Feature

Can treatment or removal of high-grade squamous intraepithelial lesions (HSIL) reduce the likelihood of developing anal cancer in people living with HIV (PLHIV)?

“In theory, looking for and treating high-grade disease (like we know works in the cervix) is a potential way to prevent anal cancer in high-risk individuals,” Joel Palefsky, MD, lead investigator of the Anal Cancer/HSIL Outcomes Research (ANCHOR) study and founder/director of the University of California, San Francisco’s Anal Neoplasia Clinic, told this news organization. “But we’ve never had any direct evidence that it worked,” he said.

Initial findings from ANCHOR – the first randomized trial to demonstrate that anal cancer can be prevented in high-risk, HIV-infected patients – promise to change that paradigm and may even portend a new standard of care.

Undoubtedly, this is welcome news for the HIV community, who are not only at increased risk for anal HSIL overall, but among whom anal cancer cases have been rising over the past decade. This is especially true for women who are expected to bear a large portion of overall burden of human papillomavirus (HPV)–associated anal squamous cell carcinoma over the next 10 to 20 years.

In the study, 4,446 PLHIV ages 35 and older with precursor anal HSIL were randomly assigned to topical (imiquimod intra-anally, perianally, or both, or fluorouracil) or ablative (infrared coagulation, hyfrecation/electrocautery) treatment, or active surveillance, and followed every 6 months for 5 years. The study population was broadly representative, including men who have sex with men (MSM), women, transgender people, and historically underrepresented minorities, a factor that reinforces the study’s importance in this specific population.

Because the primary endpoint was reached (that is, to determine if HSIL treatment and removal effectively reduces anal cancer incidence in HIV-infected men and women), the Data Safety Board halted accrual and recommended that participants in the surveillance group be offered treatment moving forward. While the investigators are currently working on publication of the results, the study is ongoing.

Still, the ANCHOR study, which is one of the largest malignancy screening studies conducted in PLHIV, has also highlighted significant challenges in how anal cancer is approached in general.

“Anal cancer has many similarities to cervical cancer, where screening for precancerous lesions and treatment have been shown to substantially reduce morbidity and mortality,” said Joseph Sparano, MD, a medical oncologist specializing in HIV and breast cancer at Icahn School of Medicine at Mount Sinai, New York. Dr. Sparano is chair and principal investigator of the AIDS Malignancy Consortium but was not involved in the ANCHOR study.

But, he explained in an interview, “it’s much more difficult and technically challenging to screen for and evaluate the anal canal histology,” noting that New York is currently the only U.S. state to recommend screening for anal dysplasia with high-resolution anoscopy in HIV-infected men and women.

Availability and access to high-resolution anoscopy is limited, said Robert Yarchoan, MD, chief of the HIV and AIDS Malignancy Branch at the National Cancer Institute’s Clinical Cancer Research Division and director of the Office of HIV and AIDS Malignancy (which, incidentally, cosponsored ANCHOR).

“There are relatively few people that do this at this time,” he added in an interview, pointing out that among those who do, most are obstetricians/gynecologists.

A bit of digging into ANCHOR’s backstory revealed that this was a point of contention at the study’s onset. While physicians participating in the study received extensive training in high-resolution anoscopy, ob/gyns were the fastest to achieve competency and/or had the most prior experience, namely because of their experience in cervical cancer screening in women.

But initial objections by the American Board of Obstetricians and Gynecologists (which at the time, insisted that its members only treat women and threatened to remove their certification if they participated in the research), almost threw a wrench into the study’s start, according to a report in The New York Times. While rational minds prevailed and the board reversed its earlier statements, lack of ample training in the procedure may signal future barriers to treatment.

Another challenge lies in how study findings might be applicable to other groups outside of the HIV/AIDS population, such as people with other forms of immunosuppression who have HSIL, or even healthy women or men who are at risk as a result of penetrative/nonpenetrative sexual or nonsexual (for example, vaginal discharge to the anus) contact.

Although he was unable to share specifics at this time, Dr. Palefsky said that when they designed the ANCHOR study, they were aware that “merely showing efficacy wouldn’t necessarily be sufficient for establishing a standard of care, where[as] other pieces of information undoubtedly would be considered by entities that make guidelines” (for example, an examination of adverse events, risks/benefits, and factors that influence quality of life).

“With that in mind, we are doing a quality-of-life study and, in fact, have [collaborated on], developed, and validated what I think is the first anal disease-specific, quality of life instrument,” Dr. Palefsky said. “The work is still ongoing because we did not complete enrollment in the study, but we are continuing it as part of the follow up.”

