Perspectives

Because of physiological changes with aging and differences in cancer biology, caring for older adults (OAs) with cancer requires careful assessment and planning.

Clark Dumontier, MD, of Brigham and Women’s Hospital in Boston, and colleagues sought to define the meaning of the terms “undertreatment” and “overtreatment” for OAs with cancer in a scoping literature review published in the Journal of Clinical Oncology.

Though OAs are typically defined as adults aged 65 years and older, in this review, the authors defined OAs as patients aged 60 years and older.

The authors theorized that a scoping review of papers about this patient population could provide clues about limitations in the oncology literature and guidance about patient management and future research. Despite comprising the majority of cancer patients, OAs are underrepresented in clinical trials.
 

About scoping reviews

Scoping reviews are used to identify existing evidence in a field, clarify concepts or definitions in the literature, survey how research on a topic is conducted, and identify knowledge gaps. In addition, scoping reviews summarize available evidence without answering a discrete research question.

Industry standards for scoping reviews have been established by the Johanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. According to these standards, scoping reviews should:

• Establish eligibility criteria with a rationale for each criterion clearly explained
• Search multiple databases in multiple languages
• Include “gray literature,” defined as studies that are unpublished or difficult to locate
• Have several independent reviewers screen titles and abstracts
• Ask multiple independent reviewers to review full text articles
• Present results with charts or diagrams that align with the review’s objective
• Graphically depict the decision process for including/excluding sources
• Identify implications for further research.

In their review, Dr. DuMontier and colleagues fulfilled many of the aforementioned criteria. The team searched three English-language databases for titles and abstracts that included the terms undertreatment and/or overtreatment, and were related to OAs with cancer, inclusive of all types of articles, cancer types, and treatments.

Definitions of undertreatment and overtreatment were extracted, and categories underlying these definitions were derived. Within a random subset of articles, two coauthors independently determined final categories of definitions and independently assigned those categories.
 

Findings and implications

To define OA, Dr. DuMontier and colleagues used a cutoff of 60 years or older. Articles mentioning undertreatment (n = 236), overtreatment (n = 71), or both (n = 51) met criteria for inclusion (n = 256), but only 14 articles (5.5%) explicitly provided formal definitions.

For most of the reviewed articles, the authors judged definitions from the surrounding context. In a random subset of 50 articles, there was a high level of agreement (87.1%; κ = 0.81) between two coauthors in independently assigning categories of definitions.

Undertreatment was applied to therapy that was less than recommended (148 articles; 62.7%) or less than recommended with worse outcomes (88 articles; 37.3%).

Overtreatment most commonly denoted intensive treatment of an OA in whom harms outweighed the benefits of treatment (38 articles; 53.5%) or intensive treatment of a cancer not expected to affect the OA during the patient’s remaining life (33 articles; 46.5%).

Overall, the authors found that undertreatment and overtreatment of OAs with cancer are imprecisely defined concepts. Formal geriatric assessment was recommended in just over half of articles, and only 26.2% recommended formal assessments of age-related vulnerabilities for management. The authors proposed definitions that accounted for both oncologic factors and geriatric domains.
 

Care of individual patients and clinical research

National Comprehensive Cancer Network (NCCN) guidelines for OAs with cancer recommend initial consideration of overall life expectancy. If a patient is a candidate for cancer treatment on that basis, the next recommended assessment is that of the patient’s capacity to understand the relevant information, appreciate the underlying values and overall medical situation, reason through decisions, and communicate a choice that is consistent with the patient’s articulated goals.

In the pretreatment evaluation of OAs in whom there are no concerns about tolerance to antineoplastic therapy, NCCN guidelines suggest geriatric screening with standardized tools and, if abnormal, comprehensive geriatric screening. The guidelines recommend considering alternative treatment options if nonmodifiable abnormalities are identified.

Referral to a geriatric clinical specialist, use of the Cancer and Aging Research Group’s Chemo Toxicity Calculator, and calculation of Chemotherapy Risk Assessment Scale for High-Age Patients score are specifically suggested if high-risk procedures (such as chemotherapy, radiation, or complex surgery, which most oncologists would consider to be “another day in the office”) are contemplated.

The American Society of Clinical Oncology (ASCO) guidelines for geriatric oncology are similarly detailed and endorse similar evaluations and management.

Employing disease-centric and geriatric domains

Dr. DuMontier and colleagues noted that, for OAs with comorbidity or psychosocial challenges, surrogate survival endpoints are unrelated to quality of life (QOL) outcomes. Nonetheless, QOL is valued by OAs at least as much as survival improvement.

Through no fault of their own, the authors’ conclusion that undertreatment and overtreatment are imperfectly defined concepts has a certain neutrality to it. However, the terms undertreatment and overtreatment are commonly used to signify that inappropriate treatment decisions were made. Therefore, the terms are inherently negative and pejorative.

As with most emotionally charged issues in oncology, it is ideal for professionals in our field to take charge when deficiencies exist. ASCO, NCCN, and the authors of this scoping review have provided a conceptual basis for doing so.

An integrated oncologist-geriatrician approach was shown to be effective in the randomized INTEGERATE trial, showing improved QOL, reduced hospital admissions, and reduced early treatment discontinuation from adverse events (ASCO 2020, Abstract 12011).

Therefore, those clinicians who have not formally, systematically, and routinely supplemented the traditional disease-centric endpoints with patient-centered criteria need to do so.

Similarly, a retrospective study published in JAMA Network Open demonstrated that geriatric and surgical comanagement of OAs with cancer was associated with significantly lower 90-day postoperative mortality and receipt of more supportive care services (physical therapy, occupational therapy, speech and swallow rehabilitation, and nutrition services), in comparison with management from the surgical service only.

These clinical and administrative changes will not only enhance patient management but also facilitate the clinical trials required to clarify optimal treatment intensity. As that occurs, we will be able to apply as much precision to the care of OAs with cancer as we do in other areas of cancer treatment.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Dumontier C et al. J Clin Oncol. 2020 Aug 1;38(22):2558-2569.

Because of physiological changes with aging and differences in cancer biology, caring for older adults (OAs) with cancer requires careful assessment and planning.

Clark Dumontier, MD, of Brigham and Women’s Hospital in Boston, and colleagues sought to define the meaning of the terms “undertreatment” and “overtreatment” for OAs with cancer in a scoping literature review published in the Journal of Clinical Oncology.

Though OAs are typically defined as adults aged 65 years and older, in this review, the authors defined OAs as patients aged 60 years and older.

The authors theorized that a scoping review of papers about this patient population could provide clues about limitations in the oncology literature and guidance about patient management and future research. Despite comprising the majority of cancer patients, OAs are underrepresented in clinical trials.
 

About scoping reviews

Scoping reviews are used to identify existing evidence in a field, clarify concepts or definitions in the literature, survey how research on a topic is conducted, and identify knowledge gaps. In addition, scoping reviews summarize available evidence without answering a discrete research question.

Industry standards for scoping reviews have been established by the Johanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. According to these standards, scoping reviews should:

• Establish eligibility criteria with a rationale for each criterion clearly explained
• Search multiple databases in multiple languages
• Include “gray literature,” defined as studies that are unpublished or difficult to locate
• Have several independent reviewers screen titles and abstracts
• Ask multiple independent reviewers to review full text articles
• Present results with charts or diagrams that align with the review’s objective
• Graphically depict the decision process for including/excluding sources
• Identify implications for further research.

In their review, Dr. DuMontier and colleagues fulfilled many of the aforementioned criteria. The team searched three English-language databases for titles and abstracts that included the terms undertreatment and/or overtreatment, and were related to OAs with cancer, inclusive of all types of articles, cancer types, and treatments.

Definitions of undertreatment and overtreatment were extracted, and categories underlying these definitions were derived. Within a random subset of articles, two coauthors independently determined final categories of definitions and independently assigned those categories.
 

Findings and implications

To define OA, Dr. DuMontier and colleagues used a cutoff of 60 years or older. Articles mentioning undertreatment (n = 236), overtreatment (n = 71), or both (n = 51) met criteria for inclusion (n = 256), but only 14 articles (5.5%) explicitly provided formal definitions.

For most of the reviewed articles, the authors judged definitions from the surrounding context. In a random subset of 50 articles, there was a high level of agreement (87.1%; κ = 0.81) between two coauthors in independently assigning categories of definitions.

Undertreatment was applied to therapy that was less than recommended (148 articles; 62.7%) or less than recommended with worse outcomes (88 articles; 37.3%).

Overtreatment most commonly denoted intensive treatment of an OA in whom harms outweighed the benefits of treatment (38 articles; 53.5%) or intensive treatment of a cancer not expected to affect the OA during the patient’s remaining life (33 articles; 46.5%).

Overall, the authors found that undertreatment and overtreatment of OAs with cancer are imprecisely defined concepts. Formal geriatric assessment was recommended in just over half of articles, and only 26.2% recommended formal assessments of age-related vulnerabilities for management. The authors proposed definitions that accounted for both oncologic factors and geriatric domains.
 

Care of individual patients and clinical research

National Comprehensive Cancer Network (NCCN) guidelines for OAs with cancer recommend initial consideration of overall life expectancy. If a patient is a candidate for cancer treatment on that basis, the next recommended assessment is that of the patient’s capacity to understand the relevant information, appreciate the underlying values and overall medical situation, reason through decisions, and communicate a choice that is consistent with the patient’s articulated goals.

In the pretreatment evaluation of OAs in whom there are no concerns about tolerance to antineoplastic therapy, NCCN guidelines suggest geriatric screening with standardized tools and, if abnormal, comprehensive geriatric screening. The guidelines recommend considering alternative treatment options if nonmodifiable abnormalities are identified.

Referral to a geriatric clinical specialist, use of the Cancer and Aging Research Group’s Chemo Toxicity Calculator, and calculation of Chemotherapy Risk Assessment Scale for High-Age Patients score are specifically suggested if high-risk procedures (such as chemotherapy, radiation, or complex surgery, which most oncologists would consider to be “another day in the office”) are contemplated.

The American Society of Clinical Oncology (ASCO) guidelines for geriatric oncology are similarly detailed and endorse similar evaluations and management.

Employing disease-centric and geriatric domains

Dr. DuMontier and colleagues noted that, for OAs with comorbidity or psychosocial challenges, surrogate survival endpoints are unrelated to quality of life (QOL) outcomes. Nonetheless, QOL is valued by OAs at least as much as survival improvement.

