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CDC releases updated draft guidance on opioid prescribing
The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.
The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”
In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.
The updated recommendations are now open for public comment via the Federal Register’s website through April 11.
“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.
“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.
Outpatient recommendations
The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.
It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.
The draft guidance includes 12 recommendations focused on four key areas:
- Helping clinicians determine whether or not to initiate opioid treatment for pain
- Opioid selection and dosage
- Duration of use and follow-up
- Assessing risk and addressing potential harms from use
The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.
In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.
It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.
Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.
“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.
“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.
A version of this article first appeared on Medscape.com.
The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.
The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”
In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.
The updated recommendations are now open for public comment via the Federal Register’s website through April 11.
“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.
“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.
Outpatient recommendations
The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.
It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.
The draft guidance includes 12 recommendations focused on four key areas:
- Helping clinicians determine whether or not to initiate opioid treatment for pain
- Opioid selection and dosage
- Duration of use and follow-up
- Assessing risk and addressing potential harms from use
The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.
In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.
It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.
Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.
“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.
“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.
A version of this article first appeared on Medscape.com.
The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.
The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”
In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.
The updated recommendations are now open for public comment via the Federal Register’s website through April 11.
“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.
“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.
Outpatient recommendations
The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.
It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.
The draft guidance includes 12 recommendations focused on four key areas:
- Helping clinicians determine whether or not to initiate opioid treatment for pain
- Opioid selection and dosage
- Duration of use and follow-up
- Assessing risk and addressing potential harms from use
The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.
In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.
It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.
Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.
“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.
“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.
A version of this article first appeared on Medscape.com.
SCAI refines cardiogenic shock classification system
The Society for Cardiovascular Angiography and Interventions (SCAI) has refined its cardiogenic shock (CS) classification system based on the literature and clinician feedback from real-world experience.
“In the 2 years since publication in 2019, the initial definition has been broadly accepted and eagerly appreciated, allowing a very intuitive way to stage these patients for better communication, triage, and treatment,” Srihari S. Naidu, MD, professor of medicine, New York Medical College, Valhalla, said in an interview.
“But the initial definition was based on consensus opinion, with a lack of real fundamental data on segregating patients into different stages. Now we have a lot more data utilizing the definition, and it became very clear that there were a couple of limitations in the initial definition,” Dr. Naidu explained.
The refined CS classification system – authored by Dr. Naidu and a multidisciplinary panel of experts from specialties that included cardiac critical care, interventional cardiology, surgery, nursing, emergency medicine, and heart failure – was published online Jan. 31 in the Journal of the Society for Cardiovascular Angiography and Interventions, with simultaneous publication in the Journal of the American College of Cardiology.
It maintains the five-stage pyramid of CS, starting with “at risk” and moving through “beginning,” “classic,” “deteriorating,” and “extremis” but now includes gradations of severity within each stage and pathways by which patients progress or recover.
“Progression across the SCAI shock stage continuum is a dynamic process, incorporating new information as available, and patient trajectories are important both for communication among clinicians and for decisionmaking regarding the next level of care and therapeutics,” the panel writes.
The second iteration adds a streamlined table incorporating commonly seen variables, based on lessons learned from validation studies and clinician experience.
“While keeping the same initial framework of looking at the three components of staging – the physical exam, the biochemical markers, and hemodynamics – we’ve made it very clear that there are some factors in each of these that are most typically seen. And then there are other factors that are consistent with that stage but don’t necessarily have to be seen, ... are not typically seen in that stage, or [are] not always present at that stage,” Dr. Naidu told this news organization.
The refined CS classification system provides more granularity on cardiac arrest as a risk modifier, which now excludes very brief episodes with rapid response to defibrillation and comprises only those patients who have impaired mental status with unknown neurologic recovery status after cardiopulmonary resuscitation.
Lactate level and thresholds have been highlighted to detect hypoperfusion but may be dissociated from hemodynamics in cases such as chronic heart failure.
In addition, patients may have other manifestations of end-organ hypoperfusion with a normal lactate level, and there are also important causes of an elevated lactate level other than shock.
The revision proposes a three-axis model of CS evaluation and prognostication that integrates shock severity, clinical phenotype, and risk modifiers as distinct elements that should be applied to individualize patient management.
The revision also places more emphasis on the trajectory of the patient with CS through hospitalization, including a “hub and spoke” model for transfer of higher-risk patients, including those with a deteriorating SCAI shock stage.
“It is our desire and belief that the revised SCAI SHOCK stage classification system will enhance both clinical care and CS research trial design,” the panel writes.
This statement has been endorsed by the American College of Cardiology, American College of Emergency Physicians, American Heart Association, European Society of Cardiology Association for Acute Cardiovascular Care, International Society for Heart and Lung Transplantation, Society of Critical Care Medicine, and Society of Thoracic Surgeons.
This research had no commercial funding. Dr. Naidu has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.
A version of this article first appeared on Medscape.com.
The Society for Cardiovascular Angiography and Interventions (SCAI) has refined its cardiogenic shock (CS) classification system based on the literature and clinician feedback from real-world experience.
“In the 2 years since publication in 2019, the initial definition has been broadly accepted and eagerly appreciated, allowing a very intuitive way to stage these patients for better communication, triage, and treatment,” Srihari S. Naidu, MD, professor of medicine, New York Medical College, Valhalla, said in an interview.
“But the initial definition was based on consensus opinion, with a lack of real fundamental data on segregating patients into different stages. Now we have a lot more data utilizing the definition, and it became very clear that there were a couple of limitations in the initial definition,” Dr. Naidu explained.
The refined CS classification system – authored by Dr. Naidu and a multidisciplinary panel of experts from specialties that included cardiac critical care, interventional cardiology, surgery, nursing, emergency medicine, and heart failure – was published online Jan. 31 in the Journal of the Society for Cardiovascular Angiography and Interventions, with simultaneous publication in the Journal of the American College of Cardiology.
It maintains the five-stage pyramid of CS, starting with “at risk” and moving through “beginning,” “classic,” “deteriorating,” and “extremis” but now includes gradations of severity within each stage and pathways by which patients progress or recover.
“Progression across the SCAI shock stage continuum is a dynamic process, incorporating new information as available, and patient trajectories are important both for communication among clinicians and for decisionmaking regarding the next level of care and therapeutics,” the panel writes.
The second iteration adds a streamlined table incorporating commonly seen variables, based on lessons learned from validation studies and clinician experience.
“While keeping the same initial framework of looking at the three components of staging – the physical exam, the biochemical markers, and hemodynamics – we’ve made it very clear that there are some factors in each of these that are most typically seen. And then there are other factors that are consistent with that stage but don’t necessarily have to be seen, ... are not typically seen in that stage, or [are] not always present at that stage,” Dr. Naidu told this news organization.
The refined CS classification system provides more granularity on cardiac arrest as a risk modifier, which now excludes very brief episodes with rapid response to defibrillation and comprises only those patients who have impaired mental status with unknown neurologic recovery status after cardiopulmonary resuscitation.
Lactate level and thresholds have been highlighted to detect hypoperfusion but may be dissociated from hemodynamics in cases such as chronic heart failure.
In addition, patients may have other manifestations of end-organ hypoperfusion with a normal lactate level, and there are also important causes of an elevated lactate level other than shock.
The revision proposes a three-axis model of CS evaluation and prognostication that integrates shock severity, clinical phenotype, and risk modifiers as distinct elements that should be applied to individualize patient management.
The revision also places more emphasis on the trajectory of the patient with CS through hospitalization, including a “hub and spoke” model for transfer of higher-risk patients, including those with a deteriorating SCAI shock stage.
“It is our desire and belief that the revised SCAI SHOCK stage classification system will enhance both clinical care and CS research trial design,” the panel writes.
This statement has been endorsed by the American College of Cardiology, American College of Emergency Physicians, American Heart Association, European Society of Cardiology Association for Acute Cardiovascular Care, International Society for Heart and Lung Transplantation, Society of Critical Care Medicine, and Society of Thoracic Surgeons.
This research had no commercial funding. Dr. Naidu has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.
A version of this article first appeared on Medscape.com.
The Society for Cardiovascular Angiography and Interventions (SCAI) has refined its cardiogenic shock (CS) classification system based on the literature and clinician feedback from real-world experience.
“In the 2 years since publication in 2019, the initial definition has been broadly accepted and eagerly appreciated, allowing a very intuitive way to stage these patients for better communication, triage, and treatment,” Srihari S. Naidu, MD, professor of medicine, New York Medical College, Valhalla, said in an interview.
“But the initial definition was based on consensus opinion, with a lack of real fundamental data on segregating patients into different stages. Now we have a lot more data utilizing the definition, and it became very clear that there were a couple of limitations in the initial definition,” Dr. Naidu explained.
The refined CS classification system – authored by Dr. Naidu and a multidisciplinary panel of experts from specialties that included cardiac critical care, interventional cardiology, surgery, nursing, emergency medicine, and heart failure – was published online Jan. 31 in the Journal of the Society for Cardiovascular Angiography and Interventions, with simultaneous publication in the Journal of the American College of Cardiology.
It maintains the five-stage pyramid of CS, starting with “at risk” and moving through “beginning,” “classic,” “deteriorating,” and “extremis” but now includes gradations of severity within each stage and pathways by which patients progress or recover.
“Progression across the SCAI shock stage continuum is a dynamic process, incorporating new information as available, and patient trajectories are important both for communication among clinicians and for decisionmaking regarding the next level of care and therapeutics,” the panel writes.
The second iteration adds a streamlined table incorporating commonly seen variables, based on lessons learned from validation studies and clinician experience.
“While keeping the same initial framework of looking at the three components of staging – the physical exam, the biochemical markers, and hemodynamics – we’ve made it very clear that there are some factors in each of these that are most typically seen. And then there are other factors that are consistent with that stage but don’t necessarily have to be seen, ... are not typically seen in that stage, or [are] not always present at that stage,” Dr. Naidu told this news organization.
The refined CS classification system provides more granularity on cardiac arrest as a risk modifier, which now excludes very brief episodes with rapid response to defibrillation and comprises only those patients who have impaired mental status with unknown neurologic recovery status after cardiopulmonary resuscitation.
Lactate level and thresholds have been highlighted to detect hypoperfusion but may be dissociated from hemodynamics in cases such as chronic heart failure.
In addition, patients may have other manifestations of end-organ hypoperfusion with a normal lactate level, and there are also important causes of an elevated lactate level other than shock.
The revision proposes a three-axis model of CS evaluation and prognostication that integrates shock severity, clinical phenotype, and risk modifiers as distinct elements that should be applied to individualize patient management.
The revision also places more emphasis on the trajectory of the patient with CS through hospitalization, including a “hub and spoke” model for transfer of higher-risk patients, including those with a deteriorating SCAI shock stage.
“It is our desire and belief that the revised SCAI SHOCK stage classification system will enhance both clinical care and CS research trial design,” the panel writes.
This statement has been endorsed by the American College of Cardiology, American College of Emergency Physicians, American Heart Association, European Society of Cardiology Association for Acute Cardiovascular Care, International Society for Heart and Lung Transplantation, Society of Critical Care Medicine, and Society of Thoracic Surgeons.
This research had no commercial funding. Dr. Naidu has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.
A version of this article first appeared on Medscape.com.
AGA clinical practice update: Expert review on managing refractory gastroparesis
Gastroparesis can be tricky to diagnose and treat, in part because its symptoms can be difficult to distinguish from functional dyspepsia. A new clinical practice update from the American Gastroenterological Association aims to help physicians treat medically refractory gastroparesis with practical advice stemming from expert opinion and a literature review.
Although gastroparesis can be caused by known factors such as diabetes and medications, the largest group is idiopathic. The authors define medically refractory gastroparesis as symptoms that are not due to medication use, that continue despite dietary changes and first-line treatment with metoclopramide.
Although the authors outline several best practice advice statements on symptom identification and management, they acknowledge that much uncertainty still exists. “Our knowledge gap remains vast, and areas for future research include study of pathophysiology and etiology, as well as identification of clinical and investigation-based predictors of response to each management approach,” the authors wrote. Their report is in Clinical Gastroenterology and Hepatology.
They also call for research to identify gastroparesis phenotypes that are most likely to respond to individual management approaches.
Common gastroparesis symptoms include nausea, vomiting, early satiety, bloating, postprandial fullness, abdominal pain, and weight loss. Many of these overlap with functional dyspepsia (FD). In fact, one study found that 42% of gastroparesis could be reclassified as having functional dyspepsia, and 37% of FD patients as having gastroparesis.
About 5 million adults in the United States, and 7.2% of the world population, report gastroparesis-like symptoms. The similarities between the two groups poses a significant diagnostic challenge. However, a careful history, physical exam, and appropriate diagnostic tests should allow the physician to rule out other conditions that may mimic gastroparesis. Repeating scintigraphy may change diagnosis from gastroparesis to FD or vice versa, but the authors note that this technique is often performed incorrectly and so should be conducted at centers that closely follow guidelines. They suggest a 4 hour meal-based test of gastric emptying over the wireless motility capsule because it provides a better physiological assessment.
They also suggest that treatment should focus on the most bothersome symptom, along with reducing the potential for complications such as esophagitis, malnutrition, and weight loss, as well as improving quality of life.
There are medications available for nausea and vomiting, although most have not been studied in large randomized controlled trials. These agents include domperidone, 5-hydroxytryptamine3 receptor antagonists, neurokinin receptor antagonists, and phenothiazine antipsychotics.
There are also medications available to increase the rate of gastric emptying. Erythromycin can be used intravenously or orally ahead of meals, while the 5-HT4 receptor agonist velusetrag improved gastric emptying in healthy volunteers with no sign of cardiac side effects. The commonly available 5-HT4 agonist prucalopride has also shown promise in improving gastric emptying.
For visceral pain, the authors suggest not using opioids because they may slow gastric emptying and increase pain perception. It is believed that neuromodulators such as tricyclic antidepressants (TCAs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may reduce perception of pain, but there is limited high-quality evidence available for these therapies. The authors suggest that higher potency tertiary tricyclic amines such as amitriptyline or imipramine may be effective, particularly in diabetic gastroparesis since they provide relief in FD.
