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Beyond DSM symptoms: Behavioral clues to diagnosing bipolar II disorder
The diagnosis of bipolar II disorder is one of the most common challenges in psychiatric practice. Bipolar II disorder is frequently misdiagnosed as major depressive disorder (MDD) because symptoms of transient hypomanic episodes are either insufficiently probed or are rather vague. However, there are many valuable biographical clues that can expedite the diagnosis of bipolar II disorder.
The late Hagop S. Akiskal, MD, who passed away in January 2021, was an internationally recognized expert in mood disorders, and a dear friend for decades. He was a keen observer of human behavior who delved into the “life stories” of patients seeking help for depression. By thinking “outside the DSM box,” Dr. Akiskal was the first to recognize and codify a variety of behavioral and biographical clues for the bipolar spectrum (of which he was a pioneer) in patients presenting with a chief complaint of depression. He proposed a colorful set of behavioral stigmata in most patients with bipolar II disorder by carefully canvassing the life experiences of the patients he treated in the mood disorder clinic he established in the 1970s, which is believed to have been the first mood specialty clinic in the country.
Based on a review of >1,000 patients in his clinic who presented with depressive symptoms and were ultimately diagnosed as bipolar II disorder, Dr. Akiskal highlighted what he labeled as “behavioral activation, flamboyance and extravagance” among those patients. He referred to the cluster of those behaviors as “the soft spectrum” of bipolar disorder, which manifests in a set of distinctive behaviors in addition to depressive symptoms. He found that research tools such as the DSM-based Structured Clinical Interview often fail and frequently lead to a misdiagnosis of bipolar II disorder as MDD. This often condemns the patient to multiple failed trials of antidepressant monotherapy, and a delay in improvement, thus increasing the risk of job loss, disrupted relationships, and even suicide.
Over 3 decades, Dr. Akiskal developed the Mood Clinic Data Questionnaire (MCDQ) to systematize unstructured observations of patients presenting with a chief complaint of depression. His tool expedites the diagnosis of bipolar II disorder by understanding the patient as an individual, revealing personal and behavioral features consistent with what he labeled as episodic “hyperthymia” within the context of recurrent depression. This “social and behavioral phenotype,” as Dr. Akiskal called it, is rarely observed among patients with MDD.
By examining many patients with bipolar II disorder, Dr. Akiskal identified several “triads” of behavioral traits in the patients’ biographical history and in some of their close blood relatives as well. He also noticed that temperamentally, patients with bipolar II disorder thrive on “activity” and lovingly referred to themselves as “activity junkies.” Some of them may qualify as workaholics.
Biographical features that suggest bipolar II disorder
Here is a summary of the unique biographical features of patients with bipolar II disorder that Dr. Akiskal described:
Multilingual. Speaking ≥3 languages is unusual among individuals born in the United States, but often encountered among those with bipolar II disorder.
Continue to: Eminence
Eminence. Patients with bipolar II disorder, as well as their family members, tend to have leadership roles and prominence in journalism, media, and entertainment, fields that require interpersonal charm and eloquence. Those are common features of the “hyperthymic” temperament.
Creativity. Artists, poets, painters, and musicians who experience depression are more likely to have bipolar II disorder than MDD.
Biographical instability and/or excess. This is exemplified by going to 3 colleges and not necessarily obtaining a degree, or by frequently changing one’s line of work or city of residence. A classic example is a professor of medicine who also practices law and regularly sings in the opera, or a physician who is board-certified in 3 distinct specialties.
Activity junkies. Examples include a person with boundless energy, such as a novelist who writes 3 books a year or a professional who regularly works 12 hours a day without getting exhausted but seeks treatment for depressive episodes.
Multiple substances of abuse, such as nicotine, alcohol, stimulants, and opiates.
Continue to: Multiple psychiatric comorbidities
Multiple psychiatric comorbidities, such as having 3 types of anxiety (panic attacks, social phobia, and obsessive-compulsive disorder) or bulimia, seasonal depression, and anxiety.
Multiple pleasure-seeking or “outrageous” behaviors, such as compulsive gambling, sexual addiction, car racing, or skydiving. Another example is having a history of shoplifting, paraphilia, or arrest for participating in a riot, all of which are suggestive of antisocial traits in a patient seeking help for depression.
Sexual excesses, such as dating or having sex with ≥3 individuals concurrently, sometimes on the same day, or demanding sexual intercourse from a partner several times a day. Dr. Akiskal suggested that “sexual prowess” may represent an evolutionary advantage for the perpetuation of bipolar II disorder.
Marital history, such as a history of ≥3 marriages, or maintaining ≥2 families in different cities without being married.
Flamboyance and/or ornamentation. Examples might include wearing loud, colorful clothing (especially red), wearing ≥3 rings, or having piercings in ≥3 different body parts (tongue, nipples, navel, genitalia). Having elaborate tattoos across the body is no longer unique to “hyperthymic” persons with bipolar II disorder because tattoos have become far more common in the general population than they were in the 1970s. However, some take their tattoos to extremes.
Continue to: The above behaviors...
The above behaviors are condensed in a list that Dr. Akiskal called “the rule of 3” in patients with depression (Table1). Not all patients with bipolar II disorder will meet all the criteria of the rule of 3, but the first item in the mental status exam (appearance) alone may reflect the “soft bipolar spectrum,” such as garish clothing, red sneakers, multiple rings, bizarre hair coloring, and multiple piercings. This might prompt the clinician to ask further questions about hypomanic episodes as well as other personal behaviors related to the rule of 3.
Dr. Akiskal’s contributions to psychiatry are legendary in their originality, creativity, and clinical relevance. The rule of 3 is but one of his clinical concepts that may help identify many individuals with bipolar II disorder who are misdiagnosed as having MDD and prescribed a treatment that does not help or may exacerbate their illness course and worsen their outcome.
Based on the referrals of patients who are “treatment-resistant” to our Resident Mood Clinic, there are numerous persons in the country with bipolar II disorder (possibly millions) who are mislabeled with MDD and receiving the wrong treatments, to which they failed to respond. Their lifestyles and behaviors can provide valuable clinical insights into their true psychopathology, and that will lead to developing the right treatment plan.
1. Akiskal HS. Searching for behavioral indicators of bipolar II in patients presenting with major depressive episodes: the “red sign,” the “rule of three” and other biographic signs of temperamental extravagance, activation and hypomania. J Affect Disord. 2005;84(2-3):279-290.
The diagnosis of bipolar II disorder is one of the most common challenges in psychiatric practice. Bipolar II disorder is frequently misdiagnosed as major depressive disorder (MDD) because symptoms of transient hypomanic episodes are either insufficiently probed or are rather vague. However, there are many valuable biographical clues that can expedite the diagnosis of bipolar II disorder.
The late Hagop S. Akiskal, MD, who passed away in January 2021, was an internationally recognized expert in mood disorders, and a dear friend for decades. He was a keen observer of human behavior who delved into the “life stories” of patients seeking help for depression. By thinking “outside the DSM box,” Dr. Akiskal was the first to recognize and codify a variety of behavioral and biographical clues for the bipolar spectrum (of which he was a pioneer) in patients presenting with a chief complaint of depression. He proposed a colorful set of behavioral stigmata in most patients with bipolar II disorder by carefully canvassing the life experiences of the patients he treated in the mood disorder clinic he established in the 1970s, which is believed to have been the first mood specialty clinic in the country.
Based on a review of >1,000 patients in his clinic who presented with depressive symptoms and were ultimately diagnosed as bipolar II disorder, Dr. Akiskal highlighted what he labeled as “behavioral activation, flamboyance and extravagance” among those patients. He referred to the cluster of those behaviors as “the soft spectrum” of bipolar disorder, which manifests in a set of distinctive behaviors in addition to depressive symptoms. He found that research tools such as the DSM-based Structured Clinical Interview often fail and frequently lead to a misdiagnosis of bipolar II disorder as MDD. This often condemns the patient to multiple failed trials of antidepressant monotherapy, and a delay in improvement, thus increasing the risk of job loss, disrupted relationships, and even suicide.
Over 3 decades, Dr. Akiskal developed the Mood Clinic Data Questionnaire (MCDQ) to systematize unstructured observations of patients presenting with a chief complaint of depression. His tool expedites the diagnosis of bipolar II disorder by understanding the patient as an individual, revealing personal and behavioral features consistent with what he labeled as episodic “hyperthymia” within the context of recurrent depression. This “social and behavioral phenotype,” as Dr. Akiskal called it, is rarely observed among patients with MDD.
By examining many patients with bipolar II disorder, Dr. Akiskal identified several “triads” of behavioral traits in the patients’ biographical history and in some of their close blood relatives as well. He also noticed that temperamentally, patients with bipolar II disorder thrive on “activity” and lovingly referred to themselves as “activity junkies.” Some of them may qualify as workaholics.
Biographical features that suggest bipolar II disorder
Here is a summary of the unique biographical features of patients with bipolar II disorder that Dr. Akiskal described:
Multilingual. Speaking ≥3 languages is unusual among individuals born in the United States, but often encountered among those with bipolar II disorder.
Continue to: Eminence
Eminence. Patients with bipolar II disorder, as well as their family members, tend to have leadership roles and prominence in journalism, media, and entertainment, fields that require interpersonal charm and eloquence. Those are common features of the “hyperthymic” temperament.
Creativity. Artists, poets, painters, and musicians who experience depression are more likely to have bipolar II disorder than MDD.
Biographical instability and/or excess. This is exemplified by going to 3 colleges and not necessarily obtaining a degree, or by frequently changing one’s line of work or city of residence. A classic example is a professor of medicine who also practices law and regularly sings in the opera, or a physician who is board-certified in 3 distinct specialties.
Activity junkies. Examples include a person with boundless energy, such as a novelist who writes 3 books a year or a professional who regularly works 12 hours a day without getting exhausted but seeks treatment for depressive episodes.
Multiple substances of abuse, such as nicotine, alcohol, stimulants, and opiates.
Continue to: Multiple psychiatric comorbidities
Multiple psychiatric comorbidities, such as having 3 types of anxiety (panic attacks, social phobia, and obsessive-compulsive disorder) or bulimia, seasonal depression, and anxiety.
Multiple pleasure-seeking or “outrageous” behaviors, such as compulsive gambling, sexual addiction, car racing, or skydiving. Another example is having a history of shoplifting, paraphilia, or arrest for participating in a riot, all of which are suggestive of antisocial traits in a patient seeking help for depression.
Sexual excesses, such as dating or having sex with ≥3 individuals concurrently, sometimes on the same day, or demanding sexual intercourse from a partner several times a day. Dr. Akiskal suggested that “sexual prowess” may represent an evolutionary advantage for the perpetuation of bipolar II disorder.
Marital history, such as a history of ≥3 marriages, or maintaining ≥2 families in different cities without being married.
Flamboyance and/or ornamentation. Examples might include wearing loud, colorful clothing (especially red), wearing ≥3 rings, or having piercings in ≥3 different body parts (tongue, nipples, navel, genitalia). Having elaborate tattoos across the body is no longer unique to “hyperthymic” persons with bipolar II disorder because tattoos have become far more common in the general population than they were in the 1970s. However, some take their tattoos to extremes.
Continue to: The above behaviors...
The above behaviors are condensed in a list that Dr. Akiskal called “the rule of 3” in patients with depression (Table1). Not all patients with bipolar II disorder will meet all the criteria of the rule of 3, but the first item in the mental status exam (appearance) alone may reflect the “soft bipolar spectrum,” such as garish clothing, red sneakers, multiple rings, bizarre hair coloring, and multiple piercings. This might prompt the clinician to ask further questions about hypomanic episodes as well as other personal behaviors related to the rule of 3.
Dr. Akiskal’s contributions to psychiatry are legendary in their originality, creativity, and clinical relevance. The rule of 3 is but one of his clinical concepts that may help identify many individuals with bipolar II disorder who are misdiagnosed as having MDD and prescribed a treatment that does not help or may exacerbate their illness course and worsen their outcome.
Based on the referrals of patients who are “treatment-resistant” to our Resident Mood Clinic, there are numerous persons in the country with bipolar II disorder (possibly millions) who are mislabeled with MDD and receiving the wrong treatments, to which they failed to respond. Their lifestyles and behaviors can provide valuable clinical insights into their true psychopathology, and that will lead to developing the right treatment plan.
The diagnosis of bipolar II disorder is one of the most common challenges in psychiatric practice. Bipolar II disorder is frequently misdiagnosed as major depressive disorder (MDD) because symptoms of transient hypomanic episodes are either insufficiently probed or are rather vague. However, there are many valuable biographical clues that can expedite the diagnosis of bipolar II disorder.
The late Hagop S. Akiskal, MD, who passed away in January 2021, was an internationally recognized expert in mood disorders, and a dear friend for decades. He was a keen observer of human behavior who delved into the “life stories” of patients seeking help for depression. By thinking “outside the DSM box,” Dr. Akiskal was the first to recognize and codify a variety of behavioral and biographical clues for the bipolar spectrum (of which he was a pioneer) in patients presenting with a chief complaint of depression. He proposed a colorful set of behavioral stigmata in most patients with bipolar II disorder by carefully canvassing the life experiences of the patients he treated in the mood disorder clinic he established in the 1970s, which is believed to have been the first mood specialty clinic in the country.
Based on a review of >1,000 patients in his clinic who presented with depressive symptoms and were ultimately diagnosed as bipolar II disorder, Dr. Akiskal highlighted what he labeled as “behavioral activation, flamboyance and extravagance” among those patients. He referred to the cluster of those behaviors as “the soft spectrum” of bipolar disorder, which manifests in a set of distinctive behaviors in addition to depressive symptoms. He found that research tools such as the DSM-based Structured Clinical Interview often fail and frequently lead to a misdiagnosis of bipolar II disorder as MDD. This often condemns the patient to multiple failed trials of antidepressant monotherapy, and a delay in improvement, thus increasing the risk of job loss, disrupted relationships, and even suicide.
Over 3 decades, Dr. Akiskal developed the Mood Clinic Data Questionnaire (MCDQ) to systematize unstructured observations of patients presenting with a chief complaint of depression. His tool expedites the diagnosis of bipolar II disorder by understanding the patient as an individual, revealing personal and behavioral features consistent with what he labeled as episodic “hyperthymia” within the context of recurrent depression. This “social and behavioral phenotype,” as Dr. Akiskal called it, is rarely observed among patients with MDD.
By examining many patients with bipolar II disorder, Dr. Akiskal identified several “triads” of behavioral traits in the patients’ biographical history and in some of their close blood relatives as well. He also noticed that temperamentally, patients with bipolar II disorder thrive on “activity” and lovingly referred to themselves as “activity junkies.” Some of them may qualify as workaholics.
Biographical features that suggest bipolar II disorder
Here is a summary of the unique biographical features of patients with bipolar II disorder that Dr. Akiskal described:
Multilingual. Speaking ≥3 languages is unusual among individuals born in the United States, but often encountered among those with bipolar II disorder.
Continue to: Eminence
Eminence. Patients with bipolar II disorder, as well as their family members, tend to have leadership roles and prominence in journalism, media, and entertainment, fields that require interpersonal charm and eloquence. Those are common features of the “hyperthymic” temperament.
