The child with hypertension: Diagnosis and management

Article Type
Changed
Fri, 01/07/2022 - 14:59

 

This transcript has been edited for clarity. The transcript and an accompanying video first appeared on Medscape.com.

Justin L. Berk, MD, MPH, MBA: Welcome back to The Cribsiders, our video recap of our pediatric medicine podcast. We interview leading experts in the field to bring clinical pearls and practice-changing knowledge, and answer lingering questions about core topics in pediatric medicine. Chris, what is our topic today?

Christopher J. Chiu, MD: I was really happy to be able to talk about our recent episode with Dr. Carissa Baker-Smith, a pediatric cardiologist and director of the Nemours preventive cardiology program. She helped us review the pediatric screening guidelines for blood pressure, including initial workup and treatment.

Dr. Berk: This was a really great episode that a lot of people found really helpful. What were some of the key takeaway pearls that you think listeners would be interested in?

Dr. Chiu: We talked about when and how we should be checking blood pressures in children. Blood pressure should be checked at every well-child visit starting at age 3. But if they have other risk factors like kidney disease or a condition such as coarctation of the aorta, then blood pressure should be checked at every visit.

Dr. Berk: One thing she spoke about was how blood pressures should be measured. How should we be checking blood pressures in the clinic?

Dr. Chiu: Clinic blood pressures are usually checked with oscillometric devices. They can differ by manufacturer, but basically they find a mean arterial pressure and then each device has a method of calculating systolic and diastolic pressures. Now after that, if the child’s blood pressure is maybe abnormal, you want to double-check a manual blood pressure using Korotkoff sounds to confirm the blood pressure.

She reminded us that blood pressure should be measured with the child sitting with their back supported, feet flat on the floor, and arm at the level of the heart. Make sure you use the right size cuff. The bladder of the cuff should be 40% of the width of the arm, and about 80%-100% of the arm circumference. She recommends sizing up if you have to.

Dr. Berk: Accuracy of blood pressure management was a really important point, especially for diagnosis at this stage. Can you walk us through what we learned about diagnosis of hypertension?

Dr. Chiu: The definitions of hypertension come from the Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents. Up until the age of 13, they define prehypertension as systolic and diastolic blood pressures between the 90th and 95th percentile, or if the blood pressure exceeds 120/80 mm Hg. Hypertension is defined when blood pressure reaches the 95th percentile. Now age 13 is when it gets a little hazy. Many changes in the guidelines happen at age 13, when hypertension starts being defined by adult guidelines. The 2017 adult hypertension guidelines define stage 1 hypertension as 130/89 to 139/89, and stage 2 hypertension as greater than 140/90.

Dr. Berk: How about workup of hypertension? The work of pediatric hypertension is always a little bit complex. What are some of the pearls you took away?

Dr. Chui: She talked about tailoring the workup to the child. So when we’re doing our workup, obviously physical exam should be the first thing we do. You have to assess and compare pulses, which is one of the most important parts of the initial evaluation. Obviously, looking at coarctation of the aorta, but also looking for things like a cushingoid appearance. If the child is less than 6 years of age, she recommends a referral to nephrology for more comprehensive renovascular workup, which probably will include renal ultrasound, urinalysis, metabolic panel, and thyroid studies.

We have to be cognizant of secondary causes of hypertension, such as endocrine tumors, hyperthyroidism, aortic disease, or even medication-induced hypertension. She told us that in the majority of these cases, especially with our obese older children, primary hypertension or essential hypertension is the most likely cause.

Dr. Berk: That was my big takeaway. If they’re really young, they need a big workup, but otherwise it is likely primary hypertension. What did we learn about treatment?

Dr. Chui: Just as we tailor our assessment to the child, we also have to tailor treatment. We know that lifestyle modification is usually the first line of treatment, especially for primary hypertension, and Dr. Baker-Smith tells us that we really need to perform counseling that meets the patient where they are. So if they like dancing to the newest TikTok trends or music videos, maybe we can encourage them to move more that way. Using our motivational interviewing skills is really key here.

If you want to start medication, Dr. Baker-Smith uses things like low-dose ACE inhibitors or calcium channel blockers, but obviously it’ll be tailored to the patient and any underlying conditions.

Dr. Berk: That’s great – a lot of wonderful pearls on the diagnosis and management of pediatric hypertension. Thank you for joining us for another video recap of The Cribsiders pediatric podcast. You can download the full podcast, Off the Cuff: Managing Pediatric Hypertension in Your Primary Care Clinic, on any podcast player, or check out our website at www.theCribsiders.com.

Christopher J. Chiu, MD, is assistant professor, department of internal medicine, division of general internal medicine, Ohio State University, Columbus; lead physician, general internal medicine, OSU Outpatient Care East; department of internal medicine, division of general internal medicine, Ohio State University Wexner Medical Center. Dr. Chiu has disclosed no relevant financial relationships. Justin L. Berk, MD, MPH, MBA, is assistant professor, department of medicine; assistant professor, department of pediatrics, Brown University, Providence, R.I.

Publications
Topics
Sections

 

This transcript has been edited for clarity. The transcript and an accompanying video first appeared on Medscape.com.

Justin L. Berk, MD, MPH, MBA: Welcome back to The Cribsiders, our video recap of our pediatric medicine podcast. We interview leading experts in the field to bring clinical pearls and practice-changing knowledge, and answer lingering questions about core topics in pediatric medicine. Chris, what is our topic today?

Christopher J. Chiu, MD: I was really happy to be able to talk about our recent episode with Dr. Carissa Baker-Smith, a pediatric cardiologist and director of the Nemours preventive cardiology program. She helped us review the pediatric screening guidelines for blood pressure, including initial workup and treatment.

Dr. Berk: This was a really great episode that a lot of people found really helpful. What were some of the key takeaway pearls that you think listeners would be interested in?

Dr. Chiu: We talked about when and how we should be checking blood pressures in children. Blood pressure should be checked at every well-child visit starting at age 3. But if they have other risk factors like kidney disease or a condition such as coarctation of the aorta, then blood pressure should be checked at every visit.

Dr. Berk: One thing she spoke about was how blood pressures should be measured. How should we be checking blood pressures in the clinic?

Dr. Chiu: Clinic blood pressures are usually checked with oscillometric devices. They can differ by manufacturer, but basically they find a mean arterial pressure and then each device has a method of calculating systolic and diastolic pressures. Now after that, if the child’s blood pressure is maybe abnormal, you want to double-check a manual blood pressure using Korotkoff sounds to confirm the blood pressure.

She reminded us that blood pressure should be measured with the child sitting with their back supported, feet flat on the floor, and arm at the level of the heart. Make sure you use the right size cuff. The bladder of the cuff should be 40% of the width of the arm, and about 80%-100% of the arm circumference. She recommends sizing up if you have to.

Dr. Berk: Accuracy of blood pressure management was a really important point, especially for diagnosis at this stage. Can you walk us through what we learned about diagnosis of hypertension?

Dr. Chiu: The definitions of hypertension come from the Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents. Up until the age of 13, they define prehypertension as systolic and diastolic blood pressures between the 90th and 95th percentile, or if the blood pressure exceeds 120/80 mm Hg. Hypertension is defined when blood pressure reaches the 95th percentile. Now age 13 is when it gets a little hazy. Many changes in the guidelines happen at age 13, when hypertension starts being defined by adult guidelines. The 2017 adult hypertension guidelines define stage 1 hypertension as 130/89 to 139/89, and stage 2 hypertension as greater than 140/90.

Dr. Berk: How about workup of hypertension? The work of pediatric hypertension is always a little bit complex. What are some of the pearls you took away?

Dr. Chui: She talked about tailoring the workup to the child. So when we’re doing our workup, obviously physical exam should be the first thing we do. You have to assess and compare pulses, which is one of the most important parts of the initial evaluation. Obviously, looking at coarctation of the aorta, but also looking for things like a cushingoid appearance. If the child is less than 6 years of age, she recommends a referral to nephrology for more comprehensive renovascular workup, which probably will include renal ultrasound, urinalysis, metabolic panel, and thyroid studies.

We have to be cognizant of secondary causes of hypertension, such as endocrine tumors, hyperthyroidism, aortic disease, or even medication-induced hypertension. She told us that in the majority of these cases, especially with our obese older children, primary hypertension or essential hypertension is the most likely cause.

Dr. Berk: That was my big takeaway. If they’re really young, they need a big workup, but otherwise it is likely primary hypertension. What did we learn about treatment?

Dr. Chui: Just as we tailor our assessment to the child, we also have to tailor treatment. We know that lifestyle modification is usually the first line of treatment, especially for primary hypertension, and Dr. Baker-Smith tells us that we really need to perform counseling that meets the patient where they are. So if they like dancing to the newest TikTok trends or music videos, maybe we can encourage them to move more that way. Using our motivational interviewing skills is really key here.

If you want to start medication, Dr. Baker-Smith uses things like low-dose ACE inhibitors or calcium channel blockers, but obviously it’ll be tailored to the patient and any underlying conditions.

Dr. Berk: That’s great – a lot of wonderful pearls on the diagnosis and management of pediatric hypertension. Thank you for joining us for another video recap of The Cribsiders pediatric podcast. You can download the full podcast, Off the Cuff: Managing Pediatric Hypertension in Your Primary Care Clinic, on any podcast player, or check out our website at www.theCribsiders.com.

Christopher J. Chiu, MD, is assistant professor, department of internal medicine, division of general internal medicine, Ohio State University, Columbus; lead physician, general internal medicine, OSU Outpatient Care East; department of internal medicine, division of general internal medicine, Ohio State University Wexner Medical Center. Dr. Chiu has disclosed no relevant financial relationships. Justin L. Berk, MD, MPH, MBA, is assistant professor, department of medicine; assistant professor, department of pediatrics, Brown University, Providence, R.I.

 

This transcript has been edited for clarity. The transcript and an accompanying video first appeared on Medscape.com.

Justin L. Berk, MD, MPH, MBA: Welcome back to The Cribsiders, our video recap of our pediatric medicine podcast. We interview leading experts in the field to bring clinical pearls and practice-changing knowledge, and answer lingering questions about core topics in pediatric medicine. Chris, what is our topic today?

Christopher J. Chiu, MD: I was really happy to be able to talk about our recent episode with Dr. Carissa Baker-Smith, a pediatric cardiologist and director of the Nemours preventive cardiology program. She helped us review the pediatric screening guidelines for blood pressure, including initial workup and treatment.

Dr. Berk: This was a really great episode that a lot of people found really helpful. What were some of the key takeaway pearls that you think listeners would be interested in?

Dr. Chiu: We talked about when and how we should be checking blood pressures in children. Blood pressure should be checked at every well-child visit starting at age 3. But if they have other risk factors like kidney disease or a condition such as coarctation of the aorta, then blood pressure should be checked at every visit.

Dr. Berk: One thing she spoke about was how blood pressures should be measured. How should we be checking blood pressures in the clinic?

Dr. Chiu: Clinic blood pressures are usually checked with oscillometric devices. They can differ by manufacturer, but basically they find a mean arterial pressure and then each device has a method of calculating systolic and diastolic pressures. Now after that, if the child’s blood pressure is maybe abnormal, you want to double-check a manual blood pressure using Korotkoff sounds to confirm the blood pressure.

She reminded us that blood pressure should be measured with the child sitting with their back supported, feet flat on the floor, and arm at the level of the heart. Make sure you use the right size cuff. The bladder of the cuff should be 40% of the width of the arm, and about 80%-100% of the arm circumference. She recommends sizing up if you have to.

Dr. Berk: Accuracy of blood pressure management was a really important point, especially for diagnosis at this stage. Can you walk us through what we learned about diagnosis of hypertension?

Dr. Chiu: The definitions of hypertension come from the Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents. Up until the age of 13, they define prehypertension as systolic and diastolic blood pressures between the 90th and 95th percentile, or if the blood pressure exceeds 120/80 mm Hg. Hypertension is defined when blood pressure reaches the 95th percentile. Now age 13 is when it gets a little hazy. Many changes in the guidelines happen at age 13, when hypertension starts being defined by adult guidelines. The 2017 adult hypertension guidelines define stage 1 hypertension as 130/89 to 139/89, and stage 2 hypertension as greater than 140/90.

Dr. Berk: How about workup of hypertension? The work of pediatric hypertension is always a little bit complex. What are some of the pearls you took away?

Dr. Chui: She talked about tailoring the workup to the child. So when we’re doing our workup, obviously physical exam should be the first thing we do. You have to assess and compare pulses, which is one of the most important parts of the initial evaluation. Obviously, looking at coarctation of the aorta, but also looking for things like a cushingoid appearance. If the child is less than 6 years of age, she recommends a referral to nephrology for more comprehensive renovascular workup, which probably will include renal ultrasound, urinalysis, metabolic panel, and thyroid studies.

We have to be cognizant of secondary causes of hypertension, such as endocrine tumors, hyperthyroidism, aortic disease, or even medication-induced hypertension. She told us that in the majority of these cases, especially with our obese older children, primary hypertension or essential hypertension is the most likely cause.

Dr. Berk: That was my big takeaway. If they’re really young, they need a big workup, but otherwise it is likely primary hypertension. What did we learn about treatment?

Dr. Chui: Just as we tailor our assessment to the child, we also have to tailor treatment. We know that lifestyle modification is usually the first line of treatment, especially for primary hypertension, and Dr. Baker-Smith tells us that we really need to perform counseling that meets the patient where they are. So if they like dancing to the newest TikTok trends or music videos, maybe we can encourage them to move more that way. Using our motivational interviewing skills is really key here.

If you want to start medication, Dr. Baker-Smith uses things like low-dose ACE inhibitors or calcium channel blockers, but obviously it’ll be tailored to the patient and any underlying conditions.

Dr. Berk: That’s great – a lot of wonderful pearls on the diagnosis and management of pediatric hypertension. Thank you for joining us for another video recap of The Cribsiders pediatric podcast. You can download the full podcast, Off the Cuff: Managing Pediatric Hypertension in Your Primary Care Clinic, on any podcast player, or check out our website at www.theCribsiders.com.

Christopher J. Chiu, MD, is assistant professor, department of internal medicine, division of general internal medicine, Ohio State University, Columbus; lead physician, general internal medicine, OSU Outpatient Care East; department of internal medicine, division of general internal medicine, Ohio State University Wexner Medical Center. Dr. Chiu has disclosed no relevant financial relationships. Justin L. Berk, MD, MPH, MBA, is assistant professor, department of medicine; assistant professor, department of pediatrics, Brown University, Providence, R.I.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Scheduled Acetaminophen to Minimize Neuropsychiatric Symptoms in Wernicke-Korsakoff Syndrome

Article Type
Changed
Thu, 01/27/2022 - 15:30

To manage the physical, cognitive, and emotional symptoms of a veteran hospitalized for Wernicke-Korsakoff syndrome secondary to chronic alcohol overuse, acetaminophen was administered in place of psychoactive medications.

Alcohol is the most common substance misused by veterans. 1 Veterans may m isuse alcohol as a result of mental illness or posttraumatic stress disorder (PTSD), having difficulties adjusting to civilian life, or because of heavy drinking habits acquired before leaving active duty. 2 One potential long-term effect of chronic alcohol misuse is Wernicke-Korsakoff syndrome (WKS), a neuropsychiatric condition secondary to a deficiency of thiamine. 3 The disease is characterized by altered mental status, oculomotor findings, and ataxia. 3 Patients with WKS may exhibit challenging behaviors, including aggression, disinhibition, and lack of awareness of their illness. 4 Due to long-standing cognitive and physical deficits, many patients require lifelong care with a focus on a palliative approach. 3

The mainstay of pharmacologic management for the neuropsychiatric symptoms of WKS continues to be psychoactive medications, such as antipsychotics, benzodiazepines, antidepressants, and anticonvulsant medications.4-6 Though atypical antipsychotic medications remain the most widely used, they have a high adverse effect (AE) profile.5,6 Among the potential AEs are metabolic syndrome, anticholinergic effects, QTc prolongation, orthostatic hypotension, extrapyramidal effects, sedation, and falls. There also is a US Food and Drug Administration boxed warning for increased risk of mortality.7 With the goal of improving and maintaining patient safety, pharmacologic interventions with lower AEs may be beneficial in the management of the neuropsychiatric symptoms of WKS.

This case describes a veteran who was initially hospitalized due to confusion, ataxia, and nystagmus secondary to chronic alcohol overuse. The aim of the case was to consider the use of acetaminophen in place of psychoactive medications as a way to manage neuropsychiatric symptoms of WKS even when pain was not present.

 

Case Presentation

A veteran presented to the local US Department of Veterans Affairs (VA) emergency department (ED) due to their spouse’s concern of acute onset confusion and ambulatory difficulties. The veteran’s medical history included extensive alcohol misuse, mild asthma, and diet-controlled hyperlipidemia. On initial evaluation, the veteran displayed symptoms of ataxia and confusion. When asked why the veteran was at the ED, the response was, “I just came to the hospital to find my sister.” Based on their medical history, clinical evaluation, and altered mental status, the veteran was admitted to the acute care medical service with a presumptive diagnosis of WKS.

On admission, the laboratory evaluation revealed normal alanine transaminase (ALT) and aspartate transaminase (AST) levels but markedly elevated γ-glutamyl transferase (GGT) consistent with alcohol toxicity. COVID-19 testing was negative. Magnetic resonance imaging (MRI) of the brain revealed evidence of alterations in the mammillary bodies and moderately severe cortical and cerebellar volume loss suggestive of long-standing alcohol use.

The veteran was hospitalized for 12 days and treated with high-dose IV thiamine, which resulted in improvement of their ophthalmic disorder (nystagmus) and ataxia. However, they continued to exhibit poor recall, confusion, and occasional agitation characterized by verbal outbursts and aggression toward the staff.

The veteran’s spouse worked full time and did not feel capable of providing the necessary follow-up care at home. The safest discharge plan found was to transfer the veteran to the local VA community living center (CLC) for physical therapy and further support of their marked cognitive decline and agitation.

Following admission to the CLC, the veteran was placed in a secured memory unit with staff trained specifically on management of veterans with cognitive impairment and behavioral concerns. As the veteran did not have decisional capacity on admission, the staff arranged a meeting with the spouse. Based on that conversation, the goals of care were to focus on a palliative approach and the hope that the veteran would one day be able to return home to their spouse.

At the CLC, the veteran was initially treated with thiamine 200 mg orally once daily and albuterol inhaler as needed. A clinical psychologist performed a comprehensive psychological evaluation on admission, which confirmed evidence of WKS with symptoms, including confusion, disorientation, and confabulation. There was no evidence of cultural diversity factors regarding the veteran’s delusional beliefs.

 

 



After the first full day in the CLC, the nursing staff observed anger and agitation that seemed to start midafternoon and continued until around dinnertime. The veteran displayed verbal outbursts, refusal to cooperate with the staff, and multiple attempts to leave the CLC. With the guidance of a geriatric psychiatrist, risperidone 1 mg once daily as needed was initiated, and staff continued with verbal redirection, both with limited efficacy. After 3 days, due to safety concerns for the veteran, other CLC patients, and CLC staff, risperidone dosing was increased to 1 mg twice daily, which had limited efficacy. Lorazepam 1 mg once daily also was added. A careful medication review was performed to minimize any potential AEs or interactions that might have contributed to the veteran’s behavior, but no pharmacologic interventions were found to fully abate their behavioral issues.

