-specific brochures, discharge instructions, and other materials to standardize content such as use of PPE, travel restrictions, social distancing, signs and symptoms to watch out for, and what to do if worsening clinically.
Dr. Bann predicted future trends on the heels of the HOMERuN survey, including the development of more evidence and consensus related to discharge criteria. “Clarity is needed specifically around hypoxemia at rest/on ambulation, as well as more flexible criteria for oxygen supplementation,” she said. “We also think there will be a considerable amount of growth in posthospitalization monitoring and support, in particular home-based and virtual/remote monitoring.”
HOMERuN is supported by the Gordon and Betty Moore Foundation, the AAMC, the Patient-Centered Outcomes Research Institute, the Clinical Data Research Networks, the Patient-Powered Research Networks, and Agency for Healthcare Research and Quality. Dr. Greysen and Dr. Bann reported having no financial disclosures.
Discharge practices for COVID-19 patients vary widely at the nation’s academic medical centers, but there are some areas of strong concordance, especially related to procedures for isolation and mitigating transmission of COVID-19.
In addition, most sites use some form of clinical criteria to determine discharge readiness, S. Ryan Greysen, MD, MHS, SFHM, said on May 5 at SHM Converge, the annual conference of the Society of Hospital Medicine.
Those rank among the key findings from of a survey of 22 academic medical centers conducted by the Hospital Medicine Re-engineering Network (HOMERuN), which was launched in 2011 as a way to advance hospital medicine through rigorous research to improve the care of hospitalized patients.
“When COVID came and changed all of our lives, HOMERuN was well positioned to examine the state of practices in member hospitals, and we set out some key principles,” Dr. Greysen said. “First, we wanted to respect the challenges and needs of sites during this extraordinary time. We wanted to support speed and flexibility from our study design to get results to the front lines as quickly as possible. Therefore, we used lightweight research methods such as cross-sectional surveys, periodic evaluations, and we use the data to support operational needs. We have developed linkages to more granular datasets such as electronic health records, but our focus to date has been mostly on the frontline experience of hospitalists and gathering consensus around clinical practice, especially in the early stages of the pandemic.”
In March and April of 2020, Dr. Greysen and colleagues collected and analyzed any discharge protocols, policies, or other documents from 22 academic medical centers. From this they created a follow-up survey containing 21 different domains that was administered to the same institutions in May and June of 2020. “It’s not meant to be a completely comprehensive list, but these 21 domains were the themes we saw coming out of these discharge practice documents,” explained Dr. Greysen, chief of hospital medicine at the University of Pennsylvania, Philadelphia, which is one of the participating sites.
Next, the researchers used a concordance table to help them keep track of which institution responded in which way for which domain, and they bundled the discharge criteria into five higher order domains: procedures for isolation and mitigating transmission; clinical criteria for discharge; nonclinical/nonisolation issues; discharge to settings other than home, and postdischarge instructions, monitoring, and follow-up.
In the procedures for isolation and mitigating transmission domain, Dr. Greysen reported that the use of isolation guidelines was the area of greatest consensus in the study, with 19 of 22 sites (86%) citing the Centers for Disease Control and Prevention and 7 (32%) also citing state department of health guidance. “Specifically, most sites included the ability to socially isolate at home (until no longer necessary per CDC guidance) as part of the criteria,” he said. Most sites (73%) required use of personal protective equipment (PPE) in transportation from the hospital and 73% gave masks and other PPE for use at home.
Session copresenter Maralyssa A. Bann, MD, a hospitalist at the University of Washington/Harborview Medical Center, Seattle, another participating site, pointed out that the institutions surveyed look to the CDC as being “the single source of truth on discharge practices,” specifically material for health care workers related to discharging COVID-19 patients. “Notable specific recent updates include the recommendation that meeting criteria for discontinuation of Transmission-Based Precautions is not a prerequisite for discharge from a health care facility,” Dr. Bann said. “Also, as of August 2020, use of symptom-based strategy for discontinuation of isolation precautions instead of repeat testing is recommended for most patients. This is a rapidly evolving area.”
Practices in the clinical criteria for discharge domain varied by site. Slightly more than one-quarter of sites (27%) gave little or no guidance by using terms like “use clinical judgment,” while 14% gave very specific detailed algorithms. “Most sites fell in between and gave some parameters, usually along the lines of symptom improvement, temperature, and oxygen requirement, but the criteria were variable,” Dr. Greysen said. “For example, in terms of temperature, many sites said that patients should be afebrile for a specific length of time, 24-72 hours, while other sites simply said afebrile at discharge.” Meanwhile, the following criteria for discharge were addressed by relatively few sites: lab criteria (36%), age (36%), high-risk comorbidities (32%), or ID consultation (18%).
In the nonclinical/nonisolation domain, 73% of sites assessed for level of support available, though this was variably defined. Slightly more than half (55%) specifically assessed activities of daily living or the presence of a caregiver to assist, while 18% reported addressing durable medical equipment such as beds and toilets and access to food or medication supplies in ways that were specific for COVID-19 patients.
In the discharge to settings other than home domain, 77% of sites addressed discharge to skilled nursing facilities, inpatient rehabilitation, or long-term care, although specific requirements were often set by the accepting facilities. In addition, 65% of sites gave specific guidance for patients experiencing unstable housing/homelessness, usually recommending a respite facility or similar, and 59% addressed congregate/shared living spaces such as assisted living facilities. “Often the strictest criteria [two negative COVID tests] were applied to discharge to these types of settings,” he said.
In the postdischarge instructions, monitoring, and follow-up domain, 73% of sites reported providing home monitoring and/or virtual follow-up care. Programs ranged from daily texting via SMS or patient portals, RN phone calls, home pulse oximeters, and/or thermometers. In addition, 55% of sites had created COVID-specific brochures, discharge instructions, and other materials to standardize content such as use of PPE, travel restrictions, social distancing, signs and symptoms to watch out for, and what to do if worsening clinically.
Dr. Bann predicted future trends on the heels of the HOMERuN survey, including the development of more evidence and consensus related to discharge criteria. “Clarity is needed specifically around hypoxemia at rest/on ambulation, as well as more flexible criteria for oxygen supplementation,” she said. “We also think there will be a considerable amount of growth in posthospitalization monitoring and support, in particular home-based and virtual/remote monitoring.”
HOMERuN is supported by the Gordon and Betty Moore Foundation, the AAMC, the Patient-Centered Outcomes Research Institute, the Clinical Data Research Networks, the Patient-Powered Research Networks, and Agency for Healthcare Research and Quality. Dr. Greysen and Dr. Bann reported having no financial disclosures.
FROM SHM CONVERGE 2021
Porous pill printing and prognostic poop
Printing meds per patient
What if there was a way to get exact doses of a medication, tailored specifically for each and every patient that needed it? Well, apparently it’s as easy as getting them out of a printer.
Researchers from the University of East Anglia in England may have found a new method to do just that.
Currently, medicine is “manufactured in ‘one-size-fits-all’ fashion,” said Dr. Sheng Qi, the research lead. But no patient is exactly the same, so why shouldn’t their medications be just as unique? Research on pharmaceutical 3D printing has been developing over the past 5 years, with the most common method requiring the drug to be put into “spaghetti-like filaments” before printing.
Dr. Qi and his team developed a process that bypasses the filaments, allowing them to 3D-print pills with varied porous structures that can regulate the rate of release of the drug into the body. This could be revolutionary for elderly patients and patients with complicated conditions – who often take many different drugs – to ensure more accurate doses that provide maximum benefits and minimal adverse effects.
Just as a custom-tailored suit perfectly fits the body for which it was made, the ability to tailor medication could have the same effect on a patient’s health. The only difference is what’s coming through the printer would be pills, not fabric.
It’s hip to be Pfizered
COVID-19 vaccination levels are rising, but we’ve heard a rumor that some people are still a bit reticent to participate. So how can physicians get more people to come in for a shot?
Make sure that they’re giving patients the right vaccine, for one thing. And by “right” vaccine, we mean, of course, the cool vaccine. Yes, the Internet has decided that the Pfizer vaccine is cooler than the others, according to the Atlantic.
There is, it seems, such a thing as “Pfizer superiority complex,” the article noted, while adding that, “on TikTok, hundreds of videos use a soundtrack of a woman explaining – slowly, voice full of disdain, like the rudest preschool teacher on Earth – ‘Only hot people get the Pfizer vaccine.’ ” A reporter from Slate was welcomed “to the ruling class” after sharing her upcoming Pfizer vaccination.
For the ultimate test of coolness, we surveyed the LOTME staff about the COVID-19 vaccines they had received. The results? Two Pfizers (coincidentally, the only two who knew what the hell TikTok is), one Moderna, one Johnson & Johnson, and one Godbold’s Vegetable Balsam (coincidentally, the same one who told us to get off his lawn).
And yes, we are checking on that last one.
Allergies stink!
A baby’s first bowel movement might mean more than just being the first of many diaper changes.
That particular bowel movement, called meconium, is a mixture of materials that have gone into a baby’s mouth late in the pregnancy, such as skin cells and amniotic fluid. Sounds lovely, right? The contents also include certain biochemicals and gut bacteria, and a lack of these can show an increased risk of allergies, eczema, and asthma.
Studies show that certain gut bacteria actually teach the immune system to accept compounds that are not harmful. Since allergies and other conditions are caused by a person’s immune system telling them harmless compounds are bad, it makes sense that lacking gut bacteria might show potential for developing such conditions.
Charisse Petersen, a researcher at the University of British Columbia in Vancouver, told NewScientist that parents could help decrease the development of allergies by not giving their children antibiotics that aren’t necessary and by letting kids play outside more.
Tom Marrs of King’s College London even noted that having a dog in the house is linked to a lower risk of allergies, so it might be time to get that puppy that the kids have been begging you for all through the pandemic.
Indiana Jones and the outhouse of parasites
Some archaeological finds are more impressive than others. Sometimes you find evidence of some long-lost civilization, sometimes you find a 200-year-old outhouse. That was the case with an outhouse buried near Dartmouth College that belonged to Mill Olcott, a wealthy businessman and politician who was a graduate of the college, and his family.
Now, that’s not particularly medically interesting, but the contents of the outhouse were very well preserved. That treasure trove included some fecal samples, and that’s where the story gets good, since they were preserved enough to be analyzed for parasites. Now, researchers know that parasites were very common in urban areas back in those days, when medicinal knowledge and sanitation were still deep in the dark ages, but whether or not people who lived in rural areas, wealthy or not, had them as well was a mystery.
