Commentary

In “Asthma: Newer Tx options mean more targeted therapy” (J Fam Pract. 2020;65:135-144), Rali et al recommend azithromycin as an add-on therapy to ICS-LABA for a select group of patients with uncontrolled persistent asthma (neutrophilic phenotype)—a Grade C recommendation. However, the best available evidence demonstrates that azithromycin is equally efficacious for uncontrolled persistent eosinophilic asthma.^1,2 Thus, family physicians need not refer patients for bronchoscopy to identify the inflammatory “phenotype.”

An important unanswered question is whether azithromycin needs to be administered continuously. Emerging evidence indicates that some patients may experience prolonged benefit after time-limited azithromycin treatment. This suggests that the mechanism of action, which has been described as anti-inflammatory, is (at least in part) antimicrobial.³

For azithromycin-treated asthma patients who experience a significant clinical response after 3 to 6 months of treatment, I recommend that the prescribing clinician try taking the patient off azithromycin to assess whether clinical improvement persists or wanes. Nothing is lost, and much is gained, by this approach; patients who relapse can resume azithromycin, and patients who remain improved are spared exposure to an unnecessary and prolonged treatment.

David L. Hahn, MD, MS
Madison, WI

In “Asthma: Newer Tx options mean more targeted therapy” (J Fam Pract. 2020;65:135-144), Rali et al recommend azithromycin as an add-on therapy to ICS-LABA for a select group of patients with uncontrolled persistent asthma (neutrophilic phenotype)—a Grade C recommendation. However, the best available evidence demonstrates that azithromycin is equally efficacious for uncontrolled persistent eosinophilic asthma.^1,2 Thus, family physicians need not refer patients for bronchoscopy to identify the inflammatory “phenotype.”

An important unanswered question is whether azithromycin needs to be administered continuously. Emerging evidence indicates that some patients may experience prolonged benefit after time-limited azithromycin treatment. This suggests that the mechanism of action, which has been described as anti-inflammatory, is (at least in part) antimicrobial.³

For azithromycin-treated asthma patients who experience a significant clinical response after 3 to 6 months of treatment, I recommend that the prescribing clinician try taking the patient off azithromycin to assess whether clinical improvement persists or wanes. Nothing is lost, and much is gained, by this approach; patients who relapse can resume azithromycin, and patients who remain improved are spared exposure to an unnecessary and prolonged treatment.

David L. Hahn, MD, MS
Madison, WI

In “Asthma: Newer Tx options mean more targeted therapy” (J Fam Pract. 2020;65:135-144), Rali et al recommend azithromycin as an add-on therapy to ICS-LABA for a select group of patients with uncontrolled persistent asthma (neutrophilic phenotype)—a Grade C recommendation. However, the best available evidence demonstrates that azithromycin is equally efficacious for uncontrolled persistent eosinophilic asthma.^1,2 Thus, family physicians need not refer patients for bronchoscopy to identify the inflammatory “phenotype.”

An important unanswered question is whether azithromycin needs to be administered continuously. Emerging evidence indicates that some patients may experience prolonged benefit after time-limited azithromycin treatment. This suggests that the mechanism of action, which has been described as anti-inflammatory, is (at least in part) antimicrobial.³

For azithromycin-treated asthma patients who experience a significant clinical response after 3 to 6 months of treatment, I recommend that the prescribing clinician try taking the patient off azithromycin to assess whether clinical improvement persists or wanes. Nothing is lost, and much is gained, by this approach; patients who relapse can resume azithromycin, and patients who remain improved are spared exposure to an unnecessary and prolonged treatment.

David L. Hahn, MD, MS
Madison, WI

The basic primary care ­evaluation recommended by Dr. Brieler et al in “Working adeptly to diagnose and treat adult ADHD” (J Fam Pract. 2020;69:145-149) is a step up from what occurs in some practices. Nonetheless, I was concerned about the idea that an attention-deficit/hyperactivity disorder (ADHD) evaluation in a primary care office might not include a behavioral health specialist. The gold standard remains a comprehensive, multidisciplinary evaluation.

Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

As a family physician who has performed comprehensive ADHD evaluations for more than 25 years, I have frequently seen adults with ADHD who were diagnosed elsewhere, without a comprehensive evaluation, and had various undiagnosed comorbidities. Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

We, as primary care physicians, can provide better care for our patients if we include a behavioral health specialist in the evaluation process.

H. C. Bean, MD, FAAFP, CPE
MGC Carolina Family Physicians
Spartanburg, SC

The basic primary care ­evaluation recommended by Dr. Brieler et al in “Working adeptly to diagnose and treat adult ADHD” (J Fam Pract. 2020;69:145-149) is a step up from what occurs in some practices. Nonetheless, I was concerned about the idea that an attention-deficit/hyperactivity disorder (ADHD) evaluation in a primary care office might not include a behavioral health specialist. The gold standard remains a comprehensive, multidisciplinary evaluation.

Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

As a family physician who has performed comprehensive ADHD evaluations for more than 25 years, I have frequently seen adults with ADHD who were diagnosed elsewhere, without a comprehensive evaluation, and had various undiagnosed comorbidities. Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

We, as primary care physicians, can provide better care for our patients if we include a behavioral health specialist in the evaluation process.

H. C. Bean, MD, FAAFP, CPE
MGC Carolina Family Physicians
Spartanburg, SC

The basic primary care ­evaluation recommended by Dr. Brieler et al in “Working adeptly to diagnose and treat adult ADHD” (J Fam Pract. 2020;69:145-149) is a step up from what occurs in some practices. Nonetheless, I was concerned about the idea that an attention-deficit/hyperactivity disorder (ADHD) evaluation in a primary care office might not include a behavioral health specialist. The gold standard remains a comprehensive, multidisciplinary evaluation.

Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

As a family physician who has performed comprehensive ADHD evaluations for more than 25 years, I have frequently seen adults with ADHD who were diagnosed elsewhere, without a comprehensive evaluation, and had various undiagnosed comorbidities. Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

We, as primary care physicians, can provide better care for our patients if we include a behavioral health specialist in the evaluation process.

H. C. Bean, MD, FAAFP, CPE
MGC Carolina Family Physicians
Spartanburg, SC

The inevitable consequences of aging finally hit me last year, at age 64. Before then, I was a (reasonably) healthy, active person. I exercised a little, ate reasonably healthy meals, and took no medications. My only visits to my doctor were for annual (sort of) exams. That all changed when I began to have neurogenic claudication in both legs. I had no history of back injury but, with worsening pain, I sought the opinion of my physician.

I was told that my insurance premium would jump to more than 4 times the previous premium because of a CAC score of 22.

It turned out that I had a dynamic spondylolisthesis and disc herniation that could only be fixed with a single-level fusion. From a neurologic perspective, the procedure was an unequivocal success. However, my recovery (with lack of exercise) had the unintended “side effect” of a 25-pound weight gain. As a family doctor, I know that the best way to reverse this gain is by increasing my exercise. However, I also know that, at my age, many specialty organizations recommend a cardiac evaluation before beginning strenuous exercise.¹

So, I set up a routine treadmill test. Although I exercised to a moderate level of intensity, the interpreting cardiologist was unwilling to call my test “totally normal” and recommended further evaluation. (One of the “unwritten rules” I’ve discovered during my career is that adverse outcomes are far more likely in medical personnel than in nonmedical personnel!)

He recommended undergoing coronary artery computed tomography angiography with coronary artery calcium (CAC) scoring. The result? A left anterior descending artery CAC score of 22, which placed me at a slightly increased risk of an adverse event over the next 10 years. (The benefit of exercise, however, far outweighed the risk.) I’m happy to report that I have lost five pounds with only mildly intensive exercise.

Along with facing the health aspects of aging, I am also faced with the economic realities. I have carried group term life insurance throughout my career. My 10-year term just happened to expire when I turned 65. I have always been insured as a “Tier 1” customer, meaning that I qualified for the best premiums due to my “healthy” ­status. That said, the transition to age 65 carries with it a significant premium increase.

Imagine my shock, though, when I was told that my premium would jump to MORE THAN 4 TIMES the previous premium for ONE-THIRD of my previous coverage! The culprit? The CAC score of 22!

It turns out that the insurance industry has adopted an underwriting standard that uses CAC—measured over a broad population, rather than a more age-confined one—to determine actuarial risk when rating life insurance policies.² As a result, my underwriting profile went all the way to “Tier 3.”

Continue to: We're used to medical consequences...

We’re used to medical consequences for tests that we order—whether a prostate biopsy for an elevated prostate-specific antigen test result, breast biopsy after abnormal mammogram, or a hemoglobin A1C test after an elevated fasting blood sugar. We can handle discussions with patients about potential diagnostic paths and readily include that information as part of shared decision-making with patients. Unfortunately, many entities are increasingly using medical information to make nonmedical decisions.

Using the CAC score to discuss the risk of adverse coronary events with my patients may be appropriate. In nonmedical settings, however, this data may be incorrectly, unfairly, or dangerously applied to our patients. I’ve begun thinking about these nonmedical applications as part of the shared decision-making process with my patients. It’s making these conversations more complicated, but life and life events for our patients take place far beyond the walls of our exam rooms.

The inevitable consequences of aging finally hit me last year, at age 64. Before then, I was a (reasonably) healthy, active person. I exercised a little, ate reasonably healthy meals, and took no medications. My only visits to my doctor were for annual (sort of) exams. That all changed when I began to have neurogenic claudication in both legs. I had no history of back injury but, with worsening pain, I sought the opinion of my physician.

I was told that my insurance premium would jump to more than 4 times the previous premium because of a CAC score of 22.

It turned out that I had a dynamic spondylolisthesis and disc herniation that could only be fixed with a single-level fusion. From a neurologic perspective, the procedure was an unequivocal success. However, my recovery (with lack of exercise) had the unintended “side effect” of a 25-pound weight gain. As a family doctor, I know that the best way to reverse this gain is by increasing my exercise. However, I also know that, at my age, many specialty organizations recommend a cardiac evaluation before beginning strenuous exercise.¹

So, I set up a routine treadmill test. Although I exercised to a moderate level of intensity, the interpreting cardiologist was unwilling to call my test “totally normal” and recommended further evaluation. (One of the “unwritten rules” I’ve discovered during my career is that adverse outcomes are far more likely in medical personnel than in nonmedical personnel!)

He recommended undergoing coronary artery computed tomography angiography with coronary artery calcium (CAC) scoring. The result? A left anterior descending artery CAC score of 22, which placed me at a slightly increased risk of an adverse event over the next 10 years. (The benefit of exercise, however, far outweighed the risk.) I’m happy to report that I have lost five pounds with only mildly intensive exercise.

Along with facing the health aspects of aging, I am also faced with the economic realities. I have carried group term life insurance throughout my career. My 10-year term just happened to expire when I turned 65. I have always been insured as a “Tier 1” customer, meaning that I qualified for the best premiums due to my “healthy” ­status. That said, the transition to age 65 carries with it a significant premium increase.

Imagine my shock, though, when I was told that my premium would jump to MORE THAN 4 TIMES the previous premium for ONE-THIRD of my previous coverage! The culprit? The CAC score of 22!

It turns out that the insurance industry has adopted an underwriting standard that uses CAC—measured over a broad population, rather than a more age-confined one—to determine actuarial risk when rating life insurance policies.² As a result, my underwriting profile went all the way to “Tier 3.”

Continue to: We're used to medical consequences...

We’re used to medical consequences for tests that we order—whether a prostate biopsy for an elevated prostate-specific antigen test result, breast biopsy after abnormal mammogram, or a hemoglobin A1C test after an elevated fasting blood sugar. We can handle discussions with patients about potential diagnostic paths and readily include that information as part of shared decision-making with patients. Unfortunately, many entities are increasingly using medical information to make nonmedical decisions.