Nonpharmaceutical options include gastric electrical stimulation (GES), which improves refractory nausea and vomiting in some patients with gastroparesis, but does not accelerate gastric emptying. It may also improve glycemic control, nutritional status, and quality of life. The treatment may be well suited to opioid-free patients with refractory or intractable nausea and vomiting whose predominant symptom is not abdominal pain.
Other therapies focus on the pylorus and its role in gastric emptying, which can be impaired as a result of abnormalities of pyloric tone and pressure. Functional lumen imaging probe (FLIP) can be used to probe pyloric tone and pressure, but it is expensive, invasive, and not widely available.
Outside of clinical trial settings, the authors advise against the use of intrapyloric botulinum toxic injection and transpyloric stent placement. Per oral endoscopic myotomy (POEM) has shown some efficacy at improving symptoms and reducing gastric emptying times, but it has not been studied in sham-controlled trials. The authors call the technique intriguing, but say it should not be considered a first-line therapy, and should be performed only at tertiary centers with expert motility specialists and endoscopists.
In extreme cases, enteral nutrition may be necessary, and a transjejunal tube or combined gastrojejunostomy tube should be emplaced beyond the pylorus. In a retrospective case series, patients experienced weight recovery with acceptable morbidity and mortality, and the implant was removed at an average of 20 months.
The authors have consulted or been on scientific advisory boards for Salix, Ironwood, Allergan, Arena, Allakos, Medtronic, Diversatek, Takeda, Quintiles, and IsoThrive.
This article was updated Feb. 17, 2022.
Gastroparesis can be tricky to diagnose and treat, in part because its symptoms can be difficult to distinguish from functional dyspepsia. A new clinical practice update from the American Gastroenterological Association aims to help physicians treat medically refractory gastroparesis with practical advice stemming from expert opinion and a literature review.
Although gastroparesis can be caused by known factors such as diabetes and medications, the largest group is idiopathic. The authors define medically refractory gastroparesis as symptoms that are not due to medication use, that continue despite dietary changes and first-line treatment with metoclopramide.
Although the authors outline several best practice advice statements on symptom identification and management, they acknowledge that much uncertainty still exists. “Our knowledge gap remains vast, and areas for future research include study of pathophysiology and etiology, as well as identification of clinical and investigation-based predictors of response to each management approach,” the authors wrote. Their report is in Clinical Gastroenterology and Hepatology.
They also call for research to identify gastroparesis phenotypes that are most likely to respond to individual management approaches.
Common gastroparesis symptoms include nausea, vomiting, early satiety, bloating, postprandial fullness, abdominal pain, and weight loss. Many of these overlap with functional dyspepsia (FD). In fact, one study found that 42% of gastroparesis could be reclassified as having functional dyspepsia, and 37% of FD patients as having gastroparesis.
About 5 million adults in the United States, and 7.2% of the world population, report gastroparesis-like symptoms. The similarities between the two groups poses a significant diagnostic challenge. However, a careful history, physical exam, and appropriate diagnostic tests should allow the physician to rule out other conditions that may mimic gastroparesis. Repeating scintigraphy may change diagnosis from gastroparesis to FD or vice versa, but the authors note that this technique is often performed incorrectly and so should be conducted at centers that closely follow guidelines. They suggest a 4 hour meal-based test of gastric emptying over the wireless motility capsule because it provides a better physiological assessment.
They also suggest that treatment should focus on the most bothersome symptom, along with reducing the potential for complications such as esophagitis, malnutrition, and weight loss, as well as improving quality of life.
There are medications available for nausea and vomiting, although most have not been studied in large randomized controlled trials. These agents include domperidone, 5-hydroxytryptamine3 receptor antagonists, neurokinin receptor antagonists, and phenothiazine antipsychotics.
There are also medications available to increase the rate of gastric emptying. Erythromycin can be used intravenously or orally ahead of meals, while the 5-HT4 receptor agonist velusetrag improved gastric emptying in healthy volunteers with no sign of cardiac side effects. The commonly available 5-HT4 agonist prucalopride has also shown promise in improving gastric emptying.
For visceral pain, the authors suggest not using opioids because they may slow gastric emptying and increase pain perception. It is believed that neuromodulators such as tricyclic antidepressants (TCAs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may reduce perception of pain, but there is limited high-quality evidence available for these therapies. The authors suggest that higher potency tertiary tricyclic amines such as amitriptyline or imipramine may be effective, particularly in diabetic gastroparesis since they provide relief in FD.
Nonpharmaceutical options include gastric electrical stimulation (GES), which improves refractory nausea and vomiting in some patients with gastroparesis, but does not accelerate gastric emptying. It may also improve glycemic control, nutritional status, and quality of life. The treatment may be well suited to opioid-free patients with refractory or intractable nausea and vomiting whose predominant symptom is not abdominal pain.
Other therapies focus on the pylorus and its role in gastric emptying, which can be impaired as a result of abnormalities of pyloric tone and pressure. Functional lumen imaging probe (FLIP) can be used to probe pyloric tone and pressure, but it is expensive, invasive, and not widely available.
Outside of clinical trial settings, the authors advise against the use of intrapyloric botulinum toxic injection and transpyloric stent placement. Per oral endoscopic myotomy (POEM) has shown some efficacy at improving symptoms and reducing gastric emptying times, but it has not been studied in sham-controlled trials. The authors call the technique intriguing, but say it should not be considered a first-line therapy, and should be performed only at tertiary centers with expert motility specialists and endoscopists.
In extreme cases, enteral nutrition may be necessary, and a transjejunal tube or combined gastrojejunostomy tube should be emplaced beyond the pylorus. In a retrospective case series, patients experienced weight recovery with acceptable morbidity and mortality, and the implant was removed at an average of 20 months.
The authors have consulted or been on scientific advisory boards for Salix, Ironwood, Allergan, Arena, Allakos, Medtronic, Diversatek, Takeda, Quintiles, and IsoThrive.
This article was updated Feb. 17, 2022.
Gastroparesis can be tricky to diagnose and treat, in part because its symptoms can be difficult to distinguish from functional dyspepsia. A new clinical practice update from the American Gastroenterological Association aims to help physicians treat medically refractory gastroparesis with practical advice stemming from expert opinion and a literature review.
Although gastroparesis can be caused by known factors such as diabetes and medications, the largest group is idiopathic. The authors define medically refractory gastroparesis as symptoms that are not due to medication use, that continue despite dietary changes and first-line treatment with metoclopramide.
Although the authors outline several best practice advice statements on symptom identification and management, they acknowledge that much uncertainty still exists. “Our knowledge gap remains vast, and areas for future research include study of pathophysiology and etiology, as well as identification of clinical and investigation-based predictors of response to each management approach,” the authors wrote. Their report is in Clinical Gastroenterology and Hepatology.
They also call for research to identify gastroparesis phenotypes that are most likely to respond to individual management approaches.
Common gastroparesis symptoms include nausea, vomiting, early satiety, bloating, postprandial fullness, abdominal pain, and weight loss. Many of these overlap with functional dyspepsia (FD). In fact, one study found that 42% of gastroparesis could be reclassified as having functional dyspepsia, and 37% of FD patients as having gastroparesis.
About 5 million adults in the United States, and 7.2% of the world population, report gastroparesis-like symptoms. The similarities between the two groups poses a significant diagnostic challenge. However, a careful history, physical exam, and appropriate diagnostic tests should allow the physician to rule out other conditions that may mimic gastroparesis. Repeating scintigraphy may change diagnosis from gastroparesis to FD or vice versa, but the authors note that this technique is often performed incorrectly and so should be conducted at centers that closely follow guidelines. They suggest a 4 hour meal-based test of gastric emptying over the wireless motility capsule because it provides a better physiological assessment.
They also suggest that treatment should focus on the most bothersome symptom, along with reducing the potential for complications such as esophagitis, malnutrition, and weight loss, as well as improving quality of life.
There are medications available for nausea and vomiting, although most have not been studied in large randomized controlled trials. These agents include domperidone, 5-hydroxytryptamine3 receptor antagonists, neurokinin receptor antagonists, and phenothiazine antipsychotics.
There are also medications available to increase the rate of gastric emptying. Erythromycin can be used intravenously or orally ahead of meals, while the 5-HT4 receptor agonist velusetrag improved gastric emptying in healthy volunteers with no sign of cardiac side effects. The commonly available 5-HT4 agonist prucalopride has also shown promise in improving gastric emptying.
For visceral pain, the authors suggest not using opioids because they may slow gastric emptying and increase pain perception. It is believed that neuromodulators such as tricyclic antidepressants (TCAs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may reduce perception of pain, but there is limited high-quality evidence available for these therapies. The authors suggest that higher potency tertiary tricyclic amines such as amitriptyline or imipramine may be effective, particularly in diabetic gastroparesis since they provide relief in FD.
Nonpharmaceutical options include gastric electrical stimulation (GES), which improves refractory nausea and vomiting in some patients with gastroparesis, but does not accelerate gastric emptying. It may also improve glycemic control, nutritional status, and quality of life. The treatment may be well suited to opioid-free patients with refractory or intractable nausea and vomiting whose predominant symptom is not abdominal pain.
Other therapies focus on the pylorus and its role in gastric emptying, which can be impaired as a result of abnormalities of pyloric tone and pressure. Functional lumen imaging probe (FLIP) can be used to probe pyloric tone and pressure, but it is expensive, invasive, and not widely available.
Outside of clinical trial settings, the authors advise against the use of intrapyloric botulinum toxic injection and transpyloric stent placement. Per oral endoscopic myotomy (POEM) has shown some efficacy at improving symptoms and reducing gastric emptying times, but it has not been studied in sham-controlled trials. The authors call the technique intriguing, but say it should not be considered a first-line therapy, and should be performed only at tertiary centers with expert motility specialists and endoscopists.
In extreme cases, enteral nutrition may be necessary, and a transjejunal tube or combined gastrojejunostomy tube should be emplaced beyond the pylorus. In a retrospective case series, patients experienced weight recovery with acceptable morbidity and mortality, and the implant was removed at an average of 20 months.
The authors have consulted or been on scientific advisory boards for Salix, Ironwood, Allergan, Arena, Allakos, Medtronic, Diversatek, Takeda, Quintiles, and IsoThrive.
This article was updated Feb. 17, 2022.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Updated guidance for COVID vaccination in rheumatology patients arrives amid continued hesitancy
As rheumatologists contend with vaccine hesitancy among certain subsets of patients, the American College of Rheumatology has released updated clinical guidelines on COVID-19 vaccination for patients with rheumatic and musculoskeletal diseases (RMDs), including new recommendations on supplemental and booster doses.
The revised guidance from this fifth version of the ACR guidelines includes strongly recommending that all RMD patients receive a booster after their primary vaccine series, regardless of whether they have been naturally infected with COVID-19. In addition, they strongly recommend third supplemental doses for patients with autoimmune inflammatory rheumatic diseases (AIIRDs) who likely mounted an inadequate vaccine response, which would then be followed by a fourth booster dose as advised by the Centers for Disease Control and Prevention for immunocompromised individuals.
Other recommendations include pre-exposure prophylaxis monoclonal antibody treatment for high-risk AIIRD patients, defined as those with moderate to severely compromised immune systems who may not mount an adequate immune response to COVID-19 vaccination, when it is available and authorized for emergency use by the Food and Drug Administration, as well as monoclonal antibody therapy for postexposure prophylaxis of asymptomatic, recently exposed high-risk AIIRD patients or as treatment for newly symptomatic, high-risk AIIRD patients. The ACR guidance notes that, currently, neither the monoclonal antibodies bamlanivimab and etesevimab (administered together) nor casirivimab and imdevimab (REGEN-COV), are licensed or available under an emergency use authorization given their lack of activity against the Omicron variant, the dominant strain of SARS-CoV-2 circulating in the United States.
Finally, the guidance clarified that the timing of intravenous immunoglobulin doses does not need to be modified around the administration of COVID vaccine doses, based on moderate consensus among task force members.
Vaccine hesitancy in community rheumatology practices
The revised guidelines were released just as Arthritis & Rheumatology published a new study that assessed vaccine hesitancy among rheumatology patients on immunomodulatory therapies. A three-item electronic survey was conducted at 101 offices within a community practice–based rheumatology research network and ultimately collected responses from 58,529 patients, 20,987 of whom had an AIIRD and were receiving targeted therapies like biologics or Janus kinase inhibitors.
Of the total respondents, 77% (n = 43,675) had been vaccinated, 16.9% were not vaccinated and did not plan to be, and 6.1% were not vaccinated but planned to be. However, AIIRD patients were 16% less likely to be vaccinated, compared with the other patients, such as those with osteoarthritis or osteoporosis who were not receiving disease-modifying antirheumatic drugs (76.9% vs. 87%; odds ratio, 0.84; 95% confidence interval, 0.77-0.92; P < .001). Multivariable analysis also found that older patients (OR, 1.49 per 10 years) and Asians (OR, 2.42; 95% CI, 1.77-3.33) were more likely to be vaccinated.
“Rheumatologists need to be asking their patients more than just: ‘Are you vaccinated?’ ” Jeffrey Curtis, MD, MPH, head of the ACR COVID-19 vaccine task force and a coauthor of the vaccine hesitancy study, said in an interview. “A year ago, that was a fine approach, but now they need to be asking whether you’ve been vaccinated, and with what, and how many times, and how recently. There are a whole lot of subtleties there; ‘vaccinated: yes or no’ is just the tip of the iceberg.”
His research into the vaccine hesitant includes recent anecdotal data from thousands of patients treated in local rheumatology community practices, many of whom cited long-term safety data and potential side effects as reasons why they were unwilling to get vaccinated. But despite their on-paper responses, he cautioned rheumatologists to think critically when determining which patients may truly be open to vaccination.