After 5 weeks of ongoing intermittent behavioral issues, the medical team again met to discuss new treatment options.A case reported by Husebo and colleagues used scheduled acetaminophen to help relieve neuropsychiatric symptoms of dementia in a patient who exhibited similar behavioral issues and did not respond well to antipsychotics or benzodiazepines.8 Although our veteran did not express or exhibit obvious pain, the medical team chose to trial this intervention, and the veteran was started on acetaminophen 650 mg orally 3 times daily. A comprehensive metabolic panel, including GGT and thyroid-stimulating hormone, was performed before starting acetaminophen; no abnormalities were noted. The clinical examination did not reveal physical abnormalities other than ataxia.

After 5 days of therapy with the scheduled acetaminophen, the veteran’s clinical behavior dramatically improved. The veteran exhibited infrequent agitated behavior and became cooperative with staff. Three days later, the scheduled lorazepam was discontinued, and eventually they were tapered off risperidone. One month after starting scheduled acetaminophen, the veteran had improved to a point where the staff determined a safe discharge plan could be initiated. The veteran’s nystagmus resolved and behavioral issues improved, although cognitive impairment persisted.

Due to COVID-19, a teleconference was scheduled with the veteran’s spouse to discuss a discharge plan. The spouse was pleased that the veteran had progressed adequately both functionally and behaviorally to make a safe discharge home possible. The spouse arranged to take family leave from their job to help support the veteran after discharge. The veteran was able to return home with a safe discharge plan 1 week later. The acetaminophen was continued with twice-daily dosing and was continued because there were no new behavioral issues. This was done to enhance postfacility adherence and minimize the risk of drug-drug interactions. Attempts to follow up with the veteran postdischarge were unfortunately unsuccessful as the family lived out of the local area.

Discussion

Alcohol misuse is a common finding in many US veterans, as well as in the general population.1,3 As a result, it is not uncommon to see patients with physical and psychological symptoms related to this abuse. Many of these patients will become verbally and physically abusive, thus having appropriate pharmacologic and nonpharmacologic interventions is important.

In this case study, the veteran was diagnosed with WKS and exhibited physical, cognitive, and emotional symptoms consistent with this disease. Although the physical symptoms improved with thiamine and abstinence from alcohol, their cognitive impairment, verbal outbursts, and aggressive demeanor persisted.

After using antipsychotic and anxiolytic medications with minimal clinical improvement, a trial of acetaminophen 650 mg 3 times daily was instituted. The patient’s behavior improved; demeanor became calmer, and they were easily redirected by the nursing staff. Psychological support was again employed, which enhanced and supported the veteran’s calmer demeanor. Although there is limited medical literature on the use of acetaminophen in clinical situations not related to pain, there has been research documenting its effect on social interaction.9,10

Acetaminophen is an analgesic medication that acts through central neural mechanisms. It has been hypothesized that social and physical pain rely on shared neurochemical underpinnings, and some of the regions of the brain involved in affective experience of physical pain also have been found to be involved in the experience of social pain.11 Acetaminophen may impact an individual’s social well-being as social pain processes.11 It has been shown to blunt reactivity to both physical pain as well as negative stimuli.11

Conclusions

A 2019 survey on alcohol and drug use found 5.6% of adults aged ≥ 18 have an alcohol use disorder.12 In severe cases, this can result in WKS. Although replacement of thiamine is critical for physical improvement, psychological deficits may persist. Small studies have advanced the concept of using scheduled acetaminophen even when the patient is not verbalizing or displaying pain.13 Although more research needs to be done on this topic, this palliative approach may be worth considering, especially if the risks of antipsychotics and anxiolytics outweigh the benefits.

References

1. National Institute on Drug Abuse. Substance use and military life drug facts. Published October 2019. Accessed November 10, 2021. https://www.drugabuse.gov/publications/drugfacts/substance-use-military-life

2. National Veterans Foundation. What statistics show about veteran substance abuse and why proper treatment is important. Published March 30, 2016. Accessed November 10, 2021. https://nvf.org/veteran-substance-abuse-statistics

3. National Center for Biotechnology Information. Korsakoff syndrome. Updated July 10, 2020. Accessed November 10, 2021. https://www.ncbi.nlm.nih.gov/books/NBK539854

4. Gerridzen IJ, Goossensen MA. Patients with Korsakoff syndrome in nursing homes: characteristics, comorbidity, and use of psychotropic drugs. Int Psychogeriatr. 2014;26(1):115-121. doi:10.1017/S1041610213001543

5. Press D, Alexander M. Management of neuropsychiatric symptoms of dementia. Updated October 2021. Accessed November 10, 2021. https://www.uptodate.com/contents/management-of-neuropsychiatric-symptoms-of-dementia

6. Steinberg M, Lyketsos CG. Atypical antipsychotic use in patients with dementia: Managing safety concerns. Am J Psychiatry. 2012;169(9):900-906. doi:10.1176/appi.ajp.2012.12030342

7. Jibson MD. Second-generation antipsychotic medications: pharmacology, administration, and side effects. https://www.uptodate.com/contents/second-generation-antipsychotic-medications-pharmacology-administration-and-side-effects

8. Husebo BS, Ballard C, Sandvik R, Nilsen OB, Aarsland D. Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial. BMJ. 2011;343:d4065. doi:10.1136/bmj.d4065

9. Fung K, Alden LE. Once hurt, twice shy: social pain contributes to social anxiety. Emotion. 2017;(2):231-239. doi:10.1037/emo0000223

10. Roberts ID, Krajbich I, Cheavens JS, Campo JV, Way BM. Acetaminophen Reduces Distrust in Individuals with Borderline Personality Disorder Features. Clin Psychol Sci. 2018;6(1):145-154. doi:10.1177/2167702617731374

11. Dewall CN, Macdonald G, Webster GD, et al. Acetaminophen reduces social pain: behavioral and neural evidence. Psychol Sci. 2010;21(7):931-937. doi:10.1177/0956797610374741

12. National Institute on Alcohol Abuse and Alcoholism. Alcohol facts and statistics. Updated June 2021. Accessed November 2, 202November 10, 2021. https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/alcohol-facts-and-statistics

13. Chibnall JT, Tait RC, Harman B, Luebbert RA. Effect of acetaminophen on behavior, well-being, and psychotropic medication use in nursing home residents with moderate-to-severe dementia. J Am Geriatrics Soc. 2005;53(11):1921-9. doi:10.1111/j.1532-5415.2005.53572.x

Article PDF
Author and Disclosure Information

David B. Brecher, MDa; and Sarah A. Morgan, ARNPa
Correspondence: 
David Brecher ([email protected])

Author affiliations

aVeterans Affairs Puget Sound Health Care System, Tacoma, Washington

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The authors report that the patient did not provide informed consent. Details about the patient and case have been changed to avoid identification.

Issue
Federal Practitioner - 39(1)a
Publications
Topics
Page Number
19-22
Sections
Author and Disclosure Information

David B. Brecher, MDa; and Sarah A. Morgan, ARNPa
Correspondence: 
David Brecher ([email protected])

Author affiliations

aVeterans Affairs Puget Sound Health Care System, Tacoma, Washington

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The authors report that the patient did not provide informed consent. Details about the patient and case have been changed to avoid identification.

Author and Disclosure Information

David B. Brecher, MDa; and Sarah A. Morgan, ARNPa
Correspondence: 
David Brecher ([email protected])

Author affiliations

aVeterans Affairs Puget Sound Health Care System, Tacoma, Washington

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The authors report that the patient did not provide informed consent. Details about the patient and case have been changed to avoid identification.

Article PDF
Article PDF
Related Articles

To manage the physical, cognitive, and emotional symptoms of a veteran hospitalized for Wernicke-Korsakoff syndrome secondary to chronic alcohol overuse, acetaminophen was administered in place of psychoactive medications.

To manage the physical, cognitive, and emotional symptoms of a veteran hospitalized for Wernicke-Korsakoff syndrome secondary to chronic alcohol overuse, acetaminophen was administered in place of psychoactive medications.

Alcohol is the most common substance misused by veterans. 1 Veterans may m isuse alcohol as a result of mental illness or posttraumatic stress disorder (PTSD), having difficulties adjusting to civilian life, or because of heavy drinking habits acquired before leaving active duty. 2 One potential long-term effect of chronic alcohol misuse is Wernicke-Korsakoff syndrome (WKS), a neuropsychiatric condition secondary to a deficiency of thiamine. 3 The disease is characterized by altered mental status, oculomotor findings, and ataxia. 3 Patients with WKS may exhibit challenging behaviors, including aggression, disinhibition, and lack of awareness of their illness. 4 Due to long-standing cognitive and physical deficits, many patients require lifelong care with a focus on a palliative approach. 3

The mainstay of pharmacologic management for the neuropsychiatric symptoms of WKS continues to be psychoactive medications, such as antipsychotics, benzodiazepines, antidepressants, and anticonvulsant medications.4-6 Though atypical antipsychotic medications remain the most widely used, they have a high adverse effect (AE) profile.5,6 Among the potential AEs are metabolic syndrome, anticholinergic effects, QTc prolongation, orthostatic hypotension, extrapyramidal effects, sedation, and falls. There also is a US Food and Drug Administration boxed warning for increased risk of mortality.7 With the goal of improving and maintaining patient safety, pharmacologic interventions with lower AEs may be beneficial in the management of the neuropsychiatric symptoms of WKS.

This case describes a veteran who was initially hospitalized due to confusion, ataxia, and nystagmus secondary to chronic alcohol overuse. The aim of the case was to consider the use of acetaminophen in place of psychoactive medications as a way to manage neuropsychiatric symptoms of WKS even when pain was not present.

 

Case Presentation

A veteran presented to the local US Department of Veterans Affairs (VA) emergency department (ED) due to their spouse’s concern of acute onset confusion and ambulatory difficulties. The veteran’s medical history included extensive alcohol misuse, mild asthma, and diet-controlled hyperlipidemia. On initial evaluation, the veteran displayed symptoms of ataxia and confusion. When asked why the veteran was at the ED, the response was, “I just came to the hospital to find my sister.” Based on their medical history, clinical evaluation, and altered mental status, the veteran was admitted to the acute care medical service with a presumptive diagnosis of WKS.

On admission, the laboratory evaluation revealed normal alanine transaminase (ALT) and aspartate transaminase (AST) levels but markedly elevated γ-glutamyl transferase (GGT) consistent with alcohol toxicity. COVID-19 testing was negative. Magnetic resonance imaging (MRI) of the brain revealed evidence of alterations in the mammillary bodies and moderately severe cortical and cerebellar volume loss suggestive of long-standing alcohol use.

The veteran was hospitalized for 12 days and treated with high-dose IV thiamine, which resulted in improvement of their ophthalmic disorder (nystagmus) and ataxia. However, they continued to exhibit poor recall, confusion, and occasional agitation characterized by verbal outbursts and aggression toward the staff.

The veteran’s spouse worked full time and did not feel capable of providing the necessary follow-up care at home. The safest discharge plan found was to transfer the veteran to the local VA community living center (CLC) for physical therapy and further support of their marked cognitive decline and agitation.

Following admission to the CLC, the veteran was placed in a secured memory unit with staff trained specifically on management of veterans with cognitive impairment and behavioral concerns. As the veteran did not have decisional capacity on admission, the staff arranged a meeting with the spouse. Based on that conversation, the goals of care were to focus on a palliative approach and the hope that the veteran would one day be able to return home to their spouse.

At the CLC, the veteran was initially treated with thiamine 200 mg orally once daily and albuterol inhaler as needed. A clinical psychologist performed a comprehensive psychological evaluation on admission, which confirmed evidence of WKS with symptoms, including confusion, disorientation, and confabulation. There was no evidence of cultural diversity factors regarding the veteran’s delusional beliefs.

 

 



After the first full day in the CLC, the nursing staff observed anger and agitation that seemed to start midafternoon and continued until around dinnertime. The veteran displayed verbal outbursts, refusal to cooperate with the staff, and multiple attempts to leave the CLC. With the guidance of a geriatric psychiatrist, risperidone 1 mg once daily as needed was initiated, and staff continued with verbal redirection, both with limited efficacy. After 3 days, due to safety concerns for the veteran, other CLC patients, and CLC staff, risperidone dosing was increased to 1 mg twice daily, which had limited efficacy. Lorazepam 1 mg once daily also was added. A careful medication review was performed to minimize any potential AEs or interactions that might have contributed to the veteran’s behavior, but no pharmacologic interventions were found to fully abate their behavioral issues.

After 5 weeks of ongoing intermittent behavioral issues, the medical team again met to discuss new treatment options.A case reported by Husebo and colleagues used scheduled acetaminophen to help relieve neuropsychiatric symptoms of dementia in a patient who exhibited similar behavioral issues and did not respond well to antipsychotics or benzodiazepines.8 Although our veteran did not express or exhibit obvious pain, the medical team chose to trial this intervention, and the veteran was started on acetaminophen 650 mg orally 3 times daily. A comprehensive metabolic panel, including GGT and thyroid-stimulating hormone, was performed before starting acetaminophen; no abnormalities were noted. The clinical examination did not reveal physical abnormalities other than ataxia.

After 5 days of therapy with the scheduled acetaminophen, the veteran’s clinical behavior dramatically improved. The veteran exhibited infrequent agitated behavior and became cooperative with staff. Three days later, the scheduled lorazepam was discontinued, and eventually they were tapered off risperidone. One month after starting scheduled acetaminophen, the veteran had improved to a point where the staff determined a safe discharge plan could be initiated. The veteran’s nystagmus resolved and behavioral issues improved, although cognitive impairment persisted.

Due to COVID-19, a teleconference was scheduled with the veteran’s spouse to discuss a discharge plan. The spouse was pleased that the veteran had progressed adequately both functionally and behaviorally to make a safe discharge home possible. The spouse arranged to take family leave from their job to help support the veteran after discharge. The veteran was able to return home with a safe discharge plan 1 week later. The acetaminophen was continued with twice-daily dosing and was continued because there were no new behavioral issues. This was done to enhance postfacility adherence and minimize the risk of drug-drug interactions. Attempts to follow up with the veteran postdischarge were unfortunately unsuccessful as the family lived out of the local area.

Discussion

Alcohol misuse is a common finding in many US veterans, as well as in the general population.1,3 As a result, it is not uncommon to see patients with physical and psychological symptoms related to this abuse. Many of these patients will become verbally and physically abusive, thus having appropriate pharmacologic and nonpharmacologic interventions is important.

In this case study, the veteran was diagnosed with WKS and exhibited physical, cognitive, and emotional symptoms consistent with this disease. Although the physical symptoms improved with thiamine and abstinence from alcohol, their cognitive impairment, verbal outbursts, and aggressive demeanor persisted.

After using antipsychotic and anxiolytic medications with minimal clinical improvement, a trial of acetaminophen 650 mg 3 times daily was instituted. The patient’s behavior improved; demeanor became calmer, and they were easily redirected by the nursing staff. Psychological support was again employed, which enhanced and supported the veteran’s calmer demeanor. Although there is limited medical literature on the use of acetaminophen in clinical situations not related to pain, there has been research documenting its effect on social interaction.9,10

Acetaminophen is an analgesic medication that acts through central neural mechanisms. It has been hypothesized that social and physical pain rely on shared neurochemical underpinnings, and some of the regions of the brain involved in affective experience of physical pain also have been found to be involved in the experience of social pain.11 Acetaminophen may impact an individual’s social well-being as social pain processes.11 It has been shown to blunt reactivity to both physical pain as well as negative stimuli.11

Conclusions

A 2019 survey on alcohol and drug use found 5.6% of adults aged ≥ 18 have an alcohol use disorder.12 In severe cases, this can result in WKS. Although replacement of thiamine is critical for physical improvement, psychological deficits may persist. Small studies have advanced the concept of using scheduled acetaminophen even when the patient is not verbalizing or displaying pain.13 Although more research needs to be done on this topic, this palliative approach may be worth considering, especially if the risks of antipsychotics and anxiolytics outweigh the benefits.

Alcohol is the most common substance misused by veterans. 1 Veterans may m isuse alcohol as a result of mental illness or posttraumatic stress disorder (PTSD), having difficulties adjusting to civilian life, or because of heavy drinking habits acquired before leaving active duty. 2 One potential long-term effect of chronic alcohol misuse is Wernicke-Korsakoff syndrome (WKS), a neuropsychiatric condition secondary to a deficiency of thiamine. 3 The disease is characterized by altered mental status, oculomotor findings, and ataxia. 3 Patients with WKS may exhibit challenging behaviors, including aggression, disinhibition, and lack of awareness of their illness. 4 Due to long-standing cognitive and physical deficits, many patients require lifelong care with a focus on a palliative approach. 3

The mainstay of pharmacologic management for the neuropsychiatric symptoms of WKS continues to be psychoactive medications, such as antipsychotics, benzodiazepines, antidepressants, and anticonvulsant medications.4-6 Though atypical antipsychotic medications remain the most widely used, they have a high adverse effect (AE) profile.5,6 Among the potential AEs are metabolic syndrome, anticholinergic effects, QTc prolongation, orthostatic hypotension, extrapyramidal effects, sedation, and falls. There also is a US Food and Drug Administration boxed warning for increased risk of mortality.7 With the goal of improving and maintaining patient safety, pharmacologic interventions with lower AEs may be beneficial in the management of the neuropsychiatric symptoms of WKS.

This case describes a veteran who was initially hospitalized due to confusion, ataxia, and nystagmus secondary to chronic alcohol overuse. The aim of the case was to consider the use of acetaminophen in place of psychoactive medications as a way to manage neuropsychiatric symptoms of WKS even when pain was not present.

 

Case Presentation

A veteran presented to the local US Department of Veterans Affairs (VA) emergency department (ED) due to their spouse’s concern of acute onset confusion and ambulatory difficulties. The veteran’s medical history included extensive alcohol misuse, mild asthma, and diet-controlled hyperlipidemia. On initial evaluation, the veteran displayed symptoms of ataxia and confusion. When asked why the veteran was at the ED, the response was, “I just came to the hospital to find my sister.” Based on their medical history, clinical evaluation, and altered mental status, the veteran was admitted to the acute care medical service with a presumptive diagnosis of WKS.

On admission, the laboratory evaluation revealed normal alanine transaminase (ALT) and aspartate transaminase (AST) levels but markedly elevated γ-glutamyl transferase (GGT) consistent with alcohol toxicity. COVID-19 testing was negative. Magnetic resonance imaging (MRI) of the brain revealed evidence of alterations in the mammillary bodies and moderately severe cortical and cerebellar volume loss suggestive of long-standing alcohol use.

The veteran was hospitalized for 12 days and treated with high-dose IV thiamine, which resulted in improvement of their ophthalmic disorder (nystagmus) and ataxia. However, they continued to exhibit poor recall, confusion, and occasional agitation characterized by verbal outbursts and aggression toward the staff.

The veteran’s spouse worked full time and did not feel capable of providing the necessary follow-up care at home. The safest discharge plan found was to transfer the veteran to the local VA community living center (CLC) for physical therapy and further support of their marked cognitive decline and agitation.

Following admission to the CLC, the veteran was placed in a secured memory unit with staff trained specifically on management of veterans with cognitive impairment and behavioral concerns. As the veteran did not have decisional capacity on admission, the staff arranged a meeting with the spouse. Based on that conversation, the goals of care were to focus on a palliative approach and the hope that the veteran would one day be able to return home to their spouse.

