Mixed Topics

Sterling Ransone Jr., MD, a family physician in Deltaville, Va., knocked on the exam room door and entered to find the patient, a 28-year-old woman, seated on the examination table. She was complaining about a fever, sore throat, and congestion.

Dr. Ransone asked if it was okay for him to lift her shirt and listen to her heart. She shook her head slightly. He decided to listen without removing the clothing, but when he put one hand on her shoulder and the stethoscope on her back, she flinched.

Instead of proceeding with the examination, Dr. Ransone, who is president-elect of the American Academy of Family Physicians, asked the patient whether everything was okay. It turned out that she had been the victim of a sexual assault and did not want a male to remove any clothing or touch her chest or back. Fortunately, Dr. Ransone’s practice had a female partner, who came in and listened to the patient’s chest.

“I’m glad I asked the patient what was going on for her because otherwise, I wouldn’t have known what she was going through,” Dr. Ransone said. “The patient felt respected and safe, and the therapeutic relationship was enhanced instead of compromised.”

Patient dignity is one of Dr. Ransone’s most important professional values. He recounts that during rounds in medical school, the attending and several interns and students crowded into the semiprivate room of an elderly woman who was lying in bed. The attending pulled off the bed covers, leaving the patient exposed while he discussed her case.

“I was mortified for her, and I learned a lot from watching this unfold, just seeing this woman lying naked in front all of these strangers and God,” said Dr. Ransone, physician practice director at Riverside Fishing Bay Family Practice, Deltaville, and assistant clinical professor of family medicine and population health at Virginia Commonwealth University, in Richmond. “I’ve been in practice for 25 years, and making sure the patient feels comfortable and respected is one of my priorities that dates back to that very first encounter.”
 

Trauma-informed care

Trauma is a common reason why patients feel reluctant to remove their clothing, according to Lauren Radziejewski, DNP, ANP-BC, clinical program manager, Mount Sinai Center for Transgender Medicine and Surgery, New York.

“We teach and endorse trauma-informed care for any type of procedure that is potentially triggering, and I would certainly put any type of care where people have to take off their clothes as potentially triggering,” she said.

Trauma can be caused by many factors. “Traumas of a sexual nature – having been subjected to sexual violence, for example – are the most obvious that come to mind, but any trauma that involves violation and disempowerment, even a nonsexual one, can make people more reluctant to be in a sensitive situation that can be perceived as invasive or disempowering,” Dr. Radziejewski said.
 

Talk before you touch

There are other reasons, often multiple intersecting reasons, why patients are reluctant to disrobe, according to Alicia Arbaje, MD, MPH, PhD, associate professor of medicine and director of transitional care research at the Center for Transformative Geriatrics Research, division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore. These include culture and religion, generational sensitivities, and body discomfort associated with transitional times in life (e.g., teen or menopausal years).

Some general approaches apply, regardless of the reason for the patient’s discomfort. Others are specific to the patient’s particular problem or concern, Dr. Arbaje said.

“So much of medicine in this day and age is to quickly get down to business, hurry, and move on to the next patient,” said Dr. Arbaje, who also serves as chair of the American Geriatric Society’s Public Education Committee. “But establishing a little bit of a relationship is crucial before beginning the physical exam with any patient, especially with seniors or other patients who might have particular discomforts.”

She advises practitioners to “spend time talking before touching.” In other words, “Find a way to create some kind of meeting, even very briefly, and establish rapport before the patient changes into a gown and before you touch the patient to examine him or her.”

She acknowledged this might be difficult to do in certain clinical settings, but “to whatever extent you can, try to build this extra time and extra step into your workflow.”

She suggested that physicians first meet with the patient in the office or examining room to hear about his or her concerns. If a gown is necessary, the patient can change into one after the physician leaves the room. This builds trust and rapport.

Choice of language is important, especially when talking with older individuals. “Address the patient by their title until you are told not to – Ms. or Mrs. Smith, or Mr. Jones – or ask, ‘How would you like to be addressed?’ And don’t use terms of endearment, like ‘dear’ or ‘sweetie,’ or the plural, such as ‘How are we feeling today?’ “ These are “infantilizing and patronizing” and can impact the patient’s level of comfort with the entire appointment, including undressing and being examined.

Regarding transgender people, “many have experienced sexual violence and inappropriate touching, but even those fortunate enough to have escaped that type of common problem typically have still undergone traumatic experiences just by being transgender, having been socialized incorrectly, misunderstood, or having the ‘wrong’ genitalia,” said Dr. Radziejewski.

Particularly when dealing with a transgender patient, “you have to assume that there may be a history of trauma. Be sensitive to the patient’s discomforts about disrobing, recognize the examination itself as a potential trigger, and take appropriate measures to mitigate the trauma.”

To do this, Dr. Radziejewski gives her patients a “menu of options,” because “when people are navigating the world after trauma, including marginalized identity, they often have a complete loss of control, so the key is to give them as much control as possible every step of the way.”

For example, Dr. Radziejewski might tell a transgender masculine patient, “I’m looking through your chart and see no documented Pap test.” She acknowledges that after explaining why the test is recommended, the patient might be uncomfortable with it. She then makes a series of suggestions that range from being completely noninvasive to more invasive.

“You can say you don’t want it at all, or you can take a swab that I will give you and do it in the bathroom yourself. If you’re more comfortable with a man performing it, I can arrange that, or if you’re more comfortable with someone other than myself – your regular provider – I can arrange that, too.” By the end of the interaction, most patients are comfortable with Dr. Radziejewski performing the exam.

Regarding invasive exams, she recommends setting up an appointment specifically dedicated to that exam, rather than trying to cram a sensitive process into the time allotted for a patent visit, when other topics are also being discussed. “This also reinforces a sense of control,” she said.

This approach is relevant not only for transgender patients but also for any patient who has experienced trauma or some type of shame associated with the body, she said.

Dr. Ransone asks transgender patients what pronoun they would like him to use when he addresses them.

Prior to the examination, talking about what will be done and why further enhances trust, comfort, and rapport.
 

Who should be present?

Dr. Arbaje suggested that the pre-examination conversation should include a discussion of who the patient would like to have present during the exam. This is particularly relevant with a geriatric patient who might have been brought in by a family member or caregiver.

Similarly, adolescents may not feel comfortable with a parent being present for an examination. To protect the teen’s privacy, Dr. Ransone asks parents to step out. “There are also subjects that adolescents won’t bring up if their parents are there,” he said.

A question that is relevant in many clinical settings is whether the presence of a chaperone enhances or detracts from the patient’s comfort. Although the use of chaperones is recommended by many societies, it is a judgment call whether a chaperone should be present during all examinations – unless the state in which one practices requires it. Seven states mandate the presence of a chaperone during an intimate exam: Alabama, Delaware, Georgia, Montana, New Jersey, Ohio, and Tennessee.

Dr. Ransone utilizes a medical scribe to take notes on patient visits. The nurse or medical assistant who escorts the patient into the exam room informs the patient that a scribe will be in the room but that the patient should feel free to say whether he or she wants to talk about something privately, in which case the scribe will leave.

Dr. Ransone’s scribe is female and serves as the chaperone during an intimate exam of a female patient. “I have assumed, and my established patients know, that there will be a chaperone present, but my patients also know they can ask for the chaperone to step out,” he said. “When that happens, I document the discussion in the patient’s chart for my own legal protection.”

He recommended that practices consider posting signage or including information about chaperones in the practice’s informational brochures regarding policies and procedures.

Armin Brott, MBA, senior editor of Talking About Men’s Health , said that having a chaperone in the room when a female practitioner is examining a male patient – even if the chaperone is male – would be “extremely uncomfortable, weird, and even voyeuristic for the male patient.”

He noted that typically, male physicians use a chaperone when examining a female patient “for their own legal self-protection and maybe to make the female patient more comfortable, but female physicians are typically less concerned about potentially being accused of violating a male patient and typically do not have chaperones.”
 

Men face unique challenges

Men have “unique needs and challenges” when it comes to healthcare, said Mr. Brott, an advisory board member of the Men’s Health Network.

Mr. Brott cited research showing that men do not seek healthcare as frequently as women do. “So it’s already hard to get men in the door of a doctor, no matter what the provider’s gender is,” he said. Notably, men are even less likely to seek medical care when the clinician is female, owing to discomfort at having to undergo an intimate exam.

“I think that many men have issues about sexuality and of becoming aroused during an exam if it’s a female practitioner doing the exam,” said Mr. Brott. “I’m sure this is something physicians and nurses are accustomed to, but for the patient, it’s extremely embarrassing. The man may worry that he’ll be perceived as making unwanted sexual overtures to the practitioner.”

The way to mitigate these concerns is through communication, according to Mr. Brott. He recalled his own experience during a catherization conducted by a female practitioner he had never met. “She came in and started dealing with me as if I wasn’t even a person. She didn’t say much. It would have helped if she had created some type of human connection and talked to me – something like, ‘I’ve done this a thousand times and here’s what you’ll be feeling,’ or, “Would you like me to describe what I’m doing, or just do it as quickly as possible?’ ”

On another occasion, Mr. Brott underwent a procedure that was performed by two female practitioners, who were more communicative and even brought some light humor to the encounter, “which set me at ease,” he said.

If a man does become aroused, reassurance would be helpful, Mr. Brott said. “You can say something like, ‘Don’t worry, it’s perfectly natural, it happens all the time. Let’s finish up, and I’ll be out of your way as soon as I can.’ ”
 

Explain at every step of the way

All the experts emphasize the critical importance of continuing to offer explanations throughout the exam, even if the exam has been discussed beforehand.

“During the exam, it’s key to explain what you’re doing each step of the way – especially with seniors, but with other patients too,” said Arbaje. “For example, ‘I’d like you to remove your arms from your shirt so I can examine the joint better.’ Often there’s apprehension about what you’re going to do next. You can also ask, ‘Is there anything I should know before I examine this part of you? How are you doing?’ “ She advised asking the patient for “ongoing feedback. ‘Is this okay? Is this too rough?’ “

This is especially important when conducting a pelvic exam or palpating the patient’s abdomen, which is a more personal area than, say, the knee. Only the body part that is being examined should be uncovered, and it should be re-covered after the exam of that body part is complete and a different body part is to then be examined.

Asking for feedback is especially important, because many older patients have been acculturated not to question physicians and other medical authorities and may suffer a sense of humiliation silently.

Dr. Arbaje noted that feedback can be nonverbal: “For example, wincing or flinching are signs of discomfort you should ask the patient about or empathetically acknowledge.”
 

Rapport building doesn’t end after the examination

Dr. Arbaje advises physicians to “spend a little more time with the patient after the examination and not just walk out the door, leaving the person as they are, half undressed or in a gown.”

In the case of an older person, this might involve helping patients get their shoes and socks on or helping them get off the table. “Spend some time closing the encounter, not just doing what you need to do and then leaving or leaving it for someone else or family to do, which can be very dehumanizing,” she said. Even a few minutes of human contact beyond the examination can enhance rapport and help the patient feel respected and more comfortable.
 

Setting the stage: Create a conducive office environment

Setting patients at ease begins well before the patient enters the examination room, experts say. The overall atmosphere of the practice – the professionalism, courtesy, and friendliness of the staff – contributes to a sense of safety that will set the stage for the patient to feel more comfortable disrobing, if necessary, and being examined.

Mr. Brott pointed out that most medical offices tend to be more “female-friendly” in decor, utilizing pastel colors and flower motifs, for example, and displaying women’s magazines in the waiting room. Gender-neutral decor and different types of reading materials might set men at ease. Receptionists and medical staff are often female, and it is helpful for practices to employ male staff to bring the patient into the examination room or check vital signs. “This would go a long way toward making a man feel welcome and comfortable, even if the physician is female,” he said.

Dr. Radziejewski agreed: “If possible, having male and female support staff available will set patients of any gender at their ease.”

The setup of the examination room may contribute to a patient’s level of comfort. In Dr. Ransone’s examination room, the patient faces the door when on the table, and the door is locked during the exam so that no one can enter.

“I think that if patients are facing away from the door, they may feel claustrophobic or trapped, and I don’t want to position myself between the patient and an exit,” Dr. Ransone said. “My exam room happens to have no windows, but I’ve seen situations where the patient is lying on the table, exposed in front of the window, which can feel vulnerable, even if the office is on a high floor and no one can see into the window.”

Dr. Ransone positions the scribe or chaperone to the side, where the patient can see them, but not directly in front, where the examination might be visible to them. “I think it would be more uncomfortable and anxiety provoking knowing that someone is standing behind me and I can’t see them,” he said.
 

Choosing the best gown ... when necessary

Is it necessary for patients to disrobe and put on a gown — especially in light of the fact that research suggests that wearing a gown can induce psychological distress?

Danielle Ofri, MD, PhD, clinical professor, department of medicine, NYU Grossman School of Medicine, New York, said that in her practice, patients wear street clothes unless the patient is to undergo a full physical exam.

Even an abdominal exam can be conducted by loosening and slightly lowering the pants. Dr. Ofri stresses that patients should retain full control over how much to expose: “The patient should always take the lead in adjusting or opening clothing for a focused physical exam. And, of course, we always need to ask permission before starting any part of the exam.”

A gown is more conducive for certain exams, such as pelvic or breast exams. Dr. Ransone said that cloth gowns are preferable to paper gowns, which can tear more easily and so lead to unnecessary exposure. Gowns that hang open at the back should be avoided. If that’s the only type available, a second gown can be provided so as to cover the backside.

