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Trends in the management of pulmonary embolism
One of the newest trends in pulmonary embolism management is treatment of cancer associated venous thromboembolism (VTE) which encompasses deep vein thrombosis (DVT) and PE. Following the clinical management of cancer-associated venous thromboembolism in the hospital, direct oral anticoagulant therapy at discharge is your starting point, except in cases of intact luminal cancers, Scott Kaatz, DO, MSc, FACP, SFHM, said during SHM Converge, the annual conference of the Society of Hospital Medicine.
Dr. Kaatz, of the division of hospital medicine at Henry Ford Hospital, Detroit, based his remarks on emerging recommendations from leading medical societies on the topic, as well as a one-page algorithm from the Anticoagulation Forum that can be accessed at https://acforum-excellence.org/Resource-Center/resource_files/1638-2020-11-30-121425.pdf.
For the short-term treatment of VTE (3-6 months) for patients with active cancer, the American Society of Hematology guideline panel suggests direct oral anticoagulants, such as apixaban, edoxaban, or rivaroxaban, over low-molecular-weight heparin (LMWH) – a conditional recommendation based on low certainty in the evidence of effects.
Dr. Kaatz also discussed the latest recommendations regarding length of VTE treatment. After completion of primary treatment for patients with DVT and/or PE provoked by a chronic risk factor such as a surgery, pregnancy, or having a leg in a cast, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “On the other hand, patients with DVT and/or PE provoked by a transient factor typically do not require antithrombotic therapy after completion of primary treatment,” said Dr. Kaatz, who is also a clinical professor of medicine at Wayne State University, Detroit.
After completion of primary treatment for patients with unprovoked DVT and/or PE, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “The recommendation does not apply to patients who have a high risk for bleeding complications,” he noted.
Transient or reversible risk factors should be also considered in length of VTE treatment. For example, according to guidelines from the European Society of Cardiology, the estimated risk for long-term VTE recurrence is high (defined as greater than 8% per year) for patients with active cancer, for patients with one or more previous episodes of VTE in the absence of a major transient or reversible factor, and for those with antiphospholipid antibody syndrome.
Dr. Kaatz also highlighted recommendations for the acute treatment of intermediate risk, or submassive PE. The ESC guidelines state that if anticoagulation is initiated parenterally, LMWH or fondaparinux is recommended over unfractionated heparin (UFH) for most patients. “The reason for that is, one drug-use evaluation study found that, after 24 hours using UFH, only about 24% of patients had reached their therapeutic goal,” Dr. Kaatz said. Guidelines for intermediate risk patients from ASH recommend anticoagulation as your starting point, while thrombolysis is reasonable to consider for submassive PE and low risk for bleeding in selected younger patients or for patients at high risk for decompensation because of concomitant cardiopulmonary disease. “The bleeding rates get much higher in patients over age 65,” he said.
Another resource Dr. Kaatz mentioned is the Pulmonary Embolism Response Team (PERT) Consortium, which was developed after initial efforts of a multidisciplinary team of physicians at Massachusetts General Hospital. The first PERT sought to coordinate and expedite the treatment of pulmonary embolus with a team of physicians from a variety of specialties. In 2019 the PERT Consortium published guidelines on the diagnosis, treatment, and follow-up of acute PE. “It includes detailed algorithms that are a little different from the ASH and ESC guidelines,” Dr. Kaatz said.
Dr. Kaatz disclosed that he is a consultant for Janssen, Pfizer, Portola/Alexion, Bristol-Myers Squibb, Novartis, and CSL Behring. He has also received research funding from Janssen, Bristol-Myers Squibb, and Osmosis. He also holds board positions with the AC Forum and the National Blood Clot Alliance Medical and Scientific Advisory Board.
One of the newest trends in pulmonary embolism management is treatment of cancer associated venous thromboembolism (VTE) which encompasses deep vein thrombosis (DVT) and PE. Following the clinical management of cancer-associated venous thromboembolism in the hospital, direct oral anticoagulant therapy at discharge is your starting point, except in cases of intact luminal cancers, Scott Kaatz, DO, MSc, FACP, SFHM, said during SHM Converge, the annual conference of the Society of Hospital Medicine.
Dr. Kaatz, of the division of hospital medicine at Henry Ford Hospital, Detroit, based his remarks on emerging recommendations from leading medical societies on the topic, as well as a one-page algorithm from the Anticoagulation Forum that can be accessed at https://acforum-excellence.org/Resource-Center/resource_files/1638-2020-11-30-121425.pdf.
For the short-term treatment of VTE (3-6 months) for patients with active cancer, the American Society of Hematology guideline panel suggests direct oral anticoagulants, such as apixaban, edoxaban, or rivaroxaban, over low-molecular-weight heparin (LMWH) – a conditional recommendation based on low certainty in the evidence of effects.
Dr. Kaatz also discussed the latest recommendations regarding length of VTE treatment. After completion of primary treatment for patients with DVT and/or PE provoked by a chronic risk factor such as a surgery, pregnancy, or having a leg in a cast, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “On the other hand, patients with DVT and/or PE provoked by a transient factor typically do not require antithrombotic therapy after completion of primary treatment,” said Dr. Kaatz, who is also a clinical professor of medicine at Wayne State University, Detroit.
After completion of primary treatment for patients with unprovoked DVT and/or PE, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “The recommendation does not apply to patients who have a high risk for bleeding complications,” he noted.
Transient or reversible risk factors should be also considered in length of VTE treatment. For example, according to guidelines from the European Society of Cardiology, the estimated risk for long-term VTE recurrence is high (defined as greater than 8% per year) for patients with active cancer, for patients with one or more previous episodes of VTE in the absence of a major transient or reversible factor, and for those with antiphospholipid antibody syndrome.
Dr. Kaatz also highlighted recommendations for the acute treatment of intermediate risk, or submassive PE. The ESC guidelines state that if anticoagulation is initiated parenterally, LMWH or fondaparinux is recommended over unfractionated heparin (UFH) for most patients. “The reason for that is, one drug-use evaluation study found that, after 24 hours using UFH, only about 24% of patients had reached their therapeutic goal,” Dr. Kaatz said. Guidelines for intermediate risk patients from ASH recommend anticoagulation as your starting point, while thrombolysis is reasonable to consider for submassive PE and low risk for bleeding in selected younger patients or for patients at high risk for decompensation because of concomitant cardiopulmonary disease. “The bleeding rates get much higher in patients over age 65,” he said.
Another resource Dr. Kaatz mentioned is the Pulmonary Embolism Response Team (PERT) Consortium, which was developed after initial efforts of a multidisciplinary team of physicians at Massachusetts General Hospital. The first PERT sought to coordinate and expedite the treatment of pulmonary embolus with a team of physicians from a variety of specialties. In 2019 the PERT Consortium published guidelines on the diagnosis, treatment, and follow-up of acute PE. “It includes detailed algorithms that are a little different from the ASH and ESC guidelines,” Dr. Kaatz said.
Dr. Kaatz disclosed that he is a consultant for Janssen, Pfizer, Portola/Alexion, Bristol-Myers Squibb, Novartis, and CSL Behring. He has also received research funding from Janssen, Bristol-Myers Squibb, and Osmosis. He also holds board positions with the AC Forum and the National Blood Clot Alliance Medical and Scientific Advisory Board.
One of the newest trends in pulmonary embolism management is treatment of cancer associated venous thromboembolism (VTE) which encompasses deep vein thrombosis (DVT) and PE. Following the clinical management of cancer-associated venous thromboembolism in the hospital, direct oral anticoagulant therapy at discharge is your starting point, except in cases of intact luminal cancers, Scott Kaatz, DO, MSc, FACP, SFHM, said during SHM Converge, the annual conference of the Society of Hospital Medicine.
Dr. Kaatz, of the division of hospital medicine at Henry Ford Hospital, Detroit, based his remarks on emerging recommendations from leading medical societies on the topic, as well as a one-page algorithm from the Anticoagulation Forum that can be accessed at https://acforum-excellence.org/Resource-Center/resource_files/1638-2020-11-30-121425.pdf.
For the short-term treatment of VTE (3-6 months) for patients with active cancer, the American Society of Hematology guideline panel suggests direct oral anticoagulants, such as apixaban, edoxaban, or rivaroxaban, over low-molecular-weight heparin (LMWH) – a conditional recommendation based on low certainty in the evidence of effects.
Dr. Kaatz also discussed the latest recommendations regarding length of VTE treatment. After completion of primary treatment for patients with DVT and/or PE provoked by a chronic risk factor such as a surgery, pregnancy, or having a leg in a cast, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “On the other hand, patients with DVT and/or PE provoked by a transient factor typically do not require antithrombotic therapy after completion of primary treatment,” said Dr. Kaatz, who is also a clinical professor of medicine at Wayne State University, Detroit.
After completion of primary treatment for patients with unprovoked DVT and/or PE, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “The recommendation does not apply to patients who have a high risk for bleeding complications,” he noted.
Transient or reversible risk factors should be also considered in length of VTE treatment. For example, according to guidelines from the European Society of Cardiology, the estimated risk for long-term VTE recurrence is high (defined as greater than 8% per year) for patients with active cancer, for patients with one or more previous episodes of VTE in the absence of a major transient or reversible factor, and for those with antiphospholipid antibody syndrome.
Dr. Kaatz also highlighted recommendations for the acute treatment of intermediate risk, or submassive PE. The ESC guidelines state that if anticoagulation is initiated parenterally, LMWH or fondaparinux is recommended over unfractionated heparin (UFH) for most patients. “The reason for that is, one drug-use evaluation study found that, after 24 hours using UFH, only about 24% of patients had reached their therapeutic goal,” Dr. Kaatz said. Guidelines for intermediate risk patients from ASH recommend anticoagulation as your starting point, while thrombolysis is reasonable to consider for submassive PE and low risk for bleeding in selected younger patients or for patients at high risk for decompensation because of concomitant cardiopulmonary disease. “The bleeding rates get much higher in patients over age 65,” he said.
Another resource Dr. Kaatz mentioned is the Pulmonary Embolism Response Team (PERT) Consortium, which was developed after initial efforts of a multidisciplinary team of physicians at Massachusetts General Hospital. The first PERT sought to coordinate and expedite the treatment of pulmonary embolus with a team of physicians from a variety of specialties. In 2019 the PERT Consortium published guidelines on the diagnosis, treatment, and follow-up of acute PE. “It includes detailed algorithms that are a little different from the ASH and ESC guidelines,” Dr. Kaatz said.