Using the CAC score to discuss the risk of adverse coronary events with my patients may be appropriate. In nonmedical settings, however, this data may be incorrectly, unfairly, or dangerously applied to our patients. I’ve begun thinking about these nonmedical applications as part of the shared decision-making process with my patients. It’s making these conversations more complicated, but life and life events for our patients take place far beyond the walls of our exam rooms.

The inevitable consequences of aging finally hit me last year, at age 64. Before then, I was a (reasonably) healthy, active person. I exercised a little, ate reasonably healthy meals, and took no medications. My only visits to my doctor were for annual (sort of) exams. That all changed when I began to have neurogenic claudication in both legs. I had no history of back injury but, with worsening pain, I sought the opinion of my physician.

I was told that my insurance premium would jump to more than 4 times the previous premium because of a CAC score of 22.

It turned out that I had a dynamic spondylolisthesis and disc herniation that could only be fixed with a single-level fusion. From a neurologic perspective, the procedure was an unequivocal success. However, my recovery (with lack of exercise) had the unintended “side effect” of a 25-pound weight gain. As a family doctor, I know that the best way to reverse this gain is by increasing my exercise. However, I also know that, at my age, many specialty organizations recommend a cardiac evaluation before beginning strenuous exercise.¹

So, I set up a routine treadmill test. Although I exercised to a moderate level of intensity, the interpreting cardiologist was unwilling to call my test “totally normal” and recommended further evaluation. (One of the “unwritten rules” I’ve discovered during my career is that adverse outcomes are far more likely in medical personnel than in nonmedical personnel!)

He recommended undergoing coronary artery computed tomography angiography with coronary artery calcium (CAC) scoring. The result? A left anterior descending artery CAC score of 22, which placed me at a slightly increased risk of an adverse event over the next 10 years. (The benefit of exercise, however, far outweighed the risk.) I’m happy to report that I have lost five pounds with only mildly intensive exercise.

Along with facing the health aspects of aging, I am also faced with the economic realities. I have carried group term life insurance throughout my career. My 10-year term just happened to expire when I turned 65. I have always been insured as a “Tier 1” customer, meaning that I qualified for the best premiums due to my “healthy” ­status. That said, the transition to age 65 carries with it a significant premium increase.

Imagine my shock, though, when I was told that my premium would jump to MORE THAN 4 TIMES the previous premium for ONE-THIRD of my previous coverage! The culprit? The CAC score of 22!

It turns out that the insurance industry has adopted an underwriting standard that uses CAC—measured over a broad population, rather than a more age-confined one—to determine actuarial risk when rating life insurance policies.² As a result, my underwriting profile went all the way to “Tier 3.”

Continue to: We're used to medical consequences...

We’re used to medical consequences for tests that we order—whether a prostate biopsy for an elevated prostate-specific antigen test result, breast biopsy after abnormal mammogram, or a hemoglobin A1C test after an elevated fasting blood sugar. We can handle discussions with patients about potential diagnostic paths and readily include that information as part of shared decision-making with patients. Unfortunately, many entities are increasingly using medical information to make nonmedical decisions.

Using the CAC score to discuss the risk of adverse coronary events with my patients may be appropriate. In nonmedical settings, however, this data may be incorrectly, unfairly, or dangerously applied to our patients. I’ve begun thinking about these nonmedical applications as part of the shared decision-making process with my patients. It’s making these conversations more complicated, but life and life events for our patients take place far beyond the walls of our exam rooms.

To the Editor: COVID-19 is a pandemic caused by the virus SARS-CoV-2. Serious complications of COVID-19 are characterized by acute respiratory distress syndrome (ARDS), pneumonia and rapidly progressing to multiorgan dysfunction syndrome (MODS).

The pathophysiology of COVID-19 is not fully understood yet and neither vaccine nor clearly effective antiviral treatment is available at this time. Based on the endothelial pathogenesis of viral sepsis, which includes ARDS as seen in severe acute respiratory syndrome (SARS) due to SARS-CoV and Middle East respiratory syndrome due to MERS-CoV,^1,2 we believe COVID-19-associated ARDS is also caused by endotheliopathy-associated vascular microthrombotic disease (EA-VMTD), which also involves multiorgan dysfunction syndrome (MODS) that has been reported as the cause of death.³ We suspect these complications are secondary to disequilibrium state (for various reasons^4,5) between insufficient ADAMTS13 and excessive exocytosis of ultra large von Willebrand factor multimers (ULVWF) from Weibel-Palade bodies present in endothelial cells due to COVID-19-induced endotheliopathy.

Endothelial-derived ULVWF multimers anchored to the endothelial surface of the vascular wall recruit platelets and initiate microthrombogenesis within the microvasculature, leading to large microthrombi strings composed of platelet and eULVWF complexes like “beads-on-a-string structures”⁶ where platelets firmly adhere to eULVWF, instead of roll on eULVWF strings.⁴ Platelets, once adhered to eULVWF strings, are rapidly activated causing platelet aggregation and also recruit leukocytes in a P-selectin dependent manner.⁴ These aggregates grow until they become sufficiently large and can no longer be held onto the eULVWF strings against the force of blood flow and released from endothelial cells into the circulation.⁴ It appears to us that in COVID-19 microthrombotic disease, large amounts of circulating complexes of endothelial-derived ULVWF decorated-platelet microthrombi strings are filtered in the microvasculature (embolism) or develops in the microvasculature in situ causing microthrombotic occlusion. During our data search, we have come across several articles published by Chang, including on endotheliopathy causing vascular microthrombotic disease based on a novel concept of “TTP-like syndrome”⁷

The genesis of EA-VMTD in TTP like syndrome is suspected to be triggered by complement activation and terminal complement complex (C5b-9, membrane attack complex, MAC) may play a key role in producing endotheliopathy.⁷ Magro and colleagues reported that COVID-19 patients have demonstrated generalized thrombotic microvascular injury involving the lungs and skin showing intense complement activation and C5b-9 deposition in the tissue.⁸ Also, recent pathology reports of COVID-19 diseased lungs showed extensive platelet-rich clotting with adherent mononuclear cells and extensive fibrin clotting,⁹ which appear consistent with involvement of NETosis.¹⁰ In another case report from Switzerland, a patient with severe COVID-19 had massive elevation of VWF antigen and activity (555% and 520%, respectively) and increased Factor VIII clotting activity (369%).¹¹ These findings support vascular endotheliopathy causing exocytosis of ULVWF and associated increase in Factor VIII causing microthrombotic disease/embolism.

COVID-19 clinical syndrome appears very much consistent with EA-VMTD presenting with ARDS and MODS as well as micro-macro-thrombotic complications, including peripheral ischemia/gangrene involving fingers and toes and skin necrosis.^8,12

We believe that an appropriate therapy may not be anticoagulation but should include antimicrothrombotic therapy targeting endotheliopathy and primary hemostasis in the early stages of the disease (platelet adhesion, activation, and aggregation; especially eULVWF) like recombinant CD59 (membrane attack complex inhibition factor [MACIF]), recombinant ADAMTS13, glycoprotein IIb/IIIa receptor blocker, therapeutic plasma exchange, and perhaps anticomplement therapy (in selected cases) and others; these need to be validated in clinical trials prior to clinical application.

Of note, ADAMTS13 is a zinc containing protease. We noted that zinc and calcium concentrations play a significant role (in vitro) in ADAMTS13 activity in citrated plasma and recombinant ADAMTS13 activity with no added chelators (recombinant ADAMTS13 activity can enhance up to 200-fold); whereas in high zinc concentrations, ADAMTS13 gets deactivated.¹³ We suggest this finding merits an urgent clinical trial since it appears to us as the best possible cost-effective treatment for COVID-19 microthrombotic complications.

In this view of clinical pathophysiology of sepsis in COVID-19, we would like to enlighten the relationship between endothelial pathogenesis of coronaviral sepsis and vascular microthrombotic disease and would urge the medical community to immediately explore appropriate therapeutic options.

N. Varatharajah, MD

Suganthi Rajah, MD

Virginia, US

To the Editor: COVID-19 is a pandemic caused by the virus SARS-CoV-2. Serious complications of COVID-19 are characterized by acute respiratory distress syndrome (ARDS), pneumonia and rapidly progressing to multiorgan dysfunction syndrome (MODS).

The pathophysiology of COVID-19 is not fully understood yet and neither vaccine nor clearly effective antiviral treatment is available at this time. Based on the endothelial pathogenesis of viral sepsis, which includes ARDS as seen in severe acute respiratory syndrome (SARS) due to SARS-CoV and Middle East respiratory syndrome due to MERS-CoV,^1,2 we believe COVID-19-associated ARDS is also caused by endotheliopathy-associated vascular microthrombotic disease (EA-VMTD), which also involves multiorgan dysfunction syndrome (MODS) that has been reported as the cause of death.³ We suspect these complications are secondary to disequilibrium state (for various reasons^4,5) between insufficient ADAMTS13 and excessive exocytosis of ultra large von Willebrand factor multimers (ULVWF) from Weibel-Palade bodies present in endothelial cells due to COVID-19-induced endotheliopathy.

Endothelial-derived ULVWF multimers anchored to the endothelial surface of the vascular wall recruit platelets and initiate microthrombogenesis within the microvasculature, leading to large microthrombi strings composed of platelet and eULVWF complexes like “beads-on-a-string structures”⁶ where platelets firmly adhere to eULVWF, instead of roll on eULVWF strings.⁴ Platelets, once adhered to eULVWF strings, are rapidly activated causing platelet aggregation and also recruit leukocytes in a P-selectin dependent manner.⁴ These aggregates grow until they become sufficiently large and can no longer be held onto the eULVWF strings against the force of blood flow and released from endothelial cells into the circulation.⁴ It appears to us that in COVID-19 microthrombotic disease, large amounts of circulating complexes of endothelial-derived ULVWF decorated-platelet microthrombi strings are filtered in the microvasculature (embolism) or develops in the microvasculature in situ causing microthrombotic occlusion. During our data search, we have come across several articles published by Chang, including on endotheliopathy causing vascular microthrombotic disease based on a novel concept of “TTP-like syndrome”⁷

The genesis of EA-VMTD in TTP like syndrome is suspected to be triggered by complement activation and terminal complement complex (C5b-9, membrane attack complex, MAC) may play a key role in producing endotheliopathy.⁷ Magro and colleagues reported that COVID-19 patients have demonstrated generalized thrombotic microvascular injury involving the lungs and skin showing intense complement activation and C5b-9 deposition in the tissue.⁸ Also, recent pathology reports of COVID-19 diseased lungs showed extensive platelet-rich clotting with adherent mononuclear cells and extensive fibrin clotting,⁹ which appear consistent with involvement of NETosis.¹⁰ In another case report from Switzerland, a patient with severe COVID-19 had massive elevation of VWF antigen and activity (555% and 520%, respectively) and increased Factor VIII clotting activity (369%).¹¹ These findings support vascular endotheliopathy causing exocytosis of ULVWF and associated increase in Factor VIII causing microthrombotic disease/embolism.

COVID-19 clinical syndrome appears very much consistent with EA-VMTD presenting with ARDS and MODS as well as micro-macro-thrombotic complications, including peripheral ischemia/gangrene involving fingers and toes and skin necrosis.^8,12

We believe that an appropriate therapy may not be anticoagulation but should include antimicrothrombotic therapy targeting endotheliopathy and primary hemostasis in the early stages of the disease (platelet adhesion, activation, and aggregation; especially eULVWF) like recombinant CD59 (membrane attack complex inhibition factor [MACIF]), recombinant ADAMTS13, glycoprotein IIb/IIIa receptor blocker, therapeutic plasma exchange, and perhaps anticomplement therapy (in selected cases) and others; these need to be validated in clinical trials prior to clinical application.