This is especially important if the examination involves walking across the room – for example, to evaluate gait – or standing on the scale. Alternatively, the patient can be given a sheet to drape over the gown, which can be moved around during the examination.

Dr. Ransome’s own practice uses gowns that fully wrap around the person. “I’ve seen too many people in gowns that are too small, so I make sure the patient has an appropriately sized gown. The extra material also leaves room for draping, while exposing only the part of the body that’s necessary,” he said.

Numerous types of modest gowns are now available, including kimono-type gowns with ties and snaps that allow partial exposure. All the experts encouraged utilizing these or similar types of gowns if possible.
 

Cultural and religious considerations

It is important for clinicians to be sensitive to cultural and religious factors that might affect patients’ attitudes toward attire and opposite-sex practitioners, said Dr. Ofri, an internist at Bellevue Hospital, New York.

For example, in Islamic and ultra-Orthodox Jewish traditions, certain parts of the body may not be exposed in the presence of a man who is unrelated by blood or marriage. Studies have shown that Hispanic and Asian women have avoided mammography because of embarrassment.

Dr. Arbaje described a 90-year-old patient whose physician ordered a pelvic ultrasound. The ultrasound department conducted the test transvaginally. “The patient, a widow, came from a Catholic background and regarded this as tantamount to ‘cheating’ on her deceased husband, and she felt violated and ashamed,” Dr. Arbaje said.

Dr. Ofri, who is the author of Medicine in Translation: Journeys With My Patients, said that she has Muslim and Orthodox Jewish male patients who allow her to examine their knees but won’t shake her hand because of the prohibition against touching an unrelated woman. Muslim female patients are willing to unsnap their veils because Dr. Ofri is female, but they would be uncomfortable with a male practitioner.

Whenever possible, gender-concordant care should be provided. If that is not possible, patients should be offered the option of not undergoing the examination, unless it’s an emergent situation, Dr. Ofri said. It may be necessary to reschedule the appointment to a time when a same-sex practitioner is available or to refer the patient to another practitioner.

Keeping cultural and religious considerations in mind is important, but there are variations in any given culture or religion. Practitioners should take cues directly from the patient, the experts advise.
 

Meeting the needs of cognitively impaired patients

Patients who are cognitively impaired have particular needs, Dr. Arbaje says. Many such patients are seniors with dementia, although developmental disabilities, neurodegenerative diseases, and other problems that affect cognition can occur among patients of any age and stage of life.

“People with dementia don’t necessarily understand what you’re doing and why you’re touching them. Even people with advanced dementia often retain a sense of modesty and may feel humiliated by an examination,” Dr. Arbaje said.

Dr. Arbaje encourages offering clear explanations of what is being done. The language one uses should be respectful and nonpatronizing, even if the patient does not understand what is being said. However, the bulk of one’s communication should be nonverbal. “Convey gentleness, safety, and reassurance through your tone and touch,” Dr. Arbaje said.

For cognitively impaired patient, it is helpful for a trusted family member or caregiver to be present during the examination, rather than a stranger. Depending on the degree of impairment, it might also be helpful for them to have a familiar object, perhaps a blanket; the odor and texture can convey familiarity and reassurance.

Nonclinical touch can also be reassuring. “We’re often scared of touching a patient because we don’t want to be considered inappropriate, but people who have dementia in later life are often understimulated, in terms of loving and caring touch,” she said. “For people in that situation, touch is typically of a practical or clinical nature – like bathing the person or taking their blood pressure. Providing reassuring touch or having someone else present to do so can help ease the patient’s fear and can be very healing.”
 

Making your patient’s eyes light up

“I can’t even count how many times I’ve had patients thank me for just explaining things clearly and giving them the right to opt out of wearing a gown or having an examination or procedure,” Dr. Radziejewski said.

“Obviously, I express recommendations, strong recommendations, but people like to know this is a place where they’ll be acknowledged for who they are, where they can feel safe and their dignity will be preserved. That should be the environment for any patient, whatever their culture, religion, age, background, or sexual identity. Offering that type of venue makes their eyes light up and makes all the difference in adherence to my recommendations and feeling empowered to truly care for their health,” she said.

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

Sterling Ransone Jr., MD, a family physician in Deltaville, Va., knocked on the exam room door and entered to find the patient, a 28-year-old woman, seated on the examination table. She was complaining about a fever, sore throat, and congestion.

Dr. Ransone asked if it was okay for him to lift her shirt and listen to her heart. She shook her head slightly. He decided to listen without removing the clothing, but when he put one hand on her shoulder and the stethoscope on her back, she flinched.

Instead of proceeding with the examination, Dr. Ransone, who is president-elect of the American Academy of Family Physicians, asked the patient whether everything was okay. It turned out that she had been the victim of a sexual assault and did not want a male to remove any clothing or touch her chest or back. Fortunately, Dr. Ransone’s practice had a female partner, who came in and listened to the patient’s chest.

“I’m glad I asked the patient what was going on for her because otherwise, I wouldn’t have known what she was going through,” Dr. Ransone said. “The patient felt respected and safe, and the therapeutic relationship was enhanced instead of compromised.”

Patient dignity is one of Dr. Ransone’s most important professional values. He recounts that during rounds in medical school, the attending and several interns and students crowded into the semiprivate room of an elderly woman who was lying in bed. The attending pulled off the bed covers, leaving the patient exposed while he discussed her case.

“I was mortified for her, and I learned a lot from watching this unfold, just seeing this woman lying naked in front all of these strangers and God,” said Dr. Ransone, physician practice director at Riverside Fishing Bay Family Practice, Deltaville, and assistant clinical professor of family medicine and population health at Virginia Commonwealth University, in Richmond. “I’ve been in practice for 25 years, and making sure the patient feels comfortable and respected is one of my priorities that dates back to that very first encounter.”
 

Trauma-informed care

Trauma is a common reason why patients feel reluctant to remove their clothing, according to Lauren Radziejewski, DNP, ANP-BC, clinical program manager, Mount Sinai Center for Transgender Medicine and Surgery, New York.

“We teach and endorse trauma-informed care for any type of procedure that is potentially triggering, and I would certainly put any type of care where people have to take off their clothes as potentially triggering,” she said.

Trauma can be caused by many factors. “Traumas of a sexual nature – having been subjected to sexual violence, for example – are the most obvious that come to mind, but any trauma that involves violation and disempowerment, even a nonsexual one, can make people more reluctant to be in a sensitive situation that can be perceived as invasive or disempowering,” Dr. Radziejewski said.
 

Talk before you touch

There are other reasons, often multiple intersecting reasons, why patients are reluctant to disrobe, according to Alicia Arbaje, MD, MPH, PhD, associate professor of medicine and director of transitional care research at the Center for Transformative Geriatrics Research, division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore. These include culture and religion, generational sensitivities, and body discomfort associated with transitional times in life (e.g., teen or menopausal years).

Some general approaches apply, regardless of the reason for the patient’s discomfort. Others are specific to the patient’s particular problem or concern, Dr. Arbaje said.

“So much of medicine in this day and age is to quickly get down to business, hurry, and move on to the next patient,” said Dr. Arbaje, who also serves as chair of the American Geriatric Society’s Public Education Committee. “But establishing a little bit of a relationship is crucial before beginning the physical exam with any patient, especially with seniors or other patients who might have particular discomforts.”

She advises practitioners to “spend time talking before touching.” In other words, “Find a way to create some kind of meeting, even very briefly, and establish rapport before the patient changes into a gown and before you touch the patient to examine him or her.”

She acknowledged this might be difficult to do in certain clinical settings, but “to whatever extent you can, try to build this extra time and extra step into your workflow.”

She suggested that physicians first meet with the patient in the office or examining room to hear about his or her concerns. If a gown is necessary, the patient can change into one after the physician leaves the room. This builds trust and rapport.

Choice of language is important, especially when talking with older individuals. “Address the patient by their title until you are told not to – Ms. or Mrs. Smith, or Mr. Jones – or ask, ‘How would you like to be addressed?’ And don’t use terms of endearment, like ‘dear’ or ‘sweetie,’ or the plural, such as ‘How are we feeling today?’ “ These are “infantilizing and patronizing” and can impact the patient’s level of comfort with the entire appointment, including undressing and being examined.

Regarding transgender people, “many have experienced sexual violence and inappropriate touching, but even those fortunate enough to have escaped that type of common problem typically have still undergone traumatic experiences just by being transgender, having been socialized incorrectly, misunderstood, or having the ‘wrong’ genitalia,” said Dr. Radziejewski.

Particularly when dealing with a transgender patient, “you have to assume that there may be a history of trauma. Be sensitive to the patient’s discomforts about disrobing, recognize the examination itself as a potential trigger, and take appropriate measures to mitigate the trauma.”

To do this, Dr. Radziejewski gives her patients a “menu of options,” because “when people are navigating the world after trauma, including marginalized identity, they often have a complete loss of control, so the key is to give them as much control as possible every step of the way.”

For example, Dr. Radziejewski might tell a transgender masculine patient, “I’m looking through your chart and see no documented Pap test.” She acknowledges that after explaining why the test is recommended, the patient might be uncomfortable with it. She then makes a series of suggestions that range from being completely noninvasive to more invasive.

“You can say you don’t want it at all, or you can take a swab that I will give you and do it in the bathroom yourself. If you’re more comfortable with a man performing it, I can arrange that, or if you’re more comfortable with someone other than myself – your regular provider – I can arrange that, too.” By the end of the interaction, most patients are comfortable with Dr. Radziejewski performing the exam.

Regarding invasive exams, she recommends setting up an appointment specifically dedicated to that exam, rather than trying to cram a sensitive process into the time allotted for a patent visit, when other topics are also being discussed. “This also reinforces a sense of control,” she said.

This approach is relevant not only for transgender patients but also for any patient who has experienced trauma or some type of shame associated with the body, she said.

Dr. Ransone asks transgender patients what pronoun they would like him to use when he addresses them.

Prior to the examination, talking about what will be done and why further enhances trust, comfort, and rapport.
 

Who should be present?

Dr. Arbaje suggested that the pre-examination conversation should include a discussion of who the patient would like to have present during the exam. This is particularly relevant with a geriatric patient who might have been brought in by a family member or caregiver.

Similarly, adolescents may not feel comfortable with a parent being present for an examination. To protect the teen’s privacy, Dr. Ransone asks parents to step out. “There are also subjects that adolescents won’t bring up if their parents are there,” he said.

A question that is relevant in many clinical settings is whether the presence of a chaperone enhances or detracts from the patient’s comfort. Although the use of chaperones is recommended by many societies, it is a judgment call whether a chaperone should be present during all examinations – unless the state in which one practices requires it. Seven states mandate the presence of a chaperone during an intimate exam: Alabama, Delaware, Georgia, Montana, New Jersey, Ohio, and Tennessee.

Dr. Ransone utilizes a medical scribe to take notes on patient visits. The nurse or medical assistant who escorts the patient into the exam room informs the patient that a scribe will be in the room but that the patient should feel free to say whether he or she wants to talk about something privately, in which case the scribe will leave.

Dr. Ransone’s scribe is female and serves as the chaperone during an intimate exam of a female patient. “I have assumed, and my established patients know, that there will be a chaperone present, but my patients also know they can ask for the chaperone to step out,” he said. “When that happens, I document the discussion in the patient’s chart for my own legal protection.”

He recommended that practices consider posting signage or including information about chaperones in the practice’s informational brochures regarding policies and procedures.

Armin Brott, MBA, senior editor of Talking About Men’s Health , said that having a chaperone in the room when a female practitioner is examining a male patient – even if the chaperone is male – would be “extremely uncomfortable, weird, and even voyeuristic for the male patient.”

He noted that typically, male physicians use a chaperone when examining a female patient “for their own legal self-protection and maybe to make the female patient more comfortable, but female physicians are typically less concerned about potentially being accused of violating a male patient and typically do not have chaperones.”
 

Men face unique challenges

Men have “unique needs and challenges” when it comes to healthcare, said Mr. Brott, an advisory board member of the Men’s Health Network.

Mr. Brott cited research showing that men do not seek healthcare as frequently as women do. “So it’s already hard to get men in the door of a doctor, no matter what the provider’s gender is,” he said. Notably, men are even less likely to seek medical care when the clinician is female, owing to discomfort at having to undergo an intimate exam.

“I think that many men have issues about sexuality and of becoming aroused during an exam if it’s a female practitioner doing the exam,” said Mr. Brott. “I’m sure this is something physicians and nurses are accustomed to, but for the patient, it’s extremely embarrassing. The man may worry that he’ll be perceived as making unwanted sexual overtures to the practitioner.”

The way to mitigate these concerns is through communication, according to Mr. Brott. He recalled his own experience during a catherization conducted by a female practitioner he had never met. “She came in and started dealing with me as if I wasn’t even a person. She didn’t say much. It would have helped if she had created some type of human connection and talked to me – something like, ‘I’ve done this a thousand times and here’s what you’ll be feeling,’ or, “Would you like me to describe what I’m doing, or just do it as quickly as possible?’ ”

On another occasion, Mr. Brott underwent a procedure that was performed by two female practitioners, who were more communicative and even brought some light humor to the encounter, “which set me at ease,” he said.

If a man does become aroused, reassurance would be helpful, Mr. Brott said. “You can say something like, ‘Don’t worry, it’s perfectly natural, it happens all the time. Let’s finish up, and I’ll be out of your way as soon as I can.’ ”
 

Explain at every step of the way

All the experts emphasize the critical importance of continuing to offer explanations throughout the exam, even if the exam has been discussed beforehand.

