Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as “phenomenal.”

Krina Patel, MD, an associate professor in the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that “the response rate of 73% in a patient population with a median of six lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.”

“We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients,” Dr. Patel said.

The new data on ide-cell, from a trial in 128 patients, were published Feb. 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, said: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3-4 months, with a median overall survival of 8-9 months.
 

Product is awaiting approval

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.
 

Strong and sustained responses

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (Jan. 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (≥50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3-16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a “very good partial response or better.”

Overall median progression-free survival was 8.8 months at the 450×106 dose but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine-release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

“Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150×106 to 450×106 CAR+ T cells,” the authors conclude. “The 450×106 dose appeared to be somewhat more effective than the other doses.”
 

New option?

“What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response,” said Dr. Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

“My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless,” Dr. Patel added. “The is the first therapy in the relapsed/refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients.”

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Dr. Patel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Dr. Munshi acts as a consultant for several pharmaceutical companies, and many coauthors also have relationships with industry, as listed in the original article.

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

Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as “phenomenal.”

Krina Patel, MD, an associate professor in the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that “the response rate of 73% in a patient population with a median of six lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.”

“We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients,” Dr. Patel said.

The new data on ide-cell, from a trial in 128 patients, were published Feb. 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, said: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3-4 months, with a median overall survival of 8-9 months.
 

Product is awaiting approval

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.
 

Strong and sustained responses

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (Jan. 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (≥50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3-16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a “very good partial response or better.”

Overall median progression-free survival was 8.8 months at the 450×106 dose but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine-release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

“Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150×106 to 450×106 CAR+ T cells,” the authors conclude. “The 450×106 dose appeared to be somewhat more effective than the other doses.”
 

New option?

“What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response,” said Dr. Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

“My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless,” Dr. Patel added. “The is the first therapy in the relapsed/refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients.”

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Dr. Patel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Dr. Munshi acts as a consultant for several pharmaceutical companies, and many coauthors also have relationships with industry, as listed in the original article.

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

Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as “phenomenal.”

Krina Patel, MD, an associate professor in the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that “the response rate of 73% in a patient population with a median of six lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.”

“We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients,” Dr. Patel said.

The new data on ide-cell, from a trial in 128 patients, were published Feb. 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, said: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3-4 months, with a median overall survival of 8-9 months.
 

Product is awaiting approval

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.
 

Strong and sustained responses

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (Jan. 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (≥50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3-16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a “very good partial response or better.”

Overall median progression-free survival was 8.8 months at the 450×106 dose but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine-release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

“Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150×106 to 450×106 CAR+ T cells,” the authors conclude. “The 450×106 dose appeared to be somewhat more effective than the other doses.”
 

New option?

“What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response,” said Dr. Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

“My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless,” Dr. Patel added. “The is the first therapy in the relapsed/refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients.”

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Dr. Patel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Dr. Munshi acts as a consultant for several pharmaceutical companies, and many coauthors also have relationships with industry, as listed in the original article.

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

Merck & Co. is withdrawing the U.S. indication for pembrolizumab (Keytruda) for metastatic small cell lung cancer (SCLC) in patients with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy, according to a company statement.

The move does not affect any of the drug’s other indications. The immunotherapy is used in the treatment of many different types of cancer.

The SCLC indication had been granted an accelerated approval by the Food and Drug Administration in 2019 based on tumor response rate and durability of response data from patient cohorts in two trials. However, the anti-PD-1 therapy failed to demonstrate statistically significant improved overall survival in a confirmatory trial, which is mandated after an accelerated approval.

The FDA is conducting “an industry-wide evaluation of indications based on accelerated approvals that have not yet met their postmarketing requirements,” said Merck.

In February of 2021, an indication for durvalumab (Imfinzi) was withdrawn by AstraZeneca in concert with the FDA after the drug failed to improve overall survival in unresectable metastatic bladder cancer in a confirmatory trial, as reported by Medscape Medical News.

“We will continue to rigorously evaluate the benefits of [pembrolizumab] in small cell lung cancer and other types of cancer, in pursuit of Merck’s mission to save and improve lives,” Roy Baynes, MD, chief medical officer, Merck Research Laboratories, said in the company statement

Dr. Baynes also championed the value of accelerated approvals.

“The accelerated pathways created by the FDA have been integral to the remarkable progress in oncology care over the past 5 years and have helped many cancer patients with advanced disease, including small cell lung cancer, access new treatments,” he said.

However, in the past, the FDA has been criticized for approving new cancer drugs based on surrogate markers such as response rates because, in many cases, subsequent studies often show that the drug fails to improve overall survival.

For example, a 2015 study found that 36 (67%) of 54 cancer drug approvals from 2008 to 2012 were made on the basis of surrogate markers – either tumor response rate or progression-free survival. Over a median follow-up period of 4.4 years, only 5 of those 36 drugs were shown in randomized studies to improve overall survival, as reported by Medscape Medical News.

The FDA says that it instituted the accelerated approval program to “allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.” The program was started in 1992, in the midst of the HIV/AIDS epidemic.

In 2020, the nonprofit Friends of Cancer Research issued a white paper calling for reform in the accelerated approval process, which included a proposal to add risk assessment to surrogate endpoints that would factor in variables such as toxicity.

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

Merck & Co. is withdrawing the U.S. indication for pembrolizumab (Keytruda) for metastatic small cell lung cancer (SCLC) in patients with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy, according to a company statement.

The move does not affect any of the drug’s other indications. The immunotherapy is used in the treatment of many different types of cancer.

The SCLC indication had been granted an accelerated approval by the Food and Drug Administration in 2019 based on tumor response rate and durability of response data from patient cohorts in two trials. However, the anti-PD-1 therapy failed to demonstrate statistically significant improved overall survival in a confirmatory trial, which is mandated after an accelerated approval.

The FDA is conducting “an industry-wide evaluation of indications based on accelerated approvals that have not yet met their postmarketing requirements,” said Merck.

In February of 2021, an indication for durvalumab (Imfinzi) was withdrawn by AstraZeneca in concert with the FDA after the drug failed to improve overall survival in unresectable metastatic bladder cancer in a confirmatory trial, as reported by Medscape Medical News.

“We will continue to rigorously evaluate the benefits of [pembrolizumab] in small cell lung cancer and other types of cancer, in pursuit of Merck’s mission to save and improve lives,” Roy Baynes, MD, chief medical officer, Merck Research Laboratories, said in the company statement

Dr. Baynes also championed the value of accelerated approvals.

“The accelerated pathways created by the FDA have been integral to the remarkable progress in oncology care over the past 5 years and have helped many cancer patients with advanced disease, including small cell lung cancer, access new treatments,” he said.

However, in the past, the FDA has been criticized for approving new cancer drugs based on surrogate markers such as response rates because, in many cases, subsequent studies often show that the drug fails to improve overall survival.

For example, a 2015 study found that 36 (67%) of 54 cancer drug approvals from 2008 to 2012 were made on the basis of surrogate markers – either tumor response rate or progression-free survival. Over a median follow-up period of 4.4 years, only 5 of those 36 drugs were shown in randomized studies to improve overall survival, as reported by Medscape Medical News.

The FDA says that it instituted the accelerated approval program to “allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.” The program was started in 1992, in the midst of the HIV/AIDS epidemic.

In 2020, the nonprofit Friends of Cancer Research issued a white paper calling for reform in the accelerated approval process, which included a proposal to add risk assessment to surrogate endpoints that would factor in variables such as toxicity.

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

Merck & Co. is withdrawing the U.S. indication for pembrolizumab (Keytruda) for metastatic small cell lung cancer (SCLC) in patients with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy, according to a company statement.

The move does not affect any of the drug’s other indications. The immunotherapy is used in the treatment of many different types of cancer.

The SCLC indication had been granted an accelerated approval by the Food and Drug Administration in 2019 based on tumor response rate and durability of response data from patient cohorts in two trials. However, the anti-PD-1 therapy failed to demonstrate statistically significant improved overall survival in a confirmatory trial, which is mandated after an accelerated approval.

The FDA is conducting “an industry-wide evaluation of indications based on accelerated approvals that have not yet met their postmarketing requirements,” said Merck.

In February of 2021, an indication for durvalumab (Imfinzi) was withdrawn by AstraZeneca in concert with the FDA after the drug failed to improve overall survival in unresectable metastatic bladder cancer in a confirmatory trial, as reported by Medscape Medical News.

“We will continue to rigorously evaluate the benefits of [pembrolizumab] in small cell lung cancer and other types of cancer, in pursuit of Merck’s mission to save and improve lives,” Roy Baynes, MD, chief medical officer, Merck Research Laboratories, said in the company statement

Dr. Baynes also championed the value of accelerated approvals.

“The accelerated pathways created by the FDA have been integral to the remarkable progress in oncology care over the past 5 years and have helped many cancer patients with advanced disease, including small cell lung cancer, access new treatments,” he said.

However, in the past, the FDA has been criticized for approving new cancer drugs based on surrogate markers such as response rates because, in many cases, subsequent studies often show that the drug fails to improve overall survival.

For example, a 2015 study found that 36 (67%) of 54 cancer drug approvals from 2008 to 2012 were made on the basis of surrogate markers – either tumor response rate or progression-free survival. Over a median follow-up period of 4.4 years, only 5 of those 36 drugs were shown in randomized studies to improve overall survival, as reported by Medscape Medical News.

The FDA says that it instituted the accelerated approval program to “allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.” The program was started in 1992, in the midst of the HIV/AIDS epidemic.

In 2020, the nonprofit Friends of Cancer Research issued a white paper calling for reform in the accelerated approval process, which included a proposal to add risk assessment to surrogate endpoints that would factor in variables such as toxicity.

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

THE CASE

A 14-year-old girl with no significant medical history presented to the office accompanied by her mother for a routine well-adolescent visit. She attended school online due to a history of severe bullying and, when interviewed alone, admitted to a lack of a social life as a result. On questioning, she denied tobacco, alcohol, or illicit drug use. Her gender identity was female. Her sexual orientation was toward both males and females, but she was not sexually active. She denied exposure to physical or emotional violence at home and said she did not feel depressed or think about suicide.

Physical examination revealed multiple erythematous linear scars surrounding the areola of both breasts. When questioned about these lesions, she admitted to cutting herself on the breasts during the past several months but again denied suicidal intent. She believed that her behavior was a normal coping mechanism. 

The physical exam was otherwise normal. Lab results, including thyroid-stimulating hormone and complete blood count, were within normal limits.

THE DIAGNOSIS

The physical exam findings and the patient’s self report pointed to a diagnosis of nonsuicidal self-injurious (NSSI) behavior involving cutting.

DISCUSSION

The NSSI behavior displayed by this patient is a common biopsychosocial disorder observed in adolescents. Self-injury is defined as the deliberate injuring of body tissues without suicidal intent.¹ Self-injurious behavior typically begins when patients are 13 to 16 years of age, and cutting is the most common form. Most acts occur on the arms, legs, wrists, and stomach.² Studies have shown that the prevalence of this behavior is on the rise among adolescents, from about 7% in 2014 to between 14% and 24% in 2015.³

Risk for suicide. Although a feature of NSSI is the lack of suicidal intent, this type of high-risk behavior is associated with past, present, and future suicide attempts. It is important for physicians to identify NSSI in an adolescent, as it is linked to a 7-fold increased risk for a suicide attempt.³

Screening for NSSI. Less than one-fifth of adolescents who injure themselves come to the attention of health care providers.⁴ We propose that primary care physicians add NSSI to the list of risky behaviors—including drug abuse, sexual activity, and depression—for which they screen during well-child visits.

Continue to: Identifying risk factors

Identifying risk factors. The case patient experienced bullying and reported a nonheterosexual orientation, both of which have been demonstrated as strong risk factors for NSSI.⁵ Female gender has also been identified as a risk factor for NSSI.³

In adolescent psychiatric samples, prevalence rates of NSSI were found to be as high as 60% for 1 incident of NSSI and around 50% for repetitive NSSI.⁶ NSSI coincides with other psychiatric comorbidities, including eating disorders, mood disorders (depression), anxiety disorders, posttraumatic stress disorder, and borderline personality disorder.³ In a study of 93 subjects, each of whom was a self-reported abuse survivor with a history of self-injury, 96% were in therapy for diagnoses that included posttraumatic stress disorder (73%), dissociative disorder (40%), borderline personality disorder (37%), and multiple personality disorder (29%).⁷

Some patients may self-harm to generate feeling when emotionally empty or to avert suicidal intent.

The experience of adverse childhood events also increases risk for NSSI. This includes parental neglect, abuse, or deprivation.⁶ Insecure paternal attachment and parental neglect are significant predictors for women, while childhood separation is a primary predictor for men.⁸ Indirect childhood maltreatment, such as witnessing domestic violence or increased parental critique, is also associated with NSSI.⁸ NSSI is also more prevalent among young people who identify with a subculture such as gothic or emo.⁶

Why they do it and how to help

In multiple studies aimed at identifying reasons for self-injury, converging evidence suggests that nearly all patients act with the intent of alleviating negative affect.⁹ Patients self-harm to regulate distress, anxiety, and frustration that they perceive to be intolerable.⁹ They may self-harm to generate feeling when emotionally empty or to avert suicidal intent.⁹ For others, self-harm is a way to communicate their distress.

How to proceed. After a physician identifies NSSI, the patient should be assessed for suicidality and medical severity of the injury.³ Factors associated with higher likelihood of suicidality in patients with NSSI include multiple self-injurious methods and locations, early age of onset, longer history of NSSI, recent worsening of the injuries, simultaneous substance use, and the perception that the patient is addicted to self-injury.¹⁰

Continue to: It is also important...

It is also important to ask the patient whether she or he has told anyone about the behavior. Participation in NSSI communities may reinforce it.³

Treatment found to be effective for NSSI involves dialectical behavioral therapy, cognitive behavioral therapy, and mentalization-based therapy.¹¹

Our patient was admitted to the hospital several weeks after her well visit because she expressed suicidal ideation. After being discharged, she was referred to outpatient Psychiatry with a treatment plan that included cognitive behavioral therapy.

THE TAKEAWAY

While our patient may have concealed her self-injurious experience because of stigma and concern about others’ reactions, there were several risk factors for NSSI in her history that prompted further investigation with a skin exam.

If a patient presents with 1 or more risk factors, an initial assessment for possible NSSI should be performed with detailed history-taking and a skin exam. Once NSSI is identified, the initial response and tone of questioning toward the patient need to convey a sense of genuine curiosity about the patient’s experience. From there, the physician can avail the patient to the proper treatment modalities.

NSSI patients can be resistant to sharing and participating in support groups. However, a referred counselor can follow up with a stepwise approach to slowly gain the trust of the individual, find the root cause, and get the patient to a point where she or he is ready to start the necessary treatment.

THE CASE

A 14-year-old girl with no significant medical history presented to the office accompanied by her mother for a routine well-adolescent visit. She attended school online due to a history of severe bullying and, when interviewed alone, admitted to a lack of a social life as a result. On questioning, she denied tobacco, alcohol, or illicit drug use. Her gender identity was female. Her sexual orientation was toward both males and females, but she was not sexually active. She denied exposure to physical or emotional violence at home and said she did not feel depressed or think about suicide.

Physical examination revealed multiple erythematous linear scars surrounding the areola of both breasts. When questioned about these lesions, she admitted to cutting herself on the breasts during the past several months but again denied suicidal intent. She believed that her behavior was a normal coping mechanism. 

The physical exam was otherwise normal. Lab results, including thyroid-stimulating hormone and complete blood count, were within normal limits.

THE DIAGNOSIS

The physical exam findings and the patient’s self report pointed to a diagnosis of nonsuicidal self-injurious (NSSI) behavior involving cutting.

DISCUSSION

The NSSI behavior displayed by this patient is a common biopsychosocial disorder observed in adolescents. Self-injury is defined as the deliberate injuring of body tissues without suicidal intent.¹ Self-injurious behavior typically begins when patients are 13 to 16 years of age, and cutting is the most common form. Most acts occur on the arms, legs, wrists, and stomach.² Studies have shown that the prevalence of this behavior is on the rise among adolescents, from about 7% in 2014 to between 14% and 24% in 2015.³

Risk for suicide. Although a feature of NSSI is the lack of suicidal intent, this type of high-risk behavior is associated with past, present, and future suicide attempts. It is important for physicians to identify NSSI in an adolescent, as it is linked to a 7-fold increased risk for a suicide attempt.³

Screening for NSSI. Less than one-fifth of adolescents who injure themselves come to the attention of health care providers.⁴ We propose that primary care physicians add NSSI to the list of risky behaviors—including drug abuse, sexual activity, and depression—for which they screen during well-child visits.

Continue to: Identifying risk factors

Identifying risk factors. The case patient experienced bullying and reported a nonheterosexual orientation, both of which have been demonstrated as strong risk factors for NSSI.⁵ Female gender has also been identified as a risk factor for NSSI.³

In adolescent psychiatric samples, prevalence rates of NSSI were found to be as high as 60% for 1 incident of NSSI and around 50% for repetitive NSSI.⁶ NSSI coincides with other psychiatric comorbidities, including eating disorders, mood disorders (depression), anxiety disorders, posttraumatic stress disorder, and borderline personality disorder.³ In a study of 93 subjects, each of whom was a self-reported abuse survivor with a history of self-injury, 96% were in therapy for diagnoses that included posttraumatic stress disorder (73%), dissociative disorder (40%), borderline personality disorder (37%), and multiple personality disorder (29%).⁷

Some patients may self-harm to generate feeling when emotionally empty or to avert suicidal intent.

The experience of adverse childhood events also increases risk for NSSI. This includes parental neglect, abuse, or deprivation.⁶ Insecure paternal attachment and parental neglect are significant predictors for women, while childhood separation is a primary predictor for men.⁸ Indirect childhood maltreatment, such as witnessing domestic violence or increased parental critique, is also associated with NSSI.⁸ NSSI is also more prevalent among young people who identify with a subculture such as gothic or emo.⁶

Why they do it and how to help

In multiple studies aimed at identifying reasons for self-injury, converging evidence suggests that nearly all patients act with the intent of alleviating negative affect.⁹ Patients self-harm to regulate distress, anxiety, and frustration that they perceive to be intolerable.⁹ They may self-harm to generate feeling when emotionally empty or to avert suicidal intent.⁹ For others, self-harm is a way to communicate their distress.

How to proceed. After a physician identifies NSSI, the patient should be assessed for suicidality and medical severity of the injury.³ Factors associated with higher likelihood of suicidality in patients with NSSI include multiple self-injurious methods and locations, early age of onset, longer history of NSSI, recent worsening of the injuries, simultaneous substance use, and the perception that the patient is addicted to self-injury.¹⁰

Continue to: It is also important...

It is also important to ask the patient whether she or he has told anyone about the behavior. Participation in NSSI communities may reinforce it.³

Treatment found to be effective for NSSI involves dialectical behavioral therapy, cognitive behavioral therapy, and mentalization-based therapy.¹¹

Our patient was admitted to the hospital several weeks after her well visit because she expressed suicidal ideation. After being discharged, she was referred to outpatient Psychiatry with a treatment plan that included cognitive behavioral therapy.

THE TAKEAWAY

While our patient may have concealed her self-injurious experience because of stigma and concern about others’ reactions, there were several risk factors for NSSI in her history that prompted further investigation with a skin exam.

If a patient presents with 1 or more risk factors, an initial assessment for possible NSSI should be performed with detailed history-taking and a skin exam. Once NSSI is identified, the initial response and tone of questioning toward the patient need to convey a sense of genuine curiosity about the patient’s experience. From there, the physician can avail the patient to the proper treatment modalities.

NSSI patients can be resistant to sharing and participating in support groups. However, a referred counselor can follow up with a stepwise approach to slowly gain the trust of the individual, find the root cause, and get the patient to a point where she or he is ready to start the necessary treatment.

THE CASE

A 14-year-old girl with no significant medical history presented to the office accompanied by her mother for a routine well-adolescent visit. She attended school online due to a history of severe bullying and, when interviewed alone, admitted to a lack of a social life as a result. On questioning, she denied tobacco, alcohol, or illicit drug use. Her gender identity was female. Her sexual orientation was toward both males and females, but she was not sexually active. She denied exposure to physical or emotional violence at home and said she did not feel depressed or think about suicide.

Physical examination revealed multiple erythematous linear scars surrounding the areola of both breasts. When questioned about these lesions, she admitted to cutting herself on the breasts during the past several months but again denied suicidal intent. She believed that her behavior was a normal coping mechanism. 

The physical exam was otherwise normal. Lab results, including thyroid-stimulating hormone and complete blood count, were within normal limits.

THE DIAGNOSIS

The physical exam findings and the patient’s self report pointed to a diagnosis of nonsuicidal self-injurious (NSSI) behavior involving cutting.

DISCUSSION

The NSSI behavior displayed by this patient is a common biopsychosocial disorder observed in adolescents. Self-injury is defined as the deliberate injuring of body tissues without suicidal intent.¹ Self-injurious behavior typically begins when patients are 13 to 16 years of age, and cutting is the most common form. Most acts occur on the arms, legs, wrists, and stomach.² Studies have shown that the prevalence of this behavior is on the rise among adolescents, from about 7% in 2014 to between 14% and 24% in 2015.³

Risk for suicide. Although a feature of NSSI is the lack of suicidal intent, this type of high-risk behavior is associated with past, present, and future suicide attempts. It is important for physicians to identify NSSI in an adolescent, as it is linked to a 7-fold increased risk for a suicide attempt.³

Screening for NSSI. Less than one-fifth of adolescents who injure themselves come to the attention of health care providers.⁴ We propose that primary care physicians add NSSI to the list of risky behaviors—including drug abuse, sexual activity, and depression—for which they screen during well-child visits.

Continue to: Identifying risk factors

Identifying risk factors. The case patient experienced bullying and reported a nonheterosexual orientation, both of which have been demonstrated as strong risk factors for NSSI.⁵ Female gender has also been identified as a risk factor for NSSI.³

In adolescent psychiatric samples, prevalence rates of NSSI were found to be as high as 60% for 1 incident of NSSI and around 50% for repetitive NSSI.⁶ NSSI coincides with other psychiatric comorbidities, including eating disorders, mood disorders (depression), anxiety disorders, posttraumatic stress disorder, and borderline personality disorder.³ In a study of 93 subjects, each of whom was a self-reported abuse survivor with a history of self-injury, 96% were in therapy for diagnoses that included posttraumatic stress disorder (73%), dissociative disorder (40%), borderline personality disorder (37%), and multiple personality disorder (29%).⁷

Some patients may self-harm to generate feeling when emotionally empty or to avert suicidal intent.

The experience of adverse childhood events also increases risk for NSSI. This includes parental neglect, abuse, or deprivation.⁶ Insecure paternal attachment and parental neglect are significant predictors for women, while childhood separation is a primary predictor for men.⁸ Indirect childhood maltreatment, such as witnessing domestic violence or increased parental critique, is also associated with NSSI.⁸ NSSI is also more prevalent among young people who identify with a subculture such as gothic or emo.⁶

Why they do it and how to help

In multiple studies aimed at identifying reasons for self-injury, converging evidence suggests that nearly all patients act with the intent of alleviating negative affect.⁹ Patients self-harm to regulate distress, anxiety, and frustration that they perceive to be intolerable.⁹ They may self-harm to generate feeling when emotionally empty or to avert suicidal intent.⁹ For others, self-harm is a way to communicate their distress.

How to proceed. After a physician identifies NSSI, the patient should be assessed for suicidality and medical severity of the injury.³ Factors associated with higher likelihood of suicidality in patients with NSSI include multiple self-injurious methods and locations, early age of onset, longer history of NSSI, recent worsening of the injuries, simultaneous substance use, and the perception that the patient is addicted to self-injury.¹⁰

Continue to: It is also important...

It is also important to ask the patient whether she or he has told anyone about the behavior. Participation in NSSI communities may reinforce it.³

Treatment found to be effective for NSSI involves dialectical behavioral therapy, cognitive behavioral therapy, and mentalization-based therapy.¹¹

Our patient was admitted to the hospital several weeks after her well visit because she expressed suicidal ideation. After being discharged, she was referred to outpatient Psychiatry with a treatment plan that included cognitive behavioral therapy.

THE TAKEAWAY

While our patient may have concealed her self-injurious experience because of stigma and concern about others’ reactions, there were several risk factors for NSSI in her history that prompted further investigation with a skin exam.