Of note, ADAMTS13 is a zinc containing protease. We noted that zinc and calcium concentrations play a significant role (in vitro) in ADAMTS13 activity in citrated plasma and recombinant ADAMTS13 activity with no added chelators (recombinant ADAMTS13 activity can enhance up to 200-fold); whereas in high zinc concentrations, ADAMTS13 gets deactivated.¹³ We suggest this finding merits an urgent clinical trial since it appears to us as the best possible cost-effective treatment for COVID-19 microthrombotic complications.

In this view of clinical pathophysiology of sepsis in COVID-19, we would like to enlighten the relationship between endothelial pathogenesis of coronaviral sepsis and vascular microthrombotic disease and would urge the medical community to immediately explore appropriate therapeutic options.

N. Varatharajah, MD

Suganthi Rajah, MD

Virginia, US

To the Editor: COVID-19 is a pandemic caused by the virus SARS-CoV-2. Serious complications of COVID-19 are characterized by acute respiratory distress syndrome (ARDS), pneumonia and rapidly progressing to multiorgan dysfunction syndrome (MODS).

The pathophysiology of COVID-19 is not fully understood yet and neither vaccine nor clearly effective antiviral treatment is available at this time. Based on the endothelial pathogenesis of viral sepsis, which includes ARDS as seen in severe acute respiratory syndrome (SARS) due to SARS-CoV and Middle East respiratory syndrome due to MERS-CoV,^1,2 we believe COVID-19-associated ARDS is also caused by endotheliopathy-associated vascular microthrombotic disease (EA-VMTD), which also involves multiorgan dysfunction syndrome (MODS) that has been reported as the cause of death.³ We suspect these complications are secondary to disequilibrium state (for various reasons^4,5) between insufficient ADAMTS13 and excessive exocytosis of ultra large von Willebrand factor multimers (ULVWF) from Weibel-Palade bodies present in endothelial cells due to COVID-19-induced endotheliopathy.

Endothelial-derived ULVWF multimers anchored to the endothelial surface of the vascular wall recruit platelets and initiate microthrombogenesis within the microvasculature, leading to large microthrombi strings composed of platelet and eULVWF complexes like “beads-on-a-string structures”⁶ where platelets firmly adhere to eULVWF, instead of roll on eULVWF strings.⁴ Platelets, once adhered to eULVWF strings, are rapidly activated causing platelet aggregation and also recruit leukocytes in a P-selectin dependent manner.⁴ These aggregates grow until they become sufficiently large and can no longer be held onto the eULVWF strings against the force of blood flow and released from endothelial cells into the circulation.⁴ It appears to us that in COVID-19 microthrombotic disease, large amounts of circulating complexes of endothelial-derived ULVWF decorated-platelet microthrombi strings are filtered in the microvasculature (embolism) or develops in the microvasculature in situ causing microthrombotic occlusion. During our data search, we have come across several articles published by Chang, including on endotheliopathy causing vascular microthrombotic disease based on a novel concept of “TTP-like syndrome”⁷

The genesis of EA-VMTD in TTP like syndrome is suspected to be triggered by complement activation and terminal complement complex (C5b-9, membrane attack complex, MAC) may play a key role in producing endotheliopathy.⁷ Magro and colleagues reported that COVID-19 patients have demonstrated generalized thrombotic microvascular injury involving the lungs and skin showing intense complement activation and C5b-9 deposition in the tissue.⁸ Also, recent pathology reports of COVID-19 diseased lungs showed extensive platelet-rich clotting with adherent mononuclear cells and extensive fibrin clotting,⁹ which appear consistent with involvement of NETosis.¹⁰ In another case report from Switzerland, a patient with severe COVID-19 had massive elevation of VWF antigen and activity (555% and 520%, respectively) and increased Factor VIII clotting activity (369%).¹¹ These findings support vascular endotheliopathy causing exocytosis of ULVWF and associated increase in Factor VIII causing microthrombotic disease/embolism.

COVID-19 clinical syndrome appears very much consistent with EA-VMTD presenting with ARDS and MODS as well as micro-macro-thrombotic complications, including peripheral ischemia/gangrene involving fingers and toes and skin necrosis.^8,12

We believe that an appropriate therapy may not be anticoagulation but should include antimicrothrombotic therapy targeting endotheliopathy and primary hemostasis in the early stages of the disease (platelet adhesion, activation, and aggregation; especially eULVWF) like recombinant CD59 (membrane attack complex inhibition factor [MACIF]), recombinant ADAMTS13, glycoprotein IIb/IIIa receptor blocker, therapeutic plasma exchange, and perhaps anticomplement therapy (in selected cases) and others; these need to be validated in clinical trials prior to clinical application.

Of note, ADAMTS13 is a zinc containing protease. We noted that zinc and calcium concentrations play a significant role (in vitro) in ADAMTS13 activity in citrated plasma and recombinant ADAMTS13 activity with no added chelators (recombinant ADAMTS13 activity can enhance up to 200-fold); whereas in high zinc concentrations, ADAMTS13 gets deactivated.¹³ We suggest this finding merits an urgent clinical trial since it appears to us as the best possible cost-effective treatment for COVID-19 microthrombotic complications.

In this view of clinical pathophysiology of sepsis in COVID-19, we would like to enlighten the relationship between endothelial pathogenesis of coronaviral sepsis and vascular microthrombotic disease and would urge the medical community to immediately explore appropriate therapeutic options.

N. Varatharajah, MD

Suganthi Rajah, MD

Virginia, US

For health care professionals, especially those in the epicenters of the pandemic, among the most distressing aspects of this first wave of COVID-19 has been the absence of any drug to treat the virus. The practitioners on the frontlines have confronted repeated surges of critically ill and dying patients without any effective treatment to offer, resulting in feelings of hopelessness, guilt, moral distress, depression, and in some tragic cases, suicide.²

On May 12th, the Centers of Disease Control and Prevention (CDC) released additional guidance on the antiviral medications that are the subject of this essay. The CDC may have updated its treatment guidelines in part to try and bring a measure of clinical reasoning and scientific order into the impassioned and politicized chaos that surrounded hydrocloroquine and remdesivir in the media.³

In this fourth installment of my series on pandemic ethics, we examine the desperate race for hope in the form of drug treatments for COVID-19. The race has been run faster than any in history thanks to biotechnology, genetic engineering, and artificial intelligence, although many experts believe it will still be a marathon rather than a sprint to a vaccine.⁴

The first editorial in this series provided a primer of the key differences between public health ethics and clinical ethics. Another crucial distinction is the far more pervasive and powerful influence of nonmedical factors in decision making, including political agendas, economic motives, journalistic hyperbole, and cultural biases and orientations. These competing interests make it even more challenging for scientists of integrity and health care institutions that are trying to uphold core values to make principled judgments about what is best for critically ill patients and the demoralized staff caring for them. In the remainder of this column, I will trace the dynamics of these forces as they impact the use of 2 drugs in federal practice: hydroxychloroquine and remdesivir.

The trajectory of hydroxychloroquine has been a political and medical roller-coaster since the pandemic hit, as is evident in its US Department of Veterans Affairs (VA) ride. Various media outlets have reported that beginning about March 26, 2020, VA placed orders for up to $400,000 of the antimalarial drug hydroxychloroquine to be given to veterans hospitalized with COVID-19.⁵ The same day the VA Office of Inspector General (OIG) issued a report critical of VA pandemic readiness and its availability of hydroxychloroquine.⁶

The VA strongly refuted the report, objecting to the premise of the OIG investigation, which was to determine whether VA facilities had on hand a 14-day supply of chloroquine or hydroxychloroquine. “This is both inaccurate and irresponsible.” Noting that the drugs were still under investigation, the VA insisted that “No conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”⁶

In April, National Institutes of Health-sponsored researchers released data that hydroxychloroquine actually increased mortality among VA patients with COVID-19,⁷ leading veterans’ groups and the Senate minority leader to demand that VA cease to use hydroxychloroquine for COVID-19.⁸ As recently as May 15, the Associated Press reported that top VA officials have defended their use of the medication and stated they will not stop administering the medication for this indication.⁹ And VA is not alone, many other health care institutions are still prescribing hydroxychloroquine even amid scientific controversy about its putative benefits. In response to the growing awareness of the potential harms of the drug, the World Health Organization on May 25 announced it was halting all hydroxychloroquine trials.¹⁰ Why then do some physicians and health care providers continue to prescribe it? Because when nothing else stands between the patient and certain death even if there are known risks and uncertain benefits, some in health care feel morally obliged to use their best clinical judgment to help a patient.

Remdesivir’s fortunes both scientific and monetary also rose and fell on the tide of mixed results from studies. Military Times reported on March 10, 2020, that the US Army Medical Research and Development Command had made an agreement with Gilead Sciences, the manufacturer of remdesivir, to provide the medication to COVID-19-positive service members.¹¹ The antiviral had failed against Ebola and hepatitis but showed some efficacy for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). On April 15, the Secretary of the Army announced that 2 COVID-19-positive soldiers had recovered after being given remdesivir.¹² In late April, the National Institute of Allergy and Infectious Diseases reported that in the scientific gold standard randomized placebo-controlled trial, remdesivir did speed the recovery of patients with advanced COVID-19. With the publication of the study in the prestigious New England Journal of Medicine on May 22, 2020, clearly the Army had bet on the right horse.¹³

This column has not been about quack cures and patent medicines that greed and ignorance breed in almost every American public health crisis—although these are by no means absent in this pandemic. This is about the serious endeavor of the top scientists and physicians in the country and, indeed, the world to discover a new medication or to repurpose an older pharmaceutical that is effective in the battle against COVID-19. The pressure on scientists and physicians to find a magic bullet in the battle against such an implacable enemy is unprecedented and unimaginable and can easily lead to sloppy science and ethical erosion.

In a utopia, pharmaceutical and vaccine research would be a matter of the discoveries of basic science trialed in the proof of concept of clinical care on a methodical, deliberate, and exacting timetable that balanced burdens and benefits.

In our current dystopia, science and medicine are only one of the many considerations affecting drug and vaccine development. As scientists and health care practitioners, we all experience a therapeutic imperative that we must heed with both caution and courage. Without caution we risk causing more harm than the disease we are fighting. Without courage we lose hope, the most potent antidote of all.

For health care professionals, especially those in the epicenters of the pandemic, among the most distressing aspects of this first wave of COVID-19 has been the absence of any drug to treat the virus. The practitioners on the frontlines have confronted repeated surges of critically ill and dying patients without any effective treatment to offer, resulting in feelings of hopelessness, guilt, moral distress, depression, and in some tragic cases, suicide.²

On May 12th, the Centers of Disease Control and Prevention (CDC) released additional guidance on the antiviral medications that are the subject of this essay. The CDC may have updated its treatment guidelines in part to try and bring a measure of clinical reasoning and scientific order into the impassioned and politicized chaos that surrounded hydrocloroquine and remdesivir in the media.³

In this fourth installment of my series on pandemic ethics, we examine the desperate race for hope in the form of drug treatments for COVID-19. The race has been run faster than any in history thanks to biotechnology, genetic engineering, and artificial intelligence, although many experts believe it will still be a marathon rather than a sprint to a vaccine.⁴

The first editorial in this series provided a primer of the key differences between public health ethics and clinical ethics. Another crucial distinction is the far more pervasive and powerful influence of nonmedical factors in decision making, including political agendas, economic motives, journalistic hyperbole, and cultural biases and orientations. These competing interests make it even more challenging for scientists of integrity and health care institutions that are trying to uphold core values to make principled judgments about what is best for critically ill patients and the demoralized staff caring for them. In the remainder of this column, I will trace the dynamics of these forces as they impact the use of 2 drugs in federal practice: hydroxychloroquine and remdesivir.