Creativity. Artists, poets, painters, and musicians who experience depression are more likely to have bipolar II disorder than MDD.
Biographical instability and/or excess. This is exemplified by going to 3 colleges and not necessarily obtaining a degree, or by frequently changing one’s line of work or city of residence. A classic example is a professor of medicine who also practices law and regularly sings in the opera, or a physician who is board-certified in 3 distinct specialties.
Activity junkies. Examples include a person with boundless energy, such as a novelist who writes 3 books a year or a professional who regularly works 12 hours a day without getting exhausted but seeks treatment for depressive episodes.
Multiple substances of abuse, such as nicotine, alcohol, stimulants, and opiates.
Continue to: Multiple psychiatric comorbidities
Multiple psychiatric comorbidities, such as having 3 types of anxiety (panic attacks, social phobia, and obsessive-compulsive disorder) or bulimia, seasonal depression, and anxiety.
Multiple pleasure-seeking or “outrageous” behaviors, such as compulsive gambling, sexual addiction, car racing, or skydiving. Another example is having a history of shoplifting, paraphilia, or arrest for participating in a riot, all of which are suggestive of antisocial traits in a patient seeking help for depression.
Sexual excesses, such as dating or having sex with ≥3 individuals concurrently, sometimes on the same day, or demanding sexual intercourse from a partner several times a day. Dr. Akiskal suggested that “sexual prowess” may represent an evolutionary advantage for the perpetuation of bipolar II disorder.
Marital history, such as a history of ≥3 marriages, or maintaining ≥2 families in different cities without being married.
Flamboyance and/or ornamentation. Examples might include wearing loud, colorful clothing (especially red), wearing ≥3 rings, or having piercings in ≥3 different body parts (tongue, nipples, navel, genitalia). Having elaborate tattoos across the body is no longer unique to “hyperthymic” persons with bipolar II disorder because tattoos have become far more common in the general population than they were in the 1970s. However, some take their tattoos to extremes.
Continue to: The above behaviors...
The above behaviors are condensed in a list that Dr. Akiskal called “the rule of 3” in patients with depression (Table1). Not all patients with bipolar II disorder will meet all the criteria of the rule of 3, but the first item in the mental status exam (appearance) alone may reflect the “soft bipolar spectrum,” such as garish clothing, red sneakers, multiple rings, bizarre hair coloring, and multiple piercings. This might prompt the clinician to ask further questions about hypomanic episodes as well as other personal behaviors related to the rule of 3.
Dr. Akiskal’s contributions to psychiatry are legendary in their originality, creativity, and clinical relevance. The rule of 3 is but one of his clinical concepts that may help identify many individuals with bipolar II disorder who are misdiagnosed as having MDD and prescribed a treatment that does not help or may exacerbate their illness course and worsen their outcome.
Based on the referrals of patients who are “treatment-resistant” to our Resident Mood Clinic, there are numerous persons in the country with bipolar II disorder (possibly millions) who are mislabeled with MDD and receiving the wrong treatments, to which they failed to respond. Their lifestyles and behaviors can provide valuable clinical insights into their true psychopathology, and that will lead to developing the right treatment plan.
1. Akiskal HS. Searching for behavioral indicators of bipolar II in patients presenting with major depressive episodes: the “red sign,” the “rule of three” and other biographic signs of temperamental extravagance, activation and hypomania. J Affect Disord. 2005;84(2-3):279-290.
1. Akiskal HS. Searching for behavioral indicators of bipolar II in patients presenting with major depressive episodes: the “red sign,” the “rule of three” and other biographic signs of temperamental extravagance, activation and hypomania. J Affect Disord. 2005;84(2-3):279-290.
Administration of ketamine for depression should be limited to psychiatrists
In the modern-day practice of medicine, turf wars are more common than one may realize. Presently, an ongoing battle over who should be prescribing and administering ketamine for novel treatment uses is being waged among psychiatrists, anesthesiologists, family physicians, and emergency physicians. Whoever emerges victorious will determine whether psychiatric care is administered in a safe and cost-effective manner, or if it will merely benefit the bottom line of the prescriber. In this article, we discuss how ketamine may have a role for treatment-resistant depression (TRD), and why psychiatrists are uniquely qualified to prescribe and administer this medication for this purpose.
New approaches to treatment-resistant depression
Antidepressant medications, long the mainstay of depression treatment, have been shown to be safe and relatively equally effective, with varying tolerability. However, 33% percent of patients do not achieve remission after 4 trials of antidepressant therapy.1 Most antidepressant efficacy studies report remission rates of 35% to 40%,2 which means many patients require subsequent switching and/or augmentation of their treatment.3 The STAR*D trial demonstrated that after 2 adequate antidepressant trials, the likelihood of remission diminishes.4
After a patient’s depression is found to be treatment-resistant, the onus of guiding treatment shifts away from the patient’s primary care physician to the more specialized psychiatrist. Few would question the suitability of a psychiatrist’s expertise in handling complicated and nuanced mental illness. In order to manage TRD, psychiatrists enter a terrain of emerging novel therapies with rapid onset, different mechanisms of action, and parenteral routes of administration.
One such therapy is esketamine, the S-enantiomer of ketamine. The FDA approved the intranasal (IN) formulation of esketamine in March 2019 after the medication had been designated as a breakthrough therapy for TRD in 2013 and studied in 6 Phase III clinical trials.5 The S-enantiomer of ketamine is known to bind to the N-methyl-
Ketamine may be administered intranasally, intravenously, or orally. A meta-analysis aimed at assessing differences in ketamine efficacy for depression based on route of administration have shown that both IV and IN ketamine are effective, though it is not possible to draw conclusions regarding a direct comparison based on available data.9 Despite several landmark published studies, such as those by Zarate et al,10 IV ketamine is not FDA-approved for TRD.
Continue to: Why psychiatrists?
Why psychiatrists?
Psychiatrists have been prescribing IN esketamine, which is covered by most commercial insurances and administered in certified healthcare settings under a Risk Evaluation and Mitigation Strategy program.5 However, anesthesiologists and emergency physicians have opened a crop of boutique and concierge health clinics offering various “packages” of IV ketamine infusions for a slew of mental ailments, including depression, anxiety, bipolar disorder, and posttraumatic stress disorder.11 Minimal investigation reveals that these services are being prescribed mainly by practitioners in fields other than psychiatry. Intravenous ketamine has long been used off-label as a treatment for depression not by psychiatrists but by practitioners of anesthesiology or emergency medicine. Although these clinicians are likely familiar with ketamine as an anesthetic, they have no foundation or expertise in the diagnosis and treatment of complex mood disorders. The FDA-approved indication for esketamine falls firmly in the realm of psychiatric treatment. Physicians who have not completed a psychiatry residency have neither the training nor experience necessary to determine whether a patient is a candidate for this treatment.
One potential adverse effect of ketamine is an emergence phenomenon, colloquially named a “K-hole,” that can induce symptoms of psychosis such as disturbing hallucinations. Patients who have a history of psychosis need to be carefully evaluated for appropriateness to receive this treatment.
Furthermore, ketamine treatments administered by physicians who are not psychiatrists are billed not through insurance but mostly via private pay. A patient may therefore be charged $350 to $1,000 per infusion, to be paid out of pocket.11 Tally that up over the standard 6 to 12 initial treatment infusions, followed by maintenance infusions, and these patients with profound depression are potentially building up significant debt. Does this practice align with the ethical principles of autonomy, justice, beneficence, and nonmaleficence that all physicians swore to uphold? Will psychiatrists take a stand against the financial exploitation of a vulnerable group that is desperate to find any potential relief from their depression?
1. Hillhouse TM, Porter JH. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015;23(1):1-21.
2. Fava M, Rush A, Trivedi M, et al. Background and rationale for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Psychiatr Clin North Am. 2003;26(2):457-494.
3. Gaynes BN, Rush AJ, Trivedi MH, et al. Primary versus specialty care outcomes for depressed outpatients managed with measurement-based care: results from STAR*D. J Gen Intern Med. 2008;23(5):551-560.
4. Gaynes BN, Warden D, Trivedi MH, et al. What did STAR*D teach us? Results from a large-scale, practical, clinical trial for patients with depression. Psychiatr Serv. 2009;60(11):1439-1445.
5. US Food and Drug Administration. Center for Drug Evaluation and Research. Esketamine clinical review. Published March 5, 2019. Accessed August 9, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000MedR.pdf
6. Zanos P, Moaddel R, Morris PJ, et al. Ketamine and ketamine metabolite pharmacology: insights into therapeutic mechanisms. Pharmacol Rev. 2018;70(3):621-660.
7. Zanos P, Gould TD. Mechanisms of ketamine action as an antidepressant. Mol Psychiatry. 2018;23(4):801-811.
8. Kaur U, Pathak BK, Singh A, et al. Esketamine: a glimmer of hope in treatment-resistant depression. Eur Arch Psychiatry Clin Neurosci. 2021;271(3):417-429.
9. McIntyre RS, Carvalho IP, Lui LMW, et al. The effect of intravenous, intranasal, and oral ketamine/esketamine in mood disorders: a meta-analysis. J Affect Disord. 2020;276:576-584.
10. Zarate CA Jr, Singh JB, Carlson PJ, et al. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006;63(8):856-864.
11. Thielking M. Ketamine gives hope to patients with severe depression. But some clinics stray from the science and hype its benefits. STAT+. Published September 18, 2018. Accessed August 5, 2021. www.statnews.com/2018/09/24/ketamine-clinics-severe-depression-treatment/
In the modern-day practice of medicine, turf wars are more common than one may realize. Presently, an ongoing battle over who should be prescribing and administering ketamine for novel treatment uses is being waged among psychiatrists, anesthesiologists, family physicians, and emergency physicians. Whoever emerges victorious will determine whether psychiatric care is administered in a safe and cost-effective manner, or if it will merely benefit the bottom line of the prescriber. In this article, we discuss how ketamine may have a role for treatment-resistant depression (TRD), and why psychiatrists are uniquely qualified to prescribe and administer this medication for this purpose.
New approaches to treatment-resistant depression
Antidepressant medications, long the mainstay of depression treatment, have been shown to be safe and relatively equally effective, with varying tolerability. However, 33% percent of patients do not achieve remission after 4 trials of antidepressant therapy.1 Most antidepressant efficacy studies report remission rates of 35% to 40%,2 which means many patients require subsequent switching and/or augmentation of their treatment.3 The STAR*D trial demonstrated that after 2 adequate antidepressant trials, the likelihood of remission diminishes.4
After a patient’s depression is found to be treatment-resistant, the onus of guiding treatment shifts away from the patient’s primary care physician to the more specialized psychiatrist. Few would question the suitability of a psychiatrist’s expertise in handling complicated and nuanced mental illness. In order to manage TRD, psychiatrists enter a terrain of emerging novel therapies with rapid onset, different mechanisms of action, and parenteral routes of administration.
One such therapy is esketamine, the S-enantiomer of ketamine. The FDA approved the intranasal (IN) formulation of esketamine in March 2019 after the medication had been designated as a breakthrough therapy for TRD in 2013 and studied in 6 Phase III clinical trials.5 The S-enantiomer of ketamine is known to bind to the N-methyl-
Ketamine may be administered intranasally, intravenously, or orally. A meta-analysis aimed at assessing differences in ketamine efficacy for depression based on route of administration have shown that both IV and IN ketamine are effective, though it is not possible to draw conclusions regarding a direct comparison based on available data.9 Despite several landmark published studies, such as those by Zarate et al,10 IV ketamine is not FDA-approved for TRD.
Continue to: Why psychiatrists?
Why psychiatrists?
Psychiatrists have been prescribing IN esketamine, which is covered by most commercial insurances and administered in certified healthcare settings under a Risk Evaluation and Mitigation Strategy program.5 However, anesthesiologists and emergency physicians have opened a crop of boutique and concierge health clinics offering various “packages” of IV ketamine infusions for a slew of mental ailments, including depression, anxiety, bipolar disorder, and posttraumatic stress disorder.11 Minimal investigation reveals that these services are being prescribed mainly by practitioners in fields other than psychiatry. Intravenous ketamine has long been used off-label as a treatment for depression not by psychiatrists but by practitioners of anesthesiology or emergency medicine. Although these clinicians are likely familiar with ketamine as an anesthetic, they have no foundation or expertise in the diagnosis and treatment of complex mood disorders. The FDA-approved indication for esketamine falls firmly in the realm of psychiatric treatment. Physicians who have not completed a psychiatry residency have neither the training nor experience necessary to determine whether a patient is a candidate for this treatment.
One potential adverse effect of ketamine is an emergence phenomenon, colloquially named a “K-hole,” that can induce symptoms of psychosis such as disturbing hallucinations. Patients who have a history of psychosis need to be carefully evaluated for appropriateness to receive this treatment.
Furthermore, ketamine treatments administered by physicians who are not psychiatrists are billed not through insurance but mostly via private pay. A patient may therefore be charged $350 to $1,000 per infusion, to be paid out of pocket.11 Tally that up over the standard 6 to 12 initial treatment infusions, followed by maintenance infusions, and these patients with profound depression are potentially building up significant debt. Does this practice align with the ethical principles of autonomy, justice, beneficence, and nonmaleficence that all physicians swore to uphold? Will psychiatrists take a stand against the financial exploitation of a vulnerable group that is desperate to find any potential relief from their depression?
In the modern-day practice of medicine, turf wars are more common than one may realize. Presently, an ongoing battle over who should be prescribing and administering ketamine for novel treatment uses is being waged among psychiatrists, anesthesiologists, family physicians, and emergency physicians. Whoever emerges victorious will determine whether psychiatric care is administered in a safe and cost-effective manner, or if it will merely benefit the bottom line of the prescriber. In this article, we discuss how ketamine may have a role for treatment-resistant depression (TRD), and why psychiatrists are uniquely qualified to prescribe and administer this medication for this purpose.
New approaches to treatment-resistant depression
Antidepressant medications, long the mainstay of depression treatment, have been shown to be safe and relatively equally effective, with varying tolerability. However, 33% percent of patients do not achieve remission after 4 trials of antidepressant therapy.1 Most antidepressant efficacy studies report remission rates of 35% to 40%,2 which means many patients require subsequent switching and/or augmentation of their treatment.3 The STAR*D trial demonstrated that after 2 adequate antidepressant trials, the likelihood of remission diminishes.4
After a patient’s depression is found to be treatment-resistant, the onus of guiding treatment shifts away from the patient’s primary care physician to the more specialized psychiatrist. Few would question the suitability of a psychiatrist’s expertise in handling complicated and nuanced mental illness. In order to manage TRD, psychiatrists enter a terrain of emerging novel therapies with rapid onset, different mechanisms of action, and parenteral routes of administration.
One such therapy is esketamine, the S-enantiomer of ketamine. The FDA approved the intranasal (IN) formulation of esketamine in March 2019 after the medication had been designated as a breakthrough therapy for TRD in 2013 and studied in 6 Phase III clinical trials.5 The S-enantiomer of ketamine is known to bind to the N-methyl-
Ketamine may be administered intranasally, intravenously, or orally. A meta-analysis aimed at assessing differences in ketamine efficacy for depression based on route of administration have shown that both IV and IN ketamine are effective, though it is not possible to draw conclusions regarding a direct comparison based on available data.9 Despite several landmark published studies, such as those by Zarate et al,10 IV ketamine is not FDA-approved for TRD.