“If you’re designing strategies to affect vaccine hesitancy, you may be wasting your time with some people,” said Dr. Curtis, professor of medicine at the University of Alabama at Birmingham. “A critical need is to figure out who are the patients who may be amendable to more information or an intervention or a little bit more time and care, and who are the people where you know, this is a lost cause: You don’t get a flu shot, you haven’t been vaccinated for shingles, [and] you’re not going to get this one either.
“In terms of a research agenda, how do we develop efficient, simple, short screening tools?” he added. “Something with a few helpful questions, on a patient portal or an iPad, that will do a good job identifying your patients at risk who haven’t had vaccination but that you might be able to spend time with, intervene, and actually change their mind. If you spend gobs of time with everyone, you’ll help some people, but clinicians don’t have an infinite amount of time.”
One of the authors of the vaccine hesitancy study acknowledged being employed by the rheumatology research network that hosted the survey. Several others, including Dr. Curtis, reported receiving grants and consulting fees from various pharmaceutical companies.
As rheumatologists contend with vaccine hesitancy among certain subsets of patients, the American College of Rheumatology has released updated clinical guidelines on COVID-19 vaccination for patients with rheumatic and musculoskeletal diseases (RMDs), including new recommendations on supplemental and booster doses.
The revised guidance from this fifth version of the ACR guidelines includes strongly recommending that all RMD patients receive a booster after their primary vaccine series, regardless of whether they have been naturally infected with COVID-19. In addition, they strongly recommend third supplemental doses for patients with autoimmune inflammatory rheumatic diseases (AIIRDs) who likely mounted an inadequate vaccine response, which would then be followed by a fourth booster dose as advised by the Centers for Disease Control and Prevention for immunocompromised individuals.
Other recommendations include pre-exposure prophylaxis monoclonal antibody treatment for high-risk AIIRD patients, defined as those with moderate to severely compromised immune systems who may not mount an adequate immune response to COVID-19 vaccination, when it is available and authorized for emergency use by the Food and Drug Administration, as well as monoclonal antibody therapy for postexposure prophylaxis of asymptomatic, recently exposed high-risk AIIRD patients or as treatment for newly symptomatic, high-risk AIIRD patients. The ACR guidance notes that, currently, neither the monoclonal antibodies bamlanivimab and etesevimab (administered together) nor casirivimab and imdevimab (REGEN-COV), are licensed or available under an emergency use authorization given their lack of activity against the Omicron variant, the dominant strain of SARS-CoV-2 circulating in the United States.
Finally, the guidance clarified that the timing of intravenous immunoglobulin doses does not need to be modified around the administration of COVID vaccine doses, based on moderate consensus among task force members.
Vaccine hesitancy in community rheumatology practices
The revised guidelines were released just as Arthritis & Rheumatology published a new study that assessed vaccine hesitancy among rheumatology patients on immunomodulatory therapies. A three-item electronic survey was conducted at 101 offices within a community practice–based rheumatology research network and ultimately collected responses from 58,529 patients, 20,987 of whom had an AIIRD and were receiving targeted therapies like biologics or Janus kinase inhibitors.
Of the total respondents, 77% (n = 43,675) had been vaccinated, 16.9% were not vaccinated and did not plan to be, and 6.1% were not vaccinated but planned to be. However, AIIRD patients were 16% less likely to be vaccinated, compared with the other patients, such as those with osteoarthritis or osteoporosis who were not receiving disease-modifying antirheumatic drugs (76.9% vs. 87%; odds ratio, 0.84; 95% confidence interval, 0.77-0.92; P < .001). Multivariable analysis also found that older patients (OR, 1.49 per 10 years) and Asians (OR, 2.42; 95% CI, 1.77-3.33) were more likely to be vaccinated.
“Rheumatologists need to be asking their patients more than just: ‘Are you vaccinated?’ ” Jeffrey Curtis, MD, MPH, head of the ACR COVID-19 vaccine task force and a coauthor of the vaccine hesitancy study, said in an interview. “A year ago, that was a fine approach, but now they need to be asking whether you’ve been vaccinated, and with what, and how many times, and how recently. There are a whole lot of subtleties there; ‘vaccinated: yes or no’ is just the tip of the iceberg.”
His research into the vaccine hesitant includes recent anecdotal data from thousands of patients treated in local rheumatology community practices, many of whom cited long-term safety data and potential side effects as reasons why they were unwilling to get vaccinated. But despite their on-paper responses, he cautioned rheumatologists to think critically when determining which patients may truly be open to vaccination.
“If you’re designing strategies to affect vaccine hesitancy, you may be wasting your time with some people,” said Dr. Curtis, professor of medicine at the University of Alabama at Birmingham. “A critical need is to figure out who are the patients who may be amendable to more information or an intervention or a little bit more time and care, and who are the people where you know, this is a lost cause: You don’t get a flu shot, you haven’t been vaccinated for shingles, [and] you’re not going to get this one either.
“In terms of a research agenda, how do we develop efficient, simple, short screening tools?” he added. “Something with a few helpful questions, on a patient portal or an iPad, that will do a good job identifying your patients at risk who haven’t had vaccination but that you might be able to spend time with, intervene, and actually change their mind. If you spend gobs of time with everyone, you’ll help some people, but clinicians don’t have an infinite amount of time.”
One of the authors of the vaccine hesitancy study acknowledged being employed by the rheumatology research network that hosted the survey. Several others, including Dr. Curtis, reported receiving grants and consulting fees from various pharmaceutical companies.
As rheumatologists contend with vaccine hesitancy among certain subsets of patients, the American College of Rheumatology has released updated clinical guidelines on COVID-19 vaccination for patients with rheumatic and musculoskeletal diseases (RMDs), including new recommendations on supplemental and booster doses.
The revised guidance from this fifth version of the ACR guidelines includes strongly recommending that all RMD patients receive a booster after their primary vaccine series, regardless of whether they have been naturally infected with COVID-19. In addition, they strongly recommend third supplemental doses for patients with autoimmune inflammatory rheumatic diseases (AIIRDs) who likely mounted an inadequate vaccine response, which would then be followed by a fourth booster dose as advised by the Centers for Disease Control and Prevention for immunocompromised individuals.
Other recommendations include pre-exposure prophylaxis monoclonal antibody treatment for high-risk AIIRD patients, defined as those with moderate to severely compromised immune systems who may not mount an adequate immune response to COVID-19 vaccination, when it is available and authorized for emergency use by the Food and Drug Administration, as well as monoclonal antibody therapy for postexposure prophylaxis of asymptomatic, recently exposed high-risk AIIRD patients or as treatment for newly symptomatic, high-risk AIIRD patients. The ACR guidance notes that, currently, neither the monoclonal antibodies bamlanivimab and etesevimab (administered together) nor casirivimab and imdevimab (REGEN-COV), are licensed or available under an emergency use authorization given their lack of activity against the Omicron variant, the dominant strain of SARS-CoV-2 circulating in the United States.
Finally, the guidance clarified that the timing of intravenous immunoglobulin doses does not need to be modified around the administration of COVID vaccine doses, based on moderate consensus among task force members.
Vaccine hesitancy in community rheumatology practices
The revised guidelines were released just as Arthritis & Rheumatology published a new study that assessed vaccine hesitancy among rheumatology patients on immunomodulatory therapies. A three-item electronic survey was conducted at 101 offices within a community practice–based rheumatology research network and ultimately collected responses from 58,529 patients, 20,987 of whom had an AIIRD and were receiving targeted therapies like biologics or Janus kinase inhibitors.
Of the total respondents, 77% (n = 43,675) had been vaccinated, 16.9% were not vaccinated and did not plan to be, and 6.1% were not vaccinated but planned to be. However, AIIRD patients were 16% less likely to be vaccinated, compared with the other patients, such as those with osteoarthritis or osteoporosis who were not receiving disease-modifying antirheumatic drugs (76.9% vs. 87%; odds ratio, 0.84; 95% confidence interval, 0.77-0.92; P < .001). Multivariable analysis also found that older patients (OR, 1.49 per 10 years) and Asians (OR, 2.42; 95% CI, 1.77-3.33) were more likely to be vaccinated.
“Rheumatologists need to be asking their patients more than just: ‘Are you vaccinated?’ ” Jeffrey Curtis, MD, MPH, head of the ACR COVID-19 vaccine task force and a coauthor of the vaccine hesitancy study, said in an interview. “A year ago, that was a fine approach, but now they need to be asking whether you’ve been vaccinated, and with what, and how many times, and how recently. There are a whole lot of subtleties there; ‘vaccinated: yes or no’ is just the tip of the iceberg.”
His research into the vaccine hesitant includes recent anecdotal data from thousands of patients treated in local rheumatology community practices, many of whom cited long-term safety data and potential side effects as reasons why they were unwilling to get vaccinated. But despite their on-paper responses, he cautioned rheumatologists to think critically when determining which patients may truly be open to vaccination.
“If you’re designing strategies to affect vaccine hesitancy, you may be wasting your time with some people,” said Dr. Curtis, professor of medicine at the University of Alabama at Birmingham. “A critical need is to figure out who are the patients who may be amendable to more information or an intervention or a little bit more time and care, and who are the people where you know, this is a lost cause: You don’t get a flu shot, you haven’t been vaccinated for shingles, [and] you’re not going to get this one either.
“In terms of a research agenda, how do we develop efficient, simple, short screening tools?” he added. “Something with a few helpful questions, on a patient portal or an iPad, that will do a good job identifying your patients at risk who haven’t had vaccination but that you might be able to spend time with, intervene, and actually change their mind. If you spend gobs of time with everyone, you’ll help some people, but clinicians don’t have an infinite amount of time.”
One of the authors of the vaccine hesitancy study acknowledged being employed by the rheumatology research network that hosted the survey. Several others, including Dr. Curtis, reported receiving grants and consulting fees from various pharmaceutical companies.
FROM ARTHRITIS & RHEUMATOLOGY
New AAD guidelines eye comorbidities in adults with atopic dermatitis
While it’s well established that atopic dermatitis (AD) in adults is associated with asthma, allergic rhinitis, and other atopic conditions, the links between AD and other comorbidities are coming into clearer focus.
“There are more comorbidities with AD than we anticipated, that are supported by data in the literature,” Dawn M.R. Davis, MD, cochair and an author of the guidelines, told this news organization. “We are learning more about the interconnectivity of various medical conditions,” she continued. “Many skin diseases over time have been noted to be impactful to the whole person and not only the skin. A classic example of that is psoriasis. We now understand that psoriasis is a multisystem inflammatory disorder.”
As for AD, “we’ve always appreciated that AD patients tend to be at higher risk for other atopic diseases such as asthma, allergic rhinoconjunctivitis, and food allergies,” said Dr. Davis, of the departments of dermatology and pediatrics at the Mayo Clinic, Rochester, Minn. “With further research, we are now able to delineate those associations more intimately and have data to support our suspicions. Additionally, we’re now understanding that these inflammatory conditions can impact more than the end organ involved, such as the skin and AD. We wanted to look at how AD can affect the whole patient.”
For the guidelines, which are the first of their kind and were published online in the Journal of the American Academy of Dermatology, Dr. Davis and project cochair Robert Sidbury, MD, MPH, chief of dermatology at Seattle Children’s Hospital, led a multidisciplinary group of 12 experts to review the association between AD and selected comorbidities. They applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) for prognosis approach for assessing the certainty of the evidence and provided statements of association based on the available evidence.
With respect to highlights for atopic and allergic conditions, the guideline authors found high-quality evidence that AD in adults is associated with food allergies, moderate-quality evidence that AD is associated with asthma, and low-quality evidence that AD in adults may be associated with eosinophilic esophagitis.
In the realm of mental health and substance use, ample evidence exists to support an association between AD and mental health conditions such as depression and anxiety, the guidelines state. “For many patients, low mood may be driven by the symptoms of AD, including chronic itch and poor sleep,” Dr. Davis and her coauthors wrote. “Successfully treating AD may alleviate depressive symptoms for some patients; for others, assessment and treatment specific to their mental health may be needed.”
The guidelines also state that low-quality evidence exists to suggest that AD in adults may be associated with alcohol abuse disorders and cigarette smoking.
The authors noted “limited but consistent evidence” supporting a link between AD and adverse bone health, including osteoporosis and fractures, while associations between AD and cardiovascular risk factors and comorbidities, including hypertension, myocardial infarction, and stroke, are more controversial.
“I have published on bone health and AD so that was not as surprising to me,” Dr. Davis said in the interview. “I found a lot of the evidence in the guidelines to be validating of patterns that we see in our patients. The most significant learning point for me was [the link to] cardiovascular disease and the link to specific mental health and substance use disorders. It validates how impactful AD is to the individual.”
According to the guidelines, moderate-quality evidence exists linking AD in adults to both alopecia areata and urticaria. “Because we are dermatologists and take care of both of those diseases, be mindful of that in your daily practice,” Dr. Davis advised. “I would also encourage our colleagues to remember to educate patients on the comorbidities of AD so that they are empowered, and to screen for those comorbidities in your office based on the patient and their history and physical exam, to the level that you think is appropriate for that person’s individual’s care.”
Christine Ko, MD, who was asked to comment on the guidelines, characterized some of the reported comorbidity associations as predictable, such as asthma, food allergy, allergic rhinitis, and skin infections. “As the authors comment, ‘associations between AD and other atopic and allergic conditions have been recognized for decades and even contribute to diagnostic criteria for AD,’ ” said Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn, who was not involved with the guidelines. “I was a bit surprised to see that atopic dermatitis in adults is associated with osteoporosis and fractures. As the authors suggest, this could be secondary to treatment with oral prednisone, and it is possible that use of dupilumab and JAK inhibitors may lessen this association.”
Shawn G. Kwatra, MD, of the department of dermatology at Johns Hopkins University, Baltimore, who was not involved with the guidelines, and was also asked to comment, said that the guidelines underscore the importance of informing adults with AD “of the risks of unchecked inflammation and the potential for multiple disease comorbidities.” Dr. Kwatra, who has AD, added that “these results make me want to be more proactive in treating my eczema to reduce the potential for development of these comorbidities.”
