The Food and Drug Administration has approved marketing for a device that will help diagnose autism spectrum disorder (ASD) in children between the ages of 18 months and 5 years old who exhibit potential symptoms.

Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to assist physicians in evaluating whether a child is at risk of having autism.

Autism is a developmental disorder that can cause social, communication, and behavioral challenges, according to the Centers for Disease Control and Prevention. The disorder affects about 1 in 54 children. The disorder is difficult to diagnose because there isn’t a medical test to diagnose the it. Instead, physicians have to look at a child’s developmental history and behavior to make a diagnosis.

Many children are not diagnosed with ASD until later in childhood, which in some cases delays treatment and early intervention. ASD may be detected as early as 18 months, but the average age of diagnosis for ASD is 4.3 years, according to the FDA.

“[ASD] can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

The safety and efficacy of the Cognoa ASD Diagnosis Aid was assessed in a study of 425 patients between the ages of 18 months and 5 years old. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard ASD diagnostic process. The device diagnosed 32% of the children with either a “Positive for ASD” or a “Negative for ASD” result. Researchers found that the device matched the panel’s conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel’s conclusions for 98% of the patients. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

Cognoa ASD Diagnosis Aid has three main components. One component includes a mobile app for caregivers to answer questions about the child’s behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze uploaded videos of patients. Another component is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.

After the machine learning–based device processes the information provided by parents and health care providers, it reports either a positive or a negative diagnosis. If there is insufficient information to make either a positive or a negative diagnosis, the ASD Diagnostic AID will report that no result can be generated.

Some of the risks associated with this device include misdiagnosis and delayed diagnosis of ASD because of a false-positive or false-negative result, or when no result is generated. Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.

The FDA emphasized that the device is indicated to aid physicians in the process of diagnosing ASD in children. This means it shouldn’t be treated as a standalone diagnostic device, but as an adjunct to the diagnostic process.

The Food and Drug Administration has approved marketing for a device that will help diagnose autism spectrum disorder (ASD) in children between the ages of 18 months and 5 years old who exhibit potential symptoms.

Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to assist physicians in evaluating whether a child is at risk of having autism.

Autism is a developmental disorder that can cause social, communication, and behavioral challenges, according to the Centers for Disease Control and Prevention. The disorder affects about 1 in 54 children. The disorder is difficult to diagnose because there isn’t a medical test to diagnose the it. Instead, physicians have to look at a child’s developmental history and behavior to make a diagnosis.

Many children are not diagnosed with ASD until later in childhood, which in some cases delays treatment and early intervention. ASD may be detected as early as 18 months, but the average age of diagnosis for ASD is 4.3 years, according to the FDA.

“[ASD] can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

The safety and efficacy of the Cognoa ASD Diagnosis Aid was assessed in a study of 425 patients between the ages of 18 months and 5 years old. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard ASD diagnostic process. The device diagnosed 32% of the children with either a “Positive for ASD” or a “Negative for ASD” result. Researchers found that the device matched the panel’s conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel’s conclusions for 98% of the patients. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

Cognoa ASD Diagnosis Aid has three main components. One component includes a mobile app for caregivers to answer questions about the child’s behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze uploaded videos of patients. Another component is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.

After the machine learning–based device processes the information provided by parents and health care providers, it reports either a positive or a negative diagnosis. If there is insufficient information to make either a positive or a negative diagnosis, the ASD Diagnostic AID will report that no result can be generated.

Some of the risks associated with this device include misdiagnosis and delayed diagnosis of ASD because of a false-positive or false-negative result, or when no result is generated. Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.

The FDA emphasized that the device is indicated to aid physicians in the process of diagnosing ASD in children. This means it shouldn’t be treated as a standalone diagnostic device, but as an adjunct to the diagnostic process.

The Food and Drug Administration has approved marketing for a device that will help diagnose autism spectrum disorder (ASD) in children between the ages of 18 months and 5 years old who exhibit potential symptoms.

Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to assist physicians in evaluating whether a child is at risk of having autism.

Autism is a developmental disorder that can cause social, communication, and behavioral challenges, according to the Centers for Disease Control and Prevention. The disorder affects about 1 in 54 children. The disorder is difficult to diagnose because there isn’t a medical test to diagnose the it. Instead, physicians have to look at a child’s developmental history and behavior to make a diagnosis.

Many children are not diagnosed with ASD until later in childhood, which in some cases delays treatment and early intervention. ASD may be detected as early as 18 months, but the average age of diagnosis for ASD is 4.3 years, according to the FDA.

“[ASD] can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

The safety and efficacy of the Cognoa ASD Diagnosis Aid was assessed in a study of 425 patients between the ages of 18 months and 5 years old. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard ASD diagnostic process. The device diagnosed 32% of the children with either a “Positive for ASD” or a “Negative for ASD” result. Researchers found that the device matched the panel’s conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel’s conclusions for 98% of the patients. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

Cognoa ASD Diagnosis Aid has three main components. One component includes a mobile app for caregivers to answer questions about the child’s behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze uploaded videos of patients. Another component is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.

After the machine learning–based device processes the information provided by parents and health care providers, it reports either a positive or a negative diagnosis. If there is insufficient information to make either a positive or a negative diagnosis, the ASD Diagnostic AID will report that no result can be generated.

Some of the risks associated with this device include misdiagnosis and delayed diagnosis of ASD because of a false-positive or false-negative result, or when no result is generated. Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.

The FDA emphasized that the device is indicated to aid physicians in the process of diagnosing ASD in children. This means it shouldn’t be treated as a standalone diagnostic device, but as an adjunct to the diagnostic process.

Multidisciplinary tumor boards are composed of providers from many fields who deliver coordinated care for patients with unresectable and high-risk skin cancers. Providers who comprise the tumor board often are radiation oncologists, hematologists/oncologists, general surgeons, dermatologists, dermatologic surgeons, and pathologists. The benefit of having a tumor board is that each patient is evaluated simultaneously by a group of physicians from various specialties who bring diverse perspectives that will contribute to the overall treatment plan. The cases often encompass high-risk tumors including unresectable basal cell carcinomas or invasive melanomas. By combining knowledge from each specialty in a team approach, the tumor board can effectively and holistically develop a care plan for each patient.

For the tumor board at the Warren Alpert Medical School of Brown University (Providence, Rhode Island), we often prepare a presentation with comprehensive details about the patient and tumor. During the presentation, we also propose a treatment plan prior to describing each patient at the weekly conference and amend the plans during the discussion. Tumor boards also provide a consulting role to the community and hospital providers in which patients are being referred by their primary provider and are seeking a second opinion or guidance.

In many ways, the tumor board is a multidisciplinary approach for patient advocacy in the form of treatment. These physicians meet on a regular basis to check on the patient’s progress and continually reevaluate how to have discussions about the patient’s care. There are many reasons why it is important to refer patients to a multidisciplinary tumor board.

Improved Workup and Diagnosis

One of the values of a tumor board is that it allows for patient data to be collected and assembled in a way that tells a story. The specialist from each field can then discuss and weigh the benefits and risks for each diagnostic test that should be performed for the workup in each patient. Physicians who refer their patients to the tumor board use their recommendations to both confirm the diagnosis and shift their treatment plans, depending on the information presented during the meeting.¹ There may be a change in the tumor type, decision to refer for surgery, cancer staging, and list of viable options, especially after reviewing pathology and imaging.² The discussion of the treatment plan may consider not only surgical considerations but also the patient’s quality of life. At times, noninvasive interventions are more appropriate and align with the patient’s goals of care. In addition, during the tumor board clinic there may be new tumors that are identified and biopsied, providing increased diagnosis and surveillance for patients who may have a higher risk for developing skin cancer.

Education for Residents and Providers

The multidisciplinary tumor board not only helps patients but also educates both residents and providers on the evidence-based therapeutic management of high-risk tumors.² Research literature on cutaneous oncology is dynamic, and the weekly tumor board meetings help providers stay informed about the best and most effective treatments for their patients.³ In addition to the attending specialists, participants of the tumor board also may include residents, medical students, medical assistance staff, nurses, physician assistants, and fellows. Furthermore, the recommendations given by the tumor board serve to educate both the patient and the provider who referred them to the tumor board. Although we have access to excellent dermatology textbooks as residents, the most impactful educational experience is seeing the patients in tumor board clinic and participating in the immensely educational discussions at the weekly conferences. Through this experience, I have learned that treatment plans should be personalized to the patient. There are many factors to take into consideration when deciphering what the best course of treatment will be for a patient. Sometimes the best option is Mohs micrographic surgery, while other times it may be scheduling several sessions of palliative radiation oncology. Treatment depends on the individual patient and their condition.

Coordination of Care

During a week that I was on call, I was consulted to biopsy a patient with a giant hemorrhagic basal cell carcinoma that caused substantial cheek and nose distortion as well as anemia secondary to acute blood loss. The patient not only did not have a dermatologist but also did not have a primary care physician given he had not had contact with the health care system in more than 30 years. The reason for him not seeking care was multifactorial, but the approach to his care became multidisciplinary. We sought to connect him with the right providers to help him in any way that we could. We presented him at our multidisciplinary tumor board and started him on sonedigib, a medication that binds to and inhibits the smoothened protein.⁴ Through the tumor board, we were able to establish sustained contact with the patient. The tumor board created effective communication between providers to get him the referrals that he needed for dermatology, pathology, radiation oncology, hematology/oncology, and otolaryngology. The discussions centered around being cognizant of the patient’s apprehension with the health care system as well as providing medical and surgical treatment that would help his quality of life. We built a consensus on what the best plan was for the patient and his family. This consensus would have been more difficult had it not been for the combined specialties of the tumor board. In general, studies have shown that weekly tumor boards have resulted in decreased mortality rates for patients with advanced cancers.⁵

Final Thoughts

The multidisciplinary tumor board is a powerful resource for hospitals and the greater medical community. At these weekly conferences you realize there may still be hope that begins at the line where your expertise ends. It represents a team of providers who compassionately refuse to give up on patients when they are the last refuge.

Multidisciplinary tumor boards are composed of providers from many fields who deliver coordinated care for patients with unresectable and high-risk skin cancers. Providers who comprise the tumor board often are radiation oncologists, hematologists/oncologists, general surgeons, dermatologists, dermatologic surgeons, and pathologists. The benefit of having a tumor board is that each patient is evaluated simultaneously by a group of physicians from various specialties who bring diverse perspectives that will contribute to the overall treatment plan. The cases often encompass high-risk tumors including unresectable basal cell carcinomas or invasive melanomas. By combining knowledge from each specialty in a team approach, the tumor board can effectively and holistically develop a care plan for each patient.

For the tumor board at the Warren Alpert Medical School of Brown University (Providence, Rhode Island), we often prepare a presentation with comprehensive details about the patient and tumor. During the presentation, we also propose a treatment plan prior to describing each patient at the weekly conference and amend the plans during the discussion. Tumor boards also provide a consulting role to the community and hospital providers in which patients are being referred by their primary provider and are seeking a second opinion or guidance.

In many ways, the tumor board is a multidisciplinary approach for patient advocacy in the form of treatment. These physicians meet on a regular basis to check on the patient’s progress and continually reevaluate how to have discussions about the patient’s care. There are many reasons why it is important to refer patients to a multidisciplinary tumor board.

Improved Workup and Diagnosis

One of the values of a tumor board is that it allows for patient data to be collected and assembled in a way that tells a story. The specialist from each field can then discuss and weigh the benefits and risks for each diagnostic test that should be performed for the workup in each patient. Physicians who refer their patients to the tumor board use their recommendations to both confirm the diagnosis and shift their treatment plans, depending on the information presented during the meeting.¹ There may be a change in the tumor type, decision to refer for surgery, cancer staging, and list of viable options, especially after reviewing pathology and imaging.² The discussion of the treatment plan may consider not only surgical considerations but also the patient’s quality of life. At times, noninvasive interventions are more appropriate and align with the patient’s goals of care. In addition, during the tumor board clinic there may be new tumors that are identified and biopsied, providing increased diagnosis and surveillance for patients who may have a higher risk for developing skin cancer.

Education for Residents and Providers

The multidisciplinary tumor board not only helps patients but also educates both residents and providers on the evidence-based therapeutic management of high-risk tumors.² Research literature on cutaneous oncology is dynamic, and the weekly tumor board meetings help providers stay informed about the best and most effective treatments for their patients.³ In addition to the attending specialists, participants of the tumor board also may include residents, medical students, medical assistance staff, nurses, physician assistants, and fellows. Furthermore, the recommendations given by the tumor board serve to educate both the patient and the provider who referred them to the tumor board. Although we have access to excellent dermatology textbooks as residents, the most impactful educational experience is seeing the patients in tumor board clinic and participating in the immensely educational discussions at the weekly conferences. Through this experience, I have learned that treatment plans should be personalized to the patient. There are many factors to take into consideration when deciphering what the best course of treatment will be for a patient. Sometimes the best option is Mohs micrographic surgery, while other times it may be scheduling several sessions of palliative radiation oncology. Treatment depends on the individual patient and their condition.

Coordination of Care

During a week that I was on call, I was consulted to biopsy a patient with a giant hemorrhagic basal cell carcinoma that caused substantial cheek and nose distortion as well as anemia secondary to acute blood loss. The patient not only did not have a dermatologist but also did not have a primary care physician given he had not had contact with the health care system in more than 30 years. The reason for him not seeking care was multifactorial, but the approach to his care became multidisciplinary. We sought to connect him with the right providers to help him in any way that we could. We presented him at our multidisciplinary tumor board and started him on sonedigib, a medication that binds to and inhibits the smoothened protein.⁴ Through the tumor board, we were able to establish sustained contact with the patient. The tumor board created effective communication between providers to get him the referrals that he needed for dermatology, pathology, radiation oncology, hematology/oncology, and otolaryngology. The discussions centered around being cognizant of the patient’s apprehension with the health care system as well as providing medical and surgical treatment that would help his quality of life. We built a consensus on what the best plan was for the patient and his family. This consensus would have been more difficult had it not been for the combined specialties of the tumor board. In general, studies have shown that weekly tumor boards have resulted in decreased mortality rates for patients with advanced cancers.⁵

Final Thoughts

The multidisciplinary tumor board is a powerful resource for hospitals and the greater medical community. At these weekly conferences you realize there may still be hope that begins at the line where your expertise ends. It represents a team of providers who compassionately refuse to give up on patients when they are the last refuge.