Of course, 200-year-old poop is 200-year-old poop, so, in a task we wouldn’t envy anyone, the samples were rehydrated and run through several sieves to isolate the ancient goodies within. When all was said and done, both tapeworm and whipworm eggs were found, a surprise considering parasitic preference for warmer environments – not something northern New England is known for. But don’t forget, parasites can be your friend, too.
We will probably never know just which member of the Olcott household the poop belonged to, but the researchers noted that it was almost certain the entire house was infected. They added that, without proper infrastructure, even wealth was unable to protect people from disease. Hmm, we can’t think of any relevance that has in today’s world. Nope, absolutely none, since our health infrastructure is literally without flaw.
Printing meds per patient
What if there was a way to get exact doses of a medication, tailored specifically for each and every patient that needed it? Well, apparently it’s as easy as getting them out of a printer.
Researchers from the University of East Anglia in England may have found a new method to do just that.
Currently, medicine is “manufactured in ‘one-size-fits-all’ fashion,” said Dr. Sheng Qi, the research lead. But no patient is exactly the same, so why shouldn’t their medications be just as unique? Research on pharmaceutical 3D printing has been developing over the past 5 years, with the most common method requiring the drug to be put into “spaghetti-like filaments” before printing.
Dr. Qi and his team developed a process that bypasses the filaments, allowing them to 3D-print pills with varied porous structures that can regulate the rate of release of the drug into the body. This could be revolutionary for elderly patients and patients with complicated conditions – who often take many different drugs – to ensure more accurate doses that provide maximum benefits and minimal adverse effects.
Just as a custom-tailored suit perfectly fits the body for which it was made, the ability to tailor medication could have the same effect on a patient’s health. The only difference is what’s coming through the printer would be pills, not fabric.
It’s hip to be Pfizered
COVID-19 vaccination levels are rising, but we’ve heard a rumor that some people are still a bit reticent to participate. So how can physicians get more people to come in for a shot?
Make sure that they’re giving patients the right vaccine, for one thing. And by “right” vaccine, we mean, of course, the cool vaccine. Yes, the Internet has decided that the Pfizer vaccine is cooler than the others, according to the Atlantic.
There is, it seems, such a thing as “Pfizer superiority complex,” the article noted, while adding that, “on TikTok, hundreds of videos use a soundtrack of a woman explaining – slowly, voice full of disdain, like the rudest preschool teacher on Earth – ‘Only hot people get the Pfizer vaccine.’ ” A reporter from Slate was welcomed “to the ruling class” after sharing her upcoming Pfizer vaccination.
For the ultimate test of coolness, we surveyed the LOTME staff about the COVID-19 vaccines they had received. The results? Two Pfizers (coincidentally, the only two who knew what the hell TikTok is), one Moderna, one Johnson & Johnson, and one Godbold’s Vegetable Balsam (coincidentally, the same one who told us to get off his lawn).
And yes, we are checking on that last one.
Allergies stink!
A baby’s first bowel movement might mean more than just being the first of many diaper changes.
That particular bowel movement, called meconium, is a mixture of materials that have gone into a baby’s mouth late in the pregnancy, such as skin cells and amniotic fluid. Sounds lovely, right? The contents also include certain biochemicals and gut bacteria, and a lack of these can show an increased risk of allergies, eczema, and asthma.
Studies show that certain gut bacteria actually teach the immune system to accept compounds that are not harmful. Since allergies and other conditions are caused by a person’s immune system telling them harmless compounds are bad, it makes sense that lacking gut bacteria might show potential for developing such conditions.
Charisse Petersen, a researcher at the University of British Columbia in Vancouver, told NewScientist that parents could help decrease the development of allergies by not giving their children antibiotics that aren’t necessary and by letting kids play outside more.
Tom Marrs of King’s College London even noted that having a dog in the house is linked to a lower risk of allergies, so it might be time to get that puppy that the kids have been begging you for all through the pandemic.
Indiana Jones and the outhouse of parasites
Some archaeological finds are more impressive than others. Sometimes you find evidence of some long-lost civilization, sometimes you find a 200-year-old outhouse. That was the case with an outhouse buried near Dartmouth College that belonged to Mill Olcott, a wealthy businessman and politician who was a graduate of the college, and his family.
Now, that’s not particularly medically interesting, but the contents of the outhouse were very well preserved. That treasure trove included some fecal samples, and that’s where the story gets good, since they were preserved enough to be analyzed for parasites. Now, researchers know that parasites were very common in urban areas back in those days, when medicinal knowledge and sanitation were still deep in the dark ages, but whether or not people who lived in rural areas, wealthy or not, had them as well was a mystery.
Of course, 200-year-old poop is 200-year-old poop, so, in a task we wouldn’t envy anyone, the samples were rehydrated and run through several sieves to isolate the ancient goodies within. When all was said and done, both tapeworm and whipworm eggs were found, a surprise considering parasitic preference for warmer environments – not something northern New England is known for. But don’t forget, parasites can be your friend, too.
We will probably never know just which member of the Olcott household the poop belonged to, but the researchers noted that it was almost certain the entire house was infected. They added that, without proper infrastructure, even wealth was unable to protect people from disease. Hmm, we can’t think of any relevance that has in today’s world. Nope, absolutely none, since our health infrastructure is literally without flaw.
Printing meds per patient
What if there was a way to get exact doses of a medication, tailored specifically for each and every patient that needed it? Well, apparently it’s as easy as getting them out of a printer.
Researchers from the University of East Anglia in England may have found a new method to do just that.
Currently, medicine is “manufactured in ‘one-size-fits-all’ fashion,” said Dr. Sheng Qi, the research lead. But no patient is exactly the same, so why shouldn’t their medications be just as unique? Research on pharmaceutical 3D printing has been developing over the past 5 years, with the most common method requiring the drug to be put into “spaghetti-like filaments” before printing.
Dr. Qi and his team developed a process that bypasses the filaments, allowing them to 3D-print pills with varied porous structures that can regulate the rate of release of the drug into the body. This could be revolutionary for elderly patients and patients with complicated conditions – who often take many different drugs – to ensure more accurate doses that provide maximum benefits and minimal adverse effects.
Just as a custom-tailored suit perfectly fits the body for which it was made, the ability to tailor medication could have the same effect on a patient’s health. The only difference is what’s coming through the printer would be pills, not fabric.
It’s hip to be Pfizered
COVID-19 vaccination levels are rising, but we’ve heard a rumor that some people are still a bit reticent to participate. So how can physicians get more people to come in for a shot?
Make sure that they’re giving patients the right vaccine, for one thing. And by “right” vaccine, we mean, of course, the cool vaccine. Yes, the Internet has decided that the Pfizer vaccine is cooler than the others, according to the Atlantic.
There is, it seems, such a thing as “Pfizer superiority complex,” the article noted, while adding that, “on TikTok, hundreds of videos use a soundtrack of a woman explaining – slowly, voice full of disdain, like the rudest preschool teacher on Earth – ‘Only hot people get the Pfizer vaccine.’ ” A reporter from Slate was welcomed “to the ruling class” after sharing her upcoming Pfizer vaccination.
For the ultimate test of coolness, we surveyed the LOTME staff about the COVID-19 vaccines they had received. The results? Two Pfizers (coincidentally, the only two who knew what the hell TikTok is), one Moderna, one Johnson & Johnson, and one Godbold’s Vegetable Balsam (coincidentally, the same one who told us to get off his lawn).
And yes, we are checking on that last one.
Allergies stink!
A baby’s first bowel movement might mean more than just being the first of many diaper changes.
That particular bowel movement, called meconium, is a mixture of materials that have gone into a baby’s mouth late in the pregnancy, such as skin cells and amniotic fluid. Sounds lovely, right? The contents also include certain biochemicals and gut bacteria, and a lack of these can show an increased risk of allergies, eczema, and asthma.
Studies show that certain gut bacteria actually teach the immune system to accept compounds that are not harmful. Since allergies and other conditions are caused by a person’s immune system telling them harmless compounds are bad, it makes sense that lacking gut bacteria might show potential for developing such conditions.
Charisse Petersen, a researcher at the University of British Columbia in Vancouver, told NewScientist that parents could help decrease the development of allergies by not giving their children antibiotics that aren’t necessary and by letting kids play outside more.
Tom Marrs of King’s College London even noted that having a dog in the house is linked to a lower risk of allergies, so it might be time to get that puppy that the kids have been begging you for all through the pandemic.
Indiana Jones and the outhouse of parasites
Some archaeological finds are more impressive than others. Sometimes you find evidence of some long-lost civilization, sometimes you find a 200-year-old outhouse. That was the case with an outhouse buried near Dartmouth College that belonged to Mill Olcott, a wealthy businessman and politician who was a graduate of the college, and his family.
Now, that’s not particularly medically interesting, but the contents of the outhouse were very well preserved. That treasure trove included some fecal samples, and that’s where the story gets good, since they were preserved enough to be analyzed for parasites. Now, researchers know that parasites were very common in urban areas back in those days, when medicinal knowledge and sanitation were still deep in the dark ages, but whether or not people who lived in rural areas, wealthy or not, had them as well was a mystery.
Of course, 200-year-old poop is 200-year-old poop, so, in a task we wouldn’t envy anyone, the samples were rehydrated and run through several sieves to isolate the ancient goodies within. When all was said and done, both tapeworm and whipworm eggs were found, a surprise considering parasitic preference for warmer environments – not something northern New England is known for. But don’t forget, parasites can be your friend, too.
We will probably never know just which member of the Olcott household the poop belonged to, but the researchers noted that it was almost certain the entire house was infected. They added that, without proper infrastructure, even wealth was unable to protect people from disease. Hmm, we can’t think of any relevance that has in today’s world. Nope, absolutely none, since our health infrastructure is literally without flaw.
Multidisciplinary approach touted for atopic dermatitis
researchers say.
“I think we really gained insight to how a more holistic approach benefited the patient,” Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, said in an interview.
At the 2021 annual meeting of the International Society of Atopic Dermatitis, he and his colleagues described a pilot program to bring the specialists together at UCSD and Rady Children’s Hospital, San Diego.
Typically, children seeking care for atopic dermatitis see allergists and dermatologists separately for 10- to 15-minute appointments. The specialists sometimes prescribe treatments that conflict or are redundant with each other and may give contradictory instructions.
Instead, Dr. Eichenfield and colleagues designed a program bringing patients in for initial assessments lasting 1-1.5 hours. Patients typically started with visits to a clinical pharmacist, who assessed what medications had been prescribed and how much the patients were actually taking.