He pointed out that the guidelines did not address racial and ethnic differences in the observed comorbidities. “Unfortunately, minority populations have a greater comorbidity burden in many inflammatory skin diseases so this will be another area needing further investigation,” he said. “As an example, our group found from multicenter data that black patients with atopic dermatitis have higher levels of C-reactive protein, blood eosinophils, and other inflammatory biomarkers.”
The AAD guidelines are the first in a four-part series on AD expected to be published over the next 1-2 years, Dr. Davis said. The subsequent guidelines will address topicals, phototherapy/systemics, and pediatrics.
The study was funded by internal funds from the AAD. Dr. Davis reported having no financial disclosures. Dr. Sidbury disclosed that he serves as an advisory board member for Pfizer, a principal investigator for Regeneron, and an investigator for Brickell Biotech and Galderma. He is also a consultant for Galderma Global and Microes. Dr. Ko reported having no financial disclosures. Dr. Kwatra is a member of the board of directors of the Skin of Color Society. He is also an advisory board member/consultant for AbbVie, Galderma, Incyte, Pfizer, Regeneron Pharmaceuticals, and Sanofi, and has served as an investigator for Galderma, Pfizer, and Sanofi.
While it’s well established that atopic dermatitis (AD) in adults is associated with asthma, allergic rhinitis, and other atopic conditions, the links between AD and other comorbidities are coming into clearer focus.
“There are more comorbidities with AD than we anticipated, that are supported by data in the literature,” Dawn M.R. Davis, MD, cochair and an author of the guidelines, told this news organization. “We are learning more about the interconnectivity of various medical conditions,” she continued. “Many skin diseases over time have been noted to be impactful to the whole person and not only the skin. A classic example of that is psoriasis. We now understand that psoriasis is a multisystem inflammatory disorder.”
As for AD, “we’ve always appreciated that AD patients tend to be at higher risk for other atopic diseases such as asthma, allergic rhinoconjunctivitis, and food allergies,” said Dr. Davis, of the departments of dermatology and pediatrics at the Mayo Clinic, Rochester, Minn. “With further research, we are now able to delineate those associations more intimately and have data to support our suspicions. Additionally, we’re now understanding that these inflammatory conditions can impact more than the end organ involved, such as the skin and AD. We wanted to look at how AD can affect the whole patient.”
For the guidelines, which are the first of their kind and were published online in the Journal of the American Academy of Dermatology, Dr. Davis and project cochair Robert Sidbury, MD, MPH, chief of dermatology at Seattle Children’s Hospital, led a multidisciplinary group of 12 experts to review the association between AD and selected comorbidities. They applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) for prognosis approach for assessing the certainty of the evidence and provided statements of association based on the available evidence.
With respect to highlights for atopic and allergic conditions, the guideline authors found high-quality evidence that AD in adults is associated with food allergies, moderate-quality evidence that AD is associated with asthma, and low-quality evidence that AD in adults may be associated with eosinophilic esophagitis.
In the realm of mental health and substance use, ample evidence exists to support an association between AD and mental health conditions such as depression and anxiety, the guidelines state. “For many patients, low mood may be driven by the symptoms of AD, including chronic itch and poor sleep,” Dr. Davis and her coauthors wrote. “Successfully treating AD may alleviate depressive symptoms for some patients; for others, assessment and treatment specific to their mental health may be needed.”
The guidelines also state that low-quality evidence exists to suggest that AD in adults may be associated with alcohol abuse disorders and cigarette smoking.
The authors noted “limited but consistent evidence” supporting a link between AD and adverse bone health, including osteoporosis and fractures, while associations between AD and cardiovascular risk factors and comorbidities, including hypertension, myocardial infarction, and stroke, are more controversial.
“I have published on bone health and AD so that was not as surprising to me,” Dr. Davis said in the interview. “I found a lot of the evidence in the guidelines to be validating of patterns that we see in our patients. The most significant learning point for me was [the link to] cardiovascular disease and the link to specific mental health and substance use disorders. It validates how impactful AD is to the individual.”
According to the guidelines, moderate-quality evidence exists linking AD in adults to both alopecia areata and urticaria. “Because we are dermatologists and take care of both of those diseases, be mindful of that in your daily practice,” Dr. Davis advised. “I would also encourage our colleagues to remember to educate patients on the comorbidities of AD so that they are empowered, and to screen for those comorbidities in your office based on the patient and their history and physical exam, to the level that you think is appropriate for that person’s individual’s care.”
Christine Ko, MD, who was asked to comment on the guidelines, characterized some of the reported comorbidity associations as predictable, such as asthma, food allergy, allergic rhinitis, and skin infections. “As the authors comment, ‘associations between AD and other atopic and allergic conditions have been recognized for decades and even contribute to diagnostic criteria for AD,’ ” said Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn, who was not involved with the guidelines. “I was a bit surprised to see that atopic dermatitis in adults is associated with osteoporosis and fractures. As the authors suggest, this could be secondary to treatment with oral prednisone, and it is possible that use of dupilumab and JAK inhibitors may lessen this association.”
Shawn G. Kwatra, MD, of the department of dermatology at Johns Hopkins University, Baltimore, who was not involved with the guidelines, and was also asked to comment, said that the guidelines underscore the importance of informing adults with AD “of the risks of unchecked inflammation and the potential for multiple disease comorbidities.” Dr. Kwatra, who has AD, added that “these results make me want to be more proactive in treating my eczema to reduce the potential for development of these comorbidities.”
He pointed out that the guidelines did not address racial and ethnic differences in the observed comorbidities. “Unfortunately, minority populations have a greater comorbidity burden in many inflammatory skin diseases so this will be another area needing further investigation,” he said. “As an example, our group found from multicenter data that black patients with atopic dermatitis have higher levels of C-reactive protein, blood eosinophils, and other inflammatory biomarkers.”
The AAD guidelines are the first in a four-part series on AD expected to be published over the next 1-2 years, Dr. Davis said. The subsequent guidelines will address topicals, phototherapy/systemics, and pediatrics.
The study was funded by internal funds from the AAD. Dr. Davis reported having no financial disclosures. Dr. Sidbury disclosed that he serves as an advisory board member for Pfizer, a principal investigator for Regeneron, and an investigator for Brickell Biotech and Galderma. He is also a consultant for Galderma Global and Microes. Dr. Ko reported having no financial disclosures. Dr. Kwatra is a member of the board of directors of the Skin of Color Society. He is also an advisory board member/consultant for AbbVie, Galderma, Incyte, Pfizer, Regeneron Pharmaceuticals, and Sanofi, and has served as an investigator for Galderma, Pfizer, and Sanofi.
While it’s well established that atopic dermatitis (AD) in adults is associated with asthma, allergic rhinitis, and other atopic conditions, the links between AD and other comorbidities are coming into clearer focus.
“There are more comorbidities with AD than we anticipated, that are supported by data in the literature,” Dawn M.R. Davis, MD, cochair and an author of the guidelines, told this news organization. “We are learning more about the interconnectivity of various medical conditions,” she continued. “Many skin diseases over time have been noted to be impactful to the whole person and not only the skin. A classic example of that is psoriasis. We now understand that psoriasis is a multisystem inflammatory disorder.”
As for AD, “we’ve always appreciated that AD patients tend to be at higher risk for other atopic diseases such as asthma, allergic rhinoconjunctivitis, and food allergies,” said Dr. Davis, of the departments of dermatology and pediatrics at the Mayo Clinic, Rochester, Minn. “With further research, we are now able to delineate those associations more intimately and have data to support our suspicions. Additionally, we’re now understanding that these inflammatory conditions can impact more than the end organ involved, such as the skin and AD. We wanted to look at how AD can affect the whole patient.”
For the guidelines, which are the first of their kind and were published online in the Journal of the American Academy of Dermatology, Dr. Davis and project cochair Robert Sidbury, MD, MPH, chief of dermatology at Seattle Children’s Hospital, led a multidisciplinary group of 12 experts to review the association between AD and selected comorbidities. They applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) for prognosis approach for assessing the certainty of the evidence and provided statements of association based on the available evidence.
With respect to highlights for atopic and allergic conditions, the guideline authors found high-quality evidence that AD in adults is associated with food allergies, moderate-quality evidence that AD is associated with asthma, and low-quality evidence that AD in adults may be associated with eosinophilic esophagitis.
In the realm of mental health and substance use, ample evidence exists to support an association between AD and mental health conditions such as depression and anxiety, the guidelines state. “For many patients, low mood may be driven by the symptoms of AD, including chronic itch and poor sleep,” Dr. Davis and her coauthors wrote. “Successfully treating AD may alleviate depressive symptoms for some patients; for others, assessment and treatment specific to their mental health may be needed.”
The guidelines also state that low-quality evidence exists to suggest that AD in adults may be associated with alcohol abuse disorders and cigarette smoking.
The authors noted “limited but consistent evidence” supporting a link between AD and adverse bone health, including osteoporosis and fractures, while associations between AD and cardiovascular risk factors and comorbidities, including hypertension, myocardial infarction, and stroke, are more controversial.
“I have published on bone health and AD so that was not as surprising to me,” Dr. Davis said in the interview. “I found a lot of the evidence in the guidelines to be validating of patterns that we see in our patients. The most significant learning point for me was [the link to] cardiovascular disease and the link to specific mental health and substance use disorders. It validates how impactful AD is to the individual.”
According to the guidelines, moderate-quality evidence exists linking AD in adults to both alopecia areata and urticaria. “Because we are dermatologists and take care of both of those diseases, be mindful of that in your daily practice,” Dr. Davis advised. “I would also encourage our colleagues to remember to educate patients on the comorbidities of AD so that they are empowered, and to screen for those comorbidities in your office based on the patient and their history and physical exam, to the level that you think is appropriate for that person’s individual’s care.”
Christine Ko, MD, who was asked to comment on the guidelines, characterized some of the reported comorbidity associations as predictable, such as asthma, food allergy, allergic rhinitis, and skin infections. “As the authors comment, ‘associations between AD and other atopic and allergic conditions have been recognized for decades and even contribute to diagnostic criteria for AD,’ ” said Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn, who was not involved with the guidelines. “I was a bit surprised to see that atopic dermatitis in adults is associated with osteoporosis and fractures. As the authors suggest, this could be secondary to treatment with oral prednisone, and it is possible that use of dupilumab and JAK inhibitors may lessen this association.”
Shawn G. Kwatra, MD, of the department of dermatology at Johns Hopkins University, Baltimore, who was not involved with the guidelines, and was also asked to comment, said that the guidelines underscore the importance of informing adults with AD “of the risks of unchecked inflammation and the potential for multiple disease comorbidities.” Dr. Kwatra, who has AD, added that “these results make me want to be more proactive in treating my eczema to reduce the potential for development of these comorbidities.”
He pointed out that the guidelines did not address racial and ethnic differences in the observed comorbidities. “Unfortunately, minority populations have a greater comorbidity burden in many inflammatory skin diseases so this will be another area needing further investigation,” he said. “As an example, our group found from multicenter data that black patients with atopic dermatitis have higher levels of C-reactive protein, blood eosinophils, and other inflammatory biomarkers.”
The AAD guidelines are the first in a four-part series on AD expected to be published over the next 1-2 years, Dr. Davis said. The subsequent guidelines will address topicals, phototherapy/systemics, and pediatrics.
The study was funded by internal funds from the AAD. Dr. Davis reported having no financial disclosures. Dr. Sidbury disclosed that he serves as an advisory board member for Pfizer, a principal investigator for Regeneron, and an investigator for Brickell Biotech and Galderma. He is also a consultant for Galderma Global and Microes. Dr. Ko reported having no financial disclosures. Dr. Kwatra is a member of the board of directors of the Skin of Color Society. He is also an advisory board member/consultant for AbbVie, Galderma, Incyte, Pfizer, Regeneron Pharmaceuticals, and Sanofi, and has served as an investigator for Galderma, Pfizer, and Sanofi.
FROM JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
USPSTF says evidence still lacking for AFib screening in asymptomatic patients
The guidance is similar to the task force’s 2018 statement on screening for AFib with electrocardiography in asymptomatic adults 65 years or older, but lowers the inclusion age to adults 50 years or older.
“This 2021 evidence review included searching for evidence on additional screening methods such as automated blood pressure cuffs, pulse oximeters, and consumer devices such as smartwatches and smartphone apps. However, even with this expanded scope, the USPSTF did not find evidence to recommend for or against screening for AF,” the task force states.
The prevalence of increases in age from less than 0.2% in adults younger than 55 years to about 10% in those 85 years or older, the group says. The prevalence is higher in men than in women, but it is uncertain if it differs by race and ethnicity.
Although AFib substantially increases the risk for stroke, the stroke risk associated with subclinical AFib, particularly that of shorter duration lasting less than 24 hours or of lower burden, as might be detected by some screening approaches, is “uncertain,” the task force adds.
The updated recommendations were published online in JAMA, along with a separate evidence report and editorial.
The task force reviewed 26 studies in 113,784 patients, including 12 new to the update.
Studies showed that systematic screening detected significantly more AFib than no screening or pulse palpation (absolute difference, 1.0%-4.8% over up to 12 months). In two of the trials, however, only 10.7% and 44.5% of participants actually received the screening test.
The review included three randomized trials of screening vs. no screening that reported on health outcomes, but only one, STROKESTOP, was powered for health outcomes. It found a significantly lower risk for the primary composite endpoint of ischemic or hemorrhagic stroke, system embolism, bleeding leading to hospitalization, and all-cause mortality with twice-daily intermittent single-lead ECG monitoring for 14 days, compared with no screening. However, there were no significant differences in any of the individual outcomes of the composite endpoint.
“Additionally, and probably the most important thing to appreciate for the STROKESTOP study is that it has several limitations,” task force member Gbenga Ogedegbe, MD, MPH, of New York University told this news organization. The intervention was not masked, and outcomes weren’t centrally adjudicated.