Multidisciplinary tumor boards are composed of providers from many fields who deliver coordinated care for patients with unresectable and high-risk skin cancers. Providers who comprise the tumor board often are radiation oncologists, hematologists/oncologists, general surgeons, dermatologists, dermatologic surgeons, and pathologists. The benefit of having a tumor board is that each patient is evaluated simultaneously by a group of physicians from various specialties who bring diverse perspectives that will contribute to the overall treatment plan. The cases often encompass high-risk tumors including unresectable basal cell carcinomas or invasive melanomas. By combining knowledge from each specialty in a team approach, the tumor board can effectively and holistically develop a care plan for each patient.

For the tumor board at the Warren Alpert Medical School of Brown University (Providence, Rhode Island), we often prepare a presentation with comprehensive details about the patient and tumor. During the presentation, we also propose a treatment plan prior to describing each patient at the weekly conference and amend the plans during the discussion. Tumor boards also provide a consulting role to the community and hospital providers in which patients are being referred by their primary provider and are seeking a second opinion or guidance.

In many ways, the tumor board is a multidisciplinary approach for patient advocacy in the form of treatment. These physicians meet on a regular basis to check on the patient’s progress and continually reevaluate how to have discussions about the patient’s care. There are many reasons why it is important to refer patients to a multidisciplinary tumor board.

Improved Workup and Diagnosis

One of the values of a tumor board is that it allows for patient data to be collected and assembled in a way that tells a story. The specialist from each field can then discuss and weigh the benefits and risks for each diagnostic test that should be performed for the workup in each patient. Physicians who refer their patients to the tumor board use their recommendations to both confirm the diagnosis and shift their treatment plans, depending on the information presented during the meeting.¹ There may be a change in the tumor type, decision to refer for surgery, cancer staging, and list of viable options, especially after reviewing pathology and imaging.² The discussion of the treatment plan may consider not only surgical considerations but also the patient’s quality of life. At times, noninvasive interventions are more appropriate and align with the patient’s goals of care. In addition, during the tumor board clinic there may be new tumors that are identified and biopsied, providing increased diagnosis and surveillance for patients who may have a higher risk for developing skin cancer.

Education for Residents and Providers

The multidisciplinary tumor board not only helps patients but also educates both residents and providers on the evidence-based therapeutic management of high-risk tumors.² Research literature on cutaneous oncology is dynamic, and the weekly tumor board meetings help providers stay informed about the best and most effective treatments for their patients.³ In addition to the attending specialists, participants of the tumor board also may include residents, medical students, medical assistance staff, nurses, physician assistants, and fellows. Furthermore, the recommendations given by the tumor board serve to educate both the patient and the provider who referred them to the tumor board. Although we have access to excellent dermatology textbooks as residents, the most impactful educational experience is seeing the patients in tumor board clinic and participating in the immensely educational discussions at the weekly conferences. Through this experience, I have learned that treatment plans should be personalized to the patient. There are many factors to take into consideration when deciphering what the best course of treatment will be for a patient. Sometimes the best option is Mohs micrographic surgery, while other times it may be scheduling several sessions of palliative radiation oncology. Treatment depends on the individual patient and their condition.

Coordination of Care

During a week that I was on call, I was consulted to biopsy a patient with a giant hemorrhagic basal cell carcinoma that caused substantial cheek and nose distortion as well as anemia secondary to acute blood loss. The patient not only did not have a dermatologist but also did not have a primary care physician given he had not had contact with the health care system in more than 30 years. The reason for him not seeking care was multifactorial, but the approach to his care became multidisciplinary. We sought to connect him with the right providers to help him in any way that we could. We presented him at our multidisciplinary tumor board and started him on sonedigib, a medication that binds to and inhibits the smoothened protein.⁴ Through the tumor board, we were able to establish sustained contact with the patient. The tumor board created effective communication between providers to get him the referrals that he needed for dermatology, pathology, radiation oncology, hematology/oncology, and otolaryngology. The discussions centered around being cognizant of the patient’s apprehension with the health care system as well as providing medical and surgical treatment that would help his quality of life. We built a consensus on what the best plan was for the patient and his family. This consensus would have been more difficult had it not been for the combined specialties of the tumor board. In general, studies have shown that weekly tumor boards have resulted in decreased mortality rates for patients with advanced cancers.⁵

Final Thoughts

The multidisciplinary tumor board is a powerful resource for hospitals and the greater medical community. At these weekly conferences you realize there may still be hope that begins at the line where your expertise ends. It represents a team of providers who compassionately refuse to give up on patients when they are the last refuge.

Advance care planning (ACP) is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences for future medical care, according to Meredith A. MacMartin, MD, director of inpatient palliative care at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

ACP “is really about planning for care in advance,” and in many ways, the inpatient setting is uniquely suited to this process, Dr. MacMartin said in a presentation at SHM Converge 2021, the annual conference of the Society of Hospital Medicine. “The key part is the advance part. You want conversations to happen before the care is actually needed,” she said.

Dr. MacMartin emphasized the importance of distinguishing between ACP and advance directives (ADs). ACP is a process, whereas ADs are documentation, “ideally of the content of advance care planning discussions,” she explained. ACP involves discussion about what is important to the patients, their goals, what information is helpful for them, and whether their current care is aligned with their goals, Dr. MacMartin said. ADs might involve a designated power of attorney for health care, a living will, and, in some states, specific clinician-signed orders regarding resuscitation or transport to hospital.

ACP is “more than whether a patient wants CPR [cardiopulmonary resuscitation] or not,” said Dr. MacMartin. ACP matters because it helps ensure that the care a patient receives aligns with the patient’s wishes and values, she said. ACP increases the likelihood that patients will die in their preferred locations, it allows them to discuss their wishes and prepare for decline, and it relieves family members of the burden of decision making, she said. From a hospital perspective, data show that use of an ACP can decrease intensive care unit (ICU) utilization and overall health care costs. “Often, when people are given the opportunity to express their wishes, they get less unnecessary care,” Dr. MacMartin noted.

Although ACP often takes place in an outpatient setting, hospitalists are in a unique position to conduct some ACP conversations with their patients, Dr. MacMartin said. “Hospitalists are available” and are physically present at least once a day, so there is a pragmatic advantage. Also, some data suggest that patients may feel more comfortable having ACP conversations with a hospitalist than with a primary care provider with whom they have a long-standing relationship, Dr. MacMartin added.

Another important advantage of ACP in the hospital setting is that, “as hospitalists, you are the expert on inpatient illness; you know what sick looks like, and you have a unique perspective on prognostication that may be harder to recreate in the outpatient setting,” Dr. MacMartin said.
 

Barriers to ACP include patient identification, logistics, attitudes

Settings in which ACP is appropriate include those in which a patient is undergoing “sentinel hospitalization,” meaning that the patient is at a transition point in the disease course. Examples are a patient newly diagnosed with metastatic solid cancer, a patient with progressive chronic kidney disease who is considering hemodialysis, or a patient who receives treatment in the ICU for longer than 7 days, Dr. MacMartin said.

Guidelines for identifying patients who might benefit from ACP include the use of the “surprise question” (“would you be surprised if this patient dies in the next year?”) as well as functional status assessments using tools such as the Australia-modified Karnofsky Performance Status or the Eastern Cooperative Oncology Group score, said Dr. MacMartin. Some studies suggest that any hospitalized patient older than 65 years should have an ACP discussion, she added.

Time pressure remains a significant barrier to ACP conversations. Some strategies to overcome this problem include enlisting help from other specialists, particularly social workers, Dr. MacMartin said. Social workers report a higher comfort level for talking to patients about death than any other medical specialty; “this is something they want to be doing,” she said. Also, the possibility of reimbursement may act as a buffer to create more time to have ACP conversations with patients, she noted.

Addressing clinicians’ discomfort with ACP conversations can be “a tougher nut to crack,” Dr. MacMartin acknowledged. Clinicians report that they don’t want to cause their patients distress, and some report that having conversations about end-of-life care is distressing for them as well. Some of these barriers can be overcome with skills training, including use of a prepared guideline or framework to help increase the comfort level for both clinicians and patients, said Dr. MacMartin.
 

A look ahead: Training strategies and COVID-19 impact

“For hospitalists interested in developing their ACP skills, I highly recommend two resources,” Dr. MacMartin said in an interview. “The Serious Illness Conversation Guide, from Ariadne Labs, is an excellent tool for any clinician to guide discussion about a patient’s goals and values,” she said.

“For clinicians wanting to build or improve their communication, including advance care planning discussions but also topics like responding to patient’s emotions, VitalTalk training offers a deeper dive into core communications skills,” she added.

“If your hospital has a palliative care team, they may also have more local resources available to you. To learn more about billing for ACP discussions, I recommend starting with your institutional billing and coding group, as these practices vary some between practices, and they will be able to provide the best guidance for clinicians. These are new codes that aren’t yet being very widely used so it’s a chance to innovate,” Dr. MacMartin noted.

“The hospital setting is an opportunity for patients to reflect on their health, both present and in the future, with a physician who has expertise in acute illness and prognostication and who is available for discussion on a daily basis during the hospitalization,” Dr. MacMartin emphasized.

As for whether the COVID-19 pandemic has affected ACP in the inpatient setting, the data are limited, but more information is forthcoming, Dr. MacMartin said. “In my personal experience and in talking to colleagues elsewhere, the pandemic has highlighted the need for ACP in some ways, as we have tried to ensure that people who wouldn’t want things like intensive care are identified early,” she said. “I hope that some of the workflows developed to identify patients who should get ACP in the hospital stay in practice and are strengthened over time,” she added.

Dr. MacMartin has disclosed no relevant financial relationships.
 

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

Advance care planning (ACP) is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences for future medical care, according to Meredith A. MacMartin, MD, director of inpatient palliative care at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

ACP “is really about planning for care in advance,” and in many ways, the inpatient setting is uniquely suited to this process, Dr. MacMartin said in a presentation at SHM Converge 2021, the annual conference of the Society of Hospital Medicine. “The key part is the advance part. You want conversations to happen before the care is actually needed,” she said.

Dr. MacMartin emphasized the importance of distinguishing between ACP and advance directives (ADs). ACP is a process, whereas ADs are documentation, “ideally of the content of advance care planning discussions,” she explained. ACP involves discussion about what is important to the patients, their goals, what information is helpful for them, and whether their current care is aligned with their goals, Dr. MacMartin said. ADs might involve a designated power of attorney for health care, a living will, and, in some states, specific clinician-signed orders regarding resuscitation or transport to hospital.

ACP is “more than whether a patient wants CPR [cardiopulmonary resuscitation] or not,” said Dr. MacMartin. ACP matters because it helps ensure that the care a patient receives aligns with the patient’s wishes and values, she said. ACP increases the likelihood that patients will die in their preferred locations, it allows them to discuss their wishes and prepare for decline, and it relieves family members of the burden of decision making, she said. From a hospital perspective, data show that use of an ACP can decrease intensive care unit (ICU) utilization and overall health care costs. “Often, when people are given the opportunity to express their wishes, they get less unnecessary care,” Dr. MacMartin noted.

Although ACP often takes place in an outpatient setting, hospitalists are in a unique position to conduct some ACP conversations with their patients, Dr. MacMartin said. “Hospitalists are available” and are physically present at least once a day, so there is a pragmatic advantage. Also, some data suggest that patients may feel more comfortable having ACP conversations with a hospitalist than with a primary care provider with whom they have a long-standing relationship, Dr. MacMartin added.

Another important advantage of ACP in the hospital setting is that, “as hospitalists, you are the expert on inpatient illness; you know what sick looks like, and you have a unique perspective on prognostication that may be harder to recreate in the outpatient setting,” Dr. MacMartin said.
 

Barriers to ACP include patient identification, logistics, attitudes

Settings in which ACP is appropriate include those in which a patient is undergoing “sentinel hospitalization,” meaning that the patient is at a transition point in the disease course. Examples are a patient newly diagnosed with metastatic solid cancer, a patient with progressive chronic kidney disease who is considering hemodialysis, or a patient who receives treatment in the ICU for longer than 7 days, Dr. MacMartin said.

Guidelines for identifying patients who might benefit from ACP include the use of the “surprise question” (“would you be surprised if this patient dies in the next year?”) as well as functional status assessments using tools such as the Australia-modified Karnofsky Performance Status or the Eastern Cooperative Oncology Group score, said Dr. MacMartin. Some studies suggest that any hospitalized patient older than 65 years should have an ACP discussion, she added.

Time pressure remains a significant barrier to ACP conversations. Some strategies to overcome this problem include enlisting help from other specialists, particularly social workers, Dr. MacMartin said. Social workers report a higher comfort level for talking to patients about death than any other medical specialty; “this is something they want to be doing,” she said. Also, the possibility of reimbursement may act as a buffer to create more time to have ACP conversations with patients, she noted.

Addressing clinicians’ discomfort with ACP conversations can be “a tougher nut to crack,” Dr. MacMartin acknowledged. Clinicians report that they don’t want to cause their patients distress, and some report that having conversations about end-of-life care is distressing for them as well. Some of these barriers can be overcome with skills training, including use of a prepared guideline or framework to help increase the comfort level for both clinicians and patients, said Dr. MacMartin.
 

A look ahead: Training strategies and COVID-19 impact

“For hospitalists interested in developing their ACP skills, I highly recommend two resources,” Dr. MacMartin said in an interview. “The Serious Illness Conversation Guide, from Ariadne Labs, is an excellent tool for any clinician to guide discussion about a patient’s goals and values,” she said.

“For clinicians wanting to build or improve their communication, including advance care planning discussions but also topics like responding to patient’s emotions, VitalTalk training offers a deeper dive into core communications skills,” she added.

“If your hospital has a palliative care team, they may also have more local resources available to you. To learn more about billing for ACP discussions, I recommend starting with your institutional billing and coding group, as these practices vary some between practices, and they will be able to provide the best guidance for clinicians. These are new codes that aren’t yet being very widely used so it’s a chance to innovate,” Dr. MacMartin noted.

“The hospital setting is an opportunity for patients to reflect on their health, both present and in the future, with a physician who has expertise in acute illness and prognostication and who is available for discussion on a daily basis during the hospitalization,” Dr. MacMartin emphasized.

