Despite an increasing rate of obesity in the United States, sleeve gastrectomy and postoperative antiobesity pharmacotherapy remain significantly underutilized, according to investigators.

A retrospective study involving almost 3 million adults with obesity found that only 0.94% had undergone sleeve gastrectomy, with 5.6% of those receiving weight-loss drugs after discharge, reported lead author Raj Shah, MD, of University Hospitals Cleveland Medical Center, and colleagues.

“While obesity has increased exponentially in the past decade, the trends of bariatric procedures and postoperative pharmacotherapy in this timeline is not well established,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.

According to coauthor Abbinaya Elangovan, MD, of MetroHealth Medical Center, Cleveland, existing data suggest a practice gap.

“We know from published studies that antiobesity measures – both surgical and pharmacotherapeutic – do not match the rates of obesity,” Dr. Elangovan said. “We wanted to see how many of the morbidly obese [patients] who get bariatric surgery get started on antiobesity pharmacotherapy. We selected sleeve gastrectomy, as that is the most common bariatric procedure performed in the United States in recent times.”

The investigators began by retrospectively screening 2,717,000 individuals with a body mass index (in kg/m₂) of at least 40 who entered the IBM Explorys database from 2010 to 2019. Out of this group, 25,540 individuals (0.94%) had undergone sleeve gastrectomy. Annual rates of the procedure increased from 0.06% in 2010 to 0.4% in 2019 (P < .0001).

Of the 25,540 patients who underwent sleeve gastrectomy, 1,440 (5.6%) were prescribed antiobesity medication after surgery, with about half (47%) of these prescriptions written within a year. The most common medication was phentermine (66%), followed by bupropion/naltrexone (16%) and phentermine/topiramate (14.4%).

Dr. Elangovan said that the rates of surgery and antiobesity pharmacotherapy found in the study were “sparse” compared with rates of obesity.

“[Future studies need] to find the barriers to antiobesity pharmacotherapy,” Dr. Elangovan said. “We know from some of the published studies that there are differences in provider perceptions, as well as patient populations who get the therapy.”

The present analysis showed that women, African Americans, and patients with commercial insurance were significantly more likely to receive postoperative weight-loss medications than other patient subgroups.

“I think insurance could be a potential concern,” Dr. Elangovan said. “This has been shown previously in the literature.” She also suggested that women may be accessing obesity-related health care more often than men.

Discussing steps to improve interventions for patients with obesity, Dr. Elangovan emphasized the amount of data supporting antiobesity pharmacotherapy.

“We know from studies published so far that combining pharmacotherapy with behavioral modifications has a greater percentage of success, compared to behavioral modifications by themselves,” Dr. Elangovan said.

According to Dr. Elangovan, primary care providers play a key role in connecting obese patients with the treatments they need, requiring familiarity with existing guidelines.

“It helps if practicing clinicians, especially primary care providers, are familiar with bariatric surgery criteria and institution policies,” Dr. Elangovan said. “It has been shown in some studies that limited experience in prescribing and concern for adverse reactions could affect the prescription of antiobesity pharmacotherapy. Targeted interventions such as educational programs may increase the appropriate usage of medications.”

Dr. Smith disclosed a relationship with US Endoscopy.

SOURCE: Shah R et al. DDW 2020, Abstract 791.

Despite an increasing rate of obesity in the United States, sleeve gastrectomy and postoperative antiobesity pharmacotherapy remain significantly underutilized, according to investigators.

A retrospective study involving almost 3 million adults with obesity found that only 0.94% had undergone sleeve gastrectomy, with 5.6% of those receiving weight-loss drugs after discharge, reported lead author Raj Shah, MD, of University Hospitals Cleveland Medical Center, and colleagues.

“While obesity has increased exponentially in the past decade, the trends of bariatric procedures and postoperative pharmacotherapy in this timeline is not well established,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.

According to coauthor Abbinaya Elangovan, MD, of MetroHealth Medical Center, Cleveland, existing data suggest a practice gap.

“We know from published studies that antiobesity measures – both surgical and pharmacotherapeutic – do not match the rates of obesity,” Dr. Elangovan said. “We wanted to see how many of the morbidly obese [patients] who get bariatric surgery get started on antiobesity pharmacotherapy. We selected sleeve gastrectomy, as that is the most common bariatric procedure performed in the United States in recent times.”

The investigators began by retrospectively screening 2,717,000 individuals with a body mass index (in kg/m₂) of at least 40 who entered the IBM Explorys database from 2010 to 2019. Out of this group, 25,540 individuals (0.94%) had undergone sleeve gastrectomy. Annual rates of the procedure increased from 0.06% in 2010 to 0.4% in 2019 (P < .0001).

Of the 25,540 patients who underwent sleeve gastrectomy, 1,440 (5.6%) were prescribed antiobesity medication after surgery, with about half (47%) of these prescriptions written within a year. The most common medication was phentermine (66%), followed by bupropion/naltrexone (16%) and phentermine/topiramate (14.4%).

Dr. Elangovan said that the rates of surgery and antiobesity pharmacotherapy found in the study were “sparse” compared with rates of obesity.

“[Future studies need] to find the barriers to antiobesity pharmacotherapy,” Dr. Elangovan said. “We know from some of the published studies that there are differences in provider perceptions, as well as patient populations who get the therapy.”

The present analysis showed that women, African Americans, and patients with commercial insurance were significantly more likely to receive postoperative weight-loss medications than other patient subgroups.

“I think insurance could be a potential concern,” Dr. Elangovan said. “This has been shown previously in the literature.” She also suggested that women may be accessing obesity-related health care more often than men.

Discussing steps to improve interventions for patients with obesity, Dr. Elangovan emphasized the amount of data supporting antiobesity pharmacotherapy.

“We know from studies published so far that combining pharmacotherapy with behavioral modifications has a greater percentage of success, compared to behavioral modifications by themselves,” Dr. Elangovan said.

According to Dr. Elangovan, primary care providers play a key role in connecting obese patients with the treatments they need, requiring familiarity with existing guidelines.

“It helps if practicing clinicians, especially primary care providers, are familiar with bariatric surgery criteria and institution policies,” Dr. Elangovan said. “It has been shown in some studies that limited experience in prescribing and concern for adverse reactions could affect the prescription of antiobesity pharmacotherapy. Targeted interventions such as educational programs may increase the appropriate usage of medications.”

Dr. Smith disclosed a relationship with US Endoscopy.

SOURCE: Shah R et al. DDW 2020, Abstract 791.

Despite an increasing rate of obesity in the United States, sleeve gastrectomy and postoperative antiobesity pharmacotherapy remain significantly underutilized, according to investigators.

A retrospective study involving almost 3 million adults with obesity found that only 0.94% had undergone sleeve gastrectomy, with 5.6% of those receiving weight-loss drugs after discharge, reported lead author Raj Shah, MD, of University Hospitals Cleveland Medical Center, and colleagues.

“While obesity has increased exponentially in the past decade, the trends of bariatric procedures and postoperative pharmacotherapy in this timeline is not well established,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.

According to coauthor Abbinaya Elangovan, MD, of MetroHealth Medical Center, Cleveland, existing data suggest a practice gap.

“We know from published studies that antiobesity measures – both surgical and pharmacotherapeutic – do not match the rates of obesity,” Dr. Elangovan said. “We wanted to see how many of the morbidly obese [patients] who get bariatric surgery get started on antiobesity pharmacotherapy. We selected sleeve gastrectomy, as that is the most common bariatric procedure performed in the United States in recent times.”

The investigators began by retrospectively screening 2,717,000 individuals with a body mass index (in kg/m₂) of at least 40 who entered the IBM Explorys database from 2010 to 2019. Out of this group, 25,540 individuals (0.94%) had undergone sleeve gastrectomy. Annual rates of the procedure increased from 0.06% in 2010 to 0.4% in 2019 (P < .0001).

Of the 25,540 patients who underwent sleeve gastrectomy, 1,440 (5.6%) were prescribed antiobesity medication after surgery, with about half (47%) of these prescriptions written within a year. The most common medication was phentermine (66%), followed by bupropion/naltrexone (16%) and phentermine/topiramate (14.4%).

Dr. Elangovan said that the rates of surgery and antiobesity pharmacotherapy found in the study were “sparse” compared with rates of obesity.

“[Future studies need] to find the barriers to antiobesity pharmacotherapy,” Dr. Elangovan said. “We know from some of the published studies that there are differences in provider perceptions, as well as patient populations who get the therapy.”

The present analysis showed that women, African Americans, and patients with commercial insurance were significantly more likely to receive postoperative weight-loss medications than other patient subgroups.

“I think insurance could be a potential concern,” Dr. Elangovan said. “This has been shown previously in the literature.” She also suggested that women may be accessing obesity-related health care more often than men.

Discussing steps to improve interventions for patients with obesity, Dr. Elangovan emphasized the amount of data supporting antiobesity pharmacotherapy.

“We know from studies published so far that combining pharmacotherapy with behavioral modifications has a greater percentage of success, compared to behavioral modifications by themselves,” Dr. Elangovan said.

According to Dr. Elangovan, primary care providers play a key role in connecting obese patients with the treatments they need, requiring familiarity with existing guidelines.

“It helps if practicing clinicians, especially primary care providers, are familiar with bariatric surgery criteria and institution policies,” Dr. Elangovan said. “It has been shown in some studies that limited experience in prescribing and concern for adverse reactions could affect the prescription of antiobesity pharmacotherapy. Targeted interventions such as educational programs may increase the appropriate usage of medications.”

Dr. Smith disclosed a relationship with US Endoscopy.

SOURCE: Shah R et al. DDW 2020, Abstract 791.

With little evidence available on the role of bronchoscopy during the COVID-19 pandemic, an expert panel has published a guideline recommending its spare use in COVID-19 patients and those with suspected COVID-19 infection.

The panel stated that in the context of the COVID-19 crisis, bronchoscopy and other aerosol-generating procedures put health care workers (HCWs) at particularly high risk of exposure and infection. They recommended deferring bronchoscopy in nonurgent cases, and advised practitioners to wear personal protective equipment when performing bronchoscopy, even on asymptomatic patients.

The guideline and expert panel report have been published online in the journal Chest. CHEST and the American Association for Bronchology and Interventional Pulmonology participated in selecting the 14 panelists. “The recommendation and suggestions outlined in this document were specifically created to address what were felt to be clinically common and urgent questions that frontline clinicians are likely to face,” wrote lead author and panel cochair Momen M. Wahidi, MD, MBA, of Duke University, Durham, N.C., and colleagues.

Only one of the six recommendations is based on graded evidence; the remainder are ungraded consensus-based statements. The guideline consists of the following recommendations for performing or using bronchoscopy:

• HCWs in the procedure or recovery rooms should wear either an N-95 respirator or powered air-purifying respirator (PAPR) when performing bronchoscopy on patients suspected or confirmed to have COVID-19. They should wear personal protective equipment (PPE) that includes a face shield, gown, and gloves, and they should discard N-95 respirators after performing bronchoscopy.
• A nasopharyngeal specimen in COVID-19 suspects should be obtained before performing bronchoscopy. If the patient has severe or progressive disease that requires intubation but an additional specimen is needed to confirm COVID-19 or another diagnosis that could change the treatment course, an option would be lower-respiratory specimen from the endotracheal aspirate or bronchoscopy with bronchoalveolar lavage.
• HCWs should wear an N-95 or PAPR when doing bronchoscopy on asymptomatic patients in an area with community spread of COVID-19 – again, with the PPE designated in the first recommendation.
• Test for COVID-19 before doing bronchoscopy on asymptomatic patients. Defer nonurgent bronchoscopy if the test is positive. If it’s negative, follow the recommendations regarding respirators and PPE when doing bronchoscopy.
• Perform timely bronchoscopy when indicated even in an area with known community spread of COVID-19. This is the only graded recommendation among the six (Grade 2C) and may be the most nuanced. Local teams should develop strategies for using bronchoscopy in their setting, taking into account local resources and availability of PPE, and they should send noninfected cancer patients from resource-depleted hospitals to other centers.
• Base the timing of bronchoscopy in patients recovering after COVID-19 on the indication for the procedure, disease severity, and time duration since symptoms resolved. The recommendation noted that the exact timing is still unknown, but that a wait of at least 30 days after symptoms recede is “reasonable.”

The expert panel added a noteworthy caveat to the recommendations. “We would like to stress that these protective strategies can be rendered completely ineffective if proper training on donning and doffing is not provided to HCW,” Dr. Wahidi and colleagues wrote. “Proper personnel instruction and practice for wearing PPE should receive as much attention by health facilities as the chosen strategy for protection.”

Dr. Wahidi and colleagues have no financial relationships to disclose.

SOURCE: Wahidi MM et al. CHEST. 2020 Apr 30. doi: 10.1016/j.chest.2020.04.036.

With little evidence available on the role of bronchoscopy during the COVID-19 pandemic, an expert panel has published a guideline recommending its spare use in COVID-19 patients and those with suspected COVID-19 infection.

The panel stated that in the context of the COVID-19 crisis, bronchoscopy and other aerosol-generating procedures put health care workers (HCWs) at particularly high risk of exposure and infection. They recommended deferring bronchoscopy in nonurgent cases, and advised practitioners to wear personal protective equipment when performing bronchoscopy, even on asymptomatic patients.

The guideline and expert panel report have been published online in the journal Chest. CHEST and the American Association for Bronchology and Interventional Pulmonology participated in selecting the 14 panelists. “The recommendation and suggestions outlined in this document were specifically created to address what were felt to be clinically common and urgent questions that frontline clinicians are likely to face,” wrote lead author and panel cochair Momen M. Wahidi, MD, MBA, of Duke University, Durham, N.C., and colleagues.

Only one of the six recommendations is based on graded evidence; the remainder are ungraded consensus-based statements. The guideline consists of the following recommendations for performing or using bronchoscopy:

• HCWs in the procedure or recovery rooms should wear either an N-95 respirator or powered air-purifying respirator (PAPR) when performing bronchoscopy on patients suspected or confirmed to have COVID-19. They should wear personal protective equipment (PPE) that includes a face shield, gown, and gloves, and they should discard N-95 respirators after performing bronchoscopy.
• A nasopharyngeal specimen in COVID-19 suspects should be obtained before performing bronchoscopy. If the patient has severe or progressive disease that requires intubation but an additional specimen is needed to confirm COVID-19 or another diagnosis that could change the treatment course, an option would be lower-respiratory specimen from the endotracheal aspirate or bronchoscopy with bronchoalveolar lavage.
• HCWs should wear an N-95 or PAPR when doing bronchoscopy on asymptomatic patients in an area with community spread of COVID-19 – again, with the PPE designated in the first recommendation.
• Test for COVID-19 before doing bronchoscopy on asymptomatic patients. Defer nonurgent bronchoscopy if the test is positive. If it’s negative, follow the recommendations regarding respirators and PPE when doing bronchoscopy.
• Perform timely bronchoscopy when indicated even in an area with known community spread of COVID-19. This is the only graded recommendation among the six (Grade 2C) and may be the most nuanced. Local teams should develop strategies for using bronchoscopy in their setting, taking into account local resources and availability of PPE, and they should send noninfected cancer patients from resource-depleted hospitals to other centers.
• Base the timing of bronchoscopy in patients recovering after COVID-19 on the indication for the procedure, disease severity, and time duration since symptoms resolved. The recommendation noted that the exact timing is still unknown, but that a wait of at least 30 days after symptoms recede is “reasonable.”