Further, “about 11% of patients in the trial had a history of transient ischemic attack (TIA), stroke, or embolism and the population that we’re looking at within the task force are people without symptoms or history of stroke or ischemic attack,” he said. “That’s the fundamental difference here. So those limitations make it difficult to say that STROKESTOP actually has benefit.”
Notably absent from the review was the recent LOOP study, which found no significant benefit on outcomes with continuous monitoring with an implantable loop recorder (ILR) over usual care in older adults.
While it “offers some context for this issue,” it was not eligible for inclusion because 25% of the population had a prior history of stroke, TIA, or embolism and “because this screening approach may not be feasible for primary care settings,” lead author of the Evidence Report Leila Kahwati, MD, MPH, from RTI International’s Social and Health Organizational Research and Evaluation Program and the University of North Carolina at Chapel Hill, explained in an email.
Treatment with warfarin (mean, 1.5 years) was associated with a lower risk for ischemic stroke (relative risk, 0.32) and all-cause mortality (relative risk, 0.68), while direct oral anticoagulants were associated with a lower incidence of stroke (adjusted odds ratio range, 0.32-0.44). Patients had an increased risk for major bleeding with both warfarin (pooled relative risk, 1.8) and direct-acting oral anticoagulants (odds ratio, 1.38-2.21), but confidence intervals did not exclude a null effect.
The USPSTF found no trials that reported on the benefits of anticoagulation therapy in screen-detected patients.
In an accompanying editorial Philip Greenland, MD, points out that the task force’s conclusion differs from the 2020 European Society of Cardiology AFib guideline, which endorses opportunistic screening for AFib by pulse palpation or ECG rhythm strip in patients 65 years or older (class I recommendation) and advises that clinicians consider systematic ECG screening to detect AFib in people 75 years or older, or those at high risk for stroke (class IIa).
To possibly resolve whether screening for AFib in asymptomatic patients is justified, “future trials may need to consider enrolling only higher risk patients and identifying those with AF of longer duration,” said Dr. Greenland, JAMA editor and professor of preventive medicine and medicine at Northwestern University, Chicago.
“One important point raised by the LOOP trial is whether there is a threshold for AF duration that is most strongly associated with stroke risk and therefore most likely to benefit from anticoagulation,” he writes. Indeed, the LOOP authors themselves questioned whether the trial’s short AFib duration of 6 minutes may have led to many low-risk patients being diagnosed and treated.
“Additionally, trials need to recognize the need for longer monitoring periods (preferably continuous), and perhaps novel wearables will allow long-term monitoring, with accurate interpretation of the ECG and long-term adherence,” Dr. Greenland said.
In a related editorial in JAMA Internal Medicine, John Mandrola, MD, Baptist Health Louisville, Ky., and Andrew Foy, MD, Pennsylvania State University, Hershey, point out that continuous ILR monitoring in the LOOP trial found threefold more AFib and led to 2.7-fold higher rates of oral anticoagulation use, compared with standard care. Yet, there was no statistically significant difference in stroke reduction, and the 20% relative reduction in thromboembolic complications in the screened group was offset by a 26% relative increase in major bleeding.
“Perhaps the most remarkable aspect of the AF screening trials is that as the tools for screening improve, from a single 12-lead ECG to 14-day recordings and then the always-on ILR, more AF is detected and more [oral anticoagulant] is used, yet there is little demonstrable improvement in outcomes,” Dr. Mandrola and Dr. Foy write.
The editorialists also point to the potential for rhythm monitoring to lead to misdiagnosis and downstream cascades of care. “If you assume a 2% AF prevalence, even a device with 98% specificity will misdiagnose approximately 2000 individuals for every million screened.”
Dr. Mandrola told this news organization that the “greatest value” of these reports on AF screening and the critical appraisal of them is as an exercise in thinking about the limits of screening for disease. As James Maxwell Glover Wilson and Gunner Jungner wrote in their 1968 textbook, “Principles and Practice of Screening for Disease”: “in theory, screening is an admirable method of combating disease … [but] in practice, there are snags.”
“It would be good for the public to understand these snags…because they also apply to cancer, coronary calcium testing, and vascular screening as well,” Dr. Mandrola said.
Asked whether it’s possible to put the genie back in the bottle now that every other patient in clinic may have an ECG on their wrist, Dr. Ogedegbe said, “if a patient has no history of stroke or TIA and is 50 years or older, really, monitoring with these devices for AFib, there’s no evidence for or against doing that. Ultimately, the clinician has got to use their clinical judgment in talking to these patients.”
A related editorial in JAMA Cardiology suggests that, to be effective, the movement toward consumer-based screening must first show that such an approach improves outcomes and must deal with the paradox that those at highest risk for AFib and AFib-related stroke may be the least likely to own these technologies unless supported by the healthcare system.
“In addition, appropriate care pathways for confirming the diagnosis and, if necessary, initiating appropriate treatment in individuals with positive findings will need to be established,” Rod Passman, MD, Northwestern University, and Ben Freedman, MBBS, PhD, University of Sydney, Australia, say. “It will also be critical to ensure that device costs and variable technological literacy do not create barriers to making screening accessible to all those at risk.”
Finally, in a related editorial in JAMA Network Open Matthew Kalscheur, MD, and Zachary D. Goldberger, MD, both from the University of Wisconsin-Madison, say the potential benefits of early AFib detection should extend beyond stroke prevention.
“Patients identified with AF likely would benefit from targeted management of modifiable risk factors that contribute to AF, including obesity, hypertension, alcohol use, sleep apnea, smoking, and diabetes,” they write.
All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. Dr. Ogedegbe has a study included in the Evidence-based Practice Center report for this topic. Dr. Kahwati reported no relevant financial conflicts of interest. Dr. Greenland reported receiving research grants from the National Institutes of Health and from the American Heart Association. Dr. Mandrola is a regular contributor to this news organization. Dr. Foy, Dr. Kalscheur, and Dr. Goldberger reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The guidance is similar to the task force’s 2018 statement on screening for AFib with electrocardiography in asymptomatic adults 65 years or older, but lowers the inclusion age to adults 50 years or older.
“This 2021 evidence review included searching for evidence on additional screening methods such as automated blood pressure cuffs, pulse oximeters, and consumer devices such as smartwatches and smartphone apps. However, even with this expanded scope, the USPSTF did not find evidence to recommend for or against screening for AF,” the task force states.
The prevalence of increases in age from less than 0.2% in adults younger than 55 years to about 10% in those 85 years or older, the group says. The prevalence is higher in men than in women, but it is uncertain if it differs by race and ethnicity.
Although AFib substantially increases the risk for stroke, the stroke risk associated with subclinical AFib, particularly that of shorter duration lasting less than 24 hours or of lower burden, as might be detected by some screening approaches, is “uncertain,” the task force adds.
The updated recommendations were published online in JAMA, along with a separate evidence report and editorial.
The task force reviewed 26 studies in 113,784 patients, including 12 new to the update.
Studies showed that systematic screening detected significantly more AFib than no screening or pulse palpation (absolute difference, 1.0%-4.8% over up to 12 months). In two of the trials, however, only 10.7% and 44.5% of participants actually received the screening test.
The review included three randomized trials of screening vs. no screening that reported on health outcomes, but only one, STROKESTOP, was powered for health outcomes. It found a significantly lower risk for the primary composite endpoint of ischemic or hemorrhagic stroke, system embolism, bleeding leading to hospitalization, and all-cause mortality with twice-daily intermittent single-lead ECG monitoring for 14 days, compared with no screening. However, there were no significant differences in any of the individual outcomes of the composite endpoint.
“Additionally, and probably the most important thing to appreciate for the STROKESTOP study is that it has several limitations,” task force member Gbenga Ogedegbe, MD, MPH, of New York University told this news organization. The intervention was not masked, and outcomes weren’t centrally adjudicated.
Further, “about 11% of patients in the trial had a history of transient ischemic attack (TIA), stroke, or embolism and the population that we’re looking at within the task force are people without symptoms or history of stroke or ischemic attack,” he said. “That’s the fundamental difference here. So those limitations make it difficult to say that STROKESTOP actually has benefit.”
Notably absent from the review was the recent LOOP study, which found no significant benefit on outcomes with continuous monitoring with an implantable loop recorder (ILR) over usual care in older adults.
While it “offers some context for this issue,” it was not eligible for inclusion because 25% of the population had a prior history of stroke, TIA, or embolism and “because this screening approach may not be feasible for primary care settings,” lead author of the Evidence Report Leila Kahwati, MD, MPH, from RTI International’s Social and Health Organizational Research and Evaluation Program and the University of North Carolina at Chapel Hill, explained in an email.
Treatment with warfarin (mean, 1.5 years) was associated with a lower risk for ischemic stroke (relative risk, 0.32) and all-cause mortality (relative risk, 0.68), while direct oral anticoagulants were associated with a lower incidence of stroke (adjusted odds ratio range, 0.32-0.44). Patients had an increased risk for major bleeding with both warfarin (pooled relative risk, 1.8) and direct-acting oral anticoagulants (odds ratio, 1.38-2.21), but confidence intervals did not exclude a null effect.
The USPSTF found no trials that reported on the benefits of anticoagulation therapy in screen-detected patients.
In an accompanying editorial Philip Greenland, MD, points out that the task force’s conclusion differs from the 2020 European Society of Cardiology AFib guideline, which endorses opportunistic screening for AFib by pulse palpation or ECG rhythm strip in patients 65 years or older (class I recommendation) and advises that clinicians consider systematic ECG screening to detect AFib in people 75 years or older, or those at high risk for stroke (class IIa).
To possibly resolve whether screening for AFib in asymptomatic patients is justified, “future trials may need to consider enrolling only higher risk patients and identifying those with AF of longer duration,” said Dr. Greenland, JAMA editor and professor of preventive medicine and medicine at Northwestern University, Chicago.
“One important point raised by the LOOP trial is whether there is a threshold for AF duration that is most strongly associated with stroke risk and therefore most likely to benefit from anticoagulation,” he writes. Indeed, the LOOP authors themselves questioned whether the trial’s short AFib duration of 6 minutes may have led to many low-risk patients being diagnosed and treated.
“Additionally, trials need to recognize the need for longer monitoring periods (preferably continuous), and perhaps novel wearables will allow long-term monitoring, with accurate interpretation of the ECG and long-term adherence,” Dr. Greenland said.
In a related editorial in JAMA Internal Medicine, John Mandrola, MD, Baptist Health Louisville, Ky., and Andrew Foy, MD, Pennsylvania State University, Hershey, point out that continuous ILR monitoring in the LOOP trial found threefold more AFib and led to 2.7-fold higher rates of oral anticoagulation use, compared with standard care. Yet, there was no statistically significant difference in stroke reduction, and the 20% relative reduction in thromboembolic complications in the screened group was offset by a 26% relative increase in major bleeding.
“Perhaps the most remarkable aspect of the AF screening trials is that as the tools for screening improve, from a single 12-lead ECG to 14-day recordings and then the always-on ILR, more AF is detected and more [oral anticoagulant] is used, yet there is little demonstrable improvement in outcomes,” Dr. Mandrola and Dr. Foy write.
The editorialists also point to the potential for rhythm monitoring to lead to misdiagnosis and downstream cascades of care. “If you assume a 2% AF prevalence, even a device with 98% specificity will misdiagnose approximately 2000 individuals for every million screened.”
Dr. Mandrola told this news organization that the “greatest value” of these reports on AF screening and the critical appraisal of them is as an exercise in thinking about the limits of screening for disease. As James Maxwell Glover Wilson and Gunner Jungner wrote in their 1968 textbook, “Principles and Practice of Screening for Disease”: “in theory, screening is an admirable method of combating disease … [but] in practice, there are snags.”
“It would be good for the public to understand these snags…because they also apply to cancer, coronary calcium testing, and vascular screening as well,” Dr. Mandrola said.
Asked whether it’s possible to put the genie back in the bottle now that every other patient in clinic may have an ECG on their wrist, Dr. Ogedegbe said, “if a patient has no history of stroke or TIA and is 50 years or older, really, monitoring with these devices for AFib, there’s no evidence for or against doing that. Ultimately, the clinician has got to use their clinical judgment in talking to these patients.”
A related editorial in JAMA Cardiology suggests that, to be effective, the movement toward consumer-based screening must first show that such an approach improves outcomes and must deal with the paradox that those at highest risk for AFib and AFib-related stroke may be the least likely to own these technologies unless supported by the healthcare system.
“In addition, appropriate care pathways for confirming the diagnosis and, if necessary, initiating appropriate treatment in individuals with positive findings will need to be established,” Rod Passman, MD, Northwestern University, and Ben Freedman, MBBS, PhD, University of Sydney, Australia, say. “It will also be critical to ensure that device costs and variable technological literacy do not create barriers to making screening accessible to all those at risk.”
Finally, in a related editorial in JAMA Network Open Matthew Kalscheur, MD, and Zachary D. Goldberger, MD, both from the University of Wisconsin-Madison, say the potential benefits of early AFib detection should extend beyond stroke prevention.
“Patients identified with AF likely would benefit from targeted management of modifiable risk factors that contribute to AF, including obesity, hypertension, alcohol use, sleep apnea, smoking, and diabetes,” they write.
All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. Dr. Ogedegbe has a study included in the Evidence-based Practice Center report for this topic. Dr. Kahwati reported no relevant financial conflicts of interest. Dr. Greenland reported receiving research grants from the National Institutes of Health and from the American Heart Association. Dr. Mandrola is a regular contributor to this news organization. Dr. Foy, Dr. Kalscheur, and Dr. Goldberger reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The guidance is similar to the task force’s 2018 statement on screening for AFib with electrocardiography in asymptomatic adults 65 years or older, but lowers the inclusion age to adults 50 years or older.
“This 2021 evidence review included searching for evidence on additional screening methods such as automated blood pressure cuffs, pulse oximeters, and consumer devices such as smartwatches and smartphone apps. However, even with this expanded scope, the USPSTF did not find evidence to recommend for or against screening for AF,” the task force states.