As for whether the COVID-19 pandemic has affected ACP in the inpatient setting, the data are limited, but more information is forthcoming, Dr. MacMartin said. “In my personal experience and in talking to colleagues elsewhere, the pandemic has highlighted the need for ACP in some ways, as we have tried to ensure that people who wouldn’t want things like intensive care are identified early,” she said. “I hope that some of the workflows developed to identify patients who should get ACP in the hospital stay in practice and are strengthened over time,” she added.

Dr. MacMartin has disclosed no relevant financial relationships.
 

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

Advance care planning (ACP) is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences for future medical care, according to Meredith A. MacMartin, MD, director of inpatient palliative care at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

ACP “is really about planning for care in advance,” and in many ways, the inpatient setting is uniquely suited to this process, Dr. MacMartin said in a presentation at SHM Converge 2021, the annual conference of the Society of Hospital Medicine. “The key part is the advance part. You want conversations to happen before the care is actually needed,” she said.

Dr. MacMartin emphasized the importance of distinguishing between ACP and advance directives (ADs). ACP is a process, whereas ADs are documentation, “ideally of the content of advance care planning discussions,” she explained. ACP involves discussion about what is important to the patients, their goals, what information is helpful for them, and whether their current care is aligned with their goals, Dr. MacMartin said. ADs might involve a designated power of attorney for health care, a living will, and, in some states, specific clinician-signed orders regarding resuscitation or transport to hospital.

ACP is “more than whether a patient wants CPR [cardiopulmonary resuscitation] or not,” said Dr. MacMartin. ACP matters because it helps ensure that the care a patient receives aligns with the patient’s wishes and values, she said. ACP increases the likelihood that patients will die in their preferred locations, it allows them to discuss their wishes and prepare for decline, and it relieves family members of the burden of decision making, she said. From a hospital perspective, data show that use of an ACP can decrease intensive care unit (ICU) utilization and overall health care costs. “Often, when people are given the opportunity to express their wishes, they get less unnecessary care,” Dr. MacMartin noted.

Although ACP often takes place in an outpatient setting, hospitalists are in a unique position to conduct some ACP conversations with their patients, Dr. MacMartin said. “Hospitalists are available” and are physically present at least once a day, so there is a pragmatic advantage. Also, some data suggest that patients may feel more comfortable having ACP conversations with a hospitalist than with a primary care provider with whom they have a long-standing relationship, Dr. MacMartin added.

Another important advantage of ACP in the hospital setting is that, “as hospitalists, you are the expert on inpatient illness; you know what sick looks like, and you have a unique perspective on prognostication that may be harder to recreate in the outpatient setting,” Dr. MacMartin said.
 

Barriers to ACP include patient identification, logistics, attitudes

Settings in which ACP is appropriate include those in which a patient is undergoing “sentinel hospitalization,” meaning that the patient is at a transition point in the disease course. Examples are a patient newly diagnosed with metastatic solid cancer, a patient with progressive chronic kidney disease who is considering hemodialysis, or a patient who receives treatment in the ICU for longer than 7 days, Dr. MacMartin said.

Guidelines for identifying patients who might benefit from ACP include the use of the “surprise question” (“would you be surprised if this patient dies in the next year?”) as well as functional status assessments using tools such as the Australia-modified Karnofsky Performance Status or the Eastern Cooperative Oncology Group score, said Dr. MacMartin. Some studies suggest that any hospitalized patient older than 65 years should have an ACP discussion, she added.

Time pressure remains a significant barrier to ACP conversations. Some strategies to overcome this problem include enlisting help from other specialists, particularly social workers, Dr. MacMartin said. Social workers report a higher comfort level for talking to patients about death than any other medical specialty; “this is something they want to be doing,” she said. Also, the possibility of reimbursement may act as a buffer to create more time to have ACP conversations with patients, she noted.

Addressing clinicians’ discomfort with ACP conversations can be “a tougher nut to crack,” Dr. MacMartin acknowledged. Clinicians report that they don’t want to cause their patients distress, and some report that having conversations about end-of-life care is distressing for them as well. Some of these barriers can be overcome with skills training, including use of a prepared guideline or framework to help increase the comfort level for both clinicians and patients, said Dr. MacMartin.
 

A look ahead: Training strategies and COVID-19 impact

“For hospitalists interested in developing their ACP skills, I highly recommend two resources,” Dr. MacMartin said in an interview. “The Serious Illness Conversation Guide, from Ariadne Labs, is an excellent tool for any clinician to guide discussion about a patient’s goals and values,” she said.

“For clinicians wanting to build or improve their communication, including advance care planning discussions but also topics like responding to patient’s emotions, VitalTalk training offers a deeper dive into core communications skills,” she added.

“If your hospital has a palliative care team, they may also have more local resources available to you. To learn more about billing for ACP discussions, I recommend starting with your institutional billing and coding group, as these practices vary some between practices, and they will be able to provide the best guidance for clinicians. These are new codes that aren’t yet being very widely used so it’s a chance to innovate,” Dr. MacMartin noted.

“The hospital setting is an opportunity for patients to reflect on their health, both present and in the future, with a physician who has expertise in acute illness and prognostication and who is available for discussion on a daily basis during the hospitalization,” Dr. MacMartin emphasized.

As for whether the COVID-19 pandemic has affected ACP in the inpatient setting, the data are limited, but more information is forthcoming, Dr. MacMartin said. “In my personal experience and in talking to colleagues elsewhere, the pandemic has highlighted the need for ACP in some ways, as we have tried to ensure that people who wouldn’t want things like intensive care are identified early,” she said. “I hope that some of the workflows developed to identify patients who should get ACP in the hospital stay in practice and are strengthened over time,” she added.

Dr. MacMartin has disclosed no relevant financial relationships.
 

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

Botulinum toxin is said to be the most lethal substance known. Inhaling just 1-3 nanograms of toxin per kilogram of body mass constitutes a lethal dose. 

Now the Centers for Disease Control and Prevention has published the first comprehensive guide to the diagnosis and treatment of botulism. The CDC has been working on these guidelines since 2015, initially establishing a technical development group and steering committee to prioritize topics for review and make recommendations. Since then, the agency published 15 systematic reviews in  Clinical Infectious Diseases early in 2018. The reviews addressed the recognition of botulism clinically, treatment with botulinum antitoxin, and complications from that treatment. They also looked at the epidemiology of botulism outbreaks and botulism in the special populations of vulnerable pediatric and pregnant patients.

In 2016, the CDC held two extended forums and convened a workshop with 72 experts. In addition to the more standard topics of diagnosis and treatment, attention was given to crisis standards of care, caring for multiple patients at once, and ethical considerations in management.

Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, said in an interview that the new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”

While clinicians are used to focusing on an individual patient, in times of crises, with multiple patients from a food-borne outbreak or a bioterrorism attack, the focus must shift to the population rather than the individual. The workshop explored issues of triaging, adding beds, and caring for patients when a hospital is overwhelmed with an acute influx of severely ill patients.

Such a mass casualty event is similar to the stress encountered this past year with COVID-19 patients swamping the hospitals, which had too little oxygen, too few ventilators, and too few staff members to care for the sudden influx of critically ill patients.
 

Diagnosis

Leslie Edwards, MHS, BSN, a CDC epidemiologist and botulism expert, said that “botulism is rare and [so] could be difficult to diagnose.” The CDC “wanted to highlight some of those key clinical factors” to speed recognition.

Hospitals and health officials are being urged to develop crisis protocols as part of emergency preparedness plans. And clinicians should be able to recognize four major syndromes: botulism from food, wounds, and inhalation, as well as iatrogenic botulism (from exposure via injection of the neurotoxin).

Botulism has a characteristic and unusual pattern of symptoms, which begin with cranial nerve palsies. Then there is typically a descending, symmetric flaccid paralysis. Symptoms might progress to respiratory failure and death. Other critical clues that implicate botulism include a lack of sensory deficits and the absence of pain.

Symptoms are most likely to be mistaken for myasthenia gravis or Guillain-Barré syndrome, but the latter has an ascending paralysis. Cranial nerve involvement can present as blurred vision, ptosis (drooping lid), diplopia (double vision), ophthalmoplegia (weak eye muscles), or difficulty with speech and swallowing. Shortness of breath and abdominal discomfort can also occur. Respiratory failure may occur from weakness or paralysis of cranial nerves. Cranial nerve signs and symptoms in the absence of fever, along with a descending paralysis, should strongly suggest the diagnosis.

With food-borne botulism, vomiting occurs in half the patients. Improperly sterilized home-canned food is the major risk factor. While the toxin is rapidly destroyed by heat, the bacterial spores are not. Wound botulism is most commonly associated with the injection of drugs, particularly black tar heroin.

Dr. Edwards stressed that “time is of the essence when it comes to botulism diagnostics and treating. Timely administration of the botulism antitoxin early in the course of illness can arrest the progression of paralysis and possibly avert the need for intubation or ventilation.”

It’s essential to note that botulism is an urgent diagnosis that has to be made on clinical grounds. Lab assays for botulinum neurotoxins take too long and are only conducted in public health laboratories. The decision to use antitoxin must not be delayed to wait for confirmation.

Clinicians should immediately contact the local or state health department’s emergency on-call team if botulism is suspected. They will arrange for expert consultation.
 

Treatment

Botulinum antitoxin is the only specific therapy for this infection. If given early – preferably within 24-48 hours of symptom onset – it can stop the progression of paralysis. But antitoxin will not reverse existing paralysis. If paralysis is still progressing outside of that 24- to 48-hour window, the antitoxin should still provide benefit. The antitoxin is available only through state health departments and a request to the CDC.

Botulism antitoxin is made from horse serum and therefore may cause a variety of allergic reactions. The risk for anaphylaxis is less than 2%, far lower than the mortality from untreated botulism.

While these guidelines have an important focus on triaging and treating mass casualties from botulism, it’s important to note that food-borne outbreaks and prevention issues are covered elsewhere on the CDC site.

Dr. Edwards has disclosed no relevant financial relationships. Dr. Adalja is a consultant for Emergent BioSolutions, which makes the heptavalent botulism antitoxin.

Dr. Stone is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research,” the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

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

Botulinum toxin is said to be the most lethal substance known. Inhaling just 1-3 nanograms of toxin per kilogram of body mass constitutes a lethal dose. 

Now the Centers for Disease Control and Prevention has published the first comprehensive guide to the diagnosis and treatment of botulism. The CDC has been working on these guidelines since 2015, initially establishing a technical development group and steering committee to prioritize topics for review and make recommendations. Since then, the agency published 15 systematic reviews in  Clinical Infectious Diseases early in 2018. The reviews addressed the recognition of botulism clinically, treatment with botulinum antitoxin, and complications from that treatment. They also looked at the epidemiology of botulism outbreaks and botulism in the special populations of vulnerable pediatric and pregnant patients.

In 2016, the CDC held two extended forums and convened a workshop with 72 experts. In addition to the more standard topics of diagnosis and treatment, attention was given to crisis standards of care, caring for multiple patients at once, and ethical considerations in management.

Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, said in an interview that the new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”

While clinicians are used to focusing on an individual patient, in times of crises, with multiple patients from a food-borne outbreak or a bioterrorism attack, the focus must shift to the population rather than the individual. The workshop explored issues of triaging, adding beds, and caring for patients when a hospital is overwhelmed with an acute influx of severely ill patients.

Such a mass casualty event is similar to the stress encountered this past year with COVID-19 patients swamping the hospitals, which had too little oxygen, too few ventilators, and too few staff members to care for the sudden influx of critically ill patients.
 

Diagnosis

Leslie Edwards, MHS, BSN, a CDC epidemiologist and botulism expert, said that “botulism is rare and [so] could be difficult to diagnose.” The CDC “wanted to highlight some of those key clinical factors” to speed recognition.

Hospitals and health officials are being urged to develop crisis protocols as part of emergency preparedness plans. And clinicians should be able to recognize four major syndromes: botulism from food, wounds, and inhalation, as well as iatrogenic botulism (from exposure via injection of the neurotoxin).

Botulism has a characteristic and unusual pattern of symptoms, which begin with cranial nerve palsies. Then there is typically a descending, symmetric flaccid paralysis. Symptoms might progress to respiratory failure and death. Other critical clues that implicate botulism include a lack of sensory deficits and the absence of pain.

Symptoms are most likely to be mistaken for myasthenia gravis or Guillain-Barré syndrome, but the latter has an ascending paralysis. Cranial nerve involvement can present as blurred vision, ptosis (drooping lid), diplopia (double vision), ophthalmoplegia (weak eye muscles), or difficulty with speech and swallowing. Shortness of breath and abdominal discomfort can also occur. Respiratory failure may occur from weakness or paralysis of cranial nerves. Cranial nerve signs and symptoms in the absence of fever, along with a descending paralysis, should strongly suggest the diagnosis.

With food-borne botulism, vomiting occurs in half the patients. Improperly sterilized home-canned food is the major risk factor. While the toxin is rapidly destroyed by heat, the bacterial spores are not. Wound botulism is most commonly associated with the injection of drugs, particularly black tar heroin.

Dr. Edwards stressed that “time is of the essence when it comes to botulism diagnostics and treating. Timely administration of the botulism antitoxin early in the course of illness can arrest the progression of paralysis and possibly avert the need for intubation or ventilation.”

It’s essential to note that botulism is an urgent diagnosis that has to be made on clinical grounds. Lab assays for botulinum neurotoxins take too long and are only conducted in public health laboratories. The decision to use antitoxin must not be delayed to wait for confirmation.

Clinicians should immediately contact the local or state health department’s emergency on-call team if botulism is suspected. They will arrange for expert consultation.
 

Treatment

Botulinum antitoxin is the only specific therapy for this infection. If given early – preferably within 24-48 hours of symptom onset – it can stop the progression of paralysis. But antitoxin will not reverse existing paralysis. If paralysis is still progressing outside of that 24- to 48-hour window, the antitoxin should still provide benefit. The antitoxin is available only through state health departments and a request to the CDC.

Botulism antitoxin is made from horse serum and therefore may cause a variety of allergic reactions. The risk for anaphylaxis is less than 2%, far lower than the mortality from untreated botulism.

While these guidelines have an important focus on triaging and treating mass casualties from botulism, it’s important to note that food-borne outbreaks and prevention issues are covered elsewhere on the CDC site.

Dr. Edwards has disclosed no relevant financial relationships. Dr. Adalja is a consultant for Emergent BioSolutions, which makes the heptavalent botulism antitoxin.