The expert panel added a noteworthy caveat to the recommendations. “We would like to stress that these protective strategies can be rendered completely ineffective if proper training on donning and doffing is not provided to HCW,” Dr. Wahidi and colleagues wrote. “Proper personnel instruction and practice for wearing PPE should receive as much attention by health facilities as the chosen strategy for protection.”

Dr. Wahidi and colleagues have no financial relationships to disclose.

SOURCE: Wahidi MM et al. CHEST. 2020 Apr 30. doi: 10.1016/j.chest.2020.04.036.

With little evidence available on the role of bronchoscopy during the COVID-19 pandemic, an expert panel has published a guideline recommending its spare use in COVID-19 patients and those with suspected COVID-19 infection.

The panel stated that in the context of the COVID-19 crisis, bronchoscopy and other aerosol-generating procedures put health care workers (HCWs) at particularly high risk of exposure and infection. They recommended deferring bronchoscopy in nonurgent cases, and advised practitioners to wear personal protective equipment when performing bronchoscopy, even on asymptomatic patients.

The guideline and expert panel report have been published online in the journal Chest. CHEST and the American Association for Bronchology and Interventional Pulmonology participated in selecting the 14 panelists. “The recommendation and suggestions outlined in this document were specifically created to address what were felt to be clinically common and urgent questions that frontline clinicians are likely to face,” wrote lead author and panel cochair Momen M. Wahidi, MD, MBA, of Duke University, Durham, N.C., and colleagues.

Only one of the six recommendations is based on graded evidence; the remainder are ungraded consensus-based statements. The guideline consists of the following recommendations for performing or using bronchoscopy:

• HCWs in the procedure or recovery rooms should wear either an N-95 respirator or powered air-purifying respirator (PAPR) when performing bronchoscopy on patients suspected or confirmed to have COVID-19. They should wear personal protective equipment (PPE) that includes a face shield, gown, and gloves, and they should discard N-95 respirators after performing bronchoscopy.
• A nasopharyngeal specimen in COVID-19 suspects should be obtained before performing bronchoscopy. If the patient has severe or progressive disease that requires intubation but an additional specimen is needed to confirm COVID-19 or another diagnosis that could change the treatment course, an option would be lower-respiratory specimen from the endotracheal aspirate or bronchoscopy with bronchoalveolar lavage.
• HCWs should wear an N-95 or PAPR when doing bronchoscopy on asymptomatic patients in an area with community spread of COVID-19 – again, with the PPE designated in the first recommendation.
• Test for COVID-19 before doing bronchoscopy on asymptomatic patients. Defer nonurgent bronchoscopy if the test is positive. If it’s negative, follow the recommendations regarding respirators and PPE when doing bronchoscopy.
• Perform timely bronchoscopy when indicated even in an area with known community spread of COVID-19. This is the only graded recommendation among the six (Grade 2C) and may be the most nuanced. Local teams should develop strategies for using bronchoscopy in their setting, taking into account local resources and availability of PPE, and they should send noninfected cancer patients from resource-depleted hospitals to other centers.
• Base the timing of bronchoscopy in patients recovering after COVID-19 on the indication for the procedure, disease severity, and time duration since symptoms resolved. The recommendation noted that the exact timing is still unknown, but that a wait of at least 30 days after symptoms recede is “reasonable.”

The expert panel added a noteworthy caveat to the recommendations. “We would like to stress that these protective strategies can be rendered completely ineffective if proper training on donning and doffing is not provided to HCW,” Dr. Wahidi and colleagues wrote. “Proper personnel instruction and practice for wearing PPE should receive as much attention by health facilities as the chosen strategy for protection.”

Dr. Wahidi and colleagues have no financial relationships to disclose.

SOURCE: Wahidi MM et al. CHEST. 2020 Apr 30. doi: 10.1016/j.chest.2020.04.036.

A practice advisory from the American Academy of Neurology provides guidance about when doctors may recommend closure of a patent foramen ovale (PFO) to reduce the risk of recurrent stroke. Patients with an embolic-appearing infarct who are younger than 60 years, have undergone a thorough evaluation to rule out other stroke mechanisms, and have discussed with doctors the potential risks and benefits may be candidates for the procedure.

“For patients with cryptogenic stroke and PFO, percutaneous PFO closure probably reduces the risk of stroke recurrence with [a hazard ratio] of 0.41 and an absolute risk reduction of 3.4% at 5 years; probably is associated with a periprocedural complication rate of 3.9%; and probably is associated with the development of serious nonperiprocedural atrial fibrillation, with a relative risk of 2.72,” according to the advisory authors’ meta-analysis.

Most procedural complications and instances of atrial fibrillation were “self-limited and are of uncertain long-term clinical consequence, given the lower rate of stroke in patients whose PFOs were closed,” the authors said. “Subgroup analysis suggests that the overall benefit seen across trials may not extend to those patients with small shunts and small, deep infarcts.” The authors estimated that the number of patients who need to be treated to prevent one stroke at 5 years is 29.

The advisory updates 2016 guidance that said clinicians should not routinely offer PFO closure outside of a research setting. Since then, three trials published in 2017 the New England Journal of Medicine (RESPECT, CLOSE, and REDUCE) and one trial published in 2018 in the Journal of the American College of Cardiology (DEFENSE-PFO) found that PFO closure reduces the risk of recurrent stroke in patients with a PFO who have had a cryptogenic stroke, compared with medical therapy alone. In addition, the Food and Drug Administration approved the Amplatzer PFO Occluder and Gore Cardioform Septal Occluder. These developments necessitated the practice advisory, the authors said. The advisory was published online April 29 in Neurology. It is endorsed by the American Heart Association/American Stroke Association, the Society for Cardiovascular Angiography and Interventions, and the European Academy of Neurology.
 

Systematic review

For the update, Steven R. Messé, MD, of the Hospital of the University of Pennsylvania in Philadelphia, and a panel of neurologists, internists, and cardiologists with expertise in stroke and PFO systematically reviewed relevant randomized studies published through August 2019 and conducted meta-analyses to make their recommendations. The literature search identified eight articles that met inclusion criteria, including one article that provided follow-up from a trial that had been included in the previous practice advisory.

“The risk of a second stroke in people with PFO and no other possible causes of stroke is very low, approximately 1% per year while being treated with just medication alone,” Dr. Messé said in a news release. “Also, it is difficult to determine with absolute certainty that the PFO is the cause of a person’s stroke. So it is important that people with PFO are educated about the benefits and risks of PFO closure.” For patients who opt to take medication only, doctors may consider prescribing antiplatelet or anticoagulant drugs, according to the advisory. “All patients with previous stroke should be treated with an antithrombotic medication indefinitely if there is no bleeding contraindication, regardless of whether a PFO is present or if it is closed,” Dr. Messé and colleagues wrote. “However, specific antithrombotic management for patients with stroke thought to be caused by PFO remains uncertain.”
 

Calls for thorough work-up

“If an alternative plausible higher-risk mechanism of stroke is identified, it is likely that the PFO was an innocent bystander,” the authors said. “Secondary stroke prevention is optimized by targeting the most likely etiology of the preceding event. ... The randomized PFO closure trials all mandated thorough evaluations for participants before enrollment ... to rule out other stroke mechanisms; moreover, all studies required TEE [transesophageal echocardiography] to characterize the PFO and ensure that it was the most likely etiology for the initial event.”

In patients being considered for PFO closure, clinicians should obtain brain imaging to confirm stroke size and distribution (level B); obtain vascular imaging of the cervical and intracranial vessels to look for dissection, vasculopathy, and atherosclerosis (level B); and perform hypercoagulable studies (level B), according to the advisory. Clinicians must perform a baseline ECG to look for atrial fibrillation (level A), and patients thought to be at risk of atrial fibrillation should receive prolonged cardiac monitoring for at least 28 days (level B).

Before PFO closure, a clinician with expertise in stroke should assess the patient to ensure that the PFO is the most plausible mechanism of stroke (level B). “If a higher-risk alternative mechanism of stroke is identified, clinicians should not routinely recommend PFO closure (level B),” the authors said. Patients also should be assessed by a clinician with expertise in assessing the anatomic features of a PFO and performing PFO closure (level B).

The randomized trials focused on patients whose PFOs were closed within 6 months of a stroke, and registry studies are needed to assess long-term outcomes, noted Dr. Messé and colleagues. “It remains unclear whether closure provides a similar benefit in these patients who otherwise still fit the studies’ inclusion criteria,” the authors said. “Long-term and large-scale safety registries for patients who have received PFO closure are needed to assess the risk of device erosion, fracture, embolization, and thrombotic and endocarditis risks, and the effect of residual shunts and incidence of atrial fibrillation.”

About 25% of the general adult population has a PFO. “It’s important to note that having a PFO is common, and that most people with PFO will never know they have it because it usually does not cause any problems,” Dr. Messé said. “However, while there is generally a very low risk of stroke in patients with PFO, in younger people who have had a stroke without any other possible causes identified, closing the PFO may reduce the risk of having another stroke better than medication alone.”

The practice advisory was developed with financial support from the AAN. Dr. Messé and most of the authors had no relevant conflicts of interest. Several authors disclosed ties to medical device and pharmaceutical companies.

[email protected]

SOURCE: Messé SR et al. Neurology. 2020 Apr 29. doi: 10.1212/WNL.0000000000009443.

A practice advisory from the American Academy of Neurology provides guidance about when doctors may recommend closure of a patent foramen ovale (PFO) to reduce the risk of recurrent stroke. Patients with an embolic-appearing infarct who are younger than 60 years, have undergone a thorough evaluation to rule out other stroke mechanisms, and have discussed with doctors the potential risks and benefits may be candidates for the procedure.

“For patients with cryptogenic stroke and PFO, percutaneous PFO closure probably reduces the risk of stroke recurrence with [a hazard ratio] of 0.41 and an absolute risk reduction of 3.4% at 5 years; probably is associated with a periprocedural complication rate of 3.9%; and probably is associated with the development of serious nonperiprocedural atrial fibrillation, with a relative risk of 2.72,” according to the advisory authors’ meta-analysis.

Most procedural complications and instances of atrial fibrillation were “self-limited and are of uncertain long-term clinical consequence, given the lower rate of stroke in patients whose PFOs were closed,” the authors said. “Subgroup analysis suggests that the overall benefit seen across trials may not extend to those patients with small shunts and small, deep infarcts.” The authors estimated that the number of patients who need to be treated to prevent one stroke at 5 years is 29.

The advisory updates 2016 guidance that said clinicians should not routinely offer PFO closure outside of a research setting. Since then, three trials published in 2017 the New England Journal of Medicine (RESPECT, CLOSE, and REDUCE) and one trial published in 2018 in the Journal of the American College of Cardiology (DEFENSE-PFO) found that PFO closure reduces the risk of recurrent stroke in patients with a PFO who have had a cryptogenic stroke, compared with medical therapy alone. In addition, the Food and Drug Administration approved the Amplatzer PFO Occluder and Gore Cardioform Septal Occluder. These developments necessitated the practice advisory, the authors said. The advisory was published online April 29 in Neurology. It is endorsed by the American Heart Association/American Stroke Association, the Society for Cardiovascular Angiography and Interventions, and the European Academy of Neurology.
 

Systematic review

For the update, Steven R. Messé, MD, of the Hospital of the University of Pennsylvania in Philadelphia, and a panel of neurologists, internists, and cardiologists with expertise in stroke and PFO systematically reviewed relevant randomized studies published through August 2019 and conducted meta-analyses to make their recommendations. The literature search identified eight articles that met inclusion criteria, including one article that provided follow-up from a trial that had been included in the previous practice advisory.

“The risk of a second stroke in people with PFO and no other possible causes of stroke is very low, approximately 1% per year while being treated with just medication alone,” Dr. Messé said in a news release. “Also, it is difficult to determine with absolute certainty that the PFO is the cause of a person’s stroke. So it is important that people with PFO are educated about the benefits and risks of PFO closure.” For patients who opt to take medication only, doctors may consider prescribing antiplatelet or anticoagulant drugs, according to the advisory. “All patients with previous stroke should be treated with an antithrombotic medication indefinitely if there is no bleeding contraindication, regardless of whether a PFO is present or if it is closed,” Dr. Messé and colleagues wrote. “However, specific antithrombotic management for patients with stroke thought to be caused by PFO remains uncertain.”
 

Calls for thorough work-up

“If an alternative plausible higher-risk mechanism of stroke is identified, it is likely that the PFO was an innocent bystander,” the authors said. “Secondary stroke prevention is optimized by targeting the most likely etiology of the preceding event. ... The randomized PFO closure trials all mandated thorough evaluations for participants before enrollment ... to rule out other stroke mechanisms; moreover, all studies required TEE [transesophageal echocardiography] to characterize the PFO and ensure that it was the most likely etiology for the initial event.”

In patients being considered for PFO closure, clinicians should obtain brain imaging to confirm stroke size and distribution (level B); obtain vascular imaging of the cervical and intracranial vessels to look for dissection, vasculopathy, and atherosclerosis (level B); and perform hypercoagulable studies (level B), according to the advisory. Clinicians must perform a baseline ECG to look for atrial fibrillation (level A), and patients thought to be at risk of atrial fibrillation should receive prolonged cardiac monitoring for at least 28 days (level B).

Before PFO closure, a clinician with expertise in stroke should assess the patient to ensure that the PFO is the most plausible mechanism of stroke (level B). “If a higher-risk alternative mechanism of stroke is identified, clinicians should not routinely recommend PFO closure (level B),” the authors said. Patients also should be assessed by a clinician with expertise in assessing the anatomic features of a PFO and performing PFO closure (level B).

The randomized trials focused on patients whose PFOs were closed within 6 months of a stroke, and registry studies are needed to assess long-term outcomes, noted Dr. Messé and colleagues. “It remains unclear whether closure provides a similar benefit in these patients who otherwise still fit the studies’ inclusion criteria,” the authors said. “Long-term and large-scale safety registries for patients who have received PFO closure are needed to assess the risk of device erosion, fracture, embolization, and thrombotic and endocarditis risks, and the effect of residual shunts and incidence of atrial fibrillation.”

About 25% of the general adult population has a PFO. “It’s important to note that having a PFO is common, and that most people with PFO will never know they have it because it usually does not cause any problems,” Dr. Messé said. “However, while there is generally a very low risk of stroke in patients with PFO, in younger people who have had a stroke without any other possible causes identified, closing the PFO may reduce the risk of having another stroke better than medication alone.”

The practice advisory was developed with financial support from the AAN. Dr. Messé and most of the authors had no relevant conflicts of interest. Several authors disclosed ties to medical device and pharmaceutical companies.