“During the exam, it’s key to explain what you’re doing each step of the way – especially with seniors, but with other patients too,” said Arbaje. “For example, ‘I’d like you to remove your arms from your shirt so I can examine the joint better.’ Often there’s apprehension about what you’re going to do next. You can also ask, ‘Is there anything I should know before I examine this part of you? How are you doing?’ “ She advised asking the patient for “ongoing feedback. ‘Is this okay? Is this too rough?’ “

This is especially important when conducting a pelvic exam or palpating the patient’s abdomen, which is a more personal area than, say, the knee. Only the body part that is being examined should be uncovered, and it should be re-covered after the exam of that body part is complete and a different body part is to then be examined.

Asking for feedback is especially important, because many older patients have been acculturated not to question physicians and other medical authorities and may suffer a sense of humiliation silently.

Dr. Arbaje noted that feedback can be nonverbal: “For example, wincing or flinching are signs of discomfort you should ask the patient about or empathetically acknowledge.”
 

Rapport building doesn’t end after the examination

Dr. Arbaje advises physicians to “spend a little more time with the patient after the examination and not just walk out the door, leaving the person as they are, half undressed or in a gown.”

In the case of an older person, this might involve helping patients get their shoes and socks on or helping them get off the table. “Spend some time closing the encounter, not just doing what you need to do and then leaving or leaving it for someone else or family to do, which can be very dehumanizing,” she said. Even a few minutes of human contact beyond the examination can enhance rapport and help the patient feel respected and more comfortable.
 

Setting the stage: Create a conducive office environment

Setting patients at ease begins well before the patient enters the examination room, experts say. The overall atmosphere of the practice – the professionalism, courtesy, and friendliness of the staff – contributes to a sense of safety that will set the stage for the patient to feel more comfortable disrobing, if necessary, and being examined.

Mr. Brott pointed out that most medical offices tend to be more “female-friendly” in decor, utilizing pastel colors and flower motifs, for example, and displaying women’s magazines in the waiting room. Gender-neutral decor and different types of reading materials might set men at ease. Receptionists and medical staff are often female, and it is helpful for practices to employ male staff to bring the patient into the examination room or check vital signs. “This would go a long way toward making a man feel welcome and comfortable, even if the physician is female,” he said.

Dr. Radziejewski agreed: “If possible, having male and female support staff available will set patients of any gender at their ease.”

The setup of the examination room may contribute to a patient’s level of comfort. In Dr. Ransone’s examination room, the patient faces the door when on the table, and the door is locked during the exam so that no one can enter.

“I think that if patients are facing away from the door, they may feel claustrophobic or trapped, and I don’t want to position myself between the patient and an exit,” Dr. Ransone said. “My exam room happens to have no windows, but I’ve seen situations where the patient is lying on the table, exposed in front of the window, which can feel vulnerable, even if the office is on a high floor and no one can see into the window.”

Dr. Ransone positions the scribe or chaperone to the side, where the patient can see them, but not directly in front, where the examination might be visible to them. “I think it would be more uncomfortable and anxiety provoking knowing that someone is standing behind me and I can’t see them,” he said.
 

Choosing the best gown ... when necessary

Is it necessary for patients to disrobe and put on a gown — especially in light of the fact that research suggests that wearing a gown can induce psychological distress?

Danielle Ofri, MD, PhD, clinical professor, department of medicine, NYU Grossman School of Medicine, New York, said that in her practice, patients wear street clothes unless the patient is to undergo a full physical exam.

Even an abdominal exam can be conducted by loosening and slightly lowering the pants. Dr. Ofri stresses that patients should retain full control over how much to expose: “The patient should always take the lead in adjusting or opening clothing for a focused physical exam. And, of course, we always need to ask permission before starting any part of the exam.”

A gown is more conducive for certain exams, such as pelvic or breast exams. Dr. Ransone said that cloth gowns are preferable to paper gowns, which can tear more easily and so lead to unnecessary exposure. Gowns that hang open at the back should be avoided. If that’s the only type available, a second gown can be provided so as to cover the backside.

This is especially important if the examination involves walking across the room – for example, to evaluate gait – or standing on the scale. Alternatively, the patient can be given a sheet to drape over the gown, which can be moved around during the examination.

Dr. Ransome’s own practice uses gowns that fully wrap around the person. “I’ve seen too many people in gowns that are too small, so I make sure the patient has an appropriately sized gown. The extra material also leaves room for draping, while exposing only the part of the body that’s necessary,” he said.

Numerous types of modest gowns are now available, including kimono-type gowns with ties and snaps that allow partial exposure. All the experts encouraged utilizing these or similar types of gowns if possible.
 

Cultural and religious considerations

It is important for clinicians to be sensitive to cultural and religious factors that might affect patients’ attitudes toward attire and opposite-sex practitioners, said Dr. Ofri, an internist at Bellevue Hospital, New York.

For example, in Islamic and ultra-Orthodox Jewish traditions, certain parts of the body may not be exposed in the presence of a man who is unrelated by blood or marriage. Studies have shown that Hispanic and Asian women have avoided mammography because of embarrassment.

Dr. Arbaje described a 90-year-old patient whose physician ordered a pelvic ultrasound. The ultrasound department conducted the test transvaginally. “The patient, a widow, came from a Catholic background and regarded this as tantamount to ‘cheating’ on her deceased husband, and she felt violated and ashamed,” Dr. Arbaje said.

Dr. Ofri, who is the author of Medicine in Translation: Journeys With My Patients, said that she has Muslim and Orthodox Jewish male patients who allow her to examine their knees but won’t shake her hand because of the prohibition against touching an unrelated woman. Muslim female patients are willing to unsnap their veils because Dr. Ofri is female, but they would be uncomfortable with a male practitioner.

Whenever possible, gender-concordant care should be provided. If that is not possible, patients should be offered the option of not undergoing the examination, unless it’s an emergent situation, Dr. Ofri said. It may be necessary to reschedule the appointment to a time when a same-sex practitioner is available or to refer the patient to another practitioner.

Keeping cultural and religious considerations in mind is important, but there are variations in any given culture or religion. Practitioners should take cues directly from the patient, the experts advise.
 

Meeting the needs of cognitively impaired patients

Patients who are cognitively impaired have particular needs, Dr. Arbaje says. Many such patients are seniors with dementia, although developmental disabilities, neurodegenerative diseases, and other problems that affect cognition can occur among patients of any age and stage of life.

“People with dementia don’t necessarily understand what you’re doing and why you’re touching them. Even people with advanced dementia often retain a sense of modesty and may feel humiliated by an examination,” Dr. Arbaje said.

Dr. Arbaje encourages offering clear explanations of what is being done. The language one uses should be respectful and nonpatronizing, even if the patient does not understand what is being said. However, the bulk of one’s communication should be nonverbal. “Convey gentleness, safety, and reassurance through your tone and touch,” Dr. Arbaje said.

For cognitively impaired patient, it is helpful for a trusted family member or caregiver to be present during the examination, rather than a stranger. Depending on the degree of impairment, it might also be helpful for them to have a familiar object, perhaps a blanket; the odor and texture can convey familiarity and reassurance.

Nonclinical touch can also be reassuring. “We’re often scared of touching a patient because we don’t want to be considered inappropriate, but people who have dementia in later life are often understimulated, in terms of loving and caring touch,” she said. “For people in that situation, touch is typically of a practical or clinical nature – like bathing the person or taking their blood pressure. Providing reassuring touch or having someone else present to do so can help ease the patient’s fear and can be very healing.”
 

Making your patient’s eyes light up

“I can’t even count how many times I’ve had patients thank me for just explaining things clearly and giving them the right to opt out of wearing a gown or having an examination or procedure,” Dr. Radziejewski said.

“Obviously, I express recommendations, strong recommendations, but people like to know this is a place where they’ll be acknowledged for who they are, where they can feel safe and their dignity will be preserved. That should be the environment for any patient, whatever their culture, religion, age, background, or sexual identity. Offering that type of venue makes their eyes light up and makes all the difference in adherence to my recommendations and feeling empowered to truly care for their health,” she said.

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

Sterling Ransone Jr., MD, a family physician in Deltaville, Va., knocked on the exam room door and entered to find the patient, a 28-year-old woman, seated on the examination table. She was complaining about a fever, sore throat, and congestion.

Dr. Ransone asked if it was okay for him to lift her shirt and listen to her heart. She shook her head slightly. He decided to listen without removing the clothing, but when he put one hand on her shoulder and the stethoscope on her back, she flinched.

Instead of proceeding with the examination, Dr. Ransone, who is president-elect of the American Academy of Family Physicians, asked the patient whether everything was okay. It turned out that she had been the victim of a sexual assault and did not want a male to remove any clothing or touch her chest or back. Fortunately, Dr. Ransone’s practice had a female partner, who came in and listened to the patient’s chest.

“I’m glad I asked the patient what was going on for her because otherwise, I wouldn’t have known what she was going through,” Dr. Ransone said. “The patient felt respected and safe, and the therapeutic relationship was enhanced instead of compromised.”

Patient dignity is one of Dr. Ransone’s most important professional values. He recounts that during rounds in medical school, the attending and several interns and students crowded into the semiprivate room of an elderly woman who was lying in bed. The attending pulled off the bed covers, leaving the patient exposed while he discussed her case.

“I was mortified for her, and I learned a lot from watching this unfold, just seeing this woman lying naked in front all of these strangers and God,” said Dr. Ransone, physician practice director at Riverside Fishing Bay Family Practice, Deltaville, and assistant clinical professor of family medicine and population health at Virginia Commonwealth University, in Richmond. “I’ve been in practice for 25 years, and making sure the patient feels comfortable and respected is one of my priorities that dates back to that very first encounter.”
 

Trauma-informed care

Trauma is a common reason why patients feel reluctant to remove their clothing, according to Lauren Radziejewski, DNP, ANP-BC, clinical program manager, Mount Sinai Center for Transgender Medicine and Surgery, New York.

“We teach and endorse trauma-informed care for any type of procedure that is potentially triggering, and I would certainly put any type of care where people have to take off their clothes as potentially triggering,” she said.

Trauma can be caused by many factors. “Traumas of a sexual nature – having been subjected to sexual violence, for example – are the most obvious that come to mind, but any trauma that involves violation and disempowerment, even a nonsexual one, can make people more reluctant to be in a sensitive situation that can be perceived as invasive or disempowering,” Dr. Radziejewski said.
 

Talk before you touch

There are other reasons, often multiple intersecting reasons, why patients are reluctant to disrobe, according to Alicia Arbaje, MD, MPH, PhD, associate professor of medicine and director of transitional care research at the Center for Transformative Geriatrics Research, division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore. These include culture and religion, generational sensitivities, and body discomfort associated with transitional times in life (e.g., teen or menopausal years).

Some general approaches apply, regardless of the reason for the patient’s discomfort. Others are specific to the patient’s particular problem or concern, Dr. Arbaje said.

“So much of medicine in this day and age is to quickly get down to business, hurry, and move on to the next patient,” said Dr. Arbaje, who also serves as chair of the American Geriatric Society’s Public Education Committee. “But establishing a little bit of a relationship is crucial before beginning the physical exam with any patient, especially with seniors or other patients who might have particular discomforts.”

She advises practitioners to “spend time talking before touching.” In other words, “Find a way to create some kind of meeting, even very briefly, and establish rapport before the patient changes into a gown and before you touch the patient to examine him or her.”

She acknowledged this might be difficult to do in certain clinical settings, but “to whatever extent you can, try to build this extra time and extra step into your workflow.”

She suggested that physicians first meet with the patient in the office or examining room to hear about his or her concerns. If a gown is necessary, the patient can change into one after the physician leaves the room. This builds trust and rapport.

Choice of language is important, especially when talking with older individuals. “Address the patient by their title until you are told not to – Ms. or Mrs. Smith, or Mr. Jones – or ask, ‘How would you like to be addressed?’ And don’t use terms of endearment, like ‘dear’ or ‘sweetie,’ or the plural, such as ‘How are we feeling today?’ “ These are “infantilizing and patronizing” and can impact the patient’s level of comfort with the entire appointment, including undressing and being examined.

Regarding transgender people, “many have experienced sexual violence and inappropriate touching, but even those fortunate enough to have escaped that type of common problem typically have still undergone traumatic experiences just by being transgender, having been socialized incorrectly, misunderstood, or having the ‘wrong’ genitalia,” said Dr. Radziejewski.

Particularly when dealing with a transgender patient, “you have to assume that there may be a history of trauma. Be sensitive to the patient’s discomforts about disrobing, recognize the examination itself as a potential trigger, and take appropriate measures to mitigate the trauma.”

To do this, Dr. Radziejewski gives her patients a “menu of options,” because “when people are navigating the world after trauma, including marginalized identity, they often have a complete loss of control, so the key is to give them as much control as possible every step of the way.”

For example, Dr. Radziejewski might tell a transgender masculine patient, “I’m looking through your chart and see no documented Pap test.” She acknowledges that after explaining why the test is recommended, the patient might be uncomfortable with it. She then makes a series of suggestions that range from being completely noninvasive to more invasive.

“You can say you don’t want it at all, or you can take a swab that I will give you and do it in the bathroom yourself. If you’re more comfortable with a man performing it, I can arrange that, or if you’re more comfortable with someone other than myself – your regular provider – I can arrange that, too.” By the end of the interaction, most patients are comfortable with Dr. Radziejewski performing the exam.