Through no fault of their own, the authors’ conclusion that undertreatment and overtreatment are imperfectly defined concepts has a certain neutrality to it. However, the terms undertreatment and overtreatment are commonly used to signify that inappropriate treatment decisions were made. Therefore, the terms are inherently negative and pejorative.

As with most emotionally charged issues in oncology, it is ideal for professionals in our field to take charge when deficiencies exist. ASCO, NCCN, and the authors of this scoping review have provided a conceptual basis for doing so.

An integrated oncologist-geriatrician approach was shown to be effective in the randomized INTEGERATE trial, showing improved QOL, reduced hospital admissions, and reduced early treatment discontinuation from adverse events (ASCO 2020, Abstract 12011).

Therefore, those clinicians who have not formally, systematically, and routinely supplemented the traditional disease-centric endpoints with patient-centered criteria need to do so.

Similarly, a retrospective study published in JAMA Network Open demonstrated that geriatric and surgical comanagement of OAs with cancer was associated with significantly lower 90-day postoperative mortality and receipt of more supportive care services (physical therapy, occupational therapy, speech and swallow rehabilitation, and nutrition services), in comparison with management from the surgical service only.

These clinical and administrative changes will not only enhance patient management but also facilitate the clinical trials required to clarify optimal treatment intensity. As that occurs, we will be able to apply as much precision to the care of OAs with cancer as we do in other areas of cancer treatment.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Dumontier C et al. J Clin Oncol. 2020 Aug 1;38(22):2558-2569.

Because of physiological changes with aging and differences in cancer biology, caring for older adults (OAs) with cancer requires careful assessment and planning.

Clark Dumontier, MD, of Brigham and Women’s Hospital in Boston, and colleagues sought to define the meaning of the terms “undertreatment” and “overtreatment” for OAs with cancer in a scoping literature review published in the Journal of Clinical Oncology.

Though OAs are typically defined as adults aged 65 years and older, in this review, the authors defined OAs as patients aged 60 years and older.

The authors theorized that a scoping review of papers about this patient population could provide clues about limitations in the oncology literature and guidance about patient management and future research. Despite comprising the majority of cancer patients, OAs are underrepresented in clinical trials.
 

About scoping reviews

Scoping reviews are used to identify existing evidence in a field, clarify concepts or definitions in the literature, survey how research on a topic is conducted, and identify knowledge gaps. In addition, scoping reviews summarize available evidence without answering a discrete research question.

Industry standards for scoping reviews have been established by the Johanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. According to these standards, scoping reviews should:

• Establish eligibility criteria with a rationale for each criterion clearly explained
• Search multiple databases in multiple languages
• Include “gray literature,” defined as studies that are unpublished or difficult to locate
• Have several independent reviewers screen titles and abstracts
• Ask multiple independent reviewers to review full text articles
• Present results with charts or diagrams that align with the review’s objective
• Graphically depict the decision process for including/excluding sources
• Identify implications for further research.

In their review, Dr. DuMontier and colleagues fulfilled many of the aforementioned criteria. The team searched three English-language databases for titles and abstracts that included the terms undertreatment and/or overtreatment, and were related to OAs with cancer, inclusive of all types of articles, cancer types, and treatments.

Definitions of undertreatment and overtreatment were extracted, and categories underlying these definitions were derived. Within a random subset of articles, two coauthors independently determined final categories of definitions and independently assigned those categories.
 

Findings and implications

To define OA, Dr. DuMontier and colleagues used a cutoff of 60 years or older. Articles mentioning undertreatment (n = 236), overtreatment (n = 71), or both (n = 51) met criteria for inclusion (n = 256), but only 14 articles (5.5%) explicitly provided formal definitions.

For most of the reviewed articles, the authors judged definitions from the surrounding context. In a random subset of 50 articles, there was a high level of agreement (87.1%; κ = 0.81) between two coauthors in independently assigning categories of definitions.

Undertreatment was applied to therapy that was less than recommended (148 articles; 62.7%) or less than recommended with worse outcomes (88 articles; 37.3%).

Overtreatment most commonly denoted intensive treatment of an OA in whom harms outweighed the benefits of treatment (38 articles; 53.5%) or intensive treatment of a cancer not expected to affect the OA during the patient’s remaining life (33 articles; 46.5%).

Overall, the authors found that undertreatment and overtreatment of OAs with cancer are imprecisely defined concepts. Formal geriatric assessment was recommended in just over half of articles, and only 26.2% recommended formal assessments of age-related vulnerabilities for management. The authors proposed definitions that accounted for both oncologic factors and geriatric domains.
 

Care of individual patients and clinical research

National Comprehensive Cancer Network (NCCN) guidelines for OAs with cancer recommend initial consideration of overall life expectancy. If a patient is a candidate for cancer treatment on that basis, the next recommended assessment is that of the patient’s capacity to understand the relevant information, appreciate the underlying values and overall medical situation, reason through decisions, and communicate a choice that is consistent with the patient’s articulated goals.

In the pretreatment evaluation of OAs in whom there are no concerns about tolerance to antineoplastic therapy, NCCN guidelines suggest geriatric screening with standardized tools and, if abnormal, comprehensive geriatric screening. The guidelines recommend considering alternative treatment options if nonmodifiable abnormalities are identified.

Referral to a geriatric clinical specialist, use of the Cancer and Aging Research Group’s Chemo Toxicity Calculator, and calculation of Chemotherapy Risk Assessment Scale for High-Age Patients score are specifically suggested if high-risk procedures (such as chemotherapy, radiation, or complex surgery, which most oncologists would consider to be “another day in the office”) are contemplated.

The American Society of Clinical Oncology (ASCO) guidelines for geriatric oncology are similarly detailed and endorse similar evaluations and management.

Employing disease-centric and geriatric domains

Dr. DuMontier and colleagues noted that, for OAs with comorbidity or psychosocial challenges, surrogate survival endpoints are unrelated to quality of life (QOL) outcomes. Nonetheless, QOL is valued by OAs at least as much as survival improvement.

Through no fault of their own, the authors’ conclusion that undertreatment and overtreatment are imperfectly defined concepts has a certain neutrality to it. However, the terms undertreatment and overtreatment are commonly used to signify that inappropriate treatment decisions were made. Therefore, the terms are inherently negative and pejorative.

As with most emotionally charged issues in oncology, it is ideal for professionals in our field to take charge when deficiencies exist. ASCO, NCCN, and the authors of this scoping review have provided a conceptual basis for doing so.

An integrated oncologist-geriatrician approach was shown to be effective in the randomized INTEGERATE trial, showing improved QOL, reduced hospital admissions, and reduced early treatment discontinuation from adverse events (ASCO 2020, Abstract 12011).

Therefore, those clinicians who have not formally, systematically, and routinely supplemented the traditional disease-centric endpoints with patient-centered criteria need to do so.

Similarly, a retrospective study published in JAMA Network Open demonstrated that geriatric and surgical comanagement of OAs with cancer was associated with significantly lower 90-day postoperative mortality and receipt of more supportive care services (physical therapy, occupational therapy, speech and swallow rehabilitation, and nutrition services), in comparison with management from the surgical service only.

These clinical and administrative changes will not only enhance patient management but also facilitate the clinical trials required to clarify optimal treatment intensity. As that occurs, we will be able to apply as much precision to the care of OAs with cancer as we do in other areas of cancer treatment.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Dumontier C et al. J Clin Oncol. 2020 Aug 1;38(22):2558-2569.

Since beginning my psychiatry residency, I have come to dread situations in which I feel like the antagonist in my patient’s life. These are moments when, due to psychiatric illness or intoxication, my patient does not want my help. In these situations, the patient’s condition may prevent shared decision-making to determine the best care for them. I experienced such a situation on my first day of residency, and that encounter taught me several valuable lessons.

An anxiety-filled first day

While working with my attending physician in a psychiatric emergency department, we met with a patient who had become agitated and was threatening staff members. The patient was also loudly protesting any use of medications. As a medical student, I had encountered patients who were agitated, but this moment felt vastly different because I was now tasked with addressing the problem. I still remember how my muscles tensed out of anxiety. As the attending took the lead in talking with the patient, the situation continued to escalate. The patient’s agitation was preventing them from being able to safely cooperate with staff despite our efforts at verbal de-escalation. As several staff members stayed with the patient, my attending and I went back to the workroom, where she instructed me to place orders for emergent medications. I sat there, an anxious intern with the solemn power and responsibility to order medications that might need to be administered against the will of an agitated patient. The moment was surreal.

A harsh reality

I had envisioned my first day of residency to be quite different. I had expected to sit with patients, healing them by listening to their stories and giving them the attention they deserved. But instead, I found myself nervously inputting medication orders, checking and rechecking that the doses and administration routes were accurate—all the while knowing that the patient would likely refuse the medications. If that occurred, the patient would need to be held by staff so the medications could be administered. Although I knew that administering emergent medications was the appropriate clinical decision to prevent harm to the patient and others, I felt conflicted by acting in opposition to the patient’s wishes. In that moment, intoxication or illness compromised patient autonomy for the sake of beneficence. I struggled with a creeping sense of guilt.

Although I did not have the chance to interact with this specific patient again, I often reflect on that encounter. I have learned that at times, the use of emergent medications or court commitments for medication administration or hospitalizations is necessary. Since that first shift, I have cared for many other patients who have received emergent medications under similar circumstances. I have observed that such treatment often stabilizes patients and enables me to engage them in meaningful conversation to optimize their care.

Lessons learned

While some of what I have experienced during my training has made me uncomfortable, I have taken with me several valuable lessons. When a patient’s intoxication or illness prevents shared decision-making, our focus as physicians should remain on the patient’s safety, health, and well-being. It is necessary to engage patients in conversations to enable us to understand what ails them and promptly determine the right treatment, tailored to their specific needs and goals.

Moving forward, I know that I will encounter many more similar situations. I hope to position myself quickly and safely alongside agitated patients to engage them in shared decision-making. As a physician, I will approach every encounter with my patients as an opportunity to understand their goals for care, and empower them to make informed decisions regarding their treatment.

Since beginning my psychiatry residency, I have come to dread situations in which I feel like the antagonist in my patient’s life. These are moments when, due to psychiatric illness or intoxication, my patient does not want my help. In these situations, the patient’s condition may prevent shared decision-making to determine the best care for them. I experienced such a situation on my first day of residency, and that encounter taught me several valuable lessons.