[email protected]

SOURCE: Messé SR et al. Neurology. 2020 Apr 29. doi: 10.1212/WNL.0000000000009443.

A practice advisory from the American Academy of Neurology provides guidance about when doctors may recommend closure of a patent foramen ovale (PFO) to reduce the risk of recurrent stroke. Patients with an embolic-appearing infarct who are younger than 60 years, have undergone a thorough evaluation to rule out other stroke mechanisms, and have discussed with doctors the potential risks and benefits may be candidates for the procedure.

“For patients with cryptogenic stroke and PFO, percutaneous PFO closure probably reduces the risk of stroke recurrence with [a hazard ratio] of 0.41 and an absolute risk reduction of 3.4% at 5 years; probably is associated with a periprocedural complication rate of 3.9%; and probably is associated with the development of serious nonperiprocedural atrial fibrillation, with a relative risk of 2.72,” according to the advisory authors’ meta-analysis.

Most procedural complications and instances of atrial fibrillation were “self-limited and are of uncertain long-term clinical consequence, given the lower rate of stroke in patients whose PFOs were closed,” the authors said. “Subgroup analysis suggests that the overall benefit seen across trials may not extend to those patients with small shunts and small, deep infarcts.” The authors estimated that the number of patients who need to be treated to prevent one stroke at 5 years is 29.

The advisory updates 2016 guidance that said clinicians should not routinely offer PFO closure outside of a research setting. Since then, three trials published in 2017 the New England Journal of Medicine (RESPECT, CLOSE, and REDUCE) and one trial published in 2018 in the Journal of the American College of Cardiology (DEFENSE-PFO) found that PFO closure reduces the risk of recurrent stroke in patients with a PFO who have had a cryptogenic stroke, compared with medical therapy alone. In addition, the Food and Drug Administration approved the Amplatzer PFO Occluder and Gore Cardioform Septal Occluder. These developments necessitated the practice advisory, the authors said. The advisory was published online April 29 in Neurology. It is endorsed by the American Heart Association/American Stroke Association, the Society for Cardiovascular Angiography and Interventions, and the European Academy of Neurology.
 

Systematic review

For the update, Steven R. Messé, MD, of the Hospital of the University of Pennsylvania in Philadelphia, and a panel of neurologists, internists, and cardiologists with expertise in stroke and PFO systematically reviewed relevant randomized studies published through August 2019 and conducted meta-analyses to make their recommendations. The literature search identified eight articles that met inclusion criteria, including one article that provided follow-up from a trial that had been included in the previous practice advisory.

“The risk of a second stroke in people with PFO and no other possible causes of stroke is very low, approximately 1% per year while being treated with just medication alone,” Dr. Messé said in a news release. “Also, it is difficult to determine with absolute certainty that the PFO is the cause of a person’s stroke. So it is important that people with PFO are educated about the benefits and risks of PFO closure.” For patients who opt to take medication only, doctors may consider prescribing antiplatelet or anticoagulant drugs, according to the advisory. “All patients with previous stroke should be treated with an antithrombotic medication indefinitely if there is no bleeding contraindication, regardless of whether a PFO is present or if it is closed,” Dr. Messé and colleagues wrote. “However, specific antithrombotic management for patients with stroke thought to be caused by PFO remains uncertain.”
 

Calls for thorough work-up

“If an alternative plausible higher-risk mechanism of stroke is identified, it is likely that the PFO was an innocent bystander,” the authors said. “Secondary stroke prevention is optimized by targeting the most likely etiology of the preceding event. ... The randomized PFO closure trials all mandated thorough evaluations for participants before enrollment ... to rule out other stroke mechanisms; moreover, all studies required TEE [transesophageal echocardiography] to characterize the PFO and ensure that it was the most likely etiology for the initial event.”

In patients being considered for PFO closure, clinicians should obtain brain imaging to confirm stroke size and distribution (level B); obtain vascular imaging of the cervical and intracranial vessels to look for dissection, vasculopathy, and atherosclerosis (level B); and perform hypercoagulable studies (level B), according to the advisory. Clinicians must perform a baseline ECG to look for atrial fibrillation (level A), and patients thought to be at risk of atrial fibrillation should receive prolonged cardiac monitoring for at least 28 days (level B).

Before PFO closure, a clinician with expertise in stroke should assess the patient to ensure that the PFO is the most plausible mechanism of stroke (level B). “If a higher-risk alternative mechanism of stroke is identified, clinicians should not routinely recommend PFO closure (level B),” the authors said. Patients also should be assessed by a clinician with expertise in assessing the anatomic features of a PFO and performing PFO closure (level B).

The randomized trials focused on patients whose PFOs were closed within 6 months of a stroke, and registry studies are needed to assess long-term outcomes, noted Dr. Messé and colleagues. “It remains unclear whether closure provides a similar benefit in these patients who otherwise still fit the studies’ inclusion criteria,” the authors said. “Long-term and large-scale safety registries for patients who have received PFO closure are needed to assess the risk of device erosion, fracture, embolization, and thrombotic and endocarditis risks, and the effect of residual shunts and incidence of atrial fibrillation.”

About 25% of the general adult population has a PFO. “It’s important to note that having a PFO is common, and that most people with PFO will never know they have it because it usually does not cause any problems,” Dr. Messé said. “However, while there is generally a very low risk of stroke in patients with PFO, in younger people who have had a stroke without any other possible causes identified, closing the PFO may reduce the risk of having another stroke better than medication alone.”

The practice advisory was developed with financial support from the AAN. Dr. Messé and most of the authors had no relevant conflicts of interest. Several authors disclosed ties to medical device and pharmaceutical companies.

[email protected]

SOURCE: Messé SR et al. Neurology. 2020 Apr 29. doi: 10.1212/WNL.0000000000009443.

Nonalcoholic fatty liver disease isn’t being diagnosed early enough; by the time it’s caught, patients often have advanced complications such as decompensated cirrhosis or hepatocellular carcinoma, according a review of Medicare claims data from 2007-2015.

Among 10,826,456 enrollees – about 20% of the Medicare population – 621,253 had International Classification of Diseases codes for NAFLD/nonalcoholic steatohepatitis (NASH), yielding a prevalence of 5.7%. That’s substantially lower than modeling estimates of 30% in the general population, indicating that there is “considerable underdiagnosis of NAFLD in real-world clinical practice,” and that less severe disease, and the opportunity to treat it before it progresses, is being missed, said investigators led by Rohit Loomba, MD, director of the NAFLD Research Center at the University of California, San Diego, NAFLD Research Center (Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679).

When the team excluded patients with other causes of liver disease such as alcohol abuse or viral hepatitis, they were left with a study population of 260,950 subjects; 71.1% had NAFLD/NASH alone, and 28.9% had NAFLD cirrhosis, almost all of them first diagnosed with decompensated cirrhosis. More than half of the 581 hepatocellular carcinoma patients had no previous diagnosis of cirrhosis.

The cumulative risk of progression of NAFLD to cirrhosis over the 8-year study period was 39%, and from compensated cirrhosis to decompensated cirrhosis, it was 45%. Among a subgroup of 258 patients with compensated cirrhosis, 19% progressed to decompensated cirrhosis or hepatocellular carcinoma, or died, over a median of a year and a half.

The findings “highlight the urgent need for an algorithm to identify individuals at higher risk of NAFLD/NASH,” so the disease is caught at a point when lifestyle and medical interventions might halt or delay progression, the team said.

Screening isn’t currently recommended in guidelines because of the limited efficacy of current treatments, but “with promising novel NAFLD/NASH interventions currently under development and review,” the team said it might be time to rethink the issue.

The majority of patients with early NAFLD/NASH have nonspecific symptoms, which makes screening difficult. However, the investigators identified several independent predictors of disease progression and death, including cardiovascular disease – present among 68.7% of subjects – dyslipidemia (84.1%), diabetes (55.5%), and renal impairment (24.3%).

The finding “supports the evaluation of certain variables” in a screening algorithm, “including advanced age and certain components of metabolic syndrome. Furthermore, important variables in previously developed noninvasive NAFLD/NASH staging algorithms including body mass index and biomarkers for liver function and insulin resistance may also warrant evaluation as components of an identification algorithm,” the team said.

It’s possible the study overestimated the risks of disease progression and mortality with NAFLD/NASH because patients with more severe disease were probably more likely to have been identified in Medicare data, the investigators said.

The mean age of the NAFLD/NASH subjects was 67.4 years, and 60% were women.

The work was funded by Gilead, which has several drugs under development for NAFLD/NASH. Two authors are Gilead employees, and the rest, including Dr. Loomba, reported funding and other ties to the company.

To help your patients better understand NASH, visit the AGA GI Patient Center at https://www.gastro.org/practice-guidance/gi-patient-center/topic/nonalcoholic-steatohepatitis-nash.

[email protected]

SOURCE: Loomba R et al. Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679.

Nonalcoholic fatty liver disease isn’t being diagnosed early enough; by the time it’s caught, patients often have advanced complications such as decompensated cirrhosis or hepatocellular carcinoma, according a review of Medicare claims data from 2007-2015.

Among 10,826,456 enrollees – about 20% of the Medicare population – 621,253 had International Classification of Diseases codes for NAFLD/nonalcoholic steatohepatitis (NASH), yielding a prevalence of 5.7%. That’s substantially lower than modeling estimates of 30% in the general population, indicating that there is “considerable underdiagnosis of NAFLD in real-world clinical practice,” and that less severe disease, and the opportunity to treat it before it progresses, is being missed, said investigators led by Rohit Loomba, MD, director of the NAFLD Research Center at the University of California, San Diego, NAFLD Research Center (Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679).

When the team excluded patients with other causes of liver disease such as alcohol abuse or viral hepatitis, they were left with a study population of 260,950 subjects; 71.1% had NAFLD/NASH alone, and 28.9% had NAFLD cirrhosis, almost all of them first diagnosed with decompensated cirrhosis. More than half of the 581 hepatocellular carcinoma patients had no previous diagnosis of cirrhosis.

The cumulative risk of progression of NAFLD to cirrhosis over the 8-year study period was 39%, and from compensated cirrhosis to decompensated cirrhosis, it was 45%. Among a subgroup of 258 patients with compensated cirrhosis, 19% progressed to decompensated cirrhosis or hepatocellular carcinoma, or died, over a median of a year and a half.

The findings “highlight the urgent need for an algorithm to identify individuals at higher risk of NAFLD/NASH,” so the disease is caught at a point when lifestyle and medical interventions might halt or delay progression, the team said.

Screening isn’t currently recommended in guidelines because of the limited efficacy of current treatments, but “with promising novel NAFLD/NASH interventions currently under development and review,” the team said it might be time to rethink the issue.

The majority of patients with early NAFLD/NASH have nonspecific symptoms, which makes screening difficult. However, the investigators identified several independent predictors of disease progression and death, including cardiovascular disease – present among 68.7% of subjects – dyslipidemia (84.1%), diabetes (55.5%), and renal impairment (24.3%).

The finding “supports the evaluation of certain variables” in a screening algorithm, “including advanced age and certain components of metabolic syndrome. Furthermore, important variables in previously developed noninvasive NAFLD/NASH staging algorithms including body mass index and biomarkers for liver function and insulin resistance may also warrant evaluation as components of an identification algorithm,” the team said.

It’s possible the study overestimated the risks of disease progression and mortality with NAFLD/NASH because patients with more severe disease were probably more likely to have been identified in Medicare data, the investigators said.

The mean age of the NAFLD/NASH subjects was 67.4 years, and 60% were women.

The work was funded by Gilead, which has several drugs under development for NAFLD/NASH. Two authors are Gilead employees, and the rest, including Dr. Loomba, reported funding and other ties to the company.

To help your patients better understand NASH, visit the AGA GI Patient Center at https://www.gastro.org/practice-guidance/gi-patient-center/topic/nonalcoholic-steatohepatitis-nash.

[email protected]

SOURCE: Loomba R et al. Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679.

Nonalcoholic fatty liver disease isn’t being diagnosed early enough; by the time it’s caught, patients often have advanced complications such as decompensated cirrhosis or hepatocellular carcinoma, according a review of Medicare claims data from 2007-2015.

Among 10,826,456 enrollees – about 20% of the Medicare population – 621,253 had International Classification of Diseases codes for NAFLD/nonalcoholic steatohepatitis (NASH), yielding a prevalence of 5.7%. That’s substantially lower than modeling estimates of 30% in the general population, indicating that there is “considerable underdiagnosis of NAFLD in real-world clinical practice,” and that less severe disease, and the opportunity to treat it before it progresses, is being missed, said investigators led by Rohit Loomba, MD, director of the NAFLD Research Center at the University of California, San Diego, NAFLD Research Center (Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679).

When the team excluded patients with other causes of liver disease such as alcohol abuse or viral hepatitis, they were left with a study population of 260,950 subjects; 71.1% had NAFLD/NASH alone, and 28.9% had NAFLD cirrhosis, almost all of them first diagnosed with decompensated cirrhosis. More than half of the 581 hepatocellular carcinoma patients had no previous diagnosis of cirrhosis.

The cumulative risk of progression of NAFLD to cirrhosis over the 8-year study period was 39%, and from compensated cirrhosis to decompensated cirrhosis, it was 45%. Among a subgroup of 258 patients with compensated cirrhosis, 19% progressed to decompensated cirrhosis or hepatocellular carcinoma, or died, over a median of a year and a half.

The findings “highlight the urgent need for an algorithm to identify individuals at higher risk of NAFLD/NASH,” so the disease is caught at a point when lifestyle and medical interventions might halt or delay progression, the team said.

Screening isn’t currently recommended in guidelines because of the limited efficacy of current treatments, but “with promising novel NAFLD/NASH interventions currently under development and review,” the team said it might be time to rethink the issue.

The majority of patients with early NAFLD/NASH have nonspecific symptoms, which makes screening difficult. However, the investigators identified several independent predictors of disease progression and death, including cardiovascular disease – present among 68.7% of subjects – dyslipidemia (84.1%), diabetes (55.5%), and renal impairment (24.3%).

The finding “supports the evaluation of certain variables” in a screening algorithm, “including advanced age and certain components of metabolic syndrome. Furthermore, important variables in previously developed noninvasive NAFLD/NASH staging algorithms including body mass index and biomarkers for liver function and insulin resistance may also warrant evaluation as components of an identification algorithm,” the team said.

It’s possible the study overestimated the risks of disease progression and mortality with NAFLD/NASH because patients with more severe disease were probably more likely to have been identified in Medicare data, the investigators said.

The mean age of the NAFLD/NASH subjects was 67.4 years, and 60% were women.

The work was funded by Gilead, which has several drugs under development for NAFLD/NASH. Two authors are Gilead employees, and the rest, including Dr. Loomba, reported funding and other ties to the company.

To help your patients better understand NASH, visit the AGA GI Patient Center at https://www.gastro.org/practice-guidance/gi-patient-center/topic/nonalcoholic-steatohepatitis-nash.

[email protected]

SOURCE: Loomba R et al. Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679.