Regarding invasive exams, she recommends setting up an appointment specifically dedicated to that exam, rather than trying to cram a sensitive process into the time allotted for a patent visit, when other topics are also being discussed. “This also reinforces a sense of control,” she said.

This approach is relevant not only for transgender patients but also for any patient who has experienced trauma or some type of shame associated with the body, she said.

Dr. Ransone asks transgender patients what pronoun they would like him to use when he addresses them.

Prior to the examination, talking about what will be done and why further enhances trust, comfort, and rapport.
 

Who should be present?

Dr. Arbaje suggested that the pre-examination conversation should include a discussion of who the patient would like to have present during the exam. This is particularly relevant with a geriatric patient who might have been brought in by a family member or caregiver.

Similarly, adolescents may not feel comfortable with a parent being present for an examination. To protect the teen’s privacy, Dr. Ransone asks parents to step out. “There are also subjects that adolescents won’t bring up if their parents are there,” he said.

A question that is relevant in many clinical settings is whether the presence of a chaperone enhances or detracts from the patient’s comfort. Although the use of chaperones is recommended by many societies, it is a judgment call whether a chaperone should be present during all examinations – unless the state in which one practices requires it. Seven states mandate the presence of a chaperone during an intimate exam: Alabama, Delaware, Georgia, Montana, New Jersey, Ohio, and Tennessee.

Dr. Ransone utilizes a medical scribe to take notes on patient visits. The nurse or medical assistant who escorts the patient into the exam room informs the patient that a scribe will be in the room but that the patient should feel free to say whether he or she wants to talk about something privately, in which case the scribe will leave.

Dr. Ransone’s scribe is female and serves as the chaperone during an intimate exam of a female patient. “I have assumed, and my established patients know, that there will be a chaperone present, but my patients also know they can ask for the chaperone to step out,” he said. “When that happens, I document the discussion in the patient’s chart for my own legal protection.”

He recommended that practices consider posting signage or including information about chaperones in the practice’s informational brochures regarding policies and procedures.

Armin Brott, MBA, senior editor of Talking About Men’s Health , said that having a chaperone in the room when a female practitioner is examining a male patient – even if the chaperone is male – would be “extremely uncomfortable, weird, and even voyeuristic for the male patient.”

He noted that typically, male physicians use a chaperone when examining a female patient “for their own legal self-protection and maybe to make the female patient more comfortable, but female physicians are typically less concerned about potentially being accused of violating a male patient and typically do not have chaperones.”
 

Men face unique challenges

Men have “unique needs and challenges” when it comes to healthcare, said Mr. Brott, an advisory board member of the Men’s Health Network.

Mr. Brott cited research showing that men do not seek healthcare as frequently as women do. “So it’s already hard to get men in the door of a doctor, no matter what the provider’s gender is,” he said. Notably, men are even less likely to seek medical care when the clinician is female, owing to discomfort at having to undergo an intimate exam.

“I think that many men have issues about sexuality and of becoming aroused during an exam if it’s a female practitioner doing the exam,” said Mr. Brott. “I’m sure this is something physicians and nurses are accustomed to, but for the patient, it’s extremely embarrassing. The man may worry that he’ll be perceived as making unwanted sexual overtures to the practitioner.”

The way to mitigate these concerns is through communication, according to Mr. Brott. He recalled his own experience during a catherization conducted by a female practitioner he had never met. “She came in and started dealing with me as if I wasn’t even a person. She didn’t say much. It would have helped if she had created some type of human connection and talked to me – something like, ‘I’ve done this a thousand times and here’s what you’ll be feeling,’ or, “Would you like me to describe what I’m doing, or just do it as quickly as possible?’ ”

On another occasion, Mr. Brott underwent a procedure that was performed by two female practitioners, who were more communicative and even brought some light humor to the encounter, “which set me at ease,” he said.

If a man does become aroused, reassurance would be helpful, Mr. Brott said. “You can say something like, ‘Don’t worry, it’s perfectly natural, it happens all the time. Let’s finish up, and I’ll be out of your way as soon as I can.’ ”
 

Explain at every step of the way

All the experts emphasize the critical importance of continuing to offer explanations throughout the exam, even if the exam has been discussed beforehand.

“During the exam, it’s key to explain what you’re doing each step of the way – especially with seniors, but with other patients too,” said Arbaje. “For example, ‘I’d like you to remove your arms from your shirt so I can examine the joint better.’ Often there’s apprehension about what you’re going to do next. You can also ask, ‘Is there anything I should know before I examine this part of you? How are you doing?’ “ She advised asking the patient for “ongoing feedback. ‘Is this okay? Is this too rough?’ “

This is especially important when conducting a pelvic exam or palpating the patient’s abdomen, which is a more personal area than, say, the knee. Only the body part that is being examined should be uncovered, and it should be re-covered after the exam of that body part is complete and a different body part is to then be examined.

Asking for feedback is especially important, because many older patients have been acculturated not to question physicians and other medical authorities and may suffer a sense of humiliation silently.

Dr. Arbaje noted that feedback can be nonverbal: “For example, wincing or flinching are signs of discomfort you should ask the patient about or empathetically acknowledge.”
 

Rapport building doesn’t end after the examination

Dr. Arbaje advises physicians to “spend a little more time with the patient after the examination and not just walk out the door, leaving the person as they are, half undressed or in a gown.”

In the case of an older person, this might involve helping patients get their shoes and socks on or helping them get off the table. “Spend some time closing the encounter, not just doing what you need to do and then leaving or leaving it for someone else or family to do, which can be very dehumanizing,” she said. Even a few minutes of human contact beyond the examination can enhance rapport and help the patient feel respected and more comfortable.
 

Setting the stage: Create a conducive office environment

Setting patients at ease begins well before the patient enters the examination room, experts say. The overall atmosphere of the practice – the professionalism, courtesy, and friendliness of the staff – contributes to a sense of safety that will set the stage for the patient to feel more comfortable disrobing, if necessary, and being examined.

Mr. Brott pointed out that most medical offices tend to be more “female-friendly” in decor, utilizing pastel colors and flower motifs, for example, and displaying women’s magazines in the waiting room. Gender-neutral decor and different types of reading materials might set men at ease. Receptionists and medical staff are often female, and it is helpful for practices to employ male staff to bring the patient into the examination room or check vital signs. “This would go a long way toward making a man feel welcome and comfortable, even if the physician is female,” he said.

Dr. Radziejewski agreed: “If possible, having male and female support staff available will set patients of any gender at their ease.”

The setup of the examination room may contribute to a patient’s level of comfort. In Dr. Ransone’s examination room, the patient faces the door when on the table, and the door is locked during the exam so that no one can enter.

“I think that if patients are facing away from the door, they may feel claustrophobic or trapped, and I don’t want to position myself between the patient and an exit,” Dr. Ransone said. “My exam room happens to have no windows, but I’ve seen situations where the patient is lying on the table, exposed in front of the window, which can feel vulnerable, even if the office is on a high floor and no one can see into the window.”

Dr. Ransone positions the scribe or chaperone to the side, where the patient can see them, but not directly in front, where the examination might be visible to them. “I think it would be more uncomfortable and anxiety provoking knowing that someone is standing behind me and I can’t see them,” he said.
 

Choosing the best gown ... when necessary

Is it necessary for patients to disrobe and put on a gown — especially in light of the fact that research suggests that wearing a gown can induce psychological distress?

Danielle Ofri, MD, PhD, clinical professor, department of medicine, NYU Grossman School of Medicine, New York, said that in her practice, patients wear street clothes unless the patient is to undergo a full physical exam.

Even an abdominal exam can be conducted by loosening and slightly lowering the pants. Dr. Ofri stresses that patients should retain full control over how much to expose: “The patient should always take the lead in adjusting or opening clothing for a focused physical exam. And, of course, we always need to ask permission before starting any part of the exam.”

A gown is more conducive for certain exams, such as pelvic or breast exams. Dr. Ransone said that cloth gowns are preferable to paper gowns, which can tear more easily and so lead to unnecessary exposure. Gowns that hang open at the back should be avoided. If that’s the only type available, a second gown can be provided so as to cover the backside.

This is especially important if the examination involves walking across the room – for example, to evaluate gait – or standing on the scale. Alternatively, the patient can be given a sheet to drape over the gown, which can be moved around during the examination.

Dr. Ransome’s own practice uses gowns that fully wrap around the person. “I’ve seen too many people in gowns that are too small, so I make sure the patient has an appropriately sized gown. The extra material also leaves room for draping, while exposing only the part of the body that’s necessary,” he said.

Numerous types of modest gowns are now available, including kimono-type gowns with ties and snaps that allow partial exposure. All the experts encouraged utilizing these or similar types of gowns if possible.
 

Cultural and religious considerations

It is important for clinicians to be sensitive to cultural and religious factors that might affect patients’ attitudes toward attire and opposite-sex practitioners, said Dr. Ofri, an internist at Bellevue Hospital, New York.

For example, in Islamic and ultra-Orthodox Jewish traditions, certain parts of the body may not be exposed in the presence of a man who is unrelated by blood or marriage. Studies have shown that Hispanic and Asian women have avoided mammography because of embarrassment.

Dr. Arbaje described a 90-year-old patient whose physician ordered a pelvic ultrasound. The ultrasound department conducted the test transvaginally. “The patient, a widow, came from a Catholic background and regarded this as tantamount to ‘cheating’ on her deceased husband, and she felt violated and ashamed,” Dr. Arbaje said.

Dr. Ofri, who is the author of Medicine in Translation: Journeys With My Patients, said that she has Muslim and Orthodox Jewish male patients who allow her to examine their knees but won’t shake her hand because of the prohibition against touching an unrelated woman. Muslim female patients are willing to unsnap their veils because Dr. Ofri is female, but they would be uncomfortable with a male practitioner.

Whenever possible, gender-concordant care should be provided. If that is not possible, patients should be offered the option of not undergoing the examination, unless it’s an emergent situation, Dr. Ofri said. It may be necessary to reschedule the appointment to a time when a same-sex practitioner is available or to refer the patient to another practitioner.

Keeping cultural and religious considerations in mind is important, but there are variations in any given culture or religion. Practitioners should take cues directly from the patient, the experts advise.
 

Meeting the needs of cognitively impaired patients

Patients who are cognitively impaired have particular needs, Dr. Arbaje says. Many such patients are seniors with dementia, although developmental disabilities, neurodegenerative diseases, and other problems that affect cognition can occur among patients of any age and stage of life.

“People with dementia don’t necessarily understand what you’re doing and why you’re touching them. Even people with advanced dementia often retain a sense of modesty and may feel humiliated by an examination,” Dr. Arbaje said.

Dr. Arbaje encourages offering clear explanations of what is being done. The language one uses should be respectful and nonpatronizing, even if the patient does not understand what is being said. However, the bulk of one’s communication should be nonverbal. “Convey gentleness, safety, and reassurance through your tone and touch,” Dr. Arbaje said.

For cognitively impaired patient, it is helpful for a trusted family member or caregiver to be present during the examination, rather than a stranger. Depending on the degree of impairment, it might also be helpful for them to have a familiar object, perhaps a blanket; the odor and texture can convey familiarity and reassurance.

Nonclinical touch can also be reassuring. “We’re often scared of touching a patient because we don’t want to be considered inappropriate, but people who have dementia in later life are often understimulated, in terms of loving and caring touch,” she said. “For people in that situation, touch is typically of a practical or clinical nature – like bathing the person or taking their blood pressure. Providing reassuring touch or having someone else present to do so can help ease the patient’s fear and can be very healing.”
 

Making your patient’s eyes light up

“I can’t even count how many times I’ve had patients thank me for just explaining things clearly and giving them the right to opt out of wearing a gown or having an examination or procedure,” Dr. Radziejewski said.

“Obviously, I express recommendations, strong recommendations, but people like to know this is a place where they’ll be acknowledged for who they are, where they can feel safe and their dignity will be preserved. That should be the environment for any patient, whatever their culture, religion, age, background, or sexual identity. Offering that type of venue makes their eyes light up and makes all the difference in adherence to my recommendations and feeling empowered to truly care for their health,” she said.

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

The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.

Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.

“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.

The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.

The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.

Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.

“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”

The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.

The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.

In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.

The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.

Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.

A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.

“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.

Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.

A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.

ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.

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

The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.

Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.

“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.

The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.

The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.

Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.

“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”

The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.

The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.

In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.

The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.

Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.

A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.

“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.

Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.

A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.

ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.

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

The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.

Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.

“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.

The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.

The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.

Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.

“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”

The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.

The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.

In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.

The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.

Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.

A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.

“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.

Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.

A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.

ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.

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

Most people think of alcohol-level testers, commonly called Breathalyzers, as tools for measuring alcohol when someone exhales. But scientists have taken the technology well beyond DUI checkpoints, aiming it instead at detecting diseases.

The breath of someone who is sick often has a chemical profile that is specific to their health condition. Methane in a person’s exhalations, for example, could signal an intestinal issue. If these chemical profiles can be matched to specific illnesses, then these testing devices could become handy screening tools for some conditions.

But existing devices typically detect only a single compound, with results taking 10 minutes or more, leading to a quest for faster devices that can identify more chemicals at the same time. Researchers have turned to a tool called a frequency comb to solve this problem.

This tool, first developed in 2008, pings breath samples with laser pulses in distinct frequency ranges of the light spectrum, separated like the teeth of a comb. Every mini-cloud of droplets we exhale contains over 1,000 compounds. When researchers send the pulses through these exhaled droplets, each chemical absorbs the light in its own specific pattern, creating a light “signature.”