The patients then proceeded to separate appointments with an allergist and a dermatologist for evaluations. These specialists then met face to face to develop a treatment plan. At least one of the specialists would then present the plan to the patient and the patient’s family.
“We had a rich set of educational materials that were developed and put online that helped with shared decision-making and increased comfort level with appropriate skin care and medication,” Dr. Eichenfield said.
He and his colleagues assigned a physician assistant trained in both pediatric dermatology and pediatric allergy to coordinate the clinic. They designed combined pediatric dermatology and pediatric allergy fellowships for two fellows. “So, part of this program ended up allowing specially trained individuals who overlapped in fields that traditionally were separate,” said Dr. Eichenfield.
To see how well the approach worked, the researchers followed the progress of 23 patients who were already receiving treatment at one or both of the institutions.
- Eczema Area and Severity Index (EASI) scores decreased from visit 1 to visit 2 by a mean of 15.36 (P < .001), which correlates to a 56.36% average decrease.
- In 20 patients (89.96%), in EASI scores improved 50%.
- Thirteen patients (56.54%) achieved 75% improvement in EASI scores.
- Body surface area scores improved by a mean of 23.21% (P = .002).
- Validated Investigator Global Assessment scores decreased in 56.52% of patients to a clinically significant level.
The study did not include any control group, nor did the researchers report any details on how long the patients had been treated before the multidisciplinary program started or how their prescriptions changed.
Patients benefited from the comprehensive assessment of their symptoms, said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital. “Some had significant environmental allergies that might not have been a contributing factor to their atopic dermatitis,” he explained. “The complexities of comorbidities and atopic dermatitis influence the patient, even if one disease state isn’t necessarily directly causative of the other.”
In surveys, patients said they especially appreciated the increased time spent with their specialists. “No one’s ever spent an hour teaching us about eczema,” some commented. The approach motivated patients to take their home treatment more effectively, Dr. Eichenfield believed.
Primary care physicians did not participate in the multidisciplinary program, but the specialists communicated with them and shared electronic medical records with them, he said.
Without a control group, it is hard to say how much difference the multidisciplinary approach made, Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, Washington, said in an interview.
“What it does show is that there is significant improvement in a variety of endpoints within this multidisciplinary approach,” Dr. Silverberg said in an interview. “And so I have no doubt that this is valid and that a multidisciplinary approach would really improve, holistically, many aspects of patient care.”
Dr. Silverberg ran a multidisciplinary program at Northwestern University, Chicago, which included sleep medicine, endocrinology, gastroenterology, and other specialties as well as dermatology, allergy, and pharmacy.
However, Dr. Silverberg pointed out, a multidisciplinary approach is more expensive than standard care because when specialists spend more time with each patient, they see fewer patients per day. “So many health care systems or academic institutions are not as open as they should be to this kind of interdisciplinary care, which is why it’s so important to have outcome measures showing that this approach actually works.”
Dr. Eichenfield and Dr. Silverberg had no relevant disclosures.
A version of this article first appeared on Medscape.com.
researchers say.
“I think we really gained insight to how a more holistic approach benefited the patient,” Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, said in an interview.
At the 2021 annual meeting of the International Society of Atopic Dermatitis, he and his colleagues described a pilot program to bring the specialists together at UCSD and Rady Children’s Hospital, San Diego.
Typically, children seeking care for atopic dermatitis see allergists and dermatologists separately for 10- to 15-minute appointments. The specialists sometimes prescribe treatments that conflict or are redundant with each other and may give contradictory instructions.
Instead, Dr. Eichenfield and colleagues designed a program bringing patients in for initial assessments lasting 1-1.5 hours. Patients typically started with visits to a clinical pharmacist, who assessed what medications had been prescribed and how much the patients were actually taking.
The patients then proceeded to separate appointments with an allergist and a dermatologist for evaluations. These specialists then met face to face to develop a treatment plan. At least one of the specialists would then present the plan to the patient and the patient’s family.
“We had a rich set of educational materials that were developed and put online that helped with shared decision-making and increased comfort level with appropriate skin care and medication,” Dr. Eichenfield said.
He and his colleagues assigned a physician assistant trained in both pediatric dermatology and pediatric allergy to coordinate the clinic. They designed combined pediatric dermatology and pediatric allergy fellowships for two fellows. “So, part of this program ended up allowing specially trained individuals who overlapped in fields that traditionally were separate,” said Dr. Eichenfield.
To see how well the approach worked, the researchers followed the progress of 23 patients who were already receiving treatment at one or both of the institutions.
- Eczema Area and Severity Index (EASI) scores decreased from visit 1 to visit 2 by a mean of 15.36 (P < .001), which correlates to a 56.36% average decrease.
- In 20 patients (89.96%), in EASI scores improved 50%.
- Thirteen patients (56.54%) achieved 75% improvement in EASI scores.
- Body surface area scores improved by a mean of 23.21% (P = .002).
- Validated Investigator Global Assessment scores decreased in 56.52% of patients to a clinically significant level.
The study did not include any control group, nor did the researchers report any details on how long the patients had been treated before the multidisciplinary program started or how their prescriptions changed.
Patients benefited from the comprehensive assessment of their symptoms, said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital. “Some had significant environmental allergies that might not have been a contributing factor to their atopic dermatitis,” he explained. “The complexities of comorbidities and atopic dermatitis influence the patient, even if one disease state isn’t necessarily directly causative of the other.”
In surveys, patients said they especially appreciated the increased time spent with their specialists. “No one’s ever spent an hour teaching us about eczema,” some commented. The approach motivated patients to take their home treatment more effectively, Dr. Eichenfield believed.
Primary care physicians did not participate in the multidisciplinary program, but the specialists communicated with them and shared electronic medical records with them, he said.
Without a control group, it is hard to say how much difference the multidisciplinary approach made, Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, Washington, said in an interview.
“What it does show is that there is significant improvement in a variety of endpoints within this multidisciplinary approach,” Dr. Silverberg said in an interview. “And so I have no doubt that this is valid and that a multidisciplinary approach would really improve, holistically, many aspects of patient care.”
Dr. Silverberg ran a multidisciplinary program at Northwestern University, Chicago, which included sleep medicine, endocrinology, gastroenterology, and other specialties as well as dermatology, allergy, and pharmacy.
However, Dr. Silverberg pointed out, a multidisciplinary approach is more expensive than standard care because when specialists spend more time with each patient, they see fewer patients per day. “So many health care systems or academic institutions are not as open as they should be to this kind of interdisciplinary care, which is why it’s so important to have outcome measures showing that this approach actually works.”
Dr. Eichenfield and Dr. Silverberg had no relevant disclosures.
A version of this article first appeared on Medscape.com.
researchers say.
“I think we really gained insight to how a more holistic approach benefited the patient,” Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, said in an interview.
At the 2021 annual meeting of the International Society of Atopic Dermatitis, he and his colleagues described a pilot program to bring the specialists together at UCSD and Rady Children’s Hospital, San Diego.
Typically, children seeking care for atopic dermatitis see allergists and dermatologists separately for 10- to 15-minute appointments. The specialists sometimes prescribe treatments that conflict or are redundant with each other and may give contradictory instructions.
Instead, Dr. Eichenfield and colleagues designed a program bringing patients in for initial assessments lasting 1-1.5 hours. Patients typically started with visits to a clinical pharmacist, who assessed what medications had been prescribed and how much the patients were actually taking.
The patients then proceeded to separate appointments with an allergist and a dermatologist for evaluations. These specialists then met face to face to develop a treatment plan. At least one of the specialists would then present the plan to the patient and the patient’s family.
“We had a rich set of educational materials that were developed and put online that helped with shared decision-making and increased comfort level with appropriate skin care and medication,” Dr. Eichenfield said.
He and his colleagues assigned a physician assistant trained in both pediatric dermatology and pediatric allergy to coordinate the clinic. They designed combined pediatric dermatology and pediatric allergy fellowships for two fellows. “So, part of this program ended up allowing specially trained individuals who overlapped in fields that traditionally were separate,” said Dr. Eichenfield.
To see how well the approach worked, the researchers followed the progress of 23 patients who were already receiving treatment at one or both of the institutions.
- Eczema Area and Severity Index (EASI) scores decreased from visit 1 to visit 2 by a mean of 15.36 (P < .001), which correlates to a 56.36% average decrease.
- In 20 patients (89.96%), in EASI scores improved 50%.
- Thirteen patients (56.54%) achieved 75% improvement in EASI scores.
- Body surface area scores improved by a mean of 23.21% (P = .002).
- Validated Investigator Global Assessment scores decreased in 56.52% of patients to a clinically significant level.
The study did not include any control group, nor did the researchers report any details on how long the patients had been treated before the multidisciplinary program started or how their prescriptions changed.
Patients benefited from the comprehensive assessment of their symptoms, said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital. “Some had significant environmental allergies that might not have been a contributing factor to their atopic dermatitis,” he explained. “The complexities of comorbidities and atopic dermatitis influence the patient, even if one disease state isn’t necessarily directly causative of the other.”
In surveys, patients said they especially appreciated the increased time spent with their specialists. “No one’s ever spent an hour teaching us about eczema,” some commented. The approach motivated patients to take their home treatment more effectively, Dr. Eichenfield believed.
Primary care physicians did not participate in the multidisciplinary program, but the specialists communicated with them and shared electronic medical records with them, he said.
Without a control group, it is hard to say how much difference the multidisciplinary approach made, Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, Washington, said in an interview.
“What it does show is that there is significant improvement in a variety of endpoints within this multidisciplinary approach,” Dr. Silverberg said in an interview. “And so I have no doubt that this is valid and that a multidisciplinary approach would really improve, holistically, many aspects of patient care.”
Dr. Silverberg ran a multidisciplinary program at Northwestern University, Chicago, which included sleep medicine, endocrinology, gastroenterology, and other specialties as well as dermatology, allergy, and pharmacy.
However, Dr. Silverberg pointed out, a multidisciplinary approach is more expensive than standard care because when specialists spend more time with each patient, they see fewer patients per day. “So many health care systems or academic institutions are not as open as they should be to this kind of interdisciplinary care, which is why it’s so important to have outcome measures showing that this approach actually works.”
Dr. Eichenfield and Dr. Silverberg had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Progress stalling on malaria elimination
In its final report on the E-2020 initiative, the World Health Organization touted its progress on its goal of eliminating malaria throughout the world. But critics are charging that progress has stalled.