Dr. Kaatz disclosed that he is a consultant for Janssen, Pfizer, Portola/Alexion, Bristol-Myers Squibb, Novartis, and CSL Behring. He has also received research funding from Janssen, Bristol-Myers Squibb, and Osmosis. He also holds board positions with the AC Forum and the National Blood Clot Alliance Medical and Scientific Advisory Board.
FROM SHM CONVERGE 2021
Expert emphasizes importance of screening for OSA prior to surgery
If you don’t have a standardized process for obstructive sleep apnea screening of all patients heading into the operating room at your hospital you should, because perioperative pulmonary complications can occur, according to Efren C. Manjarrez MD, SFHM, FACP.
If OSA is not documented in the patient’s chart, you may find yourself making a bedside assessment. “I usually don’t ask the patients this because they can’t necessarily answer the questions,” Dr. Manjarrez, associate professor in the division of hospital medicine at the University of Miami, said at SHM Converge, the annual conference of the Society of Hospital Medicine. “So, I ask their partner: ‘Does your partner snore loudly? Are they sleepy during the daytime, or are they gasping or choking in the middle of the night?’”
The following factors have a relatively high specificity for OSA: a STOP-Bang score of 5 or greater, a STOP-Bang score of 2 or greater plus male gender, and a STOP-Bang score of 2 or greater plus a body mass index greater than 35 kg/m2. Clinicians can also check the Mallampati score on their patients by having them tilt their heads back and stick out their tongues.
“If the uvula is not touching the tongue, that’s a Mallampati score of 1; that’s a pretty wide-open airway,” Dr. Manjarrez said. “However, when you do not have any form of an airway and the palate is touching the tongue, that is a Mallampati score of 4, which indicates OSA.”
Other objective data suggestive of OSA include high blood pressure, a BMI over 35 kg/m2, a neck circumference of greater than 40 cm, and male gender. In a study of patients who presented for surgery who did not have a diagnosis of sleep apnea, a high STOP-Bang score indicated a high probability of moderate to severe sleep apnea (Br J. Anaesth 2012;108[5]:768-75).
“If the STOP-Bang score is 0-2, your workup stops,” Dr. Manjarrez said. “If your STOP-Bang score is 5 or above, there’s a high likelihood they have moderate or severe sleep apnea. Patients who have a STOP-Bang of 3-4, calculate their STOP score. If the STOP score is 2 or more and they’re male, obese, and have a neck circumference of greater than 40 cm, there’s a pretty good chance they’ve got OSA.”
Screening for OSA prior to surgery matters, because the potential pulmonary complications are fairly high, “anywhere from postoperative respiratory failure to COPD exacerbation and hypoxia to pneumonia,” he continued. “These patients very commonly desaturate and are difficult for the anesthesiologists to intubate. Fortunately, we have not found significant cardiac complications in the medical literature, but we do know that patients with OSA commonly get postoperative atrial fibrillation. There are also combined complications like desaturation and AFib and difficult intubations. Patients with sleep apnea do have a higher resource utilization perioperatively. Fortunately, at this point in time the data does not show that patients with OSA going in for surgery have an increased mortality.”
To optimize the care of these patients prior to surgery, Dr. Manjarrez recommends that hospitalists document that a patient either has known OSA or suspected OSA. “If possible, obtain their sleep study results and recommended PAP settings,” he said. “Ask patients to bring their PAP device to the hospital or to assure the hospital has appropriate surrogate devices available. You also want to advise the patient and the perioperative care team of the increased risk of complications in patients at high risk for OSA and optimize other conditions that may impair cardiorespiratory function.”
Perioperative risk reduction strategies include planning for difficult intubation and mask ventilation, using regional anesthesia and analgesia, using sedatives with caution, minimizing the use of opioids and anticipating variable opioid responses. “When I have a patient with suspected sleep apnea and no red flags I write down ‘OSA precautions,’ in the chart, which means elevate the head of the bed, perform continuous pulse oximetry, and cautiously supply supplemental oxygen as needed,” he said.
Postoperatively, he continued, minimize sedative agents and opioids, use regional and nonopioid analgesics when possible, provide supplemental oxygen until the patient is able to maintain baseline SaO2 on room air in a monitored setting, maintain the patient in nonsupine position when feasible, and continuously monitor pulse oximetry.
Consider delay of elective surgery and referral to a sleep medicine specialist in cases of uncontrolled systemic conditions or impaired gas exchange, including hypoventilation syndromes (a clue being a serum HC03 of 28 or higher), severe pulmonary hypertension (a clue being right ventricular systolic blood pressure or pulmonary systolic pressure of 70 mm Hg or above, or right ventricular dilatation/dysfunction), and hypoxemia not explained by cardiac disease.
A systematic review and meta-analysis of six studies that included 904 patients with sleep apnea found that there was no significant difference in the postoperative adverse events between CPAP and no-CPAP treatment (Anesth Analg 2015;120:1013-23). However, there was a significant reduction in the Apnea-Hypopnea Index postoperatively among those who used CPAP (37 vs. 12 events per hour; P less than .001), as well as a significant reduction in hospital length of stay 4 vs. 4.4 days; P = .05).
Dr. Manjarrez reported having no financial disclosures.
If you don’t have a standardized process for obstructive sleep apnea screening of all patients heading into the operating room at your hospital you should, because perioperative pulmonary complications can occur, according to Efren C. Manjarrez MD, SFHM, FACP.
If OSA is not documented in the patient’s chart, you may find yourself making a bedside assessment. “I usually don’t ask the patients this because they can’t necessarily answer the questions,” Dr. Manjarrez, associate professor in the division of hospital medicine at the University of Miami, said at SHM Converge, the annual conference of the Society of Hospital Medicine. “So, I ask their partner: ‘Does your partner snore loudly? Are they sleepy during the daytime, or are they gasping or choking in the middle of the night?’”
The following factors have a relatively high specificity for OSA: a STOP-Bang score of 5 or greater, a STOP-Bang score of 2 or greater plus male gender, and a STOP-Bang score of 2 or greater plus a body mass index greater than 35 kg/m2. Clinicians can also check the Mallampati score on their patients by having them tilt their heads back and stick out their tongues.
“If the uvula is not touching the tongue, that’s a Mallampati score of 1; that’s a pretty wide-open airway,” Dr. Manjarrez said. “However, when you do not have any form of an airway and the palate is touching the tongue, that is a Mallampati score of 4, which indicates OSA.”
Other objective data suggestive of OSA include high blood pressure, a BMI over 35 kg/m2, a neck circumference of greater than 40 cm, and male gender. In a study of patients who presented for surgery who did not have a diagnosis of sleep apnea, a high STOP-Bang score indicated a high probability of moderate to severe sleep apnea (Br J. Anaesth 2012;108[5]:768-75).
“If the STOP-Bang score is 0-2, your workup stops,” Dr. Manjarrez said. “If your STOP-Bang score is 5 or above, there’s a high likelihood they have moderate or severe sleep apnea. Patients who have a STOP-Bang of 3-4, calculate their STOP score. If the STOP score is 2 or more and they’re male, obese, and have a neck circumference of greater than 40 cm, there’s a pretty good chance they’ve got OSA.”
Screening for OSA prior to surgery matters, because the potential pulmonary complications are fairly high, “anywhere from postoperative respiratory failure to COPD exacerbation and hypoxia to pneumonia,” he continued. “These patients very commonly desaturate and are difficult for the anesthesiologists to intubate. Fortunately, we have not found significant cardiac complications in the medical literature, but we do know that patients with OSA commonly get postoperative atrial fibrillation. There are also combined complications like desaturation and AFib and difficult intubations. Patients with sleep apnea do have a higher resource utilization perioperatively. Fortunately, at this point in time the data does not show that patients with OSA going in for surgery have an increased mortality.”
To optimize the care of these patients prior to surgery, Dr. Manjarrez recommends that hospitalists document that a patient either has known OSA or suspected OSA. “If possible, obtain their sleep study results and recommended PAP settings,” he said. “Ask patients to bring their PAP device to the hospital or to assure the hospital has appropriate surrogate devices available. You also want to advise the patient and the perioperative care team of the increased risk of complications in patients at high risk for OSA and optimize other conditions that may impair cardiorespiratory function.”
Perioperative risk reduction strategies include planning for difficult intubation and mask ventilation, using regional anesthesia and analgesia, using sedatives with caution, minimizing the use of opioids and anticipating variable opioid responses. “When I have a patient with suspected sleep apnea and no red flags I write down ‘OSA precautions,’ in the chart, which means elevate the head of the bed, perform continuous pulse oximetry, and cautiously supply supplemental oxygen as needed,” he said.
Postoperatively, he continued, minimize sedative agents and opioids, use regional and nonopioid analgesics when possible, provide supplemental oxygen until the patient is able to maintain baseline SaO2 on room air in a monitored setting, maintain the patient in nonsupine position when feasible, and continuously monitor pulse oximetry.
Consider delay of elective surgery and referral to a sleep medicine specialist in cases of uncontrolled systemic conditions or impaired gas exchange, including hypoventilation syndromes (a clue being a serum HC03 of 28 or higher), severe pulmonary hypertension (a clue being right ventricular systolic blood pressure or pulmonary systolic pressure of 70 mm Hg or above, or right ventricular dilatation/dysfunction), and hypoxemia not explained by cardiac disease.
A systematic review and meta-analysis of six studies that included 904 patients with sleep apnea found that there was no significant difference in the postoperative adverse events between CPAP and no-CPAP treatment (Anesth Analg 2015;120:1013-23). However, there was a significant reduction in the Apnea-Hypopnea Index postoperatively among those who used CPAP (37 vs. 12 events per hour; P less than .001), as well as a significant reduction in hospital length of stay 4 vs. 4.4 days; P = .05).
Dr. Manjarrez reported having no financial disclosures.
If you don’t have a standardized process for obstructive sleep apnea screening of all patients heading into the operating room at your hospital you should, because perioperative pulmonary complications can occur, according to Efren C. Manjarrez MD, SFHM, FACP.
If OSA is not documented in the patient’s chart, you may find yourself making a bedside assessment. “I usually don’t ask the patients this because they can’t necessarily answer the questions,” Dr. Manjarrez, associate professor in the division of hospital medicine at the University of Miami, said at SHM Converge, the annual conference of the Society of Hospital Medicine. “So, I ask their partner: ‘Does your partner snore loudly? Are they sleepy during the daytime, or are they gasping or choking in the middle of the night?’”