If a patient presents with 1 or more risk factors, an initial assessment for possible NSSI should be performed with detailed history-taking and a skin exam. Once NSSI is identified, the initial response and tone of questioning toward the patient need to convey a sense of genuine curiosity about the patient’s experience. From there, the physician can avail the patient to the proper treatment modalities.

NSSI patients can be resistant to sharing and participating in support groups. However, a referred counselor can follow up with a stepwise approach to slowly gain the trust of the individual, find the root cause, and get the patient to a point where she or he is ready to start the necessary treatment.

The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.

The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,¹ and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.

COVID-19 vaccines

Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.² The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.³ Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.

Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 1^2-5).

In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.⁶ States are encouraged, but not required, to follow this priority list (TABLE 2⁶).

Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 3^7,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.

Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).

Continue to: Much remains unknown...

Much remains unknown regarding the use of these COVID-19 vaccines:

• What is their duration of protection, and will booster doses be needed?
• Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
• Can they be co-administered with other vaccines?
• Will they be efficacious and safe to use during pregnancy and breastfeeding?

These issues will need to be addressed before they are recommended for non–public health emergency use.

Quadrivalent meningococcal conjugate vaccine (MenACWY)

In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 4⁹). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.

MenQuadfi, approved for those ≥ 2 years including those > 55, will likely be approved for individuals ≥ 6 months and replace Menactra.

The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)

Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.⁹ A full description of current, updated recommendations for the prevention of meningococcal disease is also available.⁹

Continue to: Ebola virus (EBOV) vaccine

A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.

The ACIP has recommended pre-­exposure vaccination with rVSVΔG-­ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.¹⁰ The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.

It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.¹¹ Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.¹⁰ The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.

The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-­moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and sweating (3%).¹⁰ Data are not available to assess the safety of the vaccine during pregnancy; vaccinating pregnant women should probably be avoided unless the risk of exposure to EBOV is high.

Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.¹⁰ The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.

The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.

The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,¹ and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.

COVID-19 vaccines

Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.² The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.³ Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.

Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 1^2-5).

In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.⁶ States are encouraged, but not required, to follow this priority list (TABLE 2⁶).

Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 3^7,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.

Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).

Continue to: Much remains unknown...

Much remains unknown regarding the use of these COVID-19 vaccines:

• What is their duration of protection, and will booster doses be needed?
• Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
• Can they be co-administered with other vaccines?
• Will they be efficacious and safe to use during pregnancy and breastfeeding?

These issues will need to be addressed before they are recommended for non–public health emergency use.

Quadrivalent meningococcal conjugate vaccine (MenACWY)

In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 4⁹). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.

MenQuadfi, approved for those ≥ 2 years including those > 55, will likely be approved for individuals ≥ 6 months and replace Menactra.

The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)

Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.⁹ A full description of current, updated recommendations for the prevention of meningococcal disease is also available.⁹

Continue to: Ebola virus (EBOV) vaccine

A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.

The ACIP has recommended pre-­exposure vaccination with rVSVΔG-­ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.¹⁰ The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.

It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.¹¹ Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.¹⁰ The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.

The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-­moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and sweating (3%).¹⁰ Data are not available to assess the safety of the vaccine during pregnancy; vaccinating pregnant women should probably be avoided unless the risk of exposure to EBOV is high.

Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.¹⁰ The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.

The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.

The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,¹ and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.

COVID-19 vaccines

Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.² The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.³ Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.

Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 1^2-5).

In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.⁶ States are encouraged, but not required, to follow this priority list (TABLE 2⁶).

Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 3^7,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.

Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).

Continue to: Much remains unknown...

Much remains unknown regarding the use of these COVID-19 vaccines:

• What is their duration of protection, and will booster doses be needed?
• Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
• Can they be co-administered with other vaccines?
• Will they be efficacious and safe to use during pregnancy and breastfeeding?

These issues will need to be addressed before they are recommended for non–public health emergency use.

Quadrivalent meningococcal conjugate vaccine (MenACWY)

In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 4⁹). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.

MenQuadfi, approved for those ≥ 2 years including those > 55, will likely be approved for individuals ≥ 6 months and replace Menactra.

The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)

Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.⁹ A full description of current, updated recommendations for the prevention of meningococcal disease is also available.⁹

Continue to: Ebola virus (EBOV) vaccine

A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.

The ACIP has recommended pre-­exposure vaccination with rVSVΔG-­ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.¹⁰ The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.

It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.¹¹ Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.¹⁰ The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.

The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-­moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and sweating (3%).¹⁰ Data are not available to assess the safety of the vaccine during pregnancy; vaccinating pregnant women should probably be avoided unless the risk of exposure to EBOV is high.

Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.¹⁰ The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.

The shoulder, or glenohumeral joint, is the most commonly dislocated large joint; dislocation occurs at a rate of 23.9 per 100,000 person/years.^1,2 There are 2 types of dislocation: traumatic anterior dislocation, which accounts for roughly 90% of dislocations, and posterior dislocation (10%).³ Anterior dislocation typically occurs when the patient’s shoulder is forcefully abducted and externally rotated.

The diagnosis is made after review of the history and mechanism of injury and performance of a complete physical exam with imaging studies—the most critical component of diagnosis.⁴ Standard radiographs (anteroposterior, axillary, and scapular Y) can confirm the presence of a dislocation; once the diagnosis is confirmed, closed reduction of the joint should be performed.¹ (Methods of reduction are beyond the scope of this article but have been recently reviewed.⁵)

Risk for recurrence drives management choices

Following an initial shoulder dislocation, the risk of recurrence is high.^6,7 Rates vary based on age, pathology after dislocation, activity level, type of immobilization, and whether surgery was performed. Overall, age is the strongest predictor of recurrence: 72% of patients ages 12 to 22 years, 56% of those ages 23 to 29 years, and 27% of those older than 30 years experience recurrence.⁶ Patients who have recurrent dislocations are at risk for arthropathy, fear of instability, and worsening surgical outcomes.⁶

Reducing the risk of a recurrent shoulder dislocation has been the focus of intense study. Proponents of surgical stabilization argue that surgery—rather than a trial of conservative treatment—is best when you consider the high risk of recurrence in young athletes (the population primarily studied), the soft-tissue and bony damage caused by recurrent instability, and the predictable improvement in quality of life following surgery.

In a recent systematic review and meta-analysis, there was evidence that, for first-time traumatic shoulder dislocations, early surgery led to fewer repeat shoulder dislocations (number needed to treat [NNT] = 2-4.7). However, a significant number of patients primarily treated nonoperatively did not experience a repeat shoulder dislocation within 2 years.²

The conflicting results from randomized trials comparing operative intervention to conservative management have led surgeons and physicians in other specialties to take different approaches to the management of shoulder dislocation.² In this review, we aim to summarize considerations for conservative vs surgical management and provide clinical guidance for primary care physicians.

When to try conservative management

Although the initial treatment after a traumatic anterior shoulder dislocation has been debated, a recent meta-analysis of randomized controlled trials showed that at least half of first-time dislocations are successfully treated with conservative management.² Management can include immobilization for comfort and/or physical therapy. Age will play a role, as mentioned earlier; in general, patients older than 30 have a significant decrease in recurrence rate and are good candidates for conservative therapy.⁶ It should be noted that much of the research with regard to management of shoulder dislocations has been done in an athletic population.

Continue to: Immobilization may benefit some

Recent evidence has determined that the duration of immobilization in internal rotation does not impact recurrent instability.^8,9 In patients older than 30, the rate of repeat dislocation is lower, and early mobilization after 1 week is advocated to avoid joint stiffness and minimize the risk of adhesive capsulitis.¹⁰

Arm position during immobilization remains controversial.¹¹ In a classic study by Itoi et al, immobilization for 3 weeks in internal rotation vs 10° of external rotation was associated with a recurrence rate of 42% vs 26%, respectively.¹² In this study, immobilization in 10° of external rotation was especially beneficial for patients ages 30 years or younger.¹²

At least half of first-time dislocations are successfully treated with conservative management.

Cadaveric and magnetic resonance imaging (MRI) studies have shown external rotation may improve the odds of labral tear healing by positioning the damaged and intact parts of the glenoid labrum in closer proximity.¹³ While this is theoretically plausible, a recent Cochrane review found insufficient evidence to determine whether immobilization in external rotation has any benefits beyond those offered by internal rotation.¹⁴ A recent systematic review and meta-analysis found that immobilization in external rotation vs internal rotation after a first-time traumatic shoulder dislocation did not change outcomes.² With that said, most would prefer to immobilize in the internal rotation position for ease.

More research is needed. A Cochrane review highlighted the need for continued research.¹⁴ Additionally, most of the available randomized controlled trials to date have consisted of young men, with the majority of dislocations related to sports activities. Women, nonathletes, and older patients have been understudied to date; extrapolating current research to those groups of patients may not be appropriate and should be a focus for future research.²

Physical therapy: The conservative standard of care

Rehabilitation after glenohumeral joint dislocation is the current standard of care in conservative management to reduce the risk for repeat dislocation.¹⁵ Depending on the specific characteristics of the instability pattern, the approach may be adapted to the patient. A recent review focused on the following 4 key points: (1) restoration of rotator cuff strength, focusing on the eccentric capacity of the external rotators, (2) normalization of rotational range of motion with particular focus on internal range of motion, (3) optimization of the flexibility and muscle performance of the scapular muscles, and (4) increasing the functional sport-specific load on the shoulder girdle.

Continue to: A common approach to the care of...

A common approach to the care of a patient after a glenohumeral joint dislocation is to place the patient’s shoulder in a sling for comfort, with permitted pain-free isometric exercise along with passive and assisted elevation up to 100°.¹⁶ This is followed by a nonaggressive rehabilitation protocol for 2 months until full recovery, which includes progressive range of motion, strength, proprioception, and return to functional activities.¹⁶

An increasing number of dislocations portends a poor outcome with nonoperative treatment.

More aggressive return-to-play protocols with accelerated timelines and functional progression have been studied, including in a multicenter observational study that followed 45 contact intercollegiate athletes prospectively after in-season anterior glenohumeral instability. Thirty-three of 45 (73%) athletes returned to sport for either all or part of the season after a median 5 days lost from competition, with 12 athletes (27%) successfully completing the season without recurrence. Athletes with a subluxation event were 5.3 times more likely to return to sport during the same season, compared with those with dislocations.¹⁷

Dynamic bracing may also allow for a safe and quicker return to sport in athletes¹⁸ but recently was shown to not impact recurrent dislocation risk.¹⁹

Return to play should be based on subjective assessment as well as objective measurements of range of motion, strength, and dynamic function.¹⁵ Patients who continue to have significant weakness and pain at 2 to 3 weeks post injury despite physical therapy should be re-evaluated with an MRI for concomitant rotator cuff tears and need for surgical referral.²⁰

When to consider surgical intervention

In a recent meta-analysis, recurrent dislocation and instability occurred at a rate of 52.9% following nonsurgical treatment.² The decision to perform surgical intervention is typically made following failure of conservative management. Other considerations include age, gender, bone loss, and cartilage defect.^21,22 Age younger than 30 years, participation in competition, contact sports, and male gender have been associated with an increased risk of recurrence.^23-25 For this reason, obtaining an MRI at time of first dislocation can help facilitate surgical decisions if the patient is at high risk for surgical need.²⁶

Continue to: An increasing number...

An increasing number of dislocations portends a poor outcome with nonoperative treatment. Kao et al demonstrated a second dislocation leads to another dislocation in 19.6% of cases, while 44.3% of those with a third dislocation event will sustain another dislocation.²⁴ Surgery should be considered for patients with recurrent instability events to prevent persistent instability and decrease the amount of bone loss that can occur with repetitive dislocations.

What are the surgical options?

Several surgical options exist to remedy the unstable shoulder. Procedures can range from an arthroscopic repair to an open stabilization combined with structural bone graft to replace a bone defect caused by repetitive dislocations.

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.²¹ These techniques cause less pain in the early postoperative period and provide for a faster return to work.²⁷ Arthroscopy has the additional advantage of allowing for complete visualization of the glenohumeral joint to identify and address concomitant pathology, such as intra-articular loose bodies or rotator cuff tears.

Open repair was the mainstay of treatment prior to development of arthroscopic techniques. Some surgeons still prefer this method—especially in high-risk groups—because of a lower risk of recurrent disloca-tion.²⁸ Open techniques often involve detachment and repair of the upper subscapularis tendon and are more likely to produce long-term losses in external rotation range of motion.²⁸

Which one is appropriate for your patient? The decision to pursue an open or arthroscopic procedure and to augment with bone graft depends on the amount of glenoid and humeral head bone loss, patient activity level, risk of recurrent dislocation, and surgeon preference.

Continue to: For the nonathletic population...

For the nonathletic population, the timing of injury is less critical and surgery is typically recommended after conservative treatment has failed. In an athletic population, the timing of injury is a necessary consideration. An injury midseason may be “rehabbed” in hopes of returning to play. Individuals with injuries occurring at the end of a season, who are unable to regain desired function, and/or with peri-articular fractures or associated full-thickness rotator cuff tears may benefit from sooner surgical intervention.²¹

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.

Owens et al have described appropriate surgical indications and recommendations for an in-season athlete.²¹ In this particular algorithm, the authors suggest obtaining an MRI for decision making, but this is specific to in-season athletes wishing to return to play. In general, an MRI is not always indicated for patients who wish to receive conservative therapy but would be indicated for surgical considerations. The algorithm otherwise uses bone and soft-tissue injury, recurrent instability, and timing in the season to help determine management.²¹

Outcomes: Surgery has advantages …

Recurrence rates following surgical intervention are considerably lower than with conservative management, especially among young, active individuals. A recent systematic review by Donohue et al demonstrated recurrent instability rates following surgical intervention as low as 2.4%.²⁹ One study comparing the outcome of arthroscopic repair vs conservative management showed that the risk of postoperative instability was reduced by 20% compared to other treatments.⁷ Furthermore, early surgical fixation can improve quality of life, produce better functional outcomes, decrease time away from activity, increase patient satisfaction, and slow the development of glenohumeral osteoarthritis produced from recurrent instability.^2,7

Complications. Surgery does carry inherent risks of infection, anesthesia effects, surgical complications, and surgical failure. Recurrent instability is the most common complication following surgical shoulder stabilization. Rates of recurrent instability after surgical stabilization depend on patient age, activity level, and amount of bone loss: males younger than 18 years who participate in contact competitive sports and have significant bone loss are more likely to have recurrent dislocation after surgery.²³ The type of surgical procedure selected may decrease this risk.

While the open procedures decrease risk of postoperative instability, these surgeries can pose a significant risk of complications. Major complications for specific open techniques have been reported in up to 30% of patients³⁰ and are associated with lower levels of surgeon experience.³¹ While the healing of bones and ligaments is always a concern, 1 of the most feared complications following stabilization surgery is iatrogenic nerve injury. Because of the axillary nerve’s close proximity to the inferior glenoid, this nerve can be injured without meticulous care and can result in paralysis of the deltoid muscle. This injury poses a major impediment to normal shoulder function. Some procedures may cause nerve injuries in up to 10% of patients, although most injuries are transient.³²

Continue to: Bottom line

Due to the void of evidence-based guidelines for conservative vs surgical management of primary shoulder dislocation, it would be prudent to have a risk-benefit discussion with patients regarding treatment options.

Patients older than 30 years and those with uncomplicated injuries are best suited for conservative management of primary shoulder dislocations. Immobilization is debated and may not change outcomes, but a progressive rehabilitative program after the initial acute injury is helpful. Risk factors for failing conservative management include recurrent dislocation, subsequent arthropathy, and additional concomitant bone or soft-­tissue injuries.

Patients younger than 30 years who have complicated injuries with bone or cartilage loss, rotator cuff tears, or recurrent instability, and highly physically active individuals are best suited for surgical management. Shoulder arthroscopy has become the mainstay of surgical treatment for shoulder dislocations. Outcomes are favorable and dislocation recurrence is low after surgical repair. Surgery does carry its own inherent risks of infection, anesthesia effects, complications during surgery, and surgical failure leading to recurrent instability.

CORRESPONDENCE
Cayce Onks, DO, MS, ATC, Penn State Hershey, Milton S. Hershey Medical Center, Penn State College of Medicine, Family and Community Medicine H154, 500 University Drive, PO Box 850, Hershey, PA 17033-0850; [email protected]

The shoulder, or glenohumeral joint, is the most commonly dislocated large joint; dislocation occurs at a rate of 23.9 per 100,000 person/years.^1,2 There are 2 types of dislocation: traumatic anterior dislocation, which accounts for roughly 90% of dislocations, and posterior dislocation (10%).³ Anterior dislocation typically occurs when the patient’s shoulder is forcefully abducted and externally rotated.

The diagnosis is made after review of the history and mechanism of injury and performance of a complete physical exam with imaging studies—the most critical component of diagnosis.⁴ Standard radiographs (anteroposterior, axillary, and scapular Y) can confirm the presence of a dislocation; once the diagnosis is confirmed, closed reduction of the joint should be performed.¹ (Methods of reduction are beyond the scope of this article but have been recently reviewed.⁵)

Risk for recurrence drives management choices

Following an initial shoulder dislocation, the risk of recurrence is high.^6,7 Rates vary based on age, pathology after dislocation, activity level, type of immobilization, and whether surgery was performed. Overall, age is the strongest predictor of recurrence: 72% of patients ages 12 to 22 years, 56% of those ages 23 to 29 years, and 27% of those older than 30 years experience recurrence.⁶ Patients who have recurrent dislocations are at risk for arthropathy, fear of instability, and worsening surgical outcomes.⁶

Reducing the risk of a recurrent shoulder dislocation has been the focus of intense study. Proponents of surgical stabilization argue that surgery—rather than a trial of conservative treatment—is best when you consider the high risk of recurrence in young athletes (the population primarily studied), the soft-tissue and bony damage caused by recurrent instability, and the predictable improvement in quality of life following surgery.

In a recent systematic review and meta-analysis, there was evidence that, for first-time traumatic shoulder dislocations, early surgery led to fewer repeat shoulder dislocations (number needed to treat [NNT] = 2-4.7). However, a significant number of patients primarily treated nonoperatively did not experience a repeat shoulder dislocation within 2 years.²

The conflicting results from randomized trials comparing operative intervention to conservative management have led surgeons and physicians in other specialties to take different approaches to the management of shoulder dislocation.² In this review, we aim to summarize considerations for conservative vs surgical management and provide clinical guidance for primary care physicians.

When to try conservative management

Although the initial treatment after a traumatic anterior shoulder dislocation has been debated, a recent meta-analysis of randomized controlled trials showed that at least half of first-time dislocations are successfully treated with conservative management.² Management can include immobilization for comfort and/or physical therapy. Age will play a role, as mentioned earlier; in general, patients older than 30 have a significant decrease in recurrence rate and are good candidates for conservative therapy.⁶ It should be noted that much of the research with regard to management of shoulder dislocations has been done in an athletic population.

Continue to: Immobilization may benefit some

Recent evidence has determined that the duration of immobilization in internal rotation does not impact recurrent instability.^8,9 In patients older than 30, the rate of repeat dislocation is lower, and early mobilization after 1 week is advocated to avoid joint stiffness and minimize the risk of adhesive capsulitis.¹⁰

Arm position during immobilization remains controversial.¹¹ In a classic study by Itoi et al, immobilization for 3 weeks in internal rotation vs 10° of external rotation was associated with a recurrence rate of 42% vs 26%, respectively.¹² In this study, immobilization in 10° of external rotation was especially beneficial for patients ages 30 years or younger.¹²

At least half of first-time dislocations are successfully treated with conservative management.

Cadaveric and magnetic resonance imaging (MRI) studies have shown external rotation may improve the odds of labral tear healing by positioning the damaged and intact parts of the glenoid labrum in closer proximity.¹³ While this is theoretically plausible, a recent Cochrane review found insufficient evidence to determine whether immobilization in external rotation has any benefits beyond those offered by internal rotation.¹⁴ A recent systematic review and meta-analysis found that immobilization in external rotation vs internal rotation after a first-time traumatic shoulder dislocation did not change outcomes.² With that said, most would prefer to immobilize in the internal rotation position for ease.

More research is needed. A Cochrane review highlighted the need for continued research.¹⁴ Additionally, most of the available randomized controlled trials to date have consisted of young men, with the majority of dislocations related to sports activities. Women, nonathletes, and older patients have been understudied to date; extrapolating current research to those groups of patients may not be appropriate and should be a focus for future research.²

Physical therapy: The conservative standard of care

Rehabilitation after glenohumeral joint dislocation is the current standard of care in conservative management to reduce the risk for repeat dislocation.¹⁵ Depending on the specific characteristics of the instability pattern, the approach may be adapted to the patient. A recent review focused on the following 4 key points: (1) restoration of rotator cuff strength, focusing on the eccentric capacity of the external rotators, (2) normalization of rotational range of motion with particular focus on internal range of motion, (3) optimization of the flexibility and muscle performance of the scapular muscles, and (4) increasing the functional sport-specific load on the shoulder girdle.

Continue to: A common approach to the care of...

A common approach to the care of a patient after a glenohumeral joint dislocation is to place the patient’s shoulder in a sling for comfort, with permitted pain-free isometric exercise along with passive and assisted elevation up to 100°.¹⁶ This is followed by a nonaggressive rehabilitation protocol for 2 months until full recovery, which includes progressive range of motion, strength, proprioception, and return to functional activities.¹⁶

An increasing number of dislocations portends a poor outcome with nonoperative treatment.

More aggressive return-to-play protocols with accelerated timelines and functional progression have been studied, including in a multicenter observational study that followed 45 contact intercollegiate athletes prospectively after in-season anterior glenohumeral instability. Thirty-three of 45 (73%) athletes returned to sport for either all or part of the season after a median 5 days lost from competition, with 12 athletes (27%) successfully completing the season without recurrence. Athletes with a subluxation event were 5.3 times more likely to return to sport during the same season, compared with those with dislocations.¹⁷

Dynamic bracing may also allow for a safe and quicker return to sport in athletes¹⁸ but recently was shown to not impact recurrent dislocation risk.¹⁹

Return to play should be based on subjective assessment as well as objective measurements of range of motion, strength, and dynamic function.¹⁵ Patients who continue to have significant weakness and pain at 2 to 3 weeks post injury despite physical therapy should be re-evaluated with an MRI for concomitant rotator cuff tears and need for surgical referral.²⁰

When to consider surgical intervention

In a recent meta-analysis, recurrent dislocation and instability occurred at a rate of 52.9% following nonsurgical treatment.² The decision to perform surgical intervention is typically made following failure of conservative management. Other considerations include age, gender, bone loss, and cartilage defect.^21,22 Age younger than 30 years, participation in competition, contact sports, and male gender have been associated with an increased risk of recurrence.^23-25 For this reason, obtaining an MRI at time of first dislocation can help facilitate surgical decisions if the patient is at high risk for surgical need.²⁶

Continue to: An increasing number...

An increasing number of dislocations portends a poor outcome with nonoperative treatment. Kao et al demonstrated a second dislocation leads to another dislocation in 19.6% of cases, while 44.3% of those with a third dislocation event will sustain another dislocation.²⁴ Surgery should be considered for patients with recurrent instability events to prevent persistent instability and decrease the amount of bone loss that can occur with repetitive dislocations.

What are the surgical options?

Several surgical options exist to remedy the unstable shoulder. Procedures can range from an arthroscopic repair to an open stabilization combined with structural bone graft to replace a bone defect caused by repetitive dislocations.

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.²¹ These techniques cause less pain in the early postoperative period and provide for a faster return to work.²⁷ Arthroscopy has the additional advantage of allowing for complete visualization of the glenohumeral joint to identify and address concomitant pathology, such as intra-articular loose bodies or rotator cuff tears.

Open repair was the mainstay of treatment prior to development of arthroscopic techniques. Some surgeons still prefer this method—especially in high-risk groups—because of a lower risk of recurrent disloca-tion.²⁸ Open techniques often involve detachment and repair of the upper subscapularis tendon and are more likely to produce long-term losses in external rotation range of motion.²⁸

Which one is appropriate for your patient? The decision to pursue an open or arthroscopic procedure and to augment with bone graft depends on the amount of glenoid and humeral head bone loss, patient activity level, risk of recurrent dislocation, and surgeon preference.

Continue to: For the nonathletic population...

For the nonathletic population, the timing of injury is less critical and surgery is typically recommended after conservative treatment has failed. In an athletic population, the timing of injury is a necessary consideration. An injury midseason may be “rehabbed” in hopes of returning to play. Individuals with injuries occurring at the end of a season, who are unable to regain desired function, and/or with peri-articular fractures or associated full-thickness rotator cuff tears may benefit from sooner surgical intervention.²¹

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.