Dr. Stone is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research,” the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

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

Botulinum toxin is said to be the most lethal substance known. Inhaling just 1-3 nanograms of toxin per kilogram of body mass constitutes a lethal dose. 

Now the Centers for Disease Control and Prevention has published the first comprehensive guide to the diagnosis and treatment of botulism. The CDC has been working on these guidelines since 2015, initially establishing a technical development group and steering committee to prioritize topics for review and make recommendations. Since then, the agency published 15 systematic reviews in  Clinical Infectious Diseases early in 2018. The reviews addressed the recognition of botulism clinically, treatment with botulinum antitoxin, and complications from that treatment. They also looked at the epidemiology of botulism outbreaks and botulism in the special populations of vulnerable pediatric and pregnant patients.

In 2016, the CDC held two extended forums and convened a workshop with 72 experts. In addition to the more standard topics of diagnosis and treatment, attention was given to crisis standards of care, caring for multiple patients at once, and ethical considerations in management.

Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, said in an interview that the new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”

While clinicians are used to focusing on an individual patient, in times of crises, with multiple patients from a food-borne outbreak or a bioterrorism attack, the focus must shift to the population rather than the individual. The workshop explored issues of triaging, adding beds, and caring for patients when a hospital is overwhelmed with an acute influx of severely ill patients.

Such a mass casualty event is similar to the stress encountered this past year with COVID-19 patients swamping the hospitals, which had too little oxygen, too few ventilators, and too few staff members to care for the sudden influx of critically ill patients.
 

Diagnosis

Leslie Edwards, MHS, BSN, a CDC epidemiologist and botulism expert, said that “botulism is rare and [so] could be difficult to diagnose.” The CDC “wanted to highlight some of those key clinical factors” to speed recognition.

Hospitals and health officials are being urged to develop crisis protocols as part of emergency preparedness plans. And clinicians should be able to recognize four major syndromes: botulism from food, wounds, and inhalation, as well as iatrogenic botulism (from exposure via injection of the neurotoxin).

Botulism has a characteristic and unusual pattern of symptoms, which begin with cranial nerve palsies. Then there is typically a descending, symmetric flaccid paralysis. Symptoms might progress to respiratory failure and death. Other critical clues that implicate botulism include a lack of sensory deficits and the absence of pain.

Symptoms are most likely to be mistaken for myasthenia gravis or Guillain-Barré syndrome, but the latter has an ascending paralysis. Cranial nerve involvement can present as blurred vision, ptosis (drooping lid), diplopia (double vision), ophthalmoplegia (weak eye muscles), or difficulty with speech and swallowing. Shortness of breath and abdominal discomfort can also occur. Respiratory failure may occur from weakness or paralysis of cranial nerves. Cranial nerve signs and symptoms in the absence of fever, along with a descending paralysis, should strongly suggest the diagnosis.

With food-borne botulism, vomiting occurs in half the patients. Improperly sterilized home-canned food is the major risk factor. While the toxin is rapidly destroyed by heat, the bacterial spores are not. Wound botulism is most commonly associated with the injection of drugs, particularly black tar heroin.

Dr. Edwards stressed that “time is of the essence when it comes to botulism diagnostics and treating. Timely administration of the botulism antitoxin early in the course of illness can arrest the progression of paralysis and possibly avert the need for intubation or ventilation.”

It’s essential to note that botulism is an urgent diagnosis that has to be made on clinical grounds. Lab assays for botulinum neurotoxins take too long and are only conducted in public health laboratories. The decision to use antitoxin must not be delayed to wait for confirmation.

Clinicians should immediately contact the local or state health department’s emergency on-call team if botulism is suspected. They will arrange for expert consultation.
 

Treatment

Botulinum antitoxin is the only specific therapy for this infection. If given early – preferably within 24-48 hours of symptom onset – it can stop the progression of paralysis. But antitoxin will not reverse existing paralysis. If paralysis is still progressing outside of that 24- to 48-hour window, the antitoxin should still provide benefit. The antitoxin is available only through state health departments and a request to the CDC.

Botulism antitoxin is made from horse serum and therefore may cause a variety of allergic reactions. The risk for anaphylaxis is less than 2%, far lower than the mortality from untreated botulism.

While these guidelines have an important focus on triaging and treating mass casualties from botulism, it’s important to note that food-borne outbreaks and prevention issues are covered elsewhere on the CDC site.

Dr. Edwards has disclosed no relevant financial relationships. Dr. Adalja is a consultant for Emergent BioSolutions, which makes the heptavalent botulism antitoxin.

Dr. Stone is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research,” the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

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

People with prediabetes, defined by having a hemoglobin A1c of 5.7%-6.4%, had a significantly increased rate of atherosclerotic cardiovascular disease events and incident chronic kidney disease in a study of nearly 337,000 people included in the UK Biobank database.

The findings suggest that people with prediabetes have “heightened risk even without progression to type 2 diabetes,” Michael C. Honigberg, MD, said at the annual scientific sessions of the American College of Cardiology.

“Hemoglobin A1c may be better considered as a continuous measure of risk rather than dichotomized” as either less than 6.5%, or 6.5% or higher, the usual threshold defining people with type 2 diabetes, said Dr. Honigberg, a cardiologist at Massachusetts General Hospital in Boston.
 

‘Prediabetes is not a benign entity’

“Our findings reinforce the notion that A1c represents a continuum of risk, with elevated risks observed, especially for atherosclerotic cardiovascular disease [ASCVD], at levels where some clinicians wouldn’t think twice about them. Prediabetes is not a benign entity in the middle-aged population we studied,” Dr. Honigberg said in an interview. “Risks are higher in individuals with type 2 diabetes,” he stressed, “however, prediabetes is so much more common that it appears to confer similar cardio, renal, and metabolic risks at a population level.”

Results from prior observational studies also showed elevated incidence rate of cardiovascular disease events in people with prediabetes, including a 2010 report based on data from about 11,000 U.S. residents, and in a more recent meta-analysis of 129 studies involving more than 10 million people. The new report by Dr. Honigberg “is the first to comprehensively evaluate diverse cardio-renal-metabolic outcomes across a range of A1c levels using a very large, contemporary database,” he noted. In addition, most prior reports did not include chronic kidney disease as an examined outcome.

The primary endpoint examined in the new analysis was the combined incidence during a median follow-up of just over 11 years of ASCVD events (coronary artery disease, ischemic stroke, or peripheral artery disease), CKD, or heart failure among 336,709 adults in the UK Biobank who at baseline had none of these conditions nor type 1 diabetes.

The vast majority, 82%, were normoglycemic at baseline, based on having an A1c of less than 5.7%; 14% had prediabetes, with an A1c of 5.7%-6.4%; and 4% had type 2 diabetes based on an A1c of at least 6.5% or on insulin treatment. Patients averaged about 57 years of age, slightly more than half were women, and average body mass index was in the overweight category except for those with type 2 diabetes.

The primary endpoint, the combined incidence of ASCVD, CKD, and heart failure, was 24% among those with type 2 diabetes, 14% in those with prediabetes, and 8% in those who were normoglycemic at entry. Concurrently with the report, the results appeared online. Most of these events involved ASCVD, which occurred in 11% of those in the prediabetes subgroup (roughly four-fifths of the events in this subgroup), and in 17% of those with type 2 diabetes (nearly three-quarters of the events in this subgroup).

In an analysis that adjusted for more than a dozen demographic and clinical factors, the presence of prediabetes linked with significant increases in the incidence rate of all three outcomes compared with people who were normoglycemic at baseline. The analysis also identified an A1c level of 5.0% as linked with the lowest incidence of each of the three adverse outcomes. And a very granular analysis suggested that a significantly elevated risk for ASCVD first appeared when A1c levels were in the range of 5.4%-5.7%; a significantly increased incidence of CKD became apparent once A1c was in the range of 6.2%-6.5%; and a significantly increased incidence of heart failure began to manifest once A1c levels reached at least 7.0%.

Need for comprehensive cardiometabolic risk management

The findings “highlight the importance of identifying and comprehensively managing cardiometabolic risk in people with prediabetes, including dietary modification, exercise, weight loss and obesity management, smoking cessation, and attention to hypertension and hypercholesterolemia,” Dr. Honigberg said. While these data cannot address the appropriateness of using novel drug interventions in people with prediabetes, they suggest that people with prediabetes should be the focus of future prevention trials testing agents such as sodium-glucose cotransporter 2 inhibitors.

“These data help us discuss risk with patients [with prediabetes], and reemphasize the importance of guideline-directed preventive care,” said Vijay Nambi, MD, PhD, a preventive cardiologist and lipid specialist at Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston, who was not involved with the study.

An additional analysis reported by Dr. Honigberg examined the risk among people with prediabetes who also were current or former smokers and in the top tertile of the prediabetes study population for systolic blood pressure, high non-HDL cholesterol, and C-reactive protein (a marker of inflammation). This very high-risk subgroup of people with prediabetes had incidence rates for ASCVD events and for heart failure that tracked identically to those with type 2 diabetes. However. the incidence rate for CKD in these high-risk people with prediabetes remained below that of patients with type 2 diabetes.

Dr. Honigberg had no disclosures. Dr. Nambi has received research funding from Amgen, Merck, and Roche.

[email protected]

People with prediabetes, defined by having a hemoglobin A1c of 5.7%-6.4%, had a significantly increased rate of atherosclerotic cardiovascular disease events and incident chronic kidney disease in a study of nearly 337,000 people included in the UK Biobank database.

The findings suggest that people with prediabetes have “heightened risk even without progression to type 2 diabetes,” Michael C. Honigberg, MD, said at the annual scientific sessions of the American College of Cardiology.

“Hemoglobin A1c may be better considered as a continuous measure of risk rather than dichotomized” as either less than 6.5%, or 6.5% or higher, the usual threshold defining people with type 2 diabetes, said Dr. Honigberg, a cardiologist at Massachusetts General Hospital in Boston.
 

‘Prediabetes is not a benign entity’

“Our findings reinforce the notion that A1c represents a continuum of risk, with elevated risks observed, especially for atherosclerotic cardiovascular disease [ASCVD], at levels where some clinicians wouldn’t think twice about them. Prediabetes is not a benign entity in the middle-aged population we studied,” Dr. Honigberg said in an interview. “Risks are higher in individuals with type 2 diabetes,” he stressed, “however, prediabetes is so much more common that it appears to confer similar cardio, renal, and metabolic risks at a population level.”

Results from prior observational studies also showed elevated incidence rate of cardiovascular disease events in people with prediabetes, including a 2010 report based on data from about 11,000 U.S. residents, and in a more recent meta-analysis of 129 studies involving more than 10 million people. The new report by Dr. Honigberg “is the first to comprehensively evaluate diverse cardio-renal-metabolic outcomes across a range of A1c levels using a very large, contemporary database,” he noted. In addition, most prior reports did not include chronic kidney disease as an examined outcome.

The primary endpoint examined in the new analysis was the combined incidence during a median follow-up of just over 11 years of ASCVD events (coronary artery disease, ischemic stroke, or peripheral artery disease), CKD, or heart failure among 336,709 adults in the UK Biobank who at baseline had none of these conditions nor type 1 diabetes.

The vast majority, 82%, were normoglycemic at baseline, based on having an A1c of less than 5.7%; 14% had prediabetes, with an A1c of 5.7%-6.4%; and 4% had type 2 diabetes based on an A1c of at least 6.5% or on insulin treatment. Patients averaged about 57 years of age, slightly more than half were women, and average body mass index was in the overweight category except for those with type 2 diabetes.

The primary endpoint, the combined incidence of ASCVD, CKD, and heart failure, was 24% among those with type 2 diabetes, 14% in those with prediabetes, and 8% in those who were normoglycemic at entry. Concurrently with the report, the results appeared online. Most of these events involved ASCVD, which occurred in 11% of those in the prediabetes subgroup (roughly four-fifths of the events in this subgroup), and in 17% of those with type 2 diabetes (nearly three-quarters of the events in this subgroup).

In an analysis that adjusted for more than a dozen demographic and clinical factors, the presence of prediabetes linked with significant increases in the incidence rate of all three outcomes compared with people who were normoglycemic at baseline. The analysis also identified an A1c level of 5.0% as linked with the lowest incidence of each of the three adverse outcomes. And a very granular analysis suggested that a significantly elevated risk for ASCVD first appeared when A1c levels were in the range of 5.4%-5.7%; a significantly increased incidence of CKD became apparent once A1c was in the range of 6.2%-6.5%; and a significantly increased incidence of heart failure began to manifest once A1c levels reached at least 7.0%.

Need for comprehensive cardiometabolic risk management

The findings “highlight the importance of identifying and comprehensively managing cardiometabolic risk in people with prediabetes, including dietary modification, exercise, weight loss and obesity management, smoking cessation, and attention to hypertension and hypercholesterolemia,” Dr. Honigberg said. While these data cannot address the appropriateness of using novel drug interventions in people with prediabetes, they suggest that people with prediabetes should be the focus of future prevention trials testing agents such as sodium-glucose cotransporter 2 inhibitors.

“These data help us discuss risk with patients [with prediabetes], and reemphasize the importance of guideline-directed preventive care,” said Vijay Nambi, MD, PhD, a preventive cardiologist and lipid specialist at Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston, who was not involved with the study.

An additional analysis reported by Dr. Honigberg examined the risk among people with prediabetes who also were current or former smokers and in the top tertile of the prediabetes study population for systolic blood pressure, high non-HDL cholesterol, and C-reactive protein (a marker of inflammation). This very high-risk subgroup of people with prediabetes had incidence rates for ASCVD events and for heart failure that tracked identically to those with type 2 diabetes. However. the incidence rate for CKD in these high-risk people with prediabetes remained below that of patients with type 2 diabetes.

Dr. Honigberg had no disclosures. Dr. Nambi has received research funding from Amgen, Merck, and Roche.

[email protected]

People with prediabetes, defined by having a hemoglobin A1c of 5.7%-6.4%, had a significantly increased rate of atherosclerotic cardiovascular disease events and incident chronic kidney disease in a study of nearly 337,000 people included in the UK Biobank database.

The findings suggest that people with prediabetes have “heightened risk even without progression to type 2 diabetes,” Michael C. Honigberg, MD, said at the annual scientific sessions of the American College of Cardiology.

“Hemoglobin A1c may be better considered as a continuous measure of risk rather than dichotomized” as either less than 6.5%, or 6.5% or higher, the usual threshold defining people with type 2 diabetes, said Dr. Honigberg, a cardiologist at Massachusetts General Hospital in Boston.
 