At the CLC, the veteran was initially treated with thiamine 200 mg orally once daily and albuterol inhaler as needed. A clinical psychologist performed a comprehensive psychological evaluation on admission, which confirmed evidence of WKS with symptoms, including confusion, disorientation, and confabulation. There was no evidence of cultural diversity factors regarding the veteran’s delusional beliefs.

 

 



After the first full day in the CLC, the nursing staff observed anger and agitation that seemed to start midafternoon and continued until around dinnertime. The veteran displayed verbal outbursts, refusal to cooperate with the staff, and multiple attempts to leave the CLC. With the guidance of a geriatric psychiatrist, risperidone 1 mg once daily as needed was initiated, and staff continued with verbal redirection, both with limited efficacy. After 3 days, due to safety concerns for the veteran, other CLC patients, and CLC staff, risperidone dosing was increased to 1 mg twice daily, which had limited efficacy. Lorazepam 1 mg once daily also was added. A careful medication review was performed to minimize any potential AEs or interactions that might have contributed to the veteran’s behavior, but no pharmacologic interventions were found to fully abate their behavioral issues.

After 5 weeks of ongoing intermittent behavioral issues, the medical team again met to discuss new treatment options.A case reported by Husebo and colleagues used scheduled acetaminophen to help relieve neuropsychiatric symptoms of dementia in a patient who exhibited similar behavioral issues and did not respond well to antipsychotics or benzodiazepines.8 Although our veteran did not express or exhibit obvious pain, the medical team chose to trial this intervention, and the veteran was started on acetaminophen 650 mg orally 3 times daily. A comprehensive metabolic panel, including GGT and thyroid-stimulating hormone, was performed before starting acetaminophen; no abnormalities were noted. The clinical examination did not reveal physical abnormalities other than ataxia.

After 5 days of therapy with the scheduled acetaminophen, the veteran’s clinical behavior dramatically improved. The veteran exhibited infrequent agitated behavior and became cooperative with staff. Three days later, the scheduled lorazepam was discontinued, and eventually they were tapered off risperidone. One month after starting scheduled acetaminophen, the veteran had improved to a point where the staff determined a safe discharge plan could be initiated. The veteran’s nystagmus resolved and behavioral issues improved, although cognitive impairment persisted.

Due to COVID-19, a teleconference was scheduled with the veteran’s spouse to discuss a discharge plan. The spouse was pleased that the veteran had progressed adequately both functionally and behaviorally to make a safe discharge home possible. The spouse arranged to take family leave from their job to help support the veteran after discharge. The veteran was able to return home with a safe discharge plan 1 week later. The acetaminophen was continued with twice-daily dosing and was continued because there were no new behavioral issues. This was done to enhance postfacility adherence and minimize the risk of drug-drug interactions. Attempts to follow up with the veteran postdischarge were unfortunately unsuccessful as the family lived out of the local area.

Discussion

Alcohol misuse is a common finding in many US veterans, as well as in the general population.1,3 As a result, it is not uncommon to see patients with physical and psychological symptoms related to this abuse. Many of these patients will become verbally and physically abusive, thus having appropriate pharmacologic and nonpharmacologic interventions is important.

In this case study, the veteran was diagnosed with WKS and exhibited physical, cognitive, and emotional symptoms consistent with this disease. Although the physical symptoms improved with thiamine and abstinence from alcohol, their cognitive impairment, verbal outbursts, and aggressive demeanor persisted.

After using antipsychotic and anxiolytic medications with minimal clinical improvement, a trial of acetaminophen 650 mg 3 times daily was instituted. The patient’s behavior improved; demeanor became calmer, and they were easily redirected by the nursing staff. Psychological support was again employed, which enhanced and supported the veteran’s calmer demeanor. Although there is limited medical literature on the use of acetaminophen in clinical situations not related to pain, there has been research documenting its effect on social interaction.9,10

Acetaminophen is an analgesic medication that acts through central neural mechanisms. It has been hypothesized that social and physical pain rely on shared neurochemical underpinnings, and some of the regions of the brain involved in affective experience of physical pain also have been found to be involved in the experience of social pain.11 Acetaminophen may impact an individual’s social well-being as social pain processes.11 It has been shown to blunt reactivity to both physical pain as well as negative stimuli.11

Conclusions

A 2019 survey on alcohol and drug use found 5.6% of adults aged ≥ 18 have an alcohol use disorder.12 In severe cases, this can result in WKS. Although replacement of thiamine is critical for physical improvement, psychological deficits may persist. Small studies have advanced the concept of using scheduled acetaminophen even when the patient is not verbalizing or displaying pain.13 Although more research needs to be done on this topic, this palliative approach may be worth considering, especially if the risks of antipsychotics and anxiolytics outweigh the benefits.

References

1. National Institute on Drug Abuse. Substance use and military life drug facts. Published October 2019. Accessed November 10, 2021. https://www.drugabuse.gov/publications/drugfacts/substance-use-military-life

2. National Veterans Foundation. What statistics show about veteran substance abuse and why proper treatment is important. Published March 30, 2016. Accessed November 10, 2021. https://nvf.org/veteran-substance-abuse-statistics

3. National Center for Biotechnology Information. Korsakoff syndrome. Updated July 10, 2020. Accessed November 10, 2021. https://www.ncbi.nlm.nih.gov/books/NBK539854

4. Gerridzen IJ, Goossensen MA. Patients with Korsakoff syndrome in nursing homes: characteristics, comorbidity, and use of psychotropic drugs. Int Psychogeriatr. 2014;26(1):115-121. doi:10.1017/S1041610213001543

5. Press D, Alexander M. Management of neuropsychiatric symptoms of dementia. Updated October 2021. Accessed November 10, 2021. https://www.uptodate.com/contents/management-of-neuropsychiatric-symptoms-of-dementia

6. Steinberg M, Lyketsos CG. Atypical antipsychotic use in patients with dementia: Managing safety concerns. Am J Psychiatry. 2012;169(9):900-906. doi:10.1176/appi.ajp.2012.12030342

7. Jibson MD. Second-generation antipsychotic medications: pharmacology, administration, and side effects. https://www.uptodate.com/contents/second-generation-antipsychotic-medications-pharmacology-administration-and-side-effects

8. Husebo BS, Ballard C, Sandvik R, Nilsen OB, Aarsland D. Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial. BMJ. 2011;343:d4065. doi:10.1136/bmj.d4065

9. Fung K, Alden LE. Once hurt, twice shy: social pain contributes to social anxiety. Emotion. 2017;(2):231-239. doi:10.1037/emo0000223

10. Roberts ID, Krajbich I, Cheavens JS, Campo JV, Way BM. Acetaminophen Reduces Distrust in Individuals with Borderline Personality Disorder Features. Clin Psychol Sci. 2018;6(1):145-154. doi:10.1177/2167702617731374

11. Dewall CN, Macdonald G, Webster GD, et al. Acetaminophen reduces social pain: behavioral and neural evidence. Psychol Sci. 2010;21(7):931-937. doi:10.1177/0956797610374741

12. National Institute on Alcohol Abuse and Alcoholism. Alcohol facts and statistics. Updated June 2021. Accessed November 2, 202November 10, 2021. https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/alcohol-facts-and-statistics

13. Chibnall JT, Tait RC, Harman B, Luebbert RA. Effect of acetaminophen on behavior, well-being, and psychotropic medication use in nursing home residents with moderate-to-severe dementia. J Am Geriatrics Soc. 2005;53(11):1921-9. doi:10.1111/j.1532-5415.2005.53572.x

References

1. National Institute on Drug Abuse. Substance use and military life drug facts. Published October 2019. Accessed November 10, 2021. https://www.drugabuse.gov/publications/drugfacts/substance-use-military-life

2. National Veterans Foundation. What statistics show about veteran substance abuse and why proper treatment is important. Published March 30, 2016. Accessed November 10, 2021. https://nvf.org/veteran-substance-abuse-statistics

3. National Center for Biotechnology Information. Korsakoff syndrome. Updated July 10, 2020. Accessed November 10, 2021. https://www.ncbi.nlm.nih.gov/books/NBK539854

4. Gerridzen IJ, Goossensen MA. Patients with Korsakoff syndrome in nursing homes: characteristics, comorbidity, and use of psychotropic drugs. Int Psychogeriatr. 2014;26(1):115-121. doi:10.1017/S1041610213001543

5. Press D, Alexander M. Management of neuropsychiatric symptoms of dementia. Updated October 2021. Accessed November 10, 2021. https://www.uptodate.com/contents/management-of-neuropsychiatric-symptoms-of-dementia

6. Steinberg M, Lyketsos CG. Atypical antipsychotic use in patients with dementia: Managing safety concerns. Am J Psychiatry. 2012;169(9):900-906. doi:10.1176/appi.ajp.2012.12030342

7. Jibson MD. Second-generation antipsychotic medications: pharmacology, administration, and side effects. https://www.uptodate.com/contents/second-generation-antipsychotic-medications-pharmacology-administration-and-side-effects

8. Husebo BS, Ballard C, Sandvik R, Nilsen OB, Aarsland D. Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial. BMJ. 2011;343:d4065. doi:10.1136/bmj.d4065

9. Fung K, Alden LE. Once hurt, twice shy: social pain contributes to social anxiety. Emotion. 2017;(2):231-239. doi:10.1037/emo0000223

10. Roberts ID, Krajbich I, Cheavens JS, Campo JV, Way BM. Acetaminophen Reduces Distrust in Individuals with Borderline Personality Disorder Features. Clin Psychol Sci. 2018;6(1):145-154. doi:10.1177/2167702617731374

11. Dewall CN, Macdonald G, Webster GD, et al. Acetaminophen reduces social pain: behavioral and neural evidence. Psychol Sci. 2010;21(7):931-937. doi:10.1177/0956797610374741

12. National Institute on Alcohol Abuse and Alcoholism. Alcohol facts and statistics. Updated June 2021. Accessed November 2, 202November 10, 2021. https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/alcohol-facts-and-statistics

13. Chibnall JT, Tait RC, Harman B, Luebbert RA. Effect of acetaminophen on behavior, well-being, and psychotropic medication use in nursing home residents with moderate-to-severe dementia. J Am Geriatrics Soc. 2005;53(11):1921-9. doi:10.1111/j.1532-5415.2005.53572.x

Issue
Federal Practitioner - 39(1)a
Issue
Federal Practitioner - 39(1)a
Page Number
19-22
Page Number
19-22
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

With sexually transmitted infections off the charts, California pushes at-home tests

Article Type
Changed
Mon, 01/10/2022 - 10:26

 



SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Publications
Topics
Sections

 



SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

 



SACRAMENTO, CALIF. – California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia, and syphilis – which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care, and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Dr. Pan said. “You’d think that went away in the Victorian era.”

Even before COVID, sexually transmitted infections hit all-time highs in the United States and California for 6 years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents – up to 78% in one survey – have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” because of reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus, or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at University of California, Los Angeles, was getting tested frequently as part of a 2-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea, and trichomoniasis, was packaged discreetly and came with easy instructions. It took Mr. Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Mr. Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent 2 hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests – if anything – depends on the type of plan they have, whether their provider is in-network, and whether they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, cofounder of the project, said that requests for test kits during the pandemic nearly tripled – and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment, or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Mr. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about 7 hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

This story was produced by Kaiser Health News (KHN), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Key questions to ask atopic dermatitis patients with sleep complaints

Article Type
Changed
Mon, 01/10/2022 - 09:49

 

If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.

According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, AD is associated with difficulty falling asleep, nighttime awakenings, early morning awakenings, increased daytime sleepiness, decreased sleep efficiency, increased arousals, awakenings, and sleep fragmentation, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.



During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:

When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.

How long does it take for you to fall asleep?

Do you wake up in the middle of the night, and for how long? What do you do if you wake up?

When do you wake up in the morning? Is it on your own, or with an alarm clock?

Does this schedule change on nonworkdays?

Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?

Do you snore? Meaning, is there concern for sleep apnea?

Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.

The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”

Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.

Dr. Abbott reported having no financial disclosures.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.

According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, AD is associated with difficulty falling asleep, nighttime awakenings, early morning awakenings, increased daytime sleepiness, decreased sleep efficiency, increased arousals, awakenings, and sleep fragmentation, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.



During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:

When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.

How long does it take for you to fall asleep?

Do you wake up in the middle of the night, and for how long? What do you do if you wake up?

When do you wake up in the morning? Is it on your own, or with an alarm clock?

Does this schedule change on nonworkdays?

Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?

Do you snore? Meaning, is there concern for sleep apnea?

Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.

The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”

Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.

Dr. Abbott reported having no financial disclosures.

 

If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.

According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, AD is associated with difficulty falling asleep, nighttime awakenings, early morning awakenings, increased daytime sleepiness, decreased sleep efficiency, increased arousals, awakenings, and sleep fragmentation, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.



During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:

When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.

How long does it take for you to fall asleep?

Do you wake up in the middle of the night, and for how long? What do you do if you wake up?

When do you wake up in the morning? Is it on your own, or with an alarm clock?

Does this schedule change on nonworkdays?

Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?

Do you snore? Meaning, is there concern for sleep apnea?

Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.

The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”

Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.

Dr. Abbott reported having no financial disclosures.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM REVOLUTIONIZING AD 2021

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

One doctor’s psychedelic journey to confront his cancer

Article Type
Changed
Tue, 01/11/2022 - 08:48

 

Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.

The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.

Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.

He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.

Dr. Bansal did not arrive at this moment lightly.

“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.

“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”

But Bansal had done his homework on psilocybin and was impressed.

People with late-stage cancer and other serious health conditions who got psilocybin-assisted psychotherapy had “significant decreases” in anxiety and depression as long as 12 months after the treatment, according to studies published in 2011, 2014, and 2016.

One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.

For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.

And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.

He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.

Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
 

Stuck in a dark place

Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019. 

Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).

It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.

“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”

But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.

“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”

As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.

At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.

With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”

He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.

Those things helped, but not enough.

The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.

If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.

As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).

The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
 

Starting the journey

By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.

The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)

Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.

This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.

Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic. 

He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.

“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.

“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”

“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.

For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.

But he did his best to set aside his doubts and embrace the journey he was about to take.
 

The day of the trip

Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.

This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.

The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.

A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.

“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”

The doctor said: “Don’t worry about it. Just trust and let go.”

And that’s just what he did.

Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.

Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.

Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.

It took about 45 minutes for the medication to kick in.
 

 

 

The investigator

The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.

Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.

He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.

“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”

“But what about the psychological effects?”

They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.

So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.

Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.

To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.

And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.

The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
 

A trip into the unknown

Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.

“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.

There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.

Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.

“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”

All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.

And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”

“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”

Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”

Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”

His therapist was clear about what to do: Stand firm and walk toward it.

“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
 

A state of peace

Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.

“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”

After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.

“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”

This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
 

After the journey

It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:

“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”

And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”

The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.

From his journal:

“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.

“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”

That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.

A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.

“It’s inspiring,” Dr. Richards said.

“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”

And the positive effects can extend deep into the family system, he said.

After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.

Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”

At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
 

After the experience

Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.

The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.

Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.

The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.

“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”

It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.

In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
 

Pradeep 2.0

Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.

“And yet it was somehow okay,” he said. “It was only pain.”

“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”

Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”

The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.

“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”

Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”

He even named his new outlook. “I call it Pradeep 2.0.”

A version of this article first appeared on WebMD.com.

Publications
Topics
Sections

 

Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.

The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.

Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.

He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.

Dr. Bansal did not arrive at this moment lightly.

“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.

“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”

But Bansal had done his homework on psilocybin and was impressed.

People with late-stage cancer and other serious health conditions who got psilocybin-assisted psychotherapy had “significant decreases” in anxiety and depression as long as 12 months after the treatment, according to studies published in 2011, 2014, and 2016.

One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.

For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.

And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.

He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.

Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
 

Stuck in a dark place

Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019. 

Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).

It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.

“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”

But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.

“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”

As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.

At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.

With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”

He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.

Those things helped, but not enough.

The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.

If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.

As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).

The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
 

Starting the journey

By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.

The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)

Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.

This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.

Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic. 

He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.

“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.

“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”

“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.

For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.

But he did his best to set aside his doubts and embrace the journey he was about to take.
 

The day of the trip

Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.

This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.

The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.

A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.

“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”

The doctor said: “Don’t worry about it. Just trust and let go.”

And that’s just what he did.

Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.

Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.

Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.

It took about 45 minutes for the medication to kick in.
 

 

 

The investigator

The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.

Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.

He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.

“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”

“But what about the psychological effects?”

They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.

So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.

Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.

To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.

And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.

The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
 

A trip into the unknown

Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.

“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.

There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.

Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.

“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”

All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.

And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”

“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”

Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”

Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”

His therapist was clear about what to do: Stand firm and walk toward it.

“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
 

A state of peace

Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.

“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”

After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.

“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”

This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
 

After the journey

It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:

“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”

And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”

The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.

From his journal:

“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.

“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”

That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.

A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.

“It’s inspiring,” Dr. Richards said.

“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”

And the positive effects can extend deep into the family system, he said.

After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.

Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”

At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
 

After the experience

Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.

The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.

Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.

The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.

“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”

It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.

In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
 

Pradeep 2.0

Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.

“And yet it was somehow okay,” he said. “It was only pain.”

“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”

Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”

The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.

“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”

Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”

He even named his new outlook. “I call it Pradeep 2.0.”

A version of this article first appeared on WebMD.com.

 

Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.

The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.

Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.

He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.

Dr. Bansal did not arrive at this moment lightly.

“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.

“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”

But Bansal had done his homework on psilocybin and was impressed.

People with late-stage cancer and other serious health conditions who got psilocybin-assisted psychotherapy had “significant decreases” in anxiety and depression as long as 12 months after the treatment, according to studies published in 2011, 2014, and 2016.

One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.

For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.

And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.

He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.

Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
 

Stuck in a dark place

Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019. 

Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).

It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.

“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”

But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.

“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”

As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.

At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.

With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”

He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.

Those things helped, but not enough.

The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.

If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.

As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).

The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
 

Starting the journey

By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.

The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)

Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.

This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.

Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic. 

He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.

“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.

“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”

“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.

For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.

But he did his best to set aside his doubts and embrace the journey he was about to take.
 

The day of the trip

Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.

This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.

The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.

A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.

“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”

The doctor said: “Don’t worry about it. Just trust and let go.”

And that’s just what he did.

Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.

Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.

Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.

It took about 45 minutes for the medication to kick in.
 

 

 

The investigator

The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.

Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.

He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.

“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”

“But what about the psychological effects?”

They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.

So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.

Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.

To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.

And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.

The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
 

A trip into the unknown

Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.

“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.

There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.

Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.

“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”

All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.

And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”

“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”

Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”

Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”

His therapist was clear about what to do: Stand firm and walk toward it.

“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
 

A state of peace

Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.

“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”

After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.

“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”

This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
 

After the journey

It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:

“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”

And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”

The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.

From his journal:

“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.

“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”

That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.

A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.

“It’s inspiring,” Dr. Richards said.

“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”

And the positive effects can extend deep into the family system, he said.

After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.

Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”

At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
 

After the experience

Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.

The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.

Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.

The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.

“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”

It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.

In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
 

Pradeep 2.0

Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.

“And yet it was somehow okay,” he said. “It was only pain.”

“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”

Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”

The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.

“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”

Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”

He even named his new outlook. “I call it Pradeep 2.0.”