Continue to: Why psychiatrists?
Why psychiatrists?
Psychiatrists have been prescribing IN esketamine, which is covered by most commercial insurances and administered in certified healthcare settings under a Risk Evaluation and Mitigation Strategy program.5 However, anesthesiologists and emergency physicians have opened a crop of boutique and concierge health clinics offering various “packages” of IV ketamine infusions for a slew of mental ailments, including depression, anxiety, bipolar disorder, and posttraumatic stress disorder.11 Minimal investigation reveals that these services are being prescribed mainly by practitioners in fields other than psychiatry. Intravenous ketamine has long been used off-label as a treatment for depression not by psychiatrists but by practitioners of anesthesiology or emergency medicine. Although these clinicians are likely familiar with ketamine as an anesthetic, they have no foundation or expertise in the diagnosis and treatment of complex mood disorders. The FDA-approved indication for esketamine falls firmly in the realm of psychiatric treatment. Physicians who have not completed a psychiatry residency have neither the training nor experience necessary to determine whether a patient is a candidate for this treatment.
One potential adverse effect of ketamine is an emergence phenomenon, colloquially named a “K-hole,” that can induce symptoms of psychosis such as disturbing hallucinations. Patients who have a history of psychosis need to be carefully evaluated for appropriateness to receive this treatment.
Furthermore, ketamine treatments administered by physicians who are not psychiatrists are billed not through insurance but mostly via private pay. A patient may therefore be charged $350 to $1,000 per infusion, to be paid out of pocket.11 Tally that up over the standard 6 to 12 initial treatment infusions, followed by maintenance infusions, and these patients with profound depression are potentially building up significant debt. Does this practice align with the ethical principles of autonomy, justice, beneficence, and nonmaleficence that all physicians swore to uphold? Will psychiatrists take a stand against the financial exploitation of a vulnerable group that is desperate to find any potential relief from their depression?
1. Hillhouse TM, Porter JH. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015;23(1):1-21.
2. Fava M, Rush A, Trivedi M, et al. Background and rationale for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Psychiatr Clin North Am. 2003;26(2):457-494.
3. Gaynes BN, Rush AJ, Trivedi MH, et al. Primary versus specialty care outcomes for depressed outpatients managed with measurement-based care: results from STAR*D. J Gen Intern Med. 2008;23(5):551-560.
4. Gaynes BN, Warden D, Trivedi MH, et al. What did STAR*D teach us? Results from a large-scale, practical, clinical trial for patients with depression. Psychiatr Serv. 2009;60(11):1439-1445.
5. US Food and Drug Administration. Center for Drug Evaluation and Research. Esketamine clinical review. Published March 5, 2019. Accessed August 9, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000MedR.pdf
6. Zanos P, Moaddel R, Morris PJ, et al. Ketamine and ketamine metabolite pharmacology: insights into therapeutic mechanisms. Pharmacol Rev. 2018;70(3):621-660.
7. Zanos P, Gould TD. Mechanisms of ketamine action as an antidepressant. Mol Psychiatry. 2018;23(4):801-811.
8. Kaur U, Pathak BK, Singh A, et al. Esketamine: a glimmer of hope in treatment-resistant depression. Eur Arch Psychiatry Clin Neurosci. 2021;271(3):417-429.
9. McIntyre RS, Carvalho IP, Lui LMW, et al. The effect of intravenous, intranasal, and oral ketamine/esketamine in mood disorders: a meta-analysis. J Affect Disord. 2020;276:576-584.
10. Zarate CA Jr, Singh JB, Carlson PJ, et al. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006;63(8):856-864.
11. Thielking M. Ketamine gives hope to patients with severe depression. But some clinics stray from the science and hype its benefits. STAT+. Published September 18, 2018. Accessed August 5, 2021. www.statnews.com/2018/09/24/ketamine-clinics-severe-depression-treatment/
1. Hillhouse TM, Porter JH. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015;23(1):1-21.
2. Fava M, Rush A, Trivedi M, et al. Background and rationale for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Psychiatr Clin North Am. 2003;26(2):457-494.
3. Gaynes BN, Rush AJ, Trivedi MH, et al. Primary versus specialty care outcomes for depressed outpatients managed with measurement-based care: results from STAR*D. J Gen Intern Med. 2008;23(5):551-560.
4. Gaynes BN, Warden D, Trivedi MH, et al. What did STAR*D teach us? Results from a large-scale, practical, clinical trial for patients with depression. Psychiatr Serv. 2009;60(11):1439-1445.
5. US Food and Drug Administration. Center for Drug Evaluation and Research. Esketamine clinical review. Published March 5, 2019. Accessed August 9, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000MedR.pdf
6. Zanos P, Moaddel R, Morris PJ, et al. Ketamine and ketamine metabolite pharmacology: insights into therapeutic mechanisms. Pharmacol Rev. 2018;70(3):621-660.
7. Zanos P, Gould TD. Mechanisms of ketamine action as an antidepressant. Mol Psychiatry. 2018;23(4):801-811.
8. Kaur U, Pathak BK, Singh A, et al. Esketamine: a glimmer of hope in treatment-resistant depression. Eur Arch Psychiatry Clin Neurosci. 2021;271(3):417-429.
9. McIntyre RS, Carvalho IP, Lui LMW, et al. The effect of intravenous, intranasal, and oral ketamine/esketamine in mood disorders: a meta-analysis. J Affect Disord. 2020;276:576-584.
10. Zarate CA Jr, Singh JB, Carlson PJ, et al. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006;63(8):856-864.
11. Thielking M. Ketamine gives hope to patients with severe depression. But some clinics stray from the science and hype its benefits. STAT+. Published September 18, 2018. Accessed August 5, 2021. www.statnews.com/2018/09/24/ketamine-clinics-severe-depression-treatment/
The other epidemic: Violence against health care workers
After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.
During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.
We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.
Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
This kind of abuse is persistent
Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.
Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.
Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.
These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
COVID and the increase in violence against health care workers
As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.
In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.
This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.
The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
Standing united against health care worker abuse
Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.
First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.
In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.
HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.
Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.
The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.
Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.
During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.
We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.
Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
This kind of abuse is persistent
Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.
Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.
Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.
These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
COVID and the increase in violence against health care workers
As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.
In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.
This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.
The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
Standing united against health care worker abuse
Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.
First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.
In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.
HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.
Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.
The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.
Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.
During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.
We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.
Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
This kind of abuse is persistent
Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.
Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.
Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.
These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
COVID and the increase in violence against health care workers
As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.
In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.
This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.
The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
Standing united against health care worker abuse
Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.
First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.
In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.
HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.
Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.
The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.
Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Stop blaming the unvaccinated
As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”
While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”
Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.
The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
The concept of blame
So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.
Labeling reminds me of one of the saddest cases in my career.
An unfortunate case
I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.
He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
The comparison
Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.
Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.
Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
Conclusion
We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.
Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.
In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.
It could be any of us.
A version of this article first appeared on Medscape.com.
As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”
While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”
Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.
The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
The concept of blame
So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.
Labeling reminds me of one of the saddest cases in my career.
An unfortunate case
I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.
He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
The comparison
Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.
Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.
Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
Conclusion
We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.
Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.
In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.
It could be any of us.
A version of this article first appeared on Medscape.com.
As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”
While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”
Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.
The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
The concept of blame
So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.
Labeling reminds me of one of the saddest cases in my career.
An unfortunate case
I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.
He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
The comparison
Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.
Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.
Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
Conclusion
We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.
Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.
In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.
It could be any of us.
A version of this article first appeared on Medscape.com.
Gender-affirming mastectomy and breast cancer screening in transmasculine patients
Since the reversal of the Medicare exclusion in 2014, the rates of gender-affirming surgery have increased markedly in the United States.1 Gender-affirming mastectomy, otherwise known as “top surgery,” is one of the more commonly performed procedures; with 97% of patients having either undergone or expressed desire for the surgery.2 The goals of this procedure are to remove all visible breast tissue and reconstruct the chest wall so it is more masculine in appearance. For transmasculine and nonbinary patients, this procedure is associated with significant improvements in mental health and quality of life.3,4 While the mastectomy procedure is often performed by plastic surgeons, patients will see an ob.gyn. in the preoperative or postoperative period. Ob.gyns. should have a general understanding of the procedure, but most importantly know how to screen for breast cancer in patients who have undergone a gender-affirming mastectomy.
Providers will likely encounter transmasculine or nonbinary patients during annual screening examinations or for a preoperative exam. If a patient is seeking a preoperative risk assessment prior to undergoing a gender-affirming mastectomy, assessing a patient’s risk status for breast cancer is paramount. While testosterone therapy is no longer a prerequisite for gender-affirming mastectomies, documenting hormone use, age at initiation, and dosage is important.5 The overall effects of testosterone on breast tissue are inconsistent. However, studies have demonstrated that patients taking testosterone are not at an increased risk of breast cancer secondary to testosterone use.5-7 Patients should be asked about a personal of family history of breast cancer, breast surgery, history of prior breast biopsies, parity, age at menarche, smoking status, and breastfeeding history if applicable. Patients with high-risk mutations or a strong family history of breast cancer should be referred to genetic counselors, surgical oncologists, and possibly undergo genetic testing.8 Before an examination, providers should counsel patients about the nature of the examination and use gender-neutral language such as “chest” to avoid exacerbating gender dysphoria.
It is important to educate transmasculine patients about their risk for the development of breast cancer after mastectomy. Larger-scale, population-based studies of breast cancer in the transgender population have reported an incidence of 5.9 per 100,000 patients-years and an overall incidence comparable to cisgender men in age-standardized national samples.5-7 Unfortunately, data on the rates of breast cancer in transmasculine patients after gender-affirming mastectomy are limited, which makes defining postoperative guidelines challenging. Additionally, the amount of residual breast tissue remaining varies based on the surgeon and technique.
Several techniques are described for mastectomy procedures with differences that can affect the amount of residual breast tissue. The most common type of gender-affirming mastectomy is the double incision. With this procedure, the nipple-areolar complex is reduced in size, removed, and thinned to improve graft take. Dissection is then carried to the level of the breast capsule and the breast tissue and axillary tail are removed en bloc.5 During the dissection, the subcutaneous fat is left on the skin flap to provide appropriate contour and to avoid creating a concave-appearing chest wall. Prior to closure, the superior and inferior flaps are inspected for any visible residual breast tissue, which is removed if needed. In a circumareolar mastectomy, the nipple-areolar complex is also reduced but is preserved on a 1- to 1.5-cm-thick pedicle to maintain perfusion.5 The mastectomy is performed through an inferior periareolar incision and all visible breast tissue and the axillary tail are removed. Breast tissue specimens are sent for pathologic evaluation at the end of the procedure.
Following gender-affirming mastectomy, there is limited evidence to guide screening. During the patient visit, the provider should obtain a thorough history regarding mastectomy type, and if unknown, attempt to acquire the operative report detailing the procedure. For low-risk patients who undergo a subcutaneous mastectomy such as the double incision or circumareolar technique, screening mammography is not indicated nor is it technically feasible.9 For patients with a high-risk genetic mutation or a strong family history of breast cancer, monitoring with alternative modalities such as breast ultrasound or breast MRI may be beneficial, although there is no evidence to currently support this suggestion. Given the variety of surgical techniques of breast tissue removal, it is difficult to develop strong evidence-based guidelines. Annual chest wall examinations have been suggested as a screening modality; however, the clinical utility of clinical breast and chest exams has been debated and is no longer recommended as a screening method in cisgender patients.9 Clinicians can promote chest self-awareness and discuss the possibility of breast cancer in postmastectomy patients at annual examination visits. As research continues to resolve some of these unknowns, it is important that patients are informed of these areas of ambiguity and updated regarding any changes in screening recommendations.10
Dr. Brandt is an ob.gyn. and fellowship-trained gender affirming surgeon in West Reading, Pa.
References
1. American Society of Plastic Surgeons. 2018 plastic surgery statistics report. https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed Aug. 20, 2021.
2. James SE et al. The report of the 2015 U.S. Transgender survey. Washington, D.C.: National Center for Transgender Equality, 2016.
3. Agarwal CA et al. J Plast Reconstr Aesthet Surg. 2018;71:651-7.
4. Poudrier G et al. Plast Reconstr Surg. 2018;80:679-83.
5. Salibian AA et al. Plast Reconstr Surg. 2020;147:213e-21e.
6. Gooren LJ et al. J Sex Med. 2013;10:3129-34.
7. Brown GR and Jones KT. Breast Cancer Res Treat. 2015;149:191-8.
8. Deutsch MF et al. Semin Reprod Med. 2017;35:434-41.
9. Phillips J et al. AJR Am J Roentgenol. 2014;202:1149-59.
10. Smith RA et al. CA Cancer J Clin. 2018;68:297-316.
Since the reversal of the Medicare exclusion in 2014, the rates of gender-affirming surgery have increased markedly in the United States.1 Gender-affirming mastectomy, otherwise known as “top surgery,” is one of the more commonly performed procedures; with 97% of patients having either undergone or expressed desire for the surgery.2 The goals of this procedure are to remove all visible breast tissue and reconstruct the chest wall so it is more masculine in appearance. For transmasculine and nonbinary patients, this procedure is associated with significant improvements in mental health and quality of life.3,4 While the mastectomy procedure is often performed by plastic surgeons, patients will see an ob.gyn. in the preoperative or postoperative period. Ob.gyns. should have a general understanding of the procedure, but most importantly know how to screen for breast cancer in patients who have undergone a gender-affirming mastectomy.
Providers will likely encounter transmasculine or nonbinary patients during annual screening examinations or for a preoperative exam. If a patient is seeking a preoperative risk assessment prior to undergoing a gender-affirming mastectomy, assessing a patient’s risk status for breast cancer is paramount. While testosterone therapy is no longer a prerequisite for gender-affirming mastectomies, documenting hormone use, age at initiation, and dosage is important.5 The overall effects of testosterone on breast tissue are inconsistent. However, studies have demonstrated that patients taking testosterone are not at an increased risk of breast cancer secondary to testosterone use.5-7 Patients should be asked about a personal of family history of breast cancer, breast surgery, history of prior breast biopsies, parity, age at menarche, smoking status, and breastfeeding history if applicable. Patients with high-risk mutations or a strong family history of breast cancer should be referred to genetic counselors, surgical oncologists, and possibly undergo genetic testing.8 Before an examination, providers should counsel patients about the nature of the examination and use gender-neutral language such as “chest” to avoid exacerbating gender dysphoria.
It is important to educate transmasculine patients about their risk for the development of breast cancer after mastectomy. Larger-scale, population-based studies of breast cancer in the transgender population have reported an incidence of 5.9 per 100,000 patients-years and an overall incidence comparable to cisgender men in age-standardized national samples.5-7 Unfortunately, data on the rates of breast cancer in transmasculine patients after gender-affirming mastectomy are limited, which makes defining postoperative guidelines challenging. Additionally, the amount of residual breast tissue remaining varies based on the surgeon and technique.