The trajectory of hydroxychloroquine has been a political and medical roller-coaster since the pandemic hit, as is evident in its US Department of Veterans Affairs (VA) ride. Various media outlets have reported that beginning about March 26, 2020, VA placed orders for up to $400,000 of the antimalarial drug hydroxychloroquine to be given to veterans hospitalized with COVID-19.⁵ The same day the VA Office of Inspector General (OIG) issued a report critical of VA pandemic readiness and its availability of hydroxychloroquine.⁶

The VA strongly refuted the report, objecting to the premise of the OIG investigation, which was to determine whether VA facilities had on hand a 14-day supply of chloroquine or hydroxychloroquine. “This is both inaccurate and irresponsible.” Noting that the drugs were still under investigation, the VA insisted that “No conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”⁶

In April, National Institutes of Health-sponsored researchers released data that hydroxychloroquine actually increased mortality among VA patients with COVID-19,⁷ leading veterans’ groups and the Senate minority leader to demand that VA cease to use hydroxychloroquine for COVID-19.⁸ As recently as May 15, the Associated Press reported that top VA officials have defended their use of the medication and stated they will not stop administering the medication for this indication.⁹ And VA is not alone, many other health care institutions are still prescribing hydroxychloroquine even amid scientific controversy about its putative benefits. In response to the growing awareness of the potential harms of the drug, the World Health Organization on May 25 announced it was halting all hydroxychloroquine trials.¹⁰ Why then do some physicians and health care providers continue to prescribe it? Because when nothing else stands between the patient and certain death even if there are known risks and uncertain benefits, some in health care feel morally obliged to use their best clinical judgment to help a patient.

Remdesivir’s fortunes both scientific and monetary also rose and fell on the tide of mixed results from studies. Military Times reported on March 10, 2020, that the US Army Medical Research and Development Command had made an agreement with Gilead Sciences, the manufacturer of remdesivir, to provide the medication to COVID-19-positive service members.¹¹ The antiviral had failed against Ebola and hepatitis but showed some efficacy for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). On April 15, the Secretary of the Army announced that 2 COVID-19-positive soldiers had recovered after being given remdesivir.¹² In late April, the National Institute of Allergy and Infectious Diseases reported that in the scientific gold standard randomized placebo-controlled trial, remdesivir did speed the recovery of patients with advanced COVID-19. With the publication of the study in the prestigious New England Journal of Medicine on May 22, 2020, clearly the Army had bet on the right horse.¹³

This column has not been about quack cures and patent medicines that greed and ignorance breed in almost every American public health crisis—although these are by no means absent in this pandemic. This is about the serious endeavor of the top scientists and physicians in the country and, indeed, the world to discover a new medication or to repurpose an older pharmaceutical that is effective in the battle against COVID-19. The pressure on scientists and physicians to find a magic bullet in the battle against such an implacable enemy is unprecedented and unimaginable and can easily lead to sloppy science and ethical erosion.

In a utopia, pharmaceutical and vaccine research would be a matter of the discoveries of basic science trialed in the proof of concept of clinical care on a methodical, deliberate, and exacting timetable that balanced burdens and benefits.

In our current dystopia, science and medicine are only one of the many considerations affecting drug and vaccine development. As scientists and health care practitioners, we all experience a therapeutic imperative that we must heed with both caution and courage. Without caution we risk causing more harm than the disease we are fighting. Without courage we lose hope, the most potent antidote of all.

For health care professionals, especially those in the epicenters of the pandemic, among the most distressing aspects of this first wave of COVID-19 has been the absence of any drug to treat the virus. The practitioners on the frontlines have confronted repeated surges of critically ill and dying patients without any effective treatment to offer, resulting in feelings of hopelessness, guilt, moral distress, depression, and in some tragic cases, suicide.²

On May 12th, the Centers of Disease Control and Prevention (CDC) released additional guidance on the antiviral medications that are the subject of this essay. The CDC may have updated its treatment guidelines in part to try and bring a measure of clinical reasoning and scientific order into the impassioned and politicized chaos that surrounded hydrocloroquine and remdesivir in the media.³

In this fourth installment of my series on pandemic ethics, we examine the desperate race for hope in the form of drug treatments for COVID-19. The race has been run faster than any in history thanks to biotechnology, genetic engineering, and artificial intelligence, although many experts believe it will still be a marathon rather than a sprint to a vaccine.⁴

The first editorial in this series provided a primer of the key differences between public health ethics and clinical ethics. Another crucial distinction is the far more pervasive and powerful influence of nonmedical factors in decision making, including political agendas, economic motives, journalistic hyperbole, and cultural biases and orientations. These competing interests make it even more challenging for scientists of integrity and health care institutions that are trying to uphold core values to make principled judgments about what is best for critically ill patients and the demoralized staff caring for them. In the remainder of this column, I will trace the dynamics of these forces as they impact the use of 2 drugs in federal practice: hydroxychloroquine and remdesivir.

The trajectory of hydroxychloroquine has been a political and medical roller-coaster since the pandemic hit, as is evident in its US Department of Veterans Affairs (VA) ride. Various media outlets have reported that beginning about March 26, 2020, VA placed orders for up to $400,000 of the antimalarial drug hydroxychloroquine to be given to veterans hospitalized with COVID-19.⁵ The same day the VA Office of Inspector General (OIG) issued a report critical of VA pandemic readiness and its availability of hydroxychloroquine.⁶

The VA strongly refuted the report, objecting to the premise of the OIG investigation, which was to determine whether VA facilities had on hand a 14-day supply of chloroquine or hydroxychloroquine. “This is both inaccurate and irresponsible.” Noting that the drugs were still under investigation, the VA insisted that “No conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”⁶

In April, National Institutes of Health-sponsored researchers released data that hydroxychloroquine actually increased mortality among VA patients with COVID-19,⁷ leading veterans’ groups and the Senate minority leader to demand that VA cease to use hydroxychloroquine for COVID-19.⁸ As recently as May 15, the Associated Press reported that top VA officials have defended their use of the medication and stated they will not stop administering the medication for this indication.⁹ And VA is not alone, many other health care institutions are still prescribing hydroxychloroquine even amid scientific controversy about its putative benefits. In response to the growing awareness of the potential harms of the drug, the World Health Organization on May 25 announced it was halting all hydroxychloroquine trials.¹⁰ Why then do some physicians and health care providers continue to prescribe it? Because when nothing else stands between the patient and certain death even if there are known risks and uncertain benefits, some in health care feel morally obliged to use their best clinical judgment to help a patient.

Remdesivir’s fortunes both scientific and monetary also rose and fell on the tide of mixed results from studies. Military Times reported on March 10, 2020, that the US Army Medical Research and Development Command had made an agreement with Gilead Sciences, the manufacturer of remdesivir, to provide the medication to COVID-19-positive service members.¹¹ The antiviral had failed against Ebola and hepatitis but showed some efficacy for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). On April 15, the Secretary of the Army announced that 2 COVID-19-positive soldiers had recovered after being given remdesivir.¹² In late April, the National Institute of Allergy and Infectious Diseases reported that in the scientific gold standard randomized placebo-controlled trial, remdesivir did speed the recovery of patients with advanced COVID-19. With the publication of the study in the prestigious New England Journal of Medicine on May 22, 2020, clearly the Army had bet on the right horse.¹³

This column has not been about quack cures and patent medicines that greed and ignorance breed in almost every American public health crisis—although these are by no means absent in this pandemic. This is about the serious endeavor of the top scientists and physicians in the country and, indeed, the world to discover a new medication or to repurpose an older pharmaceutical that is effective in the battle against COVID-19. The pressure on scientists and physicians to find a magic bullet in the battle against such an implacable enemy is unprecedented and unimaginable and can easily lead to sloppy science and ethical erosion.

In a utopia, pharmaceutical and vaccine research would be a matter of the discoveries of basic science trialed in the proof of concept of clinical care on a methodical, deliberate, and exacting timetable that balanced burdens and benefits.

In our current dystopia, science and medicine are only one of the many considerations affecting drug and vaccine development. As scientists and health care practitioners, we all experience a therapeutic imperative that we must heed with both caution and courage. Without caution we risk causing more harm than the disease we are fighting. Without courage we lose hope, the most potent antidote of all.

Most people can cope, to some degree, with the multiple weeks of social distancing and stressors related to the pandemic. But what if those stressors became a way of life for a year – or longer? What sorts of skills would be essential not only to survive but to have a renewed sense of resilience?

I know of one group that has had experiences that mirror the challenges faced by the parents of children: the parents of special needs children. As I argued previously, those parents have faced many of the challenges presented by COVID-19. Among those challenges are social distancing and difficulty accessing everyday common experiences. These parents know that they have to manage more areas of their children’s rearing than do their counterparts.

In addition to having to plan for how to deal with acute urgent or emergent medical situations involving their special needs children, these parents also must prepare for the long-term effects of managing children who require ongoing daily care, attention, and dedication.

As psychiatrists, we can teach patients several strategies that can serve as basic building blocks. These strategies can help the parents of special needs kids find a sense of mastery and comfort. The hope is that, after practicing them for long periods of time, the strategies become second nature.

Here are several strategies that might help patients with children during this pandemic:

• Take time to reset: Sometimes it is helpful for parents to take a minute away from a difficult impasse with their kids to reset and take their own “time out.” A few seconds of mental time away from the “scene” provides space and a mental reminder that the minute that just happened is finite, and that a whole new one is coming up next. The break provides a sense of hope. This cognitive reframing could be practiced often.
• Re-enter the challenging scene with a warm voice: Parents model for their children, but they also are telling their own brains that they, too, can calm down. This approach also de-escalates the situation and allows children to get used to hearing directions from someone who is in control – without hostility or irritability.
• Keep a sense of humor; it might come in handy: This is especially the case when tension is in the home, or when facing a set of challenging bad news. As an example, consider how some situations are so repetitive that they border on the ridiculous – such as a grown child having a tantrum at a store. Encourage the children to give themselves permission to cry first so they can laugh second, and then move on.
• Establish a routine for children that is self-reinforcing, and allows for together and separate times: They can, as an example: A) Get ready for the day all by themselves, or as much as they can do independently, before they come down and then B) have breakfast. Then, the child can C) do homework, and then D) go play outside. The routine would then continue on its own without outside reinforcers.
• Tell the children that they can get to the reinforcing activity only after completing the previous one. Over time, they learn to take pride in completing the first activity and doing so more independently. Not having to wait to be told what to do all the time fosters a sense of independence.
• Plan for meals and fun tasks together, and separate for individual work. This creates a sense of change and gives the day a certain flow. Establish routines that are predictable for the children that can be easily documented for the whole family on a calendar. Establish a beginning and an end time to the work day. Mark the end of the day with a chalk line establishing when the family can engage in a certain activity, for example, going for a family bike ride. Let the routine honor healthy circadian rhythms for sleep/wakeful times, and be consistent.
• Feed the brain and body the “good stuff”: Limit negative news, and surround the children with people who bring them joy or provide hope. Listen to inspirational messages and uplifting music. Give the children food that nourishes and energizes their bodies. Take in the view outside, the greenery, or the sky if there is no green around. Connect with family/friends who are far away.
• Make time to replenish with something that is meaningful/productive/helpful: Parents have very little time for themselves when they are “on,” so when they can actually take a little time to recharge, the activity should check many boxes. For example, encourage them to go for a walk (exercise) while listening to music (relax), make a phone call to someone who can relate to their situation (socialize), pray with someone (be spiritual), or sit in their rooms to get some alone quiet time (meditate). Reach out to those who are lonely. Network. Mentor. Volunteer.
• Develop an eye for noticing the positive: Instead of hoping for things to go back to the way they were, tell your patients to practice embracing without judgment the new norm. Get them to notice the time they spend with their families. Break all tasks into many smaller tasks, so there is more possibility of observing progress, and it is evident for everyone to see. Learn to notice the small changes that they want to see in their children. Celebrate all that can be celebrated by stating the obvious: “You wiped your face after eating. You are observant; you are noticing when you have something on your face.”
• State when a child is forgiving, helpful, or puts forward some effort. Label the growth witnessed. The child will learn that that is who they are over time (“observant”). Verbalizing these behaviors also will provide patients with a sense of mastery over parenting, because they are driving the emotional and behavioral development of their children in a way that also complements their family values.
• Make everyone in the family a contributor and foster a sense of gratitude: Give everyone a reason to claim that their collaboration and effort are a big part of the plan’s success. Take turns to lessen everyone’s burden and to thank them for their contributions. Older children can take on leadership roles, even in small ways. Younger children can practice being good listeners, following directions, and helping. Reverse the roles when possible.