A version of this article first appeared on WebMD.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Experts plead for more pediatric telehealth

Article Type
Changed
Fri, 01/07/2022 - 12:34

 

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

 

 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

  • Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
  • Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
  • Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
  • Mitigation of geographic barriers to accessing DBP care.
  • Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
  • Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
  • Ensuring ongoing reimbursement.
  • Parity in reimbursement for telehealth in-person visits.
  • Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

 

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

 

 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

  • Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
  • Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
  • Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
  • Mitigation of geographic barriers to accessing DBP care.
  • Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
  • Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
  • Ensuring ongoing reimbursement.
  • Parity in reimbursement for telehealth in-person visits.
  • Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

 

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

 

 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

  • Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
  • Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
  • Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
  • Mitigation of geographic barriers to accessing DBP care.
  • Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
  • Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
  • Ensuring ongoing reimbursement.
  • Parity in reimbursement for telehealth in-person visits.
  • Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Mayo Clinic fires 700 employees for refusing COVID vaccine

Article Type
Changed
Mon, 01/10/2022 - 10:27

 

The Mayo Clinic fired 700 employees this week who didn’t comply with its COVID-19 vaccine mandate.

The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.

Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.

The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.

“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.

The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.

The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.

“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”

With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”

“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”

A version of this article first appeared on WebMD.com.

Publications
Topics
Sections

 

The Mayo Clinic fired 700 employees this week who didn’t comply with its COVID-19 vaccine mandate.

The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.

Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.

The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.

“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.

The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.

The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.

“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”

With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”

“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”

A version of this article first appeared on WebMD.com.

 

The Mayo Clinic fired 700 employees this week who didn’t comply with its COVID-19 vaccine mandate.

The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.

Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.

The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.

“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.

The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.

The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.

“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”

With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”

“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”

A version of this article first appeared on WebMD.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Using Telehealth Rehabilitation Therapy to Treat a Finger Flexor Tendon Repair During COVID-19

Article Type
Changed
Thu, 01/27/2022 - 15:33

Telehealth-assisted finger rehabilitat ion therapy demonstrated good functional results following repair of a zone 2 flexor tendon laceration.

In 1948, Sterling Bunnell, MD, used the term no man’s land to describe the area between the A1 pulley at the volar aspect of the metacarpophalangeal joint and the insertion of the flexor digitorum superficialis tendons on the middle phalanx (zone 2).1 Bunnell’s description referenced the area of land in World War I between the trenches of opposing armies, and his goal was to emphasize the heightened risks of performing tendon repair in this area, as these repairs were notorious for poor outcomes. In lieu of tendon repair, Bunnell advocated treatment of tendon lacerations in this area with tendon excision and grafting.

It was not until the 1960s that researchers began to advocate for acute repair of tendons in this area.2,3 Since Verdan’s and Kleinart’s work, fastidious adherence to atraumatic technique and improvements in suture technique and rehabilitation protocols have allowed hand surgeons to repair tendons in this area with some level of success. Over the ensuing decades, acute repair of flexor tendon injuries within zone 2 has become the standard of care. The importance of meticulous technique during flexor tendon repair cannot be overemphasized; however, without appropriate hand therapy, even the most meticulous repair may fail.

COVID-19 has created significant barriers to patient care. Reducing travel and limiting face-to-face patient visits have been emphasized as methods that reduce spread of the virus, but these restrictions also prevent patients from easily accessing hand therapy. Recent adoption of telemedicine and videoconferencing technologies may help to reduce some of these barriers, but few previous studies have described the use of videoconferencing technology to supplant face-to-face hand therapy visits. This case describes the use of videoconferencing technology to provide hand therapy for a patient following repair of an acute flexor tendon laceration in zone 2.

 

Case Presentation

A patient aged < 50 years presented to a US Department of Veterans Affairs (VA) hand surgery clinic 2 days after sustaining a laceration to the flexor digitorum profundus (FDP) in zone 2 of the small finger while cleaning a knife. During the discussion of their treatment options and the recommended postoperative hand therapy protocol, the patient noted difficulty attending postoperative appointments due to COVID-19 as well as a lack of resources. Given these limitations and following discussion with our hand therapist, we discussed the potential for telehealth follow-up with videoconferencing. Four days following the injury, the patient underwent repair of the FDP. During surgery, the laceration was present at the level of the A3 pulley. The FDP was repaired using a 6-0 polypropylene synthetic suture for the epitendinous repair and 4-strand core suture repair using 3-0 Fiberwire suture in a modified cruciate fashion. The A2 and A4 pulleys were preserved, and venting of the pulleys was not required. At the time of surgery, the flexor digitorum superficialis and radial and ulnar digital neurovascular bundles were intact. Following surgical repair of the tendon, the patient was placed into a dorsal blocking splint with a plan for follow-up within 2 to 3 days.

The patient attended the first postoperative visit in person on postoperative day 2. During this visit, the postoperative splint and dressings were removed, and a forearm-based dorsal blocking orthosis was fabricated using thermoplastic. At this visit, the veteran relayed concerns regarding psychosocial and resource barriers in addition to concerns surrounding COVID-19 that would prevent travel to and from hand therapy appointments. Due to these concerns, a passive-motion protocol was initiated using the Indiana manual as a guide.4 The patient returned to the hand clinic at 2 weeks after surgery for evaluation by the operating surgeon and suture removal. All visits after the suture removal were conducted via either telehealth with videoconferencing or by telephone (Table 1).

Appointments and Treatment Timeline

The operative team evaluated the patient 5 times following surgery. Only 2 of these visits were in-person. The patient attended 6 hand therapy sessions with 2 in-person visits to occupational therapy (Figure 1). The remaining 4 visits were conducted using videoconferencing. The patient received therapy supplies by mail as needed, and their use was reviewed in telerehabilitation sessions with videoconferencing as needed. During their postoperative course, the patient experienced little edema or scar tissue formation, and recovery was uncomplicated. The patient developed a mild extensor lag for which a proximal interphalangeal joint spring extension orthosis was provided via mail (Figure 2). The patient admitted only partial adherence with this orthosis, and at discharge, a 10-degree extensor lag remained. The patient was not concerned by this extension deficit and did not experience any associated functional deficits, demonstrated by scores on the Quick Disabilities of the Arm, Shoulder and Hand questionnaire and Patient Specific Functional Scale (Table 2).

Outcome Measures

Home Exercise Program and Full Flexion at 8 Weeks

Discussion

Few studies have been published that address the efficacy of telerehabilitation after surgical management of traumatic injuries involving the upper extremity. One Australian study performed by Worboys and colleagues concluded that utilization of telehealth services for hand therapy visits may provide accurate patient assessment with favorable patient satisfaction.5 Another study performed in the UK by Gilbert and colleagues demonstrated that videoconferencing is well received by patients, as it may offer shorter wait times, improved convenience, and reduced travel cost.

The authors noted that although videoconferencing may not completely replace in-person therapy, it could act as an adjunct.6 While these in-person visits may be necessary, particularly to establish care, at least one study has demonstrated that patients may prefer follow-up via telehealth if provided the option.7 In a randomized, controlled study performed in Norway, patients were randomized to either an in-person or video consultation with an orthopedic outpatient clinic. Of patients randomized to the in-person clinic visit, 86% preferred to have follow-up via videoconferencing.7

Previous studies have demonstrated that telehealth may produce accurate patient assessment, with relatively high patient satisfaction. Given the COVID-19 pandemic and the limitations that this crisis has placed on in-person outpatient visits, clinics that previously may have been resistant to telehealth are adapting and using the technology to meet the needs of their population.8 The present case demonstrates that videoconferencing is feasible and may lead to successful results, even for cases requiring significant hand therapy follow-up, such as flexor tendon repairs.

Conclusions

Although in-person hand therapy remains the standard of care following flexor tendon repair of the hand, situations may exist in which hand therapy conducted via telehealth is better than no hand therapy at all. The present case study highlights the use of telehealth as an acceptable supplement to in-person postoperative visits.

In our case, use of a standardized protocol with an emphasis on hand function and patient satisfaction as opposed to strict range of motion measurements produced good results. Although a specific telehealth satisfaction measure was not used in this case, commonly used questionnaires may be integrated into future visits to improve telehealth implementation and patient experience. In this specific case, the veteran felt that hand function was regained and expressed general satisfaction with the telemedicine process at the conclusion of care. While telehealth was a useful adjunct in the treatment of the present patient, further study of videoconferencing should be conducted to determine whether hand therapy conducted via telehealth could be implemented more broadly following upper extremity surgery.

References

1. Hege JJ. History off-hand: Bunnell’s no-man’s land. Hand (NY). 2019;14(4):570-574. doi:10.1177/1558944717744337

2. Verdan C. Primary repair of flexor tendons. J Bone Joint Surg Am. 1960;42-A:647-657.

3. Kleinert HE, Kutz JE, Ashbell TS, et al. Primary repair of lacerated flexor tendon in no man’s land (abstract). J Bone Joint Surg. 1967;49A:577.

4. Cannon NM. Diagnosis and Treatment Manual for Physicians and Therapists: Upper Extremity Rehabilitation. 4th ed. Hand Rehabilitation Center of Indiana; 2001.

5. Worboys T, Brassington M, Ward EC, Cornwell PL. Delivering occupational therapy hand assessment and treatment sessions via telehealth. J Telemed Telecare. 2018;24(3):185-192. doi:10.1177/1357633X17691861

6. Gilbert AW, Jaggi A, May CR. What is the patient acceptability of real time 1:1 videoconferencing in an orthopaedics setting? A systematic review. Physiotherapy. 2018;104(2):178-186. doi:10.1016/j.physio.2017.11.217

7. Buvik A, Bugge E, Knutsen G, Smatresk A, Wilsgaard T. Patient reported outcomes with remote orthopaedic consultations by telemedicine: A randomised controlled trial. J Telemed Telecare. 2019;25(8):451-459. doi:10.1177/1357633X18783921

8. Loeb AE, Rao SS, Ficke JR, Morris CD, Riley LH 3rd, Levin AS. Departmental experience and lessons learned with accelerated introduction of telemedicine during the COVID-19 crisis. J Am Acad Orthop Surg. 2020;28(11):e469-e476. doi:10.5435/JAAOS-D-20-00380

Article PDF
Author and Disclosure Information

Vanessa Roberts, OTR/L, CHTa; and Nicholas Iannuzzi, MDa
Correspondence:
Vanessa Roberts ([email protected])

Author affiliations

aVeterans Affairs Puget Sound, Seattle, Washington

Author disclosures

The authors report no actual or potential conflicts of interest or outside funding source with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The authors report that the patient did not provide written informed consent. All patient information has been changed to avoid identification.

Issue
Federal Practitioner - 39(1)a
Publications
Topics
Page Number
38-41
Sections
Author and Disclosure Information

Vanessa Roberts, OTR/L, CHTa; and Nicholas Iannuzzi, MDa
Correspondence:
Vanessa Roberts ([email protected])

Author affiliations

aVeterans Affairs Puget Sound, Seattle, Washington

Author disclosures

The authors report no actual or potential conflicts of interest or outside funding source with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The authors report that the patient did not provide written informed consent. All patient information has been changed to avoid identification.

Author and Disclosure Information

Vanessa Roberts, OTR/L, CHTa; and Nicholas Iannuzzi, MDa
Correspondence:
Vanessa Roberts ([email protected])

Author affiliations

aVeterans Affairs Puget Sound, Seattle, Washington

Author disclosures

The authors report no actual or potential conflicts of interest or outside funding source with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The authors report that the patient did not provide written informed consent. All patient information has been changed to avoid identification.

Article PDF
Article PDF
Related Articles

Telehealth-assisted finger rehabilitat ion therapy demonstrated good functional results following repair of a zone 2 flexor tendon laceration.

Telehealth-assisted finger rehabilitat ion therapy demonstrated good functional results following repair of a zone 2 flexor tendon laceration.

In 1948, Sterling Bunnell, MD, used the term no man’s land to describe the area between the A1 pulley at the volar aspect of the metacarpophalangeal joint and the insertion of the flexor digitorum superficialis tendons on the middle phalanx (zone 2).1 Bunnell’s description referenced the area of land in World War I between the trenches of opposing armies, and his goal was to emphasize the heightened risks of performing tendon repair in this area, as these repairs were notorious for poor outcomes. In lieu of tendon repair, Bunnell advocated treatment of tendon lacerations in this area with tendon excision and grafting.

It was not until the 1960s that researchers began to advocate for acute repair of tendons in this area.2,3 Since Verdan’s and Kleinart’s work, fastidious adherence to atraumatic technique and improvements in suture technique and rehabilitation protocols have allowed hand surgeons to repair tendons in this area with some level of success. Over the ensuing decades, acute repair of flexor tendon injuries within zone 2 has become the standard of care. The importance of meticulous technique during flexor tendon repair cannot be overemphasized; however, without appropriate hand therapy, even the most meticulous repair may fail.

COVID-19 has created significant barriers to patient care. Reducing travel and limiting face-to-face patient visits have been emphasized as methods that reduce spread of the virus, but these restrictions also prevent patients from easily accessing hand therapy. Recent adoption of telemedicine and videoconferencing technologies may help to reduce some of these barriers, but few previous studies have described the use of videoconferencing technology to supplant face-to-face hand therapy visits. This case describes the use of videoconferencing technology to provide hand therapy for a patient following repair of an acute flexor tendon laceration in zone 2.

 

Case Presentation

A patient aged < 50 years presented to a US Department of Veterans Affairs (VA) hand surgery clinic 2 days after sustaining a laceration to the flexor digitorum profundus (FDP) in zone 2 of the small finger while cleaning a knife. During the discussion of their treatment options and the recommended postoperative hand therapy protocol, the patient noted difficulty attending postoperative appointments due to COVID-19 as well as a lack of resources. Given these limitations and following discussion with our hand therapist, we discussed the potential for telehealth follow-up with videoconferencing. Four days following the injury, the patient underwent repair of the FDP. During surgery, the laceration was present at the level of the A3 pulley. The FDP was repaired using a 6-0 polypropylene synthetic suture for the epitendinous repair and 4-strand core suture repair using 3-0 Fiberwire suture in a modified cruciate fashion. The A2 and A4 pulleys were preserved, and venting of the pulleys was not required. At the time of surgery, the flexor digitorum superficialis and radial and ulnar digital neurovascular bundles were intact. Following surgical repair of the tendon, the patient was placed into a dorsal blocking splint with a plan for follow-up within 2 to 3 days.

The patient attended the first postoperative visit in person on postoperative day 2. During this visit, the postoperative splint and dressings were removed, and a forearm-based dorsal blocking orthosis was fabricated using thermoplastic. At this visit, the veteran relayed concerns regarding psychosocial and resource barriers in addition to concerns surrounding COVID-19 that would prevent travel to and from hand therapy appointments. Due to these concerns, a passive-motion protocol was initiated using the Indiana manual as a guide.4 The patient returned to the hand clinic at 2 weeks after surgery for evaluation by the operating surgeon and suture removal. All visits after the suture removal were conducted via either telehealth with videoconferencing or by telephone (Table 1).

Appointments and Treatment Timeline

The operative team evaluated the patient 5 times following surgery. Only 2 of these visits were in-person. The patient attended 6 hand therapy sessions with 2 in-person visits to occupational therapy (Figure 1). The remaining 4 visits were conducted using videoconferencing. The patient received therapy supplies by mail as needed, and their use was reviewed in telerehabilitation sessions with videoconferencing as needed. During their postoperative course, the patient experienced little edema or scar tissue formation, and recovery was uncomplicated. The patient developed a mild extensor lag for which a proximal interphalangeal joint spring extension orthosis was provided via mail (Figure 2). The patient admitted only partial adherence with this orthosis, and at discharge, a 10-degree extensor lag remained. The patient was not concerned by this extension deficit and did not experience any associated functional deficits, demonstrated by scores on the Quick Disabilities of the Arm, Shoulder and Hand questionnaire and Patient Specific Functional Scale (Table 2).

Outcome Measures

Home Exercise Program and Full Flexion at 8 Weeks

Discussion

Few studies have been published that address the efficacy of telerehabilitation after surgical management of traumatic injuries involving the upper extremity. One Australian study performed by Worboys and colleagues concluded that utilization of telehealth services for hand therapy visits may provide accurate patient assessment with favorable patient satisfaction.5 Another study performed in the UK by Gilbert and colleagues demonstrated that videoconferencing is well received by patients, as it may offer shorter wait times, improved convenience, and reduced travel cost.

The authors noted that although videoconferencing may not completely replace in-person therapy, it could act as an adjunct.6 While these in-person visits may be necessary, particularly to establish care, at least one study has demonstrated that patients may prefer follow-up via telehealth if provided the option.7 In a randomized, controlled study performed in Norway, patients were randomized to either an in-person or video consultation with an orthopedic outpatient clinic. Of patients randomized to the in-person clinic visit, 86% preferred to have follow-up via videoconferencing.7

Previous studies have demonstrated that telehealth may produce accurate patient assessment, with relatively high patient satisfaction. Given the COVID-19 pandemic and the limitations that this crisis has placed on in-person outpatient visits, clinics that previously may have been resistant to telehealth are adapting and using the technology to meet the needs of their population.8 The present case demonstrates that videoconferencing is feasible and may lead to successful results, even for cases requiring significant hand therapy follow-up, such as flexor tendon repairs.

Conclusions

Although in-person hand therapy remains the standard of care following flexor tendon repair of the hand, situations may exist in which hand therapy conducted via telehealth is better than no hand therapy at all. The present case study highlights the use of telehealth as an acceptable supplement to in-person postoperative visits.

In our case, use of a standardized protocol with an emphasis on hand function and patient satisfaction as opposed to strict range of motion measurements produced good results. Although a specific telehealth satisfaction measure was not used in this case, commonly used questionnaires may be integrated into future visits to improve telehealth implementation and patient experience. In this specific case, the veteran felt that hand function was regained and expressed general satisfaction with the telemedicine process at the conclusion of care. While telehealth was a useful adjunct in the treatment of the present patient, further study of videoconferencing should be conducted to determine whether hand therapy conducted via telehealth could be implemented more broadly following upper extremity surgery.

In 1948, Sterling Bunnell, MD, used the term no man’s land to describe the area between the A1 pulley at the volar aspect of the metacarpophalangeal joint and the insertion of the flexor digitorum superficialis tendons on the middle phalanx (zone 2).1 Bunnell’s description referenced the area of land in World War I between the trenches of opposing armies, and his goal was to emphasize the heightened risks of performing tendon repair in this area, as these repairs were notorious for poor outcomes. In lieu of tendon repair, Bunnell advocated treatment of tendon lacerations in this area with tendon excision and grafting.

It was not until the 1960s that researchers began to advocate for acute repair of tendons in this area.2,3 Since Verdan’s and Kleinart’s work, fastidious adherence to atraumatic technique and improvements in suture technique and rehabilitation protocols have allowed hand surgeons to repair tendons in this area with some level of success. Over the ensuing decades, acute repair of flexor tendon injuries within zone 2 has become the standard of care. The importance of meticulous technique during flexor tendon repair cannot be overemphasized; however, without appropriate hand therapy, even the most meticulous repair may fail.