Nonalcoholic fatty liver disease isn’t being diagnosed early enough; by the time it’s caught, patients often have advanced complications such as decompensated cirrhosis or hepatocellular carcinoma, according a review of Medicare claims data from 2007-2015.

Among 10,826,456 enrollees – about 20% of the Medicare population – 621,253 had International Classification of Diseases codes for NAFLD/nonalcoholic steatohepatitis (NASH), yielding a prevalence of 5.7%. That’s substantially lower than modeling estimates of 30% in the general population, indicating that there is “considerable underdiagnosis of NAFLD in real-world clinical practice,” and that less severe disease, and the opportunity to treat it before it progresses, is being missed, said investigators led by Rohit Loomba, MD, director of the NAFLD Research Center at the University of California, San Diego, NAFLD Research Center (Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679).

When the team excluded patients with other causes of liver disease such as alcohol abuse or viral hepatitis, they were left with a study population of 260,950 subjects; 71.1% had NAFLD/NASH alone, and 28.9% had NAFLD cirrhosis, almost all of them first diagnosed with decompensated cirrhosis. More than half of the 581 hepatocellular carcinoma patients had no previous diagnosis of cirrhosis.

The cumulative risk of progression of NAFLD to cirrhosis over the 8-year study period was 39%, and from compensated cirrhosis to decompensated cirrhosis, it was 45%. Among a subgroup of 258 patients with compensated cirrhosis, 19% progressed to decompensated cirrhosis or hepatocellular carcinoma, or died, over a median of a year and a half.

The findings “highlight the urgent need for an algorithm to identify individuals at higher risk of NAFLD/NASH,” so the disease is caught at a point when lifestyle and medical interventions might halt or delay progression, the team said.

Screening isn’t currently recommended in guidelines because of the limited efficacy of current treatments, but “with promising novel NAFLD/NASH interventions currently under development and review,” the team said it might be time to rethink the issue.

The majority of patients with early NAFLD/NASH have nonspecific symptoms, which makes screening difficult. However, the investigators identified several independent predictors of disease progression and death, including cardiovascular disease – present among 68.7% of subjects – dyslipidemia (84.1%), diabetes (55.5%), and renal impairment (24.3%).

The finding “supports the evaluation of certain variables” in a screening algorithm, “including advanced age and certain components of metabolic syndrome. Furthermore, important variables in previously developed noninvasive NAFLD/NASH staging algorithms including body mass index and biomarkers for liver function and insulin resistance may also warrant evaluation as components of an identification algorithm,” the team said.

It’s possible the study overestimated the risks of disease progression and mortality with NAFLD/NASH because patients with more severe disease were probably more likely to have been identified in Medicare data, the investigators said.

The mean age of the NAFLD/NASH subjects was 67.4 years, and 60% were women.

The work was funded by Gilead, which has several drugs under development for NAFLD/NASH. Two authors are Gilead employees, and the rest, including Dr. Loomba, reported funding and other ties to the company.

[email protected]

SOURCE: Loomba R et al. Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679.

Nonalcoholic fatty liver disease isn’t being diagnosed early enough; by the time it’s caught, patients often have advanced complications such as decompensated cirrhosis or hepatocellular carcinoma, according a review of Medicare claims data from 2007-2015.

Among 10,826,456 enrollees – about 20% of the Medicare population – 621,253 had International Classification of Diseases codes for NAFLD/nonalcoholic steatohepatitis (NASH), yielding a prevalence of 5.7%. That’s substantially lower than modeling estimates of 30% in the general population, indicating that there is “considerable underdiagnosis of NAFLD in real-world clinical practice,” and that less severe disease, and the opportunity to treat it before it progresses, is being missed, said investigators led by Rohit Loomba, MD, director of the NAFLD Research Center at the University of California, San Diego, NAFLD Research Center (Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679).

When the team excluded patients with other causes of liver disease such as alcohol abuse or viral hepatitis, they were left with a study population of 260,950 subjects; 71.1% had NAFLD/NASH alone, and 28.9% had NAFLD cirrhosis, almost all of them first diagnosed with decompensated cirrhosis. More than half of the 581 hepatocellular carcinoma patients had no previous diagnosis of cirrhosis.

The cumulative risk of progression of NAFLD to cirrhosis over the 8-year study period was 39%, and from compensated cirrhosis to decompensated cirrhosis, it was 45%. Among a subgroup of 258 patients with compensated cirrhosis, 19% progressed to decompensated cirrhosis or hepatocellular carcinoma, or died, over a median of a year and a half.

The findings “highlight the urgent need for an algorithm to identify individuals at higher risk of NAFLD/NASH,” so the disease is caught at a point when lifestyle and medical interventions might halt or delay progression, the team said.

Screening isn’t currently recommended in guidelines because of the limited efficacy of current treatments, but “with promising novel NAFLD/NASH interventions currently under development and review,” the team said it might be time to rethink the issue.

The majority of patients with early NAFLD/NASH have nonspecific symptoms, which makes screening difficult. However, the investigators identified several independent predictors of disease progression and death, including cardiovascular disease – present among 68.7% of subjects – dyslipidemia (84.1%), diabetes (55.5%), and renal impairment (24.3%).

The finding “supports the evaluation of certain variables” in a screening algorithm, “including advanced age and certain components of metabolic syndrome. Furthermore, important variables in previously developed noninvasive NAFLD/NASH staging algorithms including body mass index and biomarkers for liver function and insulin resistance may also warrant evaluation as components of an identification algorithm,” the team said.

It’s possible the study overestimated the risks of disease progression and mortality with NAFLD/NASH because patients with more severe disease were probably more likely to have been identified in Medicare data, the investigators said.

The mean age of the NAFLD/NASH subjects was 67.4 years, and 60% were women.

The work was funded by Gilead, which has several drugs under development for NAFLD/NASH. Two authors are Gilead employees, and the rest, including Dr. Loomba, reported funding and other ties to the company.

[email protected]

SOURCE: Loomba R et al. Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679.

Nonalcoholic fatty liver disease isn’t being diagnosed early enough; by the time it’s caught, patients often have advanced complications such as decompensated cirrhosis or hepatocellular carcinoma, according a review of Medicare claims data from 2007-2015.

Among 10,826,456 enrollees – about 20% of the Medicare population – 621,253 had International Classification of Diseases codes for NAFLD/nonalcoholic steatohepatitis (NASH), yielding a prevalence of 5.7%. That’s substantially lower than modeling estimates of 30% in the general population, indicating that there is “considerable underdiagnosis of NAFLD in real-world clinical practice,” and that less severe disease, and the opportunity to treat it before it progresses, is being missed, said investigators led by Rohit Loomba, MD, director of the NAFLD Research Center at the University of California, San Diego, NAFLD Research Center (Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679).

When the team excluded patients with other causes of liver disease such as alcohol abuse or viral hepatitis, they were left with a study population of 260,950 subjects; 71.1% had NAFLD/NASH alone, and 28.9% had NAFLD cirrhosis, almost all of them first diagnosed with decompensated cirrhosis. More than half of the 581 hepatocellular carcinoma patients had no previous diagnosis of cirrhosis.

The cumulative risk of progression of NAFLD to cirrhosis over the 8-year study period was 39%, and from compensated cirrhosis to decompensated cirrhosis, it was 45%. Among a subgroup of 258 patients with compensated cirrhosis, 19% progressed to decompensated cirrhosis or hepatocellular carcinoma, or died, over a median of a year and a half.

The findings “highlight the urgent need for an algorithm to identify individuals at higher risk of NAFLD/NASH,” so the disease is caught at a point when lifestyle and medical interventions might halt or delay progression, the team said.

Screening isn’t currently recommended in guidelines because of the limited efficacy of current treatments, but “with promising novel NAFLD/NASH interventions currently under development and review,” the team said it might be time to rethink the issue.

The majority of patients with early NAFLD/NASH have nonspecific symptoms, which makes screening difficult. However, the investigators identified several independent predictors of disease progression and death, including cardiovascular disease – present among 68.7% of subjects – dyslipidemia (84.1%), diabetes (55.5%), and renal impairment (24.3%).

The finding “supports the evaluation of certain variables” in a screening algorithm, “including advanced age and certain components of metabolic syndrome. Furthermore, important variables in previously developed noninvasive NAFLD/NASH staging algorithms including body mass index and biomarkers for liver function and insulin resistance may also warrant evaluation as components of an identification algorithm,” the team said.

It’s possible the study overestimated the risks of disease progression and mortality with NAFLD/NASH because patients with more severe disease were probably more likely to have been identified in Medicare data, the investigators said.

The mean age of the NAFLD/NASH subjects was 67.4 years, and 60% were women.

The work was funded by Gilead, which has several drugs under development for NAFLD/NASH. Two authors are Gilead employees, and the rest, including Dr. Loomba, reported funding and other ties to the company.

[email protected]

SOURCE: Loomba R et al. Aliment Pharmacol Ther. 2020 May 5. doi: 10.1111/apt.15679.

Many planned randomized trials to test the efficacy of hydroxychloroquine or related drugs for preventing COVID-19 infection have, as of the end of April 2020, failed to include ECG assessment to either exclude people at the highest risk for possibly developing a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment, according to an analysis of the posted designs of several dozen studies.

“It is not only inexplicable, but also inexcusable that clinical investigators would dare to include healthy individuals in a clinical trial involving QT-prolonging medications without bothering to screen their electrocardiogram,” commented Sami Viskin, MD, an electrophysiologist at Tel Aviv Sourasky Medical Center. “The fact that we needed Dr. Gollob to ring this alarm is, itself, shocking,” he said in an interview.

“ECG screening is a good option to minimize the risk. You don’t eliminate the risk, but you can minimize it,” commented Arthur Wilde, MD, a cardiac electrophysiologist and professor of medicine at the Academic Medical Center in Amsterdam. Both Dr. Viskin and Dr. Wilde agreed with the QTc interval thresholds Dr. Gollob recommended using for excluding or discontinuing study participants.

In his commentary, Dr. Gollob estimated that if 85,000 otherwise healthy adults were randomized to received a drug that can increase the QTc interval, as many as about 3,400 people (4%) in the group could statistically be expected to have an especially high vulnerability to QT prolongation because of genetic variants they might carry that collectively have roughly this prevalence. In some people of African heritage, the prevalence of genetic risk for excessive QTc lengthening can be even higher, approaching about 10%, noted Dr. Wilde.

Dr. Gollob hoped the concerns he raised will prompt the organizers of many of these studies to revise their design, and he said he already knew of one study based in Toronto that recently added an ECG-monitoring strategy in response to the concerns he raised. He expressed optimism that more studies will follow.

“It’s a real issue to have these trials designed without ECG exclusions or monitoring. I’m glad that Dr. Gollob sent this warning, because he is right. ECG monitoring during treatment is important so you can stop the treatment in time,” Dr. Wilde said. Dr. Wilde also noted that many, if not most, of the studies listed on clinicaltrials.gov may not actually launch.

In April, representatives from several cardiology societies coauthored a document of considerations when using hydroxychloroquine, chloroquine, or azithromycin to treat patients with a diagnosed COVID-19 infection, and highlighted a QTc interval of 500 msec or greater as flagging patients who should no longer receive these drugs (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). For patients who do not yet have COVID-19 disease and the goal from treatment is prevention the potential efficacy of these drugs is reasonable to explore, but “does not exclude the need to minimize risk to research participants, especially when enrolling healthy subjects,” Dr. Gollob said.

Dr. Gollob, Dr. Viskin, and Dr. Wilde had no relevant financial disclosures.

[email protected]

Many planned randomized trials to test the efficacy of hydroxychloroquine or related drugs for preventing COVID-19 infection have, as of the end of April 2020, failed to include ECG assessment to either exclude people at the highest risk for possibly developing a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment, according to an analysis of the posted designs of several dozen studies.

“It is not only inexplicable, but also inexcusable that clinical investigators would dare to include healthy individuals in a clinical trial involving QT-prolonging medications without bothering to screen their electrocardiogram,” commented Sami Viskin, MD, an electrophysiologist at Tel Aviv Sourasky Medical Center. “The fact that we needed Dr. Gollob to ring this alarm is, itself, shocking,” he said in an interview.

“ECG screening is a good option to minimize the risk. You don’t eliminate the risk, but you can minimize it,” commented Arthur Wilde, MD, a cardiac electrophysiologist and professor of medicine at the Academic Medical Center in Amsterdam. Both Dr. Viskin and Dr. Wilde agreed with the QTc interval thresholds Dr. Gollob recommended using for excluding or discontinuing study participants.

In his commentary, Dr. Gollob estimated that if 85,000 otherwise healthy adults were randomized to received a drug that can increase the QTc interval, as many as about 3,400 people (4%) in the group could statistically be expected to have an especially high vulnerability to QT prolongation because of genetic variants they might carry that collectively have roughly this prevalence. In some people of African heritage, the prevalence of genetic risk for excessive QTc lengthening can be even higher, approaching about 10%, noted Dr. Wilde.

Dr. Gollob hoped the concerns he raised will prompt the organizers of many of these studies to revise their design, and he said he already knew of one study based in Toronto that recently added an ECG-monitoring strategy in response to the concerns he raised. He expressed optimism that more studies will follow.

“It’s a real issue to have these trials designed without ECG exclusions or monitoring. I’m glad that Dr. Gollob sent this warning, because he is right. ECG monitoring during treatment is important so you can stop the treatment in time,” Dr. Wilde said. Dr. Wilde also noted that many, if not most, of the studies listed on clinicaltrials.gov may not actually launch.

In April, representatives from several cardiology societies coauthored a document of considerations when using hydroxychloroquine, chloroquine, or azithromycin to treat patients with a diagnosed COVID-19 infection, and highlighted a QTc interval of 500 msec or greater as flagging patients who should no longer receive these drugs (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). For patients who do not yet have COVID-19 disease and the goal from treatment is prevention the potential efficacy of these drugs is reasonable to explore, but “does not exclude the need to minimize risk to research participants, especially when enrolling healthy subjects,” Dr. Gollob said.

Dr. Gollob, Dr. Viskin, and Dr. Wilde had no relevant financial disclosures.

[email protected]

Many planned randomized trials to test the efficacy of hydroxychloroquine or related drugs for preventing COVID-19 infection have, as of the end of April 2020, failed to include ECG assessment to either exclude people at the highest risk for possibly developing a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment, according to an analysis of the posted designs of several dozen studies.

“It is not only inexplicable, but also inexcusable that clinical investigators would dare to include healthy individuals in a clinical trial involving QT-prolonging medications without bothering to screen their electrocardiogram,” commented Sami Viskin, MD, an electrophysiologist at Tel Aviv Sourasky Medical Center. “The fact that we needed Dr. Gollob to ring this alarm is, itself, shocking,” he said in an interview.

“ECG screening is a good option to minimize the risk. You don’t eliminate the risk, but you can minimize it,” commented Arthur Wilde, MD, a cardiac electrophysiologist and professor of medicine at the Academic Medical Center in Amsterdam. Both Dr. Viskin and Dr. Wilde agreed with the QTc interval thresholds Dr. Gollob recommended using for excluding or discontinuing study participants.