Special needs families sometimes have to work harder than others to overcome obstacles, grow, and learn to support one another. Since the pandemic, many parents have been just as challenged. Mastering the above skills might provide a sense of fulfillment and agency, as well as an appreciation for the unexpected gifts that special children – and all children – have to offer.
 

Dr. Sotir is a psychiatrist with a private practice in Wheaton, Ill. As a parent of three children, one with special needs, she has extensive experience helping parents challenged by having special needs children find balance, support, direction, and joy in all dimensions of individual and family life. This area is the focus of her practice and public speaking. She has no disclosures.

Most people can cope, to some degree, with the multiple weeks of social distancing and stressors related to the pandemic. But what if those stressors became a way of life for a year – or longer? What sorts of skills would be essential not only to survive but to have a renewed sense of resilience?

I know of one group that has had experiences that mirror the challenges faced by the parents of children: the parents of special needs children. As I argued previously, those parents have faced many of the challenges presented by COVID-19. Among those challenges are social distancing and difficulty accessing everyday common experiences. These parents know that they have to manage more areas of their children’s rearing than do their counterparts.

In addition to having to plan for how to deal with acute urgent or emergent medical situations involving their special needs children, these parents also must prepare for the long-term effects of managing children who require ongoing daily care, attention, and dedication.

As psychiatrists, we can teach patients several strategies that can serve as basic building blocks. These strategies can help the parents of special needs kids find a sense of mastery and comfort. The hope is that, after practicing them for long periods of time, the strategies become second nature.

Here are several strategies that might help patients with children during this pandemic:

• Take time to reset: Sometimes it is helpful for parents to take a minute away from a difficult impasse with their kids to reset and take their own “time out.” A few seconds of mental time away from the “scene” provides space and a mental reminder that the minute that just happened is finite, and that a whole new one is coming up next. The break provides a sense of hope. This cognitive reframing could be practiced often.
• Re-enter the challenging scene with a warm voice: Parents model for their children, but they also are telling their own brains that they, too, can calm down. This approach also de-escalates the situation and allows children to get used to hearing directions from someone who is in control – without hostility or irritability.
• Keep a sense of humor; it might come in handy: This is especially the case when tension is in the home, or when facing a set of challenging bad news. As an example, consider how some situations are so repetitive that they border on the ridiculous – such as a grown child having a tantrum at a store. Encourage the children to give themselves permission to cry first so they can laugh second, and then move on.
• Establish a routine for children that is self-reinforcing, and allows for together and separate times: They can, as an example: A) Get ready for the day all by themselves, or as much as they can do independently, before they come down and then B) have breakfast. Then, the child can C) do homework, and then D) go play outside. The routine would then continue on its own without outside reinforcers.
• Tell the children that they can get to the reinforcing activity only after completing the previous one. Over time, they learn to take pride in completing the first activity and doing so more independently. Not having to wait to be told what to do all the time fosters a sense of independence.
• Plan for meals and fun tasks together, and separate for individual work. This creates a sense of change and gives the day a certain flow. Establish routines that are predictable for the children that can be easily documented for the whole family on a calendar. Establish a beginning and an end time to the work day. Mark the end of the day with a chalk line establishing when the family can engage in a certain activity, for example, going for a family bike ride. Let the routine honor healthy circadian rhythms for sleep/wakeful times, and be consistent.
• Feed the brain and body the “good stuff”: Limit negative news, and surround the children with people who bring them joy or provide hope. Listen to inspirational messages and uplifting music. Give the children food that nourishes and energizes their bodies. Take in the view outside, the greenery, or the sky if there is no green around. Connect with family/friends who are far away.
• Make time to replenish with something that is meaningful/productive/helpful: Parents have very little time for themselves when they are “on,” so when they can actually take a little time to recharge, the activity should check many boxes. For example, encourage them to go for a walk (exercise) while listening to music (relax), make a phone call to someone who can relate to their situation (socialize), pray with someone (be spiritual), or sit in their rooms to get some alone quiet time (meditate). Reach out to those who are lonely. Network. Mentor. Volunteer.
• Develop an eye for noticing the positive: Instead of hoping for things to go back to the way they were, tell your patients to practice embracing without judgment the new norm. Get them to notice the time they spend with their families. Break all tasks into many smaller tasks, so there is more possibility of observing progress, and it is evident for everyone to see. Learn to notice the small changes that they want to see in their children. Celebrate all that can be celebrated by stating the obvious: “You wiped your face after eating. You are observant; you are noticing when you have something on your face.”
• State when a child is forgiving, helpful, or puts forward some effort. Label the growth witnessed. The child will learn that that is who they are over time (“observant”). Verbalizing these behaviors also will provide patients with a sense of mastery over parenting, because they are driving the emotional and behavioral development of their children in a way that also complements their family values.
• Make everyone in the family a contributor and foster a sense of gratitude: Give everyone a reason to claim that their collaboration and effort are a big part of the plan’s success. Take turns to lessen everyone’s burden and to thank them for their contributions. Older children can take on leadership roles, even in small ways. Younger children can practice being good listeners, following directions, and helping. Reverse the roles when possible.

Special needs families sometimes have to work harder than others to overcome obstacles, grow, and learn to support one another. Since the pandemic, many parents have been just as challenged. Mastering the above skills might provide a sense of fulfillment and agency, as well as an appreciation for the unexpected gifts that special children – and all children – have to offer.
 

Dr. Sotir is a psychiatrist with a private practice in Wheaton, Ill. As a parent of three children, one with special needs, she has extensive experience helping parents challenged by having special needs children find balance, support, direction, and joy in all dimensions of individual and family life. This area is the focus of her practice and public speaking. She has no disclosures.

Most people can cope, to some degree, with the multiple weeks of social distancing and stressors related to the pandemic. But what if those stressors became a way of life for a year – or longer? What sorts of skills would be essential not only to survive but to have a renewed sense of resilience?

I know of one group that has had experiences that mirror the challenges faced by the parents of children: the parents of special needs children. As I argued previously, those parents have faced many of the challenges presented by COVID-19. Among those challenges are social distancing and difficulty accessing everyday common experiences. These parents know that they have to manage more areas of their children’s rearing than do their counterparts.

In addition to having to plan for how to deal with acute urgent or emergent medical situations involving their special needs children, these parents also must prepare for the long-term effects of managing children who require ongoing daily care, attention, and dedication.

As psychiatrists, we can teach patients several strategies that can serve as basic building blocks. These strategies can help the parents of special needs kids find a sense of mastery and comfort. The hope is that, after practicing them for long periods of time, the strategies become second nature.

Here are several strategies that might help patients with children during this pandemic:

• Take time to reset: Sometimes it is helpful for parents to take a minute away from a difficult impasse with their kids to reset and take their own “time out.” A few seconds of mental time away from the “scene” provides space and a mental reminder that the minute that just happened is finite, and that a whole new one is coming up next. The break provides a sense of hope. This cognitive reframing could be practiced often.
• Re-enter the challenging scene with a warm voice: Parents model for their children, but they also are telling their own brains that they, too, can calm down. This approach also de-escalates the situation and allows children to get used to hearing directions from someone who is in control – without hostility or irritability.
• Keep a sense of humor; it might come in handy: This is especially the case when tension is in the home, or when facing a set of challenging bad news. As an example, consider how some situations are so repetitive that they border on the ridiculous – such as a grown child having a tantrum at a store. Encourage the children to give themselves permission to cry first so they can laugh second, and then move on.
• Establish a routine for children that is self-reinforcing, and allows for together and separate times: They can, as an example: A) Get ready for the day all by themselves, or as much as they can do independently, before they come down and then B) have breakfast. Then, the child can C) do homework, and then D) go play outside. The routine would then continue on its own without outside reinforcers.
• Tell the children that they can get to the reinforcing activity only after completing the previous one. Over time, they learn to take pride in completing the first activity and doing so more independently. Not having to wait to be told what to do all the time fosters a sense of independence.
• Plan for meals and fun tasks together, and separate for individual work. This creates a sense of change and gives the day a certain flow. Establish routines that are predictable for the children that can be easily documented for the whole family on a calendar. Establish a beginning and an end time to the work day. Mark the end of the day with a chalk line establishing when the family can engage in a certain activity, for example, going for a family bike ride. Let the routine honor healthy circadian rhythms for sleep/wakeful times, and be consistent.
• Feed the brain and body the “good stuff”: Limit negative news, and surround the children with people who bring them joy or provide hope. Listen to inspirational messages and uplifting music. Give the children food that nourishes and energizes their bodies. Take in the view outside, the greenery, or the sky if there is no green around. Connect with family/friends who are far away.
• Make time to replenish with something that is meaningful/productive/helpful: Parents have very little time for themselves when they are “on,” so when they can actually take a little time to recharge, the activity should check many boxes. For example, encourage them to go for a walk (exercise) while listening to music (relax), make a phone call to someone who can relate to their situation (socialize), pray with someone (be spiritual), or sit in their rooms to get some alone quiet time (meditate). Reach out to those who are lonely. Network. Mentor. Volunteer.
• Develop an eye for noticing the positive: Instead of hoping for things to go back to the way they were, tell your patients to practice embracing without judgment the new norm. Get them to notice the time they spend with their families. Break all tasks into many smaller tasks, so there is more possibility of observing progress, and it is evident for everyone to see. Learn to notice the small changes that they want to see in their children. Celebrate all that can be celebrated by stating the obvious: “You wiped your face after eating. You are observant; you are noticing when you have something on your face.”
• State when a child is forgiving, helpful, or puts forward some effort. Label the growth witnessed. The child will learn that that is who they are over time (“observant”). Verbalizing these behaviors also will provide patients with a sense of mastery over parenting, because they are driving the emotional and behavioral development of their children in a way that also complements their family values.
• Make everyone in the family a contributor and foster a sense of gratitude: Give everyone a reason to claim that their collaboration and effort are a big part of the plan’s success. Take turns to lessen everyone’s burden and to thank them for their contributions. Older children can take on leadership roles, even in small ways. Younger children can practice being good listeners, following directions, and helping. Reverse the roles when possible.

Special needs families sometimes have to work harder than others to overcome obstacles, grow, and learn to support one another. Since the pandemic, many parents have been just as challenged. Mastering the above skills might provide a sense of fulfillment and agency, as well as an appreciation for the unexpected gifts that special children – and all children – have to offer.
 

Dr. Sotir is a psychiatrist with a private practice in Wheaton, Ill. As a parent of three children, one with special needs, she has extensive experience helping parents challenged by having special needs children find balance, support, direction, and joy in all dimensions of individual and family life. This area is the focus of her practice and public speaking. She has no disclosures.

Parents of children with significant special needs know a thing or two about what the population in general has been experiencing since the pandemic took hold of the nation. The last few months have tested the stamina of most families. Many people are struggling to keep some semblance of normalcy amid a radical transformation of everyday life. It seems as if everything changed overnight.