An anxiety-filled first day

While working with my attending physician in a psychiatric emergency department, we met with a patient who had become agitated and was threatening staff members. The patient was also loudly protesting any use of medications. As a medical student, I had encountered patients who were agitated, but this moment felt vastly different because I was now tasked with addressing the problem. I still remember how my muscles tensed out of anxiety. As the attending took the lead in talking with the patient, the situation continued to escalate. The patient’s agitation was preventing them from being able to safely cooperate with staff despite our efforts at verbal de-escalation. As several staff members stayed with the patient, my attending and I went back to the workroom, where she instructed me to place orders for emergent medications. I sat there, an anxious intern with the solemn power and responsibility to order medications that might need to be administered against the will of an agitated patient. The moment was surreal.

A harsh reality

I had envisioned my first day of residency to be quite different. I had expected to sit with patients, healing them by listening to their stories and giving them the attention they deserved. But instead, I found myself nervously inputting medication orders, checking and rechecking that the doses and administration routes were accurate—all the while knowing that the patient would likely refuse the medications. If that occurred, the patient would need to be held by staff so the medications could be administered. Although I knew that administering emergent medications was the appropriate clinical decision to prevent harm to the patient and others, I felt conflicted by acting in opposition to the patient’s wishes. In that moment, intoxication or illness compromised patient autonomy for the sake of beneficence. I struggled with a creeping sense of guilt.

Although I did not have the chance to interact with this specific patient again, I often reflect on that encounter. I have learned that at times, the use of emergent medications or court commitments for medication administration or hospitalizations is necessary. Since that first shift, I have cared for many other patients who have received emergent medications under similar circumstances. I have observed that such treatment often stabilizes patients and enables me to engage them in meaningful conversation to optimize their care.

Lessons learned

While some of what I have experienced during my training has made me uncomfortable, I have taken with me several valuable lessons. When a patient’s intoxication or illness prevents shared decision-making, our focus as physicians should remain on the patient’s safety, health, and well-being. It is necessary to engage patients in conversations to enable us to understand what ails them and promptly determine the right treatment, tailored to their specific needs and goals.

Moving forward, I know that I will encounter many more similar situations. I hope to position myself quickly and safely alongside agitated patients to engage them in shared decision-making. As a physician, I will approach every encounter with my patients as an opportunity to understand their goals for care, and empower them to make informed decisions regarding their treatment.

Since beginning my psychiatry residency, I have come to dread situations in which I feel like the antagonist in my patient’s life. These are moments when, due to psychiatric illness or intoxication, my patient does not want my help. In these situations, the patient’s condition may prevent shared decision-making to determine the best care for them. I experienced such a situation on my first day of residency, and that encounter taught me several valuable lessons.

An anxiety-filled first day

While working with my attending physician in a psychiatric emergency department, we met with a patient who had become agitated and was threatening staff members. The patient was also loudly protesting any use of medications. As a medical student, I had encountered patients who were agitated, but this moment felt vastly different because I was now tasked with addressing the problem. I still remember how my muscles tensed out of anxiety. As the attending took the lead in talking with the patient, the situation continued to escalate. The patient’s agitation was preventing them from being able to safely cooperate with staff despite our efforts at verbal de-escalation. As several staff members stayed with the patient, my attending and I went back to the workroom, where she instructed me to place orders for emergent medications. I sat there, an anxious intern with the solemn power and responsibility to order medications that might need to be administered against the will of an agitated patient. The moment was surreal.

A harsh reality

I had envisioned my first day of residency to be quite different. I had expected to sit with patients, healing them by listening to their stories and giving them the attention they deserved. But instead, I found myself nervously inputting medication orders, checking and rechecking that the doses and administration routes were accurate—all the while knowing that the patient would likely refuse the medications. If that occurred, the patient would need to be held by staff so the medications could be administered. Although I knew that administering emergent medications was the appropriate clinical decision to prevent harm to the patient and others, I felt conflicted by acting in opposition to the patient’s wishes. In that moment, intoxication or illness compromised patient autonomy for the sake of beneficence. I struggled with a creeping sense of guilt.

Although I did not have the chance to interact with this specific patient again, I often reflect on that encounter. I have learned that at times, the use of emergent medications or court commitments for medication administration or hospitalizations is necessary. Since that first shift, I have cared for many other patients who have received emergent medications under similar circumstances. I have observed that such treatment often stabilizes patients and enables me to engage them in meaningful conversation to optimize their care.

Lessons learned

While some of what I have experienced during my training has made me uncomfortable, I have taken with me several valuable lessons. When a patient’s intoxication or illness prevents shared decision-making, our focus as physicians should remain on the patient’s safety, health, and well-being. It is necessary to engage patients in conversations to enable us to understand what ails them and promptly determine the right treatment, tailored to their specific needs and goals.

Moving forward, I know that I will encounter many more similar situations. I hope to position myself quickly and safely alongside agitated patients to engage them in shared decision-making. As a physician, I will approach every encounter with my patients as an opportunity to understand their goals for care, and empower them to make informed decisions regarding their treatment.

My role as a mother expands and contracts in hard-won harmony with my role as a psychiatry resident. The magnitude of this responsibility compounded on itself when, seemingly overnight, the world we once trusted suddenly became unsafe. Coronavirus disease 2019 (COVID-19), deadly to immunocompromised individuals and the harbinger of a lethal autoimmune syndrome in children, was at our doorstep.

COVID-19 and parents who work in health care

After COVID-19 reached the United States, my fellow residents and I began to exchange nervous text messages, wondering what we could expect. Not only did the biological threat of the virus loom at the limited hospital entry points, but news alerts about infected front-line health care professionals and supply shortages jammed our cellphones. We quickly learned that some front-line physicians and nurses in New York had decided to live separately from their families. One article reported that a resident who was 5 months postpartum had chosen to live separately from her infant to protect her from exposure. “What a fundamental conflict of identity,” I thought as I read the article. Looking at my own young family, I felt our vulnerability overcome me. Would I have to do the same?

Difficult choices that exemplify both excitement and fear seem to define parenthood. Only months ago, I was selecting a car seat. As I scoured consumer reports, I became aware of a harrowing irony: in the excitement of nesting, I was also preparing for a collision. In March, when the quarantine began, I found myself evaluating my options for how to protect my family during a pandemic that often feels like a car crash in slow motion.

Health care professionals began to separate from their families to reduce the risk of transmission. Whether children went to live with relatives or health care workers stopped snuggling their young children, a structural boundary was formed just as the roots of attachment were taking shape. When asked about the loss inherent in this separation, these young parents expressed sadness but also said the choice was clear: their need to protect their families was absolute.

Meanwhile, some residents found themselves in a crash course on telemedicine. Safe from coronavirus exposure at work and liberated from a daily commute, these parents saw their young children more than ever before. Young child­ren saw their parents who were residents more than ever before. Perhaps the isolation of a front-line resident was sadly not a new experience.

Reassessing priorities

Now that the first wave of infections has broken over our coastal cities, residents from the front lines of COVID-19 are reuniting with their families. The sacrifices they made are re-evaluated as they begin to recognize anew the value of physical closeness with their loved ones in a dangerous world. One family that separated during the first wave said they would plan an alternate strategy, perhaps invest in a babysitter, rather than divide the household a second time.

While COVID-19 hit us hard, it has also forced a rare opportunity for self-assessment of priorities that we as trainees rarely take. We don’t have a consumer report on the safety ratings of COVID-19 plans. There is no formula for success. Instead, we each balance work and personal life with individual strategies to cope with elements outside of our control. This coping strategy may look different for each family. I hope all training departments take this plurality into account when considering the new demands on residents that have emerged during COVID-19.

My role as a mother expands and contracts in hard-won harmony with my role as a psychiatry resident. The magnitude of this responsibility compounded on itself when, seemingly overnight, the world we once trusted suddenly became unsafe. Coronavirus disease 2019 (COVID-19), deadly to immunocompromised individuals and the harbinger of a lethal autoimmune syndrome in children, was at our doorstep.

COVID-19 and parents who work in health care

After COVID-19 reached the United States, my fellow residents and I began to exchange nervous text messages, wondering what we could expect. Not only did the biological threat of the virus loom at the limited hospital entry points, but news alerts about infected front-line health care professionals and supply shortages jammed our cellphones. We quickly learned that some front-line physicians and nurses in New York had decided to live separately from their families. One article reported that a resident who was 5 months postpartum had chosen to live separately from her infant to protect her from exposure. “What a fundamental conflict of identity,” I thought as I read the article. Looking at my own young family, I felt our vulnerability overcome me. Would I have to do the same?

Difficult choices that exemplify both excitement and fear seem to define parenthood. Only months ago, I was selecting a car seat. As I scoured consumer reports, I became aware of a harrowing irony: in the excitement of nesting, I was also preparing for a collision. In March, when the quarantine began, I found myself evaluating my options for how to protect my family during a pandemic that often feels like a car crash in slow motion.

Health care professionals began to separate from their families to reduce the risk of transmission. Whether children went to live with relatives or health care workers stopped snuggling their young children, a structural boundary was formed just as the roots of attachment were taking shape. When asked about the loss inherent in this separation, these young parents expressed sadness but also said the choice was clear: their need to protect their families was absolute.

Meanwhile, some residents found themselves in a crash course on telemedicine. Safe from coronavirus exposure at work and liberated from a daily commute, these parents saw their young children more than ever before. Young child­ren saw their parents who were residents more than ever before. Perhaps the isolation of a front-line resident was sadly not a new experience.

Reassessing priorities

Now that the first wave of infections has broken over our coastal cities, residents from the front lines of COVID-19 are reuniting with their families. The sacrifices they made are re-evaluated as they begin to recognize anew the value of physical closeness with their loved ones in a dangerous world. One family that separated during the first wave said they would plan an alternate strategy, perhaps invest in a babysitter, rather than divide the household a second time.

While COVID-19 hit us hard, it has also forced a rare opportunity for self-assessment of priorities that we as trainees rarely take. We don’t have a consumer report on the safety ratings of COVID-19 plans. There is no formula for success. Instead, we each balance work and personal life with individual strategies to cope with elements outside of our control. This coping strategy may look different for each family. I hope all training departments take this plurality into account when considering the new demands on residents that have emerged during COVID-19.