The E-2020 initiative supported the efforts of 21 countries in eliminating malaria. In a remarkable achievement, especially during the COVID-19 pandemic, eight E-2020 member countries reported zero cases of malaria in 2020. The WHO’s next target is the elimination of malaria in 20 of those countries by 2025.
While applauding these successes, in an interview with this news organization, Sir Nicholas J. White, FRS, professor of tropical medicine, Mahidol University, Salaya, Thailand, and Oxford (England) University, also put those successes in perspective. For one thing, the original 2020 goal was the elimination of malaria in 10 countries. Prof. White acknowledged that there had been very “substantial reductions in global morbidity and mortality” from 2000 to 2015, but he pointed out that those advances have not been sustained.
Prof. White added, “There has never been a really good, detailed inquiry as to why progress has stalled” in the high-burden countries.
Prof. White also provided important historical context, explaining that “100 years ago, malaria was pretty much a global disease. There were few places in the world which did not have malaria. You had malaria up to the Arctic Circle. You had malaria in the United States, particularly in the Tennessee Valley in the southeastern part of the United States. The Centers for Disease Control was formed specifically to counter malaria and malaria interfering with the building of the Erie and Ottawa canals.”
Kim Lindblade, PhD, malaria elimination team lead of the WHO’s Global Malaria Program, addressed those concerns with this news organization. “It’s not completely clear why [progress] has stalled,” she said. “There are lots of potential reasons for it, including stagnating funding.”
Dr. Lindblade added that high-burden countries are “facing big challenges. [Since 2015] there’s this stagnation. We’re fighting against population growth, and countries need to get back on track to continue to decrease their malaria burden. So that’s the big focus right now, to reorganize efforts to help countries achieve the goals of the World Health Assembly.”
Asked how these countries might approach the problem differently, Dr. Lindblade said that in the recent past, there was “almost a one-size-fits-all strategy. Now we’re looking much more carefully at conditions at the district level or provincial level and saying, What is it that this particular district or province needs? … It’s becoming much more tailored to the environment and to the specific epidemiological situation. … and I think that’s gotten a lot of people very excited.”
Because of travel restrictions and lockdowns because of COVID-19, the number of imported cases of malaria has declined. That’s the good news. But the pandemic has made elimination more difficult in other ways. For example, the delivery of insecticide-treated bed nets has been delayed in some areas, as has targeted indoor spraying. People in many areas have put off seeking medical care. Diagnostic capabilities have been reduced because of health care personnel having been diverted to address the COVID-19 crisis.
Still, some of the successes in eliminating malaria have been striking. Iran, for example, reduced its cases from about 98,000 in 1991 to 12,000 just 10 years later. Since then, Iran has established rapid response teams equipped with insecticide-impregnated nets, rapid diagnostic tests, and antimalarials. A network of more than 3,700 community health volunteers has been trained and deployed throughout the country.
A key element of Iran’s success – and that of some of the other countries – is the political will to tackle malaria. This translates to funding. Notably, the most successful countries provide free primary health care to everyone, regardless of their legal or residency status. Volunteer migrant workers are trained to diagnose malaria and to educate fellow migrants about the disease and prevention strategies.
Malaysia and China are examples of two countries at risk of importing malaria through their many people who work abroad in malaria-endemic regions. They have had to increase their surveillance.
Although Malaysia has eliminated most malaria species – those transmitted through people – they still have problems with the malaria parasite hosted by monkeys.
The WHO report stresses the lessons learned through their E-2020 program. Two key criteria are political commitment and associated funding. Next are surveillance and efforts to reach everyone, even in geographically remote or marginalized communities. Close surveillance also enables strategies to be modified to local needs.
Countries need to cooperate, especially along border areas and in regard to communications. The WHO stressed the need for countries to have an integrated response in their approach to malaria, including accurate surveillance, diagnostic testing, treatment, and robust education in preventive measures.
Although these successes were not as evident in some high-burden countries, Prof. White applauded their perseverance, noting, “It’s quite difficult to sustain the political momentum. … That endgame to keep the motivation, keep the support, to getting rid of something is hard.”
Prof. White and Dr. Lindberg have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In its final report on the E-2020 initiative, the World Health Organization touted its progress on its goal of eliminating malaria throughout the world. But critics are charging that progress has stalled.
The E-2020 initiative supported the efforts of 21 countries in eliminating malaria. In a remarkable achievement, especially during the COVID-19 pandemic, eight E-2020 member countries reported zero cases of malaria in 2020. The WHO’s next target is the elimination of malaria in 20 of those countries by 2025.
While applauding these successes, in an interview with this news organization, Sir Nicholas J. White, FRS, professor of tropical medicine, Mahidol University, Salaya, Thailand, and Oxford (England) University, also put those successes in perspective. For one thing, the original 2020 goal was the elimination of malaria in 10 countries. Prof. White acknowledged that there had been very “substantial reductions in global morbidity and mortality” from 2000 to 2015, but he pointed out that those advances have not been sustained.
Prof. White added, “There has never been a really good, detailed inquiry as to why progress has stalled” in the high-burden countries.
Prof. White also provided important historical context, explaining that “100 years ago, malaria was pretty much a global disease. There were few places in the world which did not have malaria. You had malaria up to the Arctic Circle. You had malaria in the United States, particularly in the Tennessee Valley in the southeastern part of the United States. The Centers for Disease Control was formed specifically to counter malaria and malaria interfering with the building of the Erie and Ottawa canals.”
Kim Lindblade, PhD, malaria elimination team lead of the WHO’s Global Malaria Program, addressed those concerns with this news organization. “It’s not completely clear why [progress] has stalled,” she said. “There are lots of potential reasons for it, including stagnating funding.”
Dr. Lindblade added that high-burden countries are “facing big challenges. [Since 2015] there’s this stagnation. We’re fighting against population growth, and countries need to get back on track to continue to decrease their malaria burden. So that’s the big focus right now, to reorganize efforts to help countries achieve the goals of the World Health Assembly.”
Asked how these countries might approach the problem differently, Dr. Lindblade said that in the recent past, there was “almost a one-size-fits-all strategy. Now we’re looking much more carefully at conditions at the district level or provincial level and saying, What is it that this particular district or province needs? … It’s becoming much more tailored to the environment and to the specific epidemiological situation. … and I think that’s gotten a lot of people very excited.”
Because of travel restrictions and lockdowns because of COVID-19, the number of imported cases of malaria has declined. That’s the good news. But the pandemic has made elimination more difficult in other ways. For example, the delivery of insecticide-treated bed nets has been delayed in some areas, as has targeted indoor spraying. People in many areas have put off seeking medical care. Diagnostic capabilities have been reduced because of health care personnel having been diverted to address the COVID-19 crisis.
Still, some of the successes in eliminating malaria have been striking. Iran, for example, reduced its cases from about 98,000 in 1991 to 12,000 just 10 years later. Since then, Iran has established rapid response teams equipped with insecticide-impregnated nets, rapid diagnostic tests, and antimalarials. A network of more than 3,700 community health volunteers has been trained and deployed throughout the country.
A key element of Iran’s success – and that of some of the other countries – is the political will to tackle malaria. This translates to funding. Notably, the most successful countries provide free primary health care to everyone, regardless of their legal or residency status. Volunteer migrant workers are trained to diagnose malaria and to educate fellow migrants about the disease and prevention strategies.
Malaysia and China are examples of two countries at risk of importing malaria through their many people who work abroad in malaria-endemic regions. They have had to increase their surveillance.
Although Malaysia has eliminated most malaria species – those transmitted through people – they still have problems with the malaria parasite hosted by monkeys.
The WHO report stresses the lessons learned through their E-2020 program. Two key criteria are political commitment and associated funding. Next are surveillance and efforts to reach everyone, even in geographically remote or marginalized communities. Close surveillance also enables strategies to be modified to local needs.
Countries need to cooperate, especially along border areas and in regard to communications. The WHO stressed the need for countries to have an integrated response in their approach to malaria, including accurate surveillance, diagnostic testing, treatment, and robust education in preventive measures.
Although these successes were not as evident in some high-burden countries, Prof. White applauded their perseverance, noting, “It’s quite difficult to sustain the political momentum. … That endgame to keep the motivation, keep the support, to getting rid of something is hard.”
Prof. White and Dr. Lindberg have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In its final report on the E-2020 initiative, the World Health Organization touted its progress on its goal of eliminating malaria throughout the world. But critics are charging that progress has stalled.
The E-2020 initiative supported the efforts of 21 countries in eliminating malaria. In a remarkable achievement, especially during the COVID-19 pandemic, eight E-2020 member countries reported zero cases of malaria in 2020. The WHO’s next target is the elimination of malaria in 20 of those countries by 2025.
While applauding these successes, in an interview with this news organization, Sir Nicholas J. White, FRS, professor of tropical medicine, Mahidol University, Salaya, Thailand, and Oxford (England) University, also put those successes in perspective. For one thing, the original 2020 goal was the elimination of malaria in 10 countries. Prof. White acknowledged that there had been very “substantial reductions in global morbidity and mortality” from 2000 to 2015, but he pointed out that those advances have not been sustained.
Prof. White added, “There has never been a really good, detailed inquiry as to why progress has stalled” in the high-burden countries.
Prof. White also provided important historical context, explaining that “100 years ago, malaria was pretty much a global disease. There were few places in the world which did not have malaria. You had malaria up to the Arctic Circle. You had malaria in the United States, particularly in the Tennessee Valley in the southeastern part of the United States. The Centers for Disease Control was formed specifically to counter malaria and malaria interfering with the building of the Erie and Ottawa canals.”
Kim Lindblade, PhD, malaria elimination team lead of the WHO’s Global Malaria Program, addressed those concerns with this news organization. “It’s not completely clear why [progress] has stalled,” she said. “There are lots of potential reasons for it, including stagnating funding.”
Dr. Lindblade added that high-burden countries are “facing big challenges. [Since 2015] there’s this stagnation. We’re fighting against population growth, and countries need to get back on track to continue to decrease their malaria burden. So that’s the big focus right now, to reorganize efforts to help countries achieve the goals of the World Health Assembly.”
Asked how these countries might approach the problem differently, Dr. Lindblade said that in the recent past, there was “almost a one-size-fits-all strategy. Now we’re looking much more carefully at conditions at the district level or provincial level and saying, What is it that this particular district or province needs? … It’s becoming much more tailored to the environment and to the specific epidemiological situation. … and I think that’s gotten a lot of people very excited.”