COVID-19 has created significant barriers to patient care. Reducing travel and limiting face-to-face patient visits have been emphasized as methods that reduce spread of the virus, but these restrictions also prevent patients from easily accessing hand therapy. Recent adoption of telemedicine and videoconferencing technologies may help to reduce some of these barriers, but few previous studies have described the use of videoconferencing technology to supplant face-to-face hand therapy visits. This case describes the use of videoconferencing technology to provide hand therapy for a patient following repair of an acute flexor tendon laceration in zone 2.

 

Case Presentation

A patient aged < 50 years presented to a US Department of Veterans Affairs (VA) hand surgery clinic 2 days after sustaining a laceration to the flexor digitorum profundus (FDP) in zone 2 of the small finger while cleaning a knife. During the discussion of their treatment options and the recommended postoperative hand therapy protocol, the patient noted difficulty attending postoperative appointments due to COVID-19 as well as a lack of resources. Given these limitations and following discussion with our hand therapist, we discussed the potential for telehealth follow-up with videoconferencing. Four days following the injury, the patient underwent repair of the FDP. During surgery, the laceration was present at the level of the A3 pulley. The FDP was repaired using a 6-0 polypropylene synthetic suture for the epitendinous repair and 4-strand core suture repair using 3-0 Fiberwire suture in a modified cruciate fashion. The A2 and A4 pulleys were preserved, and venting of the pulleys was not required. At the time of surgery, the flexor digitorum superficialis and radial and ulnar digital neurovascular bundles were intact. Following surgical repair of the tendon, the patient was placed into a dorsal blocking splint with a plan for follow-up within 2 to 3 days.

The patient attended the first postoperative visit in person on postoperative day 2. During this visit, the postoperative splint and dressings were removed, and a forearm-based dorsal blocking orthosis was fabricated using thermoplastic. At this visit, the veteran relayed concerns regarding psychosocial and resource barriers in addition to concerns surrounding COVID-19 that would prevent travel to and from hand therapy appointments. Due to these concerns, a passive-motion protocol was initiated using the Indiana manual as a guide.4 The patient returned to the hand clinic at 2 weeks after surgery for evaluation by the operating surgeon and suture removal. All visits after the suture removal were conducted via either telehealth with videoconferencing or by telephone (Table 1).

Appointments and Treatment Timeline

The operative team evaluated the patient 5 times following surgery. Only 2 of these visits were in-person. The patient attended 6 hand therapy sessions with 2 in-person visits to occupational therapy (Figure 1). The remaining 4 visits were conducted using videoconferencing. The patient received therapy supplies by mail as needed, and their use was reviewed in telerehabilitation sessions with videoconferencing as needed. During their postoperative course, the patient experienced little edema or scar tissue formation, and recovery was uncomplicated. The patient developed a mild extensor lag for which a proximal interphalangeal joint spring extension orthosis was provided via mail (Figure 2). The patient admitted only partial adherence with this orthosis, and at discharge, a 10-degree extensor lag remained. The patient was not concerned by this extension deficit and did not experience any associated functional deficits, demonstrated by scores on the Quick Disabilities of the Arm, Shoulder and Hand questionnaire and Patient Specific Functional Scale (Table 2).

Outcome Measures

Home Exercise Program and Full Flexion at 8 Weeks

Discussion

Few studies have been published that address the efficacy of telerehabilitation after surgical management of traumatic injuries involving the upper extremity. One Australian study performed by Worboys and colleagues concluded that utilization of telehealth services for hand therapy visits may provide accurate patient assessment with favorable patient satisfaction.5 Another study performed in the UK by Gilbert and colleagues demonstrated that videoconferencing is well received by patients, as it may offer shorter wait times, improved convenience, and reduced travel cost.

The authors noted that although videoconferencing may not completely replace in-person therapy, it could act as an adjunct.6 While these in-person visits may be necessary, particularly to establish care, at least one study has demonstrated that patients may prefer follow-up via telehealth if provided the option.7 In a randomized, controlled study performed in Norway, patients were randomized to either an in-person or video consultation with an orthopedic outpatient clinic. Of patients randomized to the in-person clinic visit, 86% preferred to have follow-up via videoconferencing.7

Previous studies have demonstrated that telehealth may produce accurate patient assessment, with relatively high patient satisfaction. Given the COVID-19 pandemic and the limitations that this crisis has placed on in-person outpatient visits, clinics that previously may have been resistant to telehealth are adapting and using the technology to meet the needs of their population.8 The present case demonstrates that videoconferencing is feasible and may lead to successful results, even for cases requiring significant hand therapy follow-up, such as flexor tendon repairs.

Conclusions

Although in-person hand therapy remains the standard of care following flexor tendon repair of the hand, situations may exist in which hand therapy conducted via telehealth is better than no hand therapy at all. The present case study highlights the use of telehealth as an acceptable supplement to in-person postoperative visits.

In our case, use of a standardized protocol with an emphasis on hand function and patient satisfaction as opposed to strict range of motion measurements produced good results. Although a specific telehealth satisfaction measure was not used in this case, commonly used questionnaires may be integrated into future visits to improve telehealth implementation and patient experience. In this specific case, the veteran felt that hand function was regained and expressed general satisfaction with the telemedicine process at the conclusion of care. While telehealth was a useful adjunct in the treatment of the present patient, further study of videoconferencing should be conducted to determine whether hand therapy conducted via telehealth could be implemented more broadly following upper extremity surgery.

References

1. Hege JJ. History off-hand: Bunnell’s no-man’s land. Hand (NY). 2019;14(4):570-574. doi:10.1177/1558944717744337

2. Verdan C. Primary repair of flexor tendons. J Bone Joint Surg Am. 1960;42-A:647-657.

3. Kleinert HE, Kutz JE, Ashbell TS, et al. Primary repair of lacerated flexor tendon in no man’s land (abstract). J Bone Joint Surg. 1967;49A:577.

4. Cannon NM. Diagnosis and Treatment Manual for Physicians and Therapists: Upper Extremity Rehabilitation. 4th ed. Hand Rehabilitation Center of Indiana; 2001.

5. Worboys T, Brassington M, Ward EC, Cornwell PL. Delivering occupational therapy hand assessment and treatment sessions via telehealth. J Telemed Telecare. 2018;24(3):185-192. doi:10.1177/1357633X17691861

6. Gilbert AW, Jaggi A, May CR. What is the patient acceptability of real time 1:1 videoconferencing in an orthopaedics setting? A systematic review. Physiotherapy. 2018;104(2):178-186. doi:10.1016/j.physio.2017.11.217

7. Buvik A, Bugge E, Knutsen G, Smatresk A, Wilsgaard T. Patient reported outcomes with remote orthopaedic consultations by telemedicine: A randomised controlled trial. J Telemed Telecare. 2019;25(8):451-459. doi:10.1177/1357633X18783921

8. Loeb AE, Rao SS, Ficke JR, Morris CD, Riley LH 3rd, Levin AS. Departmental experience and lessons learned with accelerated introduction of telemedicine during the COVID-19 crisis. J Am Acad Orthop Surg. 2020;28(11):e469-e476. doi:10.5435/JAAOS-D-20-00380

References

1. Hege JJ. History off-hand: Bunnell’s no-man’s land. Hand (NY). 2019;14(4):570-574. doi:10.1177/1558944717744337

2. Verdan C. Primary repair of flexor tendons. J Bone Joint Surg Am. 1960;42-A:647-657.

3. Kleinert HE, Kutz JE, Ashbell TS, et al. Primary repair of lacerated flexor tendon in no man’s land (abstract). J Bone Joint Surg. 1967;49A:577.

4. Cannon NM. Diagnosis and Treatment Manual for Physicians and Therapists: Upper Extremity Rehabilitation. 4th ed. Hand Rehabilitation Center of Indiana; 2001.

5. Worboys T, Brassington M, Ward EC, Cornwell PL. Delivering occupational therapy hand assessment and treatment sessions via telehealth. J Telemed Telecare. 2018;24(3):185-192. doi:10.1177/1357633X17691861

6. Gilbert AW, Jaggi A, May CR. What is the patient acceptability of real time 1:1 videoconferencing in an orthopaedics setting? A systematic review. Physiotherapy. 2018;104(2):178-186. doi:10.1016/j.physio.2017.11.217

7. Buvik A, Bugge E, Knutsen G, Smatresk A, Wilsgaard T. Patient reported outcomes with remote orthopaedic consultations by telemedicine: A randomised controlled trial. J Telemed Telecare. 2019;25(8):451-459. doi:10.1177/1357633X18783921

8. Loeb AE, Rao SS, Ficke JR, Morris CD, Riley LH 3rd, Levin AS. Departmental experience and lessons learned with accelerated introduction of telemedicine during the COVID-19 crisis. J Am Acad Orthop Surg. 2020;28(11):e469-e476. doi:10.5435/JAAOS-D-20-00380

Issue
Federal Practitioner - 39(1)a
Issue
Federal Practitioner - 39(1)a
Page Number
38-41
Page Number
38-41
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

Review of Efficacy and Safety of Spinal Cord Stimulation in Veterans

Article Type
Changed
Thu, 01/27/2022 - 15:41

Lower back pain (LBP) affects an estimated 9.4% of the global population and has resulted in more years lived with disability than any other health condition.1 LBP affects a wide range of populations, but US veterans have been shown to have significantly higher rates of back pain than nonveterans. The National Institutes of Health reports that 65.6% of veterans experience chronic pain; 9.1% of veterans experience severe, chronic pain.2 Chronic back pain is treated by a range of methods, including medications, surgery, physical therapy (PT), patient education, and behavioral therapy.3 However, chronic neuropathic back pain has been shown to have limited responsiveness to medication.4

Neuropathic pain is caused by lesions in the somatosensory nervous system, resulting in spontaneous pain and amplified pain responses to both painful and nonpainful stimuli.5 The most common location for neuropathic pain is the back and legs. Between 10% and 40% of people who undergo lumbosacral spine surgery to treat neuropathic radicular pain will experience further neuropathic pain.6 This condition is referred to as failed back surgery syndrome or postlaminectomy syndrome (PLS). While neuropathic back pain has had limited responsiveness to medication and repeated lumbosacral spine surgery, spinal cord stimulation (SCS) has shown promise as an effective form of pain treatment for those experiencing PLS and other spine disorders.7-10 In addition, SCS therapy has had a very low incidence of complications, which may be on the decline with recent technological advancements.11 Patients with a diagnosis of PLS, LBP, or complex regional pain syndrome (CRPS) who have not responded to medications, therapy, and/or injections for ≥ 6 months were eligible for a trial of SCS therapy. Trial leads were placed via the percutaneous route with the battery strapped to the waistline for 3 to 5 days and were removed in clinic. Patients who experienced > 60% pain relief and functional improvement received a SCS implant.

The effectiveness of SCS has been demonstrated in a nonveteran population, but it has not been studied in a veteran population.12 US Department of Veterans Affairs (VA) health care coverage is different from Medicare and private insurance in that it is classified as a benefit and not insurance. The goals of treatment at the VA may include considerations in addition to feeling better, and patient presentations may not align with those in the private sector.

We hypothesize that SCS is both a safe and beneficial treatment option for veterans with chronic intractable spine and/or extremity pain. The purpose of this study was to determine the efficacy and safety of SCS in a veteran population.

Methods

The efficacy and safety of SCS was determined via a retrospective study. Inclusion criteria for the study consisted of any Southeastern Louisiana Veterans Health Care System (SLVHCS) patient who had an SCS trial and/or implant from 2008 to 2020. Eligible veterans must have had chronic pain for at least 6 months and had previously tried multiple medications, PT, transcutaneous nerve stimulation, facet injections, epidural steroid injections, or surgery without success. For medication therapy to be considered unsuccessful, it must have included acetaminophen, nonsteroidal anti-inflammatory drugs, and ≥ 1 adjuvant medication (gabapentin, duloxetine, amitriptyline, lidocaine, and menthol). A diagnosis of chronic LBP, PLS, cervical or lumbar spondylosis with radiculopathy, complex regional pain syndrome, or chronic pain syndrome was required for eligibility. Patients whose pain decreased by > 60% and had functional improvement in a 3- to 5-day trial received SCS implantation with percutaneous leads by a pain physician or paddle lead by a neurosurgeon.

The SLVHCS Institutional Review Board approved this study. Electronic health records were reviewed to determine patient age, anthropometric data, and date of SCS implantation. Patients were then called and interviewed to complete a survey. After obtaining verbal consent to the study, subjects were surveyed regarding whether the patient would recommend the procedure to peers, adverse effects (AEs) or complications, and the ability to decrease opiates if applicable. A verbal Pain Outcome Questionnaire (POQ) assessment of activities of daily living also was given during the phone interview regarding pain levels before SCS and at the time of the phone interview.13 (eAppendix available at doi:10.12788/fp.0204) Following the survey, a chart review was performed to corroborate the given AEs or complications and opiate use information. Before and after results of the POQ were compared via a paired sample t test, and P values < .05 were considered significant. Analyses were performed by IBM SPSS, version 26.

The primary outcome measure for this study was whether veterans would recommend SCS to their peers; in our view, this categorical outcome measure seemed to be more valuable to share with future patients who might be candidates for SCS. Since VA health care coverage and goals of treatment may be different from a nonveteran population, we opted to use this primary measure to decrease the possibility of confounding variables.

Secondary outcome measures included changes in POC scores, improvements in activities of daily living, and decreases in use of opioid pain medications.

POQ responses were recorded during the telephone interviews (0 to 10 scale). A paired sample t test was conducted to compare pain levels before and after SCS implant. Pain levels were gathered in the single phone call. Patient opioid usage, if applicable, was assessed by converting medications to morphine milligram equivalent dosing (MMED). Since patients who were on chronic opioids took multiple formulations, we changed the total daily dose to all morphine; for this study, morphine was considered equivalent to hydrocodone, and oxycodone was 1.5x morphine.

 

 

Results

Of the 90 SLVHCS patients who received an SCS implant between 2008 and 2020, 76 were reached by telephone and 65 had their responses recorded in the study. Of the 11 patients who were not included, 5 had the SCS removed; it is unclear whether these veterans would have recommended the treatment. Four were unable to quantify pain and/or SCS effects, and 2 were excluded due to a dementia diagnosis years after the implant. The mean (SD) age of participants was 63.9 (10.3) years. Forty percent of patients had a diabetes mellitus diagnosis and 1 had prediabetes. Patients’ most common qualifying diagnosis for SCS was PLS (47.7%) followed by chronic LBP (26.2%). A percutaneous 2-lead technique was the most common type of SCS type used (60.0%) followed by 1-lead (21.5%). The most common SCS manufacturer was Boston Scientific (87.7%)(Table 1). Most veterans (76.9%) recommended SCS to their peers; 13.8% did not recommend SCS; 9.2% were undecided and stated that they were unable to recommend because they did not want to persuade a peer to get SCS (Figure).

Patient Demographics

Do Veterans Recommend SCS to Their Peers?

There was a statistically significant decrease in opioid use for the 40 veterans for whom pain medication was converted (P < .001)(Table 2). Six patients reported using opioids at some point but could not remember their dose, and no records were found in their chart review, so they were not included in the MMED analysis. In that group, 4 patients reported using opioids before SCS but discontinued the opioid use after SCS implantation, and 2 patients noted using opioids before SCS and concomitantly. Eighteen subjects reported no opioid use at any point before or after SCS (Table 3).

There were few life-threatening complications of SCS. Three veterans developed skin dehiscence; 2 had dehiscence at the battery/generator site, and 1 had dehiscence at the lead anchor site. Two patients with dehiscence also had morbid obesity, and the third had postoperative malnourishment. The dehiscence occurred 3 and 8 months postoperation. All 3 patients with dehiscence had the SCS explanted, though they were eager to get a new SCS implanted as soon as possible because SCS was their most successful treatment to date.

MMED and BMI Before and After Implantation and Patient Pain Outcome Questionnaire Responses


Twenty of the 64 veterans surveyed reported other complications of SCS, including lead migration, lack of pain coverage, paresthesia and numbness, soreness around generator site, SCS shocking patient when performing full thoracic spine flexion, and shingles at the battery site (Table 4). There were 11 explants among the 76 veterans contacted. The primary reason for explant was lack of pain coverage.

Complications and Adverse Effects


Patient concerns included pain with sitting in chairs due to tenderness around the implant, SCS helping with physical pain but not mental pain, SCS only working during the day and not helping with sleep, and patients lacking education regarding possible complications of SCS.

Discussion

In this nonrandomized retrospective review, SCS was shown to be an effective treatment for intractable spine and/or extremity pain. Veterans’ pain levels were significantly reduced following SCS implantation, and more than three-fourths of veterans recommended SCS to their peers. We used the recommendation of SCS to peers as the most important metric regarding the effectiveness of SCS, as this measure was felt to be more valuable to share with future patients; furthermore, categorical analysis has been shown to be more valuable than ordinal pain scales to measure pain.14 In addition to wanting to expand the available research to the general public, we wanted a measure that we could easily relay to our patient population regarding SCS.

The explant rate of 14.5% among surveyed veterans falls at the higher end of the normal ranges found in previous studies of long-term SCS outcomes.15-17 One possible reason for the higher rate is that we did not differentiate based on the reason for the explant (ie, no benefit, further surgery needed for underlying medical condition, or SCS-specific complications). Another possible contributing factor to the higher than expected explant rate is the geographic location in the New Orleans metro area; New Orleans is considered to have one of the highest rates of obesity in the United States and obesity typically has other diseases associated with it such as hypertension and diabetes mellitus.

 

 

Limitations

Limitations of the study include the relatively low number of subjects, subjective nature of the interview questions, and the patients’ answers. Typically the POQ has been used as a prospective assessment of pain; whether it is valid in a retrospective analysis is not clear. While there was a statistically significant decrease of opioid use after getting SCS, this study can only show correlation, not causation. During the study period, there has been a drastic change in opioid prescribing patterns and efforts to decrease the amount of opioids prescribed.

Subjects also were asked to rate their pain and quality of life before SCS. Some subjects had SCS implantation up to 10 years prior to the phone interview. The variable amount of time between SCS implantation and interview likely affected subjects’ responses. Chronic pain is a moving target. Patients have good days and bad days that would likely change opinions on SCS benefits on a single phone interview. Some patients needed battery replacements at the time of the interview (battery life averaged about 3 to 5 years in our study population) and were asked to report current levels of pain from the perspective of when their batteries were still functional, further affecting results.

Conclusions

SCS was shown to improve the quality of life of US veterans at SLVHCS across a wide variety of metrics, including activities of daily living, as well as mental and physical health. For veterans with chronic intractable pain who have tried and failed more conservative treatments, SCS is a great treatment.

Files
References

1. Hoy DG, Smith E, Cross M, et al. The global burden of musculoskeletal conditions for 2010: an overview of methods. Ann Rheum Dis. 2014;73(6):982-989 doi:10.1136/annrheumdis-2013-204344

2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021

3. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.

4. Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162-173. doi:10.1016/S1474-4422(14)70251-0

5. Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1-32. doi:10.1146/annurev.neuro.051508.135531

6. Wilkinson HA. The Failed Back Syndrome: Etiology and Therapy. 2nd ed. Harper & Row; 1991.

7. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188. doi:10.1016/j.pain.2007.07.028

8. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-107. doi:10.1227/01.neu.0000144839.65524.e0

9. Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AG, van Kleef M. Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. Neuromodulation. 2013;16(6):523-529. doi:10.1111/ner.12024

10. Kumar K, Rizvi S, Bnurs SB. Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction. Neurosurgery. 2011;69(3):566-5580. doi:10.1227/NEU.0b013e3182181e60

11. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. 2011;11(2):148-153. doi:10.1111/j.1533-2500.2010.00407.x

12. Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low back pain relief compared to traditional SCS-LUMINA Study. Pain Med. 2017;18(8):1534-1548. doi:10.1093/pm/pnw286

13. Gordon DB, Polomano RC, Pellino TA, et al. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010;11(11):1172-1186. doi:10.1016/j.jpain.2010.02.012

14. Kennedy DJ, Schneider B. Lies, damn lies, and statistic: a commentary. Pain Med. 2020;21(10):2052-2054. doi:10.1093/pm/pnaa287

15. Van Buyten JP, Wille F, Smet I, et al. Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study. Neuromodulation. 2017;20(7):642-649. doi:10.1111/ner.12642

16. Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation. 2015;18(7):603-609. doi:10.1111/ner.12312

17. Pope JE, Deer TR, Falowski S, et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation. 2017;20(6):543-552. doi:10.1111/ner.12634

Article PDF
Author and Disclosure Information

Casey A. Murphy, MDa,b,c; Randolph L. Roig, MDa,b,c; W. Bradley Trimbleb; Matthew Bennettb; and Justin Doughty, MDb
Correspondence:
Casey Murphy ([email protected])

Author affiliations 

aVeterans Affairs Medical Center, New Orleans, Louisiana
bLouisiana State University School of Medicine, New Orleans
cTulane University School of Medicine, New Orleans

Author disclosures

The authors report no actual or potential conflicts of interest and no outside funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The Southeastern Louisiana Veterans Health Care System Institutional Review Board approved this study. Patients provided verbal consent prior to completing the survey.

Issue
Federal Practitioner - 39(1)a
Publications
Topics
Page Number
32-36
Sections
Files
Files
Author and Disclosure Information

Casey A. Murphy, MDa,b,c; Randolph L. Roig, MDa,b,c; W. Bradley Trimbleb; Matthew Bennettb; and Justin Doughty, MDb
Correspondence:
Casey Murphy ([email protected])

Author affiliations 

aVeterans Affairs Medical Center, New Orleans, Louisiana
bLouisiana State University School of Medicine, New Orleans
cTulane University School of Medicine, New Orleans

Author disclosures

The authors report no actual or potential conflicts of interest and no outside funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The Southeastern Louisiana Veterans Health Care System Institutional Review Board approved this study. Patients provided verbal consent prior to completing the survey.

Author and Disclosure Information

Casey A. Murphy, MDa,b,c; Randolph L. Roig, MDa,b,c; W. Bradley Trimbleb; Matthew Bennettb; and Justin Doughty, MDb
Correspondence:
Casey Murphy ([email protected])

Author affiliations 

aVeterans Affairs Medical Center, New Orleans, Louisiana
bLouisiana State University School of Medicine, New Orleans
cTulane University School of Medicine, New Orleans

Author disclosures

The authors report no actual or potential conflicts of interest and no outside funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The Southeastern Louisiana Veterans Health Care System Institutional Review Board approved this study. Patients provided verbal consent prior to completing the survey.

Article PDF
Article PDF
Related Articles

Lower back pain (LBP) affects an estimated 9.4% of the global population and has resulted in more years lived with disability than any other health condition.1 LBP affects a wide range of populations, but US veterans have been shown to have significantly higher rates of back pain than nonveterans. The National Institutes of Health reports that 65.6% of veterans experience chronic pain; 9.1% of veterans experience severe, chronic pain.2 Chronic back pain is treated by a range of methods, including medications, surgery, physical therapy (PT), patient education, and behavioral therapy.3 However, chronic neuropathic back pain has been shown to have limited responsiveness to medication.4

Neuropathic pain is caused by lesions in the somatosensory nervous system, resulting in spontaneous pain and amplified pain responses to both painful and nonpainful stimuli.5 The most common location for neuropathic pain is the back and legs. Between 10% and 40% of people who undergo lumbosacral spine surgery to treat neuropathic radicular pain will experience further neuropathic pain.6 This condition is referred to as failed back surgery syndrome or postlaminectomy syndrome (PLS). While neuropathic back pain has had limited responsiveness to medication and repeated lumbosacral spine surgery, spinal cord stimulation (SCS) has shown promise as an effective form of pain treatment for those experiencing PLS and other spine disorders.7-10 In addition, SCS therapy has had a very low incidence of complications, which may be on the decline with recent technological advancements.11 Patients with a diagnosis of PLS, LBP, or complex regional pain syndrome (CRPS) who have not responded to medications, therapy, and/or injections for ≥ 6 months were eligible for a trial of SCS therapy. Trial leads were placed via the percutaneous route with the battery strapped to the waistline for 3 to 5 days and were removed in clinic. Patients who experienced > 60% pain relief and functional improvement received a SCS implant.

The effectiveness of SCS has been demonstrated in a nonveteran population, but it has not been studied in a veteran population.12 US Department of Veterans Affairs (VA) health care coverage is different from Medicare and private insurance in that it is classified as a benefit and not insurance. The goals of treatment at the VA may include considerations in addition to feeling better, and patient presentations may not align with those in the private sector.

We hypothesize that SCS is both a safe and beneficial treatment option for veterans with chronic intractable spine and/or extremity pain. The purpose of this study was to determine the efficacy and safety of SCS in a veteran population.

Methods

The efficacy and safety of SCS was determined via a retrospective study. Inclusion criteria for the study consisted of any Southeastern Louisiana Veterans Health Care System (SLVHCS) patient who had an SCS trial and/or implant from 2008 to 2020. Eligible veterans must have had chronic pain for at least 6 months and had previously tried multiple medications, PT, transcutaneous nerve stimulation, facet injections, epidural steroid injections, or surgery without success. For medication therapy to be considered unsuccessful, it must have included acetaminophen, nonsteroidal anti-inflammatory drugs, and ≥ 1 adjuvant medication (gabapentin, duloxetine, amitriptyline, lidocaine, and menthol). A diagnosis of chronic LBP, PLS, cervical or lumbar spondylosis with radiculopathy, complex regional pain syndrome, or chronic pain syndrome was required for eligibility. Patients whose pain decreased by > 60% and had functional improvement in a 3- to 5-day trial received SCS implantation with percutaneous leads by a pain physician or paddle lead by a neurosurgeon.

The SLVHCS Institutional Review Board approved this study. Electronic health records were reviewed to determine patient age, anthropometric data, and date of SCS implantation. Patients were then called and interviewed to complete a survey. After obtaining verbal consent to the study, subjects were surveyed regarding whether the patient would recommend the procedure to peers, adverse effects (AEs) or complications, and the ability to decrease opiates if applicable. A verbal Pain Outcome Questionnaire (POQ) assessment of activities of daily living also was given during the phone interview regarding pain levels before SCS and at the time of the phone interview.13 (eAppendix available at doi:10.12788/fp.0204) Following the survey, a chart review was performed to corroborate the given AEs or complications and opiate use information. Before and after results of the POQ were compared via a paired sample t test, and P values < .05 were considered significant. Analyses were performed by IBM SPSS, version 26.

The primary outcome measure for this study was whether veterans would recommend SCS to their peers; in our view, this categorical outcome measure seemed to be more valuable to share with future patients who might be candidates for SCS. Since VA health care coverage and goals of treatment may be different from a nonveteran population, we opted to use this primary measure to decrease the possibility of confounding variables.

Secondary outcome measures included changes in POC scores, improvements in activities of daily living, and decreases in use of opioid pain medications.

POQ responses were recorded during the telephone interviews (0 to 10 scale). A paired sample t test was conducted to compare pain levels before and after SCS implant. Pain levels were gathered in the single phone call. Patient opioid usage, if applicable, was assessed by converting medications to morphine milligram equivalent dosing (MMED). Since patients who were on chronic opioids took multiple formulations, we changed the total daily dose to all morphine; for this study, morphine was considered equivalent to hydrocodone, and oxycodone was 1.5x morphine.

 

 

Results

Of the 90 SLVHCS patients who received an SCS implant between 2008 and 2020, 76 were reached by telephone and 65 had their responses recorded in the study. Of the 11 patients who were not included, 5 had the SCS removed; it is unclear whether these veterans would have recommended the treatment. Four were unable to quantify pain and/or SCS effects, and 2 were excluded due to a dementia diagnosis years after the implant. The mean (SD) age of participants was 63.9 (10.3) years. Forty percent of patients had a diabetes mellitus diagnosis and 1 had prediabetes. Patients’ most common qualifying diagnosis for SCS was PLS (47.7%) followed by chronic LBP (26.2%). A percutaneous 2-lead technique was the most common type of SCS type used (60.0%) followed by 1-lead (21.5%). The most common SCS manufacturer was Boston Scientific (87.7%)(Table 1). Most veterans (76.9%) recommended SCS to their peers; 13.8% did not recommend SCS; 9.2% were undecided and stated that they were unable to recommend because they did not want to persuade a peer to get SCS (Figure).

Patient Demographics

Do Veterans Recommend SCS to Their Peers?

There was a statistically significant decrease in opioid use for the 40 veterans for whom pain medication was converted (P < .001)(Table 2). Six patients reported using opioids at some point but could not remember their dose, and no records were found in their chart review, so they were not included in the MMED analysis. In that group, 4 patients reported using opioids before SCS but discontinued the opioid use after SCS implantation, and 2 patients noted using opioids before SCS and concomitantly. Eighteen subjects reported no opioid use at any point before or after SCS (Table 3).

There were few life-threatening complications of SCS. Three veterans developed skin dehiscence; 2 had dehiscence at the battery/generator site, and 1 had dehiscence at the lead anchor site. Two patients with dehiscence also had morbid obesity, and the third had postoperative malnourishment. The dehiscence occurred 3 and 8 months postoperation. All 3 patients with dehiscence had the SCS explanted, though they were eager to get a new SCS implanted as soon as possible because SCS was their most successful treatment to date.

MMED and BMI Before and After Implantation and Patient Pain Outcome Questionnaire Responses


Twenty of the 64 veterans surveyed reported other complications of SCS, including lead migration, lack of pain coverage, paresthesia and numbness, soreness around generator site, SCS shocking patient when performing full thoracic spine flexion, and shingles at the battery site (Table 4). There were 11 explants among the 76 veterans contacted. The primary reason for explant was lack of pain coverage.

Complications and Adverse Effects


Patient concerns included pain with sitting in chairs due to tenderness around the implant, SCS helping with physical pain but not mental pain, SCS only working during the day and not helping with sleep, and patients lacking education regarding possible complications of SCS.

Discussion

In this nonrandomized retrospective review, SCS was shown to be an effective treatment for intractable spine and/or extremity pain. Veterans’ pain levels were significantly reduced following SCS implantation, and more than three-fourths of veterans recommended SCS to their peers. We used the recommendation of SCS to peers as the most important metric regarding the effectiveness of SCS, as this measure was felt to be more valuable to share with future patients; furthermore, categorical analysis has been shown to be more valuable than ordinal pain scales to measure pain.14 In addition to wanting to expand the available research to the general public, we wanted a measure that we could easily relay to our patient population regarding SCS.

The explant rate of 14.5% among surveyed veterans falls at the higher end of the normal ranges found in previous studies of long-term SCS outcomes.15-17 One possible reason for the higher rate is that we did not differentiate based on the reason for the explant (ie, no benefit, further surgery needed for underlying medical condition, or SCS-specific complications). Another possible contributing factor to the higher than expected explant rate is the geographic location in the New Orleans metro area; New Orleans is considered to have one of the highest rates of obesity in the United States and obesity typically has other diseases associated with it such as hypertension and diabetes mellitus.

 

 

Limitations

Limitations of the study include the relatively low number of subjects, subjective nature of the interview questions, and the patients’ answers. Typically the POQ has been used as a prospective assessment of pain; whether it is valid in a retrospective analysis is not clear. While there was a statistically significant decrease of opioid use after getting SCS, this study can only show correlation, not causation. During the study period, there has been a drastic change in opioid prescribing patterns and efforts to decrease the amount of opioids prescribed.

Subjects also were asked to rate their pain and quality of life before SCS. Some subjects had SCS implantation up to 10 years prior to the phone interview. The variable amount of time between SCS implantation and interview likely affected subjects’ responses. Chronic pain is a moving target. Patients have good days and bad days that would likely change opinions on SCS benefits on a single phone interview. Some patients needed battery replacements at the time of the interview (battery life averaged about 3 to 5 years in our study population) and were asked to report current levels of pain from the perspective of when their batteries were still functional, further affecting results.

Conclusions

SCS was shown to improve the quality of life of US veterans at SLVHCS across a wide variety of metrics, including activities of daily living, as well as mental and physical health. For veterans with chronic intractable pain who have tried and failed more conservative treatments, SCS is a great treatment.

Lower back pain (LBP) affects an estimated 9.4% of the global population and has resulted in more years lived with disability than any other health condition.1 LBP affects a wide range of populations, but US veterans have been shown to have significantly higher rates of back pain than nonveterans. The National Institutes of Health reports that 65.6% of veterans experience chronic pain; 9.1% of veterans experience severe, chronic pain.2 Chronic back pain is treated by a range of methods, including medications, surgery, physical therapy (PT), patient education, and behavioral therapy.3 However, chronic neuropathic back pain has been shown to have limited responsiveness to medication.4

Neuropathic pain is caused by lesions in the somatosensory nervous system, resulting in spontaneous pain and amplified pain responses to both painful and nonpainful stimuli.5 The most common location for neuropathic pain is the back and legs. Between 10% and 40% of people who undergo lumbosacral spine surgery to treat neuropathic radicular pain will experience further neuropathic pain.6 This condition is referred to as failed back surgery syndrome or postlaminectomy syndrome (PLS). While neuropathic back pain has had limited responsiveness to medication and repeated lumbosacral spine surgery, spinal cord stimulation (SCS) has shown promise as an effective form of pain treatment for those experiencing PLS and other spine disorders.7-10 In addition, SCS therapy has had a very low incidence of complications, which may be on the decline with recent technological advancements.11 Patients with a diagnosis of PLS, LBP, or complex regional pain syndrome (CRPS) who have not responded to medications, therapy, and/or injections for ≥ 6 months were eligible for a trial of SCS therapy. Trial leads were placed via the percutaneous route with the battery strapped to the waistline for 3 to 5 days and were removed in clinic. Patients who experienced > 60% pain relief and functional improvement received a SCS implant.

The effectiveness of SCS has been demonstrated in a nonveteran population, but it has not been studied in a veteran population.12 US Department of Veterans Affairs (VA) health care coverage is different from Medicare and private insurance in that it is classified as a benefit and not insurance. The goals of treatment at the VA may include considerations in addition to feeling better, and patient presentations may not align with those in the private sector.

We hypothesize that SCS is both a safe and beneficial treatment option for veterans with chronic intractable spine and/or extremity pain. The purpose of this study was to determine the efficacy and safety of SCS in a veteran population.

Methods

The efficacy and safety of SCS was determined via a retrospective study. Inclusion criteria for the study consisted of any Southeastern Louisiana Veterans Health Care System (SLVHCS) patient who had an SCS trial and/or implant from 2008 to 2020. Eligible veterans must have had chronic pain for at least 6 months and had previously tried multiple medications, PT, transcutaneous nerve stimulation, facet injections, epidural steroid injections, or surgery without success. For medication therapy to be considered unsuccessful, it must have included acetaminophen, nonsteroidal anti-inflammatory drugs, and ≥ 1 adjuvant medication (gabapentin, duloxetine, amitriptyline, lidocaine, and menthol). A diagnosis of chronic LBP, PLS, cervical or lumbar spondylosis with radiculopathy, complex regional pain syndrome, or chronic pain syndrome was required for eligibility. Patients whose pain decreased by > 60% and had functional improvement in a 3- to 5-day trial received SCS implantation with percutaneous leads by a pain physician or paddle lead by a neurosurgeon.

The SLVHCS Institutional Review Board approved this study. Electronic health records were reviewed to determine patient age, anthropometric data, and date of SCS implantation. Patients were then called and interviewed to complete a survey. After obtaining verbal consent to the study, subjects were surveyed regarding whether the patient would recommend the procedure to peers, adverse effects (AEs) or complications, and the ability to decrease opiates if applicable. A verbal Pain Outcome Questionnaire (POQ) assessment of activities of daily living also was given during the phone interview regarding pain levels before SCS and at the time of the phone interview.13 (eAppendix available at doi:10.12788/fp.0204) Following the survey, a chart review was performed to corroborate the given AEs or complications and opiate use information. Before and after results of the POQ were compared via a paired sample t test, and P values < .05 were considered significant. Analyses were performed by IBM SPSS, version 26.

The primary outcome measure for this study was whether veterans would recommend SCS to their peers; in our view, this categorical outcome measure seemed to be more valuable to share with future patients who might be candidates for SCS. Since VA health care coverage and goals of treatment may be different from a nonveteran population, we opted to use this primary measure to decrease the possibility of confounding variables.

Secondary outcome measures included changes in POC scores, improvements in activities of daily living, and decreases in use of opioid pain medications.

POQ responses were recorded during the telephone interviews (0 to 10 scale). A paired sample t test was conducted to compare pain levels before and after SCS implant. Pain levels were gathered in the single phone call. Patient opioid usage, if applicable, was assessed by converting medications to morphine milligram equivalent dosing (MMED). Since patients who were on chronic opioids took multiple formulations, we changed the total daily dose to all morphine; for this study, morphine was considered equivalent to hydrocodone, and oxycodone was 1.5x morphine.

 

 

Results

Of the 90 SLVHCS patients who received an SCS implant between 2008 and 2020, 76 were reached by telephone and 65 had their responses recorded in the study. Of the 11 patients who were not included, 5 had the SCS removed; it is unclear whether these veterans would have recommended the treatment. Four were unable to quantify pain and/or SCS effects, and 2 were excluded due to a dementia diagnosis years after the implant. The mean (SD) age of participants was 63.9 (10.3) years. Forty percent of patients had a diabetes mellitus diagnosis and 1 had prediabetes. Patients’ most common qualifying diagnosis for SCS was PLS (47.7%) followed by chronic LBP (26.2%). A percutaneous 2-lead technique was the most common type of SCS type used (60.0%) followed by 1-lead (21.5%). The most common SCS manufacturer was Boston Scientific (87.7%)(Table 1). Most veterans (76.9%) recommended SCS to their peers; 13.8% did not recommend SCS; 9.2% were undecided and stated that they were unable to recommend because they did not want to persuade a peer to get SCS (Figure).

Patient Demographics

Do Veterans Recommend SCS to Their Peers?

There was a statistically significant decrease in opioid use for the 40 veterans for whom pain medication was converted (P < .001)(Table 2). Six patients reported using opioids at some point but could not remember their dose, and no records were found in their chart review, so they were not included in the MMED analysis. In that group, 4 patients reported using opioids before SCS but discontinued the opioid use after SCS implantation, and 2 patients noted using opioids before SCS and concomitantly. Eighteen subjects reported no opioid use at any point before or after SCS (Table 3).

There were few life-threatening complications of SCS. Three veterans developed skin dehiscence; 2 had dehiscence at the battery/generator site, and 1 had dehiscence at the lead anchor site. Two patients with dehiscence also had morbid obesity, and the third had postoperative malnourishment. The dehiscence occurred 3 and 8 months postoperation. All 3 patients with dehiscence had the SCS explanted, though they were eager to get a new SCS implanted as soon as possible because SCS was their most successful treatment to date.