Several techniques are described for mastectomy procedures with differences that can affect the amount of residual breast tissue. The most common type of gender-affirming mastectomy is the double incision. With this procedure, the nipple-areolar complex is reduced in size, removed, and thinned to improve graft take. Dissection is then carried to the level of the breast capsule and the breast tissue and axillary tail are removed en bloc.5 During the dissection, the subcutaneous fat is left on the skin flap to provide appropriate contour and to avoid creating a concave-appearing chest wall. Prior to closure, the superior and inferior flaps are inspected for any visible residual breast tissue, which is removed if needed. In a circumareolar mastectomy, the nipple-areolar complex is also reduced but is preserved on a 1- to 1.5-cm-thick pedicle to maintain perfusion.5 The mastectomy is performed through an inferior periareolar incision and all visible breast tissue and the axillary tail are removed. Breast tissue specimens are sent for pathologic evaluation at the end of the procedure.
Following gender-affirming mastectomy, there is limited evidence to guide screening. During the patient visit, the provider should obtain a thorough history regarding mastectomy type, and if unknown, attempt to acquire the operative report detailing the procedure. For low-risk patients who undergo a subcutaneous mastectomy such as the double incision or circumareolar technique, screening mammography is not indicated nor is it technically feasible.9 For patients with a high-risk genetic mutation or a strong family history of breast cancer, monitoring with alternative modalities such as breast ultrasound or breast MRI may be beneficial, although there is no evidence to currently support this suggestion. Given the variety of surgical techniques of breast tissue removal, it is difficult to develop strong evidence-based guidelines. Annual chest wall examinations have been suggested as a screening modality; however, the clinical utility of clinical breast and chest exams has been debated and is no longer recommended as a screening method in cisgender patients.9 Clinicians can promote chest self-awareness and discuss the possibility of breast cancer in postmastectomy patients at annual examination visits. As research continues to resolve some of these unknowns, it is important that patients are informed of these areas of ambiguity and updated regarding any changes in screening recommendations.10
Dr. Brandt is an ob.gyn. and fellowship-trained gender affirming surgeon in West Reading, Pa.
References
1. American Society of Plastic Surgeons. 2018 plastic surgery statistics report. https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed Aug. 20, 2021.
2. James SE et al. The report of the 2015 U.S. Transgender survey. Washington, D.C.: National Center for Transgender Equality, 2016.
3. Agarwal CA et al. J Plast Reconstr Aesthet Surg. 2018;71:651-7.
4. Poudrier G et al. Plast Reconstr Surg. 2018;80:679-83.
5. Salibian AA et al. Plast Reconstr Surg. 2020;147:213e-21e.
6. Gooren LJ et al. J Sex Med. 2013;10:3129-34.
7. Brown GR and Jones KT. Breast Cancer Res Treat. 2015;149:191-8.
8. Deutsch MF et al. Semin Reprod Med. 2017;35:434-41.
9. Phillips J et al. AJR Am J Roentgenol. 2014;202:1149-59.
10. Smith RA et al. CA Cancer J Clin. 2018;68:297-316.
Since the reversal of the Medicare exclusion in 2014, the rates of gender-affirming surgery have increased markedly in the United States.1 Gender-affirming mastectomy, otherwise known as “top surgery,” is one of the more commonly performed procedures; with 97% of patients having either undergone or expressed desire for the surgery.2 The goals of this procedure are to remove all visible breast tissue and reconstruct the chest wall so it is more masculine in appearance. For transmasculine and nonbinary patients, this procedure is associated with significant improvements in mental health and quality of life.3,4 While the mastectomy procedure is often performed by plastic surgeons, patients will see an ob.gyn. in the preoperative or postoperative period. Ob.gyns. should have a general understanding of the procedure, but most importantly know how to screen for breast cancer in patients who have undergone a gender-affirming mastectomy.
Providers will likely encounter transmasculine or nonbinary patients during annual screening examinations or for a preoperative exam. If a patient is seeking a preoperative risk assessment prior to undergoing a gender-affirming mastectomy, assessing a patient’s risk status for breast cancer is paramount. While testosterone therapy is no longer a prerequisite for gender-affirming mastectomies, documenting hormone use, age at initiation, and dosage is important.5 The overall effects of testosterone on breast tissue are inconsistent. However, studies have demonstrated that patients taking testosterone are not at an increased risk of breast cancer secondary to testosterone use.5-7 Patients should be asked about a personal of family history of breast cancer, breast surgery, history of prior breast biopsies, parity, age at menarche, smoking status, and breastfeeding history if applicable. Patients with high-risk mutations or a strong family history of breast cancer should be referred to genetic counselors, surgical oncologists, and possibly undergo genetic testing.8 Before an examination, providers should counsel patients about the nature of the examination and use gender-neutral language such as “chest” to avoid exacerbating gender dysphoria.
It is important to educate transmasculine patients about their risk for the development of breast cancer after mastectomy. Larger-scale, population-based studies of breast cancer in the transgender population have reported an incidence of 5.9 per 100,000 patients-years and an overall incidence comparable to cisgender men in age-standardized national samples.5-7 Unfortunately, data on the rates of breast cancer in transmasculine patients after gender-affirming mastectomy are limited, which makes defining postoperative guidelines challenging. Additionally, the amount of residual breast tissue remaining varies based on the surgeon and technique.
Several techniques are described for mastectomy procedures with differences that can affect the amount of residual breast tissue. The most common type of gender-affirming mastectomy is the double incision. With this procedure, the nipple-areolar complex is reduced in size, removed, and thinned to improve graft take. Dissection is then carried to the level of the breast capsule and the breast tissue and axillary tail are removed en bloc.5 During the dissection, the subcutaneous fat is left on the skin flap to provide appropriate contour and to avoid creating a concave-appearing chest wall. Prior to closure, the superior and inferior flaps are inspected for any visible residual breast tissue, which is removed if needed. In a circumareolar mastectomy, the nipple-areolar complex is also reduced but is preserved on a 1- to 1.5-cm-thick pedicle to maintain perfusion.5 The mastectomy is performed through an inferior periareolar incision and all visible breast tissue and the axillary tail are removed. Breast tissue specimens are sent for pathologic evaluation at the end of the procedure.
Following gender-affirming mastectomy, there is limited evidence to guide screening. During the patient visit, the provider should obtain a thorough history regarding mastectomy type, and if unknown, attempt to acquire the operative report detailing the procedure. For low-risk patients who undergo a subcutaneous mastectomy such as the double incision or circumareolar technique, screening mammography is not indicated nor is it technically feasible.9 For patients with a high-risk genetic mutation or a strong family history of breast cancer, monitoring with alternative modalities such as breast ultrasound or breast MRI may be beneficial, although there is no evidence to currently support this suggestion. Given the variety of surgical techniques of breast tissue removal, it is difficult to develop strong evidence-based guidelines. Annual chest wall examinations have been suggested as a screening modality; however, the clinical utility of clinical breast and chest exams has been debated and is no longer recommended as a screening method in cisgender patients.9 Clinicians can promote chest self-awareness and discuss the possibility of breast cancer in postmastectomy patients at annual examination visits. As research continues to resolve some of these unknowns, it is important that patients are informed of these areas of ambiguity and updated regarding any changes in screening recommendations.10
Dr. Brandt is an ob.gyn. and fellowship-trained gender affirming surgeon in West Reading, Pa.
References
1. American Society of Plastic Surgeons. 2018 plastic surgery statistics report. https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-full-report-2018.pdf. Accessed Aug. 20, 2021.
2. James SE et al. The report of the 2015 U.S. Transgender survey. Washington, D.C.: National Center for Transgender Equality, 2016.
3. Agarwal CA et al. J Plast Reconstr Aesthet Surg. 2018;71:651-7.
4. Poudrier G et al. Plast Reconstr Surg. 2018;80:679-83.
5. Salibian AA et al. Plast Reconstr Surg. 2020;147:213e-21e.
6. Gooren LJ et al. J Sex Med. 2013;10:3129-34.
7. Brown GR and Jones KT. Breast Cancer Res Treat. 2015;149:191-8.
8. Deutsch MF et al. Semin Reprod Med. 2017;35:434-41.
9. Phillips J et al. AJR Am J Roentgenol. 2014;202:1149-59.
10. Smith RA et al. CA Cancer J Clin. 2018;68:297-316.
Telehealth abortions are 95% effective, similar to in-person care
Telehealth abortion may be just as safe and effective as in-person care, according to a small study published online in JAMA Network Open.
Of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.
“There was no reason to expect that the medications prescribed [via telemedicine] and delivered through the mail would have different outcomes from when a patient traveled to a clinic,” study author Ushma D. Upadhyay, PhD, MPH, associate professor in the department of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, said in an interview.
Medication abortion, which usually involves taking mifepristone (Mifeprex) followed by misoprostol (Cytotec) during the first 10 weeks of pregnancy, has been available in the United States since 2000. The Food and Drug Administration’s Risk Evaluation and Mitigation Strategy requires that mifepristone be dispensed in a medical office, clinic, or hospital, prohibiting dispensing from pharmacies in an effort to reduce potential risk for complications.
In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic. However, Dr. Upadhyay hopes the findings of her current study will make this suspension permanent.
For the study, Dr. Upadhyay and colleagues examined the safety and efficacy of fully remote, medication abortion care. Eligibility for the medication was assessed using an online form that relies on patient history, or patients recalling their last period, to assess pregnancy duration and screen for ectopic pregnancy risks. Nurse practitioners reviewed the form and referred patients with unknown last menstrual period date or ectopic pregnancy risk factors for ultrasonography. A mail-order pharmacy delivered medications to eligible patients. The protocol involved three follow-up contacts: confirmation of medication administration, a 3-day assessment of symptoms, and a home pregnancy test after 4 weeks. Follow-up interactions were conducted by text, secure messaging, or telephone.
Researchers found that in addition to the 95% of the patients having a complete abortion without intervention, 5% (five) of patients required addition medical care to complete the abortion. Two of those patients were treated in EDs.
Gillian Burkhardt, MD, who was not involved in the study, said Dr. Upadhyay’s study proves what has been known all along, that medication is super safe and that women “can help to determine their own eligibility as well as in conjunction with the provider.”
“I hope that this will be one more study that the FDA can use when thinking about changing the risk evaluation administration strategy so that it’s removing the requirement that a person be in the dispensing medical office,” Dr. Burkhardt, assistant professor of family planning in the department of obstetrics & gynecology at the University of New Mexico Hospital, Albuquerque, said in an interview. “I hope it also makes providers feel more comfortable as well, because I think there’s some hesitancy among providers to provide abortion without doing an ultrasound or without seeing the patient typically in front of them.”
This isn’t the first study to suggest the safety of telemedicine abortion. A 2019 study published in Obstetrics & Gynecology, which analyzed records from nearly 6,000 patients receiving medication abortion either through telemedicine or in person at 26 Planned Parenthood health centers in four states found that ongoing pregnancy and aspiration procedures were less common among telemedicine patients. Another 2017 study published in BMJ found that women who used an online consultation service and self-sourced medical abortion during a 3-year period were able to successfully end their pregnancies with few adverse events.
Dr. Upadhyay said one limitation of the current study is its sample size, so more studies should be conducted to prove telemedicine abortion’s safety.
“I think that we need continued research on this model of care just so we have more multiple studies that contribute to the evidence that can convince providers as well that they don’t need a lot of tests and that they can mail,” Dr. Upadhyay said.
Neither Dr. Upadhyay nor Dr. Burkhardt reported conflicts of interests.
Telehealth abortion may be just as safe and effective as in-person care, according to a small study published online in JAMA Network Open.
Of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.
“There was no reason to expect that the medications prescribed [via telemedicine] and delivered through the mail would have different outcomes from when a patient traveled to a clinic,” study author Ushma D. Upadhyay, PhD, MPH, associate professor in the department of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, said in an interview.
Medication abortion, which usually involves taking mifepristone (Mifeprex) followed by misoprostol (Cytotec) during the first 10 weeks of pregnancy, has been available in the United States since 2000. The Food and Drug Administration’s Risk Evaluation and Mitigation Strategy requires that mifepristone be dispensed in a medical office, clinic, or hospital, prohibiting dispensing from pharmacies in an effort to reduce potential risk for complications.
In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic. However, Dr. Upadhyay hopes the findings of her current study will make this suspension permanent.
For the study, Dr. Upadhyay and colleagues examined the safety and efficacy of fully remote, medication abortion care. Eligibility for the medication was assessed using an online form that relies on patient history, or patients recalling their last period, to assess pregnancy duration and screen for ectopic pregnancy risks. Nurse practitioners reviewed the form and referred patients with unknown last menstrual period date or ectopic pregnancy risk factors for ultrasonography. A mail-order pharmacy delivered medications to eligible patients. The protocol involved three follow-up contacts: confirmation of medication administration, a 3-day assessment of symptoms, and a home pregnancy test after 4 weeks. Follow-up interactions were conducted by text, secure messaging, or telephone.
Researchers found that in addition to the 95% of the patients having a complete abortion without intervention, 5% (five) of patients required addition medical care to complete the abortion. Two of those patients were treated in EDs.
Gillian Burkhardt, MD, who was not involved in the study, said Dr. Upadhyay’s study proves what has been known all along, that medication is super safe and that women “can help to determine their own eligibility as well as in conjunction with the provider.”
“I hope that this will be one more study that the FDA can use when thinking about changing the risk evaluation administration strategy so that it’s removing the requirement that a person be in the dispensing medical office,” Dr. Burkhardt, assistant professor of family planning in the department of obstetrics & gynecology at the University of New Mexico Hospital, Albuquerque, said in an interview. “I hope it also makes providers feel more comfortable as well, because I think there’s some hesitancy among providers to provide abortion without doing an ultrasound or without seeing the patient typically in front of them.”
This isn’t the first study to suggest the safety of telemedicine abortion. A 2019 study published in Obstetrics & Gynecology, which analyzed records from nearly 6,000 patients receiving medication abortion either through telemedicine or in person at 26 Planned Parenthood health centers in four states found that ongoing pregnancy and aspiration procedures were less common among telemedicine patients. Another 2017 study published in BMJ found that women who used an online consultation service and self-sourced medical abortion during a 3-year period were able to successfully end their pregnancies with few adverse events.
Dr. Upadhyay said one limitation of the current study is its sample size, so more studies should be conducted to prove telemedicine abortion’s safety.
“I think that we need continued research on this model of care just so we have more multiple studies that contribute to the evidence that can convince providers as well that they don’t need a lot of tests and that they can mail,” Dr. Upadhyay said.
Neither Dr. Upadhyay nor Dr. Burkhardt reported conflicts of interests.
Telehealth abortion may be just as safe and effective as in-person care, according to a small study published online in JAMA Network Open.
Of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.
“There was no reason to expect that the medications prescribed [via telemedicine] and delivered through the mail would have different outcomes from when a patient traveled to a clinic,” study author Ushma D. Upadhyay, PhD, MPH, associate professor in the department of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, said in an interview.
Medication abortion, which usually involves taking mifepristone (Mifeprex) followed by misoprostol (Cytotec) during the first 10 weeks of pregnancy, has been available in the United States since 2000. The Food and Drug Administration’s Risk Evaluation and Mitigation Strategy requires that mifepristone be dispensed in a medical office, clinic, or hospital, prohibiting dispensing from pharmacies in an effort to reduce potential risk for complications.