Because of travel restrictions and lockdowns because of COVID-19, the number of imported cases of malaria has declined. That’s the good news. But the pandemic has made elimination more difficult in other ways. For example, the delivery of insecticide-treated bed nets has been delayed in some areas, as has targeted indoor spraying. People in many areas have put off seeking medical care. Diagnostic capabilities have been reduced because of health care personnel having been diverted to address the COVID-19 crisis.
Still, some of the successes in eliminating malaria have been striking. Iran, for example, reduced its cases from about 98,000 in 1991 to 12,000 just 10 years later. Since then, Iran has established rapid response teams equipped with insecticide-impregnated nets, rapid diagnostic tests, and antimalarials. A network of more than 3,700 community health volunteers has been trained and deployed throughout the country.
A key element of Iran’s success – and that of some of the other countries – is the political will to tackle malaria. This translates to funding. Notably, the most successful countries provide free primary health care to everyone, regardless of their legal or residency status. Volunteer migrant workers are trained to diagnose malaria and to educate fellow migrants about the disease and prevention strategies.
Malaysia and China are examples of two countries at risk of importing malaria through their many people who work abroad in malaria-endemic regions. They have had to increase their surveillance.
Although Malaysia has eliminated most malaria species – those transmitted through people – they still have problems with the malaria parasite hosted by monkeys.
The WHO report stresses the lessons learned through their E-2020 program. Two key criteria are political commitment and associated funding. Next are surveillance and efforts to reach everyone, even in geographically remote or marginalized communities. Close surveillance also enables strategies to be modified to local needs.
Countries need to cooperate, especially along border areas and in regard to communications. The WHO stressed the need for countries to have an integrated response in their approach to malaria, including accurate surveillance, diagnostic testing, treatment, and robust education in preventive measures.
Although these successes were not as evident in some high-burden countries, Prof. White applauded their perseverance, noting, “It’s quite difficult to sustain the political momentum. … That endgame to keep the motivation, keep the support, to getting rid of something is hard.”
Prof. White and Dr. Lindberg have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Restrict J&J COVID vaccine in women under 50?
Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.
The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.
The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins
They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.
The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.
They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”
In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).
The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.
The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.
As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.
In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.
At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.
In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.
One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.
All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.
The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.
In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.
Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.
However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.
“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.
They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.
They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.
They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.
The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.
They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.
“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.
The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.
In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).
The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.
They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.
This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.
Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.
A version of this article first appeared on Medscape.com.
Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.
The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.
The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins
They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.
The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.
They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”
In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).
The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.
The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.
As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.
In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.
At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.
In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.
One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.
All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.
The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.
In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.
Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.
However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.
“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.
They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.
They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.
They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.
The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.
They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.
“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.
The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.
In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).
The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.
They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.
This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.
Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.
A version of this article first appeared on Medscape.com.
Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.
The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.
The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins
They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.
The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.
They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”
In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).
The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.
The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.
As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.
In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.
At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.
In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.
One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.
All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.
The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.
In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.
Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.
However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.
“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.
They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.
They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.
They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.
The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.
They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.
“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.
The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.
In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).
The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.
They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.
This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.
Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.
A version of this article first appeared on Medscape.com.
Breast cancer survivors have specific gynecological needs
Sexual dysfunction is a common problem among breast cancer survivors, but it’s also an issue inadequately addressed by either ob.gyns. or hematologists and oncologists, according to Erin Keyser, MD, the program director of the San Antonio Uniformed Services Health Education Consortium. Dr. Keyser discussed management of sexual dysfunction and a variety of other issues frequently faced by women who have survived breast cancer at the at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.
“Despite the fact that no specialty is better qualified to render care for this consequence of cancer treatments, many obstetrician-gynecologists feel uncomfortable or ill-equipped to address sexual pain in women affected by cancer,” Dr. Keyser quoted from a 2016 article in Obstetrics & Gynecology about the sexual health of women affected by cancer. As a breast cancer survivor herself, Dr. Keyser said hematologists and oncologists are even less equipped to discuss sexual health, “so oftentimes patients get punted between their hem-onc and their gyn,” with each telling the patient to ask the other specialist.
“There’s plenty of data in chronic health disease that maintaining sexual function for women is an indicator of the overall quality of life and that many women really don’t want to bring this up,” Dr. Keyser told attendees, so the onus is on the ob.gyn. to bring it up.
The effects of breast cancer treatment can impact women’s body image, fertility, menopause, sexual function, osteoporosis, and cardiovascular disease, but the bulk of Dr. Keyser’s talk focused on sexual health and bilateral salpingo-oophorectomy (BSO).
Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University, Chicago, thought Dr. Keyser’s talk was useful for the general gynecologist but had some concerns about a few parts.
“She gave a very thoughtful analysis of whether someone should have their ovaries removed or not in a breast cancer diagnosis, ” Dr. Streicher said in an interview. “I would have liked to hear more about the consequences of an early menopause in women in terms of heart health, bone health, and cognitive function.”
Dr. Keyser noted that her talk pertained mostly to survivors of estrogen receptor (ER)–positive breast cancer since that population tends to struggle most with side effects of treatment. The most common medications used in this population are tamoxifen and aromatase inhibitors – such as anastrazole, letrozole, and exemestane – and these medications can affect management of different concerns.
Current guidance on ovarian removal
For women with a BRCA mutation, ACOG clinical guidance already exists regarding BSO. For other women, the complementary TEXT and SOFT trials changed the management of breast cancer treatment in premenopausal women, Dr. Keyser said.
Before these trials, postmenopausal hormone receptor–positive women began aromatase inhibitors and premenopausal HR-positive women began tamoxifen. These trials found that premenopausal women with HR-positive early breast cancer were less likely to experience recurrence when receiving adjuvant treatment with exemestane plus ovarian suppression compared to tamoxifen plus ovarian suppression. Ovarian suppression was achieved by either GnRH agonist injections, surgical removal of the ovaries, or radiation therapy to the ovaries.
The side effects of these treatments included hot flushes (92%), depression (87%), musculoskeletal symptoms (89%), vaginal dryness (52%), decreased libido (45%), dyspareunia (31%), osteoporosis (39%), insomnia (58%), and fatigue (61%). These are all quality of life concerns, Dr. Keyser said, and these findings raise questions about the consequences of long-term ovarian suppression. Findings from the Nurses’ Health Study showed that BSO before age 47.5 years resulted in lower mortality from ovarian cancer and breast cancer but was linked in women under 50 to increased all-cause mortality and mortality from coronary heart disease, lung cancer, and colorectal cancer, compared with ovarian conservation. Further, 74% of women who undergo risk-reducing BSO experience sexual dysfunction.
The bottom line, Dr. Keyser said, is that “premature removal of ovaries is not completely benign.” Her own recommendation is to follow ACOG guidance for women with BRCA mutations and, for women aged under 35 years, use ovarian suppression for 5-10 years, after which ovarian function may resume along with improved quality of life. In women aged over 40, remove ovaries since, after 5-10 years of treatment, there’s likely no benefit of retaining ovaries.
Addressing sexual health
Dyspareunia affects up to 45% of cancer survivors, Dr. Keyser said, and multiple treatment options exist for breast cancer survivors. The therapies she discussed included lubricants, moisturizers, local vaginal estrogen, DHEA, ospemifene, and CO2 laser therapy.
Though Dr. Keyser briefly touched on vaginal lubricants and moisturizers, Dr. Streicher was disappointed that Dr. Keyser did not clearly define and differentiate between lubricants and moisturizers or mention hyaluronic acid products. Dr. Streicher also disagreed with the way Dr. Keyser represented the benefits of coconut oil as a lubricant. “Oils are not condom compatible and are known to potentially increase the risk of infection, and not just from poor handwashing,” Dr. Streicher said.
Small retrospective studies support the safety of topical vaginal estrogen in breast cancer survivors, Dr. Keyser said, and the 10-mcg Vagifem tablet and vaginal estradiol ring appear to have the lowest systemic absorption. ACOG guidance recommends that women taking aromatase inhibitors who don’t respond to nonhormonal approaches may benefit from switching temporarily to tamoxifen with vaginal estrogen and then returning to aromatase inhibitors. However, Dr. Keyser said there’s plenty of data to support using vaginal estrogen in patients taking aromatase inhibitors.
“I do feel that it’s safe for patients, whether they’re on tamoxifen or aromatase inhibitors, to take vaginal estrogen,” Dr. Keyser said. “I usually stick with the estradiol vaginal ring or the estradiol tablet, and I base that on a patient’s comfort with placing and removing a ring.” She also, instead of asking the patient’s hematologist-oncologist, simply notifies them of the treatment since most hematologist-oncologists are less familiar with the data.
Another effective option is vaginal DHEA/prasterone, which can significantly improve sexual desire, arousal, pain, and overall sexual function. Although breast cancer patients were included in early studies on DHEA, Intrarosa manufacturers excluded breast cancer patients in their Food and Drug Administration application, resulting in a package stating that “use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer” and that “Intrarosa has not been studied in women with a history of breast cancer.” While that’s true for Intrarosa specifically, DHEA has been studied in breast cancer patients, Dr. Keyser said, so she expects to see more research in this area.
Ospemifene is another option for improving vulvovaginal atrophy but cannot be taken at the same time as tamoxifen. It has similar chemopreventive effects as tamoxifen in rat studies, but it’s not as effective. It’s a reasonable option in women with refractory genitourinary syndrome of menopause (GSM) who have completed their 5-10 years of adjuvant therapy and have no history of venous thromboembolism.
Dr. Keyser said CO2 laser therapy is still being studied for treating GSM, and current data have shown benefits for dyspareunia and vaginal dryness without documented harms. There have now been randomized, controlled trials; however, since it’s not FDA approved, it’s not covered by insurance and costs approximately $5,000 for three treatments.
Dr. Streicher was glad to see Dr. Keyser’s discussion of the safety and types of local vaginal estrogen, “although she neglected to mention the 4-mcg vaginal suppository, Imvexxy, which has the lowest systemic absorption,” Dr. Streicher said. Dr. Streicher also felt the inclusion of DHEA/prasterone and ospemifene were also important, especially since the latter is “underutilized in breast cancer patients.”
The information provided on CO2 laser therapy, however, was problematic, Dr. Streicher said, given that long-term and randomized, controlled studies have now been published. Dr. Streicher also noted that two of the devices listed on the presentation slide, Thermiva and Voltiva, are radiofrequency, not laser devices.
Aside from these treatment options, the most consistent predictor of satisfying sexual experiences in women with breast cancer is the quality of their relationships, Dr. Keyser said, so couples counseling is recommended, and treatments in general are more effective with regularly sexual activity.