The following factors have a relatively high specificity for OSA: a STOP-Bang score of 5 or greater, a STOP-Bang score of 2 or greater plus male gender, and a STOP-Bang score of 2 or greater plus a body mass index greater than 35 kg/m2. Clinicians can also check the Mallampati score on their patients by having them tilt their heads back and stick out their tongues.
“If the uvula is not touching the tongue, that’s a Mallampati score of 1; that’s a pretty wide-open airway,” Dr. Manjarrez said. “However, when you do not have any form of an airway and the palate is touching the tongue, that is a Mallampati score of 4, which indicates OSA.”
Other objective data suggestive of OSA include high blood pressure, a BMI over 35 kg/m2, a neck circumference of greater than 40 cm, and male gender. In a study of patients who presented for surgery who did not have a diagnosis of sleep apnea, a high STOP-Bang score indicated a high probability of moderate to severe sleep apnea (Br J. Anaesth 2012;108[5]:768-75).
“If the STOP-Bang score is 0-2, your workup stops,” Dr. Manjarrez said. “If your STOP-Bang score is 5 or above, there’s a high likelihood they have moderate or severe sleep apnea. Patients who have a STOP-Bang of 3-4, calculate their STOP score. If the STOP score is 2 or more and they’re male, obese, and have a neck circumference of greater than 40 cm, there’s a pretty good chance they’ve got OSA.”
Screening for OSA prior to surgery matters, because the potential pulmonary complications are fairly high, “anywhere from postoperative respiratory failure to COPD exacerbation and hypoxia to pneumonia,” he continued. “These patients very commonly desaturate and are difficult for the anesthesiologists to intubate. Fortunately, we have not found significant cardiac complications in the medical literature, but we do know that patients with OSA commonly get postoperative atrial fibrillation. There are also combined complications like desaturation and AFib and difficult intubations. Patients with sleep apnea do have a higher resource utilization perioperatively. Fortunately, at this point in time the data does not show that patients with OSA going in for surgery have an increased mortality.”
To optimize the care of these patients prior to surgery, Dr. Manjarrez recommends that hospitalists document that a patient either has known OSA or suspected OSA. “If possible, obtain their sleep study results and recommended PAP settings,” he said. “Ask patients to bring their PAP device to the hospital or to assure the hospital has appropriate surrogate devices available. You also want to advise the patient and the perioperative care team of the increased risk of complications in patients at high risk for OSA and optimize other conditions that may impair cardiorespiratory function.”
Perioperative risk reduction strategies include planning for difficult intubation and mask ventilation, using regional anesthesia and analgesia, using sedatives with caution, minimizing the use of opioids and anticipating variable opioid responses. “When I have a patient with suspected sleep apnea and no red flags I write down ‘OSA precautions,’ in the chart, which means elevate the head of the bed, perform continuous pulse oximetry, and cautiously supply supplemental oxygen as needed,” he said.
Postoperatively, he continued, minimize sedative agents and opioids, use regional and nonopioid analgesics when possible, provide supplemental oxygen until the patient is able to maintain baseline SaO2 on room air in a monitored setting, maintain the patient in nonsupine position when feasible, and continuously monitor pulse oximetry.
Consider delay of elective surgery and referral to a sleep medicine specialist in cases of uncontrolled systemic conditions or impaired gas exchange, including hypoventilation syndromes (a clue being a serum HC03 of 28 or higher), severe pulmonary hypertension (a clue being right ventricular systolic blood pressure or pulmonary systolic pressure of 70 mm Hg or above, or right ventricular dilatation/dysfunction), and hypoxemia not explained by cardiac disease.
A systematic review and meta-analysis of six studies that included 904 patients with sleep apnea found that there was no significant difference in the postoperative adverse events between CPAP and no-CPAP treatment (Anesth Analg 2015;120:1013-23). However, there was a significant reduction in the Apnea-Hypopnea Index postoperatively among those who used CPAP (37 vs. 12 events per hour; P less than .001), as well as a significant reduction in hospital length of stay 4 vs. 4.4 days; P = .05).
Dr. Manjarrez reported having no financial disclosures.
FROM SHM CONVERGE 2021
Evidence or anecdote: Clinical judgment in COVID care
As the COVID-19 pandemic continues and evidence evolves, clinical judgment is the bottom line for clinical care, according to Adarsh Bhimraj, MD, of the Cleveland Clinic, and James Walter, MD, of Northwestern Medicine, Chicago.
In a debate/discussion presented at SHM Converge, the annual conference of the Society of Hospital Medicine, Dr. Bhimraj and Dr. Walter took sides in a friendly debate on the value of remdesivir and tocilizumab for hospitalized COVID-19 patients.
Dr. Bhimraj argued for the use of remdesivir or tocilizumab in patients hospitalized with COVID-19 pneumonia, and Dr. Walter presented the case against their use.
Referendum on remdesivir
The main sources referenced by the presenters regarding remdesivir were the WHO Solidarity Trial (N Engl J Med. 2021 Feb 11. doi: 10.1056/NEJMoa2023184) and the Adaptive Covid-19 Treatment Trial (ACCT) final report (N Engl J Med. 2020 Nov 5. doi: 10.1056/NEJMoa2007764).
“The ‘debate’ is partly artificial,” and meant to illustrate how clinicians can use their own clinical faculties and reasoning to make an informed decision when treating COVID-19 patients, Dr. Bhimraj said.
The ACCT trial compared remdesivir with placebo in patients with severe enough COVID-19 to require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. The primary outcome in the study was time to recovery, and “the devil is in the details,” Dr. Bhimraj said. The outcomes clinicians should look for in studies are those that matter to patients, such as death, disability, and discomfort, he noted. Disease-oriented endpoints are easier to measure, but not always meaningful for patients, he said. The study showed an average 5-day decrease in illness, “but the fact is that it did not show a mortality benefit,” he noted.
Another large, open-label study of remdesivir across 30 countries showed no survival benefit associated with the drug, compared with standard of care, said Dr. Bhimraj. Patients treated with remdesivir remained in the hospital longer, but Dr. Bhimraj said he believed that was a bias. “I think the physicians kept the patients in the hospital longer to give the treatment rather than the treatments themselves prolonging the treatment duration,” he said.
In conclusion for remdesivir, “the solid data show that there is an early recovery,” he said. “At least for severe disease, even if there is no mortality benefit, there is a role. I argue that, if someone asks if you want to use remdesivir in severe COVID-19 patients, say yes, especially if you value people getting out of the hospital sooner. In a crisis situation, there is a role for remdesivir.”
Dr. Walter discussed the “con” side of using remdesivir. “We can start with a predata hypothesis, but integrate new data about the efficacy into a postdata hypothesis,” he said.
Dr. Walter made several points against the use of remdesivir in hospitalized COVID-19 patients. First, it has not shown any improvement in mortality and may increase the length of hospital stay, he noted.
Data from the ACCT-1 trial and the WHO solidarity trial, showed “no signal of mortality benefit at all,” he said. In addition, the World Health Organization, American College of Physicians, and National Institutes of Health all recommend against remdesivir for patients who require mechanical ventilation or extracorporeal membrane oxygenation, he said. The efficacy when used with steroids remains unclear, and long-term safety data are lacking, he added.
Taking on tocilizumab
Tocilizumab, an anti-inflammatory agent, has demonstrated an impact on several surrogate markers, notably C-reactive protein, temperature, and oxygenation. Dr. Bhimraj said. He reviewed data from eight published studies on the use of tocilizumab in COVID-19 patients.
Arguably, some trials may not have been powered adequately, and in combination, some trials show an effect on clinical deterioration, if not a mortality benefit, he said.
Consequently, in the context of COVID-19, tocilizumab “should be used early in the disease process, especially if steroids are not working,” said Dr. Bhimraj. Despite the limited evidence, “there is a niche population where this might be beneficial,” he said.
By contrast, Dr. Walter took the position of skepticism about the value of tocilizumab for COVID-19 patients.
Notably, decades of research show that tocilizumab has shown no benefit in patients with sepsis or septic shock, or those with acute respiratory distress syndrome, which have similarities to COVID-19 (JAMA. 2020 Sep 3. doi: 10.1001/jama.2020.17052).
He cited a research letter published in JAMA in September 2020, which showed that cytokine levels were in fact lower in critically ill patients with COVID-19, compared with those who had conditions including sepsis with and without ARDS.
Dr. Walter also cited data on the questionable benefit of tocilizumab when used with steroids and the negligible impact on mortality in hospitalized COVID-19 patients seen in the RECOVERY trial.
Limited data mean that therapeutic decisions related to COVID-19 are more nuanced, but they can be made, the presenters agreed.
Ultimately, when trying to decide whether a drug is efficacious, futile, or harmful, “What we have to do is consider the grand totality of the evidence,” Dr. Bhimraj emphasized.
Dr. Bhimraj and Dr. Walter had no relevant financial conflicts to disclose.
As the COVID-19 pandemic continues and evidence evolves, clinical judgment is the bottom line for clinical care, according to Adarsh Bhimraj, MD, of the Cleveland Clinic, and James Walter, MD, of Northwestern Medicine, Chicago.
In a debate/discussion presented at SHM Converge, the annual conference of the Society of Hospital Medicine, Dr. Bhimraj and Dr. Walter took sides in a friendly debate on the value of remdesivir and tocilizumab for hospitalized COVID-19 patients.
Dr. Bhimraj argued for the use of remdesivir or tocilizumab in patients hospitalized with COVID-19 pneumonia, and Dr. Walter presented the case against their use.
Referendum on remdesivir
The main sources referenced by the presenters regarding remdesivir were the WHO Solidarity Trial (N Engl J Med. 2021 Feb 11. doi: 10.1056/NEJMoa2023184) and the Adaptive Covid-19 Treatment Trial (ACCT) final report (N Engl J Med. 2020 Nov 5. doi: 10.1056/NEJMoa2007764).
“The ‘debate’ is partly artificial,” and meant to illustrate how clinicians can use their own clinical faculties and reasoning to make an informed decision when treating COVID-19 patients, Dr. Bhimraj said.
The ACCT trial compared remdesivir with placebo in patients with severe enough COVID-19 to require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. The primary outcome in the study was time to recovery, and “the devil is in the details,” Dr. Bhimraj said. The outcomes clinicians should look for in studies are those that matter to patients, such as death, disability, and discomfort, he noted. Disease-oriented endpoints are easier to measure, but not always meaningful for patients, he said. The study showed an average 5-day decrease in illness, “but the fact is that it did not show a mortality benefit,” he noted.