In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic. However, Dr. Upadhyay hopes the findings of her current study will make this suspension permanent.
For the study, Dr. Upadhyay and colleagues examined the safety and efficacy of fully remote, medication abortion care. Eligibility for the medication was assessed using an online form that relies on patient history, or patients recalling their last period, to assess pregnancy duration and screen for ectopic pregnancy risks. Nurse practitioners reviewed the form and referred patients with unknown last menstrual period date or ectopic pregnancy risk factors for ultrasonography. A mail-order pharmacy delivered medications to eligible patients. The protocol involved three follow-up contacts: confirmation of medication administration, a 3-day assessment of symptoms, and a home pregnancy test after 4 weeks. Follow-up interactions were conducted by text, secure messaging, or telephone.
Researchers found that in addition to the 95% of the patients having a complete abortion without intervention, 5% (five) of patients required addition medical care to complete the abortion. Two of those patients were treated in EDs.
Gillian Burkhardt, MD, who was not involved in the study, said Dr. Upadhyay’s study proves what has been known all along, that medication is super safe and that women “can help to determine their own eligibility as well as in conjunction with the provider.”
“I hope that this will be one more study that the FDA can use when thinking about changing the risk evaluation administration strategy so that it’s removing the requirement that a person be in the dispensing medical office,” Dr. Burkhardt, assistant professor of family planning in the department of obstetrics & gynecology at the University of New Mexico Hospital, Albuquerque, said in an interview. “I hope it also makes providers feel more comfortable as well, because I think there’s some hesitancy among providers to provide abortion without doing an ultrasound or without seeing the patient typically in front of them.”
This isn’t the first study to suggest the safety of telemedicine abortion. A 2019 study published in Obstetrics & Gynecology, which analyzed records from nearly 6,000 patients receiving medication abortion either through telemedicine or in person at 26 Planned Parenthood health centers in four states found that ongoing pregnancy and aspiration procedures were less common among telemedicine patients. Another 2017 study published in BMJ found that women who used an online consultation service and self-sourced medical abortion during a 3-year period were able to successfully end their pregnancies with few adverse events.
Dr. Upadhyay said one limitation of the current study is its sample size, so more studies should be conducted to prove telemedicine abortion’s safety.
“I think that we need continued research on this model of care just so we have more multiple studies that contribute to the evidence that can convince providers as well that they don’t need a lot of tests and that they can mail,” Dr. Upadhyay said.
Neither Dr. Upadhyay nor Dr. Burkhardt reported conflicts of interests.
FROM JAMA NETWORK OPEN
Recommendations from a gynecologic oncologist to a general ob.gyn., part 2
In this month’s column we continue to discuss recommendations from the gynecologic oncologist to the general gynecologist.
Don’t screen average-risk women for ovarian cancer.
Ovarian cancer is most often diagnosed at an advanced stage, which limits the curability of the disease. Consequently, there is a strong focus on attempting to diagnose the disease at earlier, more curable stages. This leads to the impulse by some well-intentioned providers to implement screening tests, such as ultrasounds and tumor markers, for all women. Unfortunately, the screening of “average risk” women for ovarian cancer is not recommended. Randomized controlled trials of tens of thousands of women have not observed a clinically significant decrease in ovarian cancer mortality with the addition of screening with tumor markers and ultrasound.1 These studies did observe a false-positive rate of 5%. While that may seem like a low rate of false-positive testing, the definitive diagnostic test which follows is a major abdominal surgery (oophorectomy) and serious complications are encountered in 15% of patients undergoing surgery for false-positive ovarian cancer screening.1 Therefore, quite simply, the harms are not balanced by benefits.
The key to offering patients appropriate and effective screening is case selection. It is important to identify which patients are at higher risk for ovarian cancer and offer those women testing for germline mutations and screening strategies. An important component of a well-woman visit is to take a thorough family history of cancer. Women are considered at high risk for having hereditary predisposition to ovarian cancer if they have a first- or second-degree relative with breast cancer younger than 45-50 years, or any age if Ashkenazi Jewish, triple-negative breast cancer younger than 60 years of age, two or more primary breast cancers with the first diagnosed at less than 50 years of age, male breast cancer, ovarian cancer, pancreatic cancer, a known BRCA 1/2 mutation, or a personal history of those same conditions. These women should be recommended to undergo genetic testing for BRCA 1, 2, and Lynch syndrome. They should not automatically be offered ovarian cancer screening. If a patient has a more remote family history for ovarian cancer, their personal risk may be somewhat elevated above the baseline population risk, however, not substantially enough to justify implementing screening in the absence of a confirmed genetic mutation.
While screening tests may not be appropriate for all patients, all patients should be asked about the early symptoms of ovarian cancer because these are consistently present, and frequently overlooked, prior to the eventual diagnosis of advanced disease. Those symptoms include abdominal discomfort, abdominal swelling and bloating, and urinary urgency.2 Consider offering all patients a dedicated ovarian cancer specific review of systems that includes inquiries about these symptoms at their annual wellness visits.
Opt for vertical midline incisions when surgery is anticipated to be complex
What is the first thing gynecologic oncologists do when called in to assist in a difficult gynecologic procedure? Get better exposure. Exposure is the cornerstone of safe, effective surgery. Sometimes this simply means placing a more effective retractor. In other cases, it might mean extending the incision. However, if the incision is a low transverse incision (the go-to for many gynecologists because of its favorable cosmetic and pain-producing profile) this proves to be difficult. Attempting to assist in a complicated case, such as a frozen pelvis, severed ureter or rectal injury, through a pfannensteil incision can be extraordinarily difficult, and while these incisions can be extended by incising the rectus muscle bellies, upper abdominal visualization remains elusive in most patients. This is particularly problematic if the ureter or splenic flexure need to be mobilized, or if extensive lysis of adhesions is necessary to ensure there is no occult enterotomy. As my mentor Dr. John Soper once described to me: “It’s like trying to scratch your armpit by reaching through your fly.”
While pfannensteil incisions come naturally, and comfortably, to most gynecologists, likely because of their frequent application during cesarean section, all gynecologists should be confident in the steps and anatomy for vertical midline, or paramedian incisions. This is not only beneficial for complex gynecologic cases, but also in the event of vascular emergency. In the hands of an experienced abdominal/pelvic surgeon, the vertical midline incision is the quickest way to safely enter the abdomen, and provides the kind of exposure that may be critical in safely repairing or controlling hemorrhage from a major vessel.
While low transverse incisions may be more cosmetic, less painful, and associated with fewer wound complications, our first concern as surgeons should be mitigating complications. In situations where risks of complications are high, it is best to not handicap ourselves with the incision location. And always remember, wound complications are highest when a transverse incision needs to be converted to a vertical one with a “T.”
It’s not just about diagnosis of cancer, it’s also prevention
Detection of cancer is an important role of the obstetrician gynecologist. However, equally important is being able to seize opportunities for cancer prevention. Cervical, vulvar, endometrial and ovarian cancer are all known to have preventative strategies.
All patients up to the age of 45 should be offered vaccination against HPV. Initial indications for HPV vaccination were for women up to age 26; however, recent data support the safety and efficacy of the vaccine in older women.3 HPV vaccination is most effective at preventing cancer when administered prior to exposure (ideally age 9-11), leaving this in the hands of our pediatrician colleagues. However, we must be vigilant to inquire about vaccination status for all our patients and encourage vaccines for those who were missed earlier in their life.
Patients should be counseled regarding the significant risk reduction for cancer that is gained from use of oral hormonal contraceptives and progestin-releasing IUDs (especially for endometrial and ovarian cancers). Providing them with knowledge of this information when considering options for contraception or menstrual cycle management is important in their decision-making process.
Endometrial cancer incidence is sadly on the rise in the United States, likely secondary to increasing rates of obesity. Pregnancy is a time when many women begin to gain, and accumulate, weight and therefore obstetric providers have a unique opportunity to assist patients in strategies to normalize their weight after pregnancy. Many of my patients with endometrial cancer state that they have never heard that it is associated with obesity. This suggests that more can be done to educate patients on the carcinogenic effect of obesity (for both endometrial and breast cancer), which may aid in motivating change of modifiable behaviors.
The fallopian tubes are the source of many ovarian cancers and knowledge of this has led to the recommendation to perform opportunistic salpingectomy as a cancer risk-reducing strategy. Hysterectomy and sterilization procedures are most apropos for this modification. While prospective data to confirm a reduced risk of ovarian cancer with opportunistic salpingectomy are lacking, a reduced incidence of cancer has been observed when the tubes have been removed for indicated surgeries; there appear to be no significant deleterious sequelae.4,5 A focus should be made on removal of the entire distal third of the tube, particularly the fimbriated ends, as this is the portion most implicated in malignancy.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant disclosures. Contact her at obnews@mdedge.com.
References
1. Buys SS et al. JAMA. 2011;305(22):2295.
2. Goff BA et al. JAMA. 2004;291(22):2705.
3. Castellsagué X et al. Br J Cancer. 2011;105(1):28.
4. Yoon SH et al. Eur J Cancer. 2016 Mar;55:38-46.
5. Hanley GE et al. Am J Obstet Gynecol. 2018;219(2):172.
In this month’s column we continue to discuss recommendations from the gynecologic oncologist to the general gynecologist.
Don’t screen average-risk women for ovarian cancer.
Ovarian cancer is most often diagnosed at an advanced stage, which limits the curability of the disease. Consequently, there is a strong focus on attempting to diagnose the disease at earlier, more curable stages. This leads to the impulse by some well-intentioned providers to implement screening tests, such as ultrasounds and tumor markers, for all women. Unfortunately, the screening of “average risk” women for ovarian cancer is not recommended. Randomized controlled trials of tens of thousands of women have not observed a clinically significant decrease in ovarian cancer mortality with the addition of screening with tumor markers and ultrasound.1 These studies did observe a false-positive rate of 5%. While that may seem like a low rate of false-positive testing, the definitive diagnostic test which follows is a major abdominal surgery (oophorectomy) and serious complications are encountered in 15% of patients undergoing surgery for false-positive ovarian cancer screening.1 Therefore, quite simply, the harms are not balanced by benefits.
The key to offering patients appropriate and effective screening is case selection. It is important to identify which patients are at higher risk for ovarian cancer and offer those women testing for germline mutations and screening strategies. An important component of a well-woman visit is to take a thorough family history of cancer. Women are considered at high risk for having hereditary predisposition to ovarian cancer if they have a first- or second-degree relative with breast cancer younger than 45-50 years, or any age if Ashkenazi Jewish, triple-negative breast cancer younger than 60 years of age, two or more primary breast cancers with the first diagnosed at less than 50 years of age, male breast cancer, ovarian cancer, pancreatic cancer, a known BRCA 1/2 mutation, or a personal history of those same conditions. These women should be recommended to undergo genetic testing for BRCA 1, 2, and Lynch syndrome. They should not automatically be offered ovarian cancer screening. If a patient has a more remote family history for ovarian cancer, their personal risk may be somewhat elevated above the baseline population risk, however, not substantially enough to justify implementing screening in the absence of a confirmed genetic mutation.
While screening tests may not be appropriate for all patients, all patients should be asked about the early symptoms of ovarian cancer because these are consistently present, and frequently overlooked, prior to the eventual diagnosis of advanced disease. Those symptoms include abdominal discomfort, abdominal swelling and bloating, and urinary urgency.2 Consider offering all patients a dedicated ovarian cancer specific review of systems that includes inquiries about these symptoms at their annual wellness visits.
Opt for vertical midline incisions when surgery is anticipated to be complex
What is the first thing gynecologic oncologists do when called in to assist in a difficult gynecologic procedure? Get better exposure. Exposure is the cornerstone of safe, effective surgery. Sometimes this simply means placing a more effective retractor. In other cases, it might mean extending the incision. However, if the incision is a low transverse incision (the go-to for many gynecologists because of its favorable cosmetic and pain-producing profile) this proves to be difficult. Attempting to assist in a complicated case, such as a frozen pelvis, severed ureter or rectal injury, through a pfannensteil incision can be extraordinarily difficult, and while these incisions can be extended by incising the rectus muscle bellies, upper abdominal visualization remains elusive in most patients. This is particularly problematic if the ureter or splenic flexure need to be mobilized, or if extensive lysis of adhesions is necessary to ensure there is no occult enterotomy. As my mentor Dr. John Soper once described to me: “It’s like trying to scratch your armpit by reaching through your fly.”
While pfannensteil incisions come naturally, and comfortably, to most gynecologists, likely because of their frequent application during cesarean section, all gynecologists should be confident in the steps and anatomy for vertical midline, or paramedian incisions. This is not only beneficial for complex gynecologic cases, but also in the event of vascular emergency. In the hands of an experienced abdominal/pelvic surgeon, the vertical midline incision is the quickest way to safely enter the abdomen, and provides the kind of exposure that may be critical in safely repairing or controlling hemorrhage from a major vessel.
While low transverse incisions may be more cosmetic, less painful, and associated with fewer wound complications, our first concern as surgeons should be mitigating complications. In situations where risks of complications are high, it is best to not handicap ourselves with the incision location. And always remember, wound complications are highest when a transverse incision needs to be converted to a vertical one with a “T.”
It’s not just about diagnosis of cancer, it’s also prevention
Detection of cancer is an important role of the obstetrician gynecologist. However, equally important is being able to seize opportunities for cancer prevention. Cervical, vulvar, endometrial and ovarian cancer are all known to have preventative strategies.
All patients up to the age of 45 should be offered vaccination against HPV. Initial indications for HPV vaccination were for women up to age 26; however, recent data support the safety and efficacy of the vaccine in older women.3 HPV vaccination is most effective at preventing cancer when administered prior to exposure (ideally age 9-11), leaving this in the hands of our pediatrician colleagues. However, we must be vigilant to inquire about vaccination status for all our patients and encourage vaccines for those who were missed earlier in their life.
Patients should be counseled regarding the significant risk reduction for cancer that is gained from use of oral hormonal contraceptives and progestin-releasing IUDs (especially for endometrial and ovarian cancers). Providing them with knowledge of this information when considering options for contraception or menstrual cycle management is important in their decision-making process.
Endometrial cancer incidence is sadly on the rise in the United States, likely secondary to increasing rates of obesity. Pregnancy is a time when many women begin to gain, and accumulate, weight and therefore obstetric providers have a unique opportunity to assist patients in strategies to normalize their weight after pregnancy. Many of my patients with endometrial cancer state that they have never heard that it is associated with obesity. This suggests that more can be done to educate patients on the carcinogenic effect of obesity (for both endometrial and breast cancer), which may aid in motivating change of modifiable behaviors.
The fallopian tubes are the source of many ovarian cancers and knowledge of this has led to the recommendation to perform opportunistic salpingectomy as a cancer risk-reducing strategy. Hysterectomy and sterilization procedures are most apropos for this modification. While prospective data to confirm a reduced risk of ovarian cancer with opportunistic salpingectomy are lacking, a reduced incidence of cancer has been observed when the tubes have been removed for indicated surgeries; there appear to be no significant deleterious sequelae.4,5 A focus should be made on removal of the entire distal third of the tube, particularly the fimbriated ends, as this is the portion most implicated in malignancy.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant disclosures. Contact her at obnews@mdedge.com.