In a study published in the Proceedings of the National Academy of Sciences investigators report that an updated version of the frequency comb can detect at least four and possibly up to 10 compounds linked to a health condition. In addition to accurately sorting out methane, methanol, and two chemical forms of water in breath, the combs also might be able to identify formaldehyde and ammonia, among others.

Before frequency combs become common in the clinic, though, a few steps remain. Scientists must link chemical profiles to specific diseases and find a way to make a compact version of the combs. If all goes well, the result could be a device capable of rapid, inexpensive screening for some diseases, with no need for lab testing, which would be especially welcome where testing facilities are scarce.

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

Most people think of alcohol-level testers, commonly called Breathalyzers, as tools for measuring alcohol when someone exhales. But scientists have taken the technology well beyond DUI checkpoints, aiming it instead at detecting diseases.

The breath of someone who is sick often has a chemical profile that is specific to their health condition. Methane in a person’s exhalations, for example, could signal an intestinal issue. If these chemical profiles can be matched to specific illnesses, then these testing devices could become handy screening tools for some conditions.

But existing devices typically detect only a single compound, with results taking 10 minutes or more, leading to a quest for faster devices that can identify more chemicals at the same time. Researchers have turned to a tool called a frequency comb to solve this problem.

This tool, first developed in 2008, pings breath samples with laser pulses in distinct frequency ranges of the light spectrum, separated like the teeth of a comb. Every mini-cloud of droplets we exhale contains over 1,000 compounds. When researchers send the pulses through these exhaled droplets, each chemical absorbs the light in its own specific pattern, creating a light “signature.”

In a study published in the Proceedings of the National Academy of Sciences investigators report that an updated version of the frequency comb can detect at least four and possibly up to 10 compounds linked to a health condition. In addition to accurately sorting out methane, methanol, and two chemical forms of water in breath, the combs also might be able to identify formaldehyde and ammonia, among others.

Before frequency combs become common in the clinic, though, a few steps remain. Scientists must link chemical profiles to specific diseases and find a way to make a compact version of the combs. If all goes well, the result could be a device capable of rapid, inexpensive screening for some diseases, with no need for lab testing, which would be especially welcome where testing facilities are scarce.

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

Most people think of alcohol-level testers, commonly called Breathalyzers, as tools for measuring alcohol when someone exhales. But scientists have taken the technology well beyond DUI checkpoints, aiming it instead at detecting diseases.

The breath of someone who is sick often has a chemical profile that is specific to their health condition. Methane in a person’s exhalations, for example, could signal an intestinal issue. If these chemical profiles can be matched to specific illnesses, then these testing devices could become handy screening tools for some conditions.

But existing devices typically detect only a single compound, with results taking 10 minutes or more, leading to a quest for faster devices that can identify more chemicals at the same time. Researchers have turned to a tool called a frequency comb to solve this problem.

This tool, first developed in 2008, pings breath samples with laser pulses in distinct frequency ranges of the light spectrum, separated like the teeth of a comb. Every mini-cloud of droplets we exhale contains over 1,000 compounds. When researchers send the pulses through these exhaled droplets, each chemical absorbs the light in its own specific pattern, creating a light “signature.”

In a study published in the Proceedings of the National Academy of Sciences investigators report that an updated version of the frequency comb can detect at least four and possibly up to 10 compounds linked to a health condition. In addition to accurately sorting out methane, methanol, and two chemical forms of water in breath, the combs also might be able to identify formaldehyde and ammonia, among others.

Before frequency combs become common in the clinic, though, a few steps remain. Scientists must link chemical profiles to specific diseases and find a way to make a compact version of the combs. If all goes well, the result could be a device capable of rapid, inexpensive screening for some diseases, with no need for lab testing, which would be especially welcome where testing facilities are scarce.

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

Background: Geographic cohorting localizes hospitalist teams to a single unit. It has previously been shown to improve outcomes.

An important limitation of this study is that the investigators did not evaluate clinical outcomes or provider satisfaction. This may give some pause to the widespread push toward geographic cohorting.

Bottom line: More frequent interruptions may partially offset potential increases in patient-hospitalist interactions achieved through geographic cohorting.

Citation: Kara A et al. A time motion study evaluating the impact of geographic cohorting of hospitalists. J Hosp Med. 2020;15:338-44.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

Background: Geographic cohorting localizes hospitalist teams to a single unit. It has previously been shown to improve outcomes.

An important limitation of this study is that the investigators did not evaluate clinical outcomes or provider satisfaction. This may give some pause to the widespread push toward geographic cohorting.

Bottom line: More frequent interruptions may partially offset potential increases in patient-hospitalist interactions achieved through geographic cohorting.

Citation: Kara A et al. A time motion study evaluating the impact of geographic cohorting of hospitalists. J Hosp Med. 2020;15:338-44.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

Background: Geographic cohorting localizes hospitalist teams to a single unit. It has previously been shown to improve outcomes.

An important limitation of this study is that the investigators did not evaluate clinical outcomes or provider satisfaction. This may give some pause to the widespread push toward geographic cohorting.

Bottom line: More frequent interruptions may partially offset potential increases in patient-hospitalist interactions achieved through geographic cohorting.

Citation: Kara A et al. A time motion study evaluating the impact of geographic cohorting of hospitalists. J Hosp Med. 2020;15:338-44.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

It’s difficult enough when a patient’s prostate is removed because of cancer. But it’s another thing altogether when the prostate is removed because of a medical error, as a report on 3 CBS Philly, among other news outlets, makes clear.

The patient, Eric Spangs, lives in southeastern Pennsylvania. Testing indicated an elevation in prostate-specific antigen (PSA) level. He subsequently underwent biopsy of the prostate, which appeared to indicate cancer. In time, though, Mr. Spangs learned there had been an error: the tissue section used in the microscopic diagnosis had come from the biopsy specimen of a different patient. Mr. Spangs himself didn’t actually have cancer.

Ordinarily, such news would be cause for celebration. But this was far from a normal situ ation: Following his initial cancer diagnosis, Mr. Spangs underwent a radical laparoscopic prostatectomy at a local hospital. The fact that he was now judged to be cancer free was of little consolation, especially in light of the effects of his surgery, which included urinary leakage and erectile dysfunction.

“It’s devastated me emotionally and physically,” Mr. Spangs said. It has also been emotionally devastating for his wife, Melissa. (The couple has five children.)

Their attorney, Aaron Freiwald, has filed a suit against the health system to which the local hospital belongs and the area’s largest urologic practice.

The Spangs wish to caution other patients not to make the same mistake they did: they failed to get a second opinion from an oncology specialist, as recommended by the American Cancer Society. (Eric Spangs did receive a second opinion from someone at the urologic practice, but that practice doesn’t specialize in oncology.)

The Spangs also worry about the patient who received the false-negative biopsy result. They have been assured, however, that that patient will be properly notified of his actual cancer status.
 

Fertility specialist uses own sperm to impregnate patients

A suit claims that a Rochester, N.Y., gynecologist and fertility specialist used his own sperm to inseminate multiple patients, according to a story reported by the Associated Press and other news outlets.

The suit was filed last month by the daughter — call her “Harriet Jones” — of one of the women who received fertility services from the doctor during the 1980s. Ms. Jones’s suit alleges that at the time, the doctor told her mother that the sperm donor would be a medical student at the University of Rochester. In fact, the donor was the doctor himself. He kept that fact a secret for years, even after Ms. Jones — his own daughter — sought him out for gynecologic services.

The secret gradually began to come to light in 2016, when Ms. Jones’s nonbiological father — the man who had helped to raise her — died. Curious about her biological father, Ms. Jones sought to learn his identity from the Rochester gynecologist who had treated her mother and was now her own gynecologist. The doctor said he couldn’t be of help; he claimed he hadn’t kept the relevant records.

Ms. Jones then submitted a blood sample to a direct-to-consumer genetic testing company. The results surprised her: Not only did she learn of her ethnicity, but she also discovered the existence of two half siblings, who were donor-conceived in 1984 and 1985, respectively, the very period when her own mother was undergoing insemination procedures. Ms. Jones subsequently discovered the existence of additional half siblings, all born in the first half of the 1980s.

Initially elated by the discoveries, Ms. Jones soon grew despondent and anxious. She suffered from migraine headaches, among other symptoms. Her biological father, it seemed, had been “a serial sperm donor.”

Still, she continued to go to her Rochester doctor for treatment, having no reason to suspect anything untoward about him. Her visits, including those for prolonged menstrual bleeding, involved routine breast and pelvic exams, transvaginal ultrasounds, and intrauterine contraceptive placements under sedation.

Over this period, her doctor was friendly, asking her a variety of questions about her personal life. During one especially strange visit, however, he began chuckling and said, “You’re a really good kid, such a good kid.” During this visit, he invited his wife into the exam room, presumably to meet Ms. Jones.

It was at this moment that Ms. Jones had a revelation: Could her gynecologist actually be her biological father?

In May 2021, Ms. Jones and a half brother with whom she had been in touch contacted the gynecologist’s daughter from his first marriage. All three underwent genetic testing. The results showed a 99.99% chance of a genetic link.

Ms. Jones has said in her suit that “no reasonable woman” would have submitted to pelvic examinations and other examinations by a doctor whom she knew to be her father.

Besides fraud, her suit alleges medical malpractice, battery, infliction of mental distress, and lack of informed consent. She is seeking compensation for all harm caused to her, including past and future economic damages, past unreimbursed medical expenses, and future expenses related to her mental health treatment and care.

The story included no further details about the civil litigation. As for criminal charges, it’s unlikely Ms. Jones’s biological father — her gynecologist — will face criminal charges for his alleged crimes because they fall outside of the state’s statute of limitations.
 

Parents say daughter’s stroke wasn’t identified

The Georgia parents of a young woman who died from a stroke following a series of alleged misdiagnoses are suing multiple practitioners, reports Legal Newswire and other news outlets

In June 2019, Michaela Smith was training for her job as a detention officer when she began experiencing a variety of symptoms, including headache, shortness of breath, throat swelling, and slurred speech. She was taken to the emergency department (ED) at Hamilton Medical Center, in Dalton, Ga.

There, she was examined by an attending ED doctor, who ordered a CT scan. The results were read by radiologist Michael J. Cooney, MD. In his reading, the Smith family’s lawsuit alleges, Dr. Cooney failed to identify the basilar artery sign, which is a key indicator of a vessel occlusion in stroke patients. Dr. Cooney concluded that Ms. Smith’s scan showed no acute intracranial abnormality. He sent her home without further discharge instructions.

At home, Ms. Smith fell asleep but awoke in an altered mental state, one of several classic stroke symptoms that she had been experiencing. She returned to the ED. This time, she was examined by David F. Hawkins, MD, an ED physician. Although his differential diagnosis identified Ms. Smith’s symptoms as most likely stroke related, Dr. Hawkins allegedly failed to immediately corroborate his findings with additional vascular imaging. Later in the day, Ms. Smith did undergo an MRI, which a second radiologist, Kevin F. Johnson, MD, misread as showing no signs of ischemia in her basilar artery, according to the lawsuit.

That same day, Dr. Hawkins conferred with a second neurologist, Jeffrey T. Glass, MD, who recommended that Ms. Smith be admitted to the hospital because of her deteriorating condition. The Smiths’ suit claims that Dr. Glass also failed to diagnosis their daughter’s underlying condition, although he did sign off on her transfer to Baroness Erlanger Hospital, in Chattanooga, Tenn.

There, Ms. Smith’s condition continued to worsen. She soon required mechanical ventilation and tube feeding. On July 3, 2019, she was pronounced dead.

“This is an egregious case of negligence,” said the attorney representing the Smiths, who are suing the physicians involved and their practices, as well as Hamilton Medical Center and several unnamed defendants.

“Although two radiology studies and her clinical presentation indicated that Michaela was having a catastrophic stroke, her doctors repeatedly misread the studies as normal, failed to diagnose the stroke, and failed to treat her deficits as a neurological emergency,” the family’s lawyer stated.

At press time, there had been no response from any of the defendants or their attorneys.

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

It’s difficult enough when a patient’s prostate is removed because of cancer. But it’s another thing altogether when the prostate is removed because of a medical error, as a report on 3 CBS Philly, among other news outlets, makes clear.

The patient, Eric Spangs, lives in southeastern Pennsylvania. Testing indicated an elevation in prostate-specific antigen (PSA) level. He subsequently underwent biopsy of the prostate, which appeared to indicate cancer. In time, though, Mr. Spangs learned there had been an error: the tissue section used in the microscopic diagnosis had come from the biopsy specimen of a different patient. Mr. Spangs himself didn’t actually have cancer.

Ordinarily, such news would be cause for celebration. But this was far from a normal situ ation: Following his initial cancer diagnosis, Mr. Spangs underwent a radical laparoscopic prostatectomy at a local hospital. The fact that he was now judged to be cancer free was of little consolation, especially in light of the effects of his surgery, which included urinary leakage and erectile dysfunction.

“It’s devastated me emotionally and physically,” Mr. Spangs said. It has also been emotionally devastating for his wife, Melissa. (The couple has five children.)

Their attorney, Aaron Freiwald, has filed a suit against the health system to which the local hospital belongs and the area’s largest urologic practice.