Jupiterimages/Thinkstock

In a similar way, when a child with many needs is born into a family, adjustments also have to take place to receive the new baby. Families are, in most cases, not prepared for what is to come. Their expectations usually are not in sync with how their lives end up. They are crunched for time. They need to adjust, and at the same time, they mourn the loss of their previous less demanding lifestyle. More importantly, these parents learn that this might be an adjustment that they might need to make for a long time – in some instances, for a lifetime.

Stress load over time can correlate with a sense of burnout, and mental health professionals need to be prepared to address these issues in our patients.

Here is a list of some chronic struggles with which many special needs parents must contend. These strongly resemble the challenges parents in the general population have been facing with their families during this pandemic:

• Bypassing breaks to unwind and having to be always “on” while at home: These parents take care of children who need to be chronically tube fed, can’t sleep well at night because they are often sick, have recurrent seizures or maladaptive behaviors that affect the caretakers and the rest of the family. For parents of children who are on the autism spectrum, these challenges can be a constant struggle. Almost 60% of children with autism spectrum disorder (ASD) experience bodily difficulties, such as trouble breathing. However, nearly 100% of children with ASD experienced difficulties with their abilities and activities, such as self-care tasks like eating and dressing, and emotional or behavioral health, according to a 2016 report on child and adolescent health by the Johns Hopkins Bloomberg School of Public Health.
• Taking on roles for which they are not trained: Parents may take on active roles supplementing their developmentally delayed children with educational experiences or therapeutic modalities in their own homes given that the needs might be too great to just rely on the school or therapy time. There are about 1.17 million children in the United States living with ASD and more than 12% of children with ASD have severe cases, the Hopkins report said. Parents frequently are forced to take on the role of “therapist” to meet the needs of their child.
• Staying home often: Some parents are unable to have a “regular sitter” to provide respite, because the needs of the child require a higher level of care, training, and consideration. Caring for a special child means parents often don’t have the option of leaving their older child alone. As a result, they may end up spending more time at home than their counterpart parents with children who are the same age.
• Struggling to meet everyone’s demands for attention while at home: The child might require full-time attention or prolonged hospitalizations, and the needs of other siblings are sometimes put on hold until time or energy are available for all.
• Not traveling unless absolutely necessary: Families have a hard time leaving home for vacations or for other reasons. They may have to travel with medical supplies and equipment. They need to make sure that their destination is ready to welcome their child with all needs taken into consideration (special diets, activities, and facilities). Will the vacation set them back because it might take more effort to go than to stay home?
• Avoiding unnecessary exposures: Trying to avoid infections (even the ones that may be innocuous to others) if their child is immunocompromised. These children may readily decompensate and end up hospitalized with a more serious medical complication.
• Being very aware of remaining physically distant from others: Parents must go to great lengths not to impinge on other people’s space if the child is being loud or moving in a disruptive way, or if other people negatively affect how the child responds. Some families are apprehensive because they have felt judged by others when they are in the community, restaurants, or other places of gathering.
• Feeling concerned about having the right food, medicines, and supplements in the house: Parents are constantly trying to fulfill special dietary requirements and have the reserve to make sure that all meals and treatments are accounted for in the near future. They might need oxygen or specialized formulas that are hard to find in local stores. Some treatments, when withdrawn or unavailable, can prove life threatening.
• Restricting social circles: Some families with children with severe autism may self-isolate when they feel it is hard to be around them and be friends with them, since they can’t readily participate in “usual family activities,” and the regular norms of socialization can’t apply to their family’s set of behaviors. Their child might seem to be disruptive, or loud, nonverbal, mute, or unable to easily relate to others.
• Experiencing a pervasive sense of uncertainty about the future: A child might continue to miss milestones, or might have a rare condition that hasn’t been diagnosed. When thinking of the future, parents can’t predict what level of care they need to plan and budget for.
• Being concerned about dying early and not being able to provide for their child: Parents worry about who would take care of their child for life. Who would take care of their aging adult “child” after parents are gone? They might have concerns about having a will in place early on.
• Facing financial stress secondary to losing a job or the cost of treatments: Absenteeism might be the end result of having to care for their child’s ongoing needs, appointments, and medical emergencies. Sometimes, they might depend on a caretaker who might be very difficult to replace. It might take extensive training once a candidate is found. Direct costs include medical care, hospitalizations, special education, special therapies (occupational, speech, and physical therapy), and paid caregivers. Indirect costs include lost productivity for family caregivers because of the inability to maintain employment while caring for affected individuals, as well as lost wages and benefits, the Hopkins report said.
• Struggling to coordinate daily schedules: Parents face this challenge not only with young children but with those who are chronically ill and might need ongoing 24/7 care. The schedule might include educational and therapeutic (physical, occupational, speech, language therapy, recreational) interventions regularly or daily. This schedule is to be superimposed on all the other necessary responsibilities parents already have to contend with. Forty-eight percent of school-aged children with ASD use three or more services. In addition, children with moderate or severe cases of ASD used three or more services at almost twice the rate of children with mild cases of ASD (60% vs. 35%).
• Longing for a cure or a medicine that will improve the outcome: Often, parents search for treatments so that their child could live a more comfortable or healthier life. For children who have a rare condition, there may not be sufficient research dedicated to their cause or diagnostic pursuits. Currently, it is estimated that 1 in 10 Americans has a rare disease – about 80% of which are genetically based. Of the nearly 7,000 rare diseases known to exist, less than 500 – roughly 5% – have a known treatment approved by the U.S. Food and Drug Administration, reports the National Center for Advancing Translational Diseases and the Genetic and Rare Diseases Information Center.
• Hoping for better times to come: It is difficult at times to appreciate the present when it happens to be so chronically challenging and exhausting for everyone.

Parents of children with significant special needs experience many hurdles that they learn to endure, overcome, and master. This pandemic can provide physicians with a window into the lives of these families.
 

Dr. Sotir is a psychiatrist in private practice in Wheaton, Ill. As a parent of three children, one with special needs, she has extensive experience helping parents challenged by having special needs children find balance, support, direction, and joy in all dimensions of individual and family life. This area is the focus of her practice and public speaking. In Part 2, she will explore how psychiatrists as a specialty can support these families. She has no disclosures.

Parents of children with significant special needs know a thing or two about what the population in general has been experiencing since the pandemic took hold of the nation. The last few months have tested the stamina of most families. Many people are struggling to keep some semblance of normalcy amid a radical transformation of everyday life. It seems as if everything changed overnight.

Jupiterimages/Thinkstock

In a similar way, when a child with many needs is born into a family, adjustments also have to take place to receive the new baby. Families are, in most cases, not prepared for what is to come. Their expectations usually are not in sync with how their lives end up. They are crunched for time. They need to adjust, and at the same time, they mourn the loss of their previous less demanding lifestyle. More importantly, these parents learn that this might be an adjustment that they might need to make for a long time – in some instances, for a lifetime.

Stress load over time can correlate with a sense of burnout, and mental health professionals need to be prepared to address these issues in our patients.

Here is a list of some chronic struggles with which many special needs parents must contend. These strongly resemble the challenges parents in the general population have been facing with their families during this pandemic:

• Bypassing breaks to unwind and having to be always “on” while at home: These parents take care of children who need to be chronically tube fed, can’t sleep well at night because they are often sick, have recurrent seizures or maladaptive behaviors that affect the caretakers and the rest of the family. For parents of children who are on the autism spectrum, these challenges can be a constant struggle. Almost 60% of children with autism spectrum disorder (ASD) experience bodily difficulties, such as trouble breathing. However, nearly 100% of children with ASD experienced difficulties with their abilities and activities, such as self-care tasks like eating and dressing, and emotional or behavioral health, according to a 2016 report on child and adolescent health by the Johns Hopkins Bloomberg School of Public Health.
• Taking on roles for which they are not trained: Parents may take on active roles supplementing their developmentally delayed children with educational experiences or therapeutic modalities in their own homes given that the needs might be too great to just rely on the school or therapy time. There are about 1.17 million children in the United States living with ASD and more than 12% of children with ASD have severe cases, the Hopkins report said. Parents frequently are forced to take on the role of “therapist” to meet the needs of their child.
• Staying home often: Some parents are unable to have a “regular sitter” to provide respite, because the needs of the child require a higher level of care, training, and consideration. Caring for a special child means parents often don’t have the option of leaving their older child alone. As a result, they may end up spending more time at home than their counterpart parents with children who are the same age.
• Struggling to meet everyone’s demands for attention while at home: The child might require full-time attention or prolonged hospitalizations, and the needs of other siblings are sometimes put on hold until time or energy are available for all.
• Not traveling unless absolutely necessary: Families have a hard time leaving home for vacations or for other reasons. They may have to travel with medical supplies and equipment. They need to make sure that their destination is ready to welcome their child with all needs taken into consideration (special diets, activities, and facilities). Will the vacation set them back because it might take more effort to go than to stay home?
• Avoiding unnecessary exposures: Trying to avoid infections (even the ones that may be innocuous to others) if their child is immunocompromised. These children may readily decompensate and end up hospitalized with a more serious medical complication.
• Being very aware of remaining physically distant from others: Parents must go to great lengths not to impinge on other people’s space if the child is being loud or moving in a disruptive way, or if other people negatively affect how the child responds. Some families are apprehensive because they have felt judged by others when they are in the community, restaurants, or other places of gathering.
• Feeling concerned about having the right food, medicines, and supplements in the house: Parents are constantly trying to fulfill special dietary requirements and have the reserve to make sure that all meals and treatments are accounted for in the near future. They might need oxygen or specialized formulas that are hard to find in local stores. Some treatments, when withdrawn or unavailable, can prove life threatening.
• Restricting social circles: Some families with children with severe autism may self-isolate when they feel it is hard to be around them and be friends with them, since they can’t readily participate in “usual family activities,” and the regular norms of socialization can’t apply to their family’s set of behaviors. Their child might seem to be disruptive, or loud, nonverbal, mute, or unable to easily relate to others.
• Experiencing a pervasive sense of uncertainty about the future: A child might continue to miss milestones, or might have a rare condition that hasn’t been diagnosed. When thinking of the future, parents can’t predict what level of care they need to plan and budget for.
• Being concerned about dying early and not being able to provide for their child: Parents worry about who would take care of their child for life. Who would take care of their aging adult “child” after parents are gone? They might have concerns about having a will in place early on.
• Facing financial stress secondary to losing a job or the cost of treatments: Absenteeism might be the end result of having to care for their child’s ongoing needs, appointments, and medical emergencies. Sometimes, they might depend on a caretaker who might be very difficult to replace. It might take extensive training once a candidate is found. Direct costs include medical care, hospitalizations, special education, special therapies (occupational, speech, and physical therapy), and paid caregivers. Indirect costs include lost productivity for family caregivers because of the inability to maintain employment while caring for affected individuals, as well as lost wages and benefits, the Hopkins report said.
• Struggling to coordinate daily schedules: Parents face this challenge not only with young children but with those who are chronically ill and might need ongoing 24/7 care. The schedule might include educational and therapeutic (physical, occupational, speech, language therapy, recreational) interventions regularly or daily. This schedule is to be superimposed on all the other necessary responsibilities parents already have to contend with. Forty-eight percent of school-aged children with ASD use three or more services. In addition, children with moderate or severe cases of ASD used three or more services at almost twice the rate of children with mild cases of ASD (60% vs. 35%).
• Longing for a cure or a medicine that will improve the outcome: Often, parents search for treatments so that their child could live a more comfortable or healthier life. For children who have a rare condition, there may not be sufficient research dedicated to their cause or diagnostic pursuits. Currently, it is estimated that 1 in 10 Americans has a rare disease – about 80% of which are genetically based. Of the nearly 7,000 rare diseases known to exist, less than 500 – roughly 5% – have a known treatment approved by the U.S. Food and Drug Administration, reports the National Center for Advancing Translational Diseases and the Genetic and Rare Diseases Information Center.
• Hoping for better times to come: It is difficult at times to appreciate the present when it happens to be so chronically challenging and exhausting for everyone.