MMED and BMI Before and After Implantation and Patient Pain Outcome Questionnaire Responses


Twenty of the 64 veterans surveyed reported other complications of SCS, including lead migration, lack of pain coverage, paresthesia and numbness, soreness around generator site, SCS shocking patient when performing full thoracic spine flexion, and shingles at the battery site (Table 4). There were 11 explants among the 76 veterans contacted. The primary reason for explant was lack of pain coverage.

Complications and Adverse Effects


Patient concerns included pain with sitting in chairs due to tenderness around the implant, SCS helping with physical pain but not mental pain, SCS only working during the day and not helping with sleep, and patients lacking education regarding possible complications of SCS.

Discussion

In this nonrandomized retrospective review, SCS was shown to be an effective treatment for intractable spine and/or extremity pain. Veterans’ pain levels were significantly reduced following SCS implantation, and more than three-fourths of veterans recommended SCS to their peers. We used the recommendation of SCS to peers as the most important metric regarding the effectiveness of SCS, as this measure was felt to be more valuable to share with future patients; furthermore, categorical analysis has been shown to be more valuable than ordinal pain scales to measure pain.14 In addition to wanting to expand the available research to the general public, we wanted a measure that we could easily relay to our patient population regarding SCS.

The explant rate of 14.5% among surveyed veterans falls at the higher end of the normal ranges found in previous studies of long-term SCS outcomes.15-17 One possible reason for the higher rate is that we did not differentiate based on the reason for the explant (ie, no benefit, further surgery needed for underlying medical condition, or SCS-specific complications). Another possible contributing factor to the higher than expected explant rate is the geographic location in the New Orleans metro area; New Orleans is considered to have one of the highest rates of obesity in the United States and obesity typically has other diseases associated with it such as hypertension and diabetes mellitus.

 

 

Limitations

Limitations of the study include the relatively low number of subjects, subjective nature of the interview questions, and the patients’ answers. Typically the POQ has been used as a prospective assessment of pain; whether it is valid in a retrospective analysis is not clear. While there was a statistically significant decrease of opioid use after getting SCS, this study can only show correlation, not causation. During the study period, there has been a drastic change in opioid prescribing patterns and efforts to decrease the amount of opioids prescribed.

Subjects also were asked to rate their pain and quality of life before SCS. Some subjects had SCS implantation up to 10 years prior to the phone interview. The variable amount of time between SCS implantation and interview likely affected subjects’ responses. Chronic pain is a moving target. Patients have good days and bad days that would likely change opinions on SCS benefits on a single phone interview. Some patients needed battery replacements at the time of the interview (battery life averaged about 3 to 5 years in our study population) and were asked to report current levels of pain from the perspective of when their batteries were still functional, further affecting results.

Conclusions

SCS was shown to improve the quality of life of US veterans at SLVHCS across a wide variety of metrics, including activities of daily living, as well as mental and physical health. For veterans with chronic intractable pain who have tried and failed more conservative treatments, SCS is a great treatment.

References

1. Hoy DG, Smith E, Cross M, et al. The global burden of musculoskeletal conditions for 2010: an overview of methods. Ann Rheum Dis. 2014;73(6):982-989 doi:10.1136/annrheumdis-2013-204344

2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021

3. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.

4. Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162-173. doi:10.1016/S1474-4422(14)70251-0

5. Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1-32. doi:10.1146/annurev.neuro.051508.135531

6. Wilkinson HA. The Failed Back Syndrome: Etiology and Therapy. 2nd ed. Harper & Row; 1991.

7. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188. doi:10.1016/j.pain.2007.07.028

8. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-107. doi:10.1227/01.neu.0000144839.65524.e0

9. Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AG, van Kleef M. Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. Neuromodulation. 2013;16(6):523-529. doi:10.1111/ner.12024

10. Kumar K, Rizvi S, Bnurs SB. Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction. Neurosurgery. 2011;69(3):566-5580. doi:10.1227/NEU.0b013e3182181e60

11. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. 2011;11(2):148-153. doi:10.1111/j.1533-2500.2010.00407.x

12. Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low back pain relief compared to traditional SCS-LUMINA Study. Pain Med. 2017;18(8):1534-1548. doi:10.1093/pm/pnw286

13. Gordon DB, Polomano RC, Pellino TA, et al. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010;11(11):1172-1186. doi:10.1016/j.jpain.2010.02.012

14. Kennedy DJ, Schneider B. Lies, damn lies, and statistic: a commentary. Pain Med. 2020;21(10):2052-2054. doi:10.1093/pm/pnaa287

15. Van Buyten JP, Wille F, Smet I, et al. Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study. Neuromodulation. 2017;20(7):642-649. doi:10.1111/ner.12642

16. Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation. 2015;18(7):603-609. doi:10.1111/ner.12312

17. Pope JE, Deer TR, Falowski S, et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation. 2017;20(6):543-552. doi:10.1111/ner.12634

References

1. Hoy DG, Smith E, Cross M, et al. The global burden of musculoskeletal conditions for 2010: an overview of methods. Ann Rheum Dis. 2014;73(6):982-989 doi:10.1136/annrheumdis-2013-204344

2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021

3. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.

4. Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162-173. doi:10.1016/S1474-4422(14)70251-0

5. Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1-32. doi:10.1146/annurev.neuro.051508.135531

6. Wilkinson HA. The Failed Back Syndrome: Etiology and Therapy. 2nd ed. Harper & Row; 1991.

7. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188. doi:10.1016/j.pain.2007.07.028

8. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-107. doi:10.1227/01.neu.0000144839.65524.e0

9. Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AG, van Kleef M. Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. Neuromodulation. 2013;16(6):523-529. doi:10.1111/ner.12024

10. Kumar K, Rizvi S, Bnurs SB. Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction. Neurosurgery. 2011;69(3):566-5580. doi:10.1227/NEU.0b013e3182181e60

11. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. 2011;11(2):148-153. doi:10.1111/j.1533-2500.2010.00407.x

12. Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low back pain relief compared to traditional SCS-LUMINA Study. Pain Med. 2017;18(8):1534-1548. doi:10.1093/pm/pnw286

13. Gordon DB, Polomano RC, Pellino TA, et al. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010;11(11):1172-1186. doi:10.1016/j.jpain.2010.02.012

14. Kennedy DJ, Schneider B. Lies, damn lies, and statistic: a commentary. Pain Med. 2020;21(10):2052-2054. doi:10.1093/pm/pnaa287

15. Van Buyten JP, Wille F, Smet I, et al. Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study. Neuromodulation. 2017;20(7):642-649. doi:10.1111/ner.12642

16. Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation. 2015;18(7):603-609. doi:10.1111/ner.12312

17. Pope JE, Deer TR, Falowski S, et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation. 2017;20(6):543-552. doi:10.1111/ner.12634

Issue
Federal Practitioner - 39(1)a
Issue
Federal Practitioner - 39(1)a
Page Number
32-36
Page Number
32-36
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media
Media Files

Rotating Hinge Distal Femur Replacement: A Turn for the Worse

Article Type
Changed
Thu, 01/27/2022 - 15:35

Preoperatively periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component is a rare event, and knowledge of this possible complication is important for arthroplasty surgeons.

The use of a rotating hinge distal femur replacement (DFR) for significant bone and soft tissue defects in the setting of total knee arthroplasty (TKA) revision has become increasingly more common. Although significant advancements have been made in modern DFR components, complications and failure rates remain high. The unanticipated early failure presented serves as the first reported case in the literature to our knowledge of a 180° rotation of a press-fit DFR.

Originally, DFRs were used primarily for oncology patients with substantial bone loss following large mass excisions. The utility of DFRs has grown to include massive bone loss in the setting of TKA revision, periprosthetic fractures, and periprosthetic joint infections.1-3 DFRs help restore the joint line in the setting of significant bone loss and contain a rotating hinge mechanism that provides functional movement despite the loss of soft tissue constraints around the knee.1-3

DFRs have been associated with early postoperative mobilization and decreased need for ambulatory devices at 1 year in revision TKA and periprosthetic and geriatric distal femur fractures.4-6 Advances in prosthetic design, biomechanics, and fixation technique have led to improved survival rates.3 Despite these improvements, the overall complication rate remains high at 30 to 40%.3-7 Commonly reported complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.3,4,7 Recent case studies also have reported on dislocation or disengagement of the rotating hinge.8-11

In this case report, we present a patient who had a DFR as the second stage of a 2-stage TKA revision due to a periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component. Although this is a rare event, knowledge of this possible complication is important for arthroplasty surgeons.

Case Presentation

A patient with a history of hypertension, osteopenia, and rheumatoid arthritis underwent a primary right TKA in 2007. Ten weeks postoperatively, the patient had a ground-level fall that resulted in a right periprosthetic supracondylar distal femur fracture that was treated with a distal femur locking plate. The patient healed, however, with a significant golf club deformity (Figure 1). The patient did well for more than a decade but in 2019 was admitted with pelvic inflammatory disease and adnexal abscess that was treated with broad-spectrum IV antibiotics. Shortly after this admission, the patient developed a right knee periprosthetic infection with cultures positive for Ureaplasma parvum.

Lateral Radiographs

The patient then underwent a 2-stage revision of the infected TKA. Stage 1 consisted of explant of the TKA components as well as removal of the distal femur plate and screws and placement of an articulating antibiotic cement spacer (Figure 2). The patient completed 6 weeks of IV antibiotics. Following completion of the antibiotic course, we obtained a serum erythrocyte sedimentation rate, C-reactive protein level, and white blood cell count, which were all within normal limits. A knee aspiration was performed and did not show signs of residual infection. Frozen histopathology was sent during the second stage of the revision and did not show infection. After the results of the frozen histopathology returned, the antibiotic spacer was removed, and the femoral canal was thoroughly debrided. Cement and fibrous tissue in the femoral canal were carefully removed. In the setting of significant bone loss and soft tissue compromise due to the previous infection and distal femur fracture, the Zimmer Biomet Orthopedic Salvage System (OSS) with porous coated press-fit elliptical femoral stem was utilized.

The femoral canal was reamed until good cortical chatter was obtained at 16 mm. Per the Biomet OSS guide, “For bowed (curved) long and short press-fit stems, the final flexible reamer shaft diameter may need to be larger than the definitive trial and implant diameter.” After trialing, size 15.5 mm was selected for implantation. Intraoperatively the final stem was noted to have good interference fit after insertion and was stable throughout knee range of motion and varus/valgus stress testing. The patient did well with mobilization while in the hospital postoperatively and was discharged home (Figure 3).

Five days after discharge, the patient kicked the repaired knee onto a chair for rest and elevation and experienced extreme pain and was unable to flex the knee. On presentation to the emergency department, the X-rays showed 180° rotation around the longitudinal axis of the femoral component without any other obvious component failure or fracture (Figure 4). The patient was taken back to surgery the following day. Intraoperatively, the femoral stem was found to be loose and rotated 180° (Figure 5). No failure or dislocation of the tibial or rotating hinge components were identified. The press-fit femoral stem was removed and replaced with a cemented stem (Figure 6).

Lateral Radiographs and Intraoperative Photograph


The postoperative course after the revision surgery was uneventful, and the patient is doing well clinically with no pain, functional range of motion of 5 to 105°, and has returned to regular activities without difficulty.

 

 

Discussion

Despite advancements in DFRs and increasing use in the setting of revision TKA, the procedure remains high risk with respect to postoperative complications.3-7 Vertesich and colleagues demonstrated that 43.3% of patients who underwent DFR for failed TKA developed at least 1 postoperative complication that required a return to the operating room.7Physicians need to be aware of the high rate of complications and counsel patients appropriately preoperatively.

Complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.4,7 Soft tissue failures include insufficiency or rupture of the extensor mechanism and patella dislocation.4,7 Structural failures include fracture of the hinge mechanism, dissociation of the component from the stem, rotating hinge-bushing failure, and dislocation of the hinge.4,7 In the acute postoperative period, the most common complications are infection and rotating-hinge dislocation/failure.3,12 There are various component options available for DFRs, including straight vs curved, cemented vs cementless/press-fit, and long vs short stems.13 Studies have sought to elucidate the ideal implant to decrease the rate of complications. Lu and colleagues demonstrated that curved press-fit short stems provided a stable interface without loosening over the short term (2 years) in 42 patients.13 No implant failures or incidences of aseptic loosening occurred in their study.13

The implant used in this case was a curved press-fit short-stem DFR. It was thought that this patient was young and with good enough bone quality that a press-fit short stem would be best in preserving bone stock. Both the technique guide and literature support reaming 0 to 2 mm greater than the planned stem size to accommodate the implant curvature.13 In this case, the intramedullary canal was reamed 0.5 mm larger than the curved stem that was implanted (16 mm and 15.5 mm, respectively). Intraoperatively during the index DFR, the component was stable and seemed to have a good press-fit interface. Despite this, obvious loosening of the component occurred with a relatively low-energy mechanism when the patient kicked the leg onto a chair, causing just enough force and femoral rotation to result in 180° rotation of the component.

Conclusions

We present this case report to make surgeons aware of this rare but serious complication. Although the final implant is a porous and curved stem, careful attention should be made during trialing to use the best-fitting implant to prevent this complication. If an adequate interference fit cannot be obtained, cementing the component may be required to prevent its loosening and catastrophic failure.

References

1. Sculco PK, Abdel MP, Hanssen AD, Lewallen DG. The management of bone loss in revision total knee arthroplasty: rebuild, reinforce, and augment. Bone Joint J. 2016;98-B(1 suppl A):120-124. doi:10.1302/0301-620X.98B1.36345

2. Harrison RJ Jr, Thacker MM, Pitcher JD, Temple HT, Scully SP. Distal femur replacement is useful in complex total knee arthroplasty revisions. Clin Orthop Relat Res. 2006;446:113-120. doi:10.1097/01.blo.0000214433.64774.1b

3. Smith EL, Shah A, Son SJ, et al. Survivorship of megaprostheses in revision hip and knee arthroplasty for septic and aseptic indications: a retrospective, multicenter study with minimum 2-year follow-up. Arthroplast Today. 2020;6(3):475-479. Published 2020 Jun 29. doi:10.1016/j.artd.2020.05.004

4. Wyles CC, Tibbo ME, Yuan BJ, Trousdale RT, Berry DJ, Abdel MP. Long-term results of total knee arthroplasty with contemporary distal femoral replacement. J Bone Joint Surg Am. 2020;102(1):45-51. doi:10.2106/JBJS.19.00489

5. Haidukewych GJ. Role of distal femoral replacement for periprosthetic fractures above a total knee arthroplasty: when and how?, J Orthop Trauma. 2019;33(suppl 6):S33-S35. doi:10.1097/BOT.0000000000001566

6. Hart GP, Kneisl JS, Springer BD, Patt JC, Karunakar MA. Open reduction vs distal femoral replacement arthroplasty for comminuted distal femur fractures in the patients 70 years and older: J Arthroplasty. 2017;32(1):202-206. doi:10.1016/j.arth.2016.06.006

7. Vertesich K, Puchner SE, Staats K, et al. Distal femoral reconstruction following failed total knee arthroplasty is accompanied with risk for complication and reduced joint function. BMC Musculoskelet Disord. 2019 Jan 31;20(1):47-54. doi:10.1186/s12891-019-2432-4

8. Biswas D, Haughom B, Mayle RE Jr, Della Valle CJ. Case report: Failure of rotating-hinge total knee prosthesis by disengagement of the hinge-post extension. Clin Orthop Relat Res. 2013;471(4):1389-1392. doi:10.1007/s11999-012-2736-2

9. Ward WG, Haight D, Ritchie P, Gordon S, Eckardt JJ. Dislocation of rotating hinge knee prostheses. A report of four cases. J Bone Joint Surg Am. 2005;87(5):1108-1112. doi:10.2106/JBJS.00837pp

10. Pacha-Vicente D, Malik A, Castellet-Feliu E, Nardi-Vilardaga J. Dislocation of rotating-hinge knee prostheses with antidislocation mechanism. J Arthroplasty. 2008;23(2):299-303. doi:10.1016/j.arth.2006.11.020

11. Manzano G, Schwarzkopf R. Posterior dislocation of the hinge-post extension in a rotating hinge total knee prosthesis. Case Rep Orthop. 2013;2013:756538. doi:10.1155/2013/756538

12. Vaishya R., Thapa, SS, Vaish A. Non-neoplastic indications and outcomes of the proximal and distal femur megaprosthesis: a critical review. Knee Surg Relat Res. 2020;32(1):18. Published 2020 Apr 9. doi:10.1186/s43019-020-00034-7

13. Lu M, Wang J, Xiao C, et al. Uncemented, curved, short endoprosthesis stem for distal femoral reconstruction: early follow-up outcomes. World J Surg Onc. 2018;16(1):183. doi:10.1186/s12957-018-1486-3

Article PDF
Author and Disclosure Information

Bryce N. Clinger, MDa; Kathryn C. Helmig, MDa; Scott Plaster, MDa; and Kenneth Yaw, MDb
Correspondence:
Bryce Clinger ([email protected])

Author affiliations

aDepartment of Orthopaedics and Rehabilitation, University of New Mexico, Albuquerque bDepartment of Orthopaedics, US Department of Veterans Affairs New Mexico Healthcare System, Albuquerque

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations— including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The authors report that they received verbal consent. The authors also report that the patient did not provide written informed consent to report this case in the literature. Details about the patient and the case have been changed to avoid identification.

Issue
Federal Practitioner - 39(1)a
Publications
Topics
Page Number
28-31
Sections
Author and Disclosure Information

Bryce N. Clinger, MDa; Kathryn C. Helmig, MDa; Scott Plaster, MDa; and Kenneth Yaw, MDb
Correspondence:
Bryce Clinger ([email protected])

Author affiliations

aDepartment of Orthopaedics and Rehabilitation, University of New Mexico, Albuquerque bDepartment of Orthopaedics, US Department of Veterans Affairs New Mexico Healthcare System, Albuquerque

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations— including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The authors report that they received verbal consent. The authors also report that the patient did not provide written informed consent to report this case in the literature. Details about the patient and the case have been changed to avoid identification.

Author and Disclosure Information

Bryce N. Clinger, MDa; Kathryn C. Helmig, MDa; Scott Plaster, MDa; and Kenneth Yaw, MDb
Correspondence:
Bryce Clinger ([email protected])

Author affiliations

aDepartment of Orthopaedics and Rehabilitation, University of New Mexico, Albuquerque bDepartment of Orthopaedics, US Department of Veterans Affairs New Mexico Healthcare System, Albuquerque

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations— including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The authors report that they received verbal consent. The authors also report that the patient did not provide written informed consent to report this case in the literature. Details about the patient and the case have been changed to avoid identification.

Article PDF
Article PDF
Related Articles

Preoperatively periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component is a rare event, and knowledge of this possible complication is important for arthroplasty surgeons.

Preoperatively periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component is a rare event, and knowledge of this possible complication is important for arthroplasty surgeons.

The use of a rotating hinge distal femur replacement (DFR) for significant bone and soft tissue defects in the setting of total knee arthroplasty (TKA) revision has become increasingly more common. Although significant advancements have been made in modern DFR components, complications and failure rates remain high. The unanticipated early failure presented serves as the first reported case in the literature to our knowledge of a 180° rotation of a press-fit DFR.