Another large, open-label study of remdesivir across 30 countries showed no survival benefit associated with the drug, compared with standard of care, said Dr. Bhimraj. Patients treated with remdesivir remained in the hospital longer, but Dr. Bhimraj said he believed that was a bias. “I think the physicians kept the patients in the hospital longer to give the treatment rather than the treatments themselves prolonging the treatment duration,” he said.
In conclusion for remdesivir, “the solid data show that there is an early recovery,” he said. “At least for severe disease, even if there is no mortality benefit, there is a role. I argue that, if someone asks if you want to use remdesivir in severe COVID-19 patients, say yes, especially if you value people getting out of the hospital sooner. In a crisis situation, there is a role for remdesivir.”
Dr. Walter discussed the “con” side of using remdesivir. “We can start with a predata hypothesis, but integrate new data about the efficacy into a postdata hypothesis,” he said.
Dr. Walter made several points against the use of remdesivir in hospitalized COVID-19 patients. First, it has not shown any improvement in mortality and may increase the length of hospital stay, he noted.
Data from the ACCT-1 trial and the WHO solidarity trial, showed “no signal of mortality benefit at all,” he said. In addition, the World Health Organization, American College of Physicians, and National Institutes of Health all recommend against remdesivir for patients who require mechanical ventilation or extracorporeal membrane oxygenation, he said. The efficacy when used with steroids remains unclear, and long-term safety data are lacking, he added.
Taking on tocilizumab
Tocilizumab, an anti-inflammatory agent, has demonstrated an impact on several surrogate markers, notably C-reactive protein, temperature, and oxygenation. Dr. Bhimraj said. He reviewed data from eight published studies on the use of tocilizumab in COVID-19 patients.
Arguably, some trials may not have been powered adequately, and in combination, some trials show an effect on clinical deterioration, if not a mortality benefit, he said.
Consequently, in the context of COVID-19, tocilizumab “should be used early in the disease process, especially if steroids are not working,” said Dr. Bhimraj. Despite the limited evidence, “there is a niche population where this might be beneficial,” he said.
By contrast, Dr. Walter took the position of skepticism about the value of tocilizumab for COVID-19 patients.
Notably, decades of research show that tocilizumab has shown no benefit in patients with sepsis or septic shock, or those with acute respiratory distress syndrome, which have similarities to COVID-19 (JAMA. 2020 Sep 3. doi: 10.1001/jama.2020.17052).
He cited a research letter published in JAMA in September 2020, which showed that cytokine levels were in fact lower in critically ill patients with COVID-19, compared with those who had conditions including sepsis with and without ARDS.
Dr. Walter also cited data on the questionable benefit of tocilizumab when used with steroids and the negligible impact on mortality in hospitalized COVID-19 patients seen in the RECOVERY trial.
Limited data mean that therapeutic decisions related to COVID-19 are more nuanced, but they can be made, the presenters agreed.
Ultimately, when trying to decide whether a drug is efficacious, futile, or harmful, “What we have to do is consider the grand totality of the evidence,” Dr. Bhimraj emphasized.
Dr. Bhimraj and Dr. Walter had no relevant financial conflicts to disclose.
As the COVID-19 pandemic continues and evidence evolves, clinical judgment is the bottom line for clinical care, according to Adarsh Bhimraj, MD, of the Cleveland Clinic, and James Walter, MD, of Northwestern Medicine, Chicago.
In a debate/discussion presented at SHM Converge, the annual conference of the Society of Hospital Medicine, Dr. Bhimraj and Dr. Walter took sides in a friendly debate on the value of remdesivir and tocilizumab for hospitalized COVID-19 patients.
Dr. Bhimraj argued for the use of remdesivir or tocilizumab in patients hospitalized with COVID-19 pneumonia, and Dr. Walter presented the case against their use.
Referendum on remdesivir
The main sources referenced by the presenters regarding remdesivir were the WHO Solidarity Trial (N Engl J Med. 2021 Feb 11. doi: 10.1056/NEJMoa2023184) and the Adaptive Covid-19 Treatment Trial (ACCT) final report (N Engl J Med. 2020 Nov 5. doi: 10.1056/NEJMoa2007764).
“The ‘debate’ is partly artificial,” and meant to illustrate how clinicians can use their own clinical faculties and reasoning to make an informed decision when treating COVID-19 patients, Dr. Bhimraj said.
The ACCT trial compared remdesivir with placebo in patients with severe enough COVID-19 to require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. The primary outcome in the study was time to recovery, and “the devil is in the details,” Dr. Bhimraj said. The outcomes clinicians should look for in studies are those that matter to patients, such as death, disability, and discomfort, he noted. Disease-oriented endpoints are easier to measure, but not always meaningful for patients, he said. The study showed an average 5-day decrease in illness, “but the fact is that it did not show a mortality benefit,” he noted.
Another large, open-label study of remdesivir across 30 countries showed no survival benefit associated with the drug, compared with standard of care, said Dr. Bhimraj. Patients treated with remdesivir remained in the hospital longer, but Dr. Bhimraj said he believed that was a bias. “I think the physicians kept the patients in the hospital longer to give the treatment rather than the treatments themselves prolonging the treatment duration,” he said.
In conclusion for remdesivir, “the solid data show that there is an early recovery,” he said. “At least for severe disease, even if there is no mortality benefit, there is a role. I argue that, if someone asks if you want to use remdesivir in severe COVID-19 patients, say yes, especially if you value people getting out of the hospital sooner. In a crisis situation, there is a role for remdesivir.”
Dr. Walter discussed the “con” side of using remdesivir. “We can start with a predata hypothesis, but integrate new data about the efficacy into a postdata hypothesis,” he said.
Dr. Walter made several points against the use of remdesivir in hospitalized COVID-19 patients. First, it has not shown any improvement in mortality and may increase the length of hospital stay, he noted.
Data from the ACCT-1 trial and the WHO solidarity trial, showed “no signal of mortality benefit at all,” he said. In addition, the World Health Organization, American College of Physicians, and National Institutes of Health all recommend against remdesivir for patients who require mechanical ventilation or extracorporeal membrane oxygenation, he said. The efficacy when used with steroids remains unclear, and long-term safety data are lacking, he added.
Taking on tocilizumab
Tocilizumab, an anti-inflammatory agent, has demonstrated an impact on several surrogate markers, notably C-reactive protein, temperature, and oxygenation. Dr. Bhimraj said. He reviewed data from eight published studies on the use of tocilizumab in COVID-19 patients.
Arguably, some trials may not have been powered adequately, and in combination, some trials show an effect on clinical deterioration, if not a mortality benefit, he said.
Consequently, in the context of COVID-19, tocilizumab “should be used early in the disease process, especially if steroids are not working,” said Dr. Bhimraj. Despite the limited evidence, “there is a niche population where this might be beneficial,” he said.
By contrast, Dr. Walter took the position of skepticism about the value of tocilizumab for COVID-19 patients.
Notably, decades of research show that tocilizumab has shown no benefit in patients with sepsis or septic shock, or those with acute respiratory distress syndrome, which have similarities to COVID-19 (JAMA. 2020 Sep 3. doi: 10.1001/jama.2020.17052).
He cited a research letter published in JAMA in September 2020, which showed that cytokine levels were in fact lower in critically ill patients with COVID-19, compared with those who had conditions including sepsis with and without ARDS.
Dr. Walter also cited data on the questionable benefit of tocilizumab when used with steroids and the negligible impact on mortality in hospitalized COVID-19 patients seen in the RECOVERY trial.
Limited data mean that therapeutic decisions related to COVID-19 are more nuanced, but they can be made, the presenters agreed.
Ultimately, when trying to decide whether a drug is efficacious, futile, or harmful, “What we have to do is consider the grand totality of the evidence,” Dr. Bhimraj emphasized.
Dr. Bhimraj and Dr. Walter had no relevant financial conflicts to disclose.
FROM SHM CONVERGE 2021
Weight-related COVID-19 severity starts in normal BMI range, especially in young
The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.
“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.
“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.
The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.
“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial.
Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.
For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.
Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.
Risk rises from BMI of 23 kg/m²
In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).
The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).
In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).
“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.
The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).
In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).
“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.
Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.
Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.
Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”
Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.
“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.
Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.
The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.
Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.
The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.
“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.
“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.
The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.
“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial.
Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.
For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.
Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.
Risk rises from BMI of 23 kg/m²
In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).
The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).
In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).
“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.
The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).
In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).
“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.
Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.
Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.
Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”
Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.
“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.
Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.
The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.
Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.
The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.
“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.
“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.
The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.
“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial.
Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.
For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.
Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.
Risk rises from BMI of 23 kg/m²
In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).
The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).
In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).
“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.
The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).
In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).
“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.
Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.
Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.
Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”
Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.
“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.
Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.
The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.
Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.
FROM LANCET DIABETES & ENDOCRINOLOGY
School-based asthma program improves asthma care coordination for children
Asthma care coordination for children can be improved through a school-based asthma program involving the child’s school, their family, and clinicians, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“Partnerships among schools, families, and clinicians can be powerful agents to improve the recognition of childhood asthma symptoms, asthma diagnosis and in particular management,” Sujani Kakumanu, MD, clinical associate professor of allergy and immunology at the University of Wisconsin–Madison, said in her presentation. “Emergency treatment plans and asthma action plans, as well as comprehensive education for all school personnel and school environmental mitigation plans, are crucial to controlling asthma symptoms in schools.”
The school is a unique location where families and clinicians can affect asthma outcomes because of the consistent amount of time a student spends there each day, Dr. Kakumanu explained, but everyone involved in allergy care for a child should be aware of and attempt to reduce environmental exposures and triggers found in schools that can worsen asthma, such as irritants, cleaning solutions, dust mites, pests, air pollution, and indoor air quality.
SAMPRO expansion
In 2016, the AAAAI and National Association of School Nurses provided financial support for the School-based Asthma Management Program (SAMPRO). “The impetus behind this initiative was a recognition that coordination with schools was essential to controlling pediatric asthma care,” Dr. Kakumanu said. Initially focusing on asthma alone, SAMPRO has since expanded to include resources for allergy and anaphylaxis and is known as the School-based Asthma, Allergy & Anaphylaxis Management Program (SA3MPRO).