Parents of children with significant special needs experience many hurdles that they learn to endure, overcome, and master. This pandemic can provide physicians with a window into the lives of these families.
 

Dr. Sotir is a psychiatrist in private practice in Wheaton, Ill. As a parent of three children, one with special needs, she has extensive experience helping parents challenged by having special needs children find balance, support, direction, and joy in all dimensions of individual and family life. This area is the focus of her practice and public speaking. In Part 2, she will explore how psychiatrists as a specialty can support these families. She has no disclosures.

Parents of children with significant special needs know a thing or two about what the population in general has been experiencing since the pandemic took hold of the nation. The last few months have tested the stamina of most families. Many people are struggling to keep some semblance of normalcy amid a radical transformation of everyday life. It seems as if everything changed overnight.

Jupiterimages/Thinkstock

In a similar way, when a child with many needs is born into a family, adjustments also have to take place to receive the new baby. Families are, in most cases, not prepared for what is to come. Their expectations usually are not in sync with how their lives end up. They are crunched for time. They need to adjust, and at the same time, they mourn the loss of their previous less demanding lifestyle. More importantly, these parents learn that this might be an adjustment that they might need to make for a long time – in some instances, for a lifetime.

Stress load over time can correlate with a sense of burnout, and mental health professionals need to be prepared to address these issues in our patients.

Here is a list of some chronic struggles with which many special needs parents must contend. These strongly resemble the challenges parents in the general population have been facing with their families during this pandemic:

• Bypassing breaks to unwind and having to be always “on” while at home: These parents take care of children who need to be chronically tube fed, can’t sleep well at night because they are often sick, have recurrent seizures or maladaptive behaviors that affect the caretakers and the rest of the family. For parents of children who are on the autism spectrum, these challenges can be a constant struggle. Almost 60% of children with autism spectrum disorder (ASD) experience bodily difficulties, such as trouble breathing. However, nearly 100% of children with ASD experienced difficulties with their abilities and activities, such as self-care tasks like eating and dressing, and emotional or behavioral health, according to a 2016 report on child and adolescent health by the Johns Hopkins Bloomberg School of Public Health.
• Taking on roles for which they are not trained: Parents may take on active roles supplementing their developmentally delayed children with educational experiences or therapeutic modalities in their own homes given that the needs might be too great to just rely on the school or therapy time. There are about 1.17 million children in the United States living with ASD and more than 12% of children with ASD have severe cases, the Hopkins report said. Parents frequently are forced to take on the role of “therapist” to meet the needs of their child.
• Staying home often: Some parents are unable to have a “regular sitter” to provide respite, because the needs of the child require a higher level of care, training, and consideration. Caring for a special child means parents often don’t have the option of leaving their older child alone. As a result, they may end up spending more time at home than their counterpart parents with children who are the same age.
• Struggling to meet everyone’s demands for attention while at home: The child might require full-time attention or prolonged hospitalizations, and the needs of other siblings are sometimes put on hold until time or energy are available for all.
• Not traveling unless absolutely necessary: Families have a hard time leaving home for vacations or for other reasons. They may have to travel with medical supplies and equipment. They need to make sure that their destination is ready to welcome their child with all needs taken into consideration (special diets, activities, and facilities). Will the vacation set them back because it might take more effort to go than to stay home?
• Avoiding unnecessary exposures: Trying to avoid infections (even the ones that may be innocuous to others) if their child is immunocompromised. These children may readily decompensate and end up hospitalized with a more serious medical complication.
• Being very aware of remaining physically distant from others: Parents must go to great lengths not to impinge on other people’s space if the child is being loud or moving in a disruptive way, or if other people negatively affect how the child responds. Some families are apprehensive because they have felt judged by others when they are in the community, restaurants, or other places of gathering.
• Feeling concerned about having the right food, medicines, and supplements in the house: Parents are constantly trying to fulfill special dietary requirements and have the reserve to make sure that all meals and treatments are accounted for in the near future. They might need oxygen or specialized formulas that are hard to find in local stores. Some treatments, when withdrawn or unavailable, can prove life threatening.
• Restricting social circles: Some families with children with severe autism may self-isolate when they feel it is hard to be around them and be friends with them, since they can’t readily participate in “usual family activities,” and the regular norms of socialization can’t apply to their family’s set of behaviors. Their child might seem to be disruptive, or loud, nonverbal, mute, or unable to easily relate to others.
• Experiencing a pervasive sense of uncertainty about the future: A child might continue to miss milestones, or might have a rare condition that hasn’t been diagnosed. When thinking of the future, parents can’t predict what level of care they need to plan and budget for.
• Being concerned about dying early and not being able to provide for their child: Parents worry about who would take care of their child for life. Who would take care of their aging adult “child” after parents are gone? They might have concerns about having a will in place early on.
• Facing financial stress secondary to losing a job or the cost of treatments: Absenteeism might be the end result of having to care for their child’s ongoing needs, appointments, and medical emergencies. Sometimes, they might depend on a caretaker who might be very difficult to replace. It might take extensive training once a candidate is found. Direct costs include medical care, hospitalizations, special education, special therapies (occupational, speech, and physical therapy), and paid caregivers. Indirect costs include lost productivity for family caregivers because of the inability to maintain employment while caring for affected individuals, as well as lost wages and benefits, the Hopkins report said.
• Struggling to coordinate daily schedules: Parents face this challenge not only with young children but with those who are chronically ill and might need ongoing 24/7 care. The schedule might include educational and therapeutic (physical, occupational, speech, language therapy, recreational) interventions regularly or daily. This schedule is to be superimposed on all the other necessary responsibilities parents already have to contend with. Forty-eight percent of school-aged children with ASD use three or more services. In addition, children with moderate or severe cases of ASD used three or more services at almost twice the rate of children with mild cases of ASD (60% vs. 35%).
• Longing for a cure or a medicine that will improve the outcome: Often, parents search for treatments so that their child could live a more comfortable or healthier life. For children who have a rare condition, there may not be sufficient research dedicated to their cause or diagnostic pursuits. Currently, it is estimated that 1 in 10 Americans has a rare disease – about 80% of which are genetically based. Of the nearly 7,000 rare diseases known to exist, less than 500 – roughly 5% – have a known treatment approved by the U.S. Food and Drug Administration, reports the National Center for Advancing Translational Diseases and the Genetic and Rare Diseases Information Center.
• Hoping for better times to come: It is difficult at times to appreciate the present when it happens to be so chronically challenging and exhausting for everyone.

Parents of children with significant special needs experience many hurdles that they learn to endure, overcome, and master. This pandemic can provide physicians with a window into the lives of these families.
 

Dr. Sotir is a psychiatrist in private practice in Wheaton, Ill. As a parent of three children, one with special needs, she has extensive experience helping parents challenged by having special needs children find balance, support, direction, and joy in all dimensions of individual and family life. This area is the focus of her practice and public speaking. In Part 2, she will explore how psychiatrists as a specialty can support these families. She has no disclosures.

The 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors Consensus Guidelines, which represent a consensus of nearly 20 professional organizations and patient advocates, are a culmination of almost 10 years of research.¹ With the last version issued in 2012,² these latest guidelines offer the most recent recommendations regarding safely triaging women with abnormal cervical cancer screening results.

According to the consensus, research has shown that risk-based management allows clinicians to better discriminate women who will likely develop precancer from those who can safely continue with routine screening. As you will hear from guidelines coauthor Dr. Warner Huh, one of the most important differences between these guidelines and the 2012 version is a new emphasis on the principle of “equal management for equal risk.” Essentially, this insures that all women who have the same amount of risk for progression to precancer or cancer are managed the same.

The guidelines were once again published in the Journal of Lower Genital Tract Disease, and the tables they reference are publicly available. Additionally, ASCCP is developing a new management guidelines app to facilitate the use of the guidelines on smartphones and computers. With the publicly available risk tables, and the ASCCP navigation app, the guidelines will more easily accommodate updates as new information and technology become available.

OBG Management: The latest ASCCP guidelines, published in April, represent a “paradigm shift” from results to risk-based guidelines. Can you explain what this means and why the shift was undertaken?

Warner K. Huh, MD: Yes, the shift occurred because we needed to focus less on algorithms and more on risk. We started promulgating a concept of “equal management for equal risk” back in 2012. What this means is that if we have a method to look up a risk score based on relevant test results and other pieces of information, then all patients with that score should be managed in the same manner. We wanted that to be the underlying principle.

Focusing on risk tables also makes it easier to incorporate any future technologies used for risk estimation without having to rebuild algorithms from scratch. ASCCP is developing a new management guidelines app to streamline navigation of the guidelines. This app makes them easier for clinicians to use; they simply plug in certain variables from the patient’s history and receive 1 of 5 outputs: treatment, colposcopy, or surveillance at 1, 3, or 5 years.

The only drawbacks, if you view them as such, are that the clinician must plug in all the variables, and then must sit back and trust in what we have done. Clinicians have to trust that the system works and will simplify the clinical decision making.

We spent a lot of time determining what the risk thresholds should be. Some may argue they are arbitrary, but the decisions were data-driven, and carefully, thoughtfully vetted; we deliberated about whether the cut points actually made sense clinically to a practicing clinician base. The clinical action thresholds refer to a specific percentage below which a woman falls into one bucket and above which she falls into another bucket.

The other element that is unique about the guidelines is that instead of looking at the patient’s current screening result in isolation, the user sees it along with the prior one because prior history dictates subsequent risk.

It’s important that clinicians understand why this system is so markedly different from what we have done previously, and why risk-based guidelines make infinitely more sense than algorithmic ones. It’s because: 1) they can be easier to use; 2) they incorporate new data more efficiently and effectively than algorithm-based guidelines; and 3) they can incorporate future technologies seamlessly rather than having to create yet another algorithm.

Continue to: OBG Management : What do clinicians need in order to execute the guidelines?...

OBG Management: What do clinicians need in order to execute the guidelines?

Dr. Huh: Nothing. All of the information needed—the guidelines article and risk tables—are publicly available. However, to make navigation of the guidelines easier, the plan is for the app that I mentioned. I have the app on my phone and am actively beta testing it now. We’re planning on creating a web-based application as well, that will allow users to access the Internet and their electronic health record system so that they can plug in information directly from patient charts. The web-based app will be similar to the web-based Breast Cancer Surveillance Consortium’s Risk Calculator (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm). You will pull it up, plug in the requested information, including the patient’s age; their Pap smear and genotyping results; and their previous screening history.

OBG Management: When will the app be available for users?

Dr. Huh: It will be available for release on June 8.

OBG Management: Were HPV vaccination levels incorporated into the new guidelines?

OBG Management: Have recommendations regarding colposcopy changed?

Dr. Huh: Not really. About 3 years ago, we created basic colposcopy guidelines—the ASCCP Colposcopy Standards—so everything about colposcopy references back to those guidelines. Those colposcopy standards covered terminology and risk-based colposcopy, which actually aligns beautifully with these guidelines.

OBG Management: To narrow in on some changes from the prior guidelines, can colposcopy be deferred in certain patients?

Dr. Huh: Yes. Not everyone who has an abnormal screening test needs to come back for colposcopy.

OBG Management: How has guidance for expedited treatment or treatment without colposcopic biopsy changed?

Dr. Huh: This was heavily debated within not only the treatment group that I co-chaired with Richard Guido, MD, but also within the entire steering committee. The recommendation is that if the patient has an immediate risk of CIN 3 that is >60%, the patient should go straight to treatment without a colposcopic biopsy. The main reason for this is that you do not want to biopsy a patient and then lose them to follow-up.