My role as a mother expands and contracts in hard-won harmony with my role as a psychiatry resident. The magnitude of this responsibility compounded on itself when, seemingly overnight, the world we once trusted suddenly became unsafe. Coronavirus disease 2019 (COVID-19), deadly to immunocompromised individuals and the harbinger of a lethal autoimmune syndrome in children, was at our doorstep.

COVID-19 and parents who work in health care

After COVID-19 reached the United States, my fellow residents and I began to exchange nervous text messages, wondering what we could expect. Not only did the biological threat of the virus loom at the limited hospital entry points, but news alerts about infected front-line health care professionals and supply shortages jammed our cellphones. We quickly learned that some front-line physicians and nurses in New York had decided to live separately from their families. One article reported that a resident who was 5 months postpartum had chosen to live separately from her infant to protect her from exposure. “What a fundamental conflict of identity,” I thought as I read the article. Looking at my own young family, I felt our vulnerability overcome me. Would I have to do the same?

Difficult choices that exemplify both excitement and fear seem to define parenthood. Only months ago, I was selecting a car seat. As I scoured consumer reports, I became aware of a harrowing irony: in the excitement of nesting, I was also preparing for a collision. In March, when the quarantine began, I found myself evaluating my options for how to protect my family during a pandemic that often feels like a car crash in slow motion.

Health care professionals began to separate from their families to reduce the risk of transmission. Whether children went to live with relatives or health care workers stopped snuggling their young children, a structural boundary was formed just as the roots of attachment were taking shape. When asked about the loss inherent in this separation, these young parents expressed sadness but also said the choice was clear: their need to protect their families was absolute.

Meanwhile, some residents found themselves in a crash course on telemedicine. Safe from coronavirus exposure at work and liberated from a daily commute, these parents saw their young children more than ever before. Young child­ren saw their parents who were residents more than ever before. Perhaps the isolation of a front-line resident was sadly not a new experience.

Reassessing priorities

Now that the first wave of infections has broken over our coastal cities, residents from the front lines of COVID-19 are reuniting with their families. The sacrifices they made are re-evaluated as they begin to recognize anew the value of physical closeness with their loved ones in a dangerous world. One family that separated during the first wave said they would plan an alternate strategy, perhaps invest in a babysitter, rather than divide the household a second time.

While COVID-19 hit us hard, it has also forced a rare opportunity for self-assessment of priorities that we as trainees rarely take. We don’t have a consumer report on the safety ratings of COVID-19 plans. There is no formula for success. Instead, we each balance work and personal life with individual strategies to cope with elements outside of our control. This coping strategy may look different for each family. I hope all training departments take this plurality into account when considering the new demands on residents that have emerged during COVID-19.

I am a psychiatrist at a community mental health center located close to a large city. I want to report on our experience treating 100 consecutive, non-duplicative patients during the coronavirus disease 2019 (COVID-19) pandemic. Most of these patients had medical assistance or Medicare. Fifty-one were white, 46 were black, and 3 were Asian; 50 were men, and their ages ranged from 16 to 83 (mean: 54; median: 56). Using each patient as his/her own control (pre- and post–COVID-19), here I report 6 observations I made while treating these patients.

1. Telehealth worked for most patients. Of the 100 patients, 18 were seen in-person. Of the 18 seen in person, 14 received long-acting IM injections, and 2 patients presented with urgent matters that I felt required in-person evaluations. One patient needed to fill out several forms and provide consents, and 1 patient with chronic illness was treated at the clinic because he mistakenly arrived in person for his appointment.

The remaining 82 patients had telehealth sessions. Only 9 patients said they were able to use video conferencing, so the remaining 73 patients were treated by phone. These patients were mostly poor and/or older and had no access to smartphones or computers. This is especially important because the current emergency telehealth rules allow phone-only sessions, while regular telehealth rules do not. Our clinic strongly advocates for the extension of emergency telehealth rules. I have e-mailed many elected officials about this, but I have received few replies and no substantive responses. Our clinic also needs to help our patients obtain increased audiovisual capabilities.

2. Female patients fared better in their treatment than males.

3. Older patients did better than younger patients. Older patients’ experiences of living through past crises were helpful because they were able to compare how they persevered in the past with the current pandemic.

4. White patients showed more improvements compared with black patients. White patients generally had greater access to resources and support.

5. Patients with psychotic diagnoses/symptoms improved more than those with neurotic/anxiety/depressive diagnoses or symptoms. Most of our patients with psychotic diagnoses were already in a supportive, structured living environment, so the new “COVID-19 world” may be less disruptive for them. Additionally, it was more difficult for our patients to get substances of abuse because they had less mobility and access during the pandemic.

Continue to: Support

6. Support, especially from family but also institutional support, trumped other factors. The more support and structure our patients had, the better they did.

My observations may not be generalizable because I am reporting on a relatively small population size, most patients were older, and most were established patients who were likely more stable. I plan to follow up with these patients to see how the new COVID-19 world continues to affect them, and us.

Daniel D. Storch, MD
Key Point Health Services
Catonsville, Maryland

Disclosure: The author reports no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

I am a psychiatrist at a community mental health center located close to a large city. I want to report on our experience treating 100 consecutive, non-duplicative patients during the coronavirus disease 2019 (COVID-19) pandemic. Most of these patients had medical assistance or Medicare. Fifty-one were white, 46 were black, and 3 were Asian; 50 were men, and their ages ranged from 16 to 83 (mean: 54; median: 56). Using each patient as his/her own control (pre- and post–COVID-19), here I report 6 observations I made while treating these patients.

1. Telehealth worked for most patients. Of the 100 patients, 18 were seen in-person. Of the 18 seen in person, 14 received long-acting IM injections, and 2 patients presented with urgent matters that I felt required in-person evaluations. One patient needed to fill out several forms and provide consents, and 1 patient with chronic illness was treated at the clinic because he mistakenly arrived in person for his appointment.

The remaining 82 patients had telehealth sessions. Only 9 patients said they were able to use video conferencing, so the remaining 73 patients were treated by phone. These patients were mostly poor and/or older and had no access to smartphones or computers. This is especially important because the current emergency telehealth rules allow phone-only sessions, while regular telehealth rules do not. Our clinic strongly advocates for the extension of emergency telehealth rules. I have e-mailed many elected officials about this, but I have received few replies and no substantive responses. Our clinic also needs to help our patients obtain increased audiovisual capabilities.

2. Female patients fared better in their treatment than males.

3. Older patients did better than younger patients. Older patients’ experiences of living through past crises were helpful because they were able to compare how they persevered in the past with the current pandemic.

4. White patients showed more improvements compared with black patients. White patients generally had greater access to resources and support.

5. Patients with psychotic diagnoses/symptoms improved more than those with neurotic/anxiety/depressive diagnoses or symptoms. Most of our patients with psychotic diagnoses were already in a supportive, structured living environment, so the new “COVID-19 world” may be less disruptive for them. Additionally, it was more difficult for our patients to get substances of abuse because they had less mobility and access during the pandemic.

Continue to: Support

6. Support, especially from family but also institutional support, trumped other factors. The more support and structure our patients had, the better they did.

My observations may not be generalizable because I am reporting on a relatively small population size, most patients were older, and most were established patients who were likely more stable. I plan to follow up with these patients to see how the new COVID-19 world continues to affect them, and us.

Daniel D. Storch, MD
Key Point Health Services
Catonsville, Maryland

Disclosure: The author reports no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

I am a psychiatrist at a community mental health center located close to a large city. I want to report on our experience treating 100 consecutive, non-duplicative patients during the coronavirus disease 2019 (COVID-19) pandemic. Most of these patients had medical assistance or Medicare. Fifty-one were white, 46 were black, and 3 were Asian; 50 were men, and their ages ranged from 16 to 83 (mean: 54; median: 56). Using each patient as his/her own control (pre- and post–COVID-19), here I report 6 observations I made while treating these patients.

1. Telehealth worked for most patients. Of the 100 patients, 18 were seen in-person. Of the 18 seen in person, 14 received long-acting IM injections, and 2 patients presented with urgent matters that I felt required in-person evaluations. One patient needed to fill out several forms and provide consents, and 1 patient with chronic illness was treated at the clinic because he mistakenly arrived in person for his appointment.

The remaining 82 patients had telehealth sessions. Only 9 patients said they were able to use video conferencing, so the remaining 73 patients were treated by phone. These patients were mostly poor and/or older and had no access to smartphones or computers. This is especially important because the current emergency telehealth rules allow phone-only sessions, while regular telehealth rules do not. Our clinic strongly advocates for the extension of emergency telehealth rules. I have e-mailed many elected officials about this, but I have received few replies and no substantive responses. Our clinic also needs to help our patients obtain increased audiovisual capabilities.

2. Female patients fared better in their treatment than males.

3. Older patients did better than younger patients. Older patients’ experiences of living through past crises were helpful because they were able to compare how they persevered in the past with the current pandemic.

4. White patients showed more improvements compared with black patients. White patients generally had greater access to resources and support.

5. Patients with psychotic diagnoses/symptoms improved more than those with neurotic/anxiety/depressive diagnoses or symptoms. Most of our patients with psychotic diagnoses were already in a supportive, structured living environment, so the new “COVID-19 world” may be less disruptive for them. Additionally, it was more difficult for our patients to get substances of abuse because they had less mobility and access during the pandemic.

Continue to: Support

6. Support, especially from family but also institutional support, trumped other factors. The more support and structure our patients had, the better they did.

My observations may not be generalizable because I am reporting on a relatively small population size, most patients were older, and most were established patients who were likely more stable. I plan to follow up with these patients to see how the new COVID-19 world continues to affect them, and us.

Daniel D. Storch, MD
Key Point Health Services
Catonsville, Maryland

Disclosure: The author reports no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

It’s election season again. Every 4 years, October becomes the purgatory month of politics. But this year, it’s even more complicated, being juxtaposed against a chaotic mosaic of a viral pandemic, economic travails, social upheaval, and exceptionally toxic political hyperpartisanship.

The widespread expectation is that citizens will vote for their party’s candidates, but there is now a body of evidence suggesting that our brains may be pre-wired to be liberal or conservative.

Enter neuro-politics. This discipline is younger than neuro-economics, neuro-law, neuro-ethics, neuro-marketing, neuro-art, neuro-culture, or neuro-esthetics. Neuro-politics focuses on the intersection of politics with neuroscience.¹ However, there are many antecedents to neuro-politics reflected in the writings of Plato, Aristotle, Niccolò Machiavelli, John Locke, Baruch Spinoza, Henri Bergson, William James, and others.