In discussing nonhormonal options for treating vasomotor symptoms, Dr. Keyser recommended venlafaxine, gabapentin, and low-dose paroxetine (though SSRIs and tamoxifen are contraindicated since they may reduce tamoxifen’s efficacy).
These are all off label, Dr. Streicher said it was important to note, and she would have liked to have seen a mention of the development of KNdy neurokinin disrupters along with a more in-depth discussion about which lifestyle modifications and botanicals have been shown in randomized, controlled trials to mitigate vasomotor symptoms.
Dr. Keyser wrapped up with a few additional notes and takeaways:
- The only safe reversible long-term option for contraception in HR-positive breast cancer survivors is the Paraguard IUD.
- It’s important to discuss fertility with breast cancer patients and survivors since a majority report unmet needs in this area.
- Patients taking tamoxifen need to be sure to report any vaginal spotting or bleeding since it increases risk of endometrial cancer in postmenopausal women.
- Screen for depression and anxiety.
- Ask women about sexual health and hot flashes.
- Ensure that they’re getting bone screening.
- A recommended resource is Living Beyond Breast Cancer.
Dr. Keyser had no disclosures. Dr. Streicher has consulted for Astellas Pharma and Church & Dwight, and she owns investments in InControl Medical and Sermonix Pharmaceuticals.
Sexual dysfunction is a common problem among breast cancer survivors, but it’s also an issue inadequately addressed by either ob.gyns. or hematologists and oncologists, according to Erin Keyser, MD, the program director of the San Antonio Uniformed Services Health Education Consortium. Dr. Keyser discussed management of sexual dysfunction and a variety of other issues frequently faced by women who have survived breast cancer at the at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.
“Despite the fact that no specialty is better qualified to render care for this consequence of cancer treatments, many obstetrician-gynecologists feel uncomfortable or ill-equipped to address sexual pain in women affected by cancer,” Dr. Keyser quoted from a 2016 article in Obstetrics & Gynecology about the sexual health of women affected by cancer. As a breast cancer survivor herself, Dr. Keyser said hematologists and oncologists are even less equipped to discuss sexual health, “so oftentimes patients get punted between their hem-onc and their gyn,” with each telling the patient to ask the other specialist.
“There’s plenty of data in chronic health disease that maintaining sexual function for women is an indicator of the overall quality of life and that many women really don’t want to bring this up,” Dr. Keyser told attendees, so the onus is on the ob.gyn. to bring it up.
The effects of breast cancer treatment can impact women’s body image, fertility, menopause, sexual function, osteoporosis, and cardiovascular disease, but the bulk of Dr. Keyser’s talk focused on sexual health and bilateral salpingo-oophorectomy (BSO).
Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University, Chicago, thought Dr. Keyser’s talk was useful for the general gynecologist but had some concerns about a few parts.
“She gave a very thoughtful analysis of whether someone should have their ovaries removed or not in a breast cancer diagnosis, ” Dr. Streicher said in an interview. “I would have liked to hear more about the consequences of an early menopause in women in terms of heart health, bone health, and cognitive function.”
Dr. Keyser noted that her talk pertained mostly to survivors of estrogen receptor (ER)–positive breast cancer since that population tends to struggle most with side effects of treatment. The most common medications used in this population are tamoxifen and aromatase inhibitors – such as anastrazole, letrozole, and exemestane – and these medications can affect management of different concerns.
Current guidance on ovarian removal
For women with a BRCA mutation, ACOG clinical guidance already exists regarding BSO. For other women, the complementary TEXT and SOFT trials changed the management of breast cancer treatment in premenopausal women, Dr. Keyser said.
Before these trials, postmenopausal hormone receptor–positive women began aromatase inhibitors and premenopausal HR-positive women began tamoxifen. These trials found that premenopausal women with HR-positive early breast cancer were less likely to experience recurrence when receiving adjuvant treatment with exemestane plus ovarian suppression compared to tamoxifen plus ovarian suppression. Ovarian suppression was achieved by either GnRH agonist injections, surgical removal of the ovaries, or radiation therapy to the ovaries.
The side effects of these treatments included hot flushes (92%), depression (87%), musculoskeletal symptoms (89%), vaginal dryness (52%), decreased libido (45%), dyspareunia (31%), osteoporosis (39%), insomnia (58%), and fatigue (61%). These are all quality of life concerns, Dr. Keyser said, and these findings raise questions about the consequences of long-term ovarian suppression. Findings from the Nurses’ Health Study showed that BSO before age 47.5 years resulted in lower mortality from ovarian cancer and breast cancer but was linked in women under 50 to increased all-cause mortality and mortality from coronary heart disease, lung cancer, and colorectal cancer, compared with ovarian conservation. Further, 74% of women who undergo risk-reducing BSO experience sexual dysfunction.
The bottom line, Dr. Keyser said, is that “premature removal of ovaries is not completely benign.” Her own recommendation is to follow ACOG guidance for women with BRCA mutations and, for women aged under 35 years, use ovarian suppression for 5-10 years, after which ovarian function may resume along with improved quality of life. In women aged over 40, remove ovaries since, after 5-10 years of treatment, there’s likely no benefit of retaining ovaries.
Addressing sexual health
Dyspareunia affects up to 45% of cancer survivors, Dr. Keyser said, and multiple treatment options exist for breast cancer survivors. The therapies she discussed included lubricants, moisturizers, local vaginal estrogen, DHEA, ospemifene, and CO2 laser therapy.
Though Dr. Keyser briefly touched on vaginal lubricants and moisturizers, Dr. Streicher was disappointed that Dr. Keyser did not clearly define and differentiate between lubricants and moisturizers or mention hyaluronic acid products. Dr. Streicher also disagreed with the way Dr. Keyser represented the benefits of coconut oil as a lubricant. “Oils are not condom compatible and are known to potentially increase the risk of infection, and not just from poor handwashing,” Dr. Streicher said.
Small retrospective studies support the safety of topical vaginal estrogen in breast cancer survivors, Dr. Keyser said, and the 10-mcg Vagifem tablet and vaginal estradiol ring appear to have the lowest systemic absorption. ACOG guidance recommends that women taking aromatase inhibitors who don’t respond to nonhormonal approaches may benefit from switching temporarily to tamoxifen with vaginal estrogen and then returning to aromatase inhibitors. However, Dr. Keyser said there’s plenty of data to support using vaginal estrogen in patients taking aromatase inhibitors.
“I do feel that it’s safe for patients, whether they’re on tamoxifen or aromatase inhibitors, to take vaginal estrogen,” Dr. Keyser said. “I usually stick with the estradiol vaginal ring or the estradiol tablet, and I base that on a patient’s comfort with placing and removing a ring.” She also, instead of asking the patient’s hematologist-oncologist, simply notifies them of the treatment since most hematologist-oncologists are less familiar with the data.
Another effective option is vaginal DHEA/prasterone, which can significantly improve sexual desire, arousal, pain, and overall sexual function. Although breast cancer patients were included in early studies on DHEA, Intrarosa manufacturers excluded breast cancer patients in their Food and Drug Administration application, resulting in a package stating that “use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer” and that “Intrarosa has not been studied in women with a history of breast cancer.” While that’s true for Intrarosa specifically, DHEA has been studied in breast cancer patients, Dr. Keyser said, so she expects to see more research in this area.
Ospemifene is another option for improving vulvovaginal atrophy but cannot be taken at the same time as tamoxifen. It has similar chemopreventive effects as tamoxifen in rat studies, but it’s not as effective. It’s a reasonable option in women with refractory genitourinary syndrome of menopause (GSM) who have completed their 5-10 years of adjuvant therapy and have no history of venous thromboembolism.
Dr. Keyser said CO2 laser therapy is still being studied for treating GSM, and current data have shown benefits for dyspareunia and vaginal dryness without documented harms. There have now been randomized, controlled trials; however, since it’s not FDA approved, it’s not covered by insurance and costs approximately $5,000 for three treatments.
Dr. Streicher was glad to see Dr. Keyser’s discussion of the safety and types of local vaginal estrogen, “although she neglected to mention the 4-mcg vaginal suppository, Imvexxy, which has the lowest systemic absorption,” Dr. Streicher said. Dr. Streicher also felt the inclusion of DHEA/prasterone and ospemifene were also important, especially since the latter is “underutilized in breast cancer patients.”
The information provided on CO2 laser therapy, however, was problematic, Dr. Streicher said, given that long-term and randomized, controlled studies have now been published. Dr. Streicher also noted that two of the devices listed on the presentation slide, Thermiva and Voltiva, are radiofrequency, not laser devices.
Aside from these treatment options, the most consistent predictor of satisfying sexual experiences in women with breast cancer is the quality of their relationships, Dr. Keyser said, so couples counseling is recommended, and treatments in general are more effective with regularly sexual activity.
In discussing nonhormonal options for treating vasomotor symptoms, Dr. Keyser recommended venlafaxine, gabapentin, and low-dose paroxetine (though SSRIs and tamoxifen are contraindicated since they may reduce tamoxifen’s efficacy).
These are all off label, Dr. Streicher said it was important to note, and she would have liked to have seen a mention of the development of KNdy neurokinin disrupters along with a more in-depth discussion about which lifestyle modifications and botanicals have been shown in randomized, controlled trials to mitigate vasomotor symptoms.
Dr. Keyser wrapped up with a few additional notes and takeaways:
- The only safe reversible long-term option for contraception in HR-positive breast cancer survivors is the Paraguard IUD.
- It’s important to discuss fertility with breast cancer patients and survivors since a majority report unmet needs in this area.
- Patients taking tamoxifen need to be sure to report any vaginal spotting or bleeding since it increases risk of endometrial cancer in postmenopausal women.
- Screen for depression and anxiety.
- Ask women about sexual health and hot flashes.
- Ensure that they’re getting bone screening.
- A recommended resource is Living Beyond Breast Cancer.
Dr. Keyser had no disclosures. Dr. Streicher has consulted for Astellas Pharma and Church & Dwight, and she owns investments in InControl Medical and Sermonix Pharmaceuticals.
Sexual dysfunction is a common problem among breast cancer survivors, but it’s also an issue inadequately addressed by either ob.gyns. or hematologists and oncologists, according to Erin Keyser, MD, the program director of the San Antonio Uniformed Services Health Education Consortium. Dr. Keyser discussed management of sexual dysfunction and a variety of other issues frequently faced by women who have survived breast cancer at the at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.