When a woman has >60% immediate risk of CIN 3, we are fairly certain that colposcopy is not going to change management ultimately, so we recommend that patients receive treatment right away. We have already been doing this for 15 to 20 years, so this is not a new concept. It is just more formally codified here by assigning a percentage to the risk. Those who have between 25% and 60% immediate risk of CIN 3 should receive immediate colposcopy. We realize that not all clinicians have the ability to do this, so if clinicians can’t treat immediately, we recommend they do whatever they can to prevent losing the patient to follow-up.

OBG Management: How should a positive primary HPV screening test be managed?

Dr. Huh: If a woman has a positive primary HPV screening test, genotyping should be performed. If genotyping reveals HPV 16 or 18, then the patient should proceed to colposcopy. If genotyping reveals other forms of HPV, reflex cytology or a Pap smear should follow. ●

The 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors Consensus Guidelines, which represent a consensus of nearly 20 professional organizations and patient advocates, are a culmination of almost 10 years of research.¹ With the last version issued in 2012,² these latest guidelines offer the most recent recommendations regarding safely triaging women with abnormal cervical cancer screening results.

According to the consensus, research has shown that risk-based management allows clinicians to better discriminate women who will likely develop precancer from those who can safely continue with routine screening. As you will hear from guidelines coauthor Dr. Warner Huh, one of the most important differences between these guidelines and the 2012 version is a new emphasis on the principle of “equal management for equal risk.” Essentially, this insures that all women who have the same amount of risk for progression to precancer or cancer are managed the same.

The guidelines were once again published in the Journal of Lower Genital Tract Disease, and the tables they reference are publicly available. Additionally, ASCCP is developing a new management guidelines app to facilitate the use of the guidelines on smartphones and computers. With the publicly available risk tables, and the ASCCP navigation app, the guidelines will more easily accommodate updates as new information and technology become available.

OBG Management: The latest ASCCP guidelines, published in April, represent a “paradigm shift” from results to risk-based guidelines. Can you explain what this means and why the shift was undertaken?

Warner K. Huh, MD: Yes, the shift occurred because we needed to focus less on algorithms and more on risk. We started promulgating a concept of “equal management for equal risk” back in 2012. What this means is that if we have a method to look up a risk score based on relevant test results and other pieces of information, then all patients with that score should be managed in the same manner. We wanted that to be the underlying principle.

Focusing on risk tables also makes it easier to incorporate any future technologies used for risk estimation without having to rebuild algorithms from scratch. ASCCP is developing a new management guidelines app to streamline navigation of the guidelines. This app makes them easier for clinicians to use; they simply plug in certain variables from the patient’s history and receive 1 of 5 outputs: treatment, colposcopy, or surveillance at 1, 3, or 5 years.

The only drawbacks, if you view them as such, are that the clinician must plug in all the variables, and then must sit back and trust in what we have done. Clinicians have to trust that the system works and will simplify the clinical decision making.

We spent a lot of time determining what the risk thresholds should be. Some may argue they are arbitrary, but the decisions were data-driven, and carefully, thoughtfully vetted; we deliberated about whether the cut points actually made sense clinically to a practicing clinician base. The clinical action thresholds refer to a specific percentage below which a woman falls into one bucket and above which she falls into another bucket.

The other element that is unique about the guidelines is that instead of looking at the patient’s current screening result in isolation, the user sees it along with the prior one because prior history dictates subsequent risk.

It’s important that clinicians understand why this system is so markedly different from what we have done previously, and why risk-based guidelines make infinitely more sense than algorithmic ones. It’s because: 1) they can be easier to use; 2) they incorporate new data more efficiently and effectively than algorithm-based guidelines; and 3) they can incorporate future technologies seamlessly rather than having to create yet another algorithm.

Continue to: OBG Management : What do clinicians need in order to execute the guidelines?...

OBG Management: What do clinicians need in order to execute the guidelines?

Dr. Huh: Nothing. All of the information needed—the guidelines article and risk tables—are publicly available. However, to make navigation of the guidelines easier, the plan is for the app that I mentioned. I have the app on my phone and am actively beta testing it now. We’re planning on creating a web-based application as well, that will allow users to access the Internet and their electronic health record system so that they can plug in information directly from patient charts. The web-based app will be similar to the web-based Breast Cancer Surveillance Consortium’s Risk Calculator (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm). You will pull it up, plug in the requested information, including the patient’s age; their Pap smear and genotyping results; and their previous screening history.

OBG Management: When will the app be available for users?

Dr. Huh: It will be available for release on June 8.

OBG Management: Were HPV vaccination levels incorporated into the new guidelines?

OBG Management: Have recommendations regarding colposcopy changed?

Dr. Huh: Not really. About 3 years ago, we created basic colposcopy guidelines—the ASCCP Colposcopy Standards—so everything about colposcopy references back to those guidelines. Those colposcopy standards covered terminology and risk-based colposcopy, which actually aligns beautifully with these guidelines.

OBG Management: To narrow in on some changes from the prior guidelines, can colposcopy be deferred in certain patients?

Dr. Huh: Yes. Not everyone who has an abnormal screening test needs to come back for colposcopy.

OBG Management: How has guidance for expedited treatment or treatment without colposcopic biopsy changed?

Dr. Huh: This was heavily debated within not only the treatment group that I co-chaired with Richard Guido, MD, but also within the entire steering committee. The recommendation is that if the patient has an immediate risk of CIN 3 that is >60%, the patient should go straight to treatment without a colposcopic biopsy. The main reason for this is that you do not want to biopsy a patient and then lose them to follow-up.

When a woman has >60% immediate risk of CIN 3, we are fairly certain that colposcopy is not going to change management ultimately, so we recommend that patients receive treatment right away. We have already been doing this for 15 to 20 years, so this is not a new concept. It is just more formally codified here by assigning a percentage to the risk. Those who have between 25% and 60% immediate risk of CIN 3 should receive immediate colposcopy. We realize that not all clinicians have the ability to do this, so if clinicians can’t treat immediately, we recommend they do whatever they can to prevent losing the patient to follow-up.

OBG Management: How should a positive primary HPV screening test be managed?

Dr. Huh: If a woman has a positive primary HPV screening test, genotyping should be performed. If genotyping reveals HPV 16 or 18, then the patient should proceed to colposcopy. If genotyping reveals other forms of HPV, reflex cytology or a Pap smear should follow. ●

The 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors Consensus Guidelines, which represent a consensus of nearly 20 professional organizations and patient advocates, are a culmination of almost 10 years of research.¹ With the last version issued in 2012,² these latest guidelines offer the most recent recommendations regarding safely triaging women with abnormal cervical cancer screening results.

According to the consensus, research has shown that risk-based management allows clinicians to better discriminate women who will likely develop precancer from those who can safely continue with routine screening. As you will hear from guidelines coauthor Dr. Warner Huh, one of the most important differences between these guidelines and the 2012 version is a new emphasis on the principle of “equal management for equal risk.” Essentially, this insures that all women who have the same amount of risk for progression to precancer or cancer are managed the same.

The guidelines were once again published in the Journal of Lower Genital Tract Disease, and the tables they reference are publicly available. Additionally, ASCCP is developing a new management guidelines app to facilitate the use of the guidelines on smartphones and computers. With the publicly available risk tables, and the ASCCP navigation app, the guidelines will more easily accommodate updates as new information and technology become available.

OBG Management: The latest ASCCP guidelines, published in April, represent a “paradigm shift” from results to risk-based guidelines. Can you explain what this means and why the shift was undertaken?

Warner K. Huh, MD: Yes, the shift occurred because we needed to focus less on algorithms and more on risk. We started promulgating a concept of “equal management for equal risk” back in 2012. What this means is that if we have a method to look up a risk score based on relevant test results and other pieces of information, then all patients with that score should be managed in the same manner. We wanted that to be the underlying principle.

Focusing on risk tables also makes it easier to incorporate any future technologies used for risk estimation without having to rebuild algorithms from scratch. ASCCP is developing a new management guidelines app to streamline navigation of the guidelines. This app makes them easier for clinicians to use; they simply plug in certain variables from the patient’s history and receive 1 of 5 outputs: treatment, colposcopy, or surveillance at 1, 3, or 5 years.

The only drawbacks, if you view them as such, are that the clinician must plug in all the variables, and then must sit back and trust in what we have done. Clinicians have to trust that the system works and will simplify the clinical decision making.

We spent a lot of time determining what the risk thresholds should be. Some may argue they are arbitrary, but the decisions were data-driven, and carefully, thoughtfully vetted; we deliberated about whether the cut points actually made sense clinically to a practicing clinician base. The clinical action thresholds refer to a specific percentage below which a woman falls into one bucket and above which she falls into another bucket.

The other element that is unique about the guidelines is that instead of looking at the patient’s current screening result in isolation, the user sees it along with the prior one because prior history dictates subsequent risk.

It’s important that clinicians understand why this system is so markedly different from what we have done previously, and why risk-based guidelines make infinitely more sense than algorithmic ones. It’s because: 1) they can be easier to use; 2) they incorporate new data more efficiently and effectively than algorithm-based guidelines; and 3) they can incorporate future technologies seamlessly rather than having to create yet another algorithm.

Continue to: OBG Management : What do clinicians need in order to execute the guidelines?...

OBG Management: What do clinicians need in order to execute the guidelines?

Dr. Huh: Nothing. All of the information needed—the guidelines article and risk tables—are publicly available. However, to make navigation of the guidelines easier, the plan is for the app that I mentioned. I have the app on my phone and am actively beta testing it now. We’re planning on creating a web-based application as well, that will allow users to access the Internet and their electronic health record system so that they can plug in information directly from patient charts. The web-based app will be similar to the web-based Breast Cancer Surveillance Consortium’s Risk Calculator (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm). You will pull it up, plug in the requested information, including the patient’s age; their Pap smear and genotyping results; and their previous screening history.

OBG Management: When will the app be available for users?

Dr. Huh: It will be available for release on June 8.

OBG Management: Were HPV vaccination levels incorporated into the new guidelines?

OBG Management: Have recommendations regarding colposcopy changed?

Dr. Huh: Not really. About 3 years ago, we created basic colposcopy guidelines—the ASCCP Colposcopy Standards—so everything about colposcopy references back to those guidelines. Those colposcopy standards covered terminology and risk-based colposcopy, which actually aligns beautifully with these guidelines.

OBG Management: To narrow in on some changes from the prior guidelines, can colposcopy be deferred in certain patients?

Dr. Huh: Yes. Not everyone who has an abnormal screening test needs to come back for colposcopy.

OBG Management: How has guidance for expedited treatment or treatment without colposcopic biopsy changed?

Dr. Huh: This was heavily debated within not only the treatment group that I co-chaired with Richard Guido, MD, but also within the entire steering committee. The recommendation is that if the patient has an immediate risk of CIN 3 that is >60%, the patient should go straight to treatment without a colposcopic biopsy. The main reason for this is that you do not want to biopsy a patient and then lose them to follow-up.

When a woman has >60% immediate risk of CIN 3, we are fairly certain that colposcopy is not going to change management ultimately, so we recommend that patients receive treatment right away. We have already been doing this for 15 to 20 years, so this is not a new concept. It is just more formally codified here by assigning a percentage to the risk. Those who have between 25% and 60% immediate risk of CIN 3 should receive immediate colposcopy. We realize that not all clinicians have the ability to do this, so if clinicians can’t treat immediately, we recommend they do whatever they can to prevent losing the patient to follow-up.

OBG Management: How should a positive primary HPV screening test be managed?

Dr. Huh: If a woman has a positive primary HPV screening test, genotyping should be performed. If genotyping reveals HPV 16 or 18, then the patient should proceed to colposcopy. If genotyping reveals other forms of HPV, reflex cytology or a Pap smear should follow. ●