Neuro-politics attempts to generate data to answer a variety of questions about political behavior, such as:

• Is political orientation associated with differences in certain brain regions?
• Are there reliable neural biomarkers of political orientation?
• Is political orientation modifiable, and if so, why are some individuals ferociously entrenched to one political dogma while others are able to untether themselves and adopt another political doctrine?
• What are the brain characteristics of “swing voters” who may align themselves with different parties in different election cycles?
• Is there a “religification” of politics among the ardent fanatics who regard the tenets of their political beliefs as “articles of faith?”
• Is the brain modified by certain attributes (such as educational level, age, sex, marital status, race, ethnicity, and religious affiliation) that translate to political decision-making?
• Can neuro-politics explain the sprouting of psychiatric symptoms such as obsessions, anxiety, irritability, anger, hatred, and conspiracy theories?
• Is political extremism driven by cortical structures, limbic structures, or both?

Politics and the brain

Here is a brief review of some studies that examined the relationship of political orientation or voting behavior with brain structure and function:

1. Roger Sperry, the 1981 Nobel Laureate (for his studies on split-brain patients) reported that in patients who underwent callosotomy, both cerebral hemispheres gave the same ratings of politicians when their photos were shown to each hemisphere separately.²

2. A functional magnetic resonance imaging (fMRI) study found that the faces of candidates activated participants’ ventromedial and anterior prefrontal cortices. Amygdala activation was associated with the intensity of the emotion.³

Continue to: A skin conductance...

3. A skin conductance study reported that politically liberal individuals had low reactivity to sudden noises and threatening stimuli, while conservative counterparts demonstrated high physiological reactions to noises and stimuli.⁴

4. Images of a losing candidate elicited greater activation on fMRI in the insula and ventral anterior cingulate compared to no activation by exposure to an image of the winning candidate.⁵

5. Another fMRI study found that “individualism” was associated with activation of the medial prefrontal cortex and temporo-parietal junction when participants listened to a set of political statements. On the other hand, “conservatism” activated the dorsolateral prefrontal cortex, while “radicalism” activated the ventral striatum and posterior cingulate.⁶

6. An EEG activity study of healthy individuals revealed desynchronization in the alpha band related to the politicians who lost simulated elections and were judged as “less trustworthy” when the participant watched their faces.⁷

7. A structural MRI study of young adults reported that liberalism was associated with increased gray matter volume in the anterior cingulate, while conservatism was associated with increased volume of the right amygdala. The authors replicated their findings and concluded there is a possible link between brain structure and psychological mechanisms that mediate political attitudes.⁸

Continue to: To examine the effect of...

8. To examine the effect of a “first impression” based on the physical appearance of candidates, researchers compared individuals with damage to the lateral orbitofrontal cortex (OFC) with a group that had frontal damage that spared the lateral OFC and another group of matched healthy volunteers. They used a simulated elections paradigm in which participants voted based solely on photographs of the candidates’ faces. Only the group with OFC damage was influenced by attractiveness, while those with an intact frontal lobe or non-OFC frontal damage relied on other data, such as competence.⁹ These researchers concluded that an intact OFC is necessary for political decision-making.

9. A study using cognitive tasks reported that liberals are more adept at dealing with novel information than conservatives.¹⁰

What part of your brain will you use?

Regardless of the data generated by the neuro-politics studies, the bottom line is: What part of your brain do you use when you cast your vote for an issue, a representative, a senator, or a president? Is it a purely intellectual decision (ie, cortical), or is it driven by visceral emotions (ie, limbic)? Do you believe that every single item in your party’s platform is right and virtuous, while every item in the other party’s platform is wrong and evil? Can you think of any redeeming feature of the candidate you hate or the party you despise?

One attribute that we psychiatrists possess by virtue of our training and clinical work is that we are able to transcend dichotomies and to perceive nuances and shades of gray about controversial issues. So I hope we employ the circuits of our brain where wisdom putatively resides¹¹ and which may develop further (via neuroplasticity) with the conduct of psychotherapy.¹² Those brain circuits include:

• prefrontal cortex (for emotional regulation, decision-making, and value relativism)
• lateral prefrontal cortex (to facilitate calculated, reason-based decision-making)
• medial prefrontal cortex (for emotional valence and pro-social attitudes and behaviors).

However, being human, it is quite likely that our amygdala may “seep through” and color our judgment and decisions. But let us try to cast a vote that is not only good for the country but also good for our patients, many of whom may not even be able to vote. Election season is a time to make a positive difference in our patients’ lives, not just ours. Let’s hope our brains exploit this unique opportunity.

It’s election season again. Every 4 years, October becomes the purgatory month of politics. But this year, it’s even more complicated, being juxtaposed against a chaotic mosaic of a viral pandemic, economic travails, social upheaval, and exceptionally toxic political hyperpartisanship.

The widespread expectation is that citizens will vote for their party’s candidates, but there is now a body of evidence suggesting that our brains may be pre-wired to be liberal or conservative.

Enter neuro-politics. This discipline is younger than neuro-economics, neuro-law, neuro-ethics, neuro-marketing, neuro-art, neuro-culture, or neuro-esthetics. Neuro-politics focuses on the intersection of politics with neuroscience.¹ However, there are many antecedents to neuro-politics reflected in the writings of Plato, Aristotle, Niccolò Machiavelli, John Locke, Baruch Spinoza, Henri Bergson, William James, and others.

Neuro-politics attempts to generate data to answer a variety of questions about political behavior, such as:

• Is political orientation associated with differences in certain brain regions?
• Are there reliable neural biomarkers of political orientation?
• Is political orientation modifiable, and if so, why are some individuals ferociously entrenched to one political dogma while others are able to untether themselves and adopt another political doctrine?
• What are the brain characteristics of “swing voters” who may align themselves with different parties in different election cycles?
• Is there a “religification” of politics among the ardent fanatics who regard the tenets of their political beliefs as “articles of faith?”
• Is the brain modified by certain attributes (such as educational level, age, sex, marital status, race, ethnicity, and religious affiliation) that translate to political decision-making?
• Can neuro-politics explain the sprouting of psychiatric symptoms such as obsessions, anxiety, irritability, anger, hatred, and conspiracy theories?
• Is political extremism driven by cortical structures, limbic structures, or both?

Politics and the brain

Here is a brief review of some studies that examined the relationship of political orientation or voting behavior with brain structure and function:

1. Roger Sperry, the 1981 Nobel Laureate (for his studies on split-brain patients) reported that in patients who underwent callosotomy, both cerebral hemispheres gave the same ratings of politicians when their photos were shown to each hemisphere separately.²

2. A functional magnetic resonance imaging (fMRI) study found that the faces of candidates activated participants’ ventromedial and anterior prefrontal cortices. Amygdala activation was associated with the intensity of the emotion.³

Continue to: A skin conductance...

3. A skin conductance study reported that politically liberal individuals had low reactivity to sudden noises and threatening stimuli, while conservative counterparts demonstrated high physiological reactions to noises and stimuli.⁴

4. Images of a losing candidate elicited greater activation on fMRI in the insula and ventral anterior cingulate compared to no activation by exposure to an image of the winning candidate.⁵

5. Another fMRI study found that “individualism” was associated with activation of the medial prefrontal cortex and temporo-parietal junction when participants listened to a set of political statements. On the other hand, “conservatism” activated the dorsolateral prefrontal cortex, while “radicalism” activated the ventral striatum and posterior cingulate.⁶

6. An EEG activity study of healthy individuals revealed desynchronization in the alpha band related to the politicians who lost simulated elections and were judged as “less trustworthy” when the participant watched their faces.⁷

7. A structural MRI study of young adults reported that liberalism was associated with increased gray matter volume in the anterior cingulate, while conservatism was associated with increased volume of the right amygdala. The authors replicated their findings and concluded there is a possible link between brain structure and psychological mechanisms that mediate political attitudes.⁸

Continue to: To examine the effect of...

8. To examine the effect of a “first impression” based on the physical appearance of candidates, researchers compared individuals with damage to the lateral orbitofrontal cortex (OFC) with a group that had frontal damage that spared the lateral OFC and another group of matched healthy volunteers. They used a simulated elections paradigm in which participants voted based solely on photographs of the candidates’ faces. Only the group with OFC damage was influenced by attractiveness, while those with an intact frontal lobe or non-OFC frontal damage relied on other data, such as competence.⁹ These researchers concluded that an intact OFC is necessary for political decision-making.

9. A study using cognitive tasks reported that liberals are more adept at dealing with novel information than conservatives.¹⁰

What part of your brain will you use?

Regardless of the data generated by the neuro-politics studies, the bottom line is: What part of your brain do you use when you cast your vote for an issue, a representative, a senator, or a president? Is it a purely intellectual decision (ie, cortical), or is it driven by visceral emotions (ie, limbic)? Do you believe that every single item in your party’s platform is right and virtuous, while every item in the other party’s platform is wrong and evil? Can you think of any redeeming feature of the candidate you hate or the party you despise?

One attribute that we psychiatrists possess by virtue of our training and clinical work is that we are able to transcend dichotomies and to perceive nuances and shades of gray about controversial issues. So I hope we employ the circuits of our brain where wisdom putatively resides¹¹ and which may develop further (via neuroplasticity) with the conduct of psychotherapy.¹² Those brain circuits include:

• prefrontal cortex (for emotional regulation, decision-making, and value relativism)
• lateral prefrontal cortex (to facilitate calculated, reason-based decision-making)
• medial prefrontal cortex (for emotional valence and pro-social attitudes and behaviors).

However, being human, it is quite likely that our amygdala may “seep through” and color our judgment and decisions. But let us try to cast a vote that is not only good for the country but also good for our patients, many of whom may not even be able to vote. Election season is a time to make a positive difference in our patients’ lives, not just ours. Let’s hope our brains exploit this unique opportunity.

It’s election season again. Every 4 years, October becomes the purgatory month of politics. But this year, it’s even more complicated, being juxtaposed against a chaotic mosaic of a viral pandemic, economic travails, social upheaval, and exceptionally toxic political hyperpartisanship.

The widespread expectation is that citizens will vote for their party’s candidates, but there is now a body of evidence suggesting that our brains may be pre-wired to be liberal or conservative.