“Despite the fact that no specialty is better qualified to render care for this consequence of cancer treatments, many obstetrician-gynecologists feel uncomfortable or ill-equipped to address sexual pain in women affected by cancer,” Dr. Keyser quoted from a 2016 article in Obstetrics & Gynecology about the sexual health of women affected by cancer. As a breast cancer survivor herself, Dr. Keyser said hematologists and oncologists are even less equipped to discuss sexual health, “so oftentimes patients get punted between their hem-onc and their gyn,” with each telling the patient to ask the other specialist.
“There’s plenty of data in chronic health disease that maintaining sexual function for women is an indicator of the overall quality of life and that many women really don’t want to bring this up,” Dr. Keyser told attendees, so the onus is on the ob.gyn. to bring it up.
The effects of breast cancer treatment can impact women’s body image, fertility, menopause, sexual function, osteoporosis, and cardiovascular disease, but the bulk of Dr. Keyser’s talk focused on sexual health and bilateral salpingo-oophorectomy (BSO).
Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University, Chicago, thought Dr. Keyser’s talk was useful for the general gynecologist but had some concerns about a few parts.
“She gave a very thoughtful analysis of whether someone should have their ovaries removed or not in a breast cancer diagnosis, ” Dr. Streicher said in an interview. “I would have liked to hear more about the consequences of an early menopause in women in terms of heart health, bone health, and cognitive function.”
Dr. Keyser noted that her talk pertained mostly to survivors of estrogen receptor (ER)–positive breast cancer since that population tends to struggle most with side effects of treatment. The most common medications used in this population are tamoxifen and aromatase inhibitors – such as anastrazole, letrozole, and exemestane – and these medications can affect management of different concerns.
Current guidance on ovarian removal
For women with a BRCA mutation, ACOG clinical guidance already exists regarding BSO. For other women, the complementary TEXT and SOFT trials changed the management of breast cancer treatment in premenopausal women, Dr. Keyser said.
Before these trials, postmenopausal hormone receptor–positive women began aromatase inhibitors and premenopausal HR-positive women began tamoxifen. These trials found that premenopausal women with HR-positive early breast cancer were less likely to experience recurrence when receiving adjuvant treatment with exemestane plus ovarian suppression compared to tamoxifen plus ovarian suppression. Ovarian suppression was achieved by either GnRH agonist injections, surgical removal of the ovaries, or radiation therapy to the ovaries.
The side effects of these treatments included hot flushes (92%), depression (87%), musculoskeletal symptoms (89%), vaginal dryness (52%), decreased libido (45%), dyspareunia (31%), osteoporosis (39%), insomnia (58%), and fatigue (61%). These are all quality of life concerns, Dr. Keyser said, and these findings raise questions about the consequences of long-term ovarian suppression. Findings from the Nurses’ Health Study showed that BSO before age 47.5 years resulted in lower mortality from ovarian cancer and breast cancer but was linked in women under 50 to increased all-cause mortality and mortality from coronary heart disease, lung cancer, and colorectal cancer, compared with ovarian conservation. Further, 74% of women who undergo risk-reducing BSO experience sexual dysfunction.
The bottom line, Dr. Keyser said, is that “premature removal of ovaries is not completely benign.” Her own recommendation is to follow ACOG guidance for women with BRCA mutations and, for women aged under 35 years, use ovarian suppression for 5-10 years, after which ovarian function may resume along with improved quality of life. In women aged over 40, remove ovaries since, after 5-10 years of treatment, there’s likely no benefit of retaining ovaries.
Addressing sexual health
Dyspareunia affects up to 45% of cancer survivors, Dr. Keyser said, and multiple treatment options exist for breast cancer survivors. The therapies she discussed included lubricants, moisturizers, local vaginal estrogen, DHEA, ospemifene, and CO2 laser therapy.
Though Dr. Keyser briefly touched on vaginal lubricants and moisturizers, Dr. Streicher was disappointed that Dr. Keyser did not clearly define and differentiate between lubricants and moisturizers or mention hyaluronic acid products. Dr. Streicher also disagreed with the way Dr. Keyser represented the benefits of coconut oil as a lubricant. “Oils are not condom compatible and are known to potentially increase the risk of infection, and not just from poor handwashing,” Dr. Streicher said.
Small retrospective studies support the safety of topical vaginal estrogen in breast cancer survivors, Dr. Keyser said, and the 10-mcg Vagifem tablet and vaginal estradiol ring appear to have the lowest systemic absorption. ACOG guidance recommends that women taking aromatase inhibitors who don’t respond to nonhormonal approaches may benefit from switching temporarily to tamoxifen with vaginal estrogen and then returning to aromatase inhibitors. However, Dr. Keyser said there’s plenty of data to support using vaginal estrogen in patients taking aromatase inhibitors.
“I do feel that it’s safe for patients, whether they’re on tamoxifen or aromatase inhibitors, to take vaginal estrogen,” Dr. Keyser said. “I usually stick with the estradiol vaginal ring or the estradiol tablet, and I base that on a patient’s comfort with placing and removing a ring.” She also, instead of asking the patient’s hematologist-oncologist, simply notifies them of the treatment since most hematologist-oncologists are less familiar with the data.
Another effective option is vaginal DHEA/prasterone, which can significantly improve sexual desire, arousal, pain, and overall sexual function. Although breast cancer patients were included in early studies on DHEA, Intrarosa manufacturers excluded breast cancer patients in their Food and Drug Administration application, resulting in a package stating that “use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer” and that “Intrarosa has not been studied in women with a history of breast cancer.” While that’s true for Intrarosa specifically, DHEA has been studied in breast cancer patients, Dr. Keyser said, so she expects to see more research in this area.
Ospemifene is another option for improving vulvovaginal atrophy but cannot be taken at the same time as tamoxifen. It has similar chemopreventive effects as tamoxifen in rat studies, but it’s not as effective. It’s a reasonable option in women with refractory genitourinary syndrome of menopause (GSM) who have completed their 5-10 years of adjuvant therapy and have no history of venous thromboembolism.
Dr. Keyser said CO2 laser therapy is still being studied for treating GSM, and current data have shown benefits for dyspareunia and vaginal dryness without documented harms. There have now been randomized, controlled trials; however, since it’s not FDA approved, it’s not covered by insurance and costs approximately $5,000 for three treatments.
Dr. Streicher was glad to see Dr. Keyser’s discussion of the safety and types of local vaginal estrogen, “although she neglected to mention the 4-mcg vaginal suppository, Imvexxy, which has the lowest systemic absorption,” Dr. Streicher said. Dr. Streicher also felt the inclusion of DHEA/prasterone and ospemifene were also important, especially since the latter is “underutilized in breast cancer patients.”
The information provided on CO2 laser therapy, however, was problematic, Dr. Streicher said, given that long-term and randomized, controlled studies have now been published. Dr. Streicher also noted that two of the devices listed on the presentation slide, Thermiva and Voltiva, are radiofrequency, not laser devices.
Aside from these treatment options, the most consistent predictor of satisfying sexual experiences in women with breast cancer is the quality of their relationships, Dr. Keyser said, so couples counseling is recommended, and treatments in general are more effective with regularly sexual activity.
In discussing nonhormonal options for treating vasomotor symptoms, Dr. Keyser recommended venlafaxine, gabapentin, and low-dose paroxetine (though SSRIs and tamoxifen are contraindicated since they may reduce tamoxifen’s efficacy).
These are all off label, Dr. Streicher said it was important to note, and she would have liked to have seen a mention of the development of KNdy neurokinin disrupters along with a more in-depth discussion about which lifestyle modifications and botanicals have been shown in randomized, controlled trials to mitigate vasomotor symptoms.
Dr. Keyser wrapped up with a few additional notes and takeaways:
- The only safe reversible long-term option for contraception in HR-positive breast cancer survivors is the Paraguard IUD.
- It’s important to discuss fertility with breast cancer patients and survivors since a majority report unmet needs in this area.
- Patients taking tamoxifen need to be sure to report any vaginal spotting or bleeding since it increases risk of endometrial cancer in postmenopausal women.
- Screen for depression and anxiety.
- Ask women about sexual health and hot flashes.
- Ensure that they’re getting bone screening.
- A recommended resource is Living Beyond Breast Cancer.
Dr. Keyser had no disclosures. Dr. Streicher has consulted for Astellas Pharma and Church & Dwight, and she owns investments in InControl Medical and Sermonix Pharmaceuticals.
FROM ACOG 2021
Pediatric cancer survivors at risk for opioid misuse
Survivors of childhood cancers are at increased risk for prescription opioid misuse compared with their peers, a review of a claims database revealed.
Among more than 8,000 patients age 21 or younger who had completed treatment for hematologic, central nervous system, bone, or gonadal cancers, survivors were significantly more likely than were their peers to have an opioid prescription, longer duration of prescription, and higher daily doses of opioids, and to have opioid prescriptions overlapping for a week or more, reported Xu Ji, PhD, of Emory University in Atlanta.
Teenage and young adult patients were at higher risk than were patients younger than 12, and the risk was highest among patients who had been treated for bone malignancies, as well as those who had undergone any hematopoietic stem cell transplant.
“These findings suggest that health care providers who regularly see survivors should explore nonopioid options to help prevent opioid misuse, and screen for potential misuse in those who actually receive opioids,” she said in an oral abstract presented during the annual meeting of the American Society of Pediatric Hematology/Oncology.
“This is a really important topic, and something that’s probably been underinvestigated and underexplored in our patient population,” said session comoderator Sheri Spunt, MD, Endowed Professor of Pediatric Cancer at Stanford (Calif.) University.
Database review
Dr. Ji and colleagues used the IBM MarketScan Commercial Claims and Encounters database from 2009 to 2018 to examine prescription opioid use, potential misuse, and substance use disorders in pediatric cancer survivors in the first year after completion of therapy, and to identify factors associated with risk for misuse or substance use disorders. Specifically, the period of interest was the first year after completion of all treatments, including surgery, chemotherapy, radiation, and stem cell transplant (Abstract 2015).
They looked at deidentified records on any opioid prescription and for treatment of any opioid use or substance use disorder (alcohol, psychotherapeutic drugs, marijuana, or illicit drug use disorders).
They defined indicators of potential misuse as either prescriptions for long-acting or extended-release opioids for acute pain conditions; opioid and benzodiazepine prescriptions overlapping by a week or more; opioid prescriptions overlapping by a week or more; high daily opioid dosage (prescribed daily dose of 100 or greater morphine milligram equivalent [MME]; and/or opioid dose escalation (an increase of at least 50% in mean MMEs per month twice consecutively within 1 year).