In his commentary, Dr. Gollob estimated that if 85,000 otherwise healthy adults were randomized to received a drug that can increase the QTc interval, as many as about 3,400 people (4%) in the group could statistically be expected to have an especially high vulnerability to QT prolongation because of genetic variants they might carry that collectively have roughly this prevalence. In some people of African heritage, the prevalence of genetic risk for excessive QTc lengthening can be even higher, approaching about 10%, noted Dr. Wilde.

Dr. Gollob hoped the concerns he raised will prompt the organizers of many of these studies to revise their design, and he said he already knew of one study based in Toronto that recently added an ECG-monitoring strategy in response to the concerns he raised. He expressed optimism that more studies will follow.

“It’s a real issue to have these trials designed without ECG exclusions or monitoring. I’m glad that Dr. Gollob sent this warning, because he is right. ECG monitoring during treatment is important so you can stop the treatment in time,” Dr. Wilde said. Dr. Wilde also noted that many, if not most, of the studies listed on clinicaltrials.gov may not actually launch.

In April, representatives from several cardiology societies coauthored a document of considerations when using hydroxychloroquine, chloroquine, or azithromycin to treat patients with a diagnosed COVID-19 infection, and highlighted a QTc interval of 500 msec or greater as flagging patients who should no longer receive these drugs (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). For patients who do not yet have COVID-19 disease and the goal from treatment is prevention the potential efficacy of these drugs is reasonable to explore, but “does not exclude the need to minimize risk to research participants, especially when enrolling healthy subjects,” Dr. Gollob said.

Dr. Gollob, Dr. Viskin, and Dr. Wilde had no relevant financial disclosures.

[email protected]

On Jan. 20, 2020, the first confirmed case of the 2019 novel coronavirus in the United States was admitted to Providence Regional Medical Center in Everett, Wash. Less than 3 months later, the COVID-19 pandemic has put enormous stress on the U.S. health care system, which is confronting acute resource shortage because of the surge of acute and critically ill patients, health care provider safety and burnout, and an ongoing need for managing vulnerable populations while minimizing the infection spread.

With the onset of these unprecedented challenges, telehealth has emerged as a powerful new resource for health care providers, hospitals, and health care systems across the country. This article offers a summary of government regulations that enabled telehealth expansion, and provides an overview of how two health care organizations, Providence St. Joseph Health and Sound Physicians, are employing telehealth services to combat the COVID-19 health care crisis.

The government response: Telehealth expansion

In response to the pandemic, the Centers for Medicare and Medicaid Services (CMS) have significantly increased access to telehealth services for Medicare and Medicaid beneficiaries. CMS swiftly put measures in place such as:

• Expanding telehealth beyond rural areas.
• Adding 80 services that can be provided in all settings, including patient homes
• Allowing providers to bill for telehealth visits at the same rate as in-person visits.

The U.S. Department of Health and Human Services also aided this effort by:

• Waiving requirements that physicians or other health care professionals must have licenses in the state in which they provide services, if they have an equivalent license from another state.
• Waving penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype

Without prior regulatory and reimbursement restrictions, telehealth rapidly became a powerful tool in helping to solve some of the problems brought about by the COVID-19 pandemic.

Providence Telehealth for COVID-19

Providence St. Joseph Health is a not-for-profit health care system operating 51 hospitals and 1,085 clinics across Alaska, California, Montana, New Mexico, Oregon, Texas, and Washington. Providence has developed an enterprise telemedicine network with more than 100 virtual programs. Several of these services – including Telestroke, Telepsychiatry, TeleICU, and Telehospitalist – have been scaled across several states as a clinical cloud. More than 400 telemedicine endpoints are deployed, such as robotic carts and fixed InTouch TVs. In fact, the first U.S. COVID-19 patient was treated at Providence Regional Medical Center in Everett, Wash., using the telemedical robot Vici from InTouch Health.

According to Todd Czartoski, MD, chief medical technology officer at Providence, “while telehealth has been around for many years, COVID-19 opened a lot of people’s eyes to the value of virtual care delivery.”

Providence’s telehealth response to COVID-19 has encompassed five main areas: COVID-19 home care, COVID-19 acute care, ambulatory virtual visits, behavioral health concierge (BHC) expansion, and additional support for outside partnerships.

COVID-19 Home Care

Providence rapidly deployed home monitoring for nearly 2,000 positive or presumptive COVID-19 patients. Those symptomatic, clinically stable patients are given a thermometer and a pulse oximeter, and are monitored from home by a central team of nurses and physicians using the Xealth and Twistle programs.

Providence is evaluating expansion of home monitoring to other diagnoses, including higher acuity conditions.

COVID-19 Acute Care

TeleTriage expedites the triage of suspected COVID-19 patients and reduces the use of personal protective equipment (PPE) by 50% per patient per day. To date, TeleTriage has resulted in the conservation of more than 90,000 PPE units.

TeleHospitalist services expanded from traditional night coverage to caring for patients in COVID-19 units around the clock. Currently, there are 25 telehospitalists who practice both in-person and virtual medicine.

TeleICU offers remote management of more than 180 ICU beds across 17 hospitals from two central command centers in Washington state and Alaska. The services include night-time intensivist and ICU nurse coverage, including medication and ventilator management, and family conferences. COVID-19 increased the demand for TeleICU, with anticipated expansion to more than 300 beds.

Core TeleSpecialty services include TeleStroke and TelePsychiatry across 135 remote sites.

Ambulatory Virtual Visits

Providence launched the COVID-19 hub microsite to help educate patients by providing accurate and timely information. A chatbot named Grace helps screen patients who are worried about COVID-19. Grace also suggests next steps, such as a video visit with a patient’s primary care provider or a visit using Express Care/Virtual team, a direct-to-consumer service available to patients within and outside of the health care system.

In less than 2 weeks, Providence enabled virtual visits for more than 7,000 outpatient providers, with more than 14,000 alternative visits now occurring daily. This has allowed primary and specialty providers to continue to manage their patient panels remotely. The number of Express Care/Virtual visits increased from 60 to more than 1,000 per day.

BHC Expansion

In the effort to improve care for its caregivers, Providence launched a behavioral health concierge (BHC) service that offers employees and their dependents virtual access to licensed mental health professionals. Over the last half of 2019, BHC provided more than 1,000 phone and virtual visits, depending on the individual preference of patients. Notably, 21% percent of users were physicians; 65% of users were seen the same day and 100% of users were seen within 48 hours.

COVID-19 increased demand for services that initially started in Seattle and rapidly expanded to Montana, Oregon, and California.

Outside Partnerships

Providence has established partnerships with outside facilities by providing services to 135 sites across eight states. COVID-19 accelerated the employment of new services, including TeleICU.
 

Telemedicine at Sound Physicians

Sound Physicians is a national physician-founded and -led organization that provides emergency medicine, critical care, hospital medicine, population health, and physician advisory services. Five years ago, Sound launched a telemedicine service line. I spoke with Brian Carpenter, MD, national medical director for TeleHospitalist Services at Sound, to learn about his experience implementing Telehospitalist programs across 22 hospitals and 22 skilled nursing facilities.

Prior to COVID-19, Sound offered a spectrum of telemedicine services including night-time telephonic cross coverage, as well as video-assisted admissions, transfers, and rapid responses. In 2019, Sound Telehospitalists received 88,000 connect requests, including 6,400 video-assisted new admissions and 82 rapid responses. Typically, one physician covers four to eight hospitals with back-up available for surges. The team uses a predictive model for staffing and developed an acuity-based algorithm to ensure that patients in distress are evaluated immediately, new stable admissions on average are seen within 12 minutes, and order clarifications are provided within 30 minutes.

The COVID-19 pandemic created an urgent demand for providers to support an overwhelmed health care system. Without the traditional barriers to implementation – such as lack of acceptance by medical staff, nurses and patients, strict state licensing and technology requirements, lack of reimbursement, and delays in hospital credentialing – Sound was able to develop a rapid implementation model for telemedicine services. Currently, four new hospitals are in the active implementation phase, with 40 more hospitals in the pipeline.

Implementing a telemedicine program at your hospital

In order to successfully launch a telemedicine program, Dr. Carpenter outlined the following critical implementation steps:

• In collaboration with local leadership, define the problem you are trying to solve, which helps inform the scope of the telemedicine practice and technology requirements (for example, night-time cross-coverage vs. full telemedicine service).
• Complete a discovery process (for example, existing workflow for patient admission and transfer) with the end-goal of developing a workflow and rules of engagement.
• Obtain hospital credentialing/privileges and EMR access.
• Train end-users, including physicians and nurse telepresenters.

Dr. Carpenter offered this advice to those considering a telemedicine program: “Telemedicine is not just about technology; a true telemedicine program encompasses change management, workflow development, end-user training, compliance, and mechanisms for continuous process improvement. We want to make things better for the physicians, nurses, and patients.”

Telehealth is offering support to health care providers on the front lines, patients in need of care, and health care systems managing the unprecedented surges in volume.
 

Dr. Farah is a hospitalist, physician adviser, and Lean Six Sigma Black Belt. She is a performance improvement consultant based in Corvallis, Ore., and a member of The Hospitalist’s editorial advisory board.

On Jan. 20, 2020, the first confirmed case of the 2019 novel coronavirus in the United States was admitted to Providence Regional Medical Center in Everett, Wash. Less than 3 months later, the COVID-19 pandemic has put enormous stress on the U.S. health care system, which is confronting acute resource shortage because of the surge of acute and critically ill patients, health care provider safety and burnout, and an ongoing need for managing vulnerable populations while minimizing the infection spread.

With the onset of these unprecedented challenges, telehealth has emerged as a powerful new resource for health care providers, hospitals, and health care systems across the country. This article offers a summary of government regulations that enabled telehealth expansion, and provides an overview of how two health care organizations, Providence St. Joseph Health and Sound Physicians, are employing telehealth services to combat the COVID-19 health care crisis.

The government response: Telehealth expansion

In response to the pandemic, the Centers for Medicare and Medicaid Services (CMS) have significantly increased access to telehealth services for Medicare and Medicaid beneficiaries. CMS swiftly put measures in place such as:

• Expanding telehealth beyond rural areas.
• Adding 80 services that can be provided in all settings, including patient homes
• Allowing providers to bill for telehealth visits at the same rate as in-person visits.

The U.S. Department of Health and Human Services also aided this effort by:

• Waiving requirements that physicians or other health care professionals must have licenses in the state in which they provide services, if they have an equivalent license from another state.
• Waving penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype

Without prior regulatory and reimbursement restrictions, telehealth rapidly became a powerful tool in helping to solve some of the problems brought about by the COVID-19 pandemic.

Providence Telehealth for COVID-19

Providence St. Joseph Health is a not-for-profit health care system operating 51 hospitals and 1,085 clinics across Alaska, California, Montana, New Mexico, Oregon, Texas, and Washington. Providence has developed an enterprise telemedicine network with more than 100 virtual programs. Several of these services – including Telestroke, Telepsychiatry, TeleICU, and Telehospitalist – have been scaled across several states as a clinical cloud. More than 400 telemedicine endpoints are deployed, such as robotic carts and fixed InTouch TVs. In fact, the first U.S. COVID-19 patient was treated at Providence Regional Medical Center in Everett, Wash., using the telemedical robot Vici from InTouch Health.

According to Todd Czartoski, MD, chief medical technology officer at Providence, “while telehealth has been around for many years, COVID-19 opened a lot of people’s eyes to the value of virtual care delivery.”

Providence’s telehealth response to COVID-19 has encompassed five main areas: COVID-19 home care, COVID-19 acute care, ambulatory virtual visits, behavioral health concierge (BHC) expansion, and additional support for outside partnerships.

COVID-19 Home Care

Providence rapidly deployed home monitoring for nearly 2,000 positive or presumptive COVID-19 patients. Those symptomatic, clinically stable patients are given a thermometer and a pulse oximeter, and are monitored from home by a central team of nurses and physicians using the Xealth and Twistle programs.

Providence is evaluating expansion of home monitoring to other diagnoses, including higher acuity conditions.

COVID-19 Acute Care

TeleTriage expedites the triage of suspected COVID-19 patients and reduces the use of personal protective equipment (PPE) by 50% per patient per day. To date, TeleTriage has resulted in the conservation of more than 90,000 PPE units.

TeleHospitalist services expanded from traditional night coverage to caring for patients in COVID-19 units around the clock. Currently, there are 25 telehospitalists who practice both in-person and virtual medicine.

TeleICU offers remote management of more than 180 ICU beds across 17 hospitals from two central command centers in Washington state and Alaska. The services include night-time intensivist and ICU nurse coverage, including medication and ventilator management, and family conferences. COVID-19 increased the demand for TeleICU, with anticipated expansion to more than 300 beds.

Core TeleSpecialty services include TeleStroke and TelePsychiatry across 135 remote sites.

Ambulatory Virtual Visits

Providence launched the COVID-19 hub microsite to help educate patients by providing accurate and timely information. A chatbot named Grace helps screen patients who are worried about COVID-19. Grace also suggests next steps, such as a video visit with a patient’s primary care provider or a visit using Express Care/Virtual team, a direct-to-consumer service available to patients within and outside of the health care system.

In less than 2 weeks, Providence enabled virtual visits for more than 7,000 outpatient providers, with more than 14,000 alternative visits now occurring daily. This has allowed primary and specialty providers to continue to manage their patient panels remotely. The number of Express Care/Virtual visits increased from 60 to more than 1,000 per day.

BHC Expansion

In the effort to improve care for its caregivers, Providence launched a behavioral health concierge (BHC) service that offers employees and their dependents virtual access to licensed mental health professionals. Over the last half of 2019, BHC provided more than 1,000 phone and virtual visits, depending on the individual preference of patients. Notably, 21% percent of users were physicians; 65% of users were seen the same day and 100% of users were seen within 48 hours.

COVID-19 increased demand for services that initially started in Seattle and rapidly expanded to Montana, Oregon, and California.

Outside Partnerships

Providence has established partnerships with outside facilities by providing services to 135 sites across eight states. COVID-19 accelerated the employment of new services, including TeleICU.
 

Telemedicine at Sound Physicians

Sound Physicians is a national physician-founded and -led organization that provides emergency medicine, critical care, hospital medicine, population health, and physician advisory services. Five years ago, Sound launched a telemedicine service line. I spoke with Brian Carpenter, MD, national medical director for TeleHospitalist Services at Sound, to learn about his experience implementing Telehospitalist programs across 22 hospitals and 22 skilled nursing facilities.

Prior to COVID-19, Sound offered a spectrum of telemedicine services including night-time telephonic cross coverage, as well as video-assisted admissions, transfers, and rapid responses. In 2019, Sound Telehospitalists received 88,000 connect requests, including 6,400 video-assisted new admissions and 82 rapid responses. Typically, one physician covers four to eight hospitals with back-up available for surges. The team uses a predictive model for staffing and developed an acuity-based algorithm to ensure that patients in distress are evaluated immediately, new stable admissions on average are seen within 12 minutes, and order clarifications are provided within 30 minutes.