SA3MPRO’s first tenet is the need for an engaged circle of support that includes families, schools, and clinicians of children with asthma. “Establishing and maintaining a healthy circle of support is a critical component to a school-based asthma partnership. It requires an understanding of how care is delivered in clinics as well as in hospitals and at schools,” Dr. Kakumanu said.
School nurses are uniquely positioned to help address gaps in care for children with asthma during the school day by administering medications and limiting the number of student absences caused by asthma. “In addition, school nurses and school personnel often provide key information to the health system about a student’s health status that can impact their prescriptions and their medical care,” she noted.
Setting an action plan
The second SA3MPRO tenet is the development of an asthma action plan by schools for situations when a child presents with urgent asthma symptoms that require quick action. SA3MPRO’s asthma action plan describes a child’s severity of asthma, known asthma triggers and what medications can be delivered at school, and how clinicians and schools can share HIPAA and FERPA-protected information.
Some programs are allowing school nurses to access electronic medical records to share information, Dr. Kakumanu said. UW Health at the University of Wisconsin developed the project, led by Dr. Kakumanu and Robert F. Lemanske Jr., MD, in 2017 that gave school nurses in the Madison Metropolitan School District access to the EMR. Prior to the COVID-19 pandemic, the program was linked to decreased prescriptions of steroids among pediatric clinicians, she said.
“This program allowed the quick and efficient delivery of asthma action plans to schools along with necessary authorizations, prescriptions and a consent to share information electronically. With this information and subsequent authorizations, the school nurses were able to update the school health record, manage symptoms at school as directed by the individualized asthma action plan, and coordinate school resources needed to care for the child asthma symptoms during the school day,” Dr. Kakumanu said.
“This program also addressed a common barrier with school-based partnerships, which was the lack of efficient asynchronous communication, and it did this by including the ability of school nurses and clinicians to direct message each other within a protected EMR,” she added. “In order to continue our support for families, there were also measures to include families with corresponding [EMR] messaging and with communication by phone.”
Barriers in the program at UW Health included needing annual training, sustaining momentum for organizational support and interest, monitoring infrastructure, and maintaining documents. Other challenges were in the management of systems that facilitated messaging and the need to obtain additional electronic consents separately from written consents.
Training vital
The third tenet in SA3MPRO is training, which should incorporate a recognition and treatment of asthma symptoms among school staff, students, and families; proper inhaler technique; how medical care will be delivered at the school and by whom; what emergency asthma symptoms look like; and a plan for getting the child to an emergency medical facility. “Regardless of the program that is chosen, asthma education should address health literacy and multiple multicultural beliefs and be delivered in the language that is appropriate for that school and that student body,” Dr. Kakumanu said. “Teachers, janitors, school administrators, and all levels of school personnel should be educated on how to recognize and treat asthma symptoms, especially if a school nurse is not always available on site.”
Marathon not a sprint
The last tenet in SA3MPRO is improving air quality and decreasing environmental exposure to triggers, which involves “the use of environmental recognition and mitigation plans to minimize the effect of allergens, irritants, and air pollutants within the outside and indoor environment that may affect a child with asthma during the school day.”
While these measures may seem daunting, Dr. Kakumanu said the communities that have successfully implemented a SA3MPRO plan are ones that prioritized updated and accurate data, developed a team-based approach, and secured long-term funding for the program. “Important lessons for all of us in this work is remembering that it’s a marathon and not a sprint, and that effective care coordination requires continual and consistent resources,” she said.
Dr. Kakumanu reported no relevant conflicts of interest.
Asthma care coordination for children can be improved through a school-based asthma program involving the child’s school, their family, and clinicians, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“Partnerships among schools, families, and clinicians can be powerful agents to improve the recognition of childhood asthma symptoms, asthma diagnosis and in particular management,” Sujani Kakumanu, MD, clinical associate professor of allergy and immunology at the University of Wisconsin–Madison, said in her presentation. “Emergency treatment plans and asthma action plans, as well as comprehensive education for all school personnel and school environmental mitigation plans, are crucial to controlling asthma symptoms in schools.”
The school is a unique location where families and clinicians can affect asthma outcomes because of the consistent amount of time a student spends there each day, Dr. Kakumanu explained, but everyone involved in allergy care for a child should be aware of and attempt to reduce environmental exposures and triggers found in schools that can worsen asthma, such as irritants, cleaning solutions, dust mites, pests, air pollution, and indoor air quality.
SAMPRO expansion
In 2016, the AAAAI and National Association of School Nurses provided financial support for the School-based Asthma Management Program (SAMPRO). “The impetus behind this initiative was a recognition that coordination with schools was essential to controlling pediatric asthma care,” Dr. Kakumanu said. Initially focusing on asthma alone, SAMPRO has since expanded to include resources for allergy and anaphylaxis and is known as the School-based Asthma, Allergy & Anaphylaxis Management Program (SA3MPRO).
SA3MPRO’s first tenet is the need for an engaged circle of support that includes families, schools, and clinicians of children with asthma. “Establishing and maintaining a healthy circle of support is a critical component to a school-based asthma partnership. It requires an understanding of how care is delivered in clinics as well as in hospitals and at schools,” Dr. Kakumanu said.
School nurses are uniquely positioned to help address gaps in care for children with asthma during the school day by administering medications and limiting the number of student absences caused by asthma. “In addition, school nurses and school personnel often provide key information to the health system about a student’s health status that can impact their prescriptions and their medical care,” she noted.
Setting an action plan
The second SA3MPRO tenet is the development of an asthma action plan by schools for situations when a child presents with urgent asthma symptoms that require quick action. SA3MPRO’s asthma action plan describes a child’s severity of asthma, known asthma triggers and what medications can be delivered at school, and how clinicians and schools can share HIPAA and FERPA-protected information.
Some programs are allowing school nurses to access electronic medical records to share information, Dr. Kakumanu said. UW Health at the University of Wisconsin developed the project, led by Dr. Kakumanu and Robert F. Lemanske Jr., MD, in 2017 that gave school nurses in the Madison Metropolitan School District access to the EMR. Prior to the COVID-19 pandemic, the program was linked to decreased prescriptions of steroids among pediatric clinicians, she said.
“This program allowed the quick and efficient delivery of asthma action plans to schools along with necessary authorizations, prescriptions and a consent to share information electronically. With this information and subsequent authorizations, the school nurses were able to update the school health record, manage symptoms at school as directed by the individualized asthma action plan, and coordinate school resources needed to care for the child asthma symptoms during the school day,” Dr. Kakumanu said.
“This program also addressed a common barrier with school-based partnerships, which was the lack of efficient asynchronous communication, and it did this by including the ability of school nurses and clinicians to direct message each other within a protected EMR,” she added. “In order to continue our support for families, there were also measures to include families with corresponding [EMR] messaging and with communication by phone.”
Barriers in the program at UW Health included needing annual training, sustaining momentum for organizational support and interest, monitoring infrastructure, and maintaining documents. Other challenges were in the management of systems that facilitated messaging and the need to obtain additional electronic consents separately from written consents.
Training vital
The third tenet in SA3MPRO is training, which should incorporate a recognition and treatment of asthma symptoms among school staff, students, and families; proper inhaler technique; how medical care will be delivered at the school and by whom; what emergency asthma symptoms look like; and a plan for getting the child to an emergency medical facility. “Regardless of the program that is chosen, asthma education should address health literacy and multiple multicultural beliefs and be delivered in the language that is appropriate for that school and that student body,” Dr. Kakumanu said. “Teachers, janitors, school administrators, and all levels of school personnel should be educated on how to recognize and treat asthma symptoms, especially if a school nurse is not always available on site.”
Marathon not a sprint
The last tenet in SA3MPRO is improving air quality and decreasing environmental exposure to triggers, which involves “the use of environmental recognition and mitigation plans to minimize the effect of allergens, irritants, and air pollutants within the outside and indoor environment that may affect a child with asthma during the school day.”
While these measures may seem daunting, Dr. Kakumanu said the communities that have successfully implemented a SA3MPRO plan are ones that prioritized updated and accurate data, developed a team-based approach, and secured long-term funding for the program. “Important lessons for all of us in this work is remembering that it’s a marathon and not a sprint, and that effective care coordination requires continual and consistent resources,” she said.
Dr. Kakumanu reported no relevant conflicts of interest.
Asthma care coordination for children can be improved through a school-based asthma program involving the child’s school, their family, and clinicians, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“Partnerships among schools, families, and clinicians can be powerful agents to improve the recognition of childhood asthma symptoms, asthma diagnosis and in particular management,” Sujani Kakumanu, MD, clinical associate professor of allergy and immunology at the University of Wisconsin–Madison, said in her presentation. “Emergency treatment plans and asthma action plans, as well as comprehensive education for all school personnel and school environmental mitigation plans, are crucial to controlling asthma symptoms in schools.”
The school is a unique location where families and clinicians can affect asthma outcomes because of the consistent amount of time a student spends there each day, Dr. Kakumanu explained, but everyone involved in allergy care for a child should be aware of and attempt to reduce environmental exposures and triggers found in schools that can worsen asthma, such as irritants, cleaning solutions, dust mites, pests, air pollution, and indoor air quality.
SAMPRO expansion
In 2016, the AAAAI and National Association of School Nurses provided financial support for the School-based Asthma Management Program (SAMPRO). “The impetus behind this initiative was a recognition that coordination with schools was essential to controlling pediatric asthma care,” Dr. Kakumanu said. Initially focusing on asthma alone, SAMPRO has since expanded to include resources for allergy and anaphylaxis and is known as the School-based Asthma, Allergy & Anaphylaxis Management Program (SA3MPRO).
SA3MPRO’s first tenet is the need for an engaged circle of support that includes families, schools, and clinicians of children with asthma. “Establishing and maintaining a healthy circle of support is a critical component to a school-based asthma partnership. It requires an understanding of how care is delivered in clinics as well as in hospitals and at schools,” Dr. Kakumanu said.
School nurses are uniquely positioned to help address gaps in care for children with asthma during the school day by administering medications and limiting the number of student absences caused by asthma. “In addition, school nurses and school personnel often provide key information to the health system about a student’s health status that can impact their prescriptions and their medical care,” she noted.
Setting an action plan
The second SA3MPRO tenet is the development of an asthma action plan by schools for situations when a child presents with urgent asthma symptoms that require quick action. SA3MPRO’s asthma action plan describes a child’s severity of asthma, known asthma triggers and what medications can be delivered at school, and how clinicians and schools can share HIPAA and FERPA-protected information.