‘Prediabetes is not a benign entity’

“Our findings reinforce the notion that A1c represents a continuum of risk, with elevated risks observed, especially for atherosclerotic cardiovascular disease [ASCVD], at levels where some clinicians wouldn’t think twice about them. Prediabetes is not a benign entity in the middle-aged population we studied,” Dr. Honigberg said in an interview. “Risks are higher in individuals with type 2 diabetes,” he stressed, “however, prediabetes is so much more common that it appears to confer similar cardio, renal, and metabolic risks at a population level.”

Results from prior observational studies also showed elevated incidence rate of cardiovascular disease events in people with prediabetes, including a 2010 report based on data from about 11,000 U.S. residents, and in a more recent meta-analysis of 129 studies involving more than 10 million people. The new report by Dr. Honigberg “is the first to comprehensively evaluate diverse cardio-renal-metabolic outcomes across a range of A1c levels using a very large, contemporary database,” he noted. In addition, most prior reports did not include chronic kidney disease as an examined outcome.

The primary endpoint examined in the new analysis was the combined incidence during a median follow-up of just over 11 years of ASCVD events (coronary artery disease, ischemic stroke, or peripheral artery disease), CKD, or heart failure among 336,709 adults in the UK Biobank who at baseline had none of these conditions nor type 1 diabetes.

The vast majority, 82%, were normoglycemic at baseline, based on having an A1c of less than 5.7%; 14% had prediabetes, with an A1c of 5.7%-6.4%; and 4% had type 2 diabetes based on an A1c of at least 6.5% or on insulin treatment. Patients averaged about 57 years of age, slightly more than half were women, and average body mass index was in the overweight category except for those with type 2 diabetes.

The primary endpoint, the combined incidence of ASCVD, CKD, and heart failure, was 24% among those with type 2 diabetes, 14% in those with prediabetes, and 8% in those who were normoglycemic at entry. Concurrently with the report, the results appeared online. Most of these events involved ASCVD, which occurred in 11% of those in the prediabetes subgroup (roughly four-fifths of the events in this subgroup), and in 17% of those with type 2 diabetes (nearly three-quarters of the events in this subgroup).

In an analysis that adjusted for more than a dozen demographic and clinical factors, the presence of prediabetes linked with significant increases in the incidence rate of all three outcomes compared with people who were normoglycemic at baseline. The analysis also identified an A1c level of 5.0% as linked with the lowest incidence of each of the three adverse outcomes. And a very granular analysis suggested that a significantly elevated risk for ASCVD first appeared when A1c levels were in the range of 5.4%-5.7%; a significantly increased incidence of CKD became apparent once A1c was in the range of 6.2%-6.5%; and a significantly increased incidence of heart failure began to manifest once A1c levels reached at least 7.0%.

Need for comprehensive cardiometabolic risk management

The findings “highlight the importance of identifying and comprehensively managing cardiometabolic risk in people with prediabetes, including dietary modification, exercise, weight loss and obesity management, smoking cessation, and attention to hypertension and hypercholesterolemia,” Dr. Honigberg said. While these data cannot address the appropriateness of using novel drug interventions in people with prediabetes, they suggest that people with prediabetes should be the focus of future prevention trials testing agents such as sodium-glucose cotransporter 2 inhibitors.

“These data help us discuss risk with patients [with prediabetes], and reemphasize the importance of guideline-directed preventive care,” said Vijay Nambi, MD, PhD, a preventive cardiologist and lipid specialist at Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston, who was not involved with the study.

An additional analysis reported by Dr. Honigberg examined the risk among people with prediabetes who also were current or former smokers and in the top tertile of the prediabetes study population for systolic blood pressure, high non-HDL cholesterol, and C-reactive protein (a marker of inflammation). This very high-risk subgroup of people with prediabetes had incidence rates for ASCVD events and for heart failure that tracked identically to those with type 2 diabetes. However. the incidence rate for CKD in these high-risk people with prediabetes remained below that of patients with type 2 diabetes.

Dr. Honigberg had no disclosures. Dr. Nambi has received research funding from Amgen, Merck, and Roche.

[email protected]

There were no local recurrences when Mohs surgery was used to treat early stage Merkel cell carcinomas in 53 patients at the Zitelli and Brodland Skin Cancer Center, Pittsburgh.

The results compare favorably with the standard treatment approach, wide local excision with or without radiation, which has a local recurrence rate of 4.2%-31.7% because of incomplete excision or false negative margins, said Vitaly Terushkin, MD, a Mohs surgeon who presented the findings of the study, a retrospective chart review, at the annual meeting of the American College of Mohs Surgery.

Mohs surgery as monotherapy offered “survival at least as good as historical controls treated with wide local excision plus radiation therapy, and because of the superior local control, Mohs surgery may obviate the need for adjuvant radiation and decrease the chance for additional surgery for the treatment of local recurrence,” said Dr. Terushkin, now in practice in the New York City area.

“We hope this data fuel additional studies with larger cohorts to continue to explore the value of Mohs for Merkel cell carcinoma,” he said.

The findings add to a growing body of literature supporting Mohs for many types of rare tumors. “Micrographic surgery or complete circumferential peripheral and deep margin analysis has been shown to be superior to wide local excision in a variety of tumors and clinical scenarios,” said Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington.

“When the entire margin is able to be evaluated over random bread-loafed sections, there is growing evidence that this leads to superior outcomes and disease specific mortality,” he said when asked for comment on the study results.

In all, 56 primary Merkel cell carcinomas were treated in the 53 patients from 2001 to 2019; about two-thirds of the patients had stage 1 tumors and the rest stage 2a.

They were treated with Mohs alone, without radiation. Average follow up was 4.6 years, with about a third of patients followed for 5 or more years.

The average age of the patients was 78 years, and just over half were men. In more than half the cases, tumors were located on the head and neck (62.5%), and the mean tumor size was 1.7 cm. Patients were negative for lymphadenopathy and declined lymph node biopsy.

Although there was no local recurrence, defined as tumor reemerging within or adjacent to the surgery site, 7 patients (12.7%) developed in-transit metastases, 13 (23.6%) developed nodal metastases, and 3 developed distant metastases.

The 5-year disease-specific survival rate was 91.2% for stage 1 and 68.6% for stage 2a patients, which compared favorably with historical controls treated with wide local excision with or without radiation, with reported 5-year disease-specific survival rates of 81%-87% for stage 1 disease and 63%-67% for stage 2. Although radiation wasn’t used in the study, Dr. Patel noted that more investigation is needed about the role of adjuvant radiation therapy after Mohs surgery “given recent publications showing improved outcomes in patients with narrow margin excision and postoperative radiation therapy.”

No external funding of the study was reported. Dr. Terushkin had no disclosures. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.

[email protected]

There were no local recurrences when Mohs surgery was used to treat early stage Merkel cell carcinomas in 53 patients at the Zitelli and Brodland Skin Cancer Center, Pittsburgh.

The results compare favorably with the standard treatment approach, wide local excision with or without radiation, which has a local recurrence rate of 4.2%-31.7% because of incomplete excision or false negative margins, said Vitaly Terushkin, MD, a Mohs surgeon who presented the findings of the study, a retrospective chart review, at the annual meeting of the American College of Mohs Surgery.

Mohs surgery as monotherapy offered “survival at least as good as historical controls treated with wide local excision plus radiation therapy, and because of the superior local control, Mohs surgery may obviate the need for adjuvant radiation and decrease the chance for additional surgery for the treatment of local recurrence,” said Dr. Terushkin, now in practice in the New York City area.

“We hope this data fuel additional studies with larger cohorts to continue to explore the value of Mohs for Merkel cell carcinoma,” he said.

The findings add to a growing body of literature supporting Mohs for many types of rare tumors. “Micrographic surgery or complete circumferential peripheral and deep margin analysis has been shown to be superior to wide local excision in a variety of tumors and clinical scenarios,” said Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington.

“When the entire margin is able to be evaluated over random bread-loafed sections, there is growing evidence that this leads to superior outcomes and disease specific mortality,” he said when asked for comment on the study results.

In all, 56 primary Merkel cell carcinomas were treated in the 53 patients from 2001 to 2019; about two-thirds of the patients had stage 1 tumors and the rest stage 2a.

They were treated with Mohs alone, without radiation. Average follow up was 4.6 years, with about a third of patients followed for 5 or more years.

The average age of the patients was 78 years, and just over half were men. In more than half the cases, tumors were located on the head and neck (62.5%), and the mean tumor size was 1.7 cm. Patients were negative for lymphadenopathy and declined lymph node biopsy.

Although there was no local recurrence, defined as tumor reemerging within or adjacent to the surgery site, 7 patients (12.7%) developed in-transit metastases, 13 (23.6%) developed nodal metastases, and 3 developed distant metastases.

The 5-year disease-specific survival rate was 91.2% for stage 1 and 68.6% for stage 2a patients, which compared favorably with historical controls treated with wide local excision with or without radiation, with reported 5-year disease-specific survival rates of 81%-87% for stage 1 disease and 63%-67% for stage 2. Although radiation wasn’t used in the study, Dr. Patel noted that more investigation is needed about the role of adjuvant radiation therapy after Mohs surgery “given recent publications showing improved outcomes in patients with narrow margin excision and postoperative radiation therapy.”

No external funding of the study was reported. Dr. Terushkin had no disclosures. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.

[email protected]

There were no local recurrences when Mohs surgery was used to treat early stage Merkel cell carcinomas in 53 patients at the Zitelli and Brodland Skin Cancer Center, Pittsburgh.

The results compare favorably with the standard treatment approach, wide local excision with or without radiation, which has a local recurrence rate of 4.2%-31.7% because of incomplete excision or false negative margins, said Vitaly Terushkin, MD, a Mohs surgeon who presented the findings of the study, a retrospective chart review, at the annual meeting of the American College of Mohs Surgery.

Mohs surgery as monotherapy offered “survival at least as good as historical controls treated with wide local excision plus radiation therapy, and because of the superior local control, Mohs surgery may obviate the need for adjuvant radiation and decrease the chance for additional surgery for the treatment of local recurrence,” said Dr. Terushkin, now in practice in the New York City area.

“We hope this data fuel additional studies with larger cohorts to continue to explore the value of Mohs for Merkel cell carcinoma,” he said.

The findings add to a growing body of literature supporting Mohs for many types of rare tumors. “Micrographic surgery or complete circumferential peripheral and deep margin analysis has been shown to be superior to wide local excision in a variety of tumors and clinical scenarios,” said Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington.

“When the entire margin is able to be evaluated over random bread-loafed sections, there is growing evidence that this leads to superior outcomes and disease specific mortality,” he said when asked for comment on the study results.

In all, 56 primary Merkel cell carcinomas were treated in the 53 patients from 2001 to 2019; about two-thirds of the patients had stage 1 tumors and the rest stage 2a.

They were treated with Mohs alone, without radiation. Average follow up was 4.6 years, with about a third of patients followed for 5 or more years.

The average age of the patients was 78 years, and just over half were men. In more than half the cases, tumors were located on the head and neck (62.5%), and the mean tumor size was 1.7 cm. Patients were negative for lymphadenopathy and declined lymph node biopsy.

Although there was no local recurrence, defined as tumor reemerging within or adjacent to the surgery site, 7 patients (12.7%) developed in-transit metastases, 13 (23.6%) developed nodal metastases, and 3 developed distant metastases.

The 5-year disease-specific survival rate was 91.2% for stage 1 and 68.6% for stage 2a patients, which compared favorably with historical controls treated with wide local excision with or without radiation, with reported 5-year disease-specific survival rates of 81%-87% for stage 1 disease and 63%-67% for stage 2. Although radiation wasn’t used in the study, Dr. Patel noted that more investigation is needed about the role of adjuvant radiation therapy after Mohs surgery “given recent publications showing improved outcomes in patients with narrow margin excision and postoperative radiation therapy.”

No external funding of the study was reported. Dr. Terushkin had no disclosures. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.

[email protected]

Cancer loses … by a nose

Since the human nose is unpredictable at best, we’ve learned to rely on animals for our detailed nozzle needs. But researchers have found the next best thing to man’s best friend to accurately identify cancers.

A team at the University of Pennsylvania has developed an electronic olfaction, or “e-nose,” that has a 95% accuracy rate in distinguishing benign and malignant pancreatic and ovarian cancer cells from a single blood sample. How?

The e-nose system is equipped with nanosensors that are able to detect the volatile organic compounds (VOCs) emitted by cells in a blood sample. Not only does this create an opportunity for an easier, noninvasive screening practice, but it’s fast. The e-nose can distinguish VOCs from healthy to cancerous blood cells in 20 minutes or less and is just as effective in picking up on early- and late-stage cancers. 

Lonely/Thinkstock

Do you think this is a (food) game?

Dieting and eating healthy is tough, even during the best of times, and it has not been the best of times. With all respect to Charles Dickens, it’s been the worst of times, full stop. Millions of people have spent the past year sitting around their homes doing nothing, and it’s only natural that many would let their discipline slide.

Naturally, the solution to unhealthy eating habits is to sit down and play with your phone. No, that’s not the joke, the Food Trainer app, available on all cellular devices near you, is designed to encourage healthy eating by turning it into a game of sorts. When users open the app, they’re presented with images of food, and they’re trained to tap on images of healthy food and pass on images of unhealthy ones. The process takes less than 5 minutes.

It sounds really simple, but in a study of more than 1,000 people, consumption of junk food fell by 1 point on an 8-point scale (ranging from four times per day to zero to one time per month), participants lost about half a kilogram (a little over one pound), and more healthy food was eaten. Those who used the app more regularly, along the lines of 10 times per month or more, saw greater benefits.

PxHere

It’s time for a little mass kickin’

The universe, scientists tell us, is a big place. Really big. Chromosomes, scientists tell us, are small. Really small. But despite this very fundamental difference, the universe and chromosomes share a deep, dark secret: unexplained mass.

This being a medical publication, we’ll start with chromosomes. A group of researchers measured their mass with x-rays for the first time and found that “the 46 chromosomes in each of our cells weigh 242 picograms (trillionths of a gram). This is heavier than we would expect, and, if replicated, points to unexplained excess mass in chromosomes,” Ian K. Robinson, PhD, said in a written statement.

Archana Bhatiya et al.