References
1. Buys SS et al. JAMA. 2011;305(22):2295.
2. Goff BA et al. JAMA. 2004;291(22):2705.
3. Castellsagué X et al. Br J Cancer. 2011;105(1):28.
4. Yoon SH et al. Eur J Cancer. 2016 Mar;55:38-46.
5. Hanley GE et al. Am J Obstet Gynecol. 2018;219(2):172.
In this month’s column we continue to discuss recommendations from the gynecologic oncologist to the general gynecologist.
Don’t screen average-risk women for ovarian cancer.
Ovarian cancer is most often diagnosed at an advanced stage, which limits the curability of the disease. Consequently, there is a strong focus on attempting to diagnose the disease at earlier, more curable stages. This leads to the impulse by some well-intentioned providers to implement screening tests, such as ultrasounds and tumor markers, for all women. Unfortunately, the screening of “average risk” women for ovarian cancer is not recommended. Randomized controlled trials of tens of thousands of women have not observed a clinically significant decrease in ovarian cancer mortality with the addition of screening with tumor markers and ultrasound.1 These studies did observe a false-positive rate of 5%. While that may seem like a low rate of false-positive testing, the definitive diagnostic test which follows is a major abdominal surgery (oophorectomy) and serious complications are encountered in 15% of patients undergoing surgery for false-positive ovarian cancer screening.1 Therefore, quite simply, the harms are not balanced by benefits.
The key to offering patients appropriate and effective screening is case selection. It is important to identify which patients are at higher risk for ovarian cancer and offer those women testing for germline mutations and screening strategies. An important component of a well-woman visit is to take a thorough family history of cancer. Women are considered at high risk for having hereditary predisposition to ovarian cancer if they have a first- or second-degree relative with breast cancer younger than 45-50 years, or any age if Ashkenazi Jewish, triple-negative breast cancer younger than 60 years of age, two or more primary breast cancers with the first diagnosed at less than 50 years of age, male breast cancer, ovarian cancer, pancreatic cancer, a known BRCA 1/2 mutation, or a personal history of those same conditions. These women should be recommended to undergo genetic testing for BRCA 1, 2, and Lynch syndrome. They should not automatically be offered ovarian cancer screening. If a patient has a more remote family history for ovarian cancer, their personal risk may be somewhat elevated above the baseline population risk, however, not substantially enough to justify implementing screening in the absence of a confirmed genetic mutation.
While screening tests may not be appropriate for all patients, all patients should be asked about the early symptoms of ovarian cancer because these are consistently present, and frequently overlooked, prior to the eventual diagnosis of advanced disease. Those symptoms include abdominal discomfort, abdominal swelling and bloating, and urinary urgency.2 Consider offering all patients a dedicated ovarian cancer specific review of systems that includes inquiries about these symptoms at their annual wellness visits.
Opt for vertical midline incisions when surgery is anticipated to be complex
What is the first thing gynecologic oncologists do when called in to assist in a difficult gynecologic procedure? Get better exposure. Exposure is the cornerstone of safe, effective surgery. Sometimes this simply means placing a more effective retractor. In other cases, it might mean extending the incision. However, if the incision is a low transverse incision (the go-to for many gynecologists because of its favorable cosmetic and pain-producing profile) this proves to be difficult. Attempting to assist in a complicated case, such as a frozen pelvis, severed ureter or rectal injury, through a pfannensteil incision can be extraordinarily difficult, and while these incisions can be extended by incising the rectus muscle bellies, upper abdominal visualization remains elusive in most patients. This is particularly problematic if the ureter or splenic flexure need to be mobilized, or if extensive lysis of adhesions is necessary to ensure there is no occult enterotomy. As my mentor Dr. John Soper once described to me: “It’s like trying to scratch your armpit by reaching through your fly.”
While pfannensteil incisions come naturally, and comfortably, to most gynecologists, likely because of their frequent application during cesarean section, all gynecologists should be confident in the steps and anatomy for vertical midline, or paramedian incisions. This is not only beneficial for complex gynecologic cases, but also in the event of vascular emergency. In the hands of an experienced abdominal/pelvic surgeon, the vertical midline incision is the quickest way to safely enter the abdomen, and provides the kind of exposure that may be critical in safely repairing or controlling hemorrhage from a major vessel.
While low transverse incisions may be more cosmetic, less painful, and associated with fewer wound complications, our first concern as surgeons should be mitigating complications. In situations where risks of complications are high, it is best to not handicap ourselves with the incision location. And always remember, wound complications are highest when a transverse incision needs to be converted to a vertical one with a “T.”
It’s not just about diagnosis of cancer, it’s also prevention
Detection of cancer is an important role of the obstetrician gynecologist. However, equally important is being able to seize opportunities for cancer prevention. Cervical, vulvar, endometrial and ovarian cancer are all known to have preventative strategies.
All patients up to the age of 45 should be offered vaccination against HPV. Initial indications for HPV vaccination were for women up to age 26; however, recent data support the safety and efficacy of the vaccine in older women.3 HPV vaccination is most effective at preventing cancer when administered prior to exposure (ideally age 9-11), leaving this in the hands of our pediatrician colleagues. However, we must be vigilant to inquire about vaccination status for all our patients and encourage vaccines for those who were missed earlier in their life.
Patients should be counseled regarding the significant risk reduction for cancer that is gained from use of oral hormonal contraceptives and progestin-releasing IUDs (especially for endometrial and ovarian cancers). Providing them with knowledge of this information when considering options for contraception or menstrual cycle management is important in their decision-making process.
Endometrial cancer incidence is sadly on the rise in the United States, likely secondary to increasing rates of obesity. Pregnancy is a time when many women begin to gain, and accumulate, weight and therefore obstetric providers have a unique opportunity to assist patients in strategies to normalize their weight after pregnancy. Many of my patients with endometrial cancer state that they have never heard that it is associated with obesity. This suggests that more can be done to educate patients on the carcinogenic effect of obesity (for both endometrial and breast cancer), which may aid in motivating change of modifiable behaviors.
The fallopian tubes are the source of many ovarian cancers and knowledge of this has led to the recommendation to perform opportunistic salpingectomy as a cancer risk-reducing strategy. Hysterectomy and sterilization procedures are most apropos for this modification. While prospective data to confirm a reduced risk of ovarian cancer with opportunistic salpingectomy are lacking, a reduced incidence of cancer has been observed when the tubes have been removed for indicated surgeries; there appear to be no significant deleterious sequelae.4,5 A focus should be made on removal of the entire distal third of the tube, particularly the fimbriated ends, as this is the portion most implicated in malignancy.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant disclosures. Contact her at obnews@mdedge.com.
References
1. Buys SS et al. JAMA. 2011;305(22):2295.
2. Goff BA et al. JAMA. 2004;291(22):2705.
3. Castellsagué X et al. Br J Cancer. 2011;105(1):28.
4. Yoon SH et al. Eur J Cancer. 2016 Mar;55:38-46.
5. Hanley GE et al. Am J Obstet Gynecol. 2018;219(2):172.
Not so fast food
As long as I can remember, children have been notoriously wasteful when dining in school cafeterias. Even those children who bring their own food often return home in the afternoon with their lunches half eaten. Not surprisingly, the food tossed out is often the healthier portion of the meal. Schools have tried a variety of strategies to curb this wastage, including using volunteer student monitors to police and encourage ecologically based recycling.
The authors of a recent study published on JAMA Network Open observed that when elementary and middle-school students were allowed a 20-minute seated lunch period they consumed more food and there was significantly less waste of fruits and vegetable compared with when the students’ lunch period was limited to 10 minutes. Interestingly, there was no difference in the beverage and entrée consumption when the lunch period was doubled.
The authors postulate that younger children may not have acquired the dexterity to feed themselves optimally in the shorter lunch period. I’m not sure I buy that argument. It may be simply that the children ate and drank their favorites first and needed a bit more time to allow their little guts to move things along. But, regardless of the explanation, the investigators’ observations deserve further study.
When I was in high school our lunch period was a full hour, which allowed me to make the half mile walk to home and back to eat a home-prepared meal. The noon hour was when school clubs and committees met and there was a full schedule of diversions to fill out the hour. I don’t recall the seated portion of the lunch period having any time restriction.
By the time my own children were in middle school, lunch periods lasted no longer than 20 minutes. I was not surprised to learn from this recent study that in some schools the seated lunch period has been shortened to 10 minutes. In some cases the truncated lunch periods are a response to space and time limitations. I fear that occasionally, educators and administrators have found it so difficult to keep young children who are accustomed to watching television while they eat engaged that the periods have been shortened to minimize the chaos.
Here in Maine, the governor has just announced plans to offer free breakfast and lunch to every student in response to a federal initiative. If we intend to make nutrition a cornerstone of the educational process this study from the University of Illinois at Urbana-Champaign suggests that we must do more than simply provide the food at no cost. We must somehow carve out more time in the day for the children to eat a healthy diet.
But, where is this time going to come from? Many school systems have already cannibalized physical education to the point that most children are not getting a healthy amount of exercise. It is unfortunate that we have come to expect public school systems to solve all of our societal ills and compensate for less-than-healthy home environments. But that is the reality. If we think nutrition and physical activity are important components of our children’s educations then we must make the time necessary to provide them.
Will this mean longer school days? And will those longer days cost money? You bet they will, but that may be the price we have to pay for healthier, better educated children.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
As long as I can remember, children have been notoriously wasteful when dining in school cafeterias. Even those children who bring their own food often return home in the afternoon with their lunches half eaten. Not surprisingly, the food tossed out is often the healthier portion of the meal. Schools have tried a variety of strategies to curb this wastage, including using volunteer student monitors to police and encourage ecologically based recycling.
The authors of a recent study published on JAMA Network Open observed that when elementary and middle-school students were allowed a 20-minute seated lunch period they consumed more food and there was significantly less waste of fruits and vegetable compared with when the students’ lunch period was limited to 10 minutes. Interestingly, there was no difference in the beverage and entrée consumption when the lunch period was doubled.
The authors postulate that younger children may not have acquired the dexterity to feed themselves optimally in the shorter lunch period. I’m not sure I buy that argument. It may be simply that the children ate and drank their favorites first and needed a bit more time to allow their little guts to move things along. But, regardless of the explanation, the investigators’ observations deserve further study.
When I was in high school our lunch period was a full hour, which allowed me to make the half mile walk to home and back to eat a home-prepared meal. The noon hour was when school clubs and committees met and there was a full schedule of diversions to fill out the hour. I don’t recall the seated portion of the lunch period having any time restriction.
By the time my own children were in middle school, lunch periods lasted no longer than 20 minutes. I was not surprised to learn from this recent study that in some schools the seated lunch period has been shortened to 10 minutes. In some cases the truncated lunch periods are a response to space and time limitations. I fear that occasionally, educators and administrators have found it so difficult to keep young children who are accustomed to watching television while they eat engaged that the periods have been shortened to minimize the chaos.
Here in Maine, the governor has just announced plans to offer free breakfast and lunch to every student in response to a federal initiative. If we intend to make nutrition a cornerstone of the educational process this study from the University of Illinois at Urbana-Champaign suggests that we must do more than simply provide the food at no cost. We must somehow carve out more time in the day for the children to eat a healthy diet.
But, where is this time going to come from? Many school systems have already cannibalized physical education to the point that most children are not getting a healthy amount of exercise. It is unfortunate that we have come to expect public school systems to solve all of our societal ills and compensate for less-than-healthy home environments. But that is the reality. If we think nutrition and physical activity are important components of our children’s educations then we must make the time necessary to provide them.
Will this mean longer school days? And will those longer days cost money? You bet they will, but that may be the price we have to pay for healthier, better educated children.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
As long as I can remember, children have been notoriously wasteful when dining in school cafeterias. Even those children who bring their own food often return home in the afternoon with their lunches half eaten. Not surprisingly, the food tossed out is often the healthier portion of the meal. Schools have tried a variety of strategies to curb this wastage, including using volunteer student monitors to police and encourage ecologically based recycling.
The authors of a recent study published on JAMA Network Open observed that when elementary and middle-school students were allowed a 20-minute seated lunch period they consumed more food and there was significantly less waste of fruits and vegetable compared with when the students’ lunch period was limited to 10 minutes. Interestingly, there was no difference in the beverage and entrée consumption when the lunch period was doubled.
The authors postulate that younger children may not have acquired the dexterity to feed themselves optimally in the shorter lunch period. I’m not sure I buy that argument. It may be simply that the children ate and drank their favorites first and needed a bit more time to allow their little guts to move things along. But, regardless of the explanation, the investigators’ observations deserve further study.
When I was in high school our lunch period was a full hour, which allowed me to make the half mile walk to home and back to eat a home-prepared meal. The noon hour was when school clubs and committees met and there was a full schedule of diversions to fill out the hour. I don’t recall the seated portion of the lunch period having any time restriction.
By the time my own children were in middle school, lunch periods lasted no longer than 20 minutes. I was not surprised to learn from this recent study that in some schools the seated lunch period has been shortened to 10 minutes. In some cases the truncated lunch periods are a response to space and time limitations. I fear that occasionally, educators and administrators have found it so difficult to keep young children who are accustomed to watching television while they eat engaged that the periods have been shortened to minimize the chaos.
Here in Maine, the governor has just announced plans to offer free breakfast and lunch to every student in response to a federal initiative. If we intend to make nutrition a cornerstone of the educational process this study from the University of Illinois at Urbana-Champaign suggests that we must do more than simply provide the food at no cost. We must somehow carve out more time in the day for the children to eat a healthy diet.
But, where is this time going to come from? Many school systems have already cannibalized physical education to the point that most children are not getting a healthy amount of exercise. It is unfortunate that we have come to expect public school systems to solve all of our societal ills and compensate for less-than-healthy home environments. But that is the reality. If we think nutrition and physical activity are important components of our children’s educations then we must make the time necessary to provide them.
Will this mean longer school days? And will those longer days cost money? You bet they will, but that may be the price we have to pay for healthier, better educated children.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
PAs can do more under new laws, coast to coast
Another frustrated patient awaits transfer from the hospital to a nursing home. The do-not-resuscitate form must be signed by a physician. I – a physician assistant (PA) – am available, but the physician is with a medically unstable patient. Another patient in the ED waits for this hospital bed, lying uncomfortably on a stretcher in the hallway.
As a Florida PA who has practiced in other states with far fewer barriers to medical care, I applaud the advancement of HB 431. PAs can now sign certain documents, ensuring accelerated access to therapeutic interventions and honoring end-of-life wishes with timely do-not-resuscitate orders. Children now have improved access to psychiatric medications without a lengthy wait for an appointment with a psychiatrist, given the demand for mental health services and limited physician availability.