Enter neuro-politics. This discipline is younger than neuro-economics, neuro-law, neuro-ethics, neuro-marketing, neuro-art, neuro-culture, or neuro-esthetics. Neuro-politics focuses on the intersection of politics with neuroscience.¹ However, there are many antecedents to neuro-politics reflected in the writings of Plato, Aristotle, Niccolò Machiavelli, John Locke, Baruch Spinoza, Henri Bergson, William James, and others.

Neuro-politics attempts to generate data to answer a variety of questions about political behavior, such as:

• Is political orientation associated with differences in certain brain regions?
• Are there reliable neural biomarkers of political orientation?
• Is political orientation modifiable, and if so, why are some individuals ferociously entrenched to one political dogma while others are able to untether themselves and adopt another political doctrine?
• What are the brain characteristics of “swing voters” who may align themselves with different parties in different election cycles?
• Is there a “religification” of politics among the ardent fanatics who regard the tenets of their political beliefs as “articles of faith?”
• Is the brain modified by certain attributes (such as educational level, age, sex, marital status, race, ethnicity, and religious affiliation) that translate to political decision-making?
• Can neuro-politics explain the sprouting of psychiatric symptoms such as obsessions, anxiety, irritability, anger, hatred, and conspiracy theories?
• Is political extremism driven by cortical structures, limbic structures, or both?

Politics and the brain

Here is a brief review of some studies that examined the relationship of political orientation or voting behavior with brain structure and function:

1. Roger Sperry, the 1981 Nobel Laureate (for his studies on split-brain patients) reported that in patients who underwent callosotomy, both cerebral hemispheres gave the same ratings of politicians when their photos were shown to each hemisphere separately.²

2. A functional magnetic resonance imaging (fMRI) study found that the faces of candidates activated participants’ ventromedial and anterior prefrontal cortices. Amygdala activation was associated with the intensity of the emotion.³

Continue to: A skin conductance...

3. A skin conductance study reported that politically liberal individuals had low reactivity to sudden noises and threatening stimuli, while conservative counterparts demonstrated high physiological reactions to noises and stimuli.⁴

4. Images of a losing candidate elicited greater activation on fMRI in the insula and ventral anterior cingulate compared to no activation by exposure to an image of the winning candidate.⁵

5. Another fMRI study found that “individualism” was associated with activation of the medial prefrontal cortex and temporo-parietal junction when participants listened to a set of political statements. On the other hand, “conservatism” activated the dorsolateral prefrontal cortex, while “radicalism” activated the ventral striatum and posterior cingulate.⁶

6. An EEG activity study of healthy individuals revealed desynchronization in the alpha band related to the politicians who lost simulated elections and were judged as “less trustworthy” when the participant watched their faces.⁷

7. A structural MRI study of young adults reported that liberalism was associated with increased gray matter volume in the anterior cingulate, while conservatism was associated with increased volume of the right amygdala. The authors replicated their findings and concluded there is a possible link between brain structure and psychological mechanisms that mediate political attitudes.⁸

Continue to: To examine the effect of...

8. To examine the effect of a “first impression” based on the physical appearance of candidates, researchers compared individuals with damage to the lateral orbitofrontal cortex (OFC) with a group that had frontal damage that spared the lateral OFC and another group of matched healthy volunteers. They used a simulated elections paradigm in which participants voted based solely on photographs of the candidates’ faces. Only the group with OFC damage was influenced by attractiveness, while those with an intact frontal lobe or non-OFC frontal damage relied on other data, such as competence.⁹ These researchers concluded that an intact OFC is necessary for political decision-making.

9. A study using cognitive tasks reported that liberals are more adept at dealing with novel information than conservatives.¹⁰

What part of your brain will you use?

Regardless of the data generated by the neuro-politics studies, the bottom line is: What part of your brain do you use when you cast your vote for an issue, a representative, a senator, or a president? Is it a purely intellectual decision (ie, cortical), or is it driven by visceral emotions (ie, limbic)? Do you believe that every single item in your party’s platform is right and virtuous, while every item in the other party’s platform is wrong and evil? Can you think of any redeeming feature of the candidate you hate or the party you despise?

One attribute that we psychiatrists possess by virtue of our training and clinical work is that we are able to transcend dichotomies and to perceive nuances and shades of gray about controversial issues. So I hope we employ the circuits of our brain where wisdom putatively resides¹¹ and which may develop further (via neuroplasticity) with the conduct of psychotherapy.¹² Those brain circuits include:

• prefrontal cortex (for emotional regulation, decision-making, and value relativism)
• lateral prefrontal cortex (to facilitate calculated, reason-based decision-making)
• medial prefrontal cortex (for emotional valence and pro-social attitudes and behaviors).

However, being human, it is quite likely that our amygdala may “seep through” and color our judgment and decisions. But let us try to cast a vote that is not only good for the country but also good for our patients, many of whom may not even be able to vote. Election season is a time to make a positive difference in our patients’ lives, not just ours. Let’s hope our brains exploit this unique opportunity.

Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?

For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”

Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.

At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?

One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, it can be hard to break out from the middle and bottom groups without a strong advocate or opportunities to demonstrate exceptional proficiency.

Below are three recommendations to consider for improving mentorship within departments:

1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.

2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.

3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.

If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.

Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.

Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?

For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”

Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.

At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?

One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, it can be hard to break out from the middle and bottom groups without a strong advocate or opportunities to demonstrate exceptional proficiency.

Below are three recommendations to consider for improving mentorship within departments:

1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.

2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.

3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.

If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.

Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.

Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?

For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”

Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.

At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?

One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, it can be hard to break out from the middle and bottom groups without a strong advocate or opportunities to demonstrate exceptional proficiency.

Below are three recommendations to consider for improving mentorship within departments:

1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.

2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.

3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.

If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.

Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.

1. Include and integrate pregnant women and lactating women in the clinical research agenda.

2. Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.

3. Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.

4. Remove regulatory barriers to research in pregnant women.

5. Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.

6. Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.

7. Develop separate programs to study therapeutic products used off patent in pregnant women and lactating women using the National Institute of Health Best Pharmaceuticals for Children Act (BPCA) as a model.

8. Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.

9. Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.

10. Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.

11. Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.

12. Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.

13. Optimize registries for pregnancy and lactation.

14. The Department of Health & Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.

15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Source: Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018

1. Include and integrate pregnant women and lactating women in the clinical research agenda.

2. Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.

3. Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.

4. Remove regulatory barriers to research in pregnant women.

5. Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.

6. Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.

7. Develop separate programs to study therapeutic products used off patent in pregnant women and lactating women using the National Institute of Health Best Pharmaceuticals for Children Act (BPCA) as a model.

8. Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.

9. Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.

10. Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.

11. Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.

12. Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.

13. Optimize registries for pregnancy and lactation.

14. The Department of Health & Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.

15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Source: Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018

1. Include and integrate pregnant women and lactating women in the clinical research agenda.

2. Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.

3. Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.

4. Remove regulatory barriers to research in pregnant women.

5. Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.

6. Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.

7. Develop separate programs to study therapeutic products used off patent in pregnant women and lactating women using the National Institute of Health Best Pharmaceuticals for Children Act (BPCA) as a model.

8. Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.

9. Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.

10. Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.

11. Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.

12. Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.

13. Optimize registries for pregnancy and lactation.

14. The Department of Health & Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.

15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Source: Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018

I have had friends and colleagues visibly shrink away when I say that my work involves the study of medication safety in pregnancy. “Yikes! I would never let my daughter participate in a clinical study if she was pregnant!” I hear. It’s an interesting response. Understandably protective of a loved one, except that the loved one is an adult woman who presumably can make her own choices. And the response reveals an assumption that medications are tested in all populations before approval for market. Sadly, the response is ill-informed given that pregnant women are still excluded from most if not all clinical research. My work, by the way, is focused on postapproval studies.

Antonio_Diaz/Thinkstock

Translating the above response to a larger picture, health care providers and pharmaceutical manufacturers also have their concerns about pregnant women and lactating women participating in clinical research. Along with the patient and her loved ones, all parties’ concerns are valid. However, there is a harsh reality: According to a study in the American Journal of Obstetrics & Gynecology, an estimated 50% of U.S. women take one or more prescription medications during pregnancy. Once marketed, therapies are prescribed to pregnant women, knowingly and unknowingly, and without evidence-based knowledge of their safety. If postapproval safety studies are undertaken, decades may pass as data accrue and before results become available. In general, even less is known about the safety of medications in breastmilk.

Without a path forward that includes pregnant women and lactating women in clinical research, we will remain without timely knowledge of medication safety. Further, our understanding of efficacy will be based on clinical studies of nonpregnant women. Recognizing the need for this information, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was convened in 2017 and tasked with determining this path forward.

The PRGLAC was established by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health, the PRGLAC is made up of representatives of all federal agencies with responsibilities for women’s health and research, as well as clinicians, industry experts, and other experts. The PRGLAC’s work has been conducted in two phases.

In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018, and submitted their conclusions to Congress and the Secretary of Health & Human Services in a publicly available report. The report provides 15 specific recommendations, several of which are directly relevant to obstetricians: No. 3 recommends expanding the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology, No. 6 recommends the development and implementation of evidence-based communication strategies with health care providers, and No. 13 recommends optimization of registries for pregnancy and lactation. Obstetricians can make a positive contribution to accruing medication safety data by being aware of pregnancy registries and indicating their availability to eligible patients.

In the spring of 2019, the PRGLAC reconvened with a 2-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. Four working groups (WGs) were identified to address the recommendations of the report: WG1 Research and Training, WG2 Regulatory, WG3 Communication and Registries, and WG4 Discovery. The four groups have deliberated, and a new report is being finalized. The PRGLAC’s efforts provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. Once available, the final report will be posted on the PRGLAC website.

The recommendations in this report, when implemented, are directly relevant to patient care and clinician training and will provide a path forward for the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
 

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology. She also represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy disclosed she has worked with multiple pharmaceutical manufacturers regarding medication safety studies in pregnancy, most recently Biohaven. Email her at obnews@mdedge.com.

I have had friends and colleagues visibly shrink away when I say that my work involves the study of medication safety in pregnancy. “Yikes! I would never let my daughter participate in a clinical study if she was pregnant!” I hear. It’s an interesting response. Understandably protective of a loved one, except that the loved one is an adult woman who presumably can make her own choices. And the response reveals an assumption that medications are tested in all populations before approval for market. Sadly, the response is ill-informed given that pregnant women are still excluded from most if not all clinical research. My work, by the way, is focused on postapproval studies.