Some programs are allowing school nurses to access electronic medical records to share information, Dr. Kakumanu said. UW Health at the University of Wisconsin developed the project, led by Dr. Kakumanu and Robert F. Lemanske Jr., MD, in 2017 that gave school nurses in the Madison Metropolitan School District access to the EMR. Prior to the COVID-19 pandemic, the program was linked to decreased prescriptions of steroids among pediatric clinicians, she said.
“This program allowed the quick and efficient delivery of asthma action plans to schools along with necessary authorizations, prescriptions and a consent to share information electronically. With this information and subsequent authorizations, the school nurses were able to update the school health record, manage symptoms at school as directed by the individualized asthma action plan, and coordinate school resources needed to care for the child asthma symptoms during the school day,” Dr. Kakumanu said.
“This program also addressed a common barrier with school-based partnerships, which was the lack of efficient asynchronous communication, and it did this by including the ability of school nurses and clinicians to direct message each other within a protected EMR,” she added. “In order to continue our support for families, there were also measures to include families with corresponding [EMR] messaging and with communication by phone.”
Barriers in the program at UW Health included needing annual training, sustaining momentum for organizational support and interest, monitoring infrastructure, and maintaining documents. Other challenges were in the management of systems that facilitated messaging and the need to obtain additional electronic consents separately from written consents.
Training vital
The third tenet in SA3MPRO is training, which should incorporate a recognition and treatment of asthma symptoms among school staff, students, and families; proper inhaler technique; how medical care will be delivered at the school and by whom; what emergency asthma symptoms look like; and a plan for getting the child to an emergency medical facility. “Regardless of the program that is chosen, asthma education should address health literacy and multiple multicultural beliefs and be delivered in the language that is appropriate for that school and that student body,” Dr. Kakumanu said. “Teachers, janitors, school administrators, and all levels of school personnel should be educated on how to recognize and treat asthma symptoms, especially if a school nurse is not always available on site.”
Marathon not a sprint
The last tenet in SA3MPRO is improving air quality and decreasing environmental exposure to triggers, which involves “the use of environmental recognition and mitigation plans to minimize the effect of allergens, irritants, and air pollutants within the outside and indoor environment that may affect a child with asthma during the school day.”
While these measures may seem daunting, Dr. Kakumanu said the communities that have successfully implemented a SA3MPRO plan are ones that prioritized updated and accurate data, developed a team-based approach, and secured long-term funding for the program. “Important lessons for all of us in this work is remembering that it’s a marathon and not a sprint, and that effective care coordination requires continual and consistent resources,” she said.
Dr. Kakumanu reported no relevant conflicts of interest.
FROM AAAAI 2021
Corticosteroid bursts may increase risk of sepsis, GI bleeding in children
The adverse events are rare, and the risk attenuates in subsequent months, the analysis shows. Still, the study “provides evidence that corticosteroid bursts are not innocuous but may pose potentially serious health risks,” study author Tsung-Chieh Yao, MD, PhD, and colleagues said. “Clinicians prescribing corticosteroid bursts to children need to weigh the benefits against the risks of severe adverse events.”
The study, which was published online in JAMA Pediatrics, indicates that oral corticosteroids are “not a benign medication, which is something that we should have all along known,” commented Harold J. Farber, MD, MSPH, professor of pediatrics at Baylor College of Medicine and a pediatric pulmonologist at Texas Children’s Hospital, both in Houston.
While oral corticosteroids may be important for the treatment of asthma, inflammatory bowel disease, and rheumatoid arthritis, they often are overprescribed – a phenomenon that Dr. Farber and collaborators saw when they analyzed data from children with public health insurance in Texas.
The medication is “not uncommonly used for minor asthma exacerbations or minor respiratory symptoms, which do not require oral steroids,” said Dr. Farber, who was not involved with the study. “What this study tells us is to save it for when they are really needed,” such as to treat a severe asthma exacerbation.
Despite the risk of adverse events, oral corticosteroids remain an important medication, and clinicians should aim to strike “the right balance,” Dr. Farber said.
Prior research has shown that the long-term use of oral corticosteroids is associated with adverse events such as infections, glaucoma, hyperglycemia, cardiovascular diseases, and osteoporosis. In addition, data indicate that corticosteroid bursts are associated with GI bleeding and sepsis in adults. But few studies have looked at the risk of corticosteroid bursts in children, the researchers said.
To evaluate associations of corticosteroid bursts – defined as the use of oral corticosteroids for 14 days or less – with GI bleeding, sepsis, pneumonia, and glaucoma in children, Dr. Yao and colleagues analyzed data from the National Health Insurance Research Database in Taiwan between 2013 and 2017. Dr. Yao is affiliated with the division of allergy, asthma, and rheumatology in the department of pediatrics at Chang Gung Memorial Hospital in Taoyuan City, Taiwan.
Of more than 4.5 million children in the database, 42% received at least one corticosteroid burst, typically for acute respiratory tract infections and allergic diseases. The researchers focused on 1,064,587 children who received a single corticosteroid burst, and compared the incidence of adverse events before and after treatment using a self-controlled case series design. “Corticosteroid bursts were significantly associated with a 1.4- to 2.2-fold increase of GI bleeding, sepsis, and pneumonia, but not glaucoma, within the first month after initiation of corticosteroid therapy,” the investigators reported.
Incidence rate ratios in the 5-30 days after starting corticosteroid bursts were 1.41 for GI bleeding, 2.02 for sepsis, 2.19 for pneumonia, and 0.98 for glaucoma, compared with a pretreatment reference period.
The incidence rate per 1,000 person-years for GI bleeding was 2.48 with corticosteroid bursts, compared with 1.88 without corticosteroids. For sepsis, the rates with and without corticosteroids were 0.37 and 0.34, respectively. And for pneumonia, the rates were 25.74 versus 16.39.
Further research is needed to assess the validity of these findings, the authors noted. Because many children receive corticosteroid bursts worldwide, however, the “findings call for a careful reevaluation regarding the prudent use” of this treatment.
The study was supported by grants from the National Health Research Institutes; Ministry of Science and Technology of Taiwan; National Cheng Kung University, Tainan, Taiwan; Chang Gung Medical Foundation; and the National Institutes of Health. A coauthor disclosed grants from GlaxoSmithKline outside of the study.
The adverse events are rare, and the risk attenuates in subsequent months, the analysis shows. Still, the study “provides evidence that corticosteroid bursts are not innocuous but may pose potentially serious health risks,” study author Tsung-Chieh Yao, MD, PhD, and colleagues said. “Clinicians prescribing corticosteroid bursts to children need to weigh the benefits against the risks of severe adverse events.”
The study, which was published online in JAMA Pediatrics, indicates that oral corticosteroids are “not a benign medication, which is something that we should have all along known,” commented Harold J. Farber, MD, MSPH, professor of pediatrics at Baylor College of Medicine and a pediatric pulmonologist at Texas Children’s Hospital, both in Houston.
While oral corticosteroids may be important for the treatment of asthma, inflammatory bowel disease, and rheumatoid arthritis, they often are overprescribed – a phenomenon that Dr. Farber and collaborators saw when they analyzed data from children with public health insurance in Texas.
The medication is “not uncommonly used for minor asthma exacerbations or minor respiratory symptoms, which do not require oral steroids,” said Dr. Farber, who was not involved with the study. “What this study tells us is to save it for when they are really needed,” such as to treat a severe asthma exacerbation.
Despite the risk of adverse events, oral corticosteroids remain an important medication, and clinicians should aim to strike “the right balance,” Dr. Farber said.
Prior research has shown that the long-term use of oral corticosteroids is associated with adverse events such as infections, glaucoma, hyperglycemia, cardiovascular diseases, and osteoporosis. In addition, data indicate that corticosteroid bursts are associated with GI bleeding and sepsis in adults. But few studies have looked at the risk of corticosteroid bursts in children, the researchers said.
To evaluate associations of corticosteroid bursts – defined as the use of oral corticosteroids for 14 days or less – with GI bleeding, sepsis, pneumonia, and glaucoma in children, Dr. Yao and colleagues analyzed data from the National Health Insurance Research Database in Taiwan between 2013 and 2017. Dr. Yao is affiliated with the division of allergy, asthma, and rheumatology in the department of pediatrics at Chang Gung Memorial Hospital in Taoyuan City, Taiwan.
Of more than 4.5 million children in the database, 42% received at least one corticosteroid burst, typically for acute respiratory tract infections and allergic diseases. The researchers focused on 1,064,587 children who received a single corticosteroid burst, and compared the incidence of adverse events before and after treatment using a self-controlled case series design. “Corticosteroid bursts were significantly associated with a 1.4- to 2.2-fold increase of GI bleeding, sepsis, and pneumonia, but not glaucoma, within the first month after initiation of corticosteroid therapy,” the investigators reported.
Incidence rate ratios in the 5-30 days after starting corticosteroid bursts were 1.41 for GI bleeding, 2.02 for sepsis, 2.19 for pneumonia, and 0.98 for glaucoma, compared with a pretreatment reference period.
The incidence rate per 1,000 person-years for GI bleeding was 2.48 with corticosteroid bursts, compared with 1.88 without corticosteroids. For sepsis, the rates with and without corticosteroids were 0.37 and 0.34, respectively. And for pneumonia, the rates were 25.74 versus 16.39.
Further research is needed to assess the validity of these findings, the authors noted. Because many children receive corticosteroid bursts worldwide, however, the “findings call for a careful reevaluation regarding the prudent use” of this treatment.
The study was supported by grants from the National Health Research Institutes; Ministry of Science and Technology of Taiwan; National Cheng Kung University, Tainan, Taiwan; Chang Gung Medical Foundation; and the National Institutes of Health. A coauthor disclosed grants from GlaxoSmithKline outside of the study.
The adverse events are rare, and the risk attenuates in subsequent months, the analysis shows. Still, the study “provides evidence that corticosteroid bursts are not innocuous but may pose potentially serious health risks,” study author Tsung-Chieh Yao, MD, PhD, and colleagues said. “Clinicians prescribing corticosteroid bursts to children need to weigh the benefits against the risks of severe adverse events.”
The study, which was published online in JAMA Pediatrics, indicates that oral corticosteroids are “not a benign medication, which is something that we should have all along known,” commented Harold J. Farber, MD, MSPH, professor of pediatrics at Baylor College of Medicine and a pediatric pulmonologist at Texas Children’s Hospital, both in Houston.