A photo finish for the Smart Toilet

We know that poop can tell us a lot about our health, but new research by scientists at Duke University is really on a roll. Their Smart Toilet has been created to help people keep an eye on their bowel health. The device takes pictures of poop after it is flushed and can tell whether the consistency is loose, bloody, or normal.

The Smart Toilet can really help people with issues such as irritable bowel syndrome and inflammatory bowel disease by helping them, and their doctors, keep tabs on their poop. “Typically, gastroenterologists have to rely on patient self-reported information about their stool to help determine the cause of their gastrointestinal health issues, which can be very unreliable,” study lead author Deborah Fisher said.

SutidaS/iStock/Getty Images Plus

Cancer loses … by a nose

Since the human nose is unpredictable at best, we’ve learned to rely on animals for our detailed nozzle needs. But researchers have found the next best thing to man’s best friend to accurately identify cancers.

A team at the University of Pennsylvania has developed an electronic olfaction, or “e-nose,” that has a 95% accuracy rate in distinguishing benign and malignant pancreatic and ovarian cancer cells from a single blood sample. How?

The e-nose system is equipped with nanosensors that are able to detect the volatile organic compounds (VOCs) emitted by cells in a blood sample. Not only does this create an opportunity for an easier, noninvasive screening practice, but it’s fast. The e-nose can distinguish VOCs from healthy to cancerous blood cells in 20 minutes or less and is just as effective in picking up on early- and late-stage cancers. 

Lonely/Thinkstock

Do you think this is a (food) game?

Dieting and eating healthy is tough, even during the best of times, and it has not been the best of times. With all respect to Charles Dickens, it’s been the worst of times, full stop. Millions of people have spent the past year sitting around their homes doing nothing, and it’s only natural that many would let their discipline slide.

Naturally, the solution to unhealthy eating habits is to sit down and play with your phone. No, that’s not the joke, the Food Trainer app, available on all cellular devices near you, is designed to encourage healthy eating by turning it into a game of sorts. When users open the app, they’re presented with images of food, and they’re trained to tap on images of healthy food and pass on images of unhealthy ones. The process takes less than 5 minutes.

It sounds really simple, but in a study of more than 1,000 people, consumption of junk food fell by 1 point on an 8-point scale (ranging from four times per day to zero to one time per month), participants lost about half a kilogram (a little over one pound), and more healthy food was eaten. Those who used the app more regularly, along the lines of 10 times per month or more, saw greater benefits.

PxHere

It’s time for a little mass kickin’

The universe, scientists tell us, is a big place. Really big. Chromosomes, scientists tell us, are small. Really small. But despite this very fundamental difference, the universe and chromosomes share a deep, dark secret: unexplained mass.

This being a medical publication, we’ll start with chromosomes. A group of researchers measured their mass with x-rays for the first time and found that “the 46 chromosomes in each of our cells weigh 242 picograms (trillionths of a gram). This is heavier than we would expect, and, if replicated, points to unexplained excess mass in chromosomes,” Ian K. Robinson, PhD, said in a written statement.

Archana Bhatiya et al.

A photo finish for the Smart Toilet

We know that poop can tell us a lot about our health, but new research by scientists at Duke University is really on a roll. Their Smart Toilet has been created to help people keep an eye on their bowel health. The device takes pictures of poop after it is flushed and can tell whether the consistency is loose, bloody, or normal.

The Smart Toilet can really help people with issues such as irritable bowel syndrome and inflammatory bowel disease by helping them, and their doctors, keep tabs on their poop. “Typically, gastroenterologists have to rely on patient self-reported information about their stool to help determine the cause of their gastrointestinal health issues, which can be very unreliable,” study lead author Deborah Fisher said.

SutidaS/iStock/Getty Images Plus

Cancer loses … by a nose

Since the human nose is unpredictable at best, we’ve learned to rely on animals for our detailed nozzle needs. But researchers have found the next best thing to man’s best friend to accurately identify cancers.

A team at the University of Pennsylvania has developed an electronic olfaction, or “e-nose,” that has a 95% accuracy rate in distinguishing benign and malignant pancreatic and ovarian cancer cells from a single blood sample. How?

The e-nose system is equipped with nanosensors that are able to detect the volatile organic compounds (VOCs) emitted by cells in a blood sample. Not only does this create an opportunity for an easier, noninvasive screening practice, but it’s fast. The e-nose can distinguish VOCs from healthy to cancerous blood cells in 20 minutes or less and is just as effective in picking up on early- and late-stage cancers. 

Lonely/Thinkstock

Do you think this is a (food) game?

Dieting and eating healthy is tough, even during the best of times, and it has not been the best of times. With all respect to Charles Dickens, it’s been the worst of times, full stop. Millions of people have spent the past year sitting around their homes doing nothing, and it’s only natural that many would let their discipline slide.

Naturally, the solution to unhealthy eating habits is to sit down and play with your phone. No, that’s not the joke, the Food Trainer app, available on all cellular devices near you, is designed to encourage healthy eating by turning it into a game of sorts. When users open the app, they’re presented with images of food, and they’re trained to tap on images of healthy food and pass on images of unhealthy ones. The process takes less than 5 minutes.

It sounds really simple, but in a study of more than 1,000 people, consumption of junk food fell by 1 point on an 8-point scale (ranging from four times per day to zero to one time per month), participants lost about half a kilogram (a little over one pound), and more healthy food was eaten. Those who used the app more regularly, along the lines of 10 times per month or more, saw greater benefits.

PxHere

It’s time for a little mass kickin’

The universe, scientists tell us, is a big place. Really big. Chromosomes, scientists tell us, are small. Really small. But despite this very fundamental difference, the universe and chromosomes share a deep, dark secret: unexplained mass.

This being a medical publication, we’ll start with chromosomes. A group of researchers measured their mass with x-rays for the first time and found that “the 46 chromosomes in each of our cells weigh 242 picograms (trillionths of a gram). This is heavier than we would expect, and, if replicated, points to unexplained excess mass in chromosomes,” Ian K. Robinson, PhD, said in a written statement.

Archana Bhatiya et al.

A photo finish for the Smart Toilet

We know that poop can tell us a lot about our health, but new research by scientists at Duke University is really on a roll. Their Smart Toilet has been created to help people keep an eye on their bowel health. The device takes pictures of poop after it is flushed and can tell whether the consistency is loose, bloody, or normal.

The Smart Toilet can really help people with issues such as irritable bowel syndrome and inflammatory bowel disease by helping them, and their doctors, keep tabs on their poop. “Typically, gastroenterologists have to rely on patient self-reported information about their stool to help determine the cause of their gastrointestinal health issues, which can be very unreliable,” study lead author Deborah Fisher said.

SutidaS/iStock/Getty Images Plus

In 2018, when Naomi Osaka won the U.S. Open by defeating Serena Williams, the trophy ceremony was painful to watch.

Photo by Tim Clayton/Corbis via Getty Images

Ms. Williams had argued with an umpire over a controversial call, and the ceremony began with the crowd booing. Ms. Osaka, the victor, cried while Ms. Williams comforted her and quietly assured Ms. Osaka that the crowd was not booing at her. When asked how her dream of playing against Ms. Williams compared with the reality, the new champion, looking anything but victorious, responded: “Umm, I’m gonna sort of defer from your question, I’m sorry. I know that everyone was cheering for her, and I’m sorry it had to end like this.”

It was hardly the joyous moment it should have been in this young tennis player’s life.

Ms. Osaka, now 23, entered this year’s French Open as the Women’s Tennis Association’s second-ranked player and as the highest-paid female athlete of all time. She is known for her support of Black Lives Matter. Ms. Osaka announced that she would not be attending press conferences in an Instagram post days before the competition began. “If the organizations think they can keep saying, ‘do press or you’re going to get fined,’ and continue to ignore the mental health of the athletes that are the centerpiece of their cooperation then I just gotta laugh,” Ms. Osaka posted.

She was fined $15,000 on Sunday, May 30, when she did not appear at a press conference after winning her first match. Officials noted that she would be subjected to higher fines and expulsion from the tournament if she did not attend the mandatory media briefings. On June 1, Ms. Osaka withdrew from the French Open and explained her reasons on Instagram in a post where she announced that she has been struggling with depression and social anxiety and did not mean to become a distraction for the competition.
 

Psychiatrists weigh in

Sue Kim, MD, a psychiatrist who both plays and watches tennis, brought up Ms. Osaka’s resignation for discussion on the Maryland Psychiatric Society’s listserv. “[Ms.] Osaka put out on social media her depression and wanted to have rules reviewed and revised by the governing body of tennis, for future occasions. I feel it is so unfortunate and unfair and I am interested in hearing your opinions.”

Photo by Mark Brown/Getty Images

Yusuke Sagawa, MD, a psychiatrist and tennis fan, wrote in: “During the COVID-19 pandemic, I rekindled my interest in tennis and I followed what transpired this past weekend. Naomi Osaka is an exceptionally shy and introverted person. I have noted that her speech is somewhat akin to (for lack of a better term) ‘Valley Girl’ talk, and from reading comments on tennis-related blogs, it appears she has garnered a significant amount of hatred as a result. Most of it is along the lines of people feeling her shyness and modesty is simply a masquerade.

“I have also seen YouTube videos of her signing autographs for fans. She is cooperative and pleasant, but clearly uncomfortable around large groups of people.

“Having seen many press conferences after a match,” Dr. Sagawa continued, “tennis journalists have a penchant for asking questions that are either personal or seemingly an attempt to stir up acrimony amongst players. Whatever the case, I truly do believe that this is not some sort of ruse on her part, and I hope that people come to her defense. It is disturbing to hear the comments already coming out from the ‘big names’ in the sport that have mostly been nonsupportive. Fortunately, there have also been a number of her contemporaries who have expressed this support for her.”

In the days following Ms. Osaka’s departure from the French Open, the situation has become more complex. She is now the keystone for discussions of athletes and gender, race, power, mental illness, and the role of social media as it is used in these types of communications.

Maryland psychiatrist Erik Roskes, MD, wrote: “I have followed this story from a distance and what strikes me is the intermixing of athleticism – which is presumably why we watch sports – and entertainment, the money-making part of it. The athletes are both athletes and entertainers, and [Ms.] Osaka seems to be unable to fully fulfill the latter part due to her unique traits. But like many, I wonder what if this had been Michael Phelps? Is there a gender issue at play?”

Stephanie Durruthy, MD, added: “[Ms.] Osaka brings complexity to the mental health conversations. There is no one answer to her current plight, but her being a person of color cannot be minimized. She magnified the race conversation in tennis to a higher level.

“When she was new to the Grand Slam scene, her Haitian, Japanese, and Black heritage became an issue with unending curiosity.

“[Ms.] Osaka used her platform during the 2020 U.S. Open to single-handedly highlight Black Lives Matter,” Dr. Durruthy continued. “Afterward, the tennis fans could not avoid seeing her face mask. In each match, she displayed another mask depicting the name of those killed. She described on social media her fears of being a Black person in America. The biases of gender and race are well described in the sports world.”

Lindsay Crouse wrote June 1 in the New York Times: “When Naomi Osaka dropped out of the French Open, after declining to attend media interviews that she said could trigger her anxiety, she wasn’t just protecting her mental health. She was sending a message to the establishment of one of the world’s most elite sports: I will not be controlled. This was a power move – and it packed more punch coming from a young woman of color. When the system hasn’t historically stood for you, why sacrifice yourself to uphold it? Especially when you have the power to change it instead.”

Professional sports are grueling on athletes, both physically and mentally. People will speculate about Ms. Osaka’s motives for refusing to participate in the media briefings that are mandated by her contract. Some will see it as manipulative, others as the desire of a young woman struggling with anxiety and depression to push back against a system that makes few allowances for those who suffer. As psychiatrists, we see how crippling these illnesses can be and admire those who achieve at these superhuman levels, often at the expense of their own well-being.

Dr. Kim, who started the MPS listserv discussion, ended it with: “I feel bad if Naomi Osaka needs to play a mental ‘illness’ card, as opposed to mental ‘wellness’ card.”

Let’s hope that Ms. Osaka’s withdrawal from the French Open sparks more conversation about how to accommodate athletes as they endeavor to meet both the demands of their contracts and when it might be more appropriate to be flexible for those with individual struggles.

Dr. Miller is coauthor of “ Committed: The Battle Over Involuntary Psychiatric Care ” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

In 2018, when Naomi Osaka won the U.S. Open by defeating Serena Williams, the trophy ceremony was painful to watch.

Photo by Tim Clayton/Corbis via Getty Images

Ms. Williams had argued with an umpire over a controversial call, and the ceremony began with the crowd booing. Ms. Osaka, the victor, cried while Ms. Williams comforted her and quietly assured Ms. Osaka that the crowd was not booing at her. When asked how her dream of playing against Ms. Williams compared with the reality, the new champion, looking anything but victorious, responded: “Umm, I’m gonna sort of defer from your question, I’m sorry. I know that everyone was cheering for her, and I’m sorry it had to end like this.”

It was hardly the joyous moment it should have been in this young tennis player’s life.

Ms. Osaka, now 23, entered this year’s French Open as the Women’s Tennis Association’s second-ranked player and as the highest-paid female athlete of all time. She is known for her support of Black Lives Matter. Ms. Osaka announced that she would not be attending press conferences in an Instagram post days before the competition began. “If the organizations think they can keep saying, ‘do press or you’re going to get fined,’ and continue to ignore the mental health of the athletes that are the centerpiece of their cooperation then I just gotta laugh,” Ms. Osaka posted.

She was fined $15,000 on Sunday, May 30, when she did not appear at a press conference after winning her first match. Officials noted that she would be subjected to higher fines and expulsion from the tournament if she did not attend the mandatory media briefings. On June 1, Ms. Osaka withdrew from the French Open and explained her reasons on Instagram in a post where she announced that she has been struggling with depression and social anxiety and did not mean to become a distraction for the competition.
 

Psychiatrists weigh in

Sue Kim, MD, a psychiatrist who both plays and watches tennis, brought up Ms. Osaka’s resignation for discussion on the Maryland Psychiatric Society’s listserv. “[Ms.] Osaka put out on social media her depression and wanted to have rules reviewed and revised by the governing body of tennis, for future occasions. I feel it is so unfortunate and unfair and I am interested in hearing your opinions.”