The COVID-19 pandemic created an urgent demand for providers to support an overwhelmed health care system. Without the traditional barriers to implementation – such as lack of acceptance by medical staff, nurses and patients, strict state licensing and technology requirements, lack of reimbursement, and delays in hospital credentialing – Sound was able to develop a rapid implementation model for telemedicine services. Currently, four new hospitals are in the active implementation phase, with 40 more hospitals in the pipeline.

Implementing a telemedicine program at your hospital

In order to successfully launch a telemedicine program, Dr. Carpenter outlined the following critical implementation steps:

• In collaboration with local leadership, define the problem you are trying to solve, which helps inform the scope of the telemedicine practice and technology requirements (for example, night-time cross-coverage vs. full telemedicine service).
• Complete a discovery process (for example, existing workflow for patient admission and transfer) with the end-goal of developing a workflow and rules of engagement.
• Obtain hospital credentialing/privileges and EMR access.
• Train end-users, including physicians and nurse telepresenters.

Dr. Carpenter offered this advice to those considering a telemedicine program: “Telemedicine is not just about technology; a true telemedicine program encompasses change management, workflow development, end-user training, compliance, and mechanisms for continuous process improvement. We want to make things better for the physicians, nurses, and patients.”

Telehealth is offering support to health care providers on the front lines, patients in need of care, and health care systems managing the unprecedented surges in volume.
 

Dr. Farah is a hospitalist, physician adviser, and Lean Six Sigma Black Belt. She is a performance improvement consultant based in Corvallis, Ore., and a member of The Hospitalist’s editorial advisory board.

On Jan. 20, 2020, the first confirmed case of the 2019 novel coronavirus in the United States was admitted to Providence Regional Medical Center in Everett, Wash. Less than 3 months later, the COVID-19 pandemic has put enormous stress on the U.S. health care system, which is confronting acute resource shortage because of the surge of acute and critically ill patients, health care provider safety and burnout, and an ongoing need for managing vulnerable populations while minimizing the infection spread.

With the onset of these unprecedented challenges, telehealth has emerged as a powerful new resource for health care providers, hospitals, and health care systems across the country. This article offers a summary of government regulations that enabled telehealth expansion, and provides an overview of how two health care organizations, Providence St. Joseph Health and Sound Physicians, are employing telehealth services to combat the COVID-19 health care crisis.

The government response: Telehealth expansion

In response to the pandemic, the Centers for Medicare and Medicaid Services (CMS) have significantly increased access to telehealth services for Medicare and Medicaid beneficiaries. CMS swiftly put measures in place such as:

• Expanding telehealth beyond rural areas.
• Adding 80 services that can be provided in all settings, including patient homes
• Allowing providers to bill for telehealth visits at the same rate as in-person visits.

The U.S. Department of Health and Human Services also aided this effort by:

• Waiving requirements that physicians or other health care professionals must have licenses in the state in which they provide services, if they have an equivalent license from another state.
• Waving penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype

Without prior regulatory and reimbursement restrictions, telehealth rapidly became a powerful tool in helping to solve some of the problems brought about by the COVID-19 pandemic.

Providence Telehealth for COVID-19

Providence St. Joseph Health is a not-for-profit health care system operating 51 hospitals and 1,085 clinics across Alaska, California, Montana, New Mexico, Oregon, Texas, and Washington. Providence has developed an enterprise telemedicine network with more than 100 virtual programs. Several of these services – including Telestroke, Telepsychiatry, TeleICU, and Telehospitalist – have been scaled across several states as a clinical cloud. More than 400 telemedicine endpoints are deployed, such as robotic carts and fixed InTouch TVs. In fact, the first U.S. COVID-19 patient was treated at Providence Regional Medical Center in Everett, Wash., using the telemedical robot Vici from InTouch Health.

According to Todd Czartoski, MD, chief medical technology officer at Providence, “while telehealth has been around for many years, COVID-19 opened a lot of people’s eyes to the value of virtual care delivery.”

Providence’s telehealth response to COVID-19 has encompassed five main areas: COVID-19 home care, COVID-19 acute care, ambulatory virtual visits, behavioral health concierge (BHC) expansion, and additional support for outside partnerships.

COVID-19 Home Care

Providence rapidly deployed home monitoring for nearly 2,000 positive or presumptive COVID-19 patients. Those symptomatic, clinically stable patients are given a thermometer and a pulse oximeter, and are monitored from home by a central team of nurses and physicians using the Xealth and Twistle programs.

Providence is evaluating expansion of home monitoring to other diagnoses, including higher acuity conditions.

COVID-19 Acute Care

TeleTriage expedites the triage of suspected COVID-19 patients and reduces the use of personal protective equipment (PPE) by 50% per patient per day. To date, TeleTriage has resulted in the conservation of more than 90,000 PPE units.

TeleHospitalist services expanded from traditional night coverage to caring for patients in COVID-19 units around the clock. Currently, there are 25 telehospitalists who practice both in-person and virtual medicine.

TeleICU offers remote management of more than 180 ICU beds across 17 hospitals from two central command centers in Washington state and Alaska. The services include night-time intensivist and ICU nurse coverage, including medication and ventilator management, and family conferences. COVID-19 increased the demand for TeleICU, with anticipated expansion to more than 300 beds.

Core TeleSpecialty services include TeleStroke and TelePsychiatry across 135 remote sites.

Ambulatory Virtual Visits

Providence launched the COVID-19 hub microsite to help educate patients by providing accurate and timely information. A chatbot named Grace helps screen patients who are worried about COVID-19. Grace also suggests next steps, such as a video visit with a patient’s primary care provider or a visit using Express Care/Virtual team, a direct-to-consumer service available to patients within and outside of the health care system.

In less than 2 weeks, Providence enabled virtual visits for more than 7,000 outpatient providers, with more than 14,000 alternative visits now occurring daily. This has allowed primary and specialty providers to continue to manage their patient panels remotely. The number of Express Care/Virtual visits increased from 60 to more than 1,000 per day.

BHC Expansion

In the effort to improve care for its caregivers, Providence launched a behavioral health concierge (BHC) service that offers employees and their dependents virtual access to licensed mental health professionals. Over the last half of 2019, BHC provided more than 1,000 phone and virtual visits, depending on the individual preference of patients. Notably, 21% percent of users were physicians; 65% of users were seen the same day and 100% of users were seen within 48 hours.

COVID-19 increased demand for services that initially started in Seattle and rapidly expanded to Montana, Oregon, and California.

Outside Partnerships

Providence has established partnerships with outside facilities by providing services to 135 sites across eight states. COVID-19 accelerated the employment of new services, including TeleICU.
 

Telemedicine at Sound Physicians

Sound Physicians is a national physician-founded and -led organization that provides emergency medicine, critical care, hospital medicine, population health, and physician advisory services. Five years ago, Sound launched a telemedicine service line. I spoke with Brian Carpenter, MD, national medical director for TeleHospitalist Services at Sound, to learn about his experience implementing Telehospitalist programs across 22 hospitals and 22 skilled nursing facilities.

Prior to COVID-19, Sound offered a spectrum of telemedicine services including night-time telephonic cross coverage, as well as video-assisted admissions, transfers, and rapid responses. In 2019, Sound Telehospitalists received 88,000 connect requests, including 6,400 video-assisted new admissions and 82 rapid responses. Typically, one physician covers four to eight hospitals with back-up available for surges. The team uses a predictive model for staffing and developed an acuity-based algorithm to ensure that patients in distress are evaluated immediately, new stable admissions on average are seen within 12 minutes, and order clarifications are provided within 30 minutes.

The COVID-19 pandemic created an urgent demand for providers to support an overwhelmed health care system. Without the traditional barriers to implementation – such as lack of acceptance by medical staff, nurses and patients, strict state licensing and technology requirements, lack of reimbursement, and delays in hospital credentialing – Sound was able to develop a rapid implementation model for telemedicine services. Currently, four new hospitals are in the active implementation phase, with 40 more hospitals in the pipeline.

Implementing a telemedicine program at your hospital

In order to successfully launch a telemedicine program, Dr. Carpenter outlined the following critical implementation steps:

• In collaboration with local leadership, define the problem you are trying to solve, which helps inform the scope of the telemedicine practice and technology requirements (for example, night-time cross-coverage vs. full telemedicine service).
• Complete a discovery process (for example, existing workflow for patient admission and transfer) with the end-goal of developing a workflow and rules of engagement.
• Obtain hospital credentialing/privileges and EMR access.
• Train end-users, including physicians and nurse telepresenters.

Dr. Carpenter offered this advice to those considering a telemedicine program: “Telemedicine is not just about technology; a true telemedicine program encompasses change management, workflow development, end-user training, compliance, and mechanisms for continuous process improvement. We want to make things better for the physicians, nurses, and patients.”

Telehealth is offering support to health care providers on the front lines, patients in need of care, and health care systems managing the unprecedented surges in volume.
 

Dr. Farah is a hospitalist, physician adviser, and Lean Six Sigma Black Belt. She is a performance improvement consultant based in Corvallis, Ore., and a member of The Hospitalist’s editorial advisory board.

Every family physician has experienced the onset of a bad flu season, when suddenly the phone starts ringing off the hook. As the family medicine lead physician for Cleveland Clinic Express Care Online (ECO)—specifically its on-demand virtual visit platform—I have been performing virtual visits as part of a small team of physicians and nurse practitioners for 5 years, and was capably seeing 5 to 15 patients in an afternoon across the 18 states in which I am licensed. Until recently, our Distance Health team collectively would perform between 3000 and 4000 virtual visits per month.

On Saturday, March 14, 2020, we had the virtual visit equivalent of the phone ringing off the hook—to the point of breaking the phone. The ECO Medical Director, Matthew Faiman, MD, texted me to ask if I would be willing to sign on to the platform for a bit to help out with high volume—and whoosh, just by signing on, I had 20 patients waiting in the queue, with hundreds more trying to get a visit, all related to COVID-19. And patients who would normally leave a line if the wait time was more than 5 minutes were willing to stay online for more than 3 hours, if necessary, to consult with a provider.

After handling in excess of 38 patients that afternoon (some of whom were unfortunately dropped by the platform, which was overwhelmed by sheer volume), I did my best impression of Roy Scheider in Jaws: I emailed Matt, “You’re gonna need a bigger boat.”

How we got a bigger boat

As an early pioneer in telemedicine, Cleveland Clinic was well suited to quickly ramp up its use of virtual visits (both synchronous ECO visits, which occur in real time, and asynchronous e-Visits, in which the patient provides information via images, video, audio, or text file, to be evaluated and responded to by the provider within a specified timeframe). Even with a robust existing infrastructure, however, we faced challenges that necessitated a dynamic response.

The first step was to increase available personnel. Cleveland Clinic leadership immediately put out a call for volunteers to sign on to the on-demand platform, and more than 200 primary care physicians and advanced practice providers responded. We also dedicated an additional 30 full-time nurse practitioners to our ECO team of physicians, nurse practitioners, and physician assistants.

FaceTime, Google Duo, Zoom, and Doximity are low-cost options to get your feet wet if you have no prior experience with virtual visits.

Daily live online training sessions were launched to walk staff through how to set up and conduct a virtual visit. As we navigated the day-to-day reality of increased virtual visits, our accumulated experience informed the development of what we refer to as a “distance health playbook.” This single repository of information is accessible to all caregivers, and we also created a digital pocket card containing the most pertinent information from the playbook and automatically pushed it to all Cleveland Clinic–issued iPhones. Providers literally have what they need at their fingertips, no matter where they are when they “see” a patient.

The full playbook outlines how to adopt and ramp up telemedicine services. This includes details on clinician training, scheduling visits, coding for services provided during a telemedicine visit, and demonstrating empathy from a distance. There are also patient-facing resources on how to access various digital platforms, which may be handy for less tech-savvy patients. For example, if your patient does not already have FaceTime or Skype installed on his phone, or is not familiar with the use of such programs, the playbook includes specific instructions (with screencaps) that you can share.

Continue to: While initially available...

While initially available only to Cleveland Clinic staff, the Cleveland Clinic Response to COVID-19 Digital Health Playbook is now accessible to the medical community at large via the Cleveland Clinic Web site (learn more at https://consultqd.clevelandclinic.org/cleveland-clinics-digital-health-playbook/) and a link from the US Department of Health and Human Services Web site.

What we accomplished

Within 1 week, providers who previously had little experience conducting virtual visits were helping out like seasoned professionals, and we were able to reduce wait times back to pre-COVID-19 levels while performing 8000 virtual visits in a single week. Those who were less fluent with virtual visits contributed by assessing the queue to identify patients who would be well handled with a telephone encounter; this helped to successfully meet patients’ needs and alleviate the burden on the system.

The capacity to accommodate (more) remote visits became increasingly important when, as happened in many states, Ohio Governor Mike DeWine announced social-­distancing measures and restriction of business in response to the growing surge of COVID-19 cases. This culminated in a stay-at-home order issued on March 22.

With care needs increasing, the early experience gained by our primary care teams was an invaluable asset as we transitioned patients who had upcoming in-person evaluation and management visits to virtual, phone, and e-Visits. Daily huddles were instituted to help with this process, and additional training materials and support tools were created and uploaded to an easily accessible online “toolkit.”

When the volume of video visits overwhelmed the ECO platform, upgrades were made to accommodate increased bandwidth and traffic. Permission was also granted to utilize FaceTime and Google Duo for visits, provided patients gave consent (and in accordance with HIPAA COVID-19 guidelines), when and if a disconnection occurred due to volume overloads.

Continue to: During the period from...

During the period from March 12 to March 24, more than 200 Cleveland Clinic primary care providers and APPs performed more than 54,000 digital and nontraditional encounters, serving more than 26,000 unique patients. By April 11, total outpatient visits at Cleveland Clinic had shifted from 2% remote (virtual or phone) to 75% remote.

What we learned

For medical practices currently grappling with telemedicine during the COVID-19 pandemic—many of whom may be starting from scratch as opposed to ramping up existing services—I offer the following “take-aways” from our recent experience:

Recognize that you are not alone in feeling overwhelmed in ramping up telemedicine. Our experience at Cleveland Clinic has shown that it only takes 5 to 10 virtual visits for most providers to gain comfort with the platforms.

Be innovative. There will be technical issues along the way; work with whatever platform is available: FaceTime, Google Duo, Doximity, Zoom, etc. The patient should be asked to consent to the use of these platforms.

Start with phone visits for patients who are technologically challenged.

Continue to: Utilize existing techniques when you can

Utilize existing techniques when you can. We are all developing our own innovative physical diagnosis techniques with video, but there are some evidence-based recommended techniques for use in special circumstances (eg, Ottawa ankle rules). Gaining familiarity with these and developing standard disease-specific documentation templates can be helpful.

Keep in mind that many systems were not designed to handle high volume, whether that means the platform itself or the workflow for providers. Problems require troubleshooting to determine whether the issue is related to the platform, user error, or design flaws, in order to provide the right solution in the right environment. 