Antonio_Diaz/Thinkstock

Translating the above response to a larger picture, health care providers and pharmaceutical manufacturers also have their concerns about pregnant women and lactating women participating in clinical research. Along with the patient and her loved ones, all parties’ concerns are valid. However, there is a harsh reality: According to a study in the American Journal of Obstetrics & Gynecology, an estimated 50% of U.S. women take one or more prescription medications during pregnancy. Once marketed, therapies are prescribed to pregnant women, knowingly and unknowingly, and without evidence-based knowledge of their safety. If postapproval safety studies are undertaken, decades may pass as data accrue and before results become available. In general, even less is known about the safety of medications in breastmilk.

Without a path forward that includes pregnant women and lactating women in clinical research, we will remain without timely knowledge of medication safety. Further, our understanding of efficacy will be based on clinical studies of nonpregnant women. Recognizing the need for this information, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was convened in 2017 and tasked with determining this path forward.

The PRGLAC was established by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health, the PRGLAC is made up of representatives of all federal agencies with responsibilities for women’s health and research, as well as clinicians, industry experts, and other experts. The PRGLAC’s work has been conducted in two phases.

In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018, and submitted their conclusions to Congress and the Secretary of Health & Human Services in a publicly available report. The report provides 15 specific recommendations, several of which are directly relevant to obstetricians: No. 3 recommends expanding the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology, No. 6 recommends the development and implementation of evidence-based communication strategies with health care providers, and No. 13 recommends optimization of registries for pregnancy and lactation. Obstetricians can make a positive contribution to accruing medication safety data by being aware of pregnancy registries and indicating their availability to eligible patients.

In the spring of 2019, the PRGLAC reconvened with a 2-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. Four working groups (WGs) were identified to address the recommendations of the report: WG1 Research and Training, WG2 Regulatory, WG3 Communication and Registries, and WG4 Discovery. The four groups have deliberated, and a new report is being finalized. The PRGLAC’s efforts provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. Once available, the final report will be posted on the PRGLAC website.

The recommendations in this report, when implemented, are directly relevant to patient care and clinician training and will provide a path forward for the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
 

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology. She also represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy disclosed she has worked with multiple pharmaceutical manufacturers regarding medication safety studies in pregnancy, most recently Biohaven. Email her at obnews@mdedge.com.

I have had friends and colleagues visibly shrink away when I say that my work involves the study of medication safety in pregnancy. “Yikes! I would never let my daughter participate in a clinical study if she was pregnant!” I hear. It’s an interesting response. Understandably protective of a loved one, except that the loved one is an adult woman who presumably can make her own choices. And the response reveals an assumption that medications are tested in all populations before approval for market. Sadly, the response is ill-informed given that pregnant women are still excluded from most if not all clinical research. My work, by the way, is focused on postapproval studies.

Antonio_Diaz/Thinkstock

Translating the above response to a larger picture, health care providers and pharmaceutical manufacturers also have their concerns about pregnant women and lactating women participating in clinical research. Along with the patient and her loved ones, all parties’ concerns are valid. However, there is a harsh reality: According to a study in the American Journal of Obstetrics & Gynecology, an estimated 50% of U.S. women take one or more prescription medications during pregnancy. Once marketed, therapies are prescribed to pregnant women, knowingly and unknowingly, and without evidence-based knowledge of their safety. If postapproval safety studies are undertaken, decades may pass as data accrue and before results become available. In general, even less is known about the safety of medications in breastmilk.

Without a path forward that includes pregnant women and lactating women in clinical research, we will remain without timely knowledge of medication safety. Further, our understanding of efficacy will be based on clinical studies of nonpregnant women. Recognizing the need for this information, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was convened in 2017 and tasked with determining this path forward.

The PRGLAC was established by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health, the PRGLAC is made up of representatives of all federal agencies with responsibilities for women’s health and research, as well as clinicians, industry experts, and other experts. The PRGLAC’s work has been conducted in two phases.

In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018, and submitted their conclusions to Congress and the Secretary of Health & Human Services in a publicly available report. The report provides 15 specific recommendations, several of which are directly relevant to obstetricians: No. 3 recommends expanding the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology, No. 6 recommends the development and implementation of evidence-based communication strategies with health care providers, and No. 13 recommends optimization of registries for pregnancy and lactation. Obstetricians can make a positive contribution to accruing medication safety data by being aware of pregnancy registries and indicating their availability to eligible patients.

In the spring of 2019, the PRGLAC reconvened with a 2-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. Four working groups (WGs) were identified to address the recommendations of the report: WG1 Research and Training, WG2 Regulatory, WG3 Communication and Registries, and WG4 Discovery. The four groups have deliberated, and a new report is being finalized. The PRGLAC’s efforts provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. Once available, the final report will be posted on the PRGLAC website.

The recommendations in this report, when implemented, are directly relevant to patient care and clinician training and will provide a path forward for the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
 

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology. She also represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy disclosed she has worked with multiple pharmaceutical manufacturers regarding medication safety studies in pregnancy, most recently Biohaven. Email her at obnews@mdedge.com.

In March 2020, following the announcement of the United States’ first death related to COVID-19, many physicians began using their voices to discuss the shortage of personal protective equipment (PPE). Many physicians, myself included, petitioned elected leaders at the community, state, and federal levels to address the PPE shortage.

Historically, physicians have advocated for improved public health. From seat belt laws in the 1980s and 1990s to the Affordable Care Act in the 2000s, physicians have testified at the community, state, and federal levels to advocate for the health and safety of our patients and the public. Yet while we have been making our voices heard, we are often silent at the ballot box.

In the 1996 and 2000 elections, physicians voted 9% less often than the general public, and compared with lawyers – professionals with similar educational attainment and finances – physicians voted 22% less often.¹ It is unclear why physicians are less likely to vote. In a 2016 article, David Grande, MD, and Katrina Armstrong, MD, postulated that physicians may not vote because our work hours create barriers to visiting polls.²

Despite our lack of engagement at the ballot box, voting is important to improving our patients’ social determinants of health. In a recently published systematic review, the authors found several studies supporting the association between voting and social determinants of health. Their review found that, when large numbers of people from communities participated in voting, it translated into greater influence over determining who held political power in that community. Those with power introduced and supported policies responding to their constituents’ needs, ultimately influencing their constituents’ social determinants of health.³ By voting, we as physicians are helping to address the social determinants of health in our communities.

Many medical students have been doing their part to improve the social determinants of health in their communities by pledging to vote. In 2018, the American Medical Student Association launched their “Med Out the Vote” initiative prior to the election. The organization called on all health care providers and providers in training to pledge to vote in the election.⁴ They are continuing these efforts for the 2020 elections.

We should join our nation’s medical students by also pledging to vote. To begin, we can all Make A Plan To Vote. Each plan should include the following:

• Register to vote: In many states eligible voters can register online.
• Request an absentee ballot: Many states require registered voters to request absentee ballots online or by mail.
• Vote: Submit an absentee ballot prior to election or vote in-person on election day. Some counties allow voting early in person.

In practice, our plans will differ slightly because each state has its own election laws.

This election season let us ensure all physician voices are heard. Make A Plan To Vote for your patients and communities.
 

Dr. Kumar is the pediatric editor of The Hospitalist. She is clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s.

References

1. Grande D et al. Do Doctors Vote? J Gen Intern Med. 2007 May;22(5):585-9.

2. Grande D, Armstrong K. Will Physicians Vote? Ann Intern Med. 2016;165:814-5.

3. Brown CL et al. Voting, health and interventions in healthcare settings: A scoping review. Public Health Rev. 2020 Jul. doi: 10.1186/s40985-020-00133-6.

4. American Medical Student Association. AMSA Launches Med Out the Vote Campaign, Call to Action. 2018 Jul 29. Accessed 2020 Sep 14. https://www.amsa.org/about/amsa-press-room/amsa-launches-med-out-the-vote-campaign-call-to-action/

In March 2020, following the announcement of the United States’ first death related to COVID-19, many physicians began using their voices to discuss the shortage of personal protective equipment (PPE). Many physicians, myself included, petitioned elected leaders at the community, state, and federal levels to address the PPE shortage.

Historically, physicians have advocated for improved public health. From seat belt laws in the 1980s and 1990s to the Affordable Care Act in the 2000s, physicians have testified at the community, state, and federal levels to advocate for the health and safety of our patients and the public. Yet while we have been making our voices heard, we are often silent at the ballot box.

In the 1996 and 2000 elections, physicians voted 9% less often than the general public, and compared with lawyers – professionals with similar educational attainment and finances – physicians voted 22% less often.¹ It is unclear why physicians are less likely to vote. In a 2016 article, David Grande, MD, and Katrina Armstrong, MD, postulated that physicians may not vote because our work hours create barriers to visiting polls.²

Despite our lack of engagement at the ballot box, voting is important to improving our patients’ social determinants of health. In a recently published systematic review, the authors found several studies supporting the association between voting and social determinants of health. Their review found that, when large numbers of people from communities participated in voting, it translated into greater influence over determining who held political power in that community. Those with power introduced and supported policies responding to their constituents’ needs, ultimately influencing their constituents’ social determinants of health.³ By voting, we as physicians are helping to address the social determinants of health in our communities.

Many medical students have been doing their part to improve the social determinants of health in their communities by pledging to vote. In 2018, the American Medical Student Association launched their “Med Out the Vote” initiative prior to the election. The organization called on all health care providers and providers in training to pledge to vote in the election.⁴ They are continuing these efforts for the 2020 elections.

We should join our nation’s medical students by also pledging to vote. To begin, we can all Make A Plan To Vote. Each plan should include the following:

• Register to vote: In many states eligible voters can register online.
• Request an absentee ballot: Many states require registered voters to request absentee ballots online or by mail.
• Vote: Submit an absentee ballot prior to election or vote in-person on election day. Some counties allow voting early in person.

In practice, our plans will differ slightly because each state has its own election laws.

This election season let us ensure all physician voices are heard. Make A Plan To Vote for your patients and communities.
 

Dr. Kumar is the pediatric editor of The Hospitalist. She is clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s.

References

1. Grande D et al. Do Doctors Vote? J Gen Intern Med. 2007 May;22(5):585-9.

2. Grande D, Armstrong K. Will Physicians Vote? Ann Intern Med. 2016;165:814-5.

3. Brown CL et al. Voting, health and interventions in healthcare settings: A scoping review. Public Health Rev. 2020 Jul. doi: 10.1186/s40985-020-00133-6.