Study investigators have also collected samples for a biorepository of specimens that will hopefully facilitate a better understanding of the molecular events driving progression from precancer to cancer. “A lot of people with HIV have these high-grade lesions,” Dr. Palefsky said. “If we were able to identify who’s at highest risk of all of them, that would be very important, because we prefer not to treat everybody with high-grade disease,” he noted, adding that the “underlying hope is that the biomarkers we find in the setting will also be relevant for other HPV-related cancers,” especially in women.

Dr. Yarchoan concurred. “One of the challenges is going to be to digest this information and see how to use it to potentially address the growing problem of females with HIV,” he said.

Dr. Palefsky, Dr. Sparano, and Dr. Yarchoan have disclosed no relevant financial relationships.

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

Can treatment or removal of high-grade squamous intraepithelial lesions (HSIL) reduce the likelihood of developing anal cancer in people living with HIV (PLHIV)?

“In theory, looking for and treating high-grade disease (like we know works in the cervix) is a potential way to prevent anal cancer in high-risk individuals,” Joel Palefsky, MD, lead investigator of the Anal Cancer/HSIL Outcomes Research (ANCHOR) study and founder/director of the University of California, San Francisco’s Anal Neoplasia Clinic, told this news organization. “But we’ve never had any direct evidence that it worked,” he said.

Initial findings from ANCHOR – the first randomized trial to demonstrate that anal cancer can be prevented in high-risk, HIV-infected patients – promise to change that paradigm and may even portend a new standard of care.

Undoubtedly, this is welcome news for the HIV community, who are not only at increased risk for anal HSIL overall, but among whom anal cancer cases have been rising over the past decade. This is especially true for women who are expected to bear a large portion of overall burden of human papillomavirus (HPV)–associated anal squamous cell carcinoma over the next 10 to 20 years.

In the study, 4,446 PLHIV ages 35 and older with precursor anal HSIL were randomly assigned to topical (imiquimod intra-anally, perianally, or both, or fluorouracil) or ablative (infrared coagulation, hyfrecation/electrocautery) treatment, or active surveillance, and followed every 6 months for 5 years. The study population was broadly representative, including men who have sex with men (MSM), women, transgender people, and historically underrepresented minorities, a factor that reinforces the study’s importance in this specific population.

Because the primary endpoint was reached (that is, to determine if HSIL treatment and removal effectively reduces anal cancer incidence in HIV-infected men and women), the Data Safety Board halted accrual and recommended that participants in the surveillance group be offered treatment moving forward. While the investigators are currently working on publication of the results, the study is ongoing.

Still, the ANCHOR study, which is one of the largest malignancy screening studies conducted in PLHIV, has also highlighted significant challenges in how anal cancer is approached in general.

“Anal cancer has many similarities to cervical cancer, where screening for precancerous lesions and treatment have been shown to substantially reduce morbidity and mortality,” said Joseph Sparano, MD, a medical oncologist specializing in HIV and breast cancer at Icahn School of Medicine at Mount Sinai, New York. Dr. Sparano is chair and principal investigator of the AIDS Malignancy Consortium but was not involved in the ANCHOR study.

But, he explained in an interview, “it’s much more difficult and technically challenging to screen for and evaluate the anal canal histology,” noting that New York is currently the only U.S. state to recommend screening for anal dysplasia with high-resolution anoscopy in HIV-infected men and women.

Availability and access to high-resolution anoscopy is limited, said Robert Yarchoan, MD, chief of the HIV and AIDS Malignancy Branch at the National Cancer Institute’s Clinical Cancer Research Division and director of the Office of HIV and AIDS Malignancy (which, incidentally, cosponsored ANCHOR).

“There are relatively few people that do this at this time,” he added in an interview, pointing out that among those who do, most are obstetricians/gynecologists.

A bit of digging into ANCHOR’s backstory revealed that this was a point of contention at the study’s onset. While physicians participating in the study received extensive training in high-resolution anoscopy, ob/gyns were the fastest to achieve competency and/or had the most prior experience, namely because of their experience in cervical cancer screening in women.

But initial objections by the American Board of Obstetricians and Gynecologists (which at the time, insisted that its members only treat women and threatened to remove their certification if they participated in the research), almost threw a wrench into the study’s start, according to a report in The New York Times. While rational minds prevailed and the board reversed its earlier statements, lack of ample training in the procedure may signal future barriers to treatment.