While oral corticosteroids may be important for the treatment of asthma, inflammatory bowel disease, and rheumatoid arthritis, they often are overprescribed – a phenomenon that Dr. Farber and collaborators saw when they analyzed data from children with public health insurance in Texas.
The medication is “not uncommonly used for minor asthma exacerbations or minor respiratory symptoms, which do not require oral steroids,” said Dr. Farber, who was not involved with the study. “What this study tells us is to save it for when they are really needed,” such as to treat a severe asthma exacerbation.
Despite the risk of adverse events, oral corticosteroids remain an important medication, and clinicians should aim to strike “the right balance,” Dr. Farber said.
Prior research has shown that the long-term use of oral corticosteroids is associated with adverse events such as infections, glaucoma, hyperglycemia, cardiovascular diseases, and osteoporosis. In addition, data indicate that corticosteroid bursts are associated with GI bleeding and sepsis in adults. But few studies have looked at the risk of corticosteroid bursts in children, the researchers said.
To evaluate associations of corticosteroid bursts – defined as the use of oral corticosteroids for 14 days or less – with GI bleeding, sepsis, pneumonia, and glaucoma in children, Dr. Yao and colleagues analyzed data from the National Health Insurance Research Database in Taiwan between 2013 and 2017. Dr. Yao is affiliated with the division of allergy, asthma, and rheumatology in the department of pediatrics at Chang Gung Memorial Hospital in Taoyuan City, Taiwan.
Of more than 4.5 million children in the database, 42% received at least one corticosteroid burst, typically for acute respiratory tract infections and allergic diseases. The researchers focused on 1,064,587 children who received a single corticosteroid burst, and compared the incidence of adverse events before and after treatment using a self-controlled case series design. “Corticosteroid bursts were significantly associated with a 1.4- to 2.2-fold increase of GI bleeding, sepsis, and pneumonia, but not glaucoma, within the first month after initiation of corticosteroid therapy,” the investigators reported.
Incidence rate ratios in the 5-30 days after starting corticosteroid bursts were 1.41 for GI bleeding, 2.02 for sepsis, 2.19 for pneumonia, and 0.98 for glaucoma, compared with a pretreatment reference period.
The incidence rate per 1,000 person-years for GI bleeding was 2.48 with corticosteroid bursts, compared with 1.88 without corticosteroids. For sepsis, the rates with and without corticosteroids were 0.37 and 0.34, respectively. And for pneumonia, the rates were 25.74 versus 16.39.
Further research is needed to assess the validity of these findings, the authors noted. Because many children receive corticosteroid bursts worldwide, however, the “findings call for a careful reevaluation regarding the prudent use” of this treatment.
The study was supported by grants from the National Health Research Institutes; Ministry of Science and Technology of Taiwan; National Cheng Kung University, Tainan, Taiwan; Chang Gung Medical Foundation; and the National Institutes of Health. A coauthor disclosed grants from GlaxoSmithKline outside of the study.
FROM JAMA PEDIATRICS
Ruling out PE in patients with low C-PTP and D dimer of less than 1,000 ng/mL
Background: A pulmonary embolism can be considered ruled out if patients have a low C-PTP for PE and a D-dimer level of less than 500 ng/mL. However, this occurs in approximately 30% of outpatients only. By increasing the D-dimer threshold used to define a negative test to 1,000 ng/mL in patients with a low C-PTP, we might be able to rule out a larger segment of patients and avoid chest imaging.
Study design: Prospective study.
Setting: University-based clinical centers in Canada.
Synopsis: This study enrolled 2,017 patients presenting with symptoms of PE. The Wells’ criteria was used to categorize the patient’s C-PTP as low (0-4.0), moderate (4.5-6.0), or high (6.5 or more). Patients with a low or moderate C-PTP had a D dimer drawn. Those with a low C-PTP and D dimer of less than 1,000 ng/mL or moderate C-PTP and a D dimer of less than 500 ng/mL underwent no further testing. Outcomes were assessed at 90 days. Of the 1,325 patients with a low C-PTP or moderate C-PTP and a negative D-dimer test (less than 1,000 or 500 ng/mL, respectively), none had venous thromboembolism during follow-up (95% confidence interval, 0.00-0.29). This strategy resulted in the use of chest imaging in only 34.3% of patients versus 51.9% using the prior criteria of a D-dimer level of less than 500 ng/mL (difference, –17.6 percentage points; 95% CI, −19.2 to −15.9). One limitation of the study is that almost all patients enrolled were outpatients (only one inpatient).
Bottom line: A combination of a low C-PTP and a D-dimer level of less than 1,000 ng/mL identified a group of patients at low risk for pulmonary embolism during follow-up.
Citation: Kearon C et al. Diagnosis of pulmonary embolism with D-dimer adjusted to clinical probability. N Engl J Med 2019 Nov 28;381:2125-34.
Dr. Santa is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: A pulmonary embolism can be considered ruled out if patients have a low C-PTP for PE and a D-dimer level of less than 500 ng/mL. However, this occurs in approximately 30% of outpatients only. By increasing the D-dimer threshold used to define a negative test to 1,000 ng/mL in patients with a low C-PTP, we might be able to rule out a larger segment of patients and avoid chest imaging.
Study design: Prospective study.
Setting: University-based clinical centers in Canada.
Synopsis: This study enrolled 2,017 patients presenting with symptoms of PE. The Wells’ criteria was used to categorize the patient’s C-PTP as low (0-4.0), moderate (4.5-6.0), or high (6.5 or more). Patients with a low or moderate C-PTP had a D dimer drawn. Those with a low C-PTP and D dimer of less than 1,000 ng/mL or moderate C-PTP and a D dimer of less than 500 ng/mL underwent no further testing. Outcomes were assessed at 90 days. Of the 1,325 patients with a low C-PTP or moderate C-PTP and a negative D-dimer test (less than 1,000 or 500 ng/mL, respectively), none had venous thromboembolism during follow-up (95% confidence interval, 0.00-0.29). This strategy resulted in the use of chest imaging in only 34.3% of patients versus 51.9% using the prior criteria of a D-dimer level of less than 500 ng/mL (difference, –17.6 percentage points; 95% CI, −19.2 to −15.9). One limitation of the study is that almost all patients enrolled were outpatients (only one inpatient).
Bottom line: A combination of a low C-PTP and a D-dimer level of less than 1,000 ng/mL identified a group of patients at low risk for pulmonary embolism during follow-up.
Citation: Kearon C et al. Diagnosis of pulmonary embolism with D-dimer adjusted to clinical probability. N Engl J Med 2019 Nov 28;381:2125-34.
Dr. Santa is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: A pulmonary embolism can be considered ruled out if patients have a low C-PTP for PE and a D-dimer level of less than 500 ng/mL. However, this occurs in approximately 30% of outpatients only. By increasing the D-dimer threshold used to define a negative test to 1,000 ng/mL in patients with a low C-PTP, we might be able to rule out a larger segment of patients and avoid chest imaging.
Study design: Prospective study.
Setting: University-based clinical centers in Canada.
Synopsis: This study enrolled 2,017 patients presenting with symptoms of PE. The Wells’ criteria was used to categorize the patient’s C-PTP as low (0-4.0), moderate (4.5-6.0), or high (6.5 or more). Patients with a low or moderate C-PTP had a D dimer drawn. Those with a low C-PTP and D dimer of less than 1,000 ng/mL or moderate C-PTP and a D dimer of less than 500 ng/mL underwent no further testing. Outcomes were assessed at 90 days. Of the 1,325 patients with a low C-PTP or moderate C-PTP and a negative D-dimer test (less than 1,000 or 500 ng/mL, respectively), none had venous thromboembolism during follow-up (95% confidence interval, 0.00-0.29). This strategy resulted in the use of chest imaging in only 34.3% of patients versus 51.9% using the prior criteria of a D-dimer level of less than 500 ng/mL (difference, –17.6 percentage points; 95% CI, −19.2 to −15.9). One limitation of the study is that almost all patients enrolled were outpatients (only one inpatient).
Bottom line: A combination of a low C-PTP and a D-dimer level of less than 1,000 ng/mL identified a group of patients at low risk for pulmonary embolism during follow-up.
Citation: Kearon C et al. Diagnosis of pulmonary embolism with D-dimer adjusted to clinical probability. N Engl J Med 2019 Nov 28;381:2125-34.
Dr. Santa is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Marijuana vaping more common among Hispanic teens
Hispanic adolescents were more likely to use e-cigarettes to vape marijuana than were their Black and White counterparts in 2020, according to a recent study conducted by the Centers for Disease Control and Prevention and published in JAMA Pediatrics.
Researchers found that 25.6% of Hispanic students reported vaping marijuana, compared to 19.4% of Black students and 18.2% of White students. The study, which is an analysis of 2017, 2018, and 2020 results from the National Youth Tobacco Survey, also revealed that increases in this recreational practice occurred among all racial and ethnic groups within those 3 years, with Hispanic students having the largest percent increase, 11.6%, followed by Black students at 8.8% and White students at 7.4%.
“The initial motivation [to do this study] was to gain a better understanding of the prevalence of use of marijuana in e-cigarettes among youth, particularly given the context of the 2019 outbreak of e-cigarette, or vaping, product use–associated lung injury (EVALI),” study author Christina Vaughan Watson, DrPH, health scientist at the CDC’s National Center for Chronic Disease Prevention and Health Promotion, said in an interview.
The findings could help clinicians and physicians understand demographic variations among marijuana vapers and help inform targeted interventions for specific populations.
“Understanding demographic variations among those who are using marijuana in e-cigarettes can help inform evidenced-based interventions that may resonate with specific populations,” Dr. Watson explained.
Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin in Milwaukee, who was not involved in the study, said in an interview that the findings were “eye opening” and revealed a pattern she hasn’t seen before in her adolescent clinic.
“I would have thought African-American or non-Hispanic Blacks would’ve been a higher group of use, because when we screen kids that’s what we tend to get from the population we see here,” Ms. Thew said.
Ms. Thew said the findings also had made her reconsider her clinic’s approach to screening adolescents for marijuana use as well as address possible language barriers.
“We are probably missing access to some of the kids that we may need to seek out,” she explained. “I also thought it sends a good message that we need to direct some of our education probably a little differently, especially if it’s a Hispanic population and English may not be the primary language.”
Dr. Watson said more research is needed to assess why differences in marijuana use in e-cigarettes exist among youth.