Owens et al have described appropriate surgical indications and recommendations for an in-season athlete.²¹ In this particular algorithm, the authors suggest obtaining an MRI for decision making, but this is specific to in-season athletes wishing to return to play. In general, an MRI is not always indicated for patients who wish to receive conservative therapy but would be indicated for surgical considerations. The algorithm otherwise uses bone and soft-tissue injury, recurrent instability, and timing in the season to help determine management.²¹

Outcomes: Surgery has advantages …

Recurrence rates following surgical intervention are considerably lower than with conservative management, especially among young, active individuals. A recent systematic review by Donohue et al demonstrated recurrent instability rates following surgical intervention as low as 2.4%.²⁹ One study comparing the outcome of arthroscopic repair vs conservative management showed that the risk of postoperative instability was reduced by 20% compared to other treatments.⁷ Furthermore, early surgical fixation can improve quality of life, produce better functional outcomes, decrease time away from activity, increase patient satisfaction, and slow the development of glenohumeral osteoarthritis produced from recurrent instability.^2,7

Complications. Surgery does carry inherent risks of infection, anesthesia effects, surgical complications, and surgical failure. Recurrent instability is the most common complication following surgical shoulder stabilization. Rates of recurrent instability after surgical stabilization depend on patient age, activity level, and amount of bone loss: males younger than 18 years who participate in contact competitive sports and have significant bone loss are more likely to have recurrent dislocation after surgery.²³ The type of surgical procedure selected may decrease this risk.

While the open procedures decrease risk of postoperative instability, these surgeries can pose a significant risk of complications. Major complications for specific open techniques have been reported in up to 30% of patients³⁰ and are associated with lower levels of surgeon experience.³¹ While the healing of bones and ligaments is always a concern, 1 of the most feared complications following stabilization surgery is iatrogenic nerve injury. Because of the axillary nerve’s close proximity to the inferior glenoid, this nerve can be injured without meticulous care and can result in paralysis of the deltoid muscle. This injury poses a major impediment to normal shoulder function. Some procedures may cause nerve injuries in up to 10% of patients, although most injuries are transient.³²

Continue to: Bottom line

Due to the void of evidence-based guidelines for conservative vs surgical management of primary shoulder dislocation, it would be prudent to have a risk-benefit discussion with patients regarding treatment options.

Patients older than 30 years and those with uncomplicated injuries are best suited for conservative management of primary shoulder dislocations. Immobilization is debated and may not change outcomes, but a progressive rehabilitative program after the initial acute injury is helpful. Risk factors for failing conservative management include recurrent dislocation, subsequent arthropathy, and additional concomitant bone or soft-­tissue injuries.

Patients younger than 30 years who have complicated injuries with bone or cartilage loss, rotator cuff tears, or recurrent instability, and highly physically active individuals are best suited for surgical management. Shoulder arthroscopy has become the mainstay of surgical treatment for shoulder dislocations. Outcomes are favorable and dislocation recurrence is low after surgical repair. Surgery does carry its own inherent risks of infection, anesthesia effects, complications during surgery, and surgical failure leading to recurrent instability.

CORRESPONDENCE
Cayce Onks, DO, MS, ATC, Penn State Hershey, Milton S. Hershey Medical Center, Penn State College of Medicine, Family and Community Medicine H154, 500 University Drive, PO Box 850, Hershey, PA 17033-0850; [email protected]

The shoulder, or glenohumeral joint, is the most commonly dislocated large joint; dislocation occurs at a rate of 23.9 per 100,000 person/years.^1,2 There are 2 types of dislocation: traumatic anterior dislocation, which accounts for roughly 90% of dislocations, and posterior dislocation (10%).³ Anterior dislocation typically occurs when the patient’s shoulder is forcefully abducted and externally rotated.

The diagnosis is made after review of the history and mechanism of injury and performance of a complete physical exam with imaging studies—the most critical component of diagnosis.⁴ Standard radiographs (anteroposterior, axillary, and scapular Y) can confirm the presence of a dislocation; once the diagnosis is confirmed, closed reduction of the joint should be performed.¹ (Methods of reduction are beyond the scope of this article but have been recently reviewed.⁵)

Risk for recurrence drives management choices

Following an initial shoulder dislocation, the risk of recurrence is high.^6,7 Rates vary based on age, pathology after dislocation, activity level, type of immobilization, and whether surgery was performed. Overall, age is the strongest predictor of recurrence: 72% of patients ages 12 to 22 years, 56% of those ages 23 to 29 years, and 27% of those older than 30 years experience recurrence.⁶ Patients who have recurrent dislocations are at risk for arthropathy, fear of instability, and worsening surgical outcomes.⁶

Reducing the risk of a recurrent shoulder dislocation has been the focus of intense study. Proponents of surgical stabilization argue that surgery—rather than a trial of conservative treatment—is best when you consider the high risk of recurrence in young athletes (the population primarily studied), the soft-tissue and bony damage caused by recurrent instability, and the predictable improvement in quality of life following surgery.

In a recent systematic review and meta-analysis, there was evidence that, for first-time traumatic shoulder dislocations, early surgery led to fewer repeat shoulder dislocations (number needed to treat [NNT] = 2-4.7). However, a significant number of patients primarily treated nonoperatively did not experience a repeat shoulder dislocation within 2 years.²

The conflicting results from randomized trials comparing operative intervention to conservative management have led surgeons and physicians in other specialties to take different approaches to the management of shoulder dislocation.² In this review, we aim to summarize considerations for conservative vs surgical management and provide clinical guidance for primary care physicians.

When to try conservative management

Although the initial treatment after a traumatic anterior shoulder dislocation has been debated, a recent meta-analysis of randomized controlled trials showed that at least half of first-time dislocations are successfully treated with conservative management.² Management can include immobilization for comfort and/or physical therapy. Age will play a role, as mentioned earlier; in general, patients older than 30 have a significant decrease in recurrence rate and are good candidates for conservative therapy.⁶ It should be noted that much of the research with regard to management of shoulder dislocations has been done in an athletic population.

Continue to: Immobilization may benefit some

Recent evidence has determined that the duration of immobilization in internal rotation does not impact recurrent instability.^8,9 In patients older than 30, the rate of repeat dislocation is lower, and early mobilization after 1 week is advocated to avoid joint stiffness and minimize the risk of adhesive capsulitis.¹⁰

Arm position during immobilization remains controversial.¹¹ In a classic study by Itoi et al, immobilization for 3 weeks in internal rotation vs 10° of external rotation was associated with a recurrence rate of 42% vs 26%, respectively.¹² In this study, immobilization in 10° of external rotation was especially beneficial for patients ages 30 years or younger.¹²

At least half of first-time dislocations are successfully treated with conservative management.

Cadaveric and magnetic resonance imaging (MRI) studies have shown external rotation may improve the odds of labral tear healing by positioning the damaged and intact parts of the glenoid labrum in closer proximity.¹³ While this is theoretically plausible, a recent Cochrane review found insufficient evidence to determine whether immobilization in external rotation has any benefits beyond those offered by internal rotation.¹⁴ A recent systematic review and meta-analysis found that immobilization in external rotation vs internal rotation after a first-time traumatic shoulder dislocation did not change outcomes.² With that said, most would prefer to immobilize in the internal rotation position for ease.

More research is needed. A Cochrane review highlighted the need for continued research.¹⁴ Additionally, most of the available randomized controlled trials to date have consisted of young men, with the majority of dislocations related to sports activities. Women, nonathletes, and older patients have been understudied to date; extrapolating current research to those groups of patients may not be appropriate and should be a focus for future research.²

Physical therapy: The conservative standard of care

Rehabilitation after glenohumeral joint dislocation is the current standard of care in conservative management to reduce the risk for repeat dislocation.¹⁵ Depending on the specific characteristics of the instability pattern, the approach may be adapted to the patient. A recent review focused on the following 4 key points: (1) restoration of rotator cuff strength, focusing on the eccentric capacity of the external rotators, (2) normalization of rotational range of motion with particular focus on internal range of motion, (3) optimization of the flexibility and muscle performance of the scapular muscles, and (4) increasing the functional sport-specific load on the shoulder girdle.

Continue to: A common approach to the care of...

A common approach to the care of a patient after a glenohumeral joint dislocation is to place the patient’s shoulder in a sling for comfort, with permitted pain-free isometric exercise along with passive and assisted elevation up to 100°.¹⁶ This is followed by a nonaggressive rehabilitation protocol for 2 months until full recovery, which includes progressive range of motion, strength, proprioception, and return to functional activities.¹⁶

An increasing number of dislocations portends a poor outcome with nonoperative treatment.

More aggressive return-to-play protocols with accelerated timelines and functional progression have been studied, including in a multicenter observational study that followed 45 contact intercollegiate athletes prospectively after in-season anterior glenohumeral instability. Thirty-three of 45 (73%) athletes returned to sport for either all or part of the season after a median 5 days lost from competition, with 12 athletes (27%) successfully completing the season without recurrence. Athletes with a subluxation event were 5.3 times more likely to return to sport during the same season, compared with those with dislocations.¹⁷

Dynamic bracing may also allow for a safe and quicker return to sport in athletes¹⁸ but recently was shown to not impact recurrent dislocation risk.¹⁹

Return to play should be based on subjective assessment as well as objective measurements of range of motion, strength, and dynamic function.¹⁵ Patients who continue to have significant weakness and pain at 2 to 3 weeks post injury despite physical therapy should be re-evaluated with an MRI for concomitant rotator cuff tears and need for surgical referral.²⁰

When to consider surgical intervention

In a recent meta-analysis, recurrent dislocation and instability occurred at a rate of 52.9% following nonsurgical treatment.² The decision to perform surgical intervention is typically made following failure of conservative management. Other considerations include age, gender, bone loss, and cartilage defect.^21,22 Age younger than 30 years, participation in competition, contact sports, and male gender have been associated with an increased risk of recurrence.^23-25 For this reason, obtaining an MRI at time of first dislocation can help facilitate surgical decisions if the patient is at high risk for surgical need.²⁶

Continue to: An increasing number...

An increasing number of dislocations portends a poor outcome with nonoperative treatment. Kao et al demonstrated a second dislocation leads to another dislocation in 19.6% of cases, while 44.3% of those with a third dislocation event will sustain another dislocation.²⁴ Surgery should be considered for patients with recurrent instability events to prevent persistent instability and decrease the amount of bone loss that can occur with repetitive dislocations.

What are the surgical options?

Several surgical options exist to remedy the unstable shoulder. Procedures can range from an arthroscopic repair to an open stabilization combined with structural bone graft to replace a bone defect caused by repetitive dislocations.

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.²¹ These techniques cause less pain in the early postoperative period and provide for a faster return to work.²⁷ Arthroscopy has the additional advantage of allowing for complete visualization of the glenohumeral joint to identify and address concomitant pathology, such as intra-articular loose bodies or rotator cuff tears.

Open repair was the mainstay of treatment prior to development of arthroscopic techniques. Some surgeons still prefer this method—especially in high-risk groups—because of a lower risk of recurrent disloca-tion.²⁸ Open techniques often involve detachment and repair of the upper subscapularis tendon and are more likely to produce long-term losses in external rotation range of motion.²⁸

Which one is appropriate for your patient? The decision to pursue an open or arthroscopic procedure and to augment with bone graft depends on the amount of glenoid and humeral head bone loss, patient activity level, risk of recurrent dislocation, and surgeon preference.

Continue to: For the nonathletic population...

For the nonathletic population, the timing of injury is less critical and surgery is typically recommended after conservative treatment has failed. In an athletic population, the timing of injury is a necessary consideration. An injury midseason may be “rehabbed” in hopes of returning to play. Individuals with injuries occurring at the end of a season, who are unable to regain desired function, and/or with peri-articular fractures or associated full-thickness rotator cuff tears may benefit from sooner surgical intervention.²¹

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.

Owens et al have described appropriate surgical indications and recommendations for an in-season athlete.²¹ In this particular algorithm, the authors suggest obtaining an MRI for decision making, but this is specific to in-season athletes wishing to return to play. In general, an MRI is not always indicated for patients who wish to receive conservative therapy but would be indicated for surgical considerations. The algorithm otherwise uses bone and soft-tissue injury, recurrent instability, and timing in the season to help determine management.²¹

Outcomes: Surgery has advantages …

Recurrence rates following surgical intervention are considerably lower than with conservative management, especially among young, active individuals. A recent systematic review by Donohue et al demonstrated recurrent instability rates following surgical intervention as low as 2.4%.²⁹ One study comparing the outcome of arthroscopic repair vs conservative management showed that the risk of postoperative instability was reduced by 20% compared to other treatments.⁷ Furthermore, early surgical fixation can improve quality of life, produce better functional outcomes, decrease time away from activity, increase patient satisfaction, and slow the development of glenohumeral osteoarthritis produced from recurrent instability.^2,7

Complications. Surgery does carry inherent risks of infection, anesthesia effects, surgical complications, and surgical failure. Recurrent instability is the most common complication following surgical shoulder stabilization. Rates of recurrent instability after surgical stabilization depend on patient age, activity level, and amount of bone loss: males younger than 18 years who participate in contact competitive sports and have significant bone loss are more likely to have recurrent dislocation after surgery.²³ The type of surgical procedure selected may decrease this risk.

While the open procedures decrease risk of postoperative instability, these surgeries can pose a significant risk of complications. Major complications for specific open techniques have been reported in up to 30% of patients³⁰ and are associated with lower levels of surgeon experience.³¹ While the healing of bones and ligaments is always a concern, 1 of the most feared complications following stabilization surgery is iatrogenic nerve injury. Because of the axillary nerve’s close proximity to the inferior glenoid, this nerve can be injured without meticulous care and can result in paralysis of the deltoid muscle. This injury poses a major impediment to normal shoulder function. Some procedures may cause nerve injuries in up to 10% of patients, although most injuries are transient.³²

Continue to: Bottom line

Due to the void of evidence-based guidelines for conservative vs surgical management of primary shoulder dislocation, it would be prudent to have a risk-benefit discussion with patients regarding treatment options.

Patients older than 30 years and those with uncomplicated injuries are best suited for conservative management of primary shoulder dislocations. Immobilization is debated and may not change outcomes, but a progressive rehabilitative program after the initial acute injury is helpful. Risk factors for failing conservative management include recurrent dislocation, subsequent arthropathy, and additional concomitant bone or soft-­tissue injuries.

Patients younger than 30 years who have complicated injuries with bone or cartilage loss, rotator cuff tears, or recurrent instability, and highly physically active individuals are best suited for surgical management. Shoulder arthroscopy has become the mainstay of surgical treatment for shoulder dislocations. Outcomes are favorable and dislocation recurrence is low after surgical repair. Surgery does carry its own inherent risks of infection, anesthesia effects, complications during surgery, and surgical failure leading to recurrent instability.

CORRESPONDENCE
Cayce Onks, DO, MS, ATC, Penn State Hershey, Milton S. Hershey Medical Center, Penn State College of Medicine, Family and Community Medicine H154, 500 University Drive, PO Box 850, Hershey, PA 17033-0850; [email protected]

CASE

John D,* a 25-year-old patient with an otherwise unremarkable medical history, describes 2 months of daily headache, lower-extremity weakness, and unsteady gait that began fairly suddenly during his first deployment in the US Army. He explains that these symptoms affected his ability to perform his duties and necessitated an early return stateside for evaluation and treatment.

Mr. D denies precipitating trauma or unusual environmental exposures. He reports that, stateside now, symptoms continue to affect his ability to work and attend to personal and family responsibilities.

Asked about stressors, Mr. D notes the birth of his first child approximately 3 months ago, while he was deployed, and marital stressors. He denies suicidal or homicidal ideation.

* The patient’s name has been changed to protect his identity.

The challenge of identifying and managing FND

A functional neurological disorder (FND) is a constellation of psychological, physiological, and neurological symptoms, without an identifiable organic etiology, a conscious decision, or secondary gain for the patient,¹ that adversely impacts functioning in 1 or more significant life domains.

Given the high throughput of patients in primary care practices, family physicians can expect to encounter suspected cases of FND in their practices. Regrettably, however, a lack of familiarity with the disorder and its related problems (eg, nonorganic paralysis, sensory loss, nonepileptic seizures, and abnormal movements) can add as much as $20,000 in excess direct and indirect costs of care for every such patient.¹ In this article, we synthesize the recent literature on FND so that family physicians can expand their acumen in understanding, identifying, and evaluating patients whose presentation suggests FND.

An underrecognized entity

A precise estimate of the prevalence of FND is difficult to determine because the disorder is underrecognized and misdiagnosed and because it is often accompanied by the confounding of psychological and physiological comorbidities. A 2012 study estimated the annual incidence of FND to be 4 to 12 cases for every 100,000 people²; in primary care and outpatient neurology settings, prevalence is 6% to 22% of all patients.^3,4 Stone and colleagues identified functional neurological symptoms as the second most common reason for outpatient neurology consultation,⁵ with 1 nonepileptic seizure patient seen for every 6 epileptic patients, and functional weakness presenting at the same rate as multiple sclerosis.⁶

Continue to: Demographics of patients with FND...

Demographics of patients with FND vary, depending on presenting neurological symptoms and disorder subtype. Existing data indicate a correlation between FND and younger age, female sex, physical disability,⁷ and a history of abuse or trauma.^3,8 A challenge in concretely ascertaining the prevalence of FND is that conditions such as fibromyalgia, chronic pelvic pain, globus hystericus, and nonepileptic seizures can also be characterized as medically unexplained functional disorders, even within the network of neurology care.⁴

Misdiagnosis and bias are not uncommon

Ambiguity in classifying and evaluating FND can affect physicians’ perceptions, assessment, and care of patients with suggestive presenting symptoms. A major early challenge in diagnosing FND is the inconsistency of characterizing terminology (pseudoneurological, somatic, dissociative, conversion, psychogenic, hysterical, factitious, functional, medically unexplained^9,10) and definitions in the literature. Neurological symptoms of unidentifiable organic cause can greatly diminish quality of life⁴; FND is a scientifically and clinically useful diagnosis for many combinations of nonrandomly co-occurring symptoms and clinical signs.

The pitfall of misdiagnosis. Remain cautious about making a diagnosis of FND by exclusion, which might yield an incorrect or false-negative finding because of an atypical presentation. It is important to avoid misdiagnosis by prematurely closing the differential diagnosis; instead, keep in mind that a medically unexplained diagnosis might be better explained by conducting a robust social and medical history and obtaining additional or collateral data, or both, along with appropriate consultation.^4,9

Remain cautious about making a diagnosis of FND by exclusion; an atypical presentation might lead to an incorrect or false-negative finding.

Misdiagnosis can lead to a circuitous and costly work-up, with the potential to increase the patient’s distress. You can reduce this burden with early recognition of FND and centralized management of multidisciplinary care, which are more likely to lead to an accurate and timely diagnosis—paramount to empowering patients with access to the correct information and meaningful support needed to enhance treatment and self-care.⁹

Bias, haste, and dismissal are unproductive. Even with a clear definition of FND, it is not uncommon for a physician to rapidly assess a patient’s clinical signs, make a diagnosis of “unknown etiology,” or openly question the veracity of complaints. Furthermore, be aware of inadvertently characterizing FND using the prefix “pseudo” or the term “hysterical,” which can be psychologically discomforting for many patients, who legitimately experience inexplicable symptoms. Such pejoratives can lead to stigmatizing and misleading assessments and treatment paths⁴—courses of action that can cause early and, possibly, irreparable harm to the patient–physician relationship and increase the patient’s inclination to go “doctor-shopping,” with associated loss of continuity of care.

Why is it difficult to diagnose FND?

The latest (5th) edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) describes conversion, somatoform disorder, and FND synonymously.DSM-5 diagnostic criteria for conversion disorderare¹¹:

• a specified type of symptom or deficit of altered voluntary motor or sensory function (eg, weakness, difficulty swallowing, slurred speech, seizures)
• clinical evidence of the incompatibility of the symptom or deficit and any recognized neurological or medical disorder
• incapability of better explaining the symptom or deficit as another medical or mental disorder.
• The symptom or deficit causes distress or impairment that (1) is clinically significant in occupational, social, or other important areas of function or (2) warrants medical evaluation.

The overarching feature of these criteria is the inconsistency of symptoms with recognized neurological, physiological, or psychiatric conditions. Although identification of psychological factors can help clarify and provide a treatment direction, such identification is not essential for making a diagnosis of FND. Malingering does not need to be refuted as part of establishing the diagnosis.¹²

Continue to: In contrast...

In contrast, the World Health Organization’s ICD-10 Classification of Mental and Behavioural Disorders groups diagnostic criteria for FND among the dissociative disorders¹³:

• Clinical features are specified for the individual dissociative disorder (motor, sensory, convulsions, mixed).
• Evidence is absent of a physical disorder that might explain symptoms.
• Evidence of psychological causation is present in clear temporal association with stressful events and problems or disturbed relationships, even if the patient denies such association.

Note the emphasis on psychological causation and exclusion of purposeful simulation of symptoms, as opposed to a primarily unconscious disconnection from the patient’s body or environment.

ICD-10 guidelines acknowledge the difficulty of finding definitive evidence of a psychological cause and recommend provisional diagnosis of FND if psychological factors are not readily apparent.¹⁴ Of note, many patients with FND are affected psychologically by their condition, with an impact on mood, behaviors, and interpersonal interactions, although not necessarily to a clinically diagnostic degree. Therefore, a psychiatric diagnosis alone is not a necessary precursor for the diagnosis of an FND.

CASE 

History. Mr. D’s history is positive for light alcohol consumption (“2 or 3 cans of beer on weekends”) and chewing tobacco (he reports stopping 6 months earlier) and negative for substance abuse. The family history is positive for maternal hypertension and paternal suicide when the patient was 10 years old (no other known paternal history).

Physical findings. The review of systems is positive for intermittent palpitations, lower-extremity weakness causing unsteady gait, and generalized headache.

Ask the patient to list all of his or her symptoms at the beginning of the interview; this can help elucidate a complex or ambiguous presentation.

Vital signs are within normal limits, including blood pressure (120/82 mm Hg) and heart rate (110 beats/min). The patient is not in acute distress; he is awake, alert, and oriented × 3. No murmurs are heard; lungs are clear bilaterally to auscultation. There is no tenderness on abdominal palpation, and no hepatomegaly or splenomegaly; bowel sounds are normal. No significant bruising or lacerations are noted.

Neurology exam. Cranial nerves II-XII are intact. Pupils are equal and reactive to light. Reflexes are 2+ bilaterally. Muscle strength and tone are normal; no tremors are noted. Babinski signs are normal. A Romberg test is positive (swaying).

Continue to: Mr. D has an antalgic gait...

Mr. D has an antalgic gait with significant swaying (without falling); bent posture; and unsteadiness that requires a cane. However, he is able to get up and off the exam table without assistance, and to propel himself, by rolling a chair forward and backward, without difficulty.

Conducting a diagnostic examination

Taking the history. Certain clues can aid in the diagnosis of FND (TABLE 1).¹⁵ For example, the patient might have been seen in multiple specialty practices for a multitude of vague symptoms indicative of potentially related conditions (eg, chronic fatigue, allergies and sensitivities, fibromyalgia, and other chronic pain). The history might include repeated surgeries to investigate those symptoms (eg, laparoscopy, or hysterectomy at an early age). Taking time and care to explore all clinical clues, patient reports, and collateral data are therefore key to making an accurate diagnosis.

A coexisting psychiatric diagnosis might be associated with distress from the presenting functional neurological symptoms—not linked to the FND diagnosis itself.

Note any discrepancies between the severity of reported symptoms and functional ability. A technique that can help elucidate a complex or ambiguous medical presentation is to ask the patient to list all their symptoms at the beginning of the interview. This has threefold benefit: You get a broad picture of the problem; the patient is unburdened of their concerns and experiences your validation; and a long list of symptoms can be an early clue to a diagnosis of FND.

Other helpful questions to determine the impact of symptoms on the patient’s well-­being include inquiries about¹⁶:

• functional impairment
• onset and course of symptoms
• potential causal or correlating events
• dissociative episodes
• previous diagnoses and treatments
• the patient’s perceptions of, and emotional response to, their illness
• a history of abuse.

The physical examination to determine the presence of FND varies, depending on the functional area of impact (eg, motor, neurological, sensory, speech and swallowing). Pay particular attention to presenting signs and clues, and balance them with the patient’s report (or lack of report). Endeavor to demonstrate positive functional signs, such as a positive Hoover test, which relies on the principle of synergistic muscle contraction. You might see evidence of inconsistency, such as weakness or a change in gait, under observation, that seemingly resolves when the patient is getting on and off the exam table.¹⁶Table 2^15-24 describes areas affected by FND, characteristics of the disorder, and related diagnostic examinations.