The Spangs wish to caution other patients not to make the same mistake they did: they failed to get a second opinion from an oncology specialist, as recommended by the American Cancer Society. (Eric Spangs did receive a second opinion from someone at the urologic practice, but that practice doesn’t specialize in oncology.)

The Spangs also worry about the patient who received the false-negative biopsy result. They have been assured, however, that that patient will be properly notified of his actual cancer status.
 

Fertility specialist uses own sperm to impregnate patients

A suit claims that a Rochester, N.Y., gynecologist and fertility specialist used his own sperm to inseminate multiple patients, according to a story reported by the Associated Press and other news outlets.

The suit was filed last month by the daughter — call her “Harriet Jones” — of one of the women who received fertility services from the doctor during the 1980s. Ms. Jones’s suit alleges that at the time, the doctor told her mother that the sperm donor would be a medical student at the University of Rochester. In fact, the donor was the doctor himself. He kept that fact a secret for years, even after Ms. Jones — his own daughter — sought him out for gynecologic services.

The secret gradually began to come to light in 2016, when Ms. Jones’s nonbiological father — the man who had helped to raise her — died. Curious about her biological father, Ms. Jones sought to learn his identity from the Rochester gynecologist who had treated her mother and was now her own gynecologist. The doctor said he couldn’t be of help; he claimed he hadn’t kept the relevant records.

Ms. Jones then submitted a blood sample to a direct-to-consumer genetic testing company. The results surprised her: Not only did she learn of her ethnicity, but she also discovered the existence of two half siblings, who were donor-conceived in 1984 and 1985, respectively, the very period when her own mother was undergoing insemination procedures. Ms. Jones subsequently discovered the existence of additional half siblings, all born in the first half of the 1980s.

Initially elated by the discoveries, Ms. Jones soon grew despondent and anxious. She suffered from migraine headaches, among other symptoms. Her biological father, it seemed, had been “a serial sperm donor.”

Still, she continued to go to her Rochester doctor for treatment, having no reason to suspect anything untoward about him. Her visits, including those for prolonged menstrual bleeding, involved routine breast and pelvic exams, transvaginal ultrasounds, and intrauterine contraceptive placements under sedation.

Over this period, her doctor was friendly, asking her a variety of questions about her personal life. During one especially strange visit, however, he began chuckling and said, “You’re a really good kid, such a good kid.” During this visit, he invited his wife into the exam room, presumably to meet Ms. Jones.

It was at this moment that Ms. Jones had a revelation: Could her gynecologist actually be her biological father?

In May 2021, Ms. Jones and a half brother with whom she had been in touch contacted the gynecologist’s daughter from his first marriage. All three underwent genetic testing. The results showed a 99.99% chance of a genetic link.

Ms. Jones has said in her suit that “no reasonable woman” would have submitted to pelvic examinations and other examinations by a doctor whom she knew to be her father.

Besides fraud, her suit alleges medical malpractice, battery, infliction of mental distress, and lack of informed consent. She is seeking compensation for all harm caused to her, including past and future economic damages, past unreimbursed medical expenses, and future expenses related to her mental health treatment and care.

The story included no further details about the civil litigation. As for criminal charges, it’s unlikely Ms. Jones’s biological father — her gynecologist — will face criminal charges for his alleged crimes because they fall outside of the state’s statute of limitations.
 

Parents say daughter’s stroke wasn’t identified

The Georgia parents of a young woman who died from a stroke following a series of alleged misdiagnoses are suing multiple practitioners, reports Legal Newswire and other news outlets

In June 2019, Michaela Smith was training for her job as a detention officer when she began experiencing a variety of symptoms, including headache, shortness of breath, throat swelling, and slurred speech. She was taken to the emergency department (ED) at Hamilton Medical Center, in Dalton, Ga.

There, she was examined by an attending ED doctor, who ordered a CT scan. The results were read by radiologist Michael J. Cooney, MD. In his reading, the Smith family’s lawsuit alleges, Dr. Cooney failed to identify the basilar artery sign, which is a key indicator of a vessel occlusion in stroke patients. Dr. Cooney concluded that Ms. Smith’s scan showed no acute intracranial abnormality. He sent her home without further discharge instructions.

At home, Ms. Smith fell asleep but awoke in an altered mental state, one of several classic stroke symptoms that she had been experiencing. She returned to the ED. This time, she was examined by David F. Hawkins, MD, an ED physician. Although his differential diagnosis identified Ms. Smith’s symptoms as most likely stroke related, Dr. Hawkins allegedly failed to immediately corroborate his findings with additional vascular imaging. Later in the day, Ms. Smith did undergo an MRI, which a second radiologist, Kevin F. Johnson, MD, misread as showing no signs of ischemia in her basilar artery, according to the lawsuit.

That same day, Dr. Hawkins conferred with a second neurologist, Jeffrey T. Glass, MD, who recommended that Ms. Smith be admitted to the hospital because of her deteriorating condition. The Smiths’ suit claims that Dr. Glass also failed to diagnosis their daughter’s underlying condition, although he did sign off on her transfer to Baroness Erlanger Hospital, in Chattanooga, Tenn.

There, Ms. Smith’s condition continued to worsen. She soon required mechanical ventilation and tube feeding. On July 3, 2019, she was pronounced dead.

“This is an egregious case of negligence,” said the attorney representing the Smiths, who are suing the physicians involved and their practices, as well as Hamilton Medical Center and several unnamed defendants.

“Although two radiology studies and her clinical presentation indicated that Michaela was having a catastrophic stroke, her doctors repeatedly misread the studies as normal, failed to diagnose the stroke, and failed to treat her deficits as a neurological emergency,” the family’s lawyer stated.

At press time, there had been no response from any of the defendants or their attorneys.

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

It’s difficult enough when a patient’s prostate is removed because of cancer. But it’s another thing altogether when the prostate is removed because of a medical error, as a report on 3 CBS Philly, among other news outlets, makes clear.

The patient, Eric Spangs, lives in southeastern Pennsylvania. Testing indicated an elevation in prostate-specific antigen (PSA) level. He subsequently underwent biopsy of the prostate, which appeared to indicate cancer. In time, though, Mr. Spangs learned there had been an error: the tissue section used in the microscopic diagnosis had come from the biopsy specimen of a different patient. Mr. Spangs himself didn’t actually have cancer.

Ordinarily, such news would be cause for celebration. But this was far from a normal situ ation: Following his initial cancer diagnosis, Mr. Spangs underwent a radical laparoscopic prostatectomy at a local hospital. The fact that he was now judged to be cancer free was of little consolation, especially in light of the effects of his surgery, which included urinary leakage and erectile dysfunction.

“It’s devastated me emotionally and physically,” Mr. Spangs said. It has also been emotionally devastating for his wife, Melissa. (The couple has five children.)

Their attorney, Aaron Freiwald, has filed a suit against the health system to which the local hospital belongs and the area’s largest urologic practice.

The Spangs wish to caution other patients not to make the same mistake they did: they failed to get a second opinion from an oncology specialist, as recommended by the American Cancer Society. (Eric Spangs did receive a second opinion from someone at the urologic practice, but that practice doesn’t specialize in oncology.)

The Spangs also worry about the patient who received the false-negative biopsy result. They have been assured, however, that that patient will be properly notified of his actual cancer status.
 

Fertility specialist uses own sperm to impregnate patients

A suit claims that a Rochester, N.Y., gynecologist and fertility specialist used his own sperm to inseminate multiple patients, according to a story reported by the Associated Press and other news outlets.

The suit was filed last month by the daughter — call her “Harriet Jones” — of one of the women who received fertility services from the doctor during the 1980s. Ms. Jones’s suit alleges that at the time, the doctor told her mother that the sperm donor would be a medical student at the University of Rochester. In fact, the donor was the doctor himself. He kept that fact a secret for years, even after Ms. Jones — his own daughter — sought him out for gynecologic services.

The secret gradually began to come to light in 2016, when Ms. Jones’s nonbiological father — the man who had helped to raise her — died. Curious about her biological father, Ms. Jones sought to learn his identity from the Rochester gynecologist who had treated her mother and was now her own gynecologist. The doctor said he couldn’t be of help; he claimed he hadn’t kept the relevant records.

Ms. Jones then submitted a blood sample to a direct-to-consumer genetic testing company. The results surprised her: Not only did she learn of her ethnicity, but she also discovered the existence of two half siblings, who were donor-conceived in 1984 and 1985, respectively, the very period when her own mother was undergoing insemination procedures. Ms. Jones subsequently discovered the existence of additional half siblings, all born in the first half of the 1980s.

Initially elated by the discoveries, Ms. Jones soon grew despondent and anxious. She suffered from migraine headaches, among other symptoms. Her biological father, it seemed, had been “a serial sperm donor.”

Still, she continued to go to her Rochester doctor for treatment, having no reason to suspect anything untoward about him. Her visits, including those for prolonged menstrual bleeding, involved routine breast and pelvic exams, transvaginal ultrasounds, and intrauterine contraceptive placements under sedation.

Over this period, her doctor was friendly, asking her a variety of questions about her personal life. During one especially strange visit, however, he began chuckling and said, “You’re a really good kid, such a good kid.” During this visit, he invited his wife into the exam room, presumably to meet Ms. Jones.

It was at this moment that Ms. Jones had a revelation: Could her gynecologist actually be her biological father?

In May 2021, Ms. Jones and a half brother with whom she had been in touch contacted the gynecologist’s daughter from his first marriage. All three underwent genetic testing. The results showed a 99.99% chance of a genetic link.

Ms. Jones has said in her suit that “no reasonable woman” would have submitted to pelvic examinations and other examinations by a doctor whom she knew to be her father.

Besides fraud, her suit alleges medical malpractice, battery, infliction of mental distress, and lack of informed consent. She is seeking compensation for all harm caused to her, including past and future economic damages, past unreimbursed medical expenses, and future expenses related to her mental health treatment and care.

The story included no further details about the civil litigation. As for criminal charges, it’s unlikely Ms. Jones’s biological father — her gynecologist — will face criminal charges for his alleged crimes because they fall outside of the state’s statute of limitations.
 

Parents say daughter’s stroke wasn’t identified

The Georgia parents of a young woman who died from a stroke following a series of alleged misdiagnoses are suing multiple practitioners, reports Legal Newswire and other news outlets

In June 2019, Michaela Smith was training for her job as a detention officer when she began experiencing a variety of symptoms, including headache, shortness of breath, throat swelling, and slurred speech. She was taken to the emergency department (ED) at Hamilton Medical Center, in Dalton, Ga.

There, she was examined by an attending ED doctor, who ordered a CT scan. The results were read by radiologist Michael J. Cooney, MD. In his reading, the Smith family’s lawsuit alleges, Dr. Cooney failed to identify the basilar artery sign, which is a key indicator of a vessel occlusion in stroke patients. Dr. Cooney concluded that Ms. Smith’s scan showed no acute intracranial abnormality. He sent her home without further discharge instructions.

At home, Ms. Smith fell asleep but awoke in an altered mental state, one of several classic stroke symptoms that she had been experiencing. She returned to the ED. This time, she was examined by David F. Hawkins, MD, an ED physician. Although his differential diagnosis identified Ms. Smith’s symptoms as most likely stroke related, Dr. Hawkins allegedly failed to immediately corroborate his findings with additional vascular imaging. Later in the day, Ms. Smith did undergo an MRI, which a second radiologist, Kevin F. Johnson, MD, misread as showing no signs of ischemia in her basilar artery, according to the lawsuit.

That same day, Dr. Hawkins conferred with a second neurologist, Jeffrey T. Glass, MD, who recommended that Ms. Smith be admitted to the hospital because of her deteriorating condition. The Smiths’ suit claims that Dr. Glass also failed to diagnosis their daughter’s underlying condition, although he did sign off on her transfer to Baroness Erlanger Hospital, in Chattanooga, Tenn.

There, Ms. Smith’s condition continued to worsen. She soon required mechanical ventilation and tube feeding. On July 3, 2019, she was pronounced dead.

“This is an egregious case of negligence,” said the attorney representing the Smiths, who are suing the physicians involved and their practices, as well as Hamilton Medical Center and several unnamed defendants.

“Although two radiology studies and her clinical presentation indicated that Michaela was having a catastrophic stroke, her doctors repeatedly misread the studies as normal, failed to diagnose the stroke, and failed to treat her deficits as a neurological emergency,” the family’s lawyer stated.

At press time, there had been no response from any of the defendants or their attorneys.

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

After a heart attack, the damaged area of the heart often becomes scar tissue that can’t receive electrical messages to contract and pump blood to the body. The result is a weakened heart that could get an irregular beat, known as an arrhythmia, or go into failure.

Right now, doctors have two imperfect options for repairing this damaged tissue. One is to surgically implant a scaffold that conducts electrically and bridges the heart’s signaling system past the dead tissue. But these implants require open-chest surgery, which is risky and can lead to other heart problems.

Clinicians can use an approach that avoids opening the chest, but the patch used for these procedures may not hold its shape when grafted to damaged tissue.

Now, scientists may be working on a fix that promises the best of both worlds: an injectable patch that conducts electricity and keeps its shape once grafted to heart muscle.

The patch hasn’t been tested in humans -- any such trials are still a long way off -- but early results in animals show potential.

This experimental patch can be rolled up, threaded into a catheter or a syringe, and injected into damaged heart tissue, where it unfurls and attaches to the muscle. Once in place, the patch supports normal heart function, according to results from studies using rats and pigs. The findings were published in Nature Biomedical Engineering.