Marijuana use in e-cigarettes has become increasingly popular among U.S. teens, with one in five students in grades 10 and 12 reporting vaping marijuana within the past year in a 2019 study conducted by the National Institute on Drug Abuse.
Dr. Watson and colleagues also found statistically significant increases in vaping marijuana, with 19.5% of students reporting smoking marijuana via e-cigarettes in 2020, compared to 11.1% of them vaping the drug in 2017. They believe the rise in marijuana vaping among youth may be attributed to states increasingly legalizing adult marijuana sales, which could impact ease of access and social acceptance.
Ms. Thew believes the rise in marijuana vaping among youth can be attributed to the legalization of marijuana, which may send “a message to adolescents that it must be safe for them to use,” as well as the increasing popularity of e-cigarettes.
In fact, as of April 2021, marijuana is legal for adults in 16 states and the District of Columbia. Meanwhile, medical marijuana is legal in 36 states, according to the National Conference of State Legislatures.
“I mean, there’s just definitely been a lot more use of [e-cigarettes]. Vaping and things like that definitely took off between 2019 and 2020,” Ms. Thew explained. “And I think marijuana use in itself is going up tremendously, I think more kids who would have used alcohol in the past use weed.”
Although public attitudes toward marijuana have relaxed, previous studies have linked it to memory dysfunction, as well as long-term cognitive effects that can interfere with perception of time and motor function. However, studies also have shown that cannabis use can combat age-related cognitive decline and help with pain reduction.
However, when it comes to adolescents, Dr. Watson and colleagues said e-cigarette use among youth and young adults is unsafe, regardless of the substances used in these products, including marijuana. Furthermore, they said marijuana use can lead to higher risks of more problematic use later in life, adding that evidence-based strategies to reduce marijuana use in e-cigarettes are important for protecting young people.
The study author and experts disclosed no relevant financial relationships.
Hispanic adolescents were more likely to use e-cigarettes to vape marijuana than were their Black and White counterparts in 2020, according to a recent study conducted by the Centers for Disease Control and Prevention and published in JAMA Pediatrics.
Researchers found that 25.6% of Hispanic students reported vaping marijuana, compared to 19.4% of Black students and 18.2% of White students. The study, which is an analysis of 2017, 2018, and 2020 results from the National Youth Tobacco Survey, also revealed that increases in this recreational practice occurred among all racial and ethnic groups within those 3 years, with Hispanic students having the largest percent increase, 11.6%, followed by Black students at 8.8% and White students at 7.4%.
“The initial motivation [to do this study] was to gain a better understanding of the prevalence of use of marijuana in e-cigarettes among youth, particularly given the context of the 2019 outbreak of e-cigarette, or vaping, product use–associated lung injury (EVALI),” study author Christina Vaughan Watson, DrPH, health scientist at the CDC’s National Center for Chronic Disease Prevention and Health Promotion, said in an interview.
The findings could help clinicians and physicians understand demographic variations among marijuana vapers and help inform targeted interventions for specific populations.
“Understanding demographic variations among those who are using marijuana in e-cigarettes can help inform evidenced-based interventions that may resonate with specific populations,” Dr. Watson explained.
Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin in Milwaukee, who was not involved in the study, said in an interview that the findings were “eye opening” and revealed a pattern she hasn’t seen before in her adolescent clinic.
“I would have thought African-American or non-Hispanic Blacks would’ve been a higher group of use, because when we screen kids that’s what we tend to get from the population we see here,” Ms. Thew said.
Ms. Thew said the findings also had made her reconsider her clinic’s approach to screening adolescents for marijuana use as well as address possible language barriers.
“We are probably missing access to some of the kids that we may need to seek out,” she explained. “I also thought it sends a good message that we need to direct some of our education probably a little differently, especially if it’s a Hispanic population and English may not be the primary language.”
Dr. Watson said more research is needed to assess why differences in marijuana use in e-cigarettes exist among youth.
Marijuana use in e-cigarettes has become increasingly popular among U.S. teens, with one in five students in grades 10 and 12 reporting vaping marijuana within the past year in a 2019 study conducted by the National Institute on Drug Abuse.
Dr. Watson and colleagues also found statistically significant increases in vaping marijuana, with 19.5% of students reporting smoking marijuana via e-cigarettes in 2020, compared to 11.1% of them vaping the drug in 2017. They believe the rise in marijuana vaping among youth may be attributed to states increasingly legalizing adult marijuana sales, which could impact ease of access and social acceptance.
Ms. Thew believes the rise in marijuana vaping among youth can be attributed to the legalization of marijuana, which may send “a message to adolescents that it must be safe for them to use,” as well as the increasing popularity of e-cigarettes.
In fact, as of April 2021, marijuana is legal for adults in 16 states and the District of Columbia. Meanwhile, medical marijuana is legal in 36 states, according to the National Conference of State Legislatures.
“I mean, there’s just definitely been a lot more use of [e-cigarettes]. Vaping and things like that definitely took off between 2019 and 2020,” Ms. Thew explained. “And I think marijuana use in itself is going up tremendously, I think more kids who would have used alcohol in the past use weed.”
Although public attitudes toward marijuana have relaxed, previous studies have linked it to memory dysfunction, as well as long-term cognitive effects that can interfere with perception of time and motor function. However, studies also have shown that cannabis use can combat age-related cognitive decline and help with pain reduction.
However, when it comes to adolescents, Dr. Watson and colleagues said e-cigarette use among youth and young adults is unsafe, regardless of the substances used in these products, including marijuana. Furthermore, they said marijuana use can lead to higher risks of more problematic use later in life, adding that evidence-based strategies to reduce marijuana use in e-cigarettes are important for protecting young people.
The study author and experts disclosed no relevant financial relationships.
Hispanic adolescents were more likely to use e-cigarettes to vape marijuana than were their Black and White counterparts in 2020, according to a recent study conducted by the Centers for Disease Control and Prevention and published in JAMA Pediatrics.
Researchers found that 25.6% of Hispanic students reported vaping marijuana, compared to 19.4% of Black students and 18.2% of White students. The study, which is an analysis of 2017, 2018, and 2020 results from the National Youth Tobacco Survey, also revealed that increases in this recreational practice occurred among all racial and ethnic groups within those 3 years, with Hispanic students having the largest percent increase, 11.6%, followed by Black students at 8.8% and White students at 7.4%.
“The initial motivation [to do this study] was to gain a better understanding of the prevalence of use of marijuana in e-cigarettes among youth, particularly given the context of the 2019 outbreak of e-cigarette, or vaping, product use–associated lung injury (EVALI),” study author Christina Vaughan Watson, DrPH, health scientist at the CDC’s National Center for Chronic Disease Prevention and Health Promotion, said in an interview.
The findings could help clinicians and physicians understand demographic variations among marijuana vapers and help inform targeted interventions for specific populations.
“Understanding demographic variations among those who are using marijuana in e-cigarettes can help inform evidenced-based interventions that may resonate with specific populations,” Dr. Watson explained.
Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin in Milwaukee, who was not involved in the study, said in an interview that the findings were “eye opening” and revealed a pattern she hasn’t seen before in her adolescent clinic.
“I would have thought African-American or non-Hispanic Blacks would’ve been a higher group of use, because when we screen kids that’s what we tend to get from the population we see here,” Ms. Thew said.
Ms. Thew said the findings also had made her reconsider her clinic’s approach to screening adolescents for marijuana use as well as address possible language barriers.
“We are probably missing access to some of the kids that we may need to seek out,” she explained. “I also thought it sends a good message that we need to direct some of our education probably a little differently, especially if it’s a Hispanic population and English may not be the primary language.”
Dr. Watson said more research is needed to assess why differences in marijuana use in e-cigarettes exist among youth.
Marijuana use in e-cigarettes has become increasingly popular among U.S. teens, with one in five students in grades 10 and 12 reporting vaping marijuana within the past year in a 2019 study conducted by the National Institute on Drug Abuse.
Dr. Watson and colleagues also found statistically significant increases in vaping marijuana, with 19.5% of students reporting smoking marijuana via e-cigarettes in 2020, compared to 11.1% of them vaping the drug in 2017. They believe the rise in marijuana vaping among youth may be attributed to states increasingly legalizing adult marijuana sales, which could impact ease of access and social acceptance.
Ms. Thew believes the rise in marijuana vaping among youth can be attributed to the legalization of marijuana, which may send “a message to adolescents that it must be safe for them to use,” as well as the increasing popularity of e-cigarettes.
In fact, as of April 2021, marijuana is legal for adults in 16 states and the District of Columbia. Meanwhile, medical marijuana is legal in 36 states, according to the National Conference of State Legislatures.
“I mean, there’s just definitely been a lot more use of [e-cigarettes]. Vaping and things like that definitely took off between 2019 and 2020,” Ms. Thew explained. “And I think marijuana use in itself is going up tremendously, I think more kids who would have used alcohol in the past use weed.”
Although public attitudes toward marijuana have relaxed, previous studies have linked it to memory dysfunction, as well as long-term cognitive effects that can interfere with perception of time and motor function. However, studies also have shown that cannabis use can combat age-related cognitive decline and help with pain reduction.
However, when it comes to adolescents, Dr. Watson and colleagues said e-cigarette use among youth and young adults is unsafe, regardless of the substances used in these products, including marijuana. Furthermore, they said marijuana use can lead to higher risks of more problematic use later in life, adding that evidence-based strategies to reduce marijuana use in e-cigarettes are important for protecting young people.
The study author and experts disclosed no relevant financial relationships.
FDA moves to ban menthol in cigarettes
The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.
Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.
Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.
But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.
The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.
The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.
“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.
Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.
Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.
“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”
The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”
Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.
The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”
The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.
Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”
The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.
Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.
“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.
The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.
Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.
Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.
But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.
The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.
The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.
“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.
Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.
Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.
“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”
The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”
Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.
The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”
The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.
Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”
The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.
Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.
“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.
The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.
Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.
Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.
But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.
The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.
The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.
“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.
Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.
Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.
“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”
The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”
Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.
The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”
The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.
Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”
The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.
Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.
“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.
The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.
A version of this article first appeared on WebMD.com.
Short-term oxygen prescriptions lead to inappropriate long-term use
In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.
Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.
A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.
The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.
There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.
In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.
Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.
A version of this article first appeared on Medscape.com.
In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.
Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.
A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.
The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.
There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.
In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.
Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.
A version of this article first appeared on Medscape.com.
In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.
Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.
A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.
The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.
There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.
In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.
Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.
A version of this article first appeared on Medscape.com.