Photo by Mark Brown/Getty Images

Yusuke Sagawa, MD, a psychiatrist and tennis fan, wrote in: “During the COVID-19 pandemic, I rekindled my interest in tennis and I followed what transpired this past weekend. Naomi Osaka is an exceptionally shy and introverted person. I have noted that her speech is somewhat akin to (for lack of a better term) ‘Valley Girl’ talk, and from reading comments on tennis-related blogs, it appears she has garnered a significant amount of hatred as a result. Most of it is along the lines of people feeling her shyness and modesty is simply a masquerade.

“I have also seen YouTube videos of her signing autographs for fans. She is cooperative and pleasant, but clearly uncomfortable around large groups of people.

“Having seen many press conferences after a match,” Dr. Sagawa continued, “tennis journalists have a penchant for asking questions that are either personal or seemingly an attempt to stir up acrimony amongst players. Whatever the case, I truly do believe that this is not some sort of ruse on her part, and I hope that people come to her defense. It is disturbing to hear the comments already coming out from the ‘big names’ in the sport that have mostly been nonsupportive. Fortunately, there have also been a number of her contemporaries who have expressed this support for her.”

In the days following Ms. Osaka’s departure from the French Open, the situation has become more complex. She is now the keystone for discussions of athletes and gender, race, power, mental illness, and the role of social media as it is used in these types of communications.

Maryland psychiatrist Erik Roskes, MD, wrote: “I have followed this story from a distance and what strikes me is the intermixing of athleticism – which is presumably why we watch sports – and entertainment, the money-making part of it. The athletes are both athletes and entertainers, and [Ms.] Osaka seems to be unable to fully fulfill the latter part due to her unique traits. But like many, I wonder what if this had been Michael Phelps? Is there a gender issue at play?”

Stephanie Durruthy, MD, added: “[Ms.] Osaka brings complexity to the mental health conversations. There is no one answer to her current plight, but her being a person of color cannot be minimized. She magnified the race conversation in tennis to a higher level.

“When she was new to the Grand Slam scene, her Haitian, Japanese, and Black heritage became an issue with unending curiosity.

“[Ms.] Osaka used her platform during the 2020 U.S. Open to single-handedly highlight Black Lives Matter,” Dr. Durruthy continued. “Afterward, the tennis fans could not avoid seeing her face mask. In each match, she displayed another mask depicting the name of those killed. She described on social media her fears of being a Black person in America. The biases of gender and race are well described in the sports world.”

Lindsay Crouse wrote June 1 in the New York Times: “When Naomi Osaka dropped out of the French Open, after declining to attend media interviews that she said could trigger her anxiety, she wasn’t just protecting her mental health. She was sending a message to the establishment of one of the world’s most elite sports: I will not be controlled. This was a power move – and it packed more punch coming from a young woman of color. When the system hasn’t historically stood for you, why sacrifice yourself to uphold it? Especially when you have the power to change it instead.”

Professional sports are grueling on athletes, both physically and mentally. People will speculate about Ms. Osaka’s motives for refusing to participate in the media briefings that are mandated by her contract. Some will see it as manipulative, others as the desire of a young woman struggling with anxiety and depression to push back against a system that makes few allowances for those who suffer. As psychiatrists, we see how crippling these illnesses can be and admire those who achieve at these superhuman levels, often at the expense of their own well-being.

Dr. Kim, who started the MPS listserv discussion, ended it with: “I feel bad if Naomi Osaka needs to play a mental ‘illness’ card, as opposed to mental ‘wellness’ card.”

Let’s hope that Ms. Osaka’s withdrawal from the French Open sparks more conversation about how to accommodate athletes as they endeavor to meet both the demands of their contracts and when it might be more appropriate to be flexible for those with individual struggles.

Dr. Miller is coauthor of “ Committed: The Battle Over Involuntary Psychiatric Care ” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

In 2018, when Naomi Osaka won the U.S. Open by defeating Serena Williams, the trophy ceremony was painful to watch.

Photo by Tim Clayton/Corbis via Getty Images

Ms. Williams had argued with an umpire over a controversial call, and the ceremony began with the crowd booing. Ms. Osaka, the victor, cried while Ms. Williams comforted her and quietly assured Ms. Osaka that the crowd was not booing at her. When asked how her dream of playing against Ms. Williams compared with the reality, the new champion, looking anything but victorious, responded: “Umm, I’m gonna sort of defer from your question, I’m sorry. I know that everyone was cheering for her, and I’m sorry it had to end like this.”

It was hardly the joyous moment it should have been in this young tennis player’s life.

Ms. Osaka, now 23, entered this year’s French Open as the Women’s Tennis Association’s second-ranked player and as the highest-paid female athlete of all time. She is known for her support of Black Lives Matter. Ms. Osaka announced that she would not be attending press conferences in an Instagram post days before the competition began. “If the organizations think they can keep saying, ‘do press or you’re going to get fined,’ and continue to ignore the mental health of the athletes that are the centerpiece of their cooperation then I just gotta laugh,” Ms. Osaka posted.

She was fined $15,000 on Sunday, May 30, when she did not appear at a press conference after winning her first match. Officials noted that she would be subjected to higher fines and expulsion from the tournament if she did not attend the mandatory media briefings. On June 1, Ms. Osaka withdrew from the French Open and explained her reasons on Instagram in a post where she announced that she has been struggling with depression and social anxiety and did not mean to become a distraction for the competition.
 

Psychiatrists weigh in

Sue Kim, MD, a psychiatrist who both plays and watches tennis, brought up Ms. Osaka’s resignation for discussion on the Maryland Psychiatric Society’s listserv. “[Ms.] Osaka put out on social media her depression and wanted to have rules reviewed and revised by the governing body of tennis, for future occasions. I feel it is so unfortunate and unfair and I am interested in hearing your opinions.”

Photo by Mark Brown/Getty Images

Yusuke Sagawa, MD, a psychiatrist and tennis fan, wrote in: “During the COVID-19 pandemic, I rekindled my interest in tennis and I followed what transpired this past weekend. Naomi Osaka is an exceptionally shy and introverted person. I have noted that her speech is somewhat akin to (for lack of a better term) ‘Valley Girl’ talk, and from reading comments on tennis-related blogs, it appears she has garnered a significant amount of hatred as a result. Most of it is along the lines of people feeling her shyness and modesty is simply a masquerade.

“I have also seen YouTube videos of her signing autographs for fans. She is cooperative and pleasant, but clearly uncomfortable around large groups of people.

“Having seen many press conferences after a match,” Dr. Sagawa continued, “tennis journalists have a penchant for asking questions that are either personal or seemingly an attempt to stir up acrimony amongst players. Whatever the case, I truly do believe that this is not some sort of ruse on her part, and I hope that people come to her defense. It is disturbing to hear the comments already coming out from the ‘big names’ in the sport that have mostly been nonsupportive. Fortunately, there have also been a number of her contemporaries who have expressed this support for her.”

In the days following Ms. Osaka’s departure from the French Open, the situation has become more complex. She is now the keystone for discussions of athletes and gender, race, power, mental illness, and the role of social media as it is used in these types of communications.

Maryland psychiatrist Erik Roskes, MD, wrote: “I have followed this story from a distance and what strikes me is the intermixing of athleticism – which is presumably why we watch sports – and entertainment, the money-making part of it. The athletes are both athletes and entertainers, and [Ms.] Osaka seems to be unable to fully fulfill the latter part due to her unique traits. But like many, I wonder what if this had been Michael Phelps? Is there a gender issue at play?”

Stephanie Durruthy, MD, added: “[Ms.] Osaka brings complexity to the mental health conversations. There is no one answer to her current plight, but her being a person of color cannot be minimized. She magnified the race conversation in tennis to a higher level.

“When she was new to the Grand Slam scene, her Haitian, Japanese, and Black heritage became an issue with unending curiosity.

“[Ms.] Osaka used her platform during the 2020 U.S. Open to single-handedly highlight Black Lives Matter,” Dr. Durruthy continued. “Afterward, the tennis fans could not avoid seeing her face mask. In each match, she displayed another mask depicting the name of those killed. She described on social media her fears of being a Black person in America. The biases of gender and race are well described in the sports world.”

Lindsay Crouse wrote June 1 in the New York Times: “When Naomi Osaka dropped out of the French Open, after declining to attend media interviews that she said could trigger her anxiety, she wasn’t just protecting her mental health. She was sending a message to the establishment of one of the world’s most elite sports: I will not be controlled. This was a power move – and it packed more punch coming from a young woman of color. When the system hasn’t historically stood for you, why sacrifice yourself to uphold it? Especially when you have the power to change it instead.”

Professional sports are grueling on athletes, both physically and mentally. People will speculate about Ms. Osaka’s motives for refusing to participate in the media briefings that are mandated by her contract. Some will see it as manipulative, others as the desire of a young woman struggling with anxiety and depression to push back against a system that makes few allowances for those who suffer. As psychiatrists, we see how crippling these illnesses can be and admire those who achieve at these superhuman levels, often at the expense of their own well-being.

Dr. Kim, who started the MPS listserv discussion, ended it with: “I feel bad if Naomi Osaka needs to play a mental ‘illness’ card, as opposed to mental ‘wellness’ card.”

Let’s hope that Ms. Osaka’s withdrawal from the French Open sparks more conversation about how to accommodate athletes as they endeavor to meet both the demands of their contracts and when it might be more appropriate to be flexible for those with individual struggles.

Dr. Miller is coauthor of “ Committed: The Battle Over Involuntary Psychiatric Care ” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

Although rates are generally low, interstitial lung disease (ILD) can occur at any point in the first year of treatment with trastuzumab deruxtecan (T-DXd) for HER2-positive metastatic breast cancer (MBC).

That’s according to a pooled analysis of three early clinical trials with the drug that was reported at the European Society for Medical Oncology (ESMO): Breast Cancer virtual meeting.

Over a 5-year analysis period, the rate of any grade of ILD was 15.5%. The majority (79%) of those events were grade 1 or 2, observed pulmonologist Charles A. Powell, MD, of Icahn School of Medicine at Mount Sinai in New York, who presented the findings.

Of the 245 patients who were included in the analysis, 38 had an ILD event deemed related to treatment. A respective 9 (3.7%) and 21 (8.6%) had events graded as 1 or 2, 1 patient each (0.4%) had a grade 3 or 4 event, and 6 (2.4%) patients had a grade 5 event.

The timing of the first identified ILD event varied from 1.1 months to 20.8 months, given a median of 5.6 months overall. “This highlights an opportunity for more timely detection of ILD,” Dr. Powell suggested. He added that in almost all (97%) cases, ILD occurred before 12 months and the risk may even decrease over time “suggesting that the risk is not cumulative.”

He cautioned, however: “It is important to note that this analysis is exploratory and hypothesis generating in nature.”
 

ILD occurs with other cancer drugs

ILD is not just associated with T-DXd treatment, said the invited discussant for the trial, Harold J. Burstein, MD, PhD, of the Dana-Farber Cancer Institute in Boston.

“It’s important for clinicians to remember that ILD/pneumonitis is an uncommon, but potentially very serious side effect that affects many breast cancer treatments,” he said.

That not only includes T-DXd, but other newer drugs such the cyclin dependent kinase (CDK) 4/6 inhibitors and immune checkpoint inhibitors, as well as other older more established drugs including taxanes, cyclophosphamide and even the mTOR inhibitor everolimus.

“Both clinicians and patients need to be aware of this risk. It’s part of the differential diagnosis for any patient who develops either ground glass changes or other infiltrates on a CT scan, or who has symptoms,” Dr. Burstein added.
 

Investigating ILD in T-DXd trials

T-DXd (Enhertu) is an anti-HER2-antibody drug conjugate that contains a humanized anti-HER2 IgG1 monoclonal antibody akin to trastuzumab that is linked to DXd, a topoisomerase I inhibitor that is a derivative of exatecan.

It has been approved for use in patients with HER2-positive metastatic breast cancer after two other HER2 treatments fail in the United States and Europe, and after chemotherapy in Japan, noted Dr. Powell. This is largely due to the results from the phase 2, open-label DESTINY-Breast01 trial.

“In breast cancer, T-DXd continues to demonstrate clinically meaningful efficacy with a median duration of response of more than 20 months in a heavily pretreated population,” he said. Objective response rates seen in the DESTINY-Breast01 trial were around 60%, and the median progression-free survival was a little over 19 months.

To look at the issue of drug-related ILD events in patients treated with T-DXd for HER2-positive MBC, an independent adjudication committee was formed to look at all the imaging and clinical data from the DESTINY-Breast01 trial and two single-arm phase 1 trials (NCT02564900 and NCT03383692).

In all, data on 245 patients who had been treated with T-DXd at the approved dose of 5.4 mg/kg in those trials between August 2015 and June 2020 were analyzed.
 

Dealing with lung toxicity

“We are getting new drugs to improve the treatment of cancer, but they always come with a price in terms of toxicity,” observed David Cameron, MD, professor of medical oncology at Edinburgh University in Scotland. Dr. Cameron chaired the session.

“Several measures were taken to identify and mitigate ILD,” across all the T-DXd studies, Dr. Powell explained. As well as the independent adjudication committee, available guidelines were followed and updated on how to diagnose and treat drug-induced lung injuries, and a “safe use” campaign was run in 2019.

Many patients in the early MBC studies were recruited before these measures were in place, such as the use of systemic steroids to manage low-grade events.

The bottom line, however, is that if a patient develops ILD then treatment should be stopped, Dr. Powell said. “Patients with grade 1 events may restart once the ILD has resolved, but those with grade 2 to 4 events must discontinue treatment.”

Dr. Powell concluded: “The overall clinical data support the positive risk-benefit profile of T-DXd. Phase 3 randomized controlled trials in breast cancer are ongoing.”
 

ILD also seen in monarchE trial with abemaciclib

Data on ILD events seen in the phase 3 monarchE trial were also reported separately at the ESMO Breast Cancer virtual meeting. The analysis population included 2,971 patients who had been treated with the CDK 4/6 inhibitor abemaciclib (Verzenio) together with endocrine therapy and 2,800 who had received endocrine therapy alone in the early-stage, adjuvant advanced breast cancer setting.

Most ILD (97%) events that occurred were single occurrences, with any grade of ILD occurring in a higher percentage of patients treated with abemaciclib with endocrine therapy than endocrine therapy alone (2.9% vs. 1.2%). Grade 3 events occurred in a respective 0.4% and 0.0% of patients.
 

So who’s at risk?

The risk factors for ILD and pneumonitis are not well characterized with either of the two drugs discussed, Dr. Burstein observed.