4. American Medical Student Association. AMSA Launches Med Out the Vote Campaign, Call to Action. 2018 Jul 29. Accessed 2020 Sep 14. https://www.amsa.org/about/amsa-press-room/amsa-launches-med-out-the-vote-campaign-call-to-action/

In March 2020, following the announcement of the United States’ first death related to COVID-19, many physicians began using their voices to discuss the shortage of personal protective equipment (PPE). Many physicians, myself included, petitioned elected leaders at the community, state, and federal levels to address the PPE shortage.

Historically, physicians have advocated for improved public health. From seat belt laws in the 1980s and 1990s to the Affordable Care Act in the 2000s, physicians have testified at the community, state, and federal levels to advocate for the health and safety of our patients and the public. Yet while we have been making our voices heard, we are often silent at the ballot box.

In the 1996 and 2000 elections, physicians voted 9% less often than the general public, and compared with lawyers – professionals with similar educational attainment and finances – physicians voted 22% less often.¹ It is unclear why physicians are less likely to vote. In a 2016 article, David Grande, MD, and Katrina Armstrong, MD, postulated that physicians may not vote because our work hours create barriers to visiting polls.²

Despite our lack of engagement at the ballot box, voting is important to improving our patients’ social determinants of health. In a recently published systematic review, the authors found several studies supporting the association between voting and social determinants of health. Their review found that, when large numbers of people from communities participated in voting, it translated into greater influence over determining who held political power in that community. Those with power introduced and supported policies responding to their constituents’ needs, ultimately influencing their constituents’ social determinants of health.³ By voting, we as physicians are helping to address the social determinants of health in our communities.

Many medical students have been doing their part to improve the social determinants of health in their communities by pledging to vote. In 2018, the American Medical Student Association launched their “Med Out the Vote” initiative prior to the election. The organization called on all health care providers and providers in training to pledge to vote in the election.⁴ They are continuing these efforts for the 2020 elections.

We should join our nation’s medical students by also pledging to vote. To begin, we can all Make A Plan To Vote. Each plan should include the following:

• Register to vote: In many states eligible voters can register online.
• Request an absentee ballot: Many states require registered voters to request absentee ballots online or by mail.
• Vote: Submit an absentee ballot prior to election or vote in-person on election day. Some counties allow voting early in person.

In practice, our plans will differ slightly because each state has its own election laws.

This election season let us ensure all physician voices are heard. Make A Plan To Vote for your patients and communities.
 

Dr. Kumar is the pediatric editor of The Hospitalist. She is clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s.

References

1. Grande D et al. Do Doctors Vote? J Gen Intern Med. 2007 May;22(5):585-9.

2. Grande D, Armstrong K. Will Physicians Vote? Ann Intern Med. 2016;165:814-5.

3. Brown CL et al. Voting, health and interventions in healthcare settings: A scoping review. Public Health Rev. 2020 Jul. doi: 10.1186/s40985-020-00133-6.

4. American Medical Student Association. AMSA Launches Med Out the Vote Campaign, Call to Action. 2018 Jul 29. Accessed 2020 Sep 14. https://www.amsa.org/about/amsa-press-room/amsa-launches-med-out-the-vote-campaign-call-to-action/

Below is a case involving a patient who is not yet ready to quit smoking. We later provide treatment recommendations for this patient based on a new guideline from the American Thoracic Society.

Case

A 58-year-old female comes into the office for a physical exam. She has been smoking two packs a day since she was 23 years of age. You have tried at previous visits to get her to quit, but she hasn’t been interested. The patient says she has a lot of stress, and that it is still not the right time for her to stop smoking. You tell her she needs to quit and, though the patient understands that quitting would be beneficial for her health, she just isn’t ready to try to kick the habit. How do you proceed?

The Guideline in context

Even though this patient stated that she is not ready to stop smoking, she is still a candidate for pharmacological treatment for her tobacco dependence and can be offered varenicline, according to the ATS guideline.¹

It is imperative that tobacco cessation is addressed with patients in the most effective and comprehensive ways possible. In a previously published column, we have discussed the ATS’ recommended approaches for treating patients who are ready to stop smoking cigarettes. The reality is that many patients, if not most, are not ready to quit when we speak to them during any given office visit. The ATS guideline addresses this critical issue by recommending treatment with varenicline in patients who are not ready to stop smoking. It also states that this is a better strategy than waiting to start treatment until patients say they are ready for it.

This recommendation – to prescribe varenicline to smokers even when they are not ready to quit smoking – is based on solid clinical trial evidence. Research has shown that behavior change is dynamic and that the decision to stop smoking is not always a planned one.¹ Patients often make quit attempts between office visits, and are often successful in those attempts. Because the decision to try to stop smoking is influenced by the satisfaction and physical addiction that comes from smoking, a medication such as varenicline that is a partial agonist/antagonist at the alpha4-beta2 nicotinic receptor might increase the likelihood that a patient would decide to try to stop smoking. This is because taking this type of a drug would lead the patient to no longer experience the reinforcing effects of nicotine.² This hypothesis was examined in five randomized trials.¹

In these studies, regular smokers who were not ready to make a quit attempt were randomized to varenicline versus placebo. Twice as many individuals who took varenicline stopped smoking 6 months after starting treatment.¹

Suggested treatment

This patient should be offered varenicline. This individual meets the criteria for this treatment according to the ATS guideline in that the patient is a regular smoker who doesn’t think she is ready to stop smoking but understands she needs to stop and is open to taking medication to assist her with quitting.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. Leone F T et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Jul 15;202(2):e5–e31.

2. Ebbert JO et al. Varenicline for smoking cessation: Efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-62.
 

Below is a case involving a patient who is not yet ready to quit smoking. We later provide treatment recommendations for this patient based on a new guideline from the American Thoracic Society.

Case

A 58-year-old female comes into the office for a physical exam. She has been smoking two packs a day since she was 23 years of age. You have tried at previous visits to get her to quit, but she hasn’t been interested. The patient says she has a lot of stress, and that it is still not the right time for her to stop smoking. You tell her she needs to quit and, though the patient understands that quitting would be beneficial for her health, she just isn’t ready to try to kick the habit. How do you proceed?

The Guideline in context

Even though this patient stated that she is not ready to stop smoking, she is still a candidate for pharmacological treatment for her tobacco dependence and can be offered varenicline, according to the ATS guideline.¹

It is imperative that tobacco cessation is addressed with patients in the most effective and comprehensive ways possible. In a previously published column, we have discussed the ATS’ recommended approaches for treating patients who are ready to stop smoking cigarettes. The reality is that many patients, if not most, are not ready to quit when we speak to them during any given office visit. The ATS guideline addresses this critical issue by recommending treatment with varenicline in patients who are not ready to stop smoking. It also states that this is a better strategy than waiting to start treatment until patients say they are ready for it.

This recommendation – to prescribe varenicline to smokers even when they are not ready to quit smoking – is based on solid clinical trial evidence. Research has shown that behavior change is dynamic and that the decision to stop smoking is not always a planned one.¹ Patients often make quit attempts between office visits, and are often successful in those attempts. Because the decision to try to stop smoking is influenced by the satisfaction and physical addiction that comes from smoking, a medication such as varenicline that is a partial agonist/antagonist at the alpha4-beta2 nicotinic receptor might increase the likelihood that a patient would decide to try to stop smoking. This is because taking this type of a drug would lead the patient to no longer experience the reinforcing effects of nicotine.² This hypothesis was examined in five randomized trials.¹

In these studies, regular smokers who were not ready to make a quit attempt were randomized to varenicline versus placebo. Twice as many individuals who took varenicline stopped smoking 6 months after starting treatment.¹

Suggested treatment

This patient should be offered varenicline. This individual meets the criteria for this treatment according to the ATS guideline in that the patient is a regular smoker who doesn’t think she is ready to stop smoking but understands she needs to stop and is open to taking medication to assist her with quitting.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. Leone F T et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Jul 15;202(2):e5–e31.

2. Ebbert JO et al. Varenicline for smoking cessation: Efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-62.
 

Below is a case involving a patient who is not yet ready to quit smoking. We later provide treatment recommendations for this patient based on a new guideline from the American Thoracic Society.

Case

A 58-year-old female comes into the office for a physical exam. She has been smoking two packs a day since she was 23 years of age. You have tried at previous visits to get her to quit, but she hasn’t been interested. The patient says she has a lot of stress, and that it is still not the right time for her to stop smoking. You tell her she needs to quit and, though the patient understands that quitting would be beneficial for her health, she just isn’t ready to try to kick the habit. How do you proceed?

The Guideline in context

Even though this patient stated that she is not ready to stop smoking, she is still a candidate for pharmacological treatment for her tobacco dependence and can be offered varenicline, according to the ATS guideline.¹

It is imperative that tobacco cessation is addressed with patients in the most effective and comprehensive ways possible. In a previously published column, we have discussed the ATS’ recommended approaches for treating patients who are ready to stop smoking cigarettes. The reality is that many patients, if not most, are not ready to quit when we speak to them during any given office visit. The ATS guideline addresses this critical issue by recommending treatment with varenicline in patients who are not ready to stop smoking. It also states that this is a better strategy than waiting to start treatment until patients say they are ready for it.

This recommendation – to prescribe varenicline to smokers even when they are not ready to quit smoking – is based on solid clinical trial evidence. Research has shown that behavior change is dynamic and that the decision to stop smoking is not always a planned one.¹ Patients often make quit attempts between office visits, and are often successful in those attempts. Because the decision to try to stop smoking is influenced by the satisfaction and physical addiction that comes from smoking, a medication such as varenicline that is a partial agonist/antagonist at the alpha4-beta2 nicotinic receptor might increase the likelihood that a patient would decide to try to stop smoking. This is because taking this type of a drug would lead the patient to no longer experience the reinforcing effects of nicotine.² This hypothesis was examined in five randomized trials.¹

In these studies, regular smokers who were not ready to make a quit attempt were randomized to varenicline versus placebo. Twice as many individuals who took varenicline stopped smoking 6 months after starting treatment.¹

Suggested treatment

This patient should be offered varenicline. This individual meets the criteria for this treatment according to the ATS guideline in that the patient is a regular smoker who doesn’t think she is ready to stop smoking but understands she needs to stop and is open to taking medication to assist her with quitting.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. Leone F T et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Jul 15;202(2):e5–e31.

2. Ebbert JO et al. Varenicline for smoking cessation: Efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-62.