The prevalence of increases in age from less than 0.2% in adults younger than 55 years to about 10% in those 85 years or older, the group says. The prevalence is higher in men than in women, but it is uncertain if it differs by race and ethnicity.
Although AFib substantially increases the risk for stroke, the stroke risk associated with subclinical AFib, particularly that of shorter duration lasting less than 24 hours or of lower burden, as might be detected by some screening approaches, is “uncertain,” the task force adds.
The updated recommendations were published online in JAMA, along with a separate evidence report and editorial.
The task force reviewed 26 studies in 113,784 patients, including 12 new to the update.
Studies showed that systematic screening detected significantly more AFib than no screening or pulse palpation (absolute difference, 1.0%-4.8% over up to 12 months). In two of the trials, however, only 10.7% and 44.5% of participants actually received the screening test.
The review included three randomized trials of screening vs. no screening that reported on health outcomes, but only one, STROKESTOP, was powered for health outcomes. It found a significantly lower risk for the primary composite endpoint of ischemic or hemorrhagic stroke, system embolism, bleeding leading to hospitalization, and all-cause mortality with twice-daily intermittent single-lead ECG monitoring for 14 days, compared with no screening. However, there were no significant differences in any of the individual outcomes of the composite endpoint.
“Additionally, and probably the most important thing to appreciate for the STROKESTOP study is that it has several limitations,” task force member Gbenga Ogedegbe, MD, MPH, of New York University told this news organization. The intervention was not masked, and outcomes weren’t centrally adjudicated.
Further, “about 11% of patients in the trial had a history of transient ischemic attack (TIA), stroke, or embolism and the population that we’re looking at within the task force are people without symptoms or history of stroke or ischemic attack,” he said. “That’s the fundamental difference here. So those limitations make it difficult to say that STROKESTOP actually has benefit.”
Notably absent from the review was the recent LOOP study, which found no significant benefit on outcomes with continuous monitoring with an implantable loop recorder (ILR) over usual care in older adults.
While it “offers some context for this issue,” it was not eligible for inclusion because 25% of the population had a prior history of stroke, TIA, or embolism and “because this screening approach may not be feasible for primary care settings,” lead author of the Evidence Report Leila Kahwati, MD, MPH, from RTI International’s Social and Health Organizational Research and Evaluation Program and the University of North Carolina at Chapel Hill, explained in an email.
Treatment with warfarin (mean, 1.5 years) was associated with a lower risk for ischemic stroke (relative risk, 0.32) and all-cause mortality (relative risk, 0.68), while direct oral anticoagulants were associated with a lower incidence of stroke (adjusted odds ratio range, 0.32-0.44). Patients had an increased risk for major bleeding with both warfarin (pooled relative risk, 1.8) and direct-acting oral anticoagulants (odds ratio, 1.38-2.21), but confidence intervals did not exclude a null effect.
The USPSTF found no trials that reported on the benefits of anticoagulation therapy in screen-detected patients.
In an accompanying editorial Philip Greenland, MD, points out that the task force’s conclusion differs from the 2020 European Society of Cardiology AFib guideline, which endorses opportunistic screening for AFib by pulse palpation or ECG rhythm strip in patients 65 years or older (class I recommendation) and advises that clinicians consider systematic ECG screening to detect AFib in people 75 years or older, or those at high risk for stroke (class IIa).
To possibly resolve whether screening for AFib in asymptomatic patients is justified, “future trials may need to consider enrolling only higher risk patients and identifying those with AF of longer duration,” said Dr. Greenland, JAMA editor and professor of preventive medicine and medicine at Northwestern University, Chicago.
“One important point raised by the LOOP trial is whether there is a threshold for AF duration that is most strongly associated with stroke risk and therefore most likely to benefit from anticoagulation,” he writes. Indeed, the LOOP authors themselves questioned whether the trial’s short AFib duration of 6 minutes may have led to many low-risk patients being diagnosed and treated.
“Additionally, trials need to recognize the need for longer monitoring periods (preferably continuous), and perhaps novel wearables will allow long-term monitoring, with accurate interpretation of the ECG and long-term adherence,” Dr. Greenland said.
In a related editorial in JAMA Internal Medicine, John Mandrola, MD, Baptist Health Louisville, Ky., and Andrew Foy, MD, Pennsylvania State University, Hershey, point out that continuous ILR monitoring in the LOOP trial found threefold more AFib and led to 2.7-fold higher rates of oral anticoagulation use, compared with standard care. Yet, there was no statistically significant difference in stroke reduction, and the 20% relative reduction in thromboembolic complications in the screened group was offset by a 26% relative increase in major bleeding.
“Perhaps the most remarkable aspect of the AF screening trials is that as the tools for screening improve, from a single 12-lead ECG to 14-day recordings and then the always-on ILR, more AF is detected and more [oral anticoagulant] is used, yet there is little demonstrable improvement in outcomes,” Dr. Mandrola and Dr. Foy write.
The editorialists also point to the potential for rhythm monitoring to lead to misdiagnosis and downstream cascades of care. “If you assume a 2% AF prevalence, even a device with 98% specificity will misdiagnose approximately 2000 individuals for every million screened.”
Dr. Mandrola told this news organization that the “greatest value” of these reports on AF screening and the critical appraisal of them is as an exercise in thinking about the limits of screening for disease. As James Maxwell Glover Wilson and Gunner Jungner wrote in their 1968 textbook, “Principles and Practice of Screening for Disease”: “in theory, screening is an admirable method of combating disease … [but] in practice, there are snags.”
“It would be good for the public to understand these snags…because they also apply to cancer, coronary calcium testing, and vascular screening as well,” Dr. Mandrola said.
Asked whether it’s possible to put the genie back in the bottle now that every other patient in clinic may have an ECG on their wrist, Dr. Ogedegbe said, “if a patient has no history of stroke or TIA and is 50 years or older, really, monitoring with these devices for AFib, there’s no evidence for or against doing that. Ultimately, the clinician has got to use their clinical judgment in talking to these patients.”
A related editorial in JAMA Cardiology suggests that, to be effective, the movement toward consumer-based screening must first show that such an approach improves outcomes and must deal with the paradox that those at highest risk for AFib and AFib-related stroke may be the least likely to own these technologies unless supported by the healthcare system.
“In addition, appropriate care pathways for confirming the diagnosis and, if necessary, initiating appropriate treatment in individuals with positive findings will need to be established,” Rod Passman, MD, Northwestern University, and Ben Freedman, MBBS, PhD, University of Sydney, Australia, say. “It will also be critical to ensure that device costs and variable technological literacy do not create barriers to making screening accessible to all those at risk.”
Finally, in a related editorial in JAMA Network Open Matthew Kalscheur, MD, and Zachary D. Goldberger, MD, both from the University of Wisconsin-Madison, say the potential benefits of early AFib detection should extend beyond stroke prevention.
“Patients identified with AF likely would benefit from targeted management of modifiable risk factors that contribute to AF, including obesity, hypertension, alcohol use, sleep apnea, smoking, and diabetes,” they write.
All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. Dr. Ogedegbe has a study included in the Evidence-based Practice Center report for this topic. Dr. Kahwati reported no relevant financial conflicts of interest. Dr. Greenland reported receiving research grants from the National Institutes of Health and from the American Heart Association. Dr. Mandrola is a regular contributor to this news organization. Dr. Foy, Dr. Kalscheur, and Dr. Goldberger reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ACP advocates outpatient treatment of uncomplicated diverticulitis
The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”
Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.
The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.
In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
Guidance on diagnosis and management
In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.
Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.
The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.
All three recommendations are conditional, with low-certainty evidence, according to the authors.
Colonoscopy for diagnostic evaluation and interventions
In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.
Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.
A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.
The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.
The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.
This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
Update confirms best practices
“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”
Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.
Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.
Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
Curbing antibiotic use
It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.
“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”
“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”
As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”
The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.
The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”
Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.
The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.
In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
Guidance on diagnosis and management
In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.
Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.
The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.
All three recommendations are conditional, with low-certainty evidence, according to the authors.
Colonoscopy for diagnostic evaluation and interventions
In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.
Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.
A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.
The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.
The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.
This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
Update confirms best practices
“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”
Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.
Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.
Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
Curbing antibiotic use
It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.
“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”
“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”
As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”
The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.
The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”
Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.
The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.
In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
Guidance on diagnosis and management
In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.
Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.
The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.
All three recommendations are conditional, with low-certainty evidence, according to the authors.
Colonoscopy for diagnostic evaluation and interventions
In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.
Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.
A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.
The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.
The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.
This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
Update confirms best practices
“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”
Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.
Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.
Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
Curbing antibiotic use
It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.
“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”
“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”
As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”
The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.
FROM ANNALS OF INTERNAL MEDICINE
Private insurers must cover follow-up colonoscopies
Private insurers are now required to cover the cost of follow-up colonoscopies after a positive stool-based test, according to updated guidance from the Biden administration cited in a press release from the American Gastroenterological Association.
“Now patients can choose the best colorectal cancer screening test for them without fear of a surprise bill. Patients have full coverage of the full screening continuum – from an initial stool or endoscopic test to a follow-up colonoscopy. Now that the financial barriers have been eliminated, we can focus on increasing screening so we can prevent cancer deaths,” John Inadomi, MD, president of the AGA, said in the press release.
The updated guidance, issued on Jan. 10, 2022, “will prevent patients from receiving surprise bills for a colonoscopy when they receive a positive result from a stool-based test,” according to the AGA press release.
In 2016, the U.S. Preventive Services Task Force recommended colorectal cancer screening for all adults starting at age 50 years and continuing to age 75 years, with an “A” rating. Because the Affordable Care Act (ACA) mandated coverage for preventive screenings without cost-sharing that receive an “A” or “B” grade from the USPSTF, previous statements have confirmed that cost sharing may not be imposed on patients for screening in accordance with the USPSTF recommendation, which included specialist consultation prior to the procedure, bowel prep medications, anesthesia services in conjunction with a preventive colonoscopy, polyp removal performed during the screening procedure, and any pathology exam on a polyp biopsy performed as part of the screening. By adding colonoscopies following positive stool tests to that list, the updated guidance means that all aspects of the screening procedure are now covered without cost sharing.
In May 2021, an update to the USPSTF recommendations called for a follow-up colonoscopy in the wake of a positive test: “Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The 2021 update also extended the screening recommendation to adults aged 45-49 years with a “B” rating.
Private insurers must now pay for follow-up colonoscopy as needed in addition to the initial noninvasive screening, according to the guidance.
The updated guidance is presented as part of a series of frequently asked questions regarding implementation of the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Affordable Care Act. The colonoscopy guidance falls under the heading of “Coverage of Preventive Services,” which includes evidence-based recommendations given an A or B rating by the USPSTF.
Coverage without cost sharing must begin on or after May 31, 2022, which is 1 year after the date of the latest recommendations, according to the FAQ.
Representatives of multiple organizations, including the AGA, American Cancer Society, American Cancer Society Cancer Action Network, and Fight CRC collaborated to promote the additional coverage. “We applaud the administration for supporting coverage of the full colorectal cancer screening continuum, which will improve access to lifesaving screening,” the collaborators said in the press release.
Colorectal cancer remains the second leading cancer killer in the United States, but only two-thirds of eligible individuals were screened in 2018, according to the AGA, and screening challenges were exacerbated by the arrival of the COVID-19 pandemic. The AGA estimates that colorectal cancer screening declined by 86% during the first few months of the COVID-19 pandemic in 2020.
The full Jan. 10 FAQ is available here.
This article was updated Jan. 14, 2022.
Private insurers are now required to cover the cost of follow-up colonoscopies after a positive stool-based test, according to updated guidance from the Biden administration cited in a press release from the American Gastroenterological Association.
“Now patients can choose the best colorectal cancer screening test for them without fear of a surprise bill. Patients have full coverage of the full screening continuum – from an initial stool or endoscopic test to a follow-up colonoscopy. Now that the financial barriers have been eliminated, we can focus on increasing screening so we can prevent cancer deaths,” John Inadomi, MD, president of the AGA, said in the press release.
The updated guidance, issued on Jan. 10, 2022, “will prevent patients from receiving surprise bills for a colonoscopy when they receive a positive result from a stool-based test,” according to the AGA press release.
In 2016, the U.S. Preventive Services Task Force recommended colorectal cancer screening for all adults starting at age 50 years and continuing to age 75 years, with an “A” rating. Because the Affordable Care Act (ACA) mandated coverage for preventive screenings without cost-sharing that receive an “A” or “B” grade from the USPSTF, previous statements have confirmed that cost sharing may not be imposed on patients for screening in accordance with the USPSTF recommendation, which included specialist consultation prior to the procedure, bowel prep medications, anesthesia services in conjunction with a preventive colonoscopy, polyp removal performed during the screening procedure, and any pathology exam on a polyp biopsy performed as part of the screening. By adding colonoscopies following positive stool tests to that list, the updated guidance means that all aspects of the screening procedure are now covered without cost sharing.
In May 2021, an update to the USPSTF recommendations called for a follow-up colonoscopy in the wake of a positive test: “Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The 2021 update also extended the screening recommendation to adults aged 45-49 years with a “B” rating.
Private insurers must now pay for follow-up colonoscopy as needed in addition to the initial noninvasive screening, according to the guidance.
The updated guidance is presented as part of a series of frequently asked questions regarding implementation of the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Affordable Care Act. The colonoscopy guidance falls under the heading of “Coverage of Preventive Services,” which includes evidence-based recommendations given an A or B rating by the USPSTF.
Coverage without cost sharing must begin on or after May 31, 2022, which is 1 year after the date of the latest recommendations, according to the FAQ.
Representatives of multiple organizations, including the AGA, American Cancer Society, American Cancer Society Cancer Action Network, and Fight CRC collaborated to promote the additional coverage. “We applaud the administration for supporting coverage of the full colorectal cancer screening continuum, which will improve access to lifesaving screening,” the collaborators said in the press release.