“In the abemaciclib experience, it looked like obesity might be a predisposing factor, with trastuzumab deruxtecan, it looked like patients of Asian ancestry were greater risk, but we need more data to really understand who’s at jeopardy.”

Dr. Burstein observed: “This is something patients need to be aware of as they’re contemplating this treatment.”

While data to prove the benefit of the drug need to mature, Dr. Burstein “would likely discontinue therapy” if a patient were to develop ILD or pneumonitis and treat accordingly.

As for T-DXd, he said: “It’s important that patients know that lung disease is a potentially severe side effect of treatment and that any respiratory symptoms need to be jumped on quickly.”

While prospective studies are now needed, and the phase 3 data should help to better understand the risk of ILD with T-DXd, Dr. Burstein believes it will be important to develop algorithms to ensure the safe administration of the drug.

These algorithms should include “appropriate surveillance and monitoring, especially as we think about trying to move this drug forward into the early stage setting where we’re using it in women who have favorable prognosis, and potentially curative situations for breast cancer.”

The trastuzumab deruxtecan trials were cosponsored by Daiichi Sankyo and AstraZeneca. The monarchE trial was supported by Eli Lilly.

Dr. Powell acknowledged receiving personal fees for acting as an advisory or consultant to both companies as well as to Voluntis. Dr. Burstein had nothing to disclose, and Dr. Cameron had no relevant financial interests in the data being presented.

Although rates are generally low, interstitial lung disease (ILD) can occur at any point in the first year of treatment with trastuzumab deruxtecan (T-DXd) for HER2-positive metastatic breast cancer (MBC).

That’s according to a pooled analysis of three early clinical trials with the drug that was reported at the European Society for Medical Oncology (ESMO): Breast Cancer virtual meeting.

Over a 5-year analysis period, the rate of any grade of ILD was 15.5%. The majority (79%) of those events were grade 1 or 2, observed pulmonologist Charles A. Powell, MD, of Icahn School of Medicine at Mount Sinai in New York, who presented the findings.

Of the 245 patients who were included in the analysis, 38 had an ILD event deemed related to treatment. A respective 9 (3.7%) and 21 (8.6%) had events graded as 1 or 2, 1 patient each (0.4%) had a grade 3 or 4 event, and 6 (2.4%) patients had a grade 5 event.

The timing of the first identified ILD event varied from 1.1 months to 20.8 months, given a median of 5.6 months overall. “This highlights an opportunity for more timely detection of ILD,” Dr. Powell suggested. He added that in almost all (97%) cases, ILD occurred before 12 months and the risk may even decrease over time “suggesting that the risk is not cumulative.”

He cautioned, however: “It is important to note that this analysis is exploratory and hypothesis generating in nature.”
 

ILD occurs with other cancer drugs

ILD is not just associated with T-DXd treatment, said the invited discussant for the trial, Harold J. Burstein, MD, PhD, of the Dana-Farber Cancer Institute in Boston.

“It’s important for clinicians to remember that ILD/pneumonitis is an uncommon, but potentially very serious side effect that affects many breast cancer treatments,” he said.

That not only includes T-DXd, but other newer drugs such the cyclin dependent kinase (CDK) 4/6 inhibitors and immune checkpoint inhibitors, as well as other older more established drugs including taxanes, cyclophosphamide and even the mTOR inhibitor everolimus.

“Both clinicians and patients need to be aware of this risk. It’s part of the differential diagnosis for any patient who develops either ground glass changes or other infiltrates on a CT scan, or who has symptoms,” Dr. Burstein added.
 

Investigating ILD in T-DXd trials

T-DXd (Enhertu) is an anti-HER2-antibody drug conjugate that contains a humanized anti-HER2 IgG1 monoclonal antibody akin to trastuzumab that is linked to DXd, a topoisomerase I inhibitor that is a derivative of exatecan.

It has been approved for use in patients with HER2-positive metastatic breast cancer after two other HER2 treatments fail in the United States and Europe, and after chemotherapy in Japan, noted Dr. Powell. This is largely due to the results from the phase 2, open-label DESTINY-Breast01 trial.

“In breast cancer, T-DXd continues to demonstrate clinically meaningful efficacy with a median duration of response of more than 20 months in a heavily pretreated population,” he said. Objective response rates seen in the DESTINY-Breast01 trial were around 60%, and the median progression-free survival was a little over 19 months.

To look at the issue of drug-related ILD events in patients treated with T-DXd for HER2-positive MBC, an independent adjudication committee was formed to look at all the imaging and clinical data from the DESTINY-Breast01 trial and two single-arm phase 1 trials (NCT02564900 and NCT03383692).

In all, data on 245 patients who had been treated with T-DXd at the approved dose of 5.4 mg/kg in those trials between August 2015 and June 2020 were analyzed.
 

Dealing with lung toxicity

“We are getting new drugs to improve the treatment of cancer, but they always come with a price in terms of toxicity,” observed David Cameron, MD, professor of medical oncology at Edinburgh University in Scotland. Dr. Cameron chaired the session.

“Several measures were taken to identify and mitigate ILD,” across all the T-DXd studies, Dr. Powell explained. As well as the independent adjudication committee, available guidelines were followed and updated on how to diagnose and treat drug-induced lung injuries, and a “safe use” campaign was run in 2019.

Many patients in the early MBC studies were recruited before these measures were in place, such as the use of systemic steroids to manage low-grade events.

The bottom line, however, is that if a patient develops ILD then treatment should be stopped, Dr. Powell said. “Patients with grade 1 events may restart once the ILD has resolved, but those with grade 2 to 4 events must discontinue treatment.”

Dr. Powell concluded: “The overall clinical data support the positive risk-benefit profile of T-DXd. Phase 3 randomized controlled trials in breast cancer are ongoing.”
 

ILD also seen in monarchE trial with abemaciclib

Data on ILD events seen in the phase 3 monarchE trial were also reported separately at the ESMO Breast Cancer virtual meeting. The analysis population included 2,971 patients who had been treated with the CDK 4/6 inhibitor abemaciclib (Verzenio) together with endocrine therapy and 2,800 who had received endocrine therapy alone in the early-stage, adjuvant advanced breast cancer setting.

Most ILD (97%) events that occurred were single occurrences, with any grade of ILD occurring in a higher percentage of patients treated with abemaciclib with endocrine therapy than endocrine therapy alone (2.9% vs. 1.2%). Grade 3 events occurred in a respective 0.4% and 0.0% of patients.
 

So who’s at risk?

The risk factors for ILD and pneumonitis are not well characterized with either of the two drugs discussed, Dr. Burstein observed.

“In the abemaciclib experience, it looked like obesity might be a predisposing factor, with trastuzumab deruxtecan, it looked like patients of Asian ancestry were greater risk, but we need more data to really understand who’s at jeopardy.”

Dr. Burstein observed: “This is something patients need to be aware of as they’re contemplating this treatment.”

While data to prove the benefit of the drug need to mature, Dr. Burstein “would likely discontinue therapy” if a patient were to develop ILD or pneumonitis and treat accordingly.

As for T-DXd, he said: “It’s important that patients know that lung disease is a potentially severe side effect of treatment and that any respiratory symptoms need to be jumped on quickly.”

While prospective studies are now needed, and the phase 3 data should help to better understand the risk of ILD with T-DXd, Dr. Burstein believes it will be important to develop algorithms to ensure the safe administration of the drug.

These algorithms should include “appropriate surveillance and monitoring, especially as we think about trying to move this drug forward into the early stage setting where we’re using it in women who have favorable prognosis, and potentially curative situations for breast cancer.”

The trastuzumab deruxtecan trials were cosponsored by Daiichi Sankyo and AstraZeneca. The monarchE trial was supported by Eli Lilly.

Dr. Powell acknowledged receiving personal fees for acting as an advisory or consultant to both companies as well as to Voluntis. Dr. Burstein had nothing to disclose, and Dr. Cameron had no relevant financial interests in the data being presented.

Although rates are generally low, interstitial lung disease (ILD) can occur at any point in the first year of treatment with trastuzumab deruxtecan (T-DXd) for HER2-positive metastatic breast cancer (MBC).

That’s according to a pooled analysis of three early clinical trials with the drug that was reported at the European Society for Medical Oncology (ESMO): Breast Cancer virtual meeting.

Over a 5-year analysis period, the rate of any grade of ILD was 15.5%. The majority (79%) of those events were grade 1 or 2, observed pulmonologist Charles A. Powell, MD, of Icahn School of Medicine at Mount Sinai in New York, who presented the findings.

Of the 245 patients who were included in the analysis, 38 had an ILD event deemed related to treatment. A respective 9 (3.7%) and 21 (8.6%) had events graded as 1 or 2, 1 patient each (0.4%) had a grade 3 or 4 event, and 6 (2.4%) patients had a grade 5 event.

The timing of the first identified ILD event varied from 1.1 months to 20.8 months, given a median of 5.6 months overall. “This highlights an opportunity for more timely detection of ILD,” Dr. Powell suggested. He added that in almost all (97%) cases, ILD occurred before 12 months and the risk may even decrease over time “suggesting that the risk is not cumulative.”

He cautioned, however: “It is important to note that this analysis is exploratory and hypothesis generating in nature.”
 

ILD occurs with other cancer drugs

ILD is not just associated with T-DXd treatment, said the invited discussant for the trial, Harold J. Burstein, MD, PhD, of the Dana-Farber Cancer Institute in Boston.

“It’s important for clinicians to remember that ILD/pneumonitis is an uncommon, but potentially very serious side effect that affects many breast cancer treatments,” he said.

That not only includes T-DXd, but other newer drugs such the cyclin dependent kinase (CDK) 4/6 inhibitors and immune checkpoint inhibitors, as well as other older more established drugs including taxanes, cyclophosphamide and even the mTOR inhibitor everolimus.

“Both clinicians and patients need to be aware of this risk. It’s part of the differential diagnosis for any patient who develops either ground glass changes or other infiltrates on a CT scan, or who has symptoms,” Dr. Burstein added.
 

Investigating ILD in T-DXd trials

T-DXd (Enhertu) is an anti-HER2-antibody drug conjugate that contains a humanized anti-HER2 IgG1 monoclonal antibody akin to trastuzumab that is linked to DXd, a topoisomerase I inhibitor that is a derivative of exatecan.

It has been approved for use in patients with HER2-positive metastatic breast cancer after two other HER2 treatments fail in the United States and Europe, and after chemotherapy in Japan, noted Dr. Powell. This is largely due to the results from the phase 2, open-label DESTINY-Breast01 trial.

“In breast cancer, T-DXd continues to demonstrate clinically meaningful efficacy with a median duration of response of more than 20 months in a heavily pretreated population,” he said. Objective response rates seen in the DESTINY-Breast01 trial were around 60%, and the median progression-free survival was a little over 19 months.

To look at the issue of drug-related ILD events in patients treated with T-DXd for HER2-positive MBC, an independent adjudication committee was formed to look at all the imaging and clinical data from the DESTINY-Breast01 trial and two single-arm phase 1 trials (NCT02564900 and NCT03383692).

In all, data on 245 patients who had been treated with T-DXd at the approved dose of 5.4 mg/kg in those trials between August 2015 and June 2020 were analyzed.
 

Dealing with lung toxicity

“We are getting new drugs to improve the treatment of cancer, but they always come with a price in terms of toxicity,” observed David Cameron, MD, professor of medical oncology at Edinburgh University in Scotland. Dr. Cameron chaired the session.

“Several measures were taken to identify and mitigate ILD,” across all the T-DXd studies, Dr. Powell explained. As well as the independent adjudication committee, available guidelines were followed and updated on how to diagnose and treat drug-induced lung injuries, and a “safe use” campaign was run in 2019.

Many patients in the early MBC studies were recruited before these measures were in place, such as the use of systemic steroids to manage low-grade events.

The bottom line, however, is that if a patient develops ILD then treatment should be stopped, Dr. Powell said. “Patients with grade 1 events may restart once the ILD has resolved, but those with grade 2 to 4 events must discontinue treatment.”

Dr. Powell concluded: “The overall clinical data support the positive risk-benefit profile of T-DXd. Phase 3 randomized controlled trials in breast cancer are ongoing.”
 

ILD also seen in monarchE trial with abemaciclib

Data on ILD events seen in the phase 3 monarchE trial were also reported separately at the ESMO Breast Cancer virtual meeting. The analysis population included 2,971 patients who had been treated with the CDK 4/6 inhibitor abemaciclib (Verzenio) together with endocrine therapy and 2,800 who had received endocrine therapy alone in the early-stage, adjuvant advanced breast cancer setting.

Most ILD (97%) events that occurred were single occurrences, with any grade of ILD occurring in a higher percentage of patients treated with abemaciclib with endocrine therapy than endocrine therapy alone (2.9% vs. 1.2%). Grade 3 events occurred in a respective 0.4% and 0.0% of patients.
 

So who’s at risk?

The risk factors for ILD and pneumonitis are not well characterized with either of the two drugs discussed, Dr. Burstein observed.

“In the abemaciclib experience, it looked like obesity might be a predisposing factor, with trastuzumab deruxtecan, it looked like patients of Asian ancestry were greater risk, but we need more data to really understand who’s at jeopardy.”

Dr. Burstein observed: “This is something patients need to be aware of as they’re contemplating this treatment.”

While data to prove the benefit of the drug need to mature, Dr. Burstein “would likely discontinue therapy” if a patient were to develop ILD or pneumonitis and treat accordingly.

As for T-DXd, he said: “It’s important that patients know that lung disease is a potentially severe side effect of treatment and that any respiratory symptoms need to be jumped on quickly.”

While prospective studies are now needed, and the phase 3 data should help to better understand the risk of ILD with T-DXd, Dr. Burstein believes it will be important to develop algorithms to ensure the safe administration of the drug.

These algorithms should include “appropriate surveillance and monitoring, especially as we think about trying to move this drug forward into the early stage setting where we’re using it in women who have favorable prognosis, and potentially curative situations for breast cancer.”

The trastuzumab deruxtecan trials were cosponsored by Daiichi Sankyo and AstraZeneca. The monarchE trial was supported by Eli Lilly.

Dr. Powell acknowledged receiving personal fees for acting as an advisory or consultant to both companies as well as to Voluntis. Dr. Burstein had nothing to disclose, and Dr. Cameron had no relevant financial interests in the data being presented.