Table 3^15,18,19 reviews validated special exams that can aid in making the diagnosis. Additional special tests are discussed in the literature.^15-24 These tests can be helpful in narrowing the differential diagnosis but have not been validated and should be used with caution.

Some clinical signs associated with FND might be affected by other factors, including socioeconomic status, limited access to health care, low health literacy, poor communication skills, and physician bias. Keep these factors in mind during the visit, to avoid contributing further to health disparities among groups of patients affected by these problems.

Continue to: CASE

CASE 

The work-up over the next month for Mr. D includes numerous studies, all yielding results that are negative or within normal limits: visual acuity; electrocardiography and an event monitor; laboratory testing (including a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, creatine kinase, erythrocyte sedimentation rate, C-­reactive protein, vitamin B₁₂, folate, and vitamin D); magnetic resonance imaging of the brain and lumbar spine; lumbar puncture; and electromyography.

The score on the 9-item Patient Health Questionnaire for depression is 4 (severity: “none or minimal”); on the 7-item Generalized Anxiety Disorder scale, 0 (“no anxiety disorder”).

Referral. A neurology work-up of headache, lower extremity weakness, and unsteady gait to address several diagnostic possibilities, including migraine and multiple sclerosis, is within normal limits. A cardiology work-up of palpitations is negative for arrhythmias and other concerning findings.

Mr. D declines psychiatric and psychological evaluations.

Building a differential diagnosisis a formidable task

The differential diagnosis of FND is vast. It includes neurological, physiological, and psychiatric symptoms and disorders; somatization; and malingering (Table 4).⁶ Any disorder or condition in these areas that is in the differential diagnosis can be precipitated or exacerbated by stress; most, however, do not involve loss of physical function.¹² In addition, the diagnosis of an FND does not necessarily exclude an organic disorder.

A patient’s presentation becomes complicated—and more difficult to treat—when functional symptoms and an unrelated underlying or early-stage neurological condition coexist. For example, a patient with epilepsy might also have dissociative seizures atop their organic disorder. Neurological disease is considered a risk factor for an overlying FND—just as the risk of depression or anxiety runs concurrently with other chronic diseases.¹⁴

Focus on clinical signs to narrow the differential. A thorough social and medical history and physical examination, as discussed earlier, help narrow the differential diagnosis of organic and medically unexplained disorders. Well-defined imaging or laboratory protocols do not exist to guide physicians to a definitive diagnosis, however.

Continue to: Psychiatric conditions

Psychiatric conditions can coexist with the diagnosis of FND, but might be unrelated. A systematic review of the literature showed that 17% to 42% of patients with FND had a concurrent anxiety disorder. Depression disorders were co-diagnosed in 19% to 71% of patients with FND; dissociative and personality disorders were noted, as well.²⁵ However, coexisting psychiatric diagnosis might more likely be associated with distress from the presenting functional neurological symptoms, not linked to the FND diagnosis itself.¹² This shift in understanding is reflected in the description of FND in the DSM-5.¹¹

CASE

Mr. D reports debilitating headaches at return office visits. Trials of abortive triptans provide no relief; neither do control medications (beta-blockers, coenzyme Q10, magnesium, onabotulinumtoxinA [Botox], topiramate, and valproate). Lower-extremity weakness and unsteadiness are managed with supportive devices, including a cane, and physical therapy.

Importance of establishing a multidisciplinary approach

The complexity of FND lends itself to a multidisciplinary approach during evaluation and, eventually, for treatment. The assessment and diagnostic intervention that you provide, along with the contributions of consulted specialists (including neurology, physical and occupational therapy, psychiatry, psychology, and other mental health professionals) establishes a team-based approach that can increase the patient’s sense of support and reduce excessive testing and unnecessary medications, surgeries, and other treatments.²⁶

Family physicians are in the ideal position to recognize the patient’s functional capacity and the quality of symptoms and to provide timely referral (eg, to Neurology and Psychiatry) for confirmation of the diagnosis and then treatment.

Evidence-based treatment options include:

• psychotherapy, with an emphasis on cognitive behavioral therapy
• physical therapy
• psychopharmacology
• promising combinations of physical and psychological treatment to improve long-term functionality.²⁷

A promising diagnostic tool

The most significant update in the FND literature is on functional neuroimaging for assessing the disorder. Early findings suggest an intricate relationship between mind and body regarding the pathological distortion in FND. And, there is clear evidence that neuroimaging—specifically, functional magnetic resonance imaging—shows changes in brain activity that correspond to the patient’s symptom report. That said, imaging is not the recommended standard of care in the initial work-up of FND because of its cost and the fact that the diagnosis is principally a clinical undertaking.^17,28

Call to action

Offer a generous ear. Begin the diagnostic pursuit by listening carefully and fully to the patient’s complaints, without arriving at a diagnosis with unwarranted bias or haste. This endeavor might require support from other clinical staff (eg, nurses, social workers, case managers) because the diagnostic process can be arduous and lengthy.

Continue to: Convey the diagnosis with sensitivity

Convey the diagnosis with sensitivity. Inquire about the patient’s perceptions and impairments to best personalize your diagnostic explanations. Delivery of the diagnosis might affect the patient’s acceptance and compliance with further testing and treatment of what is generally a persistent and treatment-resistant disorder; poor delivery of diagnostic information can impair the patient–physician relationship and increase the risk of disjointed care. Many patients find that improved patient–­physician communication is therapeutic.²⁹

Let the patient know that you’re taking her seriously. Validate patient concerns with a nonstigmatizing diagnostic label; discuss the diagnostic parameters and cause of symptoms in layman’s terms; and emphasize the potential for reversibility.³⁰ Some patients are not satisfied with having a diagnosis of FND until they are reassured with normal results of testing and provided with referral; even then, some seek further reassurance.

Key tenets of managing care for patients who have been given a diagnosis of FND include:

• nonjudgmental, positive regard
• meaningful expression of empathy
• multidisciplinary coordination
• avoidance of unnecessary testing and harmful treatments
• descriptive and contextual explanations of the diagnosis.

There is clear evidence that functional magnetic resonance imaging reveals changes in brain activity that correspond with the report of symptoms.

Last, keep in mind that the course of treatment for FND is potentially prolonged and multilayered.

CASE

After many visits with his family physician and the neurology and cardiology specialists, as well as an extensive work-up, the physician approaches Mr. D with the possibility of a diagnosis of FND and proposes a multidisciplinary plan that includes:

• a course of physical and occupational therapy
• development of individualized cognitive behavioral tools
• weekly personal and marital counseling
• initiation of a selective serotonin reuptake inhibitor for anxiety
• monthly visits with his family physician.

Months after his return from deployment for evaluation and treatment, Mr. D is able to return to military duty. He reports that his quality of life has improved.

CORRESPONDENCE
Roselyn W. Clemente Fuentes, MD, FAAFP, Eglin Family Medicine Residency, 307 Boatner Road, Eglin AFB, FL 32547; [email protected].

CASE

John D,* a 25-year-old patient with an otherwise unremarkable medical history, describes 2 months of daily headache, lower-extremity weakness, and unsteady gait that began fairly suddenly during his first deployment in the US Army. He explains that these symptoms affected his ability to perform his duties and necessitated an early return stateside for evaluation and treatment.

Mr. D denies precipitating trauma or unusual environmental exposures. He reports that, stateside now, symptoms continue to affect his ability to work and attend to personal and family responsibilities.

Asked about stressors, Mr. D notes the birth of his first child approximately 3 months ago, while he was deployed, and marital stressors. He denies suicidal or homicidal ideation.

* The patient’s name has been changed to protect his identity.

The challenge of identifying and managing FND

A functional neurological disorder (FND) is a constellation of psychological, physiological, and neurological symptoms, without an identifiable organic etiology, a conscious decision, or secondary gain for the patient,¹ that adversely impacts functioning in 1 or more significant life domains.

Given the high throughput of patients in primary care practices, family physicians can expect to encounter suspected cases of FND in their practices. Regrettably, however, a lack of familiarity with the disorder and its related problems (eg, nonorganic paralysis, sensory loss, nonepileptic seizures, and abnormal movements) can add as much as $20,000 in excess direct and indirect costs of care for every such patient.¹ In this article, we synthesize the recent literature on FND so that family physicians can expand their acumen in understanding, identifying, and evaluating patients whose presentation suggests FND.

An underrecognized entity

A precise estimate of the prevalence of FND is difficult to determine because the disorder is underrecognized and misdiagnosed and because it is often accompanied by the confounding of psychological and physiological comorbidities. A 2012 study estimated the annual incidence of FND to be 4 to 12 cases for every 100,000 people²; in primary care and outpatient neurology settings, prevalence is 6% to 22% of all patients.^3,4 Stone and colleagues identified functional neurological symptoms as the second most common reason for outpatient neurology consultation,⁵ with 1 nonepileptic seizure patient seen for every 6 epileptic patients, and functional weakness presenting at the same rate as multiple sclerosis.⁶

Continue to: Demographics of patients with FND...

Demographics of patients with FND vary, depending on presenting neurological symptoms and disorder subtype. Existing data indicate a correlation between FND and younger age, female sex, physical disability,⁷ and a history of abuse or trauma.^3,8 A challenge in concretely ascertaining the prevalence of FND is that conditions such as fibromyalgia, chronic pelvic pain, globus hystericus, and nonepileptic seizures can also be characterized as medically unexplained functional disorders, even within the network of neurology care.⁴

Misdiagnosis and bias are not uncommon

Ambiguity in classifying and evaluating FND can affect physicians’ perceptions, assessment, and care of patients with suggestive presenting symptoms. A major early challenge in diagnosing FND is the inconsistency of characterizing terminology (pseudoneurological, somatic, dissociative, conversion, psychogenic, hysterical, factitious, functional, medically unexplained^9,10) and definitions in the literature. Neurological symptoms of unidentifiable organic cause can greatly diminish quality of life⁴; FND is a scientifically and clinically useful diagnosis for many combinations of nonrandomly co-occurring symptoms and clinical signs.

The pitfall of misdiagnosis. Remain cautious about making a diagnosis of FND by exclusion, which might yield an incorrect or false-negative finding because of an atypical presentation. It is important to avoid misdiagnosis by prematurely closing the differential diagnosis; instead, keep in mind that a medically unexplained diagnosis might be better explained by conducting a robust social and medical history and obtaining additional or collateral data, or both, along with appropriate consultation.^4,9

Remain cautious about making a diagnosis of FND by exclusion; an atypical presentation might lead to an incorrect or false-negative finding.

Misdiagnosis can lead to a circuitous and costly work-up, with the potential to increase the patient’s distress. You can reduce this burden with early recognition of FND and centralized management of multidisciplinary care, which are more likely to lead to an accurate and timely diagnosis—paramount to empowering patients with access to the correct information and meaningful support needed to enhance treatment and self-care.⁹

Bias, haste, and dismissal are unproductive. Even with a clear definition of FND, it is not uncommon for a physician to rapidly assess a patient’s clinical signs, make a diagnosis of “unknown etiology,” or openly question the veracity of complaints. Furthermore, be aware of inadvertently characterizing FND using the prefix “pseudo” or the term “hysterical,” which can be psychologically discomforting for many patients, who legitimately experience inexplicable symptoms. Such pejoratives can lead to stigmatizing and misleading assessments and treatment paths⁴—courses of action that can cause early and, possibly, irreparable harm to the patient–physician relationship and increase the patient’s inclination to go “doctor-shopping,” with associated loss of continuity of care.

Why is it difficult to diagnose FND?

The latest (5th) edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) describes conversion, somatoform disorder, and FND synonymously.DSM-5 diagnostic criteria for conversion disorderare¹¹:

• a specified type of symptom or deficit of altered voluntary motor or sensory function (eg, weakness, difficulty swallowing, slurred speech, seizures)
• clinical evidence of the incompatibility of the symptom or deficit and any recognized neurological or medical disorder
• incapability of better explaining the symptom or deficit as another medical or mental disorder.
• The symptom or deficit causes distress or impairment that (1) is clinically significant in occupational, social, or other important areas of function or (2) warrants medical evaluation.

The overarching feature of these criteria is the inconsistency of symptoms with recognized neurological, physiological, or psychiatric conditions. Although identification of psychological factors can help clarify and provide a treatment direction, such identification is not essential for making a diagnosis of FND. Malingering does not need to be refuted as part of establishing the diagnosis.¹²

Continue to: In contrast...

In contrast, the World Health Organization’s ICD-10 Classification of Mental and Behavioural Disorders groups diagnostic criteria for FND among the dissociative disorders¹³:

• Clinical features are specified for the individual dissociative disorder (motor, sensory, convulsions, mixed).
• Evidence is absent of a physical disorder that might explain symptoms.
• Evidence of psychological causation is present in clear temporal association with stressful events and problems or disturbed relationships, even if the patient denies such association.

Note the emphasis on psychological causation and exclusion of purposeful simulation of symptoms, as opposed to a primarily unconscious disconnection from the patient’s body or environment.

ICD-10 guidelines acknowledge the difficulty of finding definitive evidence of a psychological cause and recommend provisional diagnosis of FND if psychological factors are not readily apparent.¹⁴ Of note, many patients with FND are affected psychologically by their condition, with an impact on mood, behaviors, and interpersonal interactions, although not necessarily to a clinically diagnostic degree. Therefore, a psychiatric diagnosis alone is not a necessary precursor for the diagnosis of an FND.

CASE 

History. Mr. D’s history is positive for light alcohol consumption (“2 or 3 cans of beer on weekends”) and chewing tobacco (he reports stopping 6 months earlier) and negative for substance abuse. The family history is positive for maternal hypertension and paternal suicide when the patient was 10 years old (no other known paternal history).

Physical findings. The review of systems is positive for intermittent palpitations, lower-extremity weakness causing unsteady gait, and generalized headache.

Ask the patient to list all of his or her symptoms at the beginning of the interview; this can help elucidate a complex or ambiguous presentation.

Vital signs are within normal limits, including blood pressure (120/82 mm Hg) and heart rate (110 beats/min). The patient is not in acute distress; he is awake, alert, and oriented × 3. No murmurs are heard; lungs are clear bilaterally to auscultation. There is no tenderness on abdominal palpation, and no hepatomegaly or splenomegaly; bowel sounds are normal. No significant bruising or lacerations are noted.

Neurology exam. Cranial nerves II-XII are intact. Pupils are equal and reactive to light. Reflexes are 2+ bilaterally. Muscle strength and tone are normal; no tremors are noted. Babinski signs are normal. A Romberg test is positive (swaying).

Continue to: Mr. D has an antalgic gait...

Mr. D has an antalgic gait with significant swaying (without falling); bent posture; and unsteadiness that requires a cane. However, he is able to get up and off the exam table without assistance, and to propel himself, by rolling a chair forward and backward, without difficulty.

Conducting a diagnostic examination

Taking the history. Certain clues can aid in the diagnosis of FND (TABLE 1).¹⁵ For example, the patient might have been seen in multiple specialty practices for a multitude of vague symptoms indicative of potentially related conditions (eg, chronic fatigue, allergies and sensitivities, fibromyalgia, and other chronic pain). The history might include repeated surgeries to investigate those symptoms (eg, laparoscopy, or hysterectomy at an early age). Taking time and care to explore all clinical clues, patient reports, and collateral data are therefore key to making an accurate diagnosis.

A coexisting psychiatric diagnosis might be associated with distress from the presenting functional neurological symptoms—not linked to the FND diagnosis itself.

Note any discrepancies between the severity of reported symptoms and functional ability. A technique that can help elucidate a complex or ambiguous medical presentation is to ask the patient to list all their symptoms at the beginning of the interview. This has threefold benefit: You get a broad picture of the problem; the patient is unburdened of their concerns and experiences your validation; and a long list of symptoms can be an early clue to a diagnosis of FND.

Other helpful questions to determine the impact of symptoms on the patient’s well-­being include inquiries about¹⁶:

• functional impairment
• onset and course of symptoms
• potential causal or correlating events
• dissociative episodes
• previous diagnoses and treatments
• the patient’s perceptions of, and emotional response to, their illness
• a history of abuse.

The physical examination to determine the presence of FND varies, depending on the functional area of impact (eg, motor, neurological, sensory, speech and swallowing). Pay particular attention to presenting signs and clues, and balance them with the patient’s report (or lack of report). Endeavor to demonstrate positive functional signs, such as a positive Hoover test, which relies on the principle of synergistic muscle contraction. You might see evidence of inconsistency, such as weakness or a change in gait, under observation, that seemingly resolves when the patient is getting on and off the exam table.¹⁶Table 2^15-24 describes areas affected by FND, characteristics of the disorder, and related diagnostic examinations.

Table 3^15,18,19 reviews validated special exams that can aid in making the diagnosis. Additional special tests are discussed in the literature.^15-24 These tests can be helpful in narrowing the differential diagnosis but have not been validated and should be used with caution.

Some clinical signs associated with FND might be affected by other factors, including socioeconomic status, limited access to health care, low health literacy, poor communication skills, and physician bias. Keep these factors in mind during the visit, to avoid contributing further to health disparities among groups of patients affected by these problems.

Continue to: CASE

CASE 

The work-up over the next month for Mr. D includes numerous studies, all yielding results that are negative or within normal limits: visual acuity; electrocardiography and an event monitor; laboratory testing (including a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, creatine kinase, erythrocyte sedimentation rate, C-­reactive protein, vitamin B₁₂, folate, and vitamin D); magnetic resonance imaging of the brain and lumbar spine; lumbar puncture; and electromyography.

The score on the 9-item Patient Health Questionnaire for depression is 4 (severity: “none or minimal”); on the 7-item Generalized Anxiety Disorder scale, 0 (“no anxiety disorder”).

Referral. A neurology work-up of headache, lower extremity weakness, and unsteady gait to address several diagnostic possibilities, including migraine and multiple sclerosis, is within normal limits. A cardiology work-up of palpitations is negative for arrhythmias and other concerning findings.

Mr. D declines psychiatric and psychological evaluations.

Building a differential diagnosisis a formidable task

The differential diagnosis of FND is vast. It includes neurological, physiological, and psychiatric symptoms and disorders; somatization; and malingering (Table 4).⁶ Any disorder or condition in these areas that is in the differential diagnosis can be precipitated or exacerbated by stress; most, however, do not involve loss of physical function.¹² In addition, the diagnosis of an FND does not necessarily exclude an organic disorder.

A patient’s presentation becomes complicated—and more difficult to treat—when functional symptoms and an unrelated underlying or early-stage neurological condition coexist. For example, a patient with epilepsy might also have dissociative seizures atop their organic disorder. Neurological disease is considered a risk factor for an overlying FND—just as the risk of depression or anxiety runs concurrently with other chronic diseases.¹⁴

Focus on clinical signs to narrow the differential. A thorough social and medical history and physical examination, as discussed earlier, help narrow the differential diagnosis of organic and medically unexplained disorders. Well-defined imaging or laboratory protocols do not exist to guide physicians to a definitive diagnosis, however.

Continue to: Psychiatric conditions

Psychiatric conditions can coexist with the diagnosis of FND, but might be unrelated. A systematic review of the literature showed that 17% to 42% of patients with FND had a concurrent anxiety disorder. Depression disorders were co-diagnosed in 19% to 71% of patients with FND; dissociative and personality disorders were noted, as well.²⁵ However, coexisting psychiatric diagnosis might more likely be associated with distress from the presenting functional neurological symptoms, not linked to the FND diagnosis itself.¹² This shift in understanding is reflected in the description of FND in the DSM-5.¹¹

CASE

Mr. D reports debilitating headaches at return office visits. Trials of abortive triptans provide no relief; neither do control medications (beta-blockers, coenzyme Q10, magnesium, onabotulinumtoxinA [Botox], topiramate, and valproate). Lower-extremity weakness and unsteadiness are managed with supportive devices, including a cane, and physical therapy.

Importance of establishing a multidisciplinary approach

The complexity of FND lends itself to a multidisciplinary approach during evaluation and, eventually, for treatment. The assessment and diagnostic intervention that you provide, along with the contributions of consulted specialists (including neurology, physical and occupational therapy, psychiatry, psychology, and other mental health professionals) establishes a team-based approach that can increase the patient’s sense of support and reduce excessive testing and unnecessary medications, surgeries, and other treatments.²⁶

Family physicians are in the ideal position to recognize the patient’s functional capacity and the quality of symptoms and to provide timely referral (eg, to Neurology and Psychiatry) for confirmation of the diagnosis and then treatment.

Evidence-based treatment options include:

• psychotherapy, with an emphasis on cognitive behavioral therapy
• physical therapy
• psychopharmacology
• promising combinations of physical and psychological treatment to improve long-term functionality.²⁷

A promising diagnostic tool

The most significant update in the FND literature is on functional neuroimaging for assessing the disorder. Early findings suggest an intricate relationship between mind and body regarding the pathological distortion in FND. And, there is clear evidence that neuroimaging—specifically, functional magnetic resonance imaging—shows changes in brain activity that correspond to the patient’s symptom report. That said, imaging is not the recommended standard of care in the initial work-up of FND because of its cost and the fact that the diagnosis is principally a clinical undertaking.^17,28

Call to action

Offer a generous ear. Begin the diagnostic pursuit by listening carefully and fully to the patient’s complaints, without arriving at a diagnosis with unwarranted bias or haste. This endeavor might require support from other clinical staff (eg, nurses, social workers, case managers) because the diagnostic process can be arduous and lengthy.

Continue to: Convey the diagnosis with sensitivity

Convey the diagnosis with sensitivity. Inquire about the patient’s perceptions and impairments to best personalize your diagnostic explanations. Delivery of the diagnosis might affect the patient’s acceptance and compliance with further testing and treatment of what is generally a persistent and treatment-resistant disorder; poor delivery of diagnostic information can impair the patient–physician relationship and increase the risk of disjointed care. Many patients find that improved patient–­physician communication is therapeutic.²⁹

Let the patient know that you’re taking her seriously. Validate patient concerns with a nonstigmatizing diagnostic label; discuss the diagnostic parameters and cause of symptoms in layman’s terms; and emphasize the potential for reversibility.³⁰ Some patients are not satisfied with having a diagnosis of FND until they are reassured with normal results of testing and provided with referral; even then, some seek further reassurance.

Key tenets of managing care for patients who have been given a diagnosis of FND include:

• nonjudgmental, positive regard
• meaningful expression of empathy
• multidisciplinary coordination
• avoidance of unnecessary testing and harmful treatments
• descriptive and contextual explanations of the diagnosis.

There is clear evidence that functional magnetic resonance imaging reveals changes in brain activity that correspond with the report of symptoms.

Last, keep in mind that the course of treatment for FND is potentially prolonged and multilayered.

CASE

After many visits with his family physician and the neurology and cardiology specialists, as well as an extensive work-up, the physician approaches Mr. D with the possibility of a diagnosis of FND and proposes a multidisciplinary plan that includes:

• a course of physical and occupational therapy
• development of individualized cognitive behavioral tools
• weekly personal and marital counseling
• initiation of a selective serotonin reuptake inhibitor for anxiety
• monthly visits with his family physician.

Months after his return from deployment for evaluation and treatment, Mr. D is able to return to military duty. He reports that his quality of life has improved.

CORRESPONDENCE
Roselyn W. Clemente Fuentes, MD, FAAFP, Eglin Family Medicine Residency, 307 Boatner Road, Eglin AFB, FL 32547; [email protected].

CASE

John D,* a 25-year-old patient with an otherwise unremarkable medical history, describes 2 months of daily headache, lower-extremity weakness, and unsteady gait that began fairly suddenly during his first deployment in the US Army. He explains that these symptoms affected his ability to perform his duties and necessitated an early return stateside for evaluation and treatment.

Mr. D denies precipitating trauma or unusual environmental exposures. He reports that, stateside now, symptoms continue to affect his ability to work and attend to personal and family responsibilities.

Asked about stressors, Mr. D notes the birth of his first child approximately 3 months ago, while he was deployed, and marital stressors. He denies suicidal or homicidal ideation.

* The patient’s name has been changed to protect his identity.

The challenge of identifying and managing FND

A functional neurological disorder (FND) is a constellation of psychological, physiological, and neurological symptoms, without an identifiable organic etiology, a conscious decision, or secondary gain for the patient,¹ that adversely impacts functioning in 1 or more significant life domains.