Colorectal cancer remains the second leading cancer killer in the United States, but only two-thirds of eligible individuals were screened in 2018, according to the AGA, and screening challenges were exacerbated by the arrival of the COVID-19 pandemic. The AGA estimates that colorectal cancer screening declined by 86% during the first few months of the COVID-19 pandemic in 2020.
The full Jan. 10 FAQ is available here.
This article was updated Jan. 14, 2022.
Private insurers are now required to cover the cost of follow-up colonoscopies after a positive stool-based test, according to updated guidance from the Biden administration cited in a press release from the American Gastroenterological Association.
“Now patients can choose the best colorectal cancer screening test for them without fear of a surprise bill. Patients have full coverage of the full screening continuum – from an initial stool or endoscopic test to a follow-up colonoscopy. Now that the financial barriers have been eliminated, we can focus on increasing screening so we can prevent cancer deaths,” John Inadomi, MD, president of the AGA, said in the press release.
The updated guidance, issued on Jan. 10, 2022, “will prevent patients from receiving surprise bills for a colonoscopy when they receive a positive result from a stool-based test,” according to the AGA press release.
In 2016, the U.S. Preventive Services Task Force recommended colorectal cancer screening for all adults starting at age 50 years and continuing to age 75 years, with an “A” rating. Because the Affordable Care Act (ACA) mandated coverage for preventive screenings without cost-sharing that receive an “A” or “B” grade from the USPSTF, previous statements have confirmed that cost sharing may not be imposed on patients for screening in accordance with the USPSTF recommendation, which included specialist consultation prior to the procedure, bowel prep medications, anesthesia services in conjunction with a preventive colonoscopy, polyp removal performed during the screening procedure, and any pathology exam on a polyp biopsy performed as part of the screening. By adding colonoscopies following positive stool tests to that list, the updated guidance means that all aspects of the screening procedure are now covered without cost sharing.
In May 2021, an update to the USPSTF recommendations called for a follow-up colonoscopy in the wake of a positive test: “Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The 2021 update also extended the screening recommendation to adults aged 45-49 years with a “B” rating.
Private insurers must now pay for follow-up colonoscopy as needed in addition to the initial noninvasive screening, according to the guidance.
The updated guidance is presented as part of a series of frequently asked questions regarding implementation of the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Affordable Care Act. The colonoscopy guidance falls under the heading of “Coverage of Preventive Services,” which includes evidence-based recommendations given an A or B rating by the USPSTF.
Coverage without cost sharing must begin on or after May 31, 2022, which is 1 year after the date of the latest recommendations, according to the FAQ.
Representatives of multiple organizations, including the AGA, American Cancer Society, American Cancer Society Cancer Action Network, and Fight CRC collaborated to promote the additional coverage. “We applaud the administration for supporting coverage of the full colorectal cancer screening continuum, which will improve access to lifesaving screening,” the collaborators said in the press release.
Colorectal cancer remains the second leading cancer killer in the United States, but only two-thirds of eligible individuals were screened in 2018, according to the AGA, and screening challenges were exacerbated by the arrival of the COVID-19 pandemic. The AGA estimates that colorectal cancer screening declined by 86% during the first few months of the COVID-19 pandemic in 2020.
The full Jan. 10 FAQ is available here.
This article was updated Jan. 14, 2022.
Wilderness Medical Society issues clinical guidelines for tick-borne illness
The recently published “Clinical Practice Guidelines for the Prevention and Management of Tick-Borne Illness,” from the Wilderness Medical Society, are a good compilation of treatment suggestions but are not, in fact, new recommendations, lead author Benjamin Ho, MD, of Southern Wisconsin Emergency Associates in Janesville, acknowledged in an interview.
Dr. Ho emphasized that the focus of the report was on “practitioners who practice in resource-limited settings” and are “the group’s way of solidifying a ... standard of practice” for such physicians. Dr. Ho also said that, while “a lot of the recommendations aren’t well supported, the risk-benefit ratio, we believe, supports the recommendations.”
The article first reviewed the different types of ticks and their distribution in the United States, the specific pathogen associated with each, the disease it causes, and comments about seasonal variations in biting behavior. Another table outlines the most common clinical syndromes, typical lab findings, recommended diagnostic testing, and antibiotic treatments. A third section contains images of different types of ticks and photos of ticks in various life-cycle stages and different levels of engorgement.
The authors were careful to note: “Several tick species are able to carry multiple pathogens. In one study, nearly 25% of Ixodes were coinfected with some combination of the bacteria or parasites causing Lyme disease, anaplasmosis, or babesiosis. Although TBI [tick-borne illness] diagnosis is not the focus of this [clinical practice guideline], providers should be aware of high rates of coinfection; the presence of one TBI should in many instances prompt testing for others.”
In terms of recommendations for preventing TBIs, the authors challenge the suggestion of wearing light-colored clothing. For repellents, they recommend DEET, picaridin, and permethrin. And they also give instructions for laundering clothing and removing ticks.
One recommendation is controversial: that of providing single-dose doxycycline as prophylaxis against Lyme disease. Dr. Ho stresses that this was only for “high-risk” tick bites, defined as a tick bite from an identified Ixodes vector species in which the tick was attached for at least 36 hours and that occurred in an endemic area.
The recommendation for prophylactic doxycycline originated with an article by Robert Nadelman and colleagues in the New England Journal of Medicine and has been strongly challenged by ILADS (International Lyme and Associated Diseases Society) physicians, including Daniel Cameron, MD, and others.
Sam Donta, MD, a recent member of the Department of Health & Human Services Tick-borne Working Group and a member of the Infectious Disease Society of America, said in an interview: “The problem with the one-dose doxycycline is you may not begin to develop symptoms until 2 months later.” It might mask the early symptoms of Lyme. “My impression is that the doxycycline – even the single dose – might have abrogated the ability to see an immune response. The idea, though, if you’ve had a tick bite, is to do nothing and to wait for symptoms to develop. That becomes a little bit more complex. But even then, you could choose to follow the patient and see the patient in 2 weeks and then get blood testing.”
Dr. Donta added: “I think the screening test is inadequate. So you have to go directly to the Western blot. And you have to do both the IgM and IgG” and look for specific bands.
Dr. Donta emphasized that patients should be encouraged to save any ticks that were attached and that, if at all possible, ticks should be sent to a reference lab for testing before committing a patient to a course of antibiotics. There is no harm in that brief delay, he said, and most labs can identify an array of pathogens.
The Wilderness Society guidelines on TBIs provide a good overview for clinicians practicing in limited resource settings and mirror those from the IDSA.
Dr. Ho and Dr. Donta reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The recently published “Clinical Practice Guidelines for the Prevention and Management of Tick-Borne Illness,” from the Wilderness Medical Society, are a good compilation of treatment suggestions but are not, in fact, new recommendations, lead author Benjamin Ho, MD, of Southern Wisconsin Emergency Associates in Janesville, acknowledged in an interview.
Dr. Ho emphasized that the focus of the report was on “practitioners who practice in resource-limited settings” and are “the group’s way of solidifying a ... standard of practice” for such physicians. Dr. Ho also said that, while “a lot of the recommendations aren’t well supported, the risk-benefit ratio, we believe, supports the recommendations.”
The article first reviewed the different types of ticks and their distribution in the United States, the specific pathogen associated with each, the disease it causes, and comments about seasonal variations in biting behavior. Another table outlines the most common clinical syndromes, typical lab findings, recommended diagnostic testing, and antibiotic treatments. A third section contains images of different types of ticks and photos of ticks in various life-cycle stages and different levels of engorgement.
The authors were careful to note: “Several tick species are able to carry multiple pathogens. In one study, nearly 25% of Ixodes were coinfected with some combination of the bacteria or parasites causing Lyme disease, anaplasmosis, or babesiosis. Although TBI [tick-borne illness] diagnosis is not the focus of this [clinical practice guideline], providers should be aware of high rates of coinfection; the presence of one TBI should in many instances prompt testing for others.”
In terms of recommendations for preventing TBIs, the authors challenge the suggestion of wearing light-colored clothing. For repellents, they recommend DEET, picaridin, and permethrin. And they also give instructions for laundering clothing and removing ticks.
One recommendation is controversial: that of providing single-dose doxycycline as prophylaxis against Lyme disease. Dr. Ho stresses that this was only for “high-risk” tick bites, defined as a tick bite from an identified Ixodes vector species in which the tick was attached for at least 36 hours and that occurred in an endemic area.
The recommendation for prophylactic doxycycline originated with an article by Robert Nadelman and colleagues in the New England Journal of Medicine and has been strongly challenged by ILADS (International Lyme and Associated Diseases Society) physicians, including Daniel Cameron, MD, and others.
Sam Donta, MD, a recent member of the Department of Health & Human Services Tick-borne Working Group and a member of the Infectious Disease Society of America, said in an interview: “The problem with the one-dose doxycycline is you may not begin to develop symptoms until 2 months later.” It might mask the early symptoms of Lyme. “My impression is that the doxycycline – even the single dose – might have abrogated the ability to see an immune response. The idea, though, if you’ve had a tick bite, is to do nothing and to wait for symptoms to develop. That becomes a little bit more complex. But even then, you could choose to follow the patient and see the patient in 2 weeks and then get blood testing.”
Dr. Donta added: “I think the screening test is inadequate. So you have to go directly to the Western blot. And you have to do both the IgM and IgG” and look for specific bands.
Dr. Donta emphasized that patients should be encouraged to save any ticks that were attached and that, if at all possible, ticks should be sent to a reference lab for testing before committing a patient to a course of antibiotics. There is no harm in that brief delay, he said, and most labs can identify an array of pathogens.
The Wilderness Society guidelines on TBIs provide a good overview for clinicians practicing in limited resource settings and mirror those from the IDSA.
Dr. Ho and Dr. Donta reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The recently published “Clinical Practice Guidelines for the Prevention and Management of Tick-Borne Illness,” from the Wilderness Medical Society, are a good compilation of treatment suggestions but are not, in fact, new recommendations, lead author Benjamin Ho, MD, of Southern Wisconsin Emergency Associates in Janesville, acknowledged in an interview.
Dr. Ho emphasized that the focus of the report was on “practitioners who practice in resource-limited settings” and are “the group’s way of solidifying a ... standard of practice” for such physicians. Dr. Ho also said that, while “a lot of the recommendations aren’t well supported, the risk-benefit ratio, we believe, supports the recommendations.”
The article first reviewed the different types of ticks and their distribution in the United States, the specific pathogen associated with each, the disease it causes, and comments about seasonal variations in biting behavior. Another table outlines the most common clinical syndromes, typical lab findings, recommended diagnostic testing, and antibiotic treatments. A third section contains images of different types of ticks and photos of ticks in various life-cycle stages and different levels of engorgement.
The authors were careful to note: “Several tick species are able to carry multiple pathogens. In one study, nearly 25% of Ixodes were coinfected with some combination of the bacteria or parasites causing Lyme disease, anaplasmosis, or babesiosis. Although TBI [tick-borne illness] diagnosis is not the focus of this [clinical practice guideline], providers should be aware of high rates of coinfection; the presence of one TBI should in many instances prompt testing for others.”
In terms of recommendations for preventing TBIs, the authors challenge the suggestion of wearing light-colored clothing. For repellents, they recommend DEET, picaridin, and permethrin. And they also give instructions for laundering clothing and removing ticks.
One recommendation is controversial: that of providing single-dose doxycycline as prophylaxis against Lyme disease. Dr. Ho stresses that this was only for “high-risk” tick bites, defined as a tick bite from an identified Ixodes vector species in which the tick was attached for at least 36 hours and that occurred in an endemic area.
The recommendation for prophylactic doxycycline originated with an article by Robert Nadelman and colleagues in the New England Journal of Medicine and has been strongly challenged by ILADS (International Lyme and Associated Diseases Society) physicians, including Daniel Cameron, MD, and others.
Sam Donta, MD, a recent member of the Department of Health & Human Services Tick-borne Working Group and a member of the Infectious Disease Society of America, said in an interview: “The problem with the one-dose doxycycline is you may not begin to develop symptoms until 2 months later.” It might mask the early symptoms of Lyme. “My impression is that the doxycycline – even the single dose – might have abrogated the ability to see an immune response. The idea, though, if you’ve had a tick bite, is to do nothing and to wait for symptoms to develop. That becomes a little bit more complex. But even then, you could choose to follow the patient and see the patient in 2 weeks and then get blood testing.”
Dr. Donta added: “I think the screening test is inadequate. So you have to go directly to the Western blot. And you have to do both the IgM and IgG” and look for specific bands.
Dr. Donta emphasized that patients should be encouraged to save any ticks that were attached and that, if at all possible, ticks should be sent to a reference lab for testing before committing a patient to a course of antibiotics. There is no harm in that brief delay, he said, and most labs can identify an array of pathogens.
The Wilderness Society guidelines on TBIs provide a good overview for clinicians practicing in limited resource settings and mirror those from the IDSA.
Dr. Ho and Dr. Donta reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM WILDERNESS ENVIRONMENTAL MEDICINE
AHA advice for diabetes patients to stay heart healthy
A new document from the American Heart Association summarizes the latest research on cardiovascular risk factor management in type 2 diabetes, including medications, lifestyle, and social determinants of health.
Despite the availability of effective therapies for improving cardiovascular risk, in the United States fewer than one in five people with type 2 diabetes and without known cardiovascular disease meet control targets for a combination of A1c, blood pressure, LDL cholesterol, and nonsmoking status.
That proportion drops to less than 1 in 10 if body mass index less than 30 kg/m2 is included among the targets, and even less than that among individuals with established atherosclerotic cardiovascular disease, Joshua J. Joseph, MD, and colleagues point out in their paper, published online Jan. 10 in Circulation.
“This new scientific statement is an urgent call to action to follow the latest evidence-based approaches and to develop new best practices to advance type 2 diabetes treatment and care and reduce cardiovascular disease risk,” wrote Dr. Joseph, assistant professor of medicine in the division of endocrinology, diabetes, and metabolism at The Ohio State University, Columbus, Ohio, and coauthors.