HB 431 expands medical care to patients in a state experiencing exponential growth in patient health care demands. HB 431 removes the following barriers to patient care as summarized by the Florida Academy of Physician Assistants. HB 431:
- Changes the physician:PA ratio from 1:4 to 1:10
- Allows PAs to authenticate documents such as death certificates and involuntary examinations; to order durable medical equipment, home health services, physical therapy, occupational therapy, and speech-language therapy
- Allows do-not-resuscitate orders, workers’ compensation claims, and school physical examinations with the exception of medical marijuana documents and maximum medical improvement/impairment rating documents for workman’s compensation
- Allows a fully licensed PA to procure medical devices and drugs
- Codifies that a PA can supervise a medical assistant
- Allows PAs to receive direct payment for services rendered
- Removes the long-standing restriction of PAs to prescribe any controlled psychiatric medication to patients aged under 18 years, and now allows PAs working with a pediatrician, family practice physician, internal medicine physician, or psychiatrist to prescribe a 14-day supply of schedule II psychiatric medications for those aged under 18 years
- Removes the requirement that a PA must inform a patient that they have the right to see the physician before a prescription is prescribed or dispensed
- Removes outdated language regarding prescriber number
- Improves the supervision data form submission process
Oregon HB 3036, also passed this year, significantly expands medical care provided by PAs. The Oregon legislation allows collaborative agreements with physicians at the practice level and removes the submission requirement for board approval. In contrast to Florida, Oregon completely eliminated PA ratios, improved PA prescriptive and dispensing regulations, and developed an environment that fosters team-based collaboration with accelerated patient access to quality care.
Many other states reduced these supervisory barriers during the pandemic.
PAs are trained to be flexible and meet the needs of the patient through a medical rather than nursing model. By allowing PAs to determine how best to collaborate with their clinical teams, patients are provided more efficient, patient-centered health care. Team members rely on each other for operational and clinical support through a degree of autonomy that contributes to effective patient management. These skills are expanded with the modernization of PA clinical practice and the removal of legislative barriers. A benefit to physicians through collaborative practice agreements is the reduction of their own liability for the care that PAs provide. Unlike Oregon, the state of Florida has not approved collaborative practice agreements and has retained physician supervisory barriers.
There are misconceptions in the medical community regarding the PA profession’s legislative goals. These efforts are not aimed at replacing physicians and competing for employment. The goal is to expand access and reduce barriers to patient care. There are not enough providers available to support comprehensive patient care. This is a fact.
Gaps in medical care exist and have existed since the PA profession was developed in the 1970s. Our vision has been to expand medical care through collaboration with physicians and assist with recruitment and retention challenges in various medical disciplines, particularly primary care. This is why all PA programs are based on a primary care medical model to care for patients across the lifespan, from infant care to geriatrics.
The spirit of collaboration in a team-based environment is challenged by these misconceptions and compounded by supervisory legislative and outdated practice requirements. PAs not only collaborate but also consult with and refer patients to other health care providers whenever the patient›s condition falls outside the PA’s education, training, and experience.
The changes in Florida’s HB 431 do not remove the requirement to clearly identify our roles. PAs still continue to identify themselves as physician assistants, and should a patient refuse to see a PA, they have the right to see any other provider they choose. Finally, patients are safe in the hands of a PA, as supported by numerous patient studies comparing PA clinical skills with other providers, including nurse practitioners, medical students, residents, fellows, and physicians.
Nonetheless, Florida is still behind other states in providing patients access to collaborative, team-based medical care with skilled PAs practicing as trained. Removing the remaining legislative barriers, hospital credentialing barriers, and health care perspectives will successfully provide patients superior medical care and improve the health outcomes of Florida residents.
Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucie, Fla., a member of the Hospitalist’s editorial advisory board, and also serves as a physician assistant program director at South University in West Palm Beach, Fla.
A version of this article first appeared on Medscape.com.
Another frustrated patient awaits transfer from the hospital to a nursing home. The do-not-resuscitate form must be signed by a physician. I – a physician assistant (PA) – am available, but the physician is with a medically unstable patient. Another patient in the ED waits for this hospital bed, lying uncomfortably on a stretcher in the hallway.
As a Florida PA who has practiced in other states with far fewer barriers to medical care, I applaud the advancement of HB 431. PAs can now sign certain documents, ensuring accelerated access to therapeutic interventions and honoring end-of-life wishes with timely do-not-resuscitate orders. Children now have improved access to psychiatric medications without a lengthy wait for an appointment with a psychiatrist, given the demand for mental health services and limited physician availability.
HB 431 expands medical care to patients in a state experiencing exponential growth in patient health care demands. HB 431 removes the following barriers to patient care as summarized by the Florida Academy of Physician Assistants. HB 431:
- Changes the physician:PA ratio from 1:4 to 1:10
- Allows PAs to authenticate documents such as death certificates and involuntary examinations; to order durable medical equipment, home health services, physical therapy, occupational therapy, and speech-language therapy
- Allows do-not-resuscitate orders, workers’ compensation claims, and school physical examinations with the exception of medical marijuana documents and maximum medical improvement/impairment rating documents for workman’s compensation
- Allows a fully licensed PA to procure medical devices and drugs
- Codifies that a PA can supervise a medical assistant
- Allows PAs to receive direct payment for services rendered
- Removes the long-standing restriction of PAs to prescribe any controlled psychiatric medication to patients aged under 18 years, and now allows PAs working with a pediatrician, family practice physician, internal medicine physician, or psychiatrist to prescribe a 14-day supply of schedule II psychiatric medications for those aged under 18 years
- Removes the requirement that a PA must inform a patient that they have the right to see the physician before a prescription is prescribed or dispensed
- Removes outdated language regarding prescriber number
- Improves the supervision data form submission process
Oregon HB 3036, also passed this year, significantly expands medical care provided by PAs. The Oregon legislation allows collaborative agreements with physicians at the practice level and removes the submission requirement for board approval. In contrast to Florida, Oregon completely eliminated PA ratios, improved PA prescriptive and dispensing regulations, and developed an environment that fosters team-based collaboration with accelerated patient access to quality care.
Many other states reduced these supervisory barriers during the pandemic.
PAs are trained to be flexible and meet the needs of the patient through a medical rather than nursing model. By allowing PAs to determine how best to collaborate with their clinical teams, patients are provided more efficient, patient-centered health care. Team members rely on each other for operational and clinical support through a degree of autonomy that contributes to effective patient management. These skills are expanded with the modernization of PA clinical practice and the removal of legislative barriers. A benefit to physicians through collaborative practice agreements is the reduction of their own liability for the care that PAs provide. Unlike Oregon, the state of Florida has not approved collaborative practice agreements and has retained physician supervisory barriers.
There are misconceptions in the medical community regarding the PA profession’s legislative goals. These efforts are not aimed at replacing physicians and competing for employment. The goal is to expand access and reduce barriers to patient care. There are not enough providers available to support comprehensive patient care. This is a fact.
Gaps in medical care exist and have existed since the PA profession was developed in the 1970s. Our vision has been to expand medical care through collaboration with physicians and assist with recruitment and retention challenges in various medical disciplines, particularly primary care. This is why all PA programs are based on a primary care medical model to care for patients across the lifespan, from infant care to geriatrics.
The spirit of collaboration in a team-based environment is challenged by these misconceptions and compounded by supervisory legislative and outdated practice requirements. PAs not only collaborate but also consult with and refer patients to other health care providers whenever the patient›s condition falls outside the PA’s education, training, and experience.
The changes in Florida’s HB 431 do not remove the requirement to clearly identify our roles. PAs still continue to identify themselves as physician assistants, and should a patient refuse to see a PA, they have the right to see any other provider they choose. Finally, patients are safe in the hands of a PA, as supported by numerous patient studies comparing PA clinical skills with other providers, including nurse practitioners, medical students, residents, fellows, and physicians.
Nonetheless, Florida is still behind other states in providing patients access to collaborative, team-based medical care with skilled PAs practicing as trained. Removing the remaining legislative barriers, hospital credentialing barriers, and health care perspectives will successfully provide patients superior medical care and improve the health outcomes of Florida residents.
Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucie, Fla., a member of the Hospitalist’s editorial advisory board, and also serves as a physician assistant program director at South University in West Palm Beach, Fla.
A version of this article first appeared on Medscape.com.
Another frustrated patient awaits transfer from the hospital to a nursing home. The do-not-resuscitate form must be signed by a physician. I – a physician assistant (PA) – am available, but the physician is with a medically unstable patient. Another patient in the ED waits for this hospital bed, lying uncomfortably on a stretcher in the hallway.
As a Florida PA who has practiced in other states with far fewer barriers to medical care, I applaud the advancement of HB 431. PAs can now sign certain documents, ensuring accelerated access to therapeutic interventions and honoring end-of-life wishes with timely do-not-resuscitate orders. Children now have improved access to psychiatric medications without a lengthy wait for an appointment with a psychiatrist, given the demand for mental health services and limited physician availability.
HB 431 expands medical care to patients in a state experiencing exponential growth in patient health care demands. HB 431 removes the following barriers to patient care as summarized by the Florida Academy of Physician Assistants. HB 431:
- Changes the physician:PA ratio from 1:4 to 1:10
- Allows PAs to authenticate documents such as death certificates and involuntary examinations; to order durable medical equipment, home health services, physical therapy, occupational therapy, and speech-language therapy
- Allows do-not-resuscitate orders, workers’ compensation claims, and school physical examinations with the exception of medical marijuana documents and maximum medical improvement/impairment rating documents for workman’s compensation
- Allows a fully licensed PA to procure medical devices and drugs
- Codifies that a PA can supervise a medical assistant
- Allows PAs to receive direct payment for services rendered
- Removes the long-standing restriction of PAs to prescribe any controlled psychiatric medication to patients aged under 18 years, and now allows PAs working with a pediatrician, family practice physician, internal medicine physician, or psychiatrist to prescribe a 14-day supply of schedule II psychiatric medications for those aged under 18 years
- Removes the requirement that a PA must inform a patient that they have the right to see the physician before a prescription is prescribed or dispensed
- Removes outdated language regarding prescriber number
- Improves the supervision data form submission process
Oregon HB 3036, also passed this year, significantly expands medical care provided by PAs. The Oregon legislation allows collaborative agreements with physicians at the practice level and removes the submission requirement for board approval. In contrast to Florida, Oregon completely eliminated PA ratios, improved PA prescriptive and dispensing regulations, and developed an environment that fosters team-based collaboration with accelerated patient access to quality care.
Many other states reduced these supervisory barriers during the pandemic.
PAs are trained to be flexible and meet the needs of the patient through a medical rather than nursing model. By allowing PAs to determine how best to collaborate with their clinical teams, patients are provided more efficient, patient-centered health care. Team members rely on each other for operational and clinical support through a degree of autonomy that contributes to effective patient management. These skills are expanded with the modernization of PA clinical practice and the removal of legislative barriers. A benefit to physicians through collaborative practice agreements is the reduction of their own liability for the care that PAs provide. Unlike Oregon, the state of Florida has not approved collaborative practice agreements and has retained physician supervisory barriers.
There are misconceptions in the medical community regarding the PA profession’s legislative goals. These efforts are not aimed at replacing physicians and competing for employment. The goal is to expand access and reduce barriers to patient care. There are not enough providers available to support comprehensive patient care. This is a fact.
Gaps in medical care exist and have existed since the PA profession was developed in the 1970s. Our vision has been to expand medical care through collaboration with physicians and assist with recruitment and retention challenges in various medical disciplines, particularly primary care. This is why all PA programs are based on a primary care medical model to care for patients across the lifespan, from infant care to geriatrics.
The spirit of collaboration in a team-based environment is challenged by these misconceptions and compounded by supervisory legislative and outdated practice requirements. PAs not only collaborate but also consult with and refer patients to other health care providers whenever the patient›s condition falls outside the PA’s education, training, and experience.
The changes in Florida’s HB 431 do not remove the requirement to clearly identify our roles. PAs still continue to identify themselves as physician assistants, and should a patient refuse to see a PA, they have the right to see any other provider they choose. Finally, patients are safe in the hands of a PA, as supported by numerous patient studies comparing PA clinical skills with other providers, including nurse practitioners, medical students, residents, fellows, and physicians.
Nonetheless, Florida is still behind other states in providing patients access to collaborative, team-based medical care with skilled PAs practicing as trained. Removing the remaining legislative barriers, hospital credentialing barriers, and health care perspectives will successfully provide patients superior medical care and improve the health outcomes of Florida residents.
Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucie, Fla., a member of the Hospitalist’s editorial advisory board, and also serves as a physician assistant program director at South University in West Palm Beach, Fla.
A version of this article first appeared on Medscape.com.
The older we are, the more unique we become
I was rounding at the nursing home and my day began as it often did. I reviewed the doctor communication book at the nursing station to see which patients I needed to visit and checked in with the floor nurse for any important updates.
A mother waiting for her son to visit
The first patient on my list was Rose. She had become increasingly withdrawn and less mobile. She used to walk the corridors asking when her son, Billy, would visit. We would all remind her that Billy visited her two or three times a week, but she never remembered the visits and blamed him for moving her out of her comfortable home in New Jersey where she’d lived with her husband before his death several years earlier.
Rose was declining, and we were trying to optimize her function and quality of life. She fell frequently while trying to get up at night to use the bathroom. None of our fall-reduction strategies had worked, and she had broken her hip a year prior. She’d fully recovered, but the combination of mental and physical frailty was becoming obvious to everyone, including her son. She had lost another five pounds and was approaching the end of her life.
“Good morning, Rose.” (She had demanded that I use her first name.) “How are you doing today?”
“I am doing okay, doctor. Have you seen Billy? When is he going to visit me?”
“I really can’t say when he’ll visit next, but I saw in a note that he was here yesterday.”
“No, he didn’t come to see me,” she said. “He doesn’t care about me. He spends more time with his wife and family than with his own mother.”
“Well, is there anything special that I can do for you?”
“Yes. Please tell Billy to visit his mother,” she said.
I completed her evaluation and made my way down the hall.
A wife ready to rejoin her husband
Next on my list was a widow named Violet. She reminded me of Whistler’s mother. As was her custom, she was sitting up in her chair reading her Bible when I came in. Her husband had been a minister, and she enjoyed reading the Bible or meditating for several hours each morning. Her bedside table had the most recent devotional and a picture of her husband in his vestments.
Violet was quiet and direct, and she had steely blue eyes that could communicate with your soul. Her nun-like quality was not overpowering; her manner was warm and welcoming.
“Good morning!” I said. “I hope I’m not bothering you.”
“Good morning, doctor. It’s always nice to see you.”
“I haven’t been by in a while, and I wanted to check your heart and lungs and make sure everything is going okay for you.”
“Of course; help yourself,” she said. “I feel fine. And as you know, I am ready to join my husband whenever the Lord calls me. I have lived a blessed life and do not wish to prolong it unless it is God’s will.”
“You certainly have made your wishes clear to me, and you are still in excellent health,” I said.
She really was in good health, and I made a quick note to call her daughter – who lived on the other side of the country – with an update.
A beauty queen ready for her close-up
Gabby was next on my list. She was a former beauty queen who had competed in local and state beauty contests. Her looks were the cornerstone of her identity, and she had done a truly remarkable job of maintaining her physical appearance.
Gabby had three attentive daughters who lived locally and supplied her with the latest makeup, beauty creams, and anti-aging nostrums. She always managed to look natural (and not like a caricature) with her face made up and her blond wig in place. Over the years, she’d made good use of the services offered by the local plastic surgeons and dermatologists. And to her credit – and theirs – she looked 30 years younger than her chronological age. In fairness, she had also taken good care of her overall health.