Given the high throughput of patients in primary care practices, family physicians can expect to encounter suspected cases of FND in their practices. Regrettably, however, a lack of familiarity with the disorder and its related problems (eg, nonorganic paralysis, sensory loss, nonepileptic seizures, and abnormal movements) can add as much as $20,000 in excess direct and indirect costs of care for every such patient.¹ In this article, we synthesize the recent literature on FND so that family physicians can expand their acumen in understanding, identifying, and evaluating patients whose presentation suggests FND.

An underrecognized entity

A precise estimate of the prevalence of FND is difficult to determine because the disorder is underrecognized and misdiagnosed and because it is often accompanied by the confounding of psychological and physiological comorbidities. A 2012 study estimated the annual incidence of FND to be 4 to 12 cases for every 100,000 people²; in primary care and outpatient neurology settings, prevalence is 6% to 22% of all patients.^3,4 Stone and colleagues identified functional neurological symptoms as the second most common reason for outpatient neurology consultation,⁵ with 1 nonepileptic seizure patient seen for every 6 epileptic patients, and functional weakness presenting at the same rate as multiple sclerosis.⁶

Continue to: Demographics of patients with FND...

Demographics of patients with FND vary, depending on presenting neurological symptoms and disorder subtype. Existing data indicate a correlation between FND and younger age, female sex, physical disability,⁷ and a history of abuse or trauma.^3,8 A challenge in concretely ascertaining the prevalence of FND is that conditions such as fibromyalgia, chronic pelvic pain, globus hystericus, and nonepileptic seizures can also be characterized as medically unexplained functional disorders, even within the network of neurology care.⁴

Misdiagnosis and bias are not uncommon

Ambiguity in classifying and evaluating FND can affect physicians’ perceptions, assessment, and care of patients with suggestive presenting symptoms. A major early challenge in diagnosing FND is the inconsistency of characterizing terminology (pseudoneurological, somatic, dissociative, conversion, psychogenic, hysterical, factitious, functional, medically unexplained^9,10) and definitions in the literature. Neurological symptoms of unidentifiable organic cause can greatly diminish quality of life⁴; FND is a scientifically and clinically useful diagnosis for many combinations of nonrandomly co-occurring symptoms and clinical signs.

The pitfall of misdiagnosis. Remain cautious about making a diagnosis of FND by exclusion, which might yield an incorrect or false-negative finding because of an atypical presentation. It is important to avoid misdiagnosis by prematurely closing the differential diagnosis; instead, keep in mind that a medically unexplained diagnosis might be better explained by conducting a robust social and medical history and obtaining additional or collateral data, or both, along with appropriate consultation.^4,9

Remain cautious about making a diagnosis of FND by exclusion; an atypical presentation might lead to an incorrect or false-negative finding.

Misdiagnosis can lead to a circuitous and costly work-up, with the potential to increase the patient’s distress. You can reduce this burden with early recognition of FND and centralized management of multidisciplinary care, which are more likely to lead to an accurate and timely diagnosis—paramount to empowering patients with access to the correct information and meaningful support needed to enhance treatment and self-care.⁹

Bias, haste, and dismissal are unproductive. Even with a clear definition of FND, it is not uncommon for a physician to rapidly assess a patient’s clinical signs, make a diagnosis of “unknown etiology,” or openly question the veracity of complaints. Furthermore, be aware of inadvertently characterizing FND using the prefix “pseudo” or the term “hysterical,” which can be psychologically discomforting for many patients, who legitimately experience inexplicable symptoms. Such pejoratives can lead to stigmatizing and misleading assessments and treatment paths⁴—courses of action that can cause early and, possibly, irreparable harm to the patient–physician relationship and increase the patient’s inclination to go “doctor-shopping,” with associated loss of continuity of care.

Why is it difficult to diagnose FND?

The latest (5th) edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) describes conversion, somatoform disorder, and FND synonymously.DSM-5 diagnostic criteria for conversion disorderare¹¹:

• a specified type of symptom or deficit of altered voluntary motor or sensory function (eg, weakness, difficulty swallowing, slurred speech, seizures)
• clinical evidence of the incompatibility of the symptom or deficit and any recognized neurological or medical disorder
• incapability of better explaining the symptom or deficit as another medical or mental disorder.
• The symptom or deficit causes distress or impairment that (1) is clinically significant in occupational, social, or other important areas of function or (2) warrants medical evaluation.

The overarching feature of these criteria is the inconsistency of symptoms with recognized neurological, physiological, or psychiatric conditions. Although identification of psychological factors can help clarify and provide a treatment direction, such identification is not essential for making a diagnosis of FND. Malingering does not need to be refuted as part of establishing the diagnosis.¹²

Continue to: In contrast...

In contrast, the World Health Organization’s ICD-10 Classification of Mental and Behavioural Disorders groups diagnostic criteria for FND among the dissociative disorders¹³:

• Clinical features are specified for the individual dissociative disorder (motor, sensory, convulsions, mixed).
• Evidence is absent of a physical disorder that might explain symptoms.
• Evidence of psychological causation is present in clear temporal association with stressful events and problems or disturbed relationships, even if the patient denies such association.

Note the emphasis on psychological causation and exclusion of purposeful simulation of symptoms, as opposed to a primarily unconscious disconnection from the patient’s body or environment.

ICD-10 guidelines acknowledge the difficulty of finding definitive evidence of a psychological cause and recommend provisional diagnosis of FND if psychological factors are not readily apparent.¹⁴ Of note, many patients with FND are affected psychologically by their condition, with an impact on mood, behaviors, and interpersonal interactions, although not necessarily to a clinically diagnostic degree. Therefore, a psychiatric diagnosis alone is not a necessary precursor for the diagnosis of an FND.

CASE 

History. Mr. D’s history is positive for light alcohol consumption (“2 or 3 cans of beer on weekends”) and chewing tobacco (he reports stopping 6 months earlier) and negative for substance abuse. The family history is positive for maternal hypertension and paternal suicide when the patient was 10 years old (no other known paternal history).

Physical findings. The review of systems is positive for intermittent palpitations, lower-extremity weakness causing unsteady gait, and generalized headache.

Ask the patient to list all of his or her symptoms at the beginning of the interview; this can help elucidate a complex or ambiguous presentation.

Vital signs are within normal limits, including blood pressure (120/82 mm Hg) and heart rate (110 beats/min). The patient is not in acute distress; he is awake, alert, and oriented × 3. No murmurs are heard; lungs are clear bilaterally to auscultation. There is no tenderness on abdominal palpation, and no hepatomegaly or splenomegaly; bowel sounds are normal. No significant bruising or lacerations are noted.

Neurology exam. Cranial nerves II-XII are intact. Pupils are equal and reactive to light. Reflexes are 2+ bilaterally. Muscle strength and tone are normal; no tremors are noted. Babinski signs are normal. A Romberg test is positive (swaying).

Continue to: Mr. D has an antalgic gait...

Mr. D has an antalgic gait with significant swaying (without falling); bent posture; and unsteadiness that requires a cane. However, he is able to get up and off the exam table without assistance, and to propel himself, by rolling a chair forward and backward, without difficulty.

Conducting a diagnostic examination

Taking the history. Certain clues can aid in the diagnosis of FND (TABLE 1).¹⁵ For example, the patient might have been seen in multiple specialty practices for a multitude of vague symptoms indicative of potentially related conditions (eg, chronic fatigue, allergies and sensitivities, fibromyalgia, and other chronic pain). The history might include repeated surgeries to investigate those symptoms (eg, laparoscopy, or hysterectomy at an early age). Taking time and care to explore all clinical clues, patient reports, and collateral data are therefore key to making an accurate diagnosis.

A coexisting psychiatric diagnosis might be associated with distress from the presenting functional neurological symptoms—not linked to the FND diagnosis itself.

Note any discrepancies between the severity of reported symptoms and functional ability. A technique that can help elucidate a complex or ambiguous medical presentation is to ask the patient to list all their symptoms at the beginning of the interview. This has threefold benefit: You get a broad picture of the problem; the patient is unburdened of their concerns and experiences your validation; and a long list of symptoms can be an early clue to a diagnosis of FND.

Other helpful questions to determine the impact of symptoms on the patient’s well-­being include inquiries about¹⁶:

• functional impairment
• onset and course of symptoms
• potential causal or correlating events
• dissociative episodes
• previous diagnoses and treatments
• the patient’s perceptions of, and emotional response to, their illness
• a history of abuse.

The physical examination to determine the presence of FND varies, depending on the functional area of impact (eg, motor, neurological, sensory, speech and swallowing). Pay particular attention to presenting signs and clues, and balance them with the patient’s report (or lack of report). Endeavor to demonstrate positive functional signs, such as a positive Hoover test, which relies on the principle of synergistic muscle contraction. You might see evidence of inconsistency, such as weakness or a change in gait, under observation, that seemingly resolves when the patient is getting on and off the exam table.¹⁶Table 2^15-24 describes areas affected by FND, characteristics of the disorder, and related diagnostic examinations.

Table 3^15,18,19 reviews validated special exams that can aid in making the diagnosis. Additional special tests are discussed in the literature.^15-24 These tests can be helpful in narrowing the differential diagnosis but have not been validated and should be used with caution.

Some clinical signs associated with FND might be affected by other factors, including socioeconomic status, limited access to health care, low health literacy, poor communication skills, and physician bias. Keep these factors in mind during the visit, to avoid contributing further to health disparities among groups of patients affected by these problems.

Continue to: CASE

CASE 

The work-up over the next month for Mr. D includes numerous studies, all yielding results that are negative or within normal limits: visual acuity; electrocardiography and an event monitor; laboratory testing (including a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, creatine kinase, erythrocyte sedimentation rate, C-­reactive protein, vitamin B₁₂, folate, and vitamin D); magnetic resonance imaging of the brain and lumbar spine; lumbar puncture; and electromyography.

The score on the 9-item Patient Health Questionnaire for depression is 4 (severity: “none or minimal”); on the 7-item Generalized Anxiety Disorder scale, 0 (“no anxiety disorder”).

Referral. A neurology work-up of headache, lower extremity weakness, and unsteady gait to address several diagnostic possibilities, including migraine and multiple sclerosis, is within normal limits. A cardiology work-up of palpitations is negative for arrhythmias and other concerning findings.

Mr. D declines psychiatric and psychological evaluations.

Building a differential diagnosisis a formidable task

The differential diagnosis of FND is vast. It includes neurological, physiological, and psychiatric symptoms and disorders; somatization; and malingering (Table 4).⁶ Any disorder or condition in these areas that is in the differential diagnosis can be precipitated or exacerbated by stress; most, however, do not involve loss of physical function.¹² In addition, the diagnosis of an FND does not necessarily exclude an organic disorder.

A patient’s presentation becomes complicated—and more difficult to treat—when functional symptoms and an unrelated underlying or early-stage neurological condition coexist. For example, a patient with epilepsy might also have dissociative seizures atop their organic disorder. Neurological disease is considered a risk factor for an overlying FND—just as the risk of depression or anxiety runs concurrently with other chronic diseases.¹⁴

Focus on clinical signs to narrow the differential. A thorough social and medical history and physical examination, as discussed earlier, help narrow the differential diagnosis of organic and medically unexplained disorders. Well-defined imaging or laboratory protocols do not exist to guide physicians to a definitive diagnosis, however.

Continue to: Psychiatric conditions

Psychiatric conditions can coexist with the diagnosis of FND, but might be unrelated. A systematic review of the literature showed that 17% to 42% of patients with FND had a concurrent anxiety disorder. Depression disorders were co-diagnosed in 19% to 71% of patients with FND; dissociative and personality disorders were noted, as well.²⁵ However, coexisting psychiatric diagnosis might more likely be associated with distress from the presenting functional neurological symptoms, not linked to the FND diagnosis itself.¹² This shift in understanding is reflected in the description of FND in the DSM-5.¹¹

CASE

Mr. D reports debilitating headaches at return office visits. Trials of abortive triptans provide no relief; neither do control medications (beta-blockers, coenzyme Q10, magnesium, onabotulinumtoxinA [Botox], topiramate, and valproate). Lower-extremity weakness and unsteadiness are managed with supportive devices, including a cane, and physical therapy.

Importance of establishing a multidisciplinary approach

The complexity of FND lends itself to a multidisciplinary approach during evaluation and, eventually, for treatment. The assessment and diagnostic intervention that you provide, along with the contributions of consulted specialists (including neurology, physical and occupational therapy, psychiatry, psychology, and other mental health professionals) establishes a team-based approach that can increase the patient’s sense of support and reduce excessive testing and unnecessary medications, surgeries, and other treatments.²⁶

Family physicians are in the ideal position to recognize the patient’s functional capacity and the quality of symptoms and to provide timely referral (eg, to Neurology and Psychiatry) for confirmation of the diagnosis and then treatment.

Evidence-based treatment options include:

• psychotherapy, with an emphasis on cognitive behavioral therapy
• physical therapy
• psychopharmacology
• promising combinations of physical and psychological treatment to improve long-term functionality.²⁷

A promising diagnostic tool

The most significant update in the FND literature is on functional neuroimaging for assessing the disorder. Early findings suggest an intricate relationship between mind and body regarding the pathological distortion in FND. And, there is clear evidence that neuroimaging—specifically, functional magnetic resonance imaging—shows changes in brain activity that correspond to the patient’s symptom report. That said, imaging is not the recommended standard of care in the initial work-up of FND because of its cost and the fact that the diagnosis is principally a clinical undertaking.^17,28

Call to action

Offer a generous ear. Begin the diagnostic pursuit by listening carefully and fully to the patient’s complaints, without arriving at a diagnosis with unwarranted bias or haste. This endeavor might require support from other clinical staff (eg, nurses, social workers, case managers) because the diagnostic process can be arduous and lengthy.

Continue to: Convey the diagnosis with sensitivity

Convey the diagnosis with sensitivity. Inquire about the patient’s perceptions and impairments to best personalize your diagnostic explanations. Delivery of the diagnosis might affect the patient’s acceptance and compliance with further testing and treatment of what is generally a persistent and treatment-resistant disorder; poor delivery of diagnostic information can impair the patient–physician relationship and increase the risk of disjointed care. Many patients find that improved patient–­physician communication is therapeutic.²⁹

Let the patient know that you’re taking her seriously. Validate patient concerns with a nonstigmatizing diagnostic label; discuss the diagnostic parameters and cause of symptoms in layman’s terms; and emphasize the potential for reversibility.³⁰ Some patients are not satisfied with having a diagnosis of FND until they are reassured with normal results of testing and provided with referral; even then, some seek further reassurance.

Key tenets of managing care for patients who have been given a diagnosis of FND include:

• nonjudgmental, positive regard
• meaningful expression of empathy
• multidisciplinary coordination
• avoidance of unnecessary testing and harmful treatments
• descriptive and contextual explanations of the diagnosis.

There is clear evidence that functional magnetic resonance imaging reveals changes in brain activity that correspond with the report of symptoms.

Last, keep in mind that the course of treatment for FND is potentially prolonged and multilayered.

CASE

After many visits with his family physician and the neurology and cardiology specialists, as well as an extensive work-up, the physician approaches Mr. D with the possibility of a diagnosis of FND and proposes a multidisciplinary plan that includes:

• a course of physical and occupational therapy
• development of individualized cognitive behavioral tools
• weekly personal and marital counseling
• initiation of a selective serotonin reuptake inhibitor for anxiety
• monthly visits with his family physician.

Months after his return from deployment for evaluation and treatment, Mr. D is able to return to military duty. He reports that his quality of life has improved.

CORRESPONDENCE
Roselyn W. Clemente Fuentes, MD, FAAFP, Eglin Family Medicine Residency, 307 Boatner Road, Eglin AFB, FL 32547; [email protected].

Palpitations, the sensory perception of one’s heartbeat, are reported in 16% of primary care patients, from causes that are both cardiac (ie, arrhythmias) and noncardiac.¹ Palpitations are usually benign; overall mortality is approximately 1% annually. In fact, a retrospective study found no difference in mortality and morbidity between patients with palpitations and control patients without palpitations.² However, palpitations can reflect a life-threatening cardiac condition, as we discuss in this article, making careful assessment and targeted, sometimes urgent, intervention important.³

Here, we review the clinical work-up of palpitations, recommended diagnostic testing, and the range of interventions for cardiac arrhythmias—ectopic beats, ventricular tachycardia (VT), and atrial fibrillation (AF).

Cardiac and noncardiac causes of palpitations

In a prospective cohort study of 190 consecutive patients presenting with palpitations, the cause was cardiac in 43%, psychiatric in 31%, and of a miscellaneous nature (including medication, thyrotoxicosis, caffeine, cocaine, anemia, amphetamine, and mastocytosis) in 10%; in 16%, the cause was undetermined.² In this study, 77% of patients experienced a recurrence of palpitations after their first episode.²

Cardiac arrhythmias, a common cause of palpitations, are differentiated by site of origin—supraventricular and ventricular. Noncardiac causes of palpitations, which we do not discuss here, include metabolic and psychiatric conditions, medications, and substance use. (For a summary of the causes of palpitations, see TABLE 1.^2-4)

Common complaint: ectopic beats. Premature atrial contractions (PACs; also known as premature atrial beats, atrial premature complexes, and atrial premature beats) and premature ventricular contractions (PVCs; also known as ventricular premature complexes and ventricular premature beats, and also of a variety of possible causes) result in a feeling of a skipped heartbeat or a flipping sensation in the chest.

Palpitations are usually benign. But they can reflect a life-threatening cardiac condition, making careful assessment and targeted, sometimes urgent, intervention important.

The burden of PACs is independently associated with mortality, cardiovascular hospitalization, new-onset AF, and pacemaker implantation. In a multivariate analysis, a PAC burden > 76 beats/d was an independent predictor of mortality (hazard ratio [HR] = 1.4; 95% CI, 1.2-16); cardiovascular hospitalization (HR = 1.3; 95% CI, 1.1-1.5); new-onset AF (HR = 1.8; 95% CI, 1.4-2.2); and pacemaker implantation (HR = 2.8; 95% CI, 1.9-4.2). Frequent PACs can lead to cardiac remodeling, so more intense follow-up of patients with a high PAC burden might allow for early detection of AF or subclinical cardiac disease.^5,6

A burden of PVCs > 24% is associated with an increased risk of PVC-induced cardiomyopathy and heart failure. Polymorphic PVCs are more concerning than monomorphic PVCs because the former suggests the presence of more diffuse, rather than localized, myocardial injury. The presence of frequent (> 1000 beats/d) PVCs warrants evaluation and treatment for underlying structural heart disease and ischemic heart disease. Therapy directed toward underlying heart disease can reduce the frequency of PVCs.^7-9

Continue to: The diagnostic work-up

The most important goal of the evaluation of palpitations is to determine the presence, or risk, of structural heart or coronary artery disease (CAD) by means of the history, physical examination, and electrocardiography (EKG). Patients who have an increased risk of structural heart disease need further evaluation with echocardiography; those at increased risk of CAD should have stress testing.

Hemodynamically unstable patients need admission; patients who have a history of syncope with palpitations usually should be admitted for cardiac monitoring. Patients who have had a single episode of palpitations and have normal baseline results of laboratory testing and a normal EKG, and no risk factors for structural heart disease or known CAD, can usually be observed.^3,4,10 Patients with an abnormal baseline EKG, recurrent palpitations (especially tachyarrhythmia), or significant symptoms during palpitations (syncope, presyncope, dyspnea) need further evaluation with ambulatory monitoring^3,4,10 (Figure).

Take a thorough history; ask these questions

Have the patient describe the palpitations. The history should include the patient’s detailed characterization of the palpitations (sudden or gradual onset, rhythm, duration, frequency). Certain descriptions provide possible diagnostic clues:

• Palpitations lasting < 5 minutes are less likely to be of cardiac origin (likelihood ratio [LR] = 0.38; 95% CI, 0.2-0.6).⁴
• A patient who has a regular, rapid-pounding sensation in the neck has an increased probability of atrioventricular (AV) nodal reentrant tachycardia (AVNRT) (LR = 177; 95% CI, 25-1251); absence of this sensation decreases the likelihood of AVNRT (LR = 0.07; 95% CI, 0.03-0.2).⁴
• PACs and PVCs cause a sensation of a skipped heartbeat or a flipping sensation in the chest; they are not reported as a sustained rapid heartbeat.
• Patients with a supraventricular arrhythmia often report sudden onset and cessation of palpitations.
• Patients with palpitations since childhood are more likely to have supraventricular tachycardia (SVT).⁴

Elicit apparent precipitating and alleviating factors. The history should include notation of situations that appear to the patient to lead to palpitations (eg, context, positional variation). Palpitations that affect sleep (LR = 2.3; 95% CI, 1.3-3.9) and palpitations that occur at work (LR = 2.2; 95% CI, 1.3-5) increase the likelihood of a cardiac cause.⁴ Palpitations associated with sudden change in position, such as bending forward or squatting, are more likely due to AVNRT.¹¹

Patients with an abnormal baseline EKG, recurrent palpitations, or significant symptoms during palpitations need evaluation with ambulatory monitoring.

Ask about aggravating factors (eg, exercise) and relieving factors (eg, rest, performing a Valsalva maneuver). Patients with SVT are often able to have palpitations terminated with a Valsalva maneuver, such as carotid sinus massage. Palpitations and syncope during exertion can be associated with hypertrophic cardiomyopathy, congenital coronary anomalies, and ion channelopathies, and can cause sudden cardiac death in athletes (estimated incidence, 1-3/100,000 person–years¹²).

Endeavor to identify underlying cardiac disease. A comprehensive history should also evaluate for risk factors and symptoms (chest pain, dyspnea, diaphoresis, lightheadedness, syncope) of cardiac disease, such as CAD, valvular disease, cardiomyopathy, and congenital heart disease, which increase the likelihood that the presenting complaint is a cardiac arrhythmia (LR = 2; 95% CI, 1.3-3.1).⁴ A history of syncope in a patient with palpitations should prompt evaluation for structural heart disease, such as aortic stenosis or hypertrophic cardiomyopathy, in which outflow-tract obstruction impairs cardiac output and, subsequently, cerebral blood flow.

Obtain additional key information. Determine the following in taking the history:

• Is there a family history of inherited cardiac disorders or sudden cardiac death?
• What prescription and over-the-counter medications is the patient taking? How does the patient characterize his or her use/intake of recreational drugs, nicotine, caffeine, and alcohol?
• Does the patient have a history of panic disorder, which lessens concern about a cardiac cause (LR = 0.2; 95% CI, 0.07-1.01)?⁴ (Of note: A nonpsychiatric cause can coexist in such patients, and should be considered.)

Continue to: Physical examination clues, and the utility of vagal maneuvers

Physical examination clues, and the utility of vagal maneuvers

Although most patients in whom palpitations are the presenting complaint are, in fact, asymptomatic during clinical assessment, cardiovascular examination can assist in diagnosing the arrhythmia or structural heart disease:

• Resting bradycardia increases the likelihood of a clinically significant arrhythmia (LR = 3; 95% CI, 1.27-7.0).¹¹
• A murmur, such as a midsystolic click or holosystolic murmur, detected during the cardiac exam can indicate mitral valve prolapse; a holosystolic murmur, exacerbated upon performing a Valsalva maneuver, suggests hypertrophic cardiomyopathy.
• Visible neck pulsations detected during assessment of the jugular venous pressure, known as cannon atrial (cannon A) waves, reflect abnormal contraction of the right atrium against a closed tricuspid valve during AV dissociation. Cannon A waves have an LR of 2.68 (95% CI, 1.25-5.78) for predicting AVNRT.⁴

Vagal nerve stimulation. In the rare circumstance that a patient complaining of palpitations is symptomatic during assessment, several tachycardias can be detected with the use of vagal maneuvers. Interruption of the tachycardia during carotid massage suggests a tachycardia involving the AV junction (AVNRT), whereas only a temporary pause or reduction in frequency is more common in atrial flutter, AF, and atrial tachycardias. Carotid massage has no effect on the presentation of ventricular arrhythmias.¹⁰

Diagnostic testing and the role of ambulatory monitoring

Electrocardiography. All patients with palpitations should have a 12-lead EKG, which may provide diagnostic clues (TABLE 2¹⁰).

Ambulatory monitoring. When the EKG is nondiagnostic, ambulatory cardiac monitoring has an established role in the diagnosis of recurrent palpitations. In a small study of patients presenting with palpitations to a general practitioner, the deduction of those practitioners was wrong more than half the time when they predicted a ≤ 20% chance of an arrhythmia based on the history, physical exam, and EKG alone¹³—emphasizing the importance of ambulatory monitoring in patients with recurrent palpitations.