When researchers placed the patch on damaged heart muscle in rats, they found this fix resulted in a return to mostly normal heart function within 4 weeks. Results were similar when scientists tested the patch in a small number of pigs, which are considered to resemble humans more closely than rodents.

The patched hearts did a better job in pumping oxygen-rich blood to the body, and the amount of heart tissue that wasn’t getting enough oxygen also declined.

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

After a heart attack, the damaged area of the heart often becomes scar tissue that can’t receive electrical messages to contract and pump blood to the body. The result is a weakened heart that could get an irregular beat, known as an arrhythmia, or go into failure.

Right now, doctors have two imperfect options for repairing this damaged tissue. One is to surgically implant a scaffold that conducts electrically and bridges the heart’s signaling system past the dead tissue. But these implants require open-chest surgery, which is risky and can lead to other heart problems.

Clinicians can use an approach that avoids opening the chest, but the patch used for these procedures may not hold its shape when grafted to damaged tissue.

Now, scientists may be working on a fix that promises the best of both worlds: an injectable patch that conducts electricity and keeps its shape once grafted to heart muscle.

The patch hasn’t been tested in humans -- any such trials are still a long way off -- but early results in animals show potential.

This experimental patch can be rolled up, threaded into a catheter or a syringe, and injected into damaged heart tissue, where it unfurls and attaches to the muscle. Once in place, the patch supports normal heart function, according to results from studies using rats and pigs. The findings were published in Nature Biomedical Engineering.

When researchers placed the patch on damaged heart muscle in rats, they found this fix resulted in a return to mostly normal heart function within 4 weeks. Results were similar when scientists tested the patch in a small number of pigs, which are considered to resemble humans more closely than rodents.

The patched hearts did a better job in pumping oxygen-rich blood to the body, and the amount of heart tissue that wasn’t getting enough oxygen also declined.

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

After a heart attack, the damaged area of the heart often becomes scar tissue that can’t receive electrical messages to contract and pump blood to the body. The result is a weakened heart that could get an irregular beat, known as an arrhythmia, or go into failure.

Right now, doctors have two imperfect options for repairing this damaged tissue. One is to surgically implant a scaffold that conducts electrically and bridges the heart’s signaling system past the dead tissue. But these implants require open-chest surgery, which is risky and can lead to other heart problems.

Clinicians can use an approach that avoids opening the chest, but the patch used for these procedures may not hold its shape when grafted to damaged tissue.

Now, scientists may be working on a fix that promises the best of both worlds: an injectable patch that conducts electricity and keeps its shape once grafted to heart muscle.

The patch hasn’t been tested in humans -- any such trials are still a long way off -- but early results in animals show potential.

This experimental patch can be rolled up, threaded into a catheter or a syringe, and injected into damaged heart tissue, where it unfurls and attaches to the muscle. Once in place, the patch supports normal heart function, according to results from studies using rats and pigs. The findings were published in Nature Biomedical Engineering.

When researchers placed the patch on damaged heart muscle in rats, they found this fix resulted in a return to mostly normal heart function within 4 weeks. Results were similar when scientists tested the patch in a small number of pigs, which are considered to resemble humans more closely than rodents.

The patched hearts did a better job in pumping oxygen-rich blood to the body, and the amount of heart tissue that wasn’t getting enough oxygen also declined.

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

The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.

tupungato/Thinkstock

The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.

PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.

The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.

White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.

The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.

The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.

“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.

The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.

tupungato/Thinkstock

The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.

PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.

The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.

White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.

The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.

The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.

“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.

The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.

tupungato/Thinkstock

The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.

PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.

The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.

White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.

The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.

The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.

“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.

New patient care resource: NASH Clinical Care Pathway

The American Gastroenterological Association – in collaboration with seven professional associations – assembled a multidisciplinary taskforce of 15 experts to develop an action plan to develop a nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) Clinical Care Pathway providing practical guidance across multiple disciplines of care. The guidance ranges from screening and diagnosis to management of individuals with NAFLD and NASH, as well as facilitating value-based, efficient, and safe care that is consistent with evidence-based guidelines. 

This clinical care pathway is intended to be applicable in any setting in which care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices. 

Read the special report: Clinical Care Pathway for the Risk Stratification and Management of Patients with Nonalcoholic Fatty Liver Disease. 

To learn more about the development of this publication, visit NASH.gastro.org. 
 

GI societies push CMS for payment rules favorable for practices 

As part of our longstanding collaboration and ongoing efforts on critical policy and payment issues impacting GI clinicians, AGA, the American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy submitted comments on proposed 2022 Medicare payments to physicians, ambulatory surgery centers (ASCs), and hospital outpatient departments to the CMS. We advocated for the following: 

Increased and more accurate valuation for peroral endoscopic myotomy (POEM) and capsule endoscopy services. 

Continued flexibility and payment parity for telehealth and telephone services. 

Elimination of the secondary scalar for ASCs, which contributes to the widening differential in payments to ASCs compared to the hospital outpatient department. 

You can access our letter here. 

New patient care resource: NASH Clinical Care Pathway

The American Gastroenterological Association – in collaboration with seven professional associations – assembled a multidisciplinary taskforce of 15 experts to develop an action plan to develop a nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) Clinical Care Pathway providing practical guidance across multiple disciplines of care. The guidance ranges from screening and diagnosis to management of individuals with NAFLD and NASH, as well as facilitating value-based, efficient, and safe care that is consistent with evidence-based guidelines. 

This clinical care pathway is intended to be applicable in any setting in which care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices. 

Read the special report: Clinical Care Pathway for the Risk Stratification and Management of Patients with Nonalcoholic Fatty Liver Disease. 

To learn more about the development of this publication, visit NASH.gastro.org. 
 

GI societies push CMS for payment rules favorable for practices 

As part of our longstanding collaboration and ongoing efforts on critical policy and payment issues impacting GI clinicians, AGA, the American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy submitted comments on proposed 2022 Medicare payments to physicians, ambulatory surgery centers (ASCs), and hospital outpatient departments to the CMS. We advocated for the following: 

Increased and more accurate valuation for peroral endoscopic myotomy (POEM) and capsule endoscopy services. 

Continued flexibility and payment parity for telehealth and telephone services. 

Elimination of the secondary scalar for ASCs, which contributes to the widening differential in payments to ASCs compared to the hospital outpatient department. 

You can access our letter here. 

New patient care resource: NASH Clinical Care Pathway

The American Gastroenterological Association – in collaboration with seven professional associations – assembled a multidisciplinary taskforce of 15 experts to develop an action plan to develop a nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) Clinical Care Pathway providing practical guidance across multiple disciplines of care. The guidance ranges from screening and diagnosis to management of individuals with NAFLD and NASH, as well as facilitating value-based, efficient, and safe care that is consistent with evidence-based guidelines. 

This clinical care pathway is intended to be applicable in any setting in which care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices. 

Read the special report: Clinical Care Pathway for the Risk Stratification and Management of Patients with Nonalcoholic Fatty Liver Disease. 

To learn more about the development of this publication, visit NASH.gastro.org. 
 

GI societies push CMS for payment rules favorable for practices 

As part of our longstanding collaboration and ongoing efforts on critical policy and payment issues impacting GI clinicians, AGA, the American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy submitted comments on proposed 2022 Medicare payments to physicians, ambulatory surgery centers (ASCs), and hospital outpatient departments to the CMS. We advocated for the following: 

Increased and more accurate valuation for peroral endoscopic myotomy (POEM) and capsule endoscopy services. 

Continued flexibility and payment parity for telehealth and telephone services. 

Elimination of the secondary scalar for ASCs, which contributes to the widening differential in payments to ASCs compared to the hospital outpatient department. 

You can access our letter here. 

Gastroenterology

August 2021

How to perform a high-quality endoscopic submucosal dissection
Saito Y et al. Gastroenterology. 2021 Aug;161(2):405-10. doi: 10.1053/j.gastro.2021.05.051.



Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection: A network meta-analysis
Rokkas T et al. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012.



The optimal age to stop endoscopic surveillance of patients with Barrett’s esophagus based on sex and comorbidity: A comparative cost-effectiveness analysis
Omidvari AH et al. Gastroenterology. 2021 Aug;161(2):487-94.e4. doi: 10.1053/j.gastro.2021.05.003.



Development and validation of test for “leaky gut” small intestinal and colonic permeability using sugars in healthy adults
Khoshbin K et al. Gastroenterology. 2021 Aug;161(2):463-75.e13. doi: 10.1053/j.gastro.2021.04.020.



September 2021

Pregnancy and the working gastroenterologist: Perceptions, realities, and systemic challenges
David YN et al. Gastroenterology. 2021 Sep;161(3):756-60. doi: 10.1053/j.gastro.2021.05.053.



New drugs on the horizon for functional and motility gastrointestinal disorders
Camilleri M. Gastroenterology. 2021 Sep;161(3):761-4. doi: 10.1053/j.gastro.2021.04.079.



A randomized trial comparing the specific carbohydrate diet to a Mediterranean diet in adults with Crohn’s disease
Lewis JD et al. Gastroenterology. 2021 Sep;161(3):837-52.e9. doi: 10.1053/j.gastro.2021.05.047.
 

How to promote career advancement and gender equity for women in gastroenterology: a multifaceted approach
Chua SG et al. Gastroenterology. 2021 Sep;161(3):792-7. doi: 10.1053/j.gastro.2021.06.057.



October 2021

How to approach a patient with difficult-to-treat IBS
Chang L. Gastroenterology. 2021 Oct;161(4):1092-8.e3. doi: 10.1053/j.gastro.2021.07.034.



Early-age onset colorectal neoplasia in average-risk individuals undergoing screening colonoscopy: A systematic review and meta-analysis
Kolb JM et al. Gastroenterology. 2021 Oct;161(4):1145-55.e12. doi: 10.1053/j.gastro.2021.06.006.



Adalimumab subcutaneous in participants with ulcerative colitis (VARSITY)
Peyrin-Biroulet L et al. Gastroenterology. 2021 Oct;161(4):1156-67.e3. doi: 10.1053/j.gastro.2021.06.015.



Extraintestinal manifestations of inflammatory bowel disease: Current concepts, treatment, and implications for disease management
Rogler G et al. Gastroenterology. 2021 Oct;161(4):1118-32. doi: 10.1053/j.gastro.2021.07.042.
 

Clinical Gastroenterology and Hepatology

August 2021

Health equity and telemedicine in gastroenterology and hepatology
Wegermann K et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1516-9. doi: 10.1016/j.cgh.2021.04.024.



AGA Clinical Practice Update on evaluation and management of early complications after bariatric/metabolic surgery: Expert review
Kumbhari V et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1531-7. doi: 10.1016/j.cgh.2021.03.020.



Clinical, pathology, genetic, and molecular features of colorectal tumors in adolescents and adults 25 years or younger
de Voer RM et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1642-51.e8. doi: 10.1016/j.cgh.2020.06.034.



Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis
Deepak P et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1592-601.e3. doi: 10.1016/j.cgh.2020.06.050.

September 2021

Association of adenoma detection rate and adenoma characteristics with colorectal cancer mortality after screening colonoscopy
Waldmann E et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1890-8. doi: 10.1016/j.cgh.2021.04.023.



Prevalence and characteristics of abdominal pain in the United States
Lakhoo K et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1864-72.e5. doi: 10.1016/j.cgh.2020.06.065.



Model using clinical and endoscopic characteristics identifies patients at risk for eosinophilic esophagitis according to updated diagnostic guidelines
Cotton CC et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1824-34.e2. doi: 10.1016/j.cgh.2020.06.068.



October 2021

A high-yield approach to effective endoscopy teaching and assessment
Huang HZ et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):1999-2001. doi: 10.1016/j.cgh.2021.07.013.



2021 E/M code changes: Forecasted impacts to gastroenterology practices
Francis DL et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2002-5. doi: 10.1016/j.cgh.2021.07.008.



You can’t have one without the other: Innovation and ethical dilemmas in gastroenterology and hepatology
Couri T et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2015-9. doi: 10.1016/j.cgh.2020.05.024.



Psychiatric disorders in patients with a diagnosis of celiac disease during childhood from 1973 to 2016
Lebwohl B et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2093-101.e13. doi: 10.1016/j.cgh.2020.08.018.



Mast cell and eosinophil counts in gastric and duodenal biopsy specimens from patients with and without eosinophilic gastroenteritis
Reed CC et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2102-2111. doi: 10.1016/j.cgh.2020.08.013.
 

Cellular and Molecular Gastroenterology and Hepatology

Sex differences in the exocrine pancreas and associated diseases
Wang M et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):427-41. doi: 10.1016/j.jcmgh.2021.04.005.



Mesenteric neural crest cells are the embryological basis of skip segment Hirschsprung’s disease
Yu Q et al. Cell Mol Gastroenterol Hepatol. 2021;12(1):1-24. doi: 10.1016/j.jcmgh.2020.12.010.



Helicobacter pylori–induced rev-erbα fosters gastric bacteria colonization by impairing host innate and adaptive defense
Mao MY et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):395-425. doi: 10.1016/j.jcmgh.2021.02.013.
 

Techniques and Innovations in Gastrointestinal Endoscopy

Staying (mentally) healthy: The impact of COVID-19 on personal and professional lives
Alkandari A et al. Tech Innov Gastrointest Endosc. 2021;23(2):199-206. doi: 10.1016/j.tige.2021.01.003.



Establishing new endoscopic programs in the unit pitfalls and tips for success
Siddiqui UD. Tech Innov Gastrointest Endosc. 2021;23(3):263-7. doi: 10.1016/j.tige.2021.03.002.