Gabby’s nickname was appropriate as she was chatty, to the extreme. She enjoyed being the center of attention.
When I entered her room, she was putting on her makeup. She was seated near her bedside table, which looked like it belonged in the backstage dressing room of a Broadway star. Lined up on the table were various bottles, brushes, and a mirror surrounded by lights.
“Oh, doctor, you can’t come in now. I’m a dreadful mess,” she said. “Please come back in 10 minutes. I am so embarrassed that you are seeing me this way. I just have a few things to fix, and then I will be presentable. My daughters are taking me out for lunch at the club, and I do not want to look like an old lady.”
“Gabby,” I said, “I have seen you before without your makeup. Do you remember last year when you developed pneumonia? You were really sick, and frankly, we were not sure you were going to pull through. One of the clues that you were getting ill was your smeared mascara and lipstick.”
I pressed on, and she let me examine her while she continued to apply her eyeliner.
“Everything sounds good. And I like your fresh pedicure,” I said. “Is there anything I can do for you?”
“No, thank you. Have a nice day, doctor!”
A mother devoted to her daughter’s care
Unlike my other patients, Mabel shared a room with a family member – her daughter, Hope. Mabel’s daughter had a congenital illness with significant physical, functional, and cognitive deficits. Mabel had considerable guilt regarding her daughter’s condition. Mabel’s husband had divorced her decades earlier, and she had devoted her life to caring for Hope. When Mabel’s health began to decline and she realized she could no longer care for Hope alone, the two moved into the facility together. Mabel told me that she simply couldn’t die before her daughter, because no one could oversee her care like she could.
Mabel was frail physically but sharp and vigilant mentally. Hope had had numerous hospitalizations, and Mabel had been with her through each experience. Hope could not communicate with others, but Mabel could express Hope’s concerns.
“How are you doing today?” I asked.
“Not well. I am concerned about Hope. She has not had a bowel movement in two days and does not want to eat breakfast.”
I checked out Hope, and her examination was reassuring. She looked up at me with her distorted features and managed a broad smile. I went back over to Mabel.
“She likes you, doctor. She thinks you smell good.”
I turned to Hope and thanked her for the compliment.
“I will check with the nurse and see if we can give you something simple to help your bowels.”
“Warm prune juice often works,” said Mabel. “Please come by again tomorrow to check on her. I don’t want this to progress. She is miserable.”
“I will be back tomorrow, and I will make a special trip to see you both.”
Upon reflection ...
When I sat down to write my clinical notes for the day, I realized that Rose, Violet, Gabby, and Mabel were each over 100 years old. I had seen four centenarians in a single day! Each of them manifested a fundamental principle of geriatrics: The older we are, the more unique and differentiated we become. A one-size approach to geriatric care does not fit all. Our care must be personalized to the unique individual in front of us.
Patients’ names and some details have been changed to protect their privacy. Dr. Williams is the Emeritus Ward K. Ensminger Distinguished Professor of Geriatric Medicine, University of Virginia, Charlottesville and attending physician, internal medicine and geriatrics, New Hanover Regional Medical Center, Wilmington, N.C. He disclosed no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
I was rounding at the nursing home and my day began as it often did. I reviewed the doctor communication book at the nursing station to see which patients I needed to visit and checked in with the floor nurse for any important updates.
A mother waiting for her son to visit
The first patient on my list was Rose. She had become increasingly withdrawn and less mobile. She used to walk the corridors asking when her son, Billy, would visit. We would all remind her that Billy visited her two or three times a week, but she never remembered the visits and blamed him for moving her out of her comfortable home in New Jersey where she’d lived with her husband before his death several years earlier.
Rose was declining, and we were trying to optimize her function and quality of life. She fell frequently while trying to get up at night to use the bathroom. None of our fall-reduction strategies had worked, and she had broken her hip a year prior. She’d fully recovered, but the combination of mental and physical frailty was becoming obvious to everyone, including her son. She had lost another five pounds and was approaching the end of her life.
“Good morning, Rose.” (She had demanded that I use her first name.) “How are you doing today?”
“I am doing okay, doctor. Have you seen Billy? When is he going to visit me?”
“I really can’t say when he’ll visit next, but I saw in a note that he was here yesterday.”
“No, he didn’t come to see me,” she said. “He doesn’t care about me. He spends more time with his wife and family than with his own mother.”
“Well, is there anything special that I can do for you?”
“Yes. Please tell Billy to visit his mother,” she said.
I completed her evaluation and made my way down the hall.
A wife ready to rejoin her husband
Next on my list was a widow named Violet. She reminded me of Whistler’s mother. As was her custom, she was sitting up in her chair reading her Bible when I came in. Her husband had been a minister, and she enjoyed reading the Bible or meditating for several hours each morning. Her bedside table had the most recent devotional and a picture of her husband in his vestments.
Violet was quiet and direct, and she had steely blue eyes that could communicate with your soul. Her nun-like quality was not overpowering; her manner was warm and welcoming.
“Good morning!” I said. “I hope I’m not bothering you.”
“Good morning, doctor. It’s always nice to see you.”
“I haven’t been by in a while, and I wanted to check your heart and lungs and make sure everything is going okay for you.”
“Of course; help yourself,” she said. “I feel fine. And as you know, I am ready to join my husband whenever the Lord calls me. I have lived a blessed life and do not wish to prolong it unless it is God’s will.”
“You certainly have made your wishes clear to me, and you are still in excellent health,” I said.
She really was in good health, and I made a quick note to call her daughter – who lived on the other side of the country – with an update.
A beauty queen ready for her close-up
Gabby was next on my list. She was a former beauty queen who had competed in local and state beauty contests. Her looks were the cornerstone of her identity, and she had done a truly remarkable job of maintaining her physical appearance.
Gabby had three attentive daughters who lived locally and supplied her with the latest makeup, beauty creams, and anti-aging nostrums. She always managed to look natural (and not like a caricature) with her face made up and her blond wig in place. Over the years, she’d made good use of the services offered by the local plastic surgeons and dermatologists. And to her credit – and theirs – she looked 30 years younger than her chronological age. In fairness, she had also taken good care of her overall health.
Gabby’s nickname was appropriate as she was chatty, to the extreme. She enjoyed being the center of attention.
When I entered her room, she was putting on her makeup. She was seated near her bedside table, which looked like it belonged in the backstage dressing room of a Broadway star. Lined up on the table were various bottles, brushes, and a mirror surrounded by lights.
“Oh, doctor, you can’t come in now. I’m a dreadful mess,” she said. “Please come back in 10 minutes. I am so embarrassed that you are seeing me this way. I just have a few things to fix, and then I will be presentable. My daughters are taking me out for lunch at the club, and I do not want to look like an old lady.”
“Gabby,” I said, “I have seen you before without your makeup. Do you remember last year when you developed pneumonia? You were really sick, and frankly, we were not sure you were going to pull through. One of the clues that you were getting ill was your smeared mascara and lipstick.”
I pressed on, and she let me examine her while she continued to apply her eyeliner.
“Everything sounds good. And I like your fresh pedicure,” I said. “Is there anything I can do for you?”
“No, thank you. Have a nice day, doctor!”
A mother devoted to her daughter’s care
Unlike my other patients, Mabel shared a room with a family member – her daughter, Hope. Mabel’s daughter had a congenital illness with significant physical, functional, and cognitive deficits. Mabel had considerable guilt regarding her daughter’s condition. Mabel’s husband had divorced her decades earlier, and she had devoted her life to caring for Hope. When Mabel’s health began to decline and she realized she could no longer care for Hope alone, the two moved into the facility together. Mabel told me that she simply couldn’t die before her daughter, because no one could oversee her care like she could.
Mabel was frail physically but sharp and vigilant mentally. Hope had had numerous hospitalizations, and Mabel had been with her through each experience. Hope could not communicate with others, but Mabel could express Hope’s concerns.
“How are you doing today?” I asked.
“Not well. I am concerned about Hope. She has not had a bowel movement in two days and does not want to eat breakfast.”
I checked out Hope, and her examination was reassuring. She looked up at me with her distorted features and managed a broad smile. I went back over to Mabel.
“She likes you, doctor. She thinks you smell good.”
I turned to Hope and thanked her for the compliment.
“I will check with the nurse and see if we can give you something simple to help your bowels.”
“Warm prune juice often works,” said Mabel. “Please come by again tomorrow to check on her. I don’t want this to progress. She is miserable.”
“I will be back tomorrow, and I will make a special trip to see you both.”
Upon reflection ...
When I sat down to write my clinical notes for the day, I realized that Rose, Violet, Gabby, and Mabel were each over 100 years old. I had seen four centenarians in a single day! Each of them manifested a fundamental principle of geriatrics: The older we are, the more unique and differentiated we become. A one-size approach to geriatric care does not fit all. Our care must be personalized to the unique individual in front of us.
Patients’ names and some details have been changed to protect their privacy. Dr. Williams is the Emeritus Ward K. Ensminger Distinguished Professor of Geriatric Medicine, University of Virginia, Charlottesville and attending physician, internal medicine and geriatrics, New Hanover Regional Medical Center, Wilmington, N.C. He disclosed no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
I was rounding at the nursing home and my day began as it often did. I reviewed the doctor communication book at the nursing station to see which patients I needed to visit and checked in with the floor nurse for any important updates.
A mother waiting for her son to visit
The first patient on my list was Rose. She had become increasingly withdrawn and less mobile. She used to walk the corridors asking when her son, Billy, would visit. We would all remind her that Billy visited her two or three times a week, but she never remembered the visits and blamed him for moving her out of her comfortable home in New Jersey where she’d lived with her husband before his death several years earlier.
Rose was declining, and we were trying to optimize her function and quality of life. She fell frequently while trying to get up at night to use the bathroom. None of our fall-reduction strategies had worked, and she had broken her hip a year prior. She’d fully recovered, but the combination of mental and physical frailty was becoming obvious to everyone, including her son. She had lost another five pounds and was approaching the end of her life.
“Good morning, Rose.” (She had demanded that I use her first name.) “How are you doing today?”
“I am doing okay, doctor. Have you seen Billy? When is he going to visit me?”
“I really can’t say when he’ll visit next, but I saw in a note that he was here yesterday.”
“No, he didn’t come to see me,” she said. “He doesn’t care about me. He spends more time with his wife and family than with his own mother.”
“Well, is there anything special that I can do for you?”
“Yes. Please tell Billy to visit his mother,” she said.
I completed her evaluation and made my way down the hall.
A wife ready to rejoin her husband
Next on my list was a widow named Violet. She reminded me of Whistler’s mother. As was her custom, she was sitting up in her chair reading her Bible when I came in. Her husband had been a minister, and she enjoyed reading the Bible or meditating for several hours each morning. Her bedside table had the most recent devotional and a picture of her husband in his vestments.
Violet was quiet and direct, and she had steely blue eyes that could communicate with your soul. Her nun-like quality was not overpowering; her manner was warm and welcoming.
“Good morning!” I said. “I hope I’m not bothering you.”
“Good morning, doctor. It’s always nice to see you.”
“I haven’t been by in a while, and I wanted to check your heart and lungs and make sure everything is going okay for you.”
“Of course; help yourself,” she said. “I feel fine. And as you know, I am ready to join my husband whenever the Lord calls me. I have lived a blessed life and do not wish to prolong it unless it is God’s will.”
“You certainly have made your wishes clear to me, and you are still in excellent health,” I said.
She really was in good health, and I made a quick note to call her daughter – who lived on the other side of the country – with an update.
A beauty queen ready for her close-up
Gabby was next on my list. She was a former beauty queen who had competed in local and state beauty contests. Her looks were the cornerstone of her identity, and she had done a truly remarkable job of maintaining her physical appearance.
Gabby had three attentive daughters who lived locally and supplied her with the latest makeup, beauty creams, and anti-aging nostrums. She always managed to look natural (and not like a caricature) with her face made up and her blond wig in place. Over the years, she’d made good use of the services offered by the local plastic surgeons and dermatologists. And to her credit – and theirs – she looked 30 years younger than her chronological age. In fairness, she had also taken good care of her overall health.
Gabby’s nickname was appropriate as she was chatty, to the extreme. She enjoyed being the center of attention.
When I entered her room, she was putting on her makeup. She was seated near her bedside table, which looked like it belonged in the backstage dressing room of a Broadway star. Lined up on the table were various bottles, brushes, and a mirror surrounded by lights.
“Oh, doctor, you can’t come in now. I’m a dreadful mess,” she said. “Please come back in 10 minutes. I am so embarrassed that you are seeing me this way. I just have a few things to fix, and then I will be presentable. My daughters are taking me out for lunch at the club, and I do not want to look like an old lady.”
“Gabby,” I said, “I have seen you before without your makeup. Do you remember last year when you developed pneumonia? You were really sick, and frankly, we were not sure you were going to pull through. One of the clues that you were getting ill was your smeared mascara and lipstick.”
I pressed on, and she let me examine her while she continued to apply her eyeliner.
“Everything sounds good. And I like your fresh pedicure,” I said. “Is there anything I can do for you?”
“No, thank you. Have a nice day, doctor!”
A mother devoted to her daughter’s care
Unlike my other patients, Mabel shared a room with a family member – her daughter, Hope. Mabel’s daughter had a congenital illness with significant physical, functional, and cognitive deficits. Mabel had considerable guilt regarding her daughter’s condition. Mabel’s husband had divorced her decades earlier, and she had devoted her life to caring for Hope. When Mabel’s health began to decline and she realized she could no longer care for Hope alone, the two moved into the facility together. Mabel told me that she simply couldn’t die before her daughter, because no one could oversee her care like she could.
Mabel was frail physically but sharp and vigilant mentally. Hope had had numerous hospitalizations, and Mabel had been with her through each experience. Hope could not communicate with others, but Mabel could express Hope’s concerns.
“How are you doing today?” I asked.
“Not well. I am concerned about Hope. She has not had a bowel movement in two days and does not want to eat breakfast.”
I checked out Hope, and her examination was reassuring. She looked up at me with her distorted features and managed a broad smile. I went back over to Mabel.
“She likes you, doctor. She thinks you smell good.”
I turned to Hope and thanked her for the compliment.
“I will check with the nurse and see if we can give you something simple to help your bowels.”
“Warm prune juice often works,” said Mabel. “Please come by again tomorrow to check on her. I don’t want this to progress. She is miserable.”
“I will be back tomorrow, and I will make a special trip to see you both.”
Upon reflection ...
When I sat down to write my clinical notes for the day, I realized that Rose, Violet, Gabby, and Mabel were each over 100 years old. I had seen four centenarians in a single day! Each of them manifested a fundamental principle of geriatrics: The older we are, the more unique and differentiated we become. A one-size approach to geriatric care does not fit all. Our care must be personalized to the unique individual in front of us.
Patients’ names and some details have been changed to protect their privacy. Dr. Williams is the Emeritus Ward K. Ensminger Distinguished Professor of Geriatric Medicine, University of Virginia, Charlottesville and attending physician, internal medicine and geriatrics, New Hanover Regional Medical Center, Wilmington, N.C. He disclosed no relevant financial disclosures.
A version of this article first appeared on Medscape.com.