A comprehensive history should also evaluate for risk factors and symptoms of cardiac disease (chest pain, dyspnea, diaphoresis, lightheadedness, syncope).

Which monitoring system is most suitable depends on symptom frequency, availability, cost, and patient competence. Twenty-four- to 48-hour Holter monitoring can be used in cases of frequent (eg, daily) palpitations. An automatic external loop recorder can be used for less frequent (eg, every 30 days) symptoms. Most ambulatory EKG is now automatic, and therefore does not require patient activation; older manual systems require patient activation during symptoms.

Two weeks of ambulatory EKG have proved sufficient for determining that there is a cardiac basis to palpitations. The diagnostic yield of ambulatory EKG is highest during Week 1 (1.04 diagnoses per patient), compared to Week 3 (0.17 diagnoses per patient).¹⁴

Implantable loop recorders are placed subcutaneously to provide EKG monitoring for approximately 3 years. They are better suited for diagnosing infrequent palpitations. The diagnostic yield of an implantable loop recorder over the course of 1 year for the detection of an arrhythmia is 73%, compared to 21% for a 24-hour Holter monitor, electrophysiology studies, and 4 weeks of an external loop recorder.¹⁵ Implantable loop recorders are often reserved for patients with palpitations associated with unexplained recurrent syncope.¹⁵

Continue to: Lab work

Lab work. A comprehensive metabolic panel, complete blood count, lipid panel, and thyroid panel should be ordered for all patients with palpitations. Possible additional tests include a urine drug screen (when recreational drug use is suspected); cardiac enzymes; N-terminal-pro hormone B-type natriuretic peptide (when there is evidence of CAD or heart failure); and urinary catecholamines (when pheochromocytoma is suspected).

Other investigations. Echocardiography is indicated when structural heart disease is suspected (TABLE 1^2-4). Patients who have multiple risk factors for CAD or exertional symptoms might warrant a stress test.

Management

PACs and PVCs

Typically, patients are counseled to minimize potential adrenergic precipitants, such as smoking, alcohol, stress, and caffeine. However, limited studies have demonstrated no significant arrhythmogenic potential of a modest dose of caffeine (200 mg), even in patients with known life-threatening ventricular arrhythmias.¹⁶ Beta-blockers and nondihydropyridine calcium channel blockers (CCBs) can reduce the severity of symptoms related to premature ectopic beats and might reduce their frequency, although response is inconsistent. Use of these medications for PACs is largely based on expert opinion and extrapolated from use in other supraventricular and ventricular arrhythmias.

Implantable cardioverter defibrillator therapy is indicated in patients with nonsustained VT due to prior myocardial infarction, left ventricular ejection fraction ≤ 40%, and inducible ventricular fibrillation or sustained VT on electrophysiological study.⁷

Patients with a high burden of ectopy who do not respond to treatment with AV nodal-blocking agents should be referred to Cardiology for other antiarrhythmic agents or catheter ablation. Last, asymptomatic ectopy does not need to be treated; there is no clear evidence that suppression with pharmacotherapy improves overall survival.^15,17

Supraventricular tachycardia

The priority when evaluating any tachycardia is to assess the patient’s stability. Unstable patients should be treated immediately, usually with cardioversion, before an extensive diagnostic evaluation.¹⁸ Patients with wide-complex tachycardia (QRS > 120 ms) are generally more unstable and require more urgent therapy and cardiac consultation or referral. Hemodynamically stable patients with narrow-complex SVT (QRS < 120 ms) can be treated with IV adenosine, which has an 89.7% success rate.^18,19 If adenosine is unsuccessful, cardioversion is indicated.

Stable patients with minimal symptoms and short episodes do not need treatment.

Continue to: Vagal maneuvers

Vagal maneuvers (eg, Valsalva maneuver; unilateral carotid massage after exclusion of a carotid bruit, with head tilted to the side opposite the massage, and not for longer than 10 seconds; or applying an ice-cold wet towel to the face) have a success rate of about 25% and are most effective when performed shortly after onset of arrhythmia. Vagal maneuvers can be used in all patients while preparing to administer medications.²⁰

Patients who need treatment can take the “pill-in-the-pocket” approach with single-dose oral flecainide (3 mg/kg) or combined diltiazem and propranolol. Flecainide has a 94% success rate; diltiazem–propranolol has a lower success rate (61%) but a shorter time to conversion to sinus rhythm.²¹ Patients with sustained or recurrent episodes of SVT should be referred to a cardiologist for chronic prophylactic drug therapy or radiofrequency ablation.

Atrial fibrillation

Hemodynamically unstable patients with AF or atrial flutter, defined by the presence of angina, decompensated heart failure, hypotension, pulmonary edema, or evidence of organ hypoperfusion, should be electrically cardioverted using synchronized direct current.

Hemodynamically stable patients with a rapid ventricular rate should be treated with an IV or oral beta-blocker, CCB, or amiodarone, or electrically cardioverted. IV medications are typically preferred in the acute setting for ease and rapidity of administration; however, there is no evidence that IV formulations of beta-blockers and CCBs are superior to oral formulations. Once the ventricular rate is controlled, patients can be transitioned to an oral short-acting preparation of the selected agent, then converted to an appropriate dosage of an extended-­release preparation.²²

Cardioversion can be performed in patients with AF < 48 hours. In patients with AF > 48 hours, either 4 weeks of anticoagulation can be given, followed by cardioversion, or transesophageal echocardiography should be performed to evaluate for atrial thrombus; if atrial thrombus is absent, cardioversion can be performed.²² Transesophageal echocardiography might be unnecessary in patients known to have been on sustained anticoagulation.

Rate control is noninferior to rhythm control and does not decrease survival, functional capacity, or quality of life. Rate-control medications include beta-blockers, nondihydropyridine CCBs, amiodarone, and digoxin.

When a patient reporting a history of palpitations is symptomatic during assessment, several tachycardias can be detected with the use of vagal maneuvers.

In the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) trial of 4060 patients, mortality was the same with rhythm control (21.3%) and rate control (23.8%) (HR = 1.15; 95% CI, 0.99-1.34), with no difference in the incidence of cardiac death, arrhythmic death, or death due to stroke.²³ In the RACE (RAte Control versus Electrical cardioversion for persistent atrial fibrillation) trial of 522 patients with persistent AF, rate control was noninferior to rhythm control (by cardioversion and drugs) for reducing morbidity and preventing cardiovascular death.²⁴ One possible reason why the rhythm control strategy in the RACE trial did not show superiority is the low number of patients who achieved sustained sinus rhythm.²⁵

Continue to: The recommended ventricular rate...

The recommended ventricular rate has traditionally been 60 to 80 beats/min at rest and < 110 beats/min during daily activities. However, a recent trial found fewer adverse outcomes and no change in symptoms or the outcome of hospitalization in patients randomized to more lenient control (target resting heart rate, < 110 beats/min), although the mean of the actual lenient rate achieved was 86 beats/minute.²⁴

Rhythm control. Antiarrhythmic agents or procedural interventions can be used in patients who fail or remain symptomatic despite rate control.²⁶ Surgical measures include AV node ablation with placement of a pacemaker; atrial pacing with an implantable atrial defibrillator; the Maze procedure (open-heart surgery) to interrupt reentrant circuits in the left atrium; and percutaneous radiofrequency or cryotherapy ablation of arrhythmogenic foci in and around the junction of the pulmonary veins and left atrium.²⁷

There is no significant benefit to immediate catheter ablation over standard medical therapy in adults with symptomatic AF in reducing the composite outcome of death, stroke, serious bleeding, and cardiac arrest. Catheter ablation is associated with a lower AF recurrence rate (50%) than drug therapy (69%) at 3 years.²⁸

Anticoagulation. Patients at high risk of embolic stroke based on their score on the CHA2DS2-VASc^a risk stratification tool (ie, a score ≥ 2) should be anticoagulated.^29,30 Options include a novel oral anticoagulant (dabigatran, rivaroxaban, apixaban, or edoxaban), the preferred class of agents for nonvalvular AF, and warfarin, with a target International Normalized Ratio of 2 to 3. Novel oral anticoagulants have been compared to warfarin for prevention of stroke in AF and were found more effective than warfarin, although at the expense of an increased risk of gastrointestinal bleeding.³¹ Percutaneous left atrial appendage closure, using a device such as the Watchman implant, is a noninferior surgical method to prevent embolic stroke in patients who are intolerant of, or have a contraindication to, anticoagulation.³²

CORRESPONDENCE
Anne Mounsey, MD, Department of Family Medicine, University of North Carolina, 590 Manning Drive, Chapel Hill, NC 27599; [email protected].

Palpitations, the sensory perception of one’s heartbeat, are reported in 16% of primary care patients, from causes that are both cardiac (ie, arrhythmias) and noncardiac.¹ Palpitations are usually benign; overall mortality is approximately 1% annually. In fact, a retrospective study found no difference in mortality and morbidity between patients with palpitations and control patients without palpitations.² However, palpitations can reflect a life-threatening cardiac condition, as we discuss in this article, making careful assessment and targeted, sometimes urgent, intervention important.³

Here, we review the clinical work-up of palpitations, recommended diagnostic testing, and the range of interventions for cardiac arrhythmias—ectopic beats, ventricular tachycardia (VT), and atrial fibrillation (AF).

Cardiac and noncardiac causes of palpitations

In a prospective cohort study of 190 consecutive patients presenting with palpitations, the cause was cardiac in 43%, psychiatric in 31%, and of a miscellaneous nature (including medication, thyrotoxicosis, caffeine, cocaine, anemia, amphetamine, and mastocytosis) in 10%; in 16%, the cause was undetermined.² In this study, 77% of patients experienced a recurrence of palpitations after their first episode.²

Cardiac arrhythmias, a common cause of palpitations, are differentiated by site of origin—supraventricular and ventricular. Noncardiac causes of palpitations, which we do not discuss here, include metabolic and psychiatric conditions, medications, and substance use. (For a summary of the causes of palpitations, see TABLE 1.^2-4)

Common complaint: ectopic beats. Premature atrial contractions (PACs; also known as premature atrial beats, atrial premature complexes, and atrial premature beats) and premature ventricular contractions (PVCs; also known as ventricular premature complexes and ventricular premature beats, and also of a variety of possible causes) result in a feeling of a skipped heartbeat or a flipping sensation in the chest.

Palpitations are usually benign. But they can reflect a life-threatening cardiac condition, making careful assessment and targeted, sometimes urgent, intervention important.

The burden of PACs is independently associated with mortality, cardiovascular hospitalization, new-onset AF, and pacemaker implantation. In a multivariate analysis, a PAC burden > 76 beats/d was an independent predictor of mortality (hazard ratio [HR] = 1.4; 95% CI, 1.2-16); cardiovascular hospitalization (HR = 1.3; 95% CI, 1.1-1.5); new-onset AF (HR = 1.8; 95% CI, 1.4-2.2); and pacemaker implantation (HR = 2.8; 95% CI, 1.9-4.2). Frequent PACs can lead to cardiac remodeling, so more intense follow-up of patients with a high PAC burden might allow for early detection of AF or subclinical cardiac disease.^5,6

A burden of PVCs > 24% is associated with an increased risk of PVC-induced cardiomyopathy and heart failure. Polymorphic PVCs are more concerning than monomorphic PVCs because the former suggests the presence of more diffuse, rather than localized, myocardial injury. The presence of frequent (> 1000 beats/d) PVCs warrants evaluation and treatment for underlying structural heart disease and ischemic heart disease. Therapy directed toward underlying heart disease can reduce the frequency of PVCs.^7-9

Continue to: The diagnostic work-up

The most important goal of the evaluation of palpitations is to determine the presence, or risk, of structural heart or coronary artery disease (CAD) by means of the history, physical examination, and electrocardiography (EKG). Patients who have an increased risk of structural heart disease need further evaluation with echocardiography; those at increased risk of CAD should have stress testing.

Hemodynamically unstable patients need admission; patients who have a history of syncope with palpitations usually should be admitted for cardiac monitoring. Patients who have had a single episode of palpitations and have normal baseline results of laboratory testing and a normal EKG, and no risk factors for structural heart disease or known CAD, can usually be observed.^3,4,10 Patients with an abnormal baseline EKG, recurrent palpitations (especially tachyarrhythmia), or significant symptoms during palpitations (syncope, presyncope, dyspnea) need further evaluation with ambulatory monitoring^3,4,10 (Figure).

Take a thorough history; ask these questions

Have the patient describe the palpitations. The history should include the patient’s detailed characterization of the palpitations (sudden or gradual onset, rhythm, duration, frequency). Certain descriptions provide possible diagnostic clues:

• Palpitations lasting < 5 minutes are less likely to be of cardiac origin (likelihood ratio [LR] = 0.38; 95% CI, 0.2-0.6).⁴
• A patient who has a regular, rapid-pounding sensation in the neck has an increased probability of atrioventricular (AV) nodal reentrant tachycardia (AVNRT) (LR = 177; 95% CI, 25-1251); absence of this sensation decreases the likelihood of AVNRT (LR = 0.07; 95% CI, 0.03-0.2).⁴
• PACs and PVCs cause a sensation of a skipped heartbeat or a flipping sensation in the chest; they are not reported as a sustained rapid heartbeat.
• Patients with a supraventricular arrhythmia often report sudden onset and cessation of palpitations.
• Patients with palpitations since childhood are more likely to have supraventricular tachycardia (SVT).⁴

Elicit apparent precipitating and alleviating factors. The history should include notation of situations that appear to the patient to lead to palpitations (eg, context, positional variation). Palpitations that affect sleep (LR = 2.3; 95% CI, 1.3-3.9) and palpitations that occur at work (LR = 2.2; 95% CI, 1.3-5) increase the likelihood of a cardiac cause.⁴ Palpitations associated with sudden change in position, such as bending forward or squatting, are more likely due to AVNRT.¹¹

Patients with an abnormal baseline EKG, recurrent palpitations, or significant symptoms during palpitations need evaluation with ambulatory monitoring.

Ask about aggravating factors (eg, exercise) and relieving factors (eg, rest, performing a Valsalva maneuver). Patients with SVT are often able to have palpitations terminated with a Valsalva maneuver, such as carotid sinus massage. Palpitations and syncope during exertion can be associated with hypertrophic cardiomyopathy, congenital coronary anomalies, and ion channelopathies, and can cause sudden cardiac death in athletes (estimated incidence, 1-3/100,000 person–years¹²).

Endeavor to identify underlying cardiac disease. A comprehensive history should also evaluate for risk factors and symptoms (chest pain, dyspnea, diaphoresis, lightheadedness, syncope) of cardiac disease, such as CAD, valvular disease, cardiomyopathy, and congenital heart disease, which increase the likelihood that the presenting complaint is a cardiac arrhythmia (LR = 2; 95% CI, 1.3-3.1).⁴ A history of syncope in a patient with palpitations should prompt evaluation for structural heart disease, such as aortic stenosis or hypertrophic cardiomyopathy, in which outflow-tract obstruction impairs cardiac output and, subsequently, cerebral blood flow.

Obtain additional key information. Determine the following in taking the history:

• Is there a family history of inherited cardiac disorders or sudden cardiac death?
• What prescription and over-the-counter medications is the patient taking? How does the patient characterize his or her use/intake of recreational drugs, nicotine, caffeine, and alcohol?
• Does the patient have a history of panic disorder, which lessens concern about a cardiac cause (LR = 0.2; 95% CI, 0.07-1.01)?⁴ (Of note: A nonpsychiatric cause can coexist in such patients, and should be considered.)

Continue to: Physical examination clues, and the utility of vagal maneuvers

Physical examination clues, and the utility of vagal maneuvers

Although most patients in whom palpitations are the presenting complaint are, in fact, asymptomatic during clinical assessment, cardiovascular examination can assist in diagnosing the arrhythmia or structural heart disease:

• Resting bradycardia increases the likelihood of a clinically significant arrhythmia (LR = 3; 95% CI, 1.27-7.0).¹¹
• A murmur, such as a midsystolic click or holosystolic murmur, detected during the cardiac exam can indicate mitral valve prolapse; a holosystolic murmur, exacerbated upon performing a Valsalva maneuver, suggests hypertrophic cardiomyopathy.
• Visible neck pulsations detected during assessment of the jugular venous pressure, known as cannon atrial (cannon A) waves, reflect abnormal contraction of the right atrium against a closed tricuspid valve during AV dissociation. Cannon A waves have an LR of 2.68 (95% CI, 1.25-5.78) for predicting AVNRT.⁴

Vagal nerve stimulation. In the rare circumstance that a patient complaining of palpitations is symptomatic during assessment, several tachycardias can be detected with the use of vagal maneuvers. Interruption of the tachycardia during carotid massage suggests a tachycardia involving the AV junction (AVNRT), whereas only a temporary pause or reduction in frequency is more common in atrial flutter, AF, and atrial tachycardias. Carotid massage has no effect on the presentation of ventricular arrhythmias.¹⁰

Diagnostic testing and the role of ambulatory monitoring

Electrocardiography. All patients with palpitations should have a 12-lead EKG, which may provide diagnostic clues (TABLE 2¹⁰).

Ambulatory monitoring. When the EKG is nondiagnostic, ambulatory cardiac monitoring has an established role in the diagnosis of recurrent palpitations. In a small study of patients presenting with palpitations to a general practitioner, the deduction of those practitioners was wrong more than half the time when they predicted a ≤ 20% chance of an arrhythmia based on the history, physical exam, and EKG alone¹³—emphasizing the importance of ambulatory monitoring in patients with recurrent palpitations.

A comprehensive history should also evaluate for risk factors and symptoms of cardiac disease (chest pain, dyspnea, diaphoresis, lightheadedness, syncope).

Which monitoring system is most suitable depends on symptom frequency, availability, cost, and patient competence. Twenty-four- to 48-hour Holter monitoring can be used in cases of frequent (eg, daily) palpitations. An automatic external loop recorder can be used for less frequent (eg, every 30 days) symptoms. Most ambulatory EKG is now automatic, and therefore does not require patient activation; older manual systems require patient activation during symptoms.

Two weeks of ambulatory EKG have proved sufficient for determining that there is a cardiac basis to palpitations. The diagnostic yield of ambulatory EKG is highest during Week 1 (1.04 diagnoses per patient), compared to Week 3 (0.17 diagnoses per patient).¹⁴

Implantable loop recorders are placed subcutaneously to provide EKG monitoring for approximately 3 years. They are better suited for diagnosing infrequent palpitations. The diagnostic yield of an implantable loop recorder over the course of 1 year for the detection of an arrhythmia is 73%, compared to 21% for a 24-hour Holter monitor, electrophysiology studies, and 4 weeks of an external loop recorder.¹⁵ Implantable loop recorders are often reserved for patients with palpitations associated with unexplained recurrent syncope.¹⁵

Continue to: Lab work

Lab work. A comprehensive metabolic panel, complete blood count, lipid panel, and thyroid panel should be ordered for all patients with palpitations. Possible additional tests include a urine drug screen (when recreational drug use is suspected); cardiac enzymes; N-terminal-pro hormone B-type natriuretic peptide (when there is evidence of CAD or heart failure); and urinary catecholamines (when pheochromocytoma is suspected).

Other investigations. Echocardiography is indicated when structural heart disease is suspected (TABLE 1^2-4). Patients who have multiple risk factors for CAD or exertional symptoms might warrant a stress test.

Management

PACs and PVCs

Typically, patients are counseled to minimize potential adrenergic precipitants, such as smoking, alcohol, stress, and caffeine. However, limited studies have demonstrated no significant arrhythmogenic potential of a modest dose of caffeine (200 mg), even in patients with known life-threatening ventricular arrhythmias.¹⁶ Beta-blockers and nondihydropyridine calcium channel blockers (CCBs) can reduce the severity of symptoms related to premature ectopic beats and might reduce their frequency, although response is inconsistent. Use of these medications for PACs is largely based on expert opinion and extrapolated from use in other supraventricular and ventricular arrhythmias.

Implantable cardioverter defibrillator therapy is indicated in patients with nonsustained VT due to prior myocardial infarction, left ventricular ejection fraction ≤ 40%, and inducible ventricular fibrillation or sustained VT on electrophysiological study.⁷

Patients with a high burden of ectopy who do not respond to treatment with AV nodal-blocking agents should be referred to Cardiology for other antiarrhythmic agents or catheter ablation. Last, asymptomatic ectopy does not need to be treated; there is no clear evidence that suppression with pharmacotherapy improves overall survival.^15,17

Supraventricular tachycardia

The priority when evaluating any tachycardia is to assess the patient’s stability. Unstable patients should be treated immediately, usually with cardioversion, before an extensive diagnostic evaluation.¹⁸ Patients with wide-complex tachycardia (QRS > 120 ms) are generally more unstable and require more urgent therapy and cardiac consultation or referral. Hemodynamically stable patients with narrow-complex SVT (QRS < 120 ms) can be treated with IV adenosine, which has an 89.7% success rate.^18,19 If adenosine is unsuccessful, cardioversion is indicated.

Stable patients with minimal symptoms and short episodes do not need treatment.

Continue to: Vagal maneuvers

Vagal maneuvers (eg, Valsalva maneuver; unilateral carotid massage after exclusion of a carotid bruit, with head tilted to the side opposite the massage, and not for longer than 10 seconds; or applying an ice-cold wet towel to the face) have a success rate of about 25% and are most effective when performed shortly after onset of arrhythmia. Vagal maneuvers can be used in all patients while preparing to administer medications.²⁰

Patients who need treatment can take the “pill-in-the-pocket” approach with single-dose oral flecainide (3 mg/kg) or combined diltiazem and propranolol. Flecainide has a 94% success rate; diltiazem–propranolol has a lower success rate (61%) but a shorter time to conversion to sinus rhythm.²¹ Patients with sustained or recurrent episodes of SVT should be referred to a cardiologist for chronic prophylactic drug therapy or radiofrequency ablation.

Atrial fibrillation

Hemodynamically unstable patients with AF or atrial flutter, defined by the presence of angina, decompensated heart failure, hypotension, pulmonary edema, or evidence of organ hypoperfusion, should be electrically cardioverted using synchronized direct current.

Hemodynamically stable patients with a rapid ventricular rate should be treated with an IV or oral beta-blocker, CCB, or amiodarone, or electrically cardioverted. IV medications are typically preferred in the acute setting for ease and rapidity of administration; however, there is no evidence that IV formulations of beta-blockers and CCBs are superior to oral formulations. Once the ventricular rate is controlled, patients can be transitioned to an oral short-acting preparation of the selected agent, then converted to an appropriate dosage of an extended-­release preparation.²²

Cardioversion can be performed in patients with AF < 48 hours. In patients with AF > 48 hours, either 4 weeks of anticoagulation can be given, followed by cardioversion, or transesophageal echocardiography should be performed to evaluate for atrial thrombus; if atrial thrombus is absent, cardioversion can be performed.²² Transesophageal echocardiography might be unnecessary in patients known to have been on sustained anticoagulation.

Rate control is noninferior to rhythm control and does not decrease survival, functional capacity, or quality of life. Rate-control medications include beta-blockers, nondihydropyridine CCBs, amiodarone, and digoxin.

When a patient reporting a history of palpitations is symptomatic during assessment, several tachycardias can be detected with the use of vagal maneuvers.

In the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) trial of 4060 patients, mortality was the same with rhythm control (21.3%) and rate control (23.8%) (HR = 1.15; 95% CI, 0.99-1.34), with no difference in the incidence of cardiac death, arrhythmic death, or death due to stroke.²³ In the RACE (RAte Control versus Electrical cardioversion for persistent atrial fibrillation) trial of 522 patients with persistent AF, rate control was noninferior to rhythm control (by cardioversion and drugs) for reducing morbidity and preventing cardiovascular death.²⁴ One possible reason why the rhythm control strategy in the RACE trial did not show superiority is the low number of patients who achieved sustained sinus rhythm.²⁵

Continue to: The recommended ventricular rate...