Chief of endoscopy: Specific challenges to leading the team and running the unit
Michelle A. Anderson MA et al. Tech Innov Gastrointest Endosc. 2021;23(3):249-55. doi: 10.1016/j.tige.2021.03.004.



Safety in endoscopy for patients and healthcare workers During the COVID-19 pandemic
Lui RN. Tech Innov Gastrointest Endosc. 2021;23(2):170-178. doi: 10.1016/j.tige.2020.10.004.

Gastroenterology

August 2021

How to perform a high-quality endoscopic submucosal dissection
Saito Y et al. Gastroenterology. 2021 Aug;161(2):405-10. doi: 10.1053/j.gastro.2021.05.051.



Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection: A network meta-analysis
Rokkas T et al. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012.



The optimal age to stop endoscopic surveillance of patients with Barrett’s esophagus based on sex and comorbidity: A comparative cost-effectiveness analysis
Omidvari AH et al. Gastroenterology. 2021 Aug;161(2):487-94.e4. doi: 10.1053/j.gastro.2021.05.003.



Development and validation of test for “leaky gut” small intestinal and colonic permeability using sugars in healthy adults
Khoshbin K et al. Gastroenterology. 2021 Aug;161(2):463-75.e13. doi: 10.1053/j.gastro.2021.04.020.



September 2021

Pregnancy and the working gastroenterologist: Perceptions, realities, and systemic challenges
David YN et al. Gastroenterology. 2021 Sep;161(3):756-60. doi: 10.1053/j.gastro.2021.05.053.



New drugs on the horizon for functional and motility gastrointestinal disorders
Camilleri M. Gastroenterology. 2021 Sep;161(3):761-4. doi: 10.1053/j.gastro.2021.04.079.



A randomized trial comparing the specific carbohydrate diet to a Mediterranean diet in adults with Crohn’s disease
Lewis JD et al. Gastroenterology. 2021 Sep;161(3):837-52.e9. doi: 10.1053/j.gastro.2021.05.047.
 

How to promote career advancement and gender equity for women in gastroenterology: a multifaceted approach
Chua SG et al. Gastroenterology. 2021 Sep;161(3):792-7. doi: 10.1053/j.gastro.2021.06.057.



October 2021

How to approach a patient with difficult-to-treat IBS
Chang L. Gastroenterology. 2021 Oct;161(4):1092-8.e3. doi: 10.1053/j.gastro.2021.07.034.



Early-age onset colorectal neoplasia in average-risk individuals undergoing screening colonoscopy: A systematic review and meta-analysis
Kolb JM et al. Gastroenterology. 2021 Oct;161(4):1145-55.e12. doi: 10.1053/j.gastro.2021.06.006.



Adalimumab subcutaneous in participants with ulcerative colitis (VARSITY)
Peyrin-Biroulet L et al. Gastroenterology. 2021 Oct;161(4):1156-67.e3. doi: 10.1053/j.gastro.2021.06.015.



Extraintestinal manifestations of inflammatory bowel disease: Current concepts, treatment, and implications for disease management
Rogler G et al. Gastroenterology. 2021 Oct;161(4):1118-32. doi: 10.1053/j.gastro.2021.07.042.
 

Clinical Gastroenterology and Hepatology

August 2021

Health equity and telemedicine in gastroenterology and hepatology
Wegermann K et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1516-9. doi: 10.1016/j.cgh.2021.04.024.



AGA Clinical Practice Update on evaluation and management of early complications after bariatric/metabolic surgery: Expert review
Kumbhari V et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1531-7. doi: 10.1016/j.cgh.2021.03.020.



Clinical, pathology, genetic, and molecular features of colorectal tumors in adolescents and adults 25 years or younger
de Voer RM et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1642-51.e8. doi: 10.1016/j.cgh.2020.06.034.



Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis
Deepak P et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1592-601.e3. doi: 10.1016/j.cgh.2020.06.050.

September 2021

Association of adenoma detection rate and adenoma characteristics with colorectal cancer mortality after screening colonoscopy
Waldmann E et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1890-8. doi: 10.1016/j.cgh.2021.04.023.



Prevalence and characteristics of abdominal pain in the United States
Lakhoo K et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1864-72.e5. doi: 10.1016/j.cgh.2020.06.065.



Model using clinical and endoscopic characteristics identifies patients at risk for eosinophilic esophagitis according to updated diagnostic guidelines
Cotton CC et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1824-34.e2. doi: 10.1016/j.cgh.2020.06.068.



October 2021

A high-yield approach to effective endoscopy teaching and assessment
Huang HZ et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):1999-2001. doi: 10.1016/j.cgh.2021.07.013.



2021 E/M code changes: Forecasted impacts to gastroenterology practices
Francis DL et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2002-5. doi: 10.1016/j.cgh.2021.07.008.



You can’t have one without the other: Innovation and ethical dilemmas in gastroenterology and hepatology
Couri T et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2015-9. doi: 10.1016/j.cgh.2020.05.024.



Psychiatric disorders in patients with a diagnosis of celiac disease during childhood from 1973 to 2016
Lebwohl B et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2093-101.e13. doi: 10.1016/j.cgh.2020.08.018.



Mast cell and eosinophil counts in gastric and duodenal biopsy specimens from patients with and without eosinophilic gastroenteritis
Reed CC et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2102-2111. doi: 10.1016/j.cgh.2020.08.013.
 

Cellular and Molecular Gastroenterology and Hepatology

Sex differences in the exocrine pancreas and associated diseases
Wang M et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):427-41. doi: 10.1016/j.jcmgh.2021.04.005.



Mesenteric neural crest cells are the embryological basis of skip segment Hirschsprung’s disease
Yu Q et al. Cell Mol Gastroenterol Hepatol. 2021;12(1):1-24. doi: 10.1016/j.jcmgh.2020.12.010.



Helicobacter pylori–induced rev-erbα fosters gastric bacteria colonization by impairing host innate and adaptive defense
Mao MY et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):395-425. doi: 10.1016/j.jcmgh.2021.02.013.
 

Techniques and Innovations in Gastrointestinal Endoscopy

Staying (mentally) healthy: The impact of COVID-19 on personal and professional lives
Alkandari A et al. Tech Innov Gastrointest Endosc. 2021;23(2):199-206. doi: 10.1016/j.tige.2021.01.003.



Establishing new endoscopic programs in the unit pitfalls and tips for success
Siddiqui UD. Tech Innov Gastrointest Endosc. 2021;23(3):263-7. doi: 10.1016/j.tige.2021.03.002.



Chief of endoscopy: Specific challenges to leading the team and running the unit
Michelle A. Anderson MA et al. Tech Innov Gastrointest Endosc. 2021;23(3):249-55. doi: 10.1016/j.tige.2021.03.004.



Safety in endoscopy for patients and healthcare workers During the COVID-19 pandemic
Lui RN. Tech Innov Gastrointest Endosc. 2021;23(2):170-178. doi: 10.1016/j.tige.2020.10.004.

Gastroenterology

August 2021

How to perform a high-quality endoscopic submucosal dissection
Saito Y et al. Gastroenterology. 2021 Aug;161(2):405-10. doi: 10.1053/j.gastro.2021.05.051.



Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection: A network meta-analysis
Rokkas T et al. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012.



The optimal age to stop endoscopic surveillance of patients with Barrett’s esophagus based on sex and comorbidity: A comparative cost-effectiveness analysis
Omidvari AH et al. Gastroenterology. 2021 Aug;161(2):487-94.e4. doi: 10.1053/j.gastro.2021.05.003.



Development and validation of test for “leaky gut” small intestinal and colonic permeability using sugars in healthy adults
Khoshbin K et al. Gastroenterology. 2021 Aug;161(2):463-75.e13. doi: 10.1053/j.gastro.2021.04.020.



September 2021

Pregnancy and the working gastroenterologist: Perceptions, realities, and systemic challenges
David YN et al. Gastroenterology. 2021 Sep;161(3):756-60. doi: 10.1053/j.gastro.2021.05.053.



New drugs on the horizon for functional and motility gastrointestinal disorders
Camilleri M. Gastroenterology. 2021 Sep;161(3):761-4. doi: 10.1053/j.gastro.2021.04.079.



A randomized trial comparing the specific carbohydrate diet to a Mediterranean diet in adults with Crohn’s disease
Lewis JD et al. Gastroenterology. 2021 Sep;161(3):837-52.e9. doi: 10.1053/j.gastro.2021.05.047.
 

How to promote career advancement and gender equity for women in gastroenterology: a multifaceted approach
Chua SG et al. Gastroenterology. 2021 Sep;161(3):792-7. doi: 10.1053/j.gastro.2021.06.057.



October 2021

How to approach a patient with difficult-to-treat IBS
Chang L. Gastroenterology. 2021 Oct;161(4):1092-8.e3. doi: 10.1053/j.gastro.2021.07.034.



Early-age onset colorectal neoplasia in average-risk individuals undergoing screening colonoscopy: A systematic review and meta-analysis
Kolb JM et al. Gastroenterology. 2021 Oct;161(4):1145-55.e12. doi: 10.1053/j.gastro.2021.06.006.



Adalimumab subcutaneous in participants with ulcerative colitis (VARSITY)
Peyrin-Biroulet L et al. Gastroenterology. 2021 Oct;161(4):1156-67.e3. doi: 10.1053/j.gastro.2021.06.015.



Extraintestinal manifestations of inflammatory bowel disease: Current concepts, treatment, and implications for disease management
Rogler G et al. Gastroenterology. 2021 Oct;161(4):1118-32. doi: 10.1053/j.gastro.2021.07.042.
 

Clinical Gastroenterology and Hepatology

August 2021

Health equity and telemedicine in gastroenterology and hepatology
Wegermann K et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1516-9. doi: 10.1016/j.cgh.2021.04.024.



AGA Clinical Practice Update on evaluation and management of early complications after bariatric/metabolic surgery: Expert review
Kumbhari V et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1531-7. doi: 10.1016/j.cgh.2021.03.020.



Clinical, pathology, genetic, and molecular features of colorectal tumors in adolescents and adults 25 years or younger
de Voer RM et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1642-51.e8. doi: 10.1016/j.cgh.2020.06.034.



Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis
Deepak P et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1592-601.e3. doi: 10.1016/j.cgh.2020.06.050.

September 2021

Association of adenoma detection rate and adenoma characteristics with colorectal cancer mortality after screening colonoscopy
Waldmann E et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1890-8. doi: 10.1016/j.cgh.2021.04.023.



Prevalence and characteristics of abdominal pain in the United States
Lakhoo K et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1864-72.e5. doi: 10.1016/j.cgh.2020.06.065.



Model using clinical and endoscopic characteristics identifies patients at risk for eosinophilic esophagitis according to updated diagnostic guidelines
Cotton CC et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1824-34.e2. doi: 10.1016/j.cgh.2020.06.068.



October 2021

A high-yield approach to effective endoscopy teaching and assessment
Huang HZ et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):1999-2001. doi: 10.1016/j.cgh.2021.07.013.



2021 E/M code changes: Forecasted impacts to gastroenterology practices
Francis DL et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2002-5. doi: 10.1016/j.cgh.2021.07.008.



You can’t have one without the other: Innovation and ethical dilemmas in gastroenterology and hepatology
Couri T et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2015-9. doi: 10.1016/j.cgh.2020.05.024.



Psychiatric disorders in patients with a diagnosis of celiac disease during childhood from 1973 to 2016
Lebwohl B et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2093-101.e13. doi: 10.1016/j.cgh.2020.08.018.



Mast cell and eosinophil counts in gastric and duodenal biopsy specimens from patients with and without eosinophilic gastroenteritis
Reed CC et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2102-2111. doi: 10.1016/j.cgh.2020.08.013.
 

Cellular and Molecular Gastroenterology and Hepatology

Sex differences in the exocrine pancreas and associated diseases
Wang M et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):427-41. doi: 10.1016/j.jcmgh.2021.04.005.



Mesenteric neural crest cells are the embryological basis of skip segment Hirschsprung’s disease
Yu Q et al. Cell Mol Gastroenterol Hepatol. 2021;12(1):1-24. doi: 10.1016/j.jcmgh.2020.12.010.



Helicobacter pylori–induced rev-erbα fosters gastric bacteria colonization by impairing host innate and adaptive defense
Mao MY et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):395-425. doi: 10.1016/j.jcmgh.2021.02.013.
 

Techniques and Innovations in Gastrointestinal Endoscopy

Staying (mentally) healthy: The impact of COVID-19 on personal and professional lives
Alkandari A et al. Tech Innov Gastrointest Endosc. 2021;23(2):199-206. doi: 10.1016/j.tige.2021.01.003.



Establishing new endoscopic programs in the unit pitfalls and tips for success
Siddiqui UD. Tech Innov Gastrointest Endosc. 2021;23(3):263-7. doi: 10.1016/j.tige.2021.03.002.



Chief of endoscopy: Specific challenges to leading the team and running the unit
Michelle A. Anderson MA et al. Tech Innov Gastrointest Endosc. 2021;23(3):249-55. doi: 10.1016/j.tige.2021.03.004.



Safety in endoscopy for patients and healthcare workers During the COVID-19 pandemic
Lui RN. Tech Innov Gastrointest Endosc. 2021;23(2):170-178. doi: 10.1016/j.tige.2020.10.004.

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”

The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.

Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.

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

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”

The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.

Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.

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

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”

The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.

Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.

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