The statement is not a guideline but an expert analysis that may inform future clinical practice guidelines, according to a press release from the AHA.
The new statement reviews evidence through June 2020 for lifestyle management of diabetes and weight, glycemic targets and control, blood pressure management, lipid management, antithrombotic therapy, and screening for cardiovascular and renal complications, including imaging. It also discusses the clinical implications of recent cardiovascular outcomes trials of newer glucose-lowering medications.
However, Dr. Joseph and colleagues point out, clinical care and treatment account for just 10%-20% of modifiable contributors to health outcomes. The other 80%-90% relate to social determinants of health, including health-related behaviors, socioeconomic factors, environmental factors, and racism.
“If we are to continue to advance the management of cardiovascular risk factors, we must also address the [social determinants of health] in the delivery of health care,” they noted.
Overall, they advise a patient-centered approach, meaning “reframing our clinical encounters to think about patients as people who live in families, communities, and societies that must be considered in their cardiovascular risk management.”
“People with [type 2 diabetes] face numerous barriers to health including access to care and equitable care, which must be considered when developing individualized care plans with our patients,” Dr. Joseph said in the AHA press release.
Lifestyle, medications for lowering A1c, BP, lipids
For lifestyle management, the authors say, “culturally appropriate recommendations through diabetes self-management education and support and medical nutrition therapy are key to meeting individualized goals for behavioral change and diabetes self-management.”
The document summarizes recommendations from other professional societies regarding glycemic targets and glucose lowering medications, i.e., target A1c levels of either < 7% or < 6.5% for the majority, with adjustments based on individual factors, such as life expectancy. It advises on use of metformin as first-line therapy followed by a sodium-glucose cotransporter-2 inhibitor or a glucagon-like peptide-1 agonist for those with established cardiovascular disease or risk factors.
“Cost may be a barrier to taking some [type 2 diabetes] medications as prescribed; however, many of these medications are now more commonly covered by more health insurance plans,” Dr. Joseph said.
“Another barrier is recognition by patients that these newer [type 2 diabetes] medications are also effective in reducing the risk of heart disease, stroke, heart failure, and kidney disease.”
Blood pressure treatment guidelines differ between those of the AHA/American College of Cardiology (ACC) and the American Diabetes Association (ADA), most notably that the AHA/ACC guidelines advise a general target of < 130/80 mm Hg, whereas ADA advises < 140/90 mm Hg or < 130/80 mm Hg for those with high risk if it can be safely achieved.
The decision should be “patient-centered with shared decision-making,” Dr. Joseph and colleagues advised.
For lipid-lowering, the document cites the 2018 ACC/AHA cholesterol guidelines, which include advising statins as first-line therapy for both primary and secondary prevention in diabetes, with highest intensity statins used in those at highest risk. But again, treatment should be individualized, and other agents should be used for patients in whom statins don’t work or aren’t tolerated.
And while use of antiplatelets – that is, aspirin – is well established as secondary prevention in type 2 diabetes, given new data suggesting that the risk for major bleeding could outweigh the benefits for primary prevention, “the relative benefits of antithrombotic approaches need to be weighed carefully against risks using a patient-centered approach,” the authors advised.
Among the many imaging tests available to facilitate cardiovascular risk stratification in type 2 diabetes, coronary artery calcification (CAC) CT screening is one of the few with sufficient data to support routine use in selected patients. The National Lipid Association, for example, recommends escalation to high-intensity statin for CAC > 100.
“One avenue to continue to address and advance diabetes management is through breaking down the four walls of the clinic or hospital through community engagement, clinic-to-community connections, and academic-community-government partnerships that may help address and support modifiable lifestyle behaviors such as physical activity, nutrition, smoking cessation and stress management,” Dr. Joseph concluded.
The AHA receives funding primarily from individuals. Foundations and corporations, including pharmaceutical, device manufacturers, and other companies, also make donations and fund AHA programs and events. The AHA’s strict policies prevent these relationships from influencing the science content. Revenues from pharmaceutical and biotech companies, device manufacturers, and health insurance providers and the AHA’s financial information are available on the association’s website. Dr. Joseph has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new document from the American Heart Association summarizes the latest research on cardiovascular risk factor management in type 2 diabetes, including medications, lifestyle, and social determinants of health.
Despite the availability of effective therapies for improving cardiovascular risk, in the United States fewer than one in five people with type 2 diabetes and without known cardiovascular disease meet control targets for a combination of A1c, blood pressure, LDL cholesterol, and nonsmoking status.
That proportion drops to less than 1 in 10 if body mass index less than 30 kg/m2 is included among the targets, and even less than that among individuals with established atherosclerotic cardiovascular disease, Joshua J. Joseph, MD, and colleagues point out in their paper, published online Jan. 10 in Circulation.
“This new scientific statement is an urgent call to action to follow the latest evidence-based approaches and to develop new best practices to advance type 2 diabetes treatment and care and reduce cardiovascular disease risk,” wrote Dr. Joseph, assistant professor of medicine in the division of endocrinology, diabetes, and metabolism at The Ohio State University, Columbus, Ohio, and coauthors.
The statement is not a guideline but an expert analysis that may inform future clinical practice guidelines, according to a press release from the AHA.
The new statement reviews evidence through June 2020 for lifestyle management of diabetes and weight, glycemic targets and control, blood pressure management, lipid management, antithrombotic therapy, and screening for cardiovascular and renal complications, including imaging. It also discusses the clinical implications of recent cardiovascular outcomes trials of newer glucose-lowering medications.
However, Dr. Joseph and colleagues point out, clinical care and treatment account for just 10%-20% of modifiable contributors to health outcomes. The other 80%-90% relate to social determinants of health, including health-related behaviors, socioeconomic factors, environmental factors, and racism.
“If we are to continue to advance the management of cardiovascular risk factors, we must also address the [social determinants of health] in the delivery of health care,” they noted.
Overall, they advise a patient-centered approach, meaning “reframing our clinical encounters to think about patients as people who live in families, communities, and societies that must be considered in their cardiovascular risk management.”
“People with [type 2 diabetes] face numerous barriers to health including access to care and equitable care, which must be considered when developing individualized care plans with our patients,” Dr. Joseph said in the AHA press release.
Lifestyle, medications for lowering A1c, BP, lipids
For lifestyle management, the authors say, “culturally appropriate recommendations through diabetes self-management education and support and medical nutrition therapy are key to meeting individualized goals for behavioral change and diabetes self-management.”
The document summarizes recommendations from other professional societies regarding glycemic targets and glucose lowering medications, i.e., target A1c levels of either < 7% or < 6.5% for the majority, with adjustments based on individual factors, such as life expectancy. It advises on use of metformin as first-line therapy followed by a sodium-glucose cotransporter-2 inhibitor or a glucagon-like peptide-1 agonist for those with established cardiovascular disease or risk factors.
“Cost may be a barrier to taking some [type 2 diabetes] medications as prescribed; however, many of these medications are now more commonly covered by more health insurance plans,” Dr. Joseph said.
“Another barrier is recognition by patients that these newer [type 2 diabetes] medications are also effective in reducing the risk of heart disease, stroke, heart failure, and kidney disease.”
Blood pressure treatment guidelines differ between those of the AHA/American College of Cardiology (ACC) and the American Diabetes Association (ADA), most notably that the AHA/ACC guidelines advise a general target of < 130/80 mm Hg, whereas ADA advises < 140/90 mm Hg or < 130/80 mm Hg for those with high risk if it can be safely achieved.
The decision should be “patient-centered with shared decision-making,” Dr. Joseph and colleagues advised.
For lipid-lowering, the document cites the 2018 ACC/AHA cholesterol guidelines, which include advising statins as first-line therapy for both primary and secondary prevention in diabetes, with highest intensity statins used in those at highest risk. But again, treatment should be individualized, and other agents should be used for patients in whom statins don’t work or aren’t tolerated.
And while use of antiplatelets – that is, aspirin – is well established as secondary prevention in type 2 diabetes, given new data suggesting that the risk for major bleeding could outweigh the benefits for primary prevention, “the relative benefits of antithrombotic approaches need to be weighed carefully against risks using a patient-centered approach,” the authors advised.
Among the many imaging tests available to facilitate cardiovascular risk stratification in type 2 diabetes, coronary artery calcification (CAC) CT screening is one of the few with sufficient data to support routine use in selected patients. The National Lipid Association, for example, recommends escalation to high-intensity statin for CAC > 100.
“One avenue to continue to address and advance diabetes management is through breaking down the four walls of the clinic or hospital through community engagement, clinic-to-community connections, and academic-community-government partnerships that may help address and support modifiable lifestyle behaviors such as physical activity, nutrition, smoking cessation and stress management,” Dr. Joseph concluded.
The AHA receives funding primarily from individuals. Foundations and corporations, including pharmaceutical, device manufacturers, and other companies, also make donations and fund AHA programs and events. The AHA’s strict policies prevent these relationships from influencing the science content. Revenues from pharmaceutical and biotech companies, device manufacturers, and health insurance providers and the AHA’s financial information are available on the association’s website. Dr. Joseph has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new document from the American Heart Association summarizes the latest research on cardiovascular risk factor management in type 2 diabetes, including medications, lifestyle, and social determinants of health.
Despite the availability of effective therapies for improving cardiovascular risk, in the United States fewer than one in five people with type 2 diabetes and without known cardiovascular disease meet control targets for a combination of A1c, blood pressure, LDL cholesterol, and nonsmoking status.
That proportion drops to less than 1 in 10 if body mass index less than 30 kg/m2 is included among the targets, and even less than that among individuals with established atherosclerotic cardiovascular disease, Joshua J. Joseph, MD, and colleagues point out in their paper, published online Jan. 10 in Circulation.
“This new scientific statement is an urgent call to action to follow the latest evidence-based approaches and to develop new best practices to advance type 2 diabetes treatment and care and reduce cardiovascular disease risk,” wrote Dr. Joseph, assistant professor of medicine in the division of endocrinology, diabetes, and metabolism at The Ohio State University, Columbus, Ohio, and coauthors.
The statement is not a guideline but an expert analysis that may inform future clinical practice guidelines, according to a press release from the AHA.
The new statement reviews evidence through June 2020 for lifestyle management of diabetes and weight, glycemic targets and control, blood pressure management, lipid management, antithrombotic therapy, and screening for cardiovascular and renal complications, including imaging. It also discusses the clinical implications of recent cardiovascular outcomes trials of newer glucose-lowering medications.
However, Dr. Joseph and colleagues point out, clinical care and treatment account for just 10%-20% of modifiable contributors to health outcomes. The other 80%-90% relate to social determinants of health, including health-related behaviors, socioeconomic factors, environmental factors, and racism.
“If we are to continue to advance the management of cardiovascular risk factors, we must also address the [social determinants of health] in the delivery of health care,” they noted.
Overall, they advise a patient-centered approach, meaning “reframing our clinical encounters to think about patients as people who live in families, communities, and societies that must be considered in their cardiovascular risk management.”
“People with [type 2 diabetes] face numerous barriers to health including access to care and equitable care, which must be considered when developing individualized care plans with our patients,” Dr. Joseph said in the AHA press release.
Lifestyle, medications for lowering A1c, BP, lipids
For lifestyle management, the authors say, “culturally appropriate recommendations through diabetes self-management education and support and medical nutrition therapy are key to meeting individualized goals for behavioral change and diabetes self-management.”
The document summarizes recommendations from other professional societies regarding glycemic targets and glucose lowering medications, i.e., target A1c levels of either < 7% or < 6.5% for the majority, with adjustments based on individual factors, such as life expectancy. It advises on use of metformin as first-line therapy followed by a sodium-glucose cotransporter-2 inhibitor or a glucagon-like peptide-1 agonist for those with established cardiovascular disease or risk factors.
“Cost may be a barrier to taking some [type 2 diabetes] medications as prescribed; however, many of these medications are now more commonly covered by more health insurance plans,” Dr. Joseph said.
“Another barrier is recognition by patients that these newer [type 2 diabetes] medications are also effective in reducing the risk of heart disease, stroke, heart failure, and kidney disease.”
Blood pressure treatment guidelines differ between those of the AHA/American College of Cardiology (ACC) and the American Diabetes Association (ADA), most notably that the AHA/ACC guidelines advise a general target of < 130/80 mm Hg, whereas ADA advises < 140/90 mm Hg or < 130/80 mm Hg for those with high risk if it can be safely achieved.
The decision should be “patient-centered with shared decision-making,” Dr. Joseph and colleagues advised.
For lipid-lowering, the document cites the 2018 ACC/AHA cholesterol guidelines, which include advising statins as first-line therapy for both primary and secondary prevention in diabetes, with highest intensity statins used in those at highest risk. But again, treatment should be individualized, and other agents should be used for patients in whom statins don’t work or aren’t tolerated.
And while use of antiplatelets – that is, aspirin – is well established as secondary prevention in type 2 diabetes, given new data suggesting that the risk for major bleeding could outweigh the benefits for primary prevention, “the relative benefits of antithrombotic approaches need to be weighed carefully against risks using a patient-centered approach,” the authors advised.
Among the many imaging tests available to facilitate cardiovascular risk stratification in type 2 diabetes, coronary artery calcification (CAC) CT screening is one of the few with sufficient data to support routine use in selected patients. The National Lipid Association, for example, recommends escalation to high-intensity statin for CAC > 100.
“One avenue to continue to address and advance diabetes management is through breaking down the four walls of the clinic or hospital through community engagement, clinic-to-community connections, and academic-community-government partnerships that may help address and support modifiable lifestyle behaviors such as physical activity, nutrition, smoking cessation and stress management,” Dr. Joseph concluded.
The AHA receives funding primarily from individuals. Foundations and corporations, including pharmaceutical, device manufacturers, and other companies, also make donations and fund AHA programs and events. The AHA’s strict policies prevent these relationships from influencing the science content. Revenues from pharmaceutical and biotech companies, device manufacturers, and health insurance providers and the AHA’s financial information are available on the association’s website. Dr. Joseph has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.