They compared outcomes between a total of 8,635 survivors and 44,175 controls, matched on a 1:5 basis with survivors by age, sex, and region, and continuous enrollment during the 1-year posttherapy period.
In each of three age categories – 0 to 11 years, 12 to 17 years, and 18 years and older – survivors were significantly more likely to have received an opioid prescription, at 15% for the youngest survivors vs. 2% of controls, 25% vs. 8% for 12- to 17-year-olds, and 28% vs. 12% for those 18 and older (P < .01 for all three comparisons).
Survivors were also significantly more likely to have any indicator of potential misuse (1.6% vs. 0.1%, 4.6% vs. 0.5%, and 7.4% vs. 1.2%, respectively, P < .001 for all) and both the youngest and oldest groups (but not 12- to 17-year-olds) were significantly more like to have opioid or substance use disorder (0.4% vs. 0% for 0-11 years, 5.76% vs. 4.2% for 18 years and older, P < .001 for both).
Among patients with any opioid prescription, survivors were significantly more likely than were controls of any age to have indicators for potential misuse. For example, 13% of survivors aged 18 years and older had prescriptions for high opioid doses, compared with 5% of controls, and 12% had prescription overlap, vs. 2%.
Compared with patients with leukemia, patients treated for bone malignancies had a 6% greater risk for having any indicator of misuse, while patients with other malignancies were at slightly lower risk for misuse than those who completed leukemia therapy.
Patients who received any stem cell transplant had an 8.4% greater risk for misuse compared with patients who had surgery only.
Opioids pre- and posttreatment?
“Being someone who takes care of a lot of bone cancer patients, I do see patients with these issues,” Dr. Spunt said.
Audience member Jack H. Staddon, MD, PhD, of the Billings (Montana) Clinic, noted the possibility that opioid use during treatment may have been carried on into the posttreatment period, and asked whether use of narcotics during treatment was an independent risk factor for posttreatment narcotic use or misuse.
The researchers plan to investigate this question in future studies, Dr. Ji replied.
They did not report a study funding source. Dr. Ji and coauthors and Dr. Staddon reported no relevant disclosures.
Survivors of childhood cancers are at increased risk for prescription opioid misuse compared with their peers, a review of a claims database revealed.
Among more than 8,000 patients age 21 or younger who had completed treatment for hematologic, central nervous system, bone, or gonadal cancers, survivors were significantly more likely than were their peers to have an opioid prescription, longer duration of prescription, and higher daily doses of opioids, and to have opioid prescriptions overlapping for a week or more, reported Xu Ji, PhD, of Emory University in Atlanta.
Teenage and young adult patients were at higher risk than were patients younger than 12, and the risk was highest among patients who had been treated for bone malignancies, as well as those who had undergone any hematopoietic stem cell transplant.
“These findings suggest that health care providers who regularly see survivors should explore nonopioid options to help prevent opioid misuse, and screen for potential misuse in those who actually receive opioids,” she said in an oral abstract presented during the annual meeting of the American Society of Pediatric Hematology/Oncology.
“This is a really important topic, and something that’s probably been underinvestigated and underexplored in our patient population,” said session comoderator Sheri Spunt, MD, Endowed Professor of Pediatric Cancer at Stanford (Calif.) University.
Database review
Dr. Ji and colleagues used the IBM MarketScan Commercial Claims and Encounters database from 2009 to 2018 to examine prescription opioid use, potential misuse, and substance use disorders in pediatric cancer survivors in the first year after completion of therapy, and to identify factors associated with risk for misuse or substance use disorders. Specifically, the period of interest was the first year after completion of all treatments, including surgery, chemotherapy, radiation, and stem cell transplant (Abstract 2015).
They looked at deidentified records on any opioid prescription and for treatment of any opioid use or substance use disorder (alcohol, psychotherapeutic drugs, marijuana, or illicit drug use disorders).
They defined indicators of potential misuse as either prescriptions for long-acting or extended-release opioids for acute pain conditions; opioid and benzodiazepine prescriptions overlapping by a week or more; opioid prescriptions overlapping by a week or more; high daily opioid dosage (prescribed daily dose of 100 or greater morphine milligram equivalent [MME]; and/or opioid dose escalation (an increase of at least 50% in mean MMEs per month twice consecutively within 1 year).
They compared outcomes between a total of 8,635 survivors and 44,175 controls, matched on a 1:5 basis with survivors by age, sex, and region, and continuous enrollment during the 1-year posttherapy period.
In each of three age categories – 0 to 11 years, 12 to 17 years, and 18 years and older – survivors were significantly more likely to have received an opioid prescription, at 15% for the youngest survivors vs. 2% of controls, 25% vs. 8% for 12- to 17-year-olds, and 28% vs. 12% for those 18 and older (P < .01 for all three comparisons).
Survivors were also significantly more likely to have any indicator of potential misuse (1.6% vs. 0.1%, 4.6% vs. 0.5%, and 7.4% vs. 1.2%, respectively, P < .001 for all) and both the youngest and oldest groups (but not 12- to 17-year-olds) were significantly more like to have opioid or substance use disorder (0.4% vs. 0% for 0-11 years, 5.76% vs. 4.2% for 18 years and older, P < .001 for both).
Among patients with any opioid prescription, survivors were significantly more likely than were controls of any age to have indicators for potential misuse. For example, 13% of survivors aged 18 years and older had prescriptions for high opioid doses, compared with 5% of controls, and 12% had prescription overlap, vs. 2%.
Compared with patients with leukemia, patients treated for bone malignancies had a 6% greater risk for having any indicator of misuse, while patients with other malignancies were at slightly lower risk for misuse than those who completed leukemia therapy.
Patients who received any stem cell transplant had an 8.4% greater risk for misuse compared with patients who had surgery only.
Opioids pre- and posttreatment?
“Being someone who takes care of a lot of bone cancer patients, I do see patients with these issues,” Dr. Spunt said.
Audience member Jack H. Staddon, MD, PhD, of the Billings (Montana) Clinic, noted the possibility that opioid use during treatment may have been carried on into the posttreatment period, and asked whether use of narcotics during treatment was an independent risk factor for posttreatment narcotic use or misuse.
The researchers plan to investigate this question in future studies, Dr. Ji replied.
They did not report a study funding source. Dr. Ji and coauthors and Dr. Staddon reported no relevant disclosures.
Survivors of childhood cancers are at increased risk for prescription opioid misuse compared with their peers, a review of a claims database revealed.
Among more than 8,000 patients age 21 or younger who had completed treatment for hematologic, central nervous system, bone, or gonadal cancers, survivors were significantly more likely than were their peers to have an opioid prescription, longer duration of prescription, and higher daily doses of opioids, and to have opioid prescriptions overlapping for a week or more, reported Xu Ji, PhD, of Emory University in Atlanta.
Teenage and young adult patients were at higher risk than were patients younger than 12, and the risk was highest among patients who had been treated for bone malignancies, as well as those who had undergone any hematopoietic stem cell transplant.
“These findings suggest that health care providers who regularly see survivors should explore nonopioid options to help prevent opioid misuse, and screen for potential misuse in those who actually receive opioids,” she said in an oral abstract presented during the annual meeting of the American Society of Pediatric Hematology/Oncology.
“This is a really important topic, and something that’s probably been underinvestigated and underexplored in our patient population,” said session comoderator Sheri Spunt, MD, Endowed Professor of Pediatric Cancer at Stanford (Calif.) University.
Database review
Dr. Ji and colleagues used the IBM MarketScan Commercial Claims and Encounters database from 2009 to 2018 to examine prescription opioid use, potential misuse, and substance use disorders in pediatric cancer survivors in the first year after completion of therapy, and to identify factors associated with risk for misuse or substance use disorders. Specifically, the period of interest was the first year after completion of all treatments, including surgery, chemotherapy, radiation, and stem cell transplant (Abstract 2015).
They looked at deidentified records on any opioid prescription and for treatment of any opioid use or substance use disorder (alcohol, psychotherapeutic drugs, marijuana, or illicit drug use disorders).
They defined indicators of potential misuse as either prescriptions for long-acting or extended-release opioids for acute pain conditions; opioid and benzodiazepine prescriptions overlapping by a week or more; opioid prescriptions overlapping by a week or more; high daily opioid dosage (prescribed daily dose of 100 or greater morphine milligram equivalent [MME]; and/or opioid dose escalation (an increase of at least 50% in mean MMEs per month twice consecutively within 1 year).
They compared outcomes between a total of 8,635 survivors and 44,175 controls, matched on a 1:5 basis with survivors by age, sex, and region, and continuous enrollment during the 1-year posttherapy period.
In each of three age categories – 0 to 11 years, 12 to 17 years, and 18 years and older – survivors were significantly more likely to have received an opioid prescription, at 15% for the youngest survivors vs. 2% of controls, 25% vs. 8% for 12- to 17-year-olds, and 28% vs. 12% for those 18 and older (P < .01 for all three comparisons).
Survivors were also significantly more likely to have any indicator of potential misuse (1.6% vs. 0.1%, 4.6% vs. 0.5%, and 7.4% vs. 1.2%, respectively, P < .001 for all) and both the youngest and oldest groups (but not 12- to 17-year-olds) were significantly more like to have opioid or substance use disorder (0.4% vs. 0% for 0-11 years, 5.76% vs. 4.2% for 18 years and older, P < .001 for both).
Among patients with any opioid prescription, survivors were significantly more likely than were controls of any age to have indicators for potential misuse. For example, 13% of survivors aged 18 years and older had prescriptions for high opioid doses, compared with 5% of controls, and 12% had prescription overlap, vs. 2%.
Compared with patients with leukemia, patients treated for bone malignancies had a 6% greater risk for having any indicator of misuse, while patients with other malignancies were at slightly lower risk for misuse than those who completed leukemia therapy.
Patients who received any stem cell transplant had an 8.4% greater risk for misuse compared with patients who had surgery only.
Opioids pre- and posttreatment?
“Being someone who takes care of a lot of bone cancer patients, I do see patients with these issues,” Dr. Spunt said.
Audience member Jack H. Staddon, MD, PhD, of the Billings (Montana) Clinic, noted the possibility that opioid use during treatment may have been carried on into the posttreatment period, and asked whether use of narcotics during treatment was an independent risk factor for posttreatment narcotic use or misuse.
The researchers plan to investigate this question in future studies, Dr. Ji replied.
They did not report a study funding source. Dr. Ji and coauthors and Dr. Staddon reported no relevant disclosures.
FROM 2021 ASPHO CONFERENCE