The recommended ventricular rate has traditionally been 60 to 80 beats/min at rest and < 110 beats/min during daily activities. However, a recent trial found fewer adverse outcomes and no change in symptoms or the outcome of hospitalization in patients randomized to more lenient control (target resting heart rate, < 110 beats/min), although the mean of the actual lenient rate achieved was 86 beats/minute.²⁴

Rhythm control. Antiarrhythmic agents or procedural interventions can be used in patients who fail or remain symptomatic despite rate control.²⁶ Surgical measures include AV node ablation with placement of a pacemaker; atrial pacing with an implantable atrial defibrillator; the Maze procedure (open-heart surgery) to interrupt reentrant circuits in the left atrium; and percutaneous radiofrequency or cryotherapy ablation of arrhythmogenic foci in and around the junction of the pulmonary veins and left atrium.²⁷

There is no significant benefit to immediate catheter ablation over standard medical therapy in adults with symptomatic AF in reducing the composite outcome of death, stroke, serious bleeding, and cardiac arrest. Catheter ablation is associated with a lower AF recurrence rate (50%) than drug therapy (69%) at 3 years.²⁸

Anticoagulation. Patients at high risk of embolic stroke based on their score on the CHA2DS2-VASc^a risk stratification tool (ie, a score ≥ 2) should be anticoagulated.^29,30 Options include a novel oral anticoagulant (dabigatran, rivaroxaban, apixaban, or edoxaban), the preferred class of agents for nonvalvular AF, and warfarin, with a target International Normalized Ratio of 2 to 3. Novel oral anticoagulants have been compared to warfarin for prevention of stroke in AF and were found more effective than warfarin, although at the expense of an increased risk of gastrointestinal bleeding.³¹ Percutaneous left atrial appendage closure, using a device such as the Watchman implant, is a noninferior surgical method to prevent embolic stroke in patients who are intolerant of, or have a contraindication to, anticoagulation.³²

CORRESPONDENCE
Anne Mounsey, MD, Department of Family Medicine, University of North Carolina, 590 Manning Drive, Chapel Hill, NC 27599; [email protected].

Palpitations, the sensory perception of one’s heartbeat, are reported in 16% of primary care patients, from causes that are both cardiac (ie, arrhythmias) and noncardiac.¹ Palpitations are usually benign; overall mortality is approximately 1% annually. In fact, a retrospective study found no difference in mortality and morbidity between patients with palpitations and control patients without palpitations.² However, palpitations can reflect a life-threatening cardiac condition, as we discuss in this article, making careful assessment and targeted, sometimes urgent, intervention important.³

Here, we review the clinical work-up of palpitations, recommended diagnostic testing, and the range of interventions for cardiac arrhythmias—ectopic beats, ventricular tachycardia (VT), and atrial fibrillation (AF).

Cardiac and noncardiac causes of palpitations

In a prospective cohort study of 190 consecutive patients presenting with palpitations, the cause was cardiac in 43%, psychiatric in 31%, and of a miscellaneous nature (including medication, thyrotoxicosis, caffeine, cocaine, anemia, amphetamine, and mastocytosis) in 10%; in 16%, the cause was undetermined.² In this study, 77% of patients experienced a recurrence of palpitations after their first episode.²

Cardiac arrhythmias, a common cause of palpitations, are differentiated by site of origin—supraventricular and ventricular. Noncardiac causes of palpitations, which we do not discuss here, include metabolic and psychiatric conditions, medications, and substance use. (For a summary of the causes of palpitations, see TABLE 1.^2-4)

Common complaint: ectopic beats. Premature atrial contractions (PACs; also known as premature atrial beats, atrial premature complexes, and atrial premature beats) and premature ventricular contractions (PVCs; also known as ventricular premature complexes and ventricular premature beats, and also of a variety of possible causes) result in a feeling of a skipped heartbeat or a flipping sensation in the chest.

Palpitations are usually benign. But they can reflect a life-threatening cardiac condition, making careful assessment and targeted, sometimes urgent, intervention important.

The burden of PACs is independently associated with mortality, cardiovascular hospitalization, new-onset AF, and pacemaker implantation. In a multivariate analysis, a PAC burden > 76 beats/d was an independent predictor of mortality (hazard ratio [HR] = 1.4; 95% CI, 1.2-16); cardiovascular hospitalization (HR = 1.3; 95% CI, 1.1-1.5); new-onset AF (HR = 1.8; 95% CI, 1.4-2.2); and pacemaker implantation (HR = 2.8; 95% CI, 1.9-4.2). Frequent PACs can lead to cardiac remodeling, so more intense follow-up of patients with a high PAC burden might allow for early detection of AF or subclinical cardiac disease.^5,6

A burden of PVCs > 24% is associated with an increased risk of PVC-induced cardiomyopathy and heart failure. Polymorphic PVCs are more concerning than monomorphic PVCs because the former suggests the presence of more diffuse, rather than localized, myocardial injury. The presence of frequent (> 1000 beats/d) PVCs warrants evaluation and treatment for underlying structural heart disease and ischemic heart disease. Therapy directed toward underlying heart disease can reduce the frequency of PVCs.^7-9

Continue to: The diagnostic work-up

The most important goal of the evaluation of palpitations is to determine the presence, or risk, of structural heart or coronary artery disease (CAD) by means of the history, physical examination, and electrocardiography (EKG). Patients who have an increased risk of structural heart disease need further evaluation with echocardiography; those at increased risk of CAD should have stress testing.

Hemodynamically unstable patients need admission; patients who have a history of syncope with palpitations usually should be admitted for cardiac monitoring. Patients who have had a single episode of palpitations and have normal baseline results of laboratory testing and a normal EKG, and no risk factors for structural heart disease or known CAD, can usually be observed.^3,4,10 Patients with an abnormal baseline EKG, recurrent palpitations (especially tachyarrhythmia), or significant symptoms during palpitations (syncope, presyncope, dyspnea) need further evaluation with ambulatory monitoring^3,4,10 (Figure).

Take a thorough history; ask these questions

Have the patient describe the palpitations. The history should include the patient’s detailed characterization of the palpitations (sudden or gradual onset, rhythm, duration, frequency). Certain descriptions provide possible diagnostic clues:

• Palpitations lasting < 5 minutes are less likely to be of cardiac origin (likelihood ratio [LR] = 0.38; 95% CI, 0.2-0.6).⁴
• A patient who has a regular, rapid-pounding sensation in the neck has an increased probability of atrioventricular (AV) nodal reentrant tachycardia (AVNRT) (LR = 177; 95% CI, 25-1251); absence of this sensation decreases the likelihood of AVNRT (LR = 0.07; 95% CI, 0.03-0.2).⁴
• PACs and PVCs cause a sensation of a skipped heartbeat or a flipping sensation in the chest; they are not reported as a sustained rapid heartbeat.
• Patients with a supraventricular arrhythmia often report sudden onset and cessation of palpitations.
• Patients with palpitations since childhood are more likely to have supraventricular tachycardia (SVT).⁴

Elicit apparent precipitating and alleviating factors. The history should include notation of situations that appear to the patient to lead to palpitations (eg, context, positional variation). Palpitations that affect sleep (LR = 2.3; 95% CI, 1.3-3.9) and palpitations that occur at work (LR = 2.2; 95% CI, 1.3-5) increase the likelihood of a cardiac cause.⁴ Palpitations associated with sudden change in position, such as bending forward or squatting, are more likely due to AVNRT.¹¹

Patients with an abnormal baseline EKG, recurrent palpitations, or significant symptoms during palpitations need evaluation with ambulatory monitoring.

Ask about aggravating factors (eg, exercise) and relieving factors (eg, rest, performing a Valsalva maneuver). Patients with SVT are often able to have palpitations terminated with a Valsalva maneuver, such as carotid sinus massage. Palpitations and syncope during exertion can be associated with hypertrophic cardiomyopathy, congenital coronary anomalies, and ion channelopathies, and can cause sudden cardiac death in athletes (estimated incidence, 1-3/100,000 person–years¹²).

Endeavor to identify underlying cardiac disease. A comprehensive history should also evaluate for risk factors and symptoms (chest pain, dyspnea, diaphoresis, lightheadedness, syncope) of cardiac disease, such as CAD, valvular disease, cardiomyopathy, and congenital heart disease, which increase the likelihood that the presenting complaint is a cardiac arrhythmia (LR = 2; 95% CI, 1.3-3.1).⁴ A history of syncope in a patient with palpitations should prompt evaluation for structural heart disease, such as aortic stenosis or hypertrophic cardiomyopathy, in which outflow-tract obstruction impairs cardiac output and, subsequently, cerebral blood flow.

Obtain additional key information. Determine the following in taking the history:

• Is there a family history of inherited cardiac disorders or sudden cardiac death?
• What prescription and over-the-counter medications is the patient taking? How does the patient characterize his or her use/intake of recreational drugs, nicotine, caffeine, and alcohol?
• Does the patient have a history of panic disorder, which lessens concern about a cardiac cause (LR = 0.2; 95% CI, 0.07-1.01)?⁴ (Of note: A nonpsychiatric cause can coexist in such patients, and should be considered.)

Continue to: Physical examination clues, and the utility of vagal maneuvers

Physical examination clues, and the utility of vagal maneuvers

Although most patients in whom palpitations are the presenting complaint are, in fact, asymptomatic during clinical assessment, cardiovascular examination can assist in diagnosing the arrhythmia or structural heart disease:

• Resting bradycardia increases the likelihood of a clinically significant arrhythmia (LR = 3; 95% CI, 1.27-7.0).¹¹
• A murmur, such as a midsystolic click or holosystolic murmur, detected during the cardiac exam can indicate mitral valve prolapse; a holosystolic murmur, exacerbated upon performing a Valsalva maneuver, suggests hypertrophic cardiomyopathy.
• Visible neck pulsations detected during assessment of the jugular venous pressure, known as cannon atrial (cannon A) waves, reflect abnormal contraction of the right atrium against a closed tricuspid valve during AV dissociation. Cannon A waves have an LR of 2.68 (95% CI, 1.25-5.78) for predicting AVNRT.⁴

Vagal nerve stimulation. In the rare circumstance that a patient complaining of palpitations is symptomatic during assessment, several tachycardias can be detected with the use of vagal maneuvers. Interruption of the tachycardia during carotid massage suggests a tachycardia involving the AV junction (AVNRT), whereas only a temporary pause or reduction in frequency is more common in atrial flutter, AF, and atrial tachycardias. Carotid massage has no effect on the presentation of ventricular arrhythmias.¹⁰

Diagnostic testing and the role of ambulatory monitoring

Electrocardiography. All patients with palpitations should have a 12-lead EKG, which may provide diagnostic clues (TABLE 2¹⁰).

Ambulatory monitoring. When the EKG is nondiagnostic, ambulatory cardiac monitoring has an established role in the diagnosis of recurrent palpitations. In a small study of patients presenting with palpitations to a general practitioner, the deduction of those practitioners was wrong more than half the time when they predicted a ≤ 20% chance of an arrhythmia based on the history, physical exam, and EKG alone¹³—emphasizing the importance of ambulatory monitoring in patients with recurrent palpitations.

A comprehensive history should also evaluate for risk factors and symptoms of cardiac disease (chest pain, dyspnea, diaphoresis, lightheadedness, syncope).

Which monitoring system is most suitable depends on symptom frequency, availability, cost, and patient competence. Twenty-four- to 48-hour Holter monitoring can be used in cases of frequent (eg, daily) palpitations. An automatic external loop recorder can be used for less frequent (eg, every 30 days) symptoms. Most ambulatory EKG is now automatic, and therefore does not require patient activation; older manual systems require patient activation during symptoms.

Two weeks of ambulatory EKG have proved sufficient for determining that there is a cardiac basis to palpitations. The diagnostic yield of ambulatory EKG is highest during Week 1 (1.04 diagnoses per patient), compared to Week 3 (0.17 diagnoses per patient).¹⁴

Implantable loop recorders are placed subcutaneously to provide EKG monitoring for approximately 3 years. They are better suited for diagnosing infrequent palpitations. The diagnostic yield of an implantable loop recorder over the course of 1 year for the detection of an arrhythmia is 73%, compared to 21% for a 24-hour Holter monitor, electrophysiology studies, and 4 weeks of an external loop recorder.¹⁵ Implantable loop recorders are often reserved for patients with palpitations associated with unexplained recurrent syncope.¹⁵

Continue to: Lab work

Lab work. A comprehensive metabolic panel, complete blood count, lipid panel, and thyroid panel should be ordered for all patients with palpitations. Possible additional tests include a urine drug screen (when recreational drug use is suspected); cardiac enzymes; N-terminal-pro hormone B-type natriuretic peptide (when there is evidence of CAD or heart failure); and urinary catecholamines (when pheochromocytoma is suspected).

Other investigations. Echocardiography is indicated when structural heart disease is suspected (TABLE 1^2-4). Patients who have multiple risk factors for CAD or exertional symptoms might warrant a stress test.

Management

PACs and PVCs

Typically, patients are counseled to minimize potential adrenergic precipitants, such as smoking, alcohol, stress, and caffeine. However, limited studies have demonstrated no significant arrhythmogenic potential of a modest dose of caffeine (200 mg), even in patients with known life-threatening ventricular arrhythmias.¹⁶ Beta-blockers and nondihydropyridine calcium channel blockers (CCBs) can reduce the severity of symptoms related to premature ectopic beats and might reduce their frequency, although response is inconsistent. Use of these medications for PACs is largely based on expert opinion and extrapolated from use in other supraventricular and ventricular arrhythmias.

Implantable cardioverter defibrillator therapy is indicated in patients with nonsustained VT due to prior myocardial infarction, left ventricular ejection fraction ≤ 40%, and inducible ventricular fibrillation or sustained VT on electrophysiological study.⁷

Patients with a high burden of ectopy who do not respond to treatment with AV nodal-blocking agents should be referred to Cardiology for other antiarrhythmic agents or catheter ablation. Last, asymptomatic ectopy does not need to be treated; there is no clear evidence that suppression with pharmacotherapy improves overall survival.^15,17

Supraventricular tachycardia

The priority when evaluating any tachycardia is to assess the patient’s stability. Unstable patients should be treated immediately, usually with cardioversion, before an extensive diagnostic evaluation.¹⁸ Patients with wide-complex tachycardia (QRS > 120 ms) are generally more unstable and require more urgent therapy and cardiac consultation or referral. Hemodynamically stable patients with narrow-complex SVT (QRS < 120 ms) can be treated with IV adenosine, which has an 89.7% success rate.^18,19 If adenosine is unsuccessful, cardioversion is indicated.

Stable patients with minimal symptoms and short episodes do not need treatment.

Continue to: Vagal maneuvers

Vagal maneuvers (eg, Valsalva maneuver; unilateral carotid massage after exclusion of a carotid bruit, with head tilted to the side opposite the massage, and not for longer than 10 seconds; or applying an ice-cold wet towel to the face) have a success rate of about 25% and are most effective when performed shortly after onset of arrhythmia. Vagal maneuvers can be used in all patients while preparing to administer medications.²⁰

Patients who need treatment can take the “pill-in-the-pocket” approach with single-dose oral flecainide (3 mg/kg) or combined diltiazem and propranolol. Flecainide has a 94% success rate; diltiazem–propranolol has a lower success rate (61%) but a shorter time to conversion to sinus rhythm.²¹ Patients with sustained or recurrent episodes of SVT should be referred to a cardiologist for chronic prophylactic drug therapy or radiofrequency ablation.

Atrial fibrillation

Hemodynamically unstable patients with AF or atrial flutter, defined by the presence of angina, decompensated heart failure, hypotension, pulmonary edema, or evidence of organ hypoperfusion, should be electrically cardioverted using synchronized direct current.

Hemodynamically stable patients with a rapid ventricular rate should be treated with an IV or oral beta-blocker, CCB, or amiodarone, or electrically cardioverted. IV medications are typically preferred in the acute setting for ease and rapidity of administration; however, there is no evidence that IV formulations of beta-blockers and CCBs are superior to oral formulations. Once the ventricular rate is controlled, patients can be transitioned to an oral short-acting preparation of the selected agent, then converted to an appropriate dosage of an extended-­release preparation.²²

Cardioversion can be performed in patients with AF < 48 hours. In patients with AF > 48 hours, either 4 weeks of anticoagulation can be given, followed by cardioversion, or transesophageal echocardiography should be performed to evaluate for atrial thrombus; if atrial thrombus is absent, cardioversion can be performed.²² Transesophageal echocardiography might be unnecessary in patients known to have been on sustained anticoagulation.

Rate control is noninferior to rhythm control and does not decrease survival, functional capacity, or quality of life. Rate-control medications include beta-blockers, nondihydropyridine CCBs, amiodarone, and digoxin.

When a patient reporting a history of palpitations is symptomatic during assessment, several tachycardias can be detected with the use of vagal maneuvers.

In the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) trial of 4060 patients, mortality was the same with rhythm control (21.3%) and rate control (23.8%) (HR = 1.15; 95% CI, 0.99-1.34), with no difference in the incidence of cardiac death, arrhythmic death, or death due to stroke.²³ In the RACE (RAte Control versus Electrical cardioversion for persistent atrial fibrillation) trial of 522 patients with persistent AF, rate control was noninferior to rhythm control (by cardioversion and drugs) for reducing morbidity and preventing cardiovascular death.²⁴ One possible reason why the rhythm control strategy in the RACE trial did not show superiority is the low number of patients who achieved sustained sinus rhythm.²⁵

Continue to: The recommended ventricular rate...

The recommended ventricular rate has traditionally been 60 to 80 beats/min at rest and < 110 beats/min during daily activities. However, a recent trial found fewer adverse outcomes and no change in symptoms or the outcome of hospitalization in patients randomized to more lenient control (target resting heart rate, < 110 beats/min), although the mean of the actual lenient rate achieved was 86 beats/minute.²⁴

Rhythm control. Antiarrhythmic agents or procedural interventions can be used in patients who fail or remain symptomatic despite rate control.²⁶ Surgical measures include AV node ablation with placement of a pacemaker; atrial pacing with an implantable atrial defibrillator; the Maze procedure (open-heart surgery) to interrupt reentrant circuits in the left atrium; and percutaneous radiofrequency or cryotherapy ablation of arrhythmogenic foci in and around the junction of the pulmonary veins and left atrium.²⁷

There is no significant benefit to immediate catheter ablation over standard medical therapy in adults with symptomatic AF in reducing the composite outcome of death, stroke, serious bleeding, and cardiac arrest. Catheter ablation is associated with a lower AF recurrence rate (50%) than drug therapy (69%) at 3 years.²⁸

Anticoagulation. Patients at high risk of embolic stroke based on their score on the CHA2DS2-VASc^a risk stratification tool (ie, a score ≥ 2) should be anticoagulated.^29,30 Options include a novel oral anticoagulant (dabigatran, rivaroxaban, apixaban, or edoxaban), the preferred class of agents for nonvalvular AF, and warfarin, with a target International Normalized Ratio of 2 to 3. Novel oral anticoagulants have been compared to warfarin for prevention of stroke in AF and were found more effective than warfarin, although at the expense of an increased risk of gastrointestinal bleeding.³¹ Percutaneous left atrial appendage closure, using a device such as the Watchman implant, is a noninferior surgical method to prevent embolic stroke in patients who are intolerant of, or have a contraindication to, anticoagulation.³²

CORRESPONDENCE
Anne Mounsey, MD, Department of Family Medicine, University of North Carolina, 590 Manning Drive, Chapel Hill, NC 27599; [email protected].

Hospitalists across the United States have been and continue to be a critical part of our nation’s response to COVID-19. On National Hospitalist Day, Thursday, March 4, 2021, the Society of Hospital Medicine invites you to celebrate the individuals and teams that make up the hospital medicine community.

Courtesy Joseph Li

On this special day, SHM encourages you to share your story, showcase your team’s efforts to improve patient care, express your pride for the specialty, or share how you are making a difference in your hospital and in the lives of patients.

Here are just a few of the ways you can celebrate:

• Register for our live roundtable, featuring Mark Shapiro, MD, hospitalist and host of the Explore the Space podcast, and four hospitalist panelists, on March 4 at 7 p.m. ET/4 p.m. PT.
• Download shareable graphics, posters, Zoom backgrounds, and coloring book pages
• Enter our social media photo contest and follow the #HowWeHospitalist hashtag across all platforms
• Read special hospitalist profiles in the Hospitalist, including: Eric E. Howell, MD, MHM; Grace Huang, MD; Bridget McGrath, PA-C, FHM; and Harry Cho, MD, SFHM

Thank you for all you do and continue to do for hospital medicine. We hope you take some time today to celebrate you and your colleagues, as well as your commendable contributions to health care and the future of the specialty.

To learn more about National Hospitalist Day, visit hospitalmedicine.org/hospitalistday.




 

Hospitalists across the United States have been and continue to be a critical part of our nation’s response to COVID-19. On National Hospitalist Day, Thursday, March 4, 2021, the Society of Hospital Medicine invites you to celebrate the individuals and teams that make up the hospital medicine community.

Courtesy Joseph Li

On this special day, SHM encourages you to share your story, showcase your team’s efforts to improve patient care, express your pride for the specialty, or share how you are making a difference in your hospital and in the lives of patients.

Here are just a few of the ways you can celebrate:

• Register for our live roundtable, featuring Mark Shapiro, MD, hospitalist and host of the Explore the Space podcast, and four hospitalist panelists, on March 4 at 7 p.m. ET/4 p.m. PT.
• Download shareable graphics, posters, Zoom backgrounds, and coloring book pages
• Enter our social media photo contest and follow the #HowWeHospitalist hashtag across all platforms
• Read special hospitalist profiles in the Hospitalist, including: Eric E. Howell, MD, MHM; Grace Huang, MD; Bridget McGrath, PA-C, FHM; and Harry Cho, MD, SFHM

Thank you for all you do and continue to do for hospital medicine. We hope you take some time today to celebrate you and your colleagues, as well as your commendable contributions to health care and the future of the specialty.

To learn more about National Hospitalist Day, visit hospitalmedicine.org/hospitalistday.




 

Hospitalists across the United States have been and continue to be a critical part of our nation’s response to COVID-19. On National Hospitalist Day, Thursday, March 4, 2021, the Society of Hospital Medicine invites you to celebrate the individuals and teams that make up the hospital medicine community.

Courtesy Joseph Li

On this special day, SHM encourages you to share your story, showcase your team’s efforts to improve patient care, express your pride for the specialty, or share how you are making a difference in your hospital and in the lives of patients.

Here are just a few of the ways you can celebrate:

• Register for our live roundtable, featuring Mark Shapiro, MD, hospitalist and host of the Explore the Space podcast, and four hospitalist panelists, on March 4 at 7 p.m. ET/4 p.m. PT.
• Download shareable graphics, posters, Zoom backgrounds, and coloring book pages
• Enter our social media photo contest and follow the #HowWeHospitalist hashtag across all platforms
• Read special hospitalist profiles in the Hospitalist, including: Eric E. Howell, MD, MHM; Grace Huang, MD; Bridget McGrath, PA-C, FHM; and Harry Cho, MD, SFHM

Thank you for all you do and continue to do for hospital medicine. We hope you take some time today to celebrate you and your colleagues, as well as your commendable contributions to health care and the future of the specialty.

To learn more about National Hospitalist Day, visit hospitalmedicine.org/hospitalistday.




 

United Healthcare recently became the latest major insurer to offer a “virtual primary care service.” Initially, the service will be part of some employer-sponsored insurance plans in 11 states. United intends to expand its footprint next year.

United is using the platform and the medical group of American Well, a telehealth service, to provide virtual primary care. Besides minor acute care, United’s virtual service covers annual wellness visits, routine follow-ups for chronic conditions, lab tests, and specialist referrals with little or no cost sharing.

The giant insurer is now offering its virtual primary care plan in Arizona, Colorado, Illinois, Maryland, North Carolina, Ohio, South Carolina, Texas, Virginia, Washington, D.C., and West Virginia.

Other insurers are offering similar virtual primary care plans. For example, Humana has partnered with Doctor on Demand, and Cigna is working with MDLive to offer virtual primary care plans. Both of these plans encourage consumers to form ongoing relationships with physicians hired by the telehealth services. Similarly, Harvard Pilgrim, which has also joined with Doctor on Demand, said that consumers get “virtual PCPs” along with a full care team.

Humana has priced the premiums for its virtual service at about half the cost of Humana’s most popular traditional plan. There are no copays for telehealth visits; there are $5 copays for common lab tests and prescriptions. Cigna said that its virtual plan makes coverage “more affordable,” but doesn’t provide any specifics.

According to United spokeswoman Maria Shydlo, the insurer’s virtual primary care service is not cheaper than its traditional products.
 

Increased telehealth adoption

When the COVID-19 pandemic first struck last year, telehealth was a lifesaver for primary care practices. Physicians were able to treat half or more of their patients through telehealth, including video and phone consultations.

That initial romance with telehealth did not last. Today, telehealth represents 9% of adult primary care visits. However, that’s still a much higher percentage than before 2020, and telehealth has become a fixture of primary care.

Prior to the pandemic, telehealth services dominated the virtual care space. Some large groups experimented with having their doctors conduct virtual consults with their patients. Other physicians dabbled with telehealth or stayed out of it entirely because health plans paid much less for virtual visits than for in-person visits.