Even with our robust existing system, Cleveland Clinic required upgrades to accommodate the increased volume in virtual visits. By contrast, a physician in private practice may have purchased access to an entry-level system that was designed to work for occasional use but when asked to perform outside its design, simply cannot meet the needs of its client. Furthermore, small practices do not have an IT department on hand to address technical issues. This is why I would advise my family medicine colleagues to deal with the present need with a present solution: FaceTime, Google Duo, Zoom, and Doximity are low-cost options to get your feet wet if you have no prior experience with virtual visits.

As you get a better handle on your needs and capabilities, you will be better able to prepare for your future practice needs, including a more robust and HIPAA-compliant virtual visit platform. You will have built yourself that “bigger boat.”

Every family physician has experienced the onset of a bad flu season, when suddenly the phone starts ringing off the hook. As the family medicine lead physician for Cleveland Clinic Express Care Online (ECO)—specifically its on-demand virtual visit platform—I have been performing virtual visits as part of a small team of physicians and nurse practitioners for 5 years, and was capably seeing 5 to 15 patients in an afternoon across the 18 states in which I am licensed. Until recently, our Distance Health team collectively would perform between 3000 and 4000 virtual visits per month.

On Saturday, March 14, 2020, we had the virtual visit equivalent of the phone ringing off the hook—to the point of breaking the phone. The ECO Medical Director, Matthew Faiman, MD, texted me to ask if I would be willing to sign on to the platform for a bit to help out with high volume—and whoosh, just by signing on, I had 20 patients waiting in the queue, with hundreds more trying to get a visit, all related to COVID-19. And patients who would normally leave a line if the wait time was more than 5 minutes were willing to stay online for more than 3 hours, if necessary, to consult with a provider.

After handling in excess of 38 patients that afternoon (some of whom were unfortunately dropped by the platform, which was overwhelmed by sheer volume), I did my best impression of Roy Scheider in Jaws: I emailed Matt, “You’re gonna need a bigger boat.”

How we got a bigger boat

As an early pioneer in telemedicine, Cleveland Clinic was well suited to quickly ramp up its use of virtual visits (both synchronous ECO visits, which occur in real time, and asynchronous e-Visits, in which the patient provides information via images, video, audio, or text file, to be evaluated and responded to by the provider within a specified timeframe). Even with a robust existing infrastructure, however, we faced challenges that necessitated a dynamic response.

The first step was to increase available personnel. Cleveland Clinic leadership immediately put out a call for volunteers to sign on to the on-demand platform, and more than 200 primary care physicians and advanced practice providers responded. We also dedicated an additional 30 full-time nurse practitioners to our ECO team of physicians, nurse practitioners, and physician assistants.

FaceTime, Google Duo, Zoom, and Doximity are low-cost options to get your feet wet if you have no prior experience with virtual visits.

Daily live online training sessions were launched to walk staff through how to set up and conduct a virtual visit. As we navigated the day-to-day reality of increased virtual visits, our accumulated experience informed the development of what we refer to as a “distance health playbook.” This single repository of information is accessible to all caregivers, and we also created a digital pocket card containing the most pertinent information from the playbook and automatically pushed it to all Cleveland Clinic–issued iPhones. Providers literally have what they need at their fingertips, no matter where they are when they “see” a patient.

The full playbook outlines how to adopt and ramp up telemedicine services. This includes details on clinician training, scheduling visits, coding for services provided during a telemedicine visit, and demonstrating empathy from a distance. There are also patient-facing resources on how to access various digital platforms, which may be handy for less tech-savvy patients. For example, if your patient does not already have FaceTime or Skype installed on his phone, or is not familiar with the use of such programs, the playbook includes specific instructions (with screencaps) that you can share.

Continue to: While initially available...

While initially available only to Cleveland Clinic staff, the Cleveland Clinic Response to COVID-19 Digital Health Playbook is now accessible to the medical community at large via the Cleveland Clinic Web site (learn more at https://consultqd.clevelandclinic.org/cleveland-clinics-digital-health-playbook/) and a link from the US Department of Health and Human Services Web site.

What we accomplished

Within 1 week, providers who previously had little experience conducting virtual visits were helping out like seasoned professionals, and we were able to reduce wait times back to pre-COVID-19 levels while performing 8000 virtual visits in a single week. Those who were less fluent with virtual visits contributed by assessing the queue to identify patients who would be well handled with a telephone encounter; this helped to successfully meet patients’ needs and alleviate the burden on the system.

The capacity to accommodate (more) remote visits became increasingly important when, as happened in many states, Ohio Governor Mike DeWine announced social-­distancing measures and restriction of business in response to the growing surge of COVID-19 cases. This culminated in a stay-at-home order issued on March 22.

With care needs increasing, the early experience gained by our primary care teams was an invaluable asset as we transitioned patients who had upcoming in-person evaluation and management visits to virtual, phone, and e-Visits. Daily huddles were instituted to help with this process, and additional training materials and support tools were created and uploaded to an easily accessible online “toolkit.”

When the volume of video visits overwhelmed the ECO platform, upgrades were made to accommodate increased bandwidth and traffic. Permission was also granted to utilize FaceTime and Google Duo for visits, provided patients gave consent (and in accordance with HIPAA COVID-19 guidelines), when and if a disconnection occurred due to volume overloads.

Continue to: During the period from...

During the period from March 12 to March 24, more than 200 Cleveland Clinic primary care providers and APPs performed more than 54,000 digital and nontraditional encounters, serving more than 26,000 unique patients. By April 11, total outpatient visits at Cleveland Clinic had shifted from 2% remote (virtual or phone) to 75% remote.

What we learned

For medical practices currently grappling with telemedicine during the COVID-19 pandemic—many of whom may be starting from scratch as opposed to ramping up existing services—I offer the following “take-aways” from our recent experience:

Recognize that you are not alone in feeling overwhelmed in ramping up telemedicine. Our experience at Cleveland Clinic has shown that it only takes 5 to 10 virtual visits for most providers to gain comfort with the platforms.

Be innovative. There will be technical issues along the way; work with whatever platform is available: FaceTime, Google Duo, Doximity, Zoom, etc. The patient should be asked to consent to the use of these platforms.

Start with phone visits for patients who are technologically challenged.

Continue to: Utilize existing techniques when you can

Utilize existing techniques when you can. We are all developing our own innovative physical diagnosis techniques with video, but there are some evidence-based recommended techniques for use in special circumstances (eg, Ottawa ankle rules). Gaining familiarity with these and developing standard disease-specific documentation templates can be helpful.

Keep in mind that many systems were not designed to handle high volume, whether that means the platform itself or the workflow for providers. Problems require troubleshooting to determine whether the issue is related to the platform, user error, or design flaws, in order to provide the right solution in the right environment. 

Even with our robust existing system, Cleveland Clinic required upgrades to accommodate the increased volume in virtual visits. By contrast, a physician in private practice may have purchased access to an entry-level system that was designed to work for occasional use but when asked to perform outside its design, simply cannot meet the needs of its client. Furthermore, small practices do not have an IT department on hand to address technical issues. This is why I would advise my family medicine colleagues to deal with the present need with a present solution: FaceTime, Google Duo, Zoom, and Doximity are low-cost options to get your feet wet if you have no prior experience with virtual visits.

As you get a better handle on your needs and capabilities, you will be better able to prepare for your future practice needs, including a more robust and HIPAA-compliant virtual visit platform. You will have built yourself that “bigger boat.”

Every family physician has experienced the onset of a bad flu season, when suddenly the phone starts ringing off the hook. As the family medicine lead physician for Cleveland Clinic Express Care Online (ECO)—specifically its on-demand virtual visit platform—I have been performing virtual visits as part of a small team of physicians and nurse practitioners for 5 years, and was capably seeing 5 to 15 patients in an afternoon across the 18 states in which I am licensed. Until recently, our Distance Health team collectively would perform between 3000 and 4000 virtual visits per month.

On Saturday, March 14, 2020, we had the virtual visit equivalent of the phone ringing off the hook—to the point of breaking the phone. The ECO Medical Director, Matthew Faiman, MD, texted me to ask if I would be willing to sign on to the platform for a bit to help out with high volume—and whoosh, just by signing on, I had 20 patients waiting in the queue, with hundreds more trying to get a visit, all related to COVID-19. And patients who would normally leave a line if the wait time was more than 5 minutes were willing to stay online for more than 3 hours, if necessary, to consult with a provider.

After handling in excess of 38 patients that afternoon (some of whom were unfortunately dropped by the platform, which was overwhelmed by sheer volume), I did my best impression of Roy Scheider in Jaws: I emailed Matt, “You’re gonna need a bigger boat.”

How we got a bigger boat

As an early pioneer in telemedicine, Cleveland Clinic was well suited to quickly ramp up its use of virtual visits (both synchronous ECO visits, which occur in real time, and asynchronous e-Visits, in which the patient provides information via images, video, audio, or text file, to be evaluated and responded to by the provider within a specified timeframe). Even with a robust existing infrastructure, however, we faced challenges that necessitated a dynamic response.

The first step was to increase available personnel. Cleveland Clinic leadership immediately put out a call for volunteers to sign on to the on-demand platform, and more than 200 primary care physicians and advanced practice providers responded. We also dedicated an additional 30 full-time nurse practitioners to our ECO team of physicians, nurse practitioners, and physician assistants.

FaceTime, Google Duo, Zoom, and Doximity are low-cost options to get your feet wet if you have no prior experience with virtual visits.

Daily live online training sessions were launched to walk staff through how to set up and conduct a virtual visit. As we navigated the day-to-day reality of increased virtual visits, our accumulated experience informed the development of what we refer to as a “distance health playbook.” This single repository of information is accessible to all caregivers, and we also created a digital pocket card containing the most pertinent information from the playbook and automatically pushed it to all Cleveland Clinic–issued iPhones. Providers literally have what they need at their fingertips, no matter where they are when they “see” a patient.

The full playbook outlines how to adopt and ramp up telemedicine services. This includes details on clinician training, scheduling visits, coding for services provided during a telemedicine visit, and demonstrating empathy from a distance. There are also patient-facing resources on how to access various digital platforms, which may be handy for less tech-savvy patients. For example, if your patient does not already have FaceTime or Skype installed on his phone, or is not familiar with the use of such programs, the playbook includes specific instructions (with screencaps) that you can share.

Continue to: While initially available...

While initially available only to Cleveland Clinic staff, the Cleveland Clinic Response to COVID-19 Digital Health Playbook is now accessible to the medical community at large via the Cleveland Clinic Web site (learn more at https://consultqd.clevelandclinic.org/cleveland-clinics-digital-health-playbook/) and a link from the US Department of Health and Human Services Web site.

What we accomplished

Within 1 week, providers who previously had little experience conducting virtual visits were helping out like seasoned professionals, and we were able to reduce wait times back to pre-COVID-19 levels while performing 8000 virtual visits in a single week. Those who were less fluent with virtual visits contributed by assessing the queue to identify patients who would be well handled with a telephone encounter; this helped to successfully meet patients’ needs and alleviate the burden on the system.

The capacity to accommodate (more) remote visits became increasingly important when, as happened in many states, Ohio Governor Mike DeWine announced social-­distancing measures and restriction of business in response to the growing surge of COVID-19 cases. This culminated in a stay-at-home order issued on March 22.

With care needs increasing, the early experience gained by our primary care teams was an invaluable asset as we transitioned patients who had upcoming in-person evaluation and management visits to virtual, phone, and e-Visits. Daily huddles were instituted to help with this process, and additional training materials and support tools were created and uploaded to an easily accessible online “toolkit.”

When the volume of video visits overwhelmed the ECO platform, upgrades were made to accommodate increased bandwidth and traffic. Permission was also granted to utilize FaceTime and Google Duo for visits, provided patients gave consent (and in accordance with HIPAA COVID-19 guidelines), when and if a disconnection occurred due to volume overloads.

Continue to: During the period from...

During the period from March 12 to March 24, more than 200 Cleveland Clinic primary care providers and APPs performed more than 54,000 digital and nontraditional encounters, serving more than 26,000 unique patients. By April 11, total outpatient visits at Cleveland Clinic had shifted from 2% remote (virtual or phone) to 75% remote.

What we learned

For medical practices currently grappling with telemedicine during the COVID-19 pandemic—many of whom may be starting from scratch as opposed to ramping up existing services—I offer the following “take-aways” from our recent experience:

Recognize that you are not alone in feeling overwhelmed in ramping up telemedicine. Our experience at Cleveland Clinic has shown that it only takes 5 to 10 virtual visits for most providers to gain comfort with the platforms.

Be innovative. There will be technical issues along the way; work with whatever platform is available: FaceTime, Google Duo, Doximity, Zoom, etc. The patient should be asked to consent to the use of these platforms.

Start with phone visits for patients who are technologically challenged.

Continue to: Utilize existing techniques when you can

Utilize existing techniques when you can. We are all developing our own innovative physical diagnosis techniques with video, but there are some evidence-based recommended techniques for use in special circumstances (eg, Ottawa ankle rules). Gaining familiarity with these and developing standard disease-specific documentation templates can be helpful.

Keep in mind that many systems were not designed to handle high volume, whether that means the platform itself or the workflow for providers. Problems require troubleshooting to determine whether the issue is related to the platform, user error, or design flaws, in order to provide the right solution in the right environment. 

Even with our robust existing system, Cleveland Clinic required upgrades to accommodate the increased volume in virtual visits. By contrast, a physician in private practice may have purchased access to an entry-level system that was designed to work for occasional use but when asked to perform outside its design, simply cannot meet the needs of its client. Furthermore, small practices do not have an IT department on hand to address technical issues. This is why I would advise my family medicine colleagues to deal with the present need with a present solution: FaceTime, Google Duo, Zoom, and Doximity are low-cost options to get your feet wet if you have no prior experience with virtual visits.

As you get a better handle on your needs and capabilities, you will be better able to prepare for your future practice needs, including a more robust and HIPAA-compliant virtual visit platform. You will have built yourself that “bigger boat.”

Recently, like in other major cities, Phoenix had a flyover by the Blue Angels to honor frontline health care workers. My kids and I watched it. While I think the gesture is nice, in my mind it brings up questions about whether the money for it could have been better spent elsewhere. But that’s not the point of my column.

Watching the whole thing, I couldn’t help but think about my role in the crisis. While I have friends on the front lines, I’m certainly not there. I’m probably as close to back line as you can be without being retired.

This is simply the nature of my practice. I’m primarily outpatient. Inpatient consults are few and far between in the era of the neuro-hospitalist. I still see patients, both by video and in person. If someone wants to come in and see me, I’ll be available if I’m able.

I see a lot of conditions, but no one is going to a neurologist to be evaluated for COVID-19. Nor should they. Even though there are reports of neurological complications of the disease, none of them are outpatient issues or presenting symptoms.

I was asked if I’d volunteer to practice inpatient general medicine in a pinch, and my answer to that would have to be no. This isn’t cowardice, as one person accused me of. I’ve been to the hospital and seen patients since this started.