Another challenge lies in how study findings might be applicable to other groups outside of the HIV/AIDS population, such as people with other forms of immunosuppression who have HSIL, or even healthy women or men who are at risk as a result of penetrative/nonpenetrative sexual or nonsexual (for example, vaginal discharge to the anus) contact.

Although he was unable to share specifics at this time, Dr. Palefsky said that when they designed the ANCHOR study, they were aware that “merely showing efficacy wouldn’t necessarily be sufficient for establishing a standard of care, where[as] other pieces of information undoubtedly would be considered by entities that make guidelines” (for example, an examination of adverse events, risks/benefits, and factors that influence quality of life).

“With that in mind, we are doing a quality-of-life study and, in fact, have [collaborated on], developed, and validated what I think is the first anal disease-specific, quality of life instrument,” Dr. Palefsky said. “The work is still ongoing because we did not complete enrollment in the study, but we are continuing it as part of the follow up.”

Study investigators have also collected samples for a biorepository of specimens that will hopefully facilitate a better understanding of the molecular events driving progression from precancer to cancer. “A lot of people with HIV have these high-grade lesions,” Dr. Palefsky said. “If we were able to identify who’s at highest risk of all of them, that would be very important, because we prefer not to treat everybody with high-grade disease,” he noted, adding that the “underlying hope is that the biomarkers we find in the setting will also be relevant for other HPV-related cancers,” especially in women.

Dr. Yarchoan concurred. “One of the challenges is going to be to digest this information and see how to use it to potentially address the growing problem of females with HIV,” he said.

Dr. Palefsky, Dr. Sparano, and Dr. Yarchoan have disclosed no relevant financial relationships.

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

Can treatment or removal of high-grade squamous intraepithelial lesions (HSIL) reduce the likelihood of developing anal cancer in people living with HIV (PLHIV)?

“In theory, looking for and treating high-grade disease (like we know works in the cervix) is a potential way to prevent anal cancer in high-risk individuals,” Joel Palefsky, MD, lead investigator of the Anal Cancer/HSIL Outcomes Research (ANCHOR) study and founder/director of the University of California, San Francisco’s Anal Neoplasia Clinic, told this news organization. “But we’ve never had any direct evidence that it worked,” he said.

Initial findings from ANCHOR – the first randomized trial to demonstrate that anal cancer can be prevented in high-risk, HIV-infected patients – promise to change that paradigm and may even portend a new standard of care.

Undoubtedly, this is welcome news for the HIV community, who are not only at increased risk for anal HSIL overall, but among whom anal cancer cases have been rising over the past decade. This is especially true for women who are expected to bear a large portion of overall burden of human papillomavirus (HPV)–associated anal squamous cell carcinoma over the next 10 to 20 years.

In the study, 4,446 PLHIV ages 35 and older with precursor anal HSIL were randomly assigned to topical (imiquimod intra-anally, perianally, or both, or fluorouracil) or ablative (infrared coagulation, hyfrecation/electrocautery) treatment, or active surveillance, and followed every 6 months for 5 years. The study population was broadly representative, including men who have sex with men (MSM), women, transgender people, and historically underrepresented minorities, a factor that reinforces the study’s importance in this specific population.

Because the primary endpoint was reached (that is, to determine if HSIL treatment and removal effectively reduces anal cancer incidence in HIV-infected men and women), the Data Safety Board halted accrual and recommended that participants in the surveillance group be offered treatment moving forward. While the investigators are currently working on publication of the results, the study is ongoing.

Still, the ANCHOR study, which is one of the largest malignancy screening studies conducted in PLHIV, has also highlighted significant challenges in how anal cancer is approached in general.

“Anal cancer has many similarities to cervical cancer, where screening for precancerous lesions and treatment have been shown to substantially reduce morbidity and mortality,” said Joseph Sparano, MD, a medical oncologist specializing in HIV and breast cancer at Icahn School of Medicine at Mount Sinai, New York. Dr. Sparano is chair and principal investigator of the AIDS Malignancy Consortium but was not involved in the ANCHOR study.

But, he explained in an interview, “it’s much more difficult and technically challenging to screen for and evaluate the anal canal histology,” noting that New York is currently the only U.S. state to recommend screening for anal dysplasia with high-resolution anoscopy in HIV-infected men and women.

Availability and access to high-resolution anoscopy is limited, said Robert Yarchoan, MD, chief of the HIV and AIDS Malignancy Branch at the National Cancer Institute’s Clinical Cancer Research Division and director of the Office of HIV and AIDS Malignancy (which, incidentally, cosponsored ANCHOR).