That began to change as more and more states passed laws requiring payment parity. (Today, 36 states do.) Then as the pandemic took hold, Medicare loosened its regulations, allowing coverage of telehealth everywhere and establishing parity. But it’s unclear what will happen after the public health emergency ends.

United and other insurers portray their virtual primary care plans as an effort to connect more consumers with primary care physicians. Having a relationship with a primary care doctor, United noted in a press release, increases access to care, including preventive services. Moreover, a United survey found that a quarter of respondents preferred a virtual relationship with a primary care doctor.
 

Physician have mostly positive but mixed reactions

This news organization interviewed several physicians who practice in states where United has introduced its new offering. Only one doctor had heard about it, and another, solo family physician Will Sawyer, MD, of Cincinnati no longer contracts with United. Nevertheless, they all had strong opinions about virtual primary care plans from United and other insurers.

Dr. Sawyer is a big proponent of telehealth and notes that it’s “incredibly convenient” for older people, many of whom are afraid to come to the office out of fear they might contract COVID-19. He has found that telehealth can be useful for many kinds of acute and chronic care. But he believes (although he admits he does not have evidence) that United started its virtual primary care service mainly to save money.

No to some kinds of telehealth doctors

The physicians we spoke with were unified in their opposition to virtual primary care plans that mainly use physicians hired by telehealth services. Dr. Sawyer noted that one-off consultations with telehealth doctors might be okay for urgent care. “But what we’re trying to do with patients is change their behavior for better health outcomes, and that doesn’t happen in these one-off contacts,” he said.

Even if a patient were able to develop an online relationship with a telehealth doctor, Dr. Basch said, there are any number of situations in which an in-person visit might be necessary. “Whether it’s a urologic visit, a cardiac visit, or an allergy visit, do I need to listen to you or put my hands on you to palpate your liver? Or is this just a conversation with someone I know to see how they’re doing, how they’re managing their meds? Ninety percent of a diagnosis is history.”

Although the virtual plans allow a telehealth physician to refer a patient to an in-network specialist for an office visit, this isn’t the same as their primary care physician asking them to come in to be examined.

Moreover, Dr. Basch noted, people with chronic conditions can’t be treated only virtually. “I wouldn’t say that primary care should be done predominantly through virtual visits. It may be okay for young and healthy patients, but not for older people with chronic conditions. There are times when they should see their doctor in person.”
 

What can be done via telehealth

On the other hand, Dr. Basch heartily approves of conducting routine follow-up visits virtually for patients with chronic diseases, as long as the physician knows the patient’s history. Telehealth can also be used to coach patients on exercise, nutrition, and other lifestyle changes.

Dr. Kubitschek estimates that around 40%-50% of primary care can be delivered through telehealth. But the remainder encompasses potentially serious conditions that should be diagnosed and treated in face-to-face encounters, he said. “For example, if a patient has abdominal pain, you have to examine the person to get a clue of what they’re talking about. The pains are often diffuse, but they might be painful locally, which could indicate a mass or a bladder distension.”

For that reason, he doesn’t support the idea of patients depending on telehealth doctors in virtual primary care plans. “These doctors would not be available to care for the patient in an urgent situation without sending them to a costly emergency room or urgent care clinic. In those settings, excess testing is done because of a lack of familiarity with the patient and his or her history and exam. I think a combination of in-person and telehealth visits presents the best circumstance for the patient and the physician. Having said that, I do believe that telehealth alone is better than no interaction with a health care provider.”
 

United approach can help with prevention

Donny Aga, MD, an internist with Kelsey-Seybold, a multispecialty group in Houston, has been a member of United’s virtual health advisory group for the past 2 years. In his view, United’s virtual primary care service is moving in the right direction by covering preventive and chronic care. Noting that 25%-30% of patients nationally have put off wellness and chronic care visits out of fear of COVID-19, he said that,“if health plans like United are willing to cover preventive services through telehealth, that will allow us to catch up on a lot of the needed screening tests and exams. So it’s a very positive step forward.”

On the other hand, he said, virtual plans that depend solely on telehealth doctors are not the way to manage chronic conditions. “Primary care is best done by your own primary care physician, not by someone who doesn’t know you from a distance.”

Regarding the virtual plans in which patients can establish relationships with telehealth physicians, Dr. Aga said that this approach can benefit some patients, especially those who live in rural areas and don’t have access to primary care. But there are drawbacks, including the telehealth providers’ lack of knowledge about local specialists.

“The negative is that you don’t have a [primary care physicians] who’s local, who knows you, who has examined you before, and who has a good relationship with those specialists and knows who is the right specialist to see for your problem,” Dr. Aga said. “It’s very difficult, if you don’t live and work in that area, to know the best places to send people.”
 

Virtual visits cost less

Like Dr. Basch, Dr. Aga said it’s possible that some insurance companies might begin to cover office visits only for certain conditions or services if they can be managed more cheaply via telehealth. He hopes that doesn’t happen; if it does, he predicts that patients and doctors will push back hard.

Why would a virtual primary care visit cost a health plan less than an in-person visit if it’s paying doctors the same for both? Dr. Aga said it’s because fewer prescriptions and lab tests are ordered in telehealth encounters. He bases this assertion on the quarter of a million virtual visits that Kelsey-Seybold has conducted and also alludes to published studies.

The characteristics of telehealth visits might explain this phenomenon, he said. “These visits are typically much shorter, and it’s easy to be problem-centric and problem based. Physicians use more of their intuitive skills, rather than just lab everybody up and get an x-ray, because that patient’s not there, and it’s easier to draw blood or get an x-ray if somebody is there.”
 

Cutting practice overhead

From the perspective of Kelsey-Seybold, which is now conducting about a fifth of its visits virtually, “infrastructure costs are less” for telehealth, Aga notes. Although Dr. Kubitschek and Dr. Sawyer say it doesn’t take less time to conduct a telehealth visit than an office visit, other practice costs may decrease in relationship to the percentage of a doctor’s visits that are virtual.

“If implemented appropriately, telehealth consults should cost less in terms of the ancillary costs surrounding care,” said Dr. Basch. He recalls that, some years ago, a five-doctor primary care group in Portland, Ore., began charging small monthly fees to patients for full-service care that included email access. After a while, 40% of their patients were coming in, and the rest received care by email or phone. As a result, the doctors were able to downsize to a smaller office space because they didn’t need a waiting room.

Although Dr. Basch doesn’t believe it would be appropriate for practices to do something like this in the midst of a pandemic, he sees the possibility of it happening in the future. “Eventually, a group might be able to say: ‘Yes, our practice expenses can be lower if we do this smartly. We could do as well as we’ve done on whatever insurance pays for office visits, knowing that we can deliver care to the same patient panel at, say, 10% lower overhead with telehealth.’ ”

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

United Healthcare recently became the latest major insurer to offer a “virtual primary care service.” Initially, the service will be part of some employer-sponsored insurance plans in 11 states. United intends to expand its footprint next year.

United is using the platform and the medical group of American Well, a telehealth service, to provide virtual primary care. Besides minor acute care, United’s virtual service covers annual wellness visits, routine follow-ups for chronic conditions, lab tests, and specialist referrals with little or no cost sharing.

The giant insurer is now offering its virtual primary care plan in Arizona, Colorado, Illinois, Maryland, North Carolina, Ohio, South Carolina, Texas, Virginia, Washington, D.C., and West Virginia.

Other insurers are offering similar virtual primary care plans. For example, Humana has partnered with Doctor on Demand, and Cigna is working with MDLive to offer virtual primary care plans. Both of these plans encourage consumers to form ongoing relationships with physicians hired by the telehealth services. Similarly, Harvard Pilgrim, which has also joined with Doctor on Demand, said that consumers get “virtual PCPs” along with a full care team.

Humana has priced the premiums for its virtual service at about half the cost of Humana’s most popular traditional plan. There are no copays for telehealth visits; there are $5 copays for common lab tests and prescriptions. Cigna said that its virtual plan makes coverage “more affordable,” but doesn’t provide any specifics.

According to United spokeswoman Maria Shydlo, the insurer’s virtual primary care service is not cheaper than its traditional products.
 

Increased telehealth adoption

When the COVID-19 pandemic first struck last year, telehealth was a lifesaver for primary care practices. Physicians were able to treat half or more of their patients through telehealth, including video and phone consultations.

That initial romance with telehealth did not last. Today, telehealth represents 9% of adult primary care visits. However, that’s still a much higher percentage than before 2020, and telehealth has become a fixture of primary care.

Prior to the pandemic, telehealth services dominated the virtual care space. Some large groups experimented with having their doctors conduct virtual consults with their patients. Other physicians dabbled with telehealth or stayed out of it entirely because health plans paid much less for virtual visits than for in-person visits.

That began to change as more and more states passed laws requiring payment parity. (Today, 36 states do.) Then as the pandemic took hold, Medicare loosened its regulations, allowing coverage of telehealth everywhere and establishing parity. But it’s unclear what will happen after the public health emergency ends.

United and other insurers portray their virtual primary care plans as an effort to connect more consumers with primary care physicians. Having a relationship with a primary care doctor, United noted in a press release, increases access to care, including preventive services. Moreover, a United survey found that a quarter of respondents preferred a virtual relationship with a primary care doctor.
 

Physician have mostly positive but mixed reactions

This news organization interviewed several physicians who practice in states where United has introduced its new offering. Only one doctor had heard about it, and another, solo family physician Will Sawyer, MD, of Cincinnati no longer contracts with United. Nevertheless, they all had strong opinions about virtual primary care plans from United and other insurers.

Dr. Sawyer is a big proponent of telehealth and notes that it’s “incredibly convenient” for older people, many of whom are afraid to come to the office out of fear they might contract COVID-19. He has found that telehealth can be useful for many kinds of acute and chronic care. But he believes (although he admits he does not have evidence) that United started its virtual primary care service mainly to save money.

No to some kinds of telehealth doctors

The physicians we spoke with were unified in their opposition to virtual primary care plans that mainly use physicians hired by telehealth services. Dr. Sawyer noted that one-off consultations with telehealth doctors might be okay for urgent care. “But what we’re trying to do with patients is change their behavior for better health outcomes, and that doesn’t happen in these one-off contacts,” he said.

Even if a patient were able to develop an online relationship with a telehealth doctor, Dr. Basch said, there are any number of situations in which an in-person visit might be necessary. “Whether it’s a urologic visit, a cardiac visit, or an allergy visit, do I need to listen to you or put my hands on you to palpate your liver? Or is this just a conversation with someone I know to see how they’re doing, how they’re managing their meds? Ninety percent of a diagnosis is history.”

Although the virtual plans allow a telehealth physician to refer a patient to an in-network specialist for an office visit, this isn’t the same as their primary care physician asking them to come in to be examined.

Moreover, Dr. Basch noted, people with chronic conditions can’t be treated only virtually. “I wouldn’t say that primary care should be done predominantly through virtual visits. It may be okay for young and healthy patients, but not for older people with chronic conditions. There are times when they should see their doctor in person.”
 

What can be done via telehealth

On the other hand, Dr. Basch heartily approves of conducting routine follow-up visits virtually for patients with chronic diseases, as long as the physician knows the patient’s history. Telehealth can also be used to coach patients on exercise, nutrition, and other lifestyle changes.

Dr. Kubitschek estimates that around 40%-50% of primary care can be delivered through telehealth. But the remainder encompasses potentially serious conditions that should be diagnosed and treated in face-to-face encounters, he said. “For example, if a patient has abdominal pain, you have to examine the person to get a clue of what they’re talking about. The pains are often diffuse, but they might be painful locally, which could indicate a mass or a bladder distension.”

For that reason, he doesn’t support the idea of patients depending on telehealth doctors in virtual primary care plans. “These doctors would not be available to care for the patient in an urgent situation without sending them to a costly emergency room or urgent care clinic. In those settings, excess testing is done because of a lack of familiarity with the patient and his or her history and exam. I think a combination of in-person and telehealth visits presents the best circumstance for the patient and the physician. Having said that, I do believe that telehealth alone is better than no interaction with a health care provider.”
 

United approach can help with prevention

Donny Aga, MD, an internist with Kelsey-Seybold, a multispecialty group in Houston, has been a member of United’s virtual health advisory group for the past 2 years. In his view, United’s virtual primary care service is moving in the right direction by covering preventive and chronic care. Noting that 25%-30% of patients nationally have put off wellness and chronic care visits out of fear of COVID-19, he said that,“if health plans like United are willing to cover preventive services through telehealth, that will allow us to catch up on a lot of the needed screening tests and exams. So it’s a very positive step forward.”

On the other hand, he said, virtual plans that depend solely on telehealth doctors are not the way to manage chronic conditions. “Primary care is best done by your own primary care physician, not by someone who doesn’t know you from a distance.”

Regarding the virtual plans in which patients can establish relationships with telehealth physicians, Dr. Aga said that this approach can benefit some patients, especially those who live in rural areas and don’t have access to primary care. But there are drawbacks, including the telehealth providers’ lack of knowledge about local specialists.

“The negative is that you don’t have a [primary care physicians] who’s local, who knows you, who has examined you before, and who has a good relationship with those specialists and knows who is the right specialist to see for your problem,” Dr. Aga said. “It’s very difficult, if you don’t live and work in that area, to know the best places to send people.”
 

Virtual visits cost less

Like Dr. Basch, Dr. Aga said it’s possible that some insurance companies might begin to cover office visits only for certain conditions or services if they can be managed more cheaply via telehealth. He hopes that doesn’t happen; if it does, he predicts that patients and doctors will push back hard.

Why would a virtual primary care visit cost a health plan less than an in-person visit if it’s paying doctors the same for both? Dr. Aga said it’s because fewer prescriptions and lab tests are ordered in telehealth encounters. He bases this assertion on the quarter of a million virtual visits that Kelsey-Seybold has conducted and also alludes to published studies.

The characteristics of telehealth visits might explain this phenomenon, he said. “These visits are typically much shorter, and it’s easy to be problem-centric and problem based. Physicians use more of their intuitive skills, rather than just lab everybody up and get an x-ray, because that patient’s not there, and it’s easier to draw blood or get an x-ray if somebody is there.”
 

Cutting practice overhead

From the perspective of Kelsey-Seybold, which is now conducting about a fifth of its visits virtually, “infrastructure costs are less” for telehealth, Aga notes. Although Dr. Kubitschek and Dr. Sawyer say it doesn’t take less time to conduct a telehealth visit than an office visit, other practice costs may decrease in relationship to the percentage of a doctor’s visits that are virtual.

“If implemented appropriately, telehealth consults should cost less in terms of the ancillary costs surrounding care,” said Dr. Basch. He recalls that, some years ago, a five-doctor primary care group in Portland, Ore., began charging small monthly fees to patients for full-service care that included email access. After a while, 40% of their patients were coming in, and the rest received care by email or phone. As a result, the doctors were able to downsize to a smaller office space because they didn’t need a waiting room.

Although Dr. Basch doesn’t believe it would be appropriate for practices to do something like this in the midst of a pandemic, he sees the possibility of it happening in the future. “Eventually, a group might be able to say: ‘Yes, our practice expenses can be lower if we do this smartly. We could do as well as we’ve done on whatever insurance pays for office visits, knowing that we can deliver care to the same patient panel at, say, 10% lower overhead with telehealth.’ ”

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

United Healthcare recently became the latest major insurer to offer a “virtual primary care service.” Initially, the service will be part of some employer-sponsored insurance plans in 11 states. United intends to expand its footprint next year.

United is using the platform and the medical group of American Well, a telehealth service, to provide virtual primary care. Besides minor acute care, United’s virtual service covers annual wellness visits, routine follow-ups for chronic conditions, lab tests, and specialist referrals with little or no cost sharing.

The giant insurer is now offering its virtual primary care plan in Arizona, Colorado, Illinois, Maryland, North Carolina, Ohio, South Carolina, Texas, Virginia, Washington, D.C., and West Virginia.

Other insurers are offering similar virtual primary care plans. For example, Humana has partnered with Doctor on Demand, and Cigna is working with MDLive to offer virtual primary care plans. Both of these plans encourage consumers to form ongoing relationships with physicians hired by the telehealth services. Similarly, Harvard Pilgrim, which has also joined with Doctor on Demand, said that consumers get “virtual PCPs” along with a full care team.

Humana has priced the premiums for its virtual service at about half the cost of Humana’s most popular traditional plan. There are no copays for telehealth visits; there are $5 copays for common lab tests and prescriptions. Cigna said that its virtual plan makes coverage “more affordable,” but doesn’t provide any specifics.

According to United spokeswoman Maria Shydlo, the insurer’s virtual primary care service is not cheaper than its traditional products.
 

Increased telehealth adoption

When the COVID-19 pandemic first struck last year, telehealth was a lifesaver for primary care practices. Physicians were able to treat half or more of their patients through telehealth, including video and phone consultations.

That initial romance with telehealth did not last. Today, telehealth represents 9% of adult primary care visits. However, that’s still a much higher percentage than before 2020, and telehealth has become a fixture of primary care.

Prior to the pandemic, telehealth services dominated the virtual care space. Some large groups experimented with having their doctors conduct virtual consults with their patients. Other physicians dabbled with telehealth or stayed out of it entirely because health plans paid much less for virtual visits than for in-person visits.

That began to change as more and more states passed laws requiring payment parity. (Today, 36 states do.) Then as the pandemic took hold, Medicare loosened its regulations, allowing coverage of telehealth everywhere and establishing parity. But it’s unclear what will happen after the public health emergency ends.

United and other insurers portray their virtual primary care plans as an effort to connect more consumers with primary care physicians. Having a relationship with a primary care doctor, United noted in a press release, increases access to care, including preventive services. Moreover, a United survey found that a quarter of respondents preferred a virtual relationship with a primary care doctor.
 

Physician have mostly positive but mixed reactions

This news organization interviewed several physicians who practice in states where United has introduced its new offering. Only one doctor had heard about it, and another, solo family physician Will Sawyer, MD, of Cincinnati no longer contracts with United. Nevertheless, they all had strong opinions about virtual primary care plans from United and other insurers.

Dr. Sawyer is a big proponent of telehealth and notes that it’s “incredibly convenient” for older people, many of whom are afraid to come to the office out of fear they might contract COVID-19. He has found that telehealth can be useful for many kinds of acute and chronic care. But he believes (although he admits he does not have evidence) that United started its virtual primary care service mainly to save money.

No to some kinds of telehealth doctors

The physicians we spoke with were unified in their opposition to virtual primary care plans that mainly use physicians hired by telehealth services. Dr. Sawyer noted that one-off consultations with telehealth doctors might be okay for urgent care. “But what we’re trying to do with patients is change their behavior for better health outcomes, and that doesn’t happen in these one-off contacts,” he said.

Even if a patient were able to develop an online relationship with a telehealth doctor, Dr. Basch said, there are any number of situations in which an in-person visit might be necessary. “Whether it’s a urologic visit, a cardiac visit, or an allergy visit, do I need to listen to you or put my hands on you to palpate your liver? Or is this just a conversation with someone I know to see how they’re doing, how they’re managing their meds? Ninety percent of a diagnosis is history.”

Although the virtual plans allow a telehealth physician to refer a patient to an in-network specialist for an office visit, this isn’t the same as their primary care physician asking them to come in to be examined.

Moreover, Dr. Basch noted, people with chronic conditions can’t be treated only virtually. “I wouldn’t say that primary care should be done predominantly through virtual visits. It may be okay for young and healthy patients, but not for older people with chronic conditions. There are times when they should see their doctor in person.”
 

What can be done via telehealth

On the other hand, Dr. Basch heartily approves of conducting routine follow-up visits virtually for patients with chronic diseases, as long as the physician knows the patient’s history. Telehealth can also be used to coach patients on exercise, nutrition, and other lifestyle changes.

Dr. Kubitschek estimates that around 40%-50% of primary care can be delivered through telehealth. But the remainder encompasses potentially serious conditions that should be diagnosed and treated in face-to-face encounters, he said. “For example, if a patient has abdominal pain, you have to examine the person to get a clue of what they’re talking about. The pains are often diffuse, but they might be painful locally, which could indicate a mass or a bladder distension.”

For that reason, he doesn’t support the idea of patients depending on telehealth doctors in virtual primary care plans. “These doctors would not be available to care for the patient in an urgent situation without sending them to a costly emergency room or urgent care clinic. In those settings, excess testing is done because of a lack of familiarity with the patient and his or her history and exam. I think a combination of in-person and telehealth visits presents the best circumstance for the patient and the physician. Having said that, I do believe that telehealth alone is better than no interaction with a health care provider.”
 

United approach can help with prevention

Donny Aga, MD, an internist with Kelsey-Seybold, a multispecialty group in Houston, has been a member of United’s virtual health advisory group for the past 2 years. In his view, United’s virtual primary care service is moving in the right direction by covering preventive and chronic care. Noting that 25%-30% of patients nationally have put off wellness and chronic care visits out of fear of COVID-19, he said that,“if health plans like United are willing to cover preventive services through telehealth, that will allow us to catch up on a lot of the needed screening tests and exams. So it’s a very positive step forward.”

On the other hand, he said, virtual plans that depend solely on telehealth doctors are not the way to manage chronic conditions. “Primary care is best done by your own primary care physician, not by someone who doesn’t know you from a distance.”

Regarding the virtual plans in which patients can establish relationships with telehealth physicians, Dr. Aga said that this approach can benefit some patients, especially those who live in rural areas and don’t have access to primary care. But there are drawbacks, including the telehealth providers’ lack of knowledge about local specialists.

“The negative is that you don’t have a [primary care physicians] who’s local, who knows you, who has examined you before, and who has a good relationship with those specialists and knows who is the right specialist to see for your problem,” Dr. Aga said. “It’s very difficult, if you don’t live and work in that area, to know the best places to send people.”
 

Virtual visits cost less

Like Dr. Basch, Dr. Aga said it’s possible that some insurance companies might begin to cover office visits only for certain conditions or services if they can be managed more cheaply via telehealth. He hopes that doesn’t happen; if it does, he predicts that patients and doctors will push back hard.

Why would a virtual primary care visit cost a health plan less than an in-person visit if it’s paying doctors the same for both? Dr. Aga said it’s because fewer prescriptions and lab tests are ordered in telehealth encounters. He bases this assertion on the quarter of a million virtual visits that Kelsey-Seybold has conducted and also alludes to published studies.

The characteristics of telehealth visits might explain this phenomenon, he said. “These visits are typically much shorter, and it’s easy to be problem-centric and problem based. Physicians use more of their intuitive skills, rather than just lab everybody up and get an x-ray, because that patient’s not there, and it’s easier to draw blood or get an x-ray if somebody is there.”
 

Cutting practice overhead

From the perspective of Kelsey-Seybold, which is now conducting about a fifth of its visits virtually, “infrastructure costs are less” for telehealth, Aga notes. Although Dr. Kubitschek and Dr. Sawyer say it doesn’t take less time to conduct a telehealth visit than an office visit, other practice costs may decrease in relationship to the percentage of a doctor’s visits that are virtual.

“If implemented appropriately, telehealth consults should cost less in terms of the ancillary costs surrounding care,” said Dr. Basch. He recalls that, some years ago, a five-doctor primary care group in Portland, Ore., began charging small monthly fees to patients for full-service care that included email access. After a while, 40% of their patients were coming in, and the rest received care by email or phone. As a result, the doctors were able to downsize to a smaller office space because they didn’t need a waiting room.

Although Dr. Basch doesn’t believe it would be appropriate for practices to do something like this in the midst of a pandemic, he sees the possibility of it happening in the future. “Eventually, a group might be able to say: ‘Yes, our practice expenses can be lower if we do this smartly. We could do as well as we’ve done on whatever insurance pays for office visits, knowing that we can deliver care to the same patient panel at, say, 10% lower overhead with telehealth.’ ”

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

Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.

Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.

“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.

Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.

In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.

Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.

Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.

The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
 

More rural women receive long-duration antibiotics

In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).

However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).

The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.

From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.

The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.

However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.

“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
 

Data support need for education and stewardship

“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.

“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.

To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.

The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.

Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.

Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.

“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.

Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.

In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.

Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.

Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.

The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
 

More rural women receive long-duration antibiotics

In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).

However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).

The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.

From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.

The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.

However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.

“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
 

Data support need for education and stewardship

“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.

“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.

To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.

The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.

Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.

Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.

“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.

Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.

In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.

Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.

Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.

The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
 

More rural women receive long-duration antibiotics

In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).

However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).

The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.

From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.

The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.

However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.

“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
 

Data support need for education and stewardship

“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.

“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.

To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.

The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.