I’m no more an internist than I am an electrician. Like other neurologists of my era, I did a 1-year general medicine internship. For me, that was in 1993. I haven’t practiced it since, nor have I kept up on it except as it crosses into neurology.

A lot has changed in the last 27 years in my field alone. For me to jump back into general medicine after that time would likely do more harm than good to the patients I would see.

So I sit in my office doing what I always have: Trying to provide the best care I can to those who do need my services as a neurologist.

I may not be on the front line in our current crisis, but for those who seek my help I’m still front and center for them. And I will be until I retire.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Recently, like in other major cities, Phoenix had a flyover by the Blue Angels to honor frontline health care workers. My kids and I watched it. While I think the gesture is nice, in my mind it brings up questions about whether the money for it could have been better spent elsewhere. But that’s not the point of my column.

Watching the whole thing, I couldn’t help but think about my role in the crisis. While I have friends on the front lines, I’m certainly not there. I’m probably as close to back line as you can be without being retired.

This is simply the nature of my practice. I’m primarily outpatient. Inpatient consults are few and far between in the era of the neuro-hospitalist. I still see patients, both by video and in person. If someone wants to come in and see me, I’ll be available if I’m able.

I see a lot of conditions, but no one is going to a neurologist to be evaluated for COVID-19. Nor should they. Even though there are reports of neurological complications of the disease, none of them are outpatient issues or presenting symptoms.

I was asked if I’d volunteer to practice inpatient general medicine in a pinch, and my answer to that would have to be no. This isn’t cowardice, as one person accused me of. I’ve been to the hospital and seen patients since this started.

I’m no more an internist than I am an electrician. Like other neurologists of my era, I did a 1-year general medicine internship. For me, that was in 1993. I haven’t practiced it since, nor have I kept up on it except as it crosses into neurology.

A lot has changed in the last 27 years in my field alone. For me to jump back into general medicine after that time would likely do more harm than good to the patients I would see.

So I sit in my office doing what I always have: Trying to provide the best care I can to those who do need my services as a neurologist.

I may not be on the front line in our current crisis, but for those who seek my help I’m still front and center for them. And I will be until I retire.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Recently, like in other major cities, Phoenix had a flyover by the Blue Angels to honor frontline health care workers. My kids and I watched it. While I think the gesture is nice, in my mind it brings up questions about whether the money for it could have been better spent elsewhere. But that’s not the point of my column.

Watching the whole thing, I couldn’t help but think about my role in the crisis. While I have friends on the front lines, I’m certainly not there. I’m probably as close to back line as you can be without being retired.

This is simply the nature of my practice. I’m primarily outpatient. Inpatient consults are few and far between in the era of the neuro-hospitalist. I still see patients, both by video and in person. If someone wants to come in and see me, I’ll be available if I’m able.

I see a lot of conditions, but no one is going to a neurologist to be evaluated for COVID-19. Nor should they. Even though there are reports of neurological complications of the disease, none of them are outpatient issues or presenting symptoms.

I was asked if I’d volunteer to practice inpatient general medicine in a pinch, and my answer to that would have to be no. This isn’t cowardice, as one person accused me of. I’ve been to the hospital and seen patients since this started.

I’m no more an internist than I am an electrician. Like other neurologists of my era, I did a 1-year general medicine internship. For me, that was in 1993. I haven’t practiced it since, nor have I kept up on it except as it crosses into neurology.

A lot has changed in the last 27 years in my field alone. For me to jump back into general medicine after that time would likely do more harm than good to the patients I would see.

So I sit in my office doing what I always have: Trying to provide the best care I can to those who do need my services as a neurologist.

I may not be on the front line in our current crisis, but for those who seek my help I’m still front and center for them. And I will be until I retire.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Children whose parents are coping with illness and injuries were more likely to need medical treatment and prescriptions for gastrointestinal conditions, for which previous research already has indicated a brain-gut connection, an investigator said.

In a self-controlled case series using records from the Military Health System Data Repository, pediatric visits for disorders linked to gut-brain interactions were found to have increased 9% (incidence rate ratio, 1.09; 95% CI, 1.07-1.10) following a parent’s illness or injury, reported lead author Patrick Short, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., said in an interview. The Military Health System Data Repository receives records from the Department of Defense’s global network of more than 260 medical facilities as well as outside health care organizations where military families are seen.

A secondary analysis done for this study found children of brain injured parents had 4% more postinjury visits for abdominal pain and 23% increased odds of antispasmodic prescription, compared with children whose parents had other physical injuries, Dr. Short said. He presented his research in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19. The study focused on children aged 3-16 years with a parent who served in the military and was ill or injured between 2004 and 2014. Excluded from this research were records for children with diagnosed systemic or organic gastrointestinal disease, such as celiac disease.

The study used ICD-9 codes to identify outpatient visits for irritable bowel syndrome, abdominal pain, constipation, and fecal incontinence in the 2 years before and after parental injury or diagnosis of illness. Outpatient pharmacy records showed which of the children studied took laxatives and antispasmodics.

Parental injury or illness was defined by the placement of the children’s mothers and fathers on the injured, ill, or wounded file in the data repository. The data file generally covers people with conditions that severely limit their ability to do their usual jobs. These include traumatic brain injury, PTSD, amputation, shrapnel injury, and illnesses such as cancer.

There was a 7% increase in visits for constipation but fecal incontinence did not significantly change following parental illness or injury, Dr. Short said. But the odds of being prescribed an antispasmodic increased 23% following parents’ injuries and serious illnesses, while the odds for laxative prescription decreased by 5%.

The study highlights the potential physical impact of stress on children when families experience a crisis, Dr. Short said in an interview. Children may feel anxious about their parent’s health, while at the same time experiencing unavoidable disruption in family life because of an injury or illness.

“It impacts the day-to-day regimens and routines and decreases the family support,” Dr. Short said. “As humans we are limited in what we have to offer. When we are trying to take care of things on our own, it limits what we can give to people around us.”

The findings of this study should serve to remind physicians to alert parents that their children could experience worsening of GI conditions because of the stress of an ill or injured parent. They then can focus on securing help ahead of the time for the child, such as therapy, he said.

The next step in advancing on the research he prepared for DDW could be testing through prospective studies how well preventive measures such as family counseling work, Dr. Short said.

Dr. Short’s research adds to the growing body of evidence about the brain-gut connection, said Kara Gross Margolis, MD, a spokesperson for the American Gastroenterological Association. An associate professor of pediatrics at Columbia University Medical Center, New York, Dr. Margolis has published research on the brain-gut axis. Her lab focuses on the effects of neurotransmitters and inflammation on enteric nervous system development and function.

Physicians should take a broad view when treating children for functional GI illnesses. Behavioral therapy and antidepressants, for example, have been shown to help children with conditions such as irritable bowel syndrome and other functional gastrointestinal diseases, said Dr. Margolis.

“In a number of these cases, we not only have to treat the gut. We have to treat the brain as well,” Dr. Margolis said.

“When mental health issues are involved that impact the parents of these kids, You have to look at a family as an entire unit,” she added. “You not only treat the child for those symptoms, but you really have to look at how their parents can also be cared for so that their impact on their children will be positive as well.”

Research in the vein explored by Dr. Short will be important to remember as society works through the legacy of the COVID-19 pandemic, Dr. Margolis said. “We have huge numbers of families undergoing tremendous stress due to loss of jobs, health care, medical issues, and parental injury potentially from coronavirus.”

No outside funding was reported, and the study was covered through Uniformed Services University budget.

SOURCE: Short P et al. DDW 2020, Abstract 815.

Children whose parents are coping with illness and injuries were more likely to need medical treatment and prescriptions for gastrointestinal conditions, for which previous research already has indicated a brain-gut connection, an investigator said.

In a self-controlled case series using records from the Military Health System Data Repository, pediatric visits for disorders linked to gut-brain interactions were found to have increased 9% (incidence rate ratio, 1.09; 95% CI, 1.07-1.10) following a parent’s illness or injury, reported lead author Patrick Short, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., said in an interview. The Military Health System Data Repository receives records from the Department of Defense’s global network of more than 260 medical facilities as well as outside health care organizations where military families are seen.

A secondary analysis done for this study found children of brain injured parents had 4% more postinjury visits for abdominal pain and 23% increased odds of antispasmodic prescription, compared with children whose parents had other physical injuries, Dr. Short said. He presented his research in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19. The study focused on children aged 3-16 years with a parent who served in the military and was ill or injured between 2004 and 2014. Excluded from this research were records for children with diagnosed systemic or organic gastrointestinal disease, such as celiac disease.

The study used ICD-9 codes to identify outpatient visits for irritable bowel syndrome, abdominal pain, constipation, and fecal incontinence in the 2 years before and after parental injury or diagnosis of illness. Outpatient pharmacy records showed which of the children studied took laxatives and antispasmodics.

Parental injury or illness was defined by the placement of the children’s mothers and fathers on the injured, ill, or wounded file in the data repository. The data file generally covers people with conditions that severely limit their ability to do their usual jobs. These include traumatic brain injury, PTSD, amputation, shrapnel injury, and illnesses such as cancer.

There was a 7% increase in visits for constipation but fecal incontinence did not significantly change following parental illness or injury, Dr. Short said. But the odds of being prescribed an antispasmodic increased 23% following parents’ injuries and serious illnesses, while the odds for laxative prescription decreased by 5%.

The study highlights the potential physical impact of stress on children when families experience a crisis, Dr. Short said in an interview. Children may feel anxious about their parent’s health, while at the same time experiencing unavoidable disruption in family life because of an injury or illness.

“It impacts the day-to-day regimens and routines and decreases the family support,” Dr. Short said. “As humans we are limited in what we have to offer. When we are trying to take care of things on our own, it limits what we can give to people around us.”

The findings of this study should serve to remind physicians to alert parents that their children could experience worsening of GI conditions because of the stress of an ill or injured parent. They then can focus on securing help ahead of the time for the child, such as therapy, he said.

The next step in advancing on the research he prepared for DDW could be testing through prospective studies how well preventive measures such as family counseling work, Dr. Short said.

Dr. Short’s research adds to the growing body of evidence about the brain-gut connection, said Kara Gross Margolis, MD, a spokesperson for the American Gastroenterological Association. An associate professor of pediatrics at Columbia University Medical Center, New York, Dr. Margolis has published research on the brain-gut axis. Her lab focuses on the effects of neurotransmitters and inflammation on enteric nervous system development and function.

Physicians should take a broad view when treating children for functional GI illnesses. Behavioral therapy and antidepressants, for example, have been shown to help children with conditions such as irritable bowel syndrome and other functional gastrointestinal diseases, said Dr. Margolis.

“In a number of these cases, we not only have to treat the gut. We have to treat the brain as well,” Dr. Margolis said.

“When mental health issues are involved that impact the parents of these kids, You have to look at a family as an entire unit,” she added. “You not only treat the child for those symptoms, but you really have to look at how their parents can also be cared for so that their impact on their children will be positive as well.”

Research in the vein explored by Dr. Short will be important to remember as society works through the legacy of the COVID-19 pandemic, Dr. Margolis said. “We have huge numbers of families undergoing tremendous stress due to loss of jobs, health care, medical issues, and parental injury potentially from coronavirus.”

No outside funding was reported, and the study was covered through Uniformed Services University budget.

SOURCE: Short P et al. DDW 2020, Abstract 815.

Children whose parents are coping with illness and injuries were more likely to need medical treatment and prescriptions for gastrointestinal conditions, for which previous research already has indicated a brain-gut connection, an investigator said.

In a self-controlled case series using records from the Military Health System Data Repository, pediatric visits for disorders linked to gut-brain interactions were found to have increased 9% (incidence rate ratio, 1.09; 95% CI, 1.07-1.10) following a parent’s illness or injury, reported lead author Patrick Short, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., said in an interview. The Military Health System Data Repository receives records from the Department of Defense’s global network of more than 260 medical facilities as well as outside health care organizations where military families are seen.

A secondary analysis done for this study found children of brain injured parents had 4% more postinjury visits for abdominal pain and 23% increased odds of antispasmodic prescription, compared with children whose parents had other physical injuries, Dr. Short said. He presented his research in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19. The study focused on children aged 3-16 years with a parent who served in the military and was ill or injured between 2004 and 2014. Excluded from this research were records for children with diagnosed systemic or organic gastrointestinal disease, such as celiac disease.

The study used ICD-9 codes to identify outpatient visits for irritable bowel syndrome, abdominal pain, constipation, and fecal incontinence in the 2 years before and after parental injury or diagnosis of illness. Outpatient pharmacy records showed which of the children studied took laxatives and antispasmodics.

Parental injury or illness was defined by the placement of the children’s mothers and fathers on the injured, ill, or wounded file in the data repository. The data file generally covers people with conditions that severely limit their ability to do their usual jobs. These include traumatic brain injury, PTSD, amputation, shrapnel injury, and illnesses such as cancer.

There was a 7% increase in visits for constipation but fecal incontinence did not significantly change following parental illness or injury, Dr. Short said. But the odds of being prescribed an antispasmodic increased 23% following parents’ injuries and serious illnesses, while the odds for laxative prescription decreased by 5%.

The study highlights the potential physical impact of stress on children when families experience a crisis, Dr. Short said in an interview. Children may feel anxious about their parent’s health, while at the same time experiencing unavoidable disruption in family life because of an injury or illness.

“It impacts the day-to-day regimens and routines and decreases the family support,” Dr. Short said. “As humans we are limited in what we have to offer. When we are trying to take care of things on our own, it limits what we can give to people around us.”

The findings of this study should serve to remind physicians to alert parents that their children could experience worsening of GI conditions because of the stress of an ill or injured parent. They then can focus on securing help ahead of the time for the child, such as therapy, he said.

The next step in advancing on the research he prepared for DDW could be testing through prospective studies how well preventive measures such as family counseling work, Dr. Short said.

Dr. Short’s research adds to the growing body of evidence about the brain-gut connection, said Kara Gross Margolis, MD, a spokesperson for the American Gastroenterological Association. An associate professor of pediatrics at Columbia University Medical Center, New York, Dr. Margolis has published research on the brain-gut axis. Her lab focuses on the effects of neurotransmitters and inflammation on enteric nervous system development and function.

Physicians should take a broad view when treating children for functional GI illnesses. Behavioral therapy and antidepressants, for example, have been shown to help children with conditions such as irritable bowel syndrome and other functional gastrointestinal diseases, said Dr. Margolis.

“In a number of these cases, we not only have to treat the gut. We have to treat the brain as well,” Dr. Margolis said.

“When mental health issues are involved that impact the parents of these kids, You have to look at a family as an entire unit,” she added. “You not only treat the child for those symptoms, but you really have to look at how their parents can also be cared for so that their impact on their children will be positive as well.”

Research in the vein explored by Dr. Short will be important to remember as society works through the legacy of the COVID-19 pandemic, Dr. Margolis said. “We have huge numbers of families undergoing tremendous stress due to loss of jobs, health care, medical issues, and parental injury potentially from coronavirus.”

No outside funding was reported, and the study was covered through Uniformed Services University budget.

SOURCE: Short P et al. DDW 2020, Abstract 815.