Originally, DFRs were used primarily for oncology patients with substantial bone loss following large mass excisions. The utility of DFRs has grown to include massive bone loss in the setting of TKA revision, periprosthetic fractures, and periprosthetic joint infections.1-3 DFRs help restore the joint line in the setting of significant bone loss and contain a rotating hinge mechanism that provides functional movement despite the loss of soft tissue constraints around the knee.1-3

DFRs have been associated with early postoperative mobilization and decreased need for ambulatory devices at 1 year in revision TKA and periprosthetic and geriatric distal femur fractures.4-6 Advances in prosthetic design, biomechanics, and fixation technique have led to improved survival rates.3 Despite these improvements, the overall complication rate remains high at 30 to 40%.3-7 Commonly reported complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.3,4,7 Recent case studies also have reported on dislocation or disengagement of the rotating hinge.8-11

In this case report, we present a patient who had a DFR as the second stage of a 2-stage TKA revision due to a periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component. Although this is a rare event, knowledge of this possible complication is important for arthroplasty surgeons.

Case Presentation

A patient with a history of hypertension, osteopenia, and rheumatoid arthritis underwent a primary right TKA in 2007. Ten weeks postoperatively, the patient had a ground-level fall that resulted in a right periprosthetic supracondylar distal femur fracture that was treated with a distal femur locking plate. The patient healed, however, with a significant golf club deformity (Figure 1). The patient did well for more than a decade but in 2019 was admitted with pelvic inflammatory disease and adnexal abscess that was treated with broad-spectrum IV antibiotics. Shortly after this admission, the patient developed a right knee periprosthetic infection with cultures positive for Ureaplasma parvum.

Lateral Radiographs

The patient then underwent a 2-stage revision of the infected TKA. Stage 1 consisted of explant of the TKA components as well as removal of the distal femur plate and screws and placement of an articulating antibiotic cement spacer (Figure 2). The patient completed 6 weeks of IV antibiotics. Following completion of the antibiotic course, we obtained a serum erythrocyte sedimentation rate, C-reactive protein level, and white blood cell count, which were all within normal limits. A knee aspiration was performed and did not show signs of residual infection. Frozen histopathology was sent during the second stage of the revision and did not show infection. After the results of the frozen histopathology returned, the antibiotic spacer was removed, and the femoral canal was thoroughly debrided. Cement and fibrous tissue in the femoral canal were carefully removed. In the setting of significant bone loss and soft tissue compromise due to the previous infection and distal femur fracture, the Zimmer Biomet Orthopedic Salvage System (OSS) with porous coated press-fit elliptical femoral stem was utilized.

The femoral canal was reamed until good cortical chatter was obtained at 16 mm. Per the Biomet OSS guide, “For bowed (curved) long and short press-fit stems, the final flexible reamer shaft diameter may need to be larger than the definitive trial and implant diameter.” After trialing, size 15.5 mm was selected for implantation. Intraoperatively the final stem was noted to have good interference fit after insertion and was stable throughout knee range of motion and varus/valgus stress testing. The patient did well with mobilization while in the hospital postoperatively and was discharged home (Figure 3).

Five days after discharge, the patient kicked the repaired knee onto a chair for rest and elevation and experienced extreme pain and was unable to flex the knee. On presentation to the emergency department, the X-rays showed 180° rotation around the longitudinal axis of the femoral component without any other obvious component failure or fracture (Figure 4). The patient was taken back to surgery the following day. Intraoperatively, the femoral stem was found to be loose and rotated 180° (Figure 5). No failure or dislocation of the tibial or rotating hinge components were identified. The press-fit femoral stem was removed and replaced with a cemented stem (Figure 6).

Lateral Radiographs and Intraoperative Photograph


The postoperative course after the revision surgery was uneventful, and the patient is doing well clinically with no pain, functional range of motion of 5 to 105°, and has returned to regular activities without difficulty.

 

 

Discussion

Despite advancements in DFRs and increasing use in the setting of revision TKA, the procedure remains high risk with respect to postoperative complications.3-7 Vertesich and colleagues demonstrated that 43.3% of patients who underwent DFR for failed TKA developed at least 1 postoperative complication that required a return to the operating room.7Physicians need to be aware of the high rate of complications and counsel patients appropriately preoperatively.

Complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.4,7 Soft tissue failures include insufficiency or rupture of the extensor mechanism and patella dislocation.4,7 Structural failures include fracture of the hinge mechanism, dissociation of the component from the stem, rotating hinge-bushing failure, and dislocation of the hinge.4,7 In the acute postoperative period, the most common complications are infection and rotating-hinge dislocation/failure.3,12 There are various component options available for DFRs, including straight vs curved, cemented vs cementless/press-fit, and long vs short stems.13 Studies have sought to elucidate the ideal implant to decrease the rate of complications. Lu and colleagues demonstrated that curved press-fit short stems provided a stable interface without loosening over the short term (2 years) in 42 patients.13 No implant failures or incidences of aseptic loosening occurred in their study.13

The implant used in this case was a curved press-fit short-stem DFR. It was thought that this patient was young and with good enough bone quality that a press-fit short stem would be best in preserving bone stock. Both the technique guide and literature support reaming 0 to 2 mm greater than the planned stem size to accommodate the implant curvature.13 In this case, the intramedullary canal was reamed 0.5 mm larger than the curved stem that was implanted (16 mm and 15.5 mm, respectively). Intraoperatively during the index DFR, the component was stable and seemed to have a good press-fit interface. Despite this, obvious loosening of the component occurred with a relatively low-energy mechanism when the patient kicked the leg onto a chair, causing just enough force and femoral rotation to result in 180° rotation of the component.

Conclusions

We present this case report to make surgeons aware of this rare but serious complication. Although the final implant is a porous and curved stem, careful attention should be made during trialing to use the best-fitting implant to prevent this complication. If an adequate interference fit cannot be obtained, cementing the component may be required to prevent its loosening and catastrophic failure.

The use of a rotating hinge distal femur replacement (DFR) for significant bone and soft tissue defects in the setting of total knee arthroplasty (TKA) revision has become increasingly more common. Although significant advancements have been made in modern DFR components, complications and failure rates remain high. The unanticipated early failure presented serves as the first reported case in the literature to our knowledge of a 180° rotation of a press-fit DFR.

Originally, DFRs were used primarily for oncology patients with substantial bone loss following large mass excisions. The utility of DFRs has grown to include massive bone loss in the setting of TKA revision, periprosthetic fractures, and periprosthetic joint infections.1-3 DFRs help restore the joint line in the setting of significant bone loss and contain a rotating hinge mechanism that provides functional movement despite the loss of soft tissue constraints around the knee.1-3

DFRs have been associated with early postoperative mobilization and decreased need for ambulatory devices at 1 year in revision TKA and periprosthetic and geriatric distal femur fractures.4-6 Advances in prosthetic design, biomechanics, and fixation technique have led to improved survival rates.3 Despite these improvements, the overall complication rate remains high at 30 to 40%.3-7 Commonly reported complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.3,4,7 Recent case studies also have reported on dislocation or disengagement of the rotating hinge.8-11

In this case report, we present a patient who had a DFR as the second stage of a 2-stage TKA revision due to a periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component. Although this is a rare event, knowledge of this possible complication is important for arthroplasty surgeons.

Case Presentation

A patient with a history of hypertension, osteopenia, and rheumatoid arthritis underwent a primary right TKA in 2007. Ten weeks postoperatively, the patient had a ground-level fall that resulted in a right periprosthetic supracondylar distal femur fracture that was treated with a distal femur locking plate. The patient healed, however, with a significant golf club deformity (Figure 1). The patient did well for more than a decade but in 2019 was admitted with pelvic inflammatory disease and adnexal abscess that was treated with broad-spectrum IV antibiotics. Shortly after this admission, the patient developed a right knee periprosthetic infection with cultures positive for Ureaplasma parvum.

Lateral Radiographs

The patient then underwent a 2-stage revision of the infected TKA. Stage 1 consisted of explant of the TKA components as well as removal of the distal femur plate and screws and placement of an articulating antibiotic cement spacer (Figure 2). The patient completed 6 weeks of IV antibiotics. Following completion of the antibiotic course, we obtained a serum erythrocyte sedimentation rate, C-reactive protein level, and white blood cell count, which were all within normal limits. A knee aspiration was performed and did not show signs of residual infection. Frozen histopathology was sent during the second stage of the revision and did not show infection. After the results of the frozen histopathology returned, the antibiotic spacer was removed, and the femoral canal was thoroughly debrided. Cement and fibrous tissue in the femoral canal were carefully removed. In the setting of significant bone loss and soft tissue compromise due to the previous infection and distal femur fracture, the Zimmer Biomet Orthopedic Salvage System (OSS) with porous coated press-fit elliptical femoral stem was utilized.

The femoral canal was reamed until good cortical chatter was obtained at 16 mm. Per the Biomet OSS guide, “For bowed (curved) long and short press-fit stems, the final flexible reamer shaft diameter may need to be larger than the definitive trial and implant diameter.” After trialing, size 15.5 mm was selected for implantation. Intraoperatively the final stem was noted to have good interference fit after insertion and was stable throughout knee range of motion and varus/valgus stress testing. The patient did well with mobilization while in the hospital postoperatively and was discharged home (Figure 3).

Five days after discharge, the patient kicked the repaired knee onto a chair for rest and elevation and experienced extreme pain and was unable to flex the knee. On presentation to the emergency department, the X-rays showed 180° rotation around the longitudinal axis of the femoral component without any other obvious component failure or fracture (Figure 4). The patient was taken back to surgery the following day. Intraoperatively, the femoral stem was found to be loose and rotated 180° (Figure 5). No failure or dislocation of the tibial or rotating hinge components were identified. The press-fit femoral stem was removed and replaced with a cemented stem (Figure 6).

Lateral Radiographs and Intraoperative Photograph


The postoperative course after the revision surgery was uneventful, and the patient is doing well clinically with no pain, functional range of motion of 5 to 105°, and has returned to regular activities without difficulty.

 

 

Discussion

Despite advancements in DFRs and increasing use in the setting of revision TKA, the procedure remains high risk with respect to postoperative complications.3-7 Vertesich and colleagues demonstrated that 43.3% of patients who underwent DFR for failed TKA developed at least 1 postoperative complication that required a return to the operating room.7Physicians need to be aware of the high rate of complications and counsel patients appropriately preoperatively.

Complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.4,7 Soft tissue failures include insufficiency or rupture of the extensor mechanism and patella dislocation.4,7 Structural failures include fracture of the hinge mechanism, dissociation of the component from the stem, rotating hinge-bushing failure, and dislocation of the hinge.4,7 In the acute postoperative period, the most common complications are infection and rotating-hinge dislocation/failure.3,12 There are various component options available for DFRs, including straight vs curved, cemented vs cementless/press-fit, and long vs short stems.13 Studies have sought to elucidate the ideal implant to decrease the rate of complications. Lu and colleagues demonstrated that curved press-fit short stems provided a stable interface without loosening over the short term (2 years) in 42 patients.13 No implant failures or incidences of aseptic loosening occurred in their study.13

The implant used in this case was a curved press-fit short-stem DFR. It was thought that this patient was young and with good enough bone quality that a press-fit short stem would be best in preserving bone stock. Both the technique guide and literature support reaming 0 to 2 mm greater than the planned stem size to accommodate the implant curvature.13 In this case, the intramedullary canal was reamed 0.5 mm larger than the curved stem that was implanted (16 mm and 15.5 mm, respectively). Intraoperatively during the index DFR, the component was stable and seemed to have a good press-fit interface. Despite this, obvious loosening of the component occurred with a relatively low-energy mechanism when the patient kicked the leg onto a chair, causing just enough force and femoral rotation to result in 180° rotation of the component.

Conclusions

We present this case report to make surgeons aware of this rare but serious complication. Although the final implant is a porous and curved stem, careful attention should be made during trialing to use the best-fitting implant to prevent this complication. If an adequate interference fit cannot be obtained, cementing the component may be required to prevent its loosening and catastrophic failure.

References

1. Sculco PK, Abdel MP, Hanssen AD, Lewallen DG. The management of bone loss in revision total knee arthroplasty: rebuild, reinforce, and augment. Bone Joint J. 2016;98-B(1 suppl A):120-124. doi:10.1302/0301-620X.98B1.36345

2. Harrison RJ Jr, Thacker MM, Pitcher JD, Temple HT, Scully SP. Distal femur replacement is useful in complex total knee arthroplasty revisions. Clin Orthop Relat Res. 2006;446:113-120. doi:10.1097/01.blo.0000214433.64774.1b

3. Smith EL, Shah A, Son SJ, et al. Survivorship of megaprostheses in revision hip and knee arthroplasty for septic and aseptic indications: a retrospective, multicenter study with minimum 2-year follow-up. Arthroplast Today. 2020;6(3):475-479. Published 2020 Jun 29. doi:10.1016/j.artd.2020.05.004

4. Wyles CC, Tibbo ME, Yuan BJ, Trousdale RT, Berry DJ, Abdel MP. Long-term results of total knee arthroplasty with contemporary distal femoral replacement. J Bone Joint Surg Am. 2020;102(1):45-51. doi:10.2106/JBJS.19.00489

5. Haidukewych GJ. Role of distal femoral replacement for periprosthetic fractures above a total knee arthroplasty: when and how?, J Orthop Trauma. 2019;33(suppl 6):S33-S35. doi:10.1097/BOT.0000000000001566

6. Hart GP, Kneisl JS, Springer BD, Patt JC, Karunakar MA. Open reduction vs distal femoral replacement arthroplasty for comminuted distal femur fractures in the patients 70 years and older: J Arthroplasty. 2017;32(1):202-206. doi:10.1016/j.arth.2016.06.006

7. Vertesich K, Puchner SE, Staats K, et al. Distal femoral reconstruction following failed total knee arthroplasty is accompanied with risk for complication and reduced joint function. BMC Musculoskelet Disord. 2019 Jan 31;20(1):47-54. doi:10.1186/s12891-019-2432-4

8. Biswas D, Haughom B, Mayle RE Jr, Della Valle CJ. Case report: Failure of rotating-hinge total knee prosthesis by disengagement of the hinge-post extension. Clin Orthop Relat Res. 2013;471(4):1389-1392. doi:10.1007/s11999-012-2736-2

9. Ward WG, Haight D, Ritchie P, Gordon S, Eckardt JJ. Dislocation of rotating hinge knee prostheses. A report of four cases. J Bone Joint Surg Am. 2005;87(5):1108-1112. doi:10.2106/JBJS.00837pp

10. Pacha-Vicente D, Malik A, Castellet-Feliu E, Nardi-Vilardaga J. Dislocation of rotating-hinge knee prostheses with antidislocation mechanism. J Arthroplasty. 2008;23(2):299-303. doi:10.1016/j.arth.2006.11.020

11. Manzano G, Schwarzkopf R. Posterior dislocation of the hinge-post extension in a rotating hinge total knee prosthesis. Case Rep Orthop. 2013;2013:756538. doi:10.1155/2013/756538

12. Vaishya R., Thapa, SS, Vaish A. Non-neoplastic indications and outcomes of the proximal and distal femur megaprosthesis: a critical review. Knee Surg Relat Res. 2020;32(1):18. Published 2020 Apr 9. doi:10.1186/s43019-020-00034-7

13. Lu M, Wang J, Xiao C, et al. Uncemented, curved, short endoprosthesis stem for distal femoral reconstruction: early follow-up outcomes. World J Surg Onc. 2018;16(1):183. doi:10.1186/s12957-018-1486-3

References

1. Sculco PK, Abdel MP, Hanssen AD, Lewallen DG. The management of bone loss in revision total knee arthroplasty: rebuild, reinforce, and augment. Bone Joint J. 2016;98-B(1 suppl A):120-124. doi:10.1302/0301-620X.98B1.36345

2. Harrison RJ Jr, Thacker MM, Pitcher JD, Temple HT, Scully SP. Distal femur replacement is useful in complex total knee arthroplasty revisions. Clin Orthop Relat Res. 2006;446:113-120. doi:10.1097/01.blo.0000214433.64774.1b

3. Smith EL, Shah A, Son SJ, et al. Survivorship of megaprostheses in revision hip and knee arthroplasty for septic and aseptic indications: a retrospective, multicenter study with minimum 2-year follow-up. Arthroplast Today. 2020;6(3):475-479. Published 2020 Jun 29. doi:10.1016/j.artd.2020.05.004

4. Wyles CC, Tibbo ME, Yuan BJ, Trousdale RT, Berry DJ, Abdel MP. Long-term results of total knee arthroplasty with contemporary distal femoral replacement. J Bone Joint Surg Am. 2020;102(1):45-51. doi:10.2106/JBJS.19.00489

5. Haidukewych GJ. Role of distal femoral replacement for periprosthetic fractures above a total knee arthroplasty: when and how?, J Orthop Trauma. 2019;33(suppl 6):S33-S35. doi:10.1097/BOT.0000000000001566

6. Hart GP, Kneisl JS, Springer BD, Patt JC, Karunakar MA. Open reduction vs distal femoral replacement arthroplasty for comminuted distal femur fractures in the patients 70 years and older: J Arthroplasty. 2017;32(1):202-206. doi:10.1016/j.arth.2016.06.006

7. Vertesich K, Puchner SE, Staats K, et al. Distal femoral reconstruction following failed total knee arthroplasty is accompanied with risk for complication and reduced joint function. BMC Musculoskelet Disord. 2019 Jan 31;20(1):47-54. doi:10.1186/s12891-019-2432-4

8. Biswas D, Haughom B, Mayle RE Jr, Della Valle CJ. Case report: Failure of rotating-hinge total knee prosthesis by disengagement of the hinge-post extension. Clin Orthop Relat Res. 2013;471(4):1389-1392. doi:10.1007/s11999-012-2736-2

9. Ward WG, Haight D, Ritchie P, Gordon S, Eckardt JJ. Dislocation of rotating hinge knee prostheses. A report of four cases. J Bone Joint Surg Am. 2005;87(5):1108-1112. doi:10.2106/JBJS.00837pp

10. Pacha-Vicente D, Malik A, Castellet-Feliu E, Nardi-Vilardaga J. Dislocation of rotating-hinge knee prostheses with antidislocation mechanism. J Arthroplasty. 2008;23(2):299-303. doi:10.1016/j.arth.2006.11.020

11. Manzano G, Schwarzkopf R. Posterior dislocation of the hinge-post extension in a rotating hinge total knee prosthesis. Case Rep Orthop. 2013;2013:756538. doi:10.1155/2013/756538

12. Vaishya R., Thapa, SS, Vaish A. Non-neoplastic indications and outcomes of the proximal and distal femur megaprosthesis: a critical review. Knee Surg Relat Res. 2020;32(1):18. Published 2020 Apr 9. doi:10.1186/s43019-020-00034-7

13. Lu M, Wang J, Xiao C, et al. Uncemented, curved, short endoprosthesis stem for distal femoral reconstruction: early follow-up outcomes. World J Surg Onc. 2018;16(1):183. doi:10.1186/s12957-018-1486-3

Issue
Federal Practitioner - 39(1)a
Issue
Federal Practitioner - 39(1)a
Page Number
28-31
Page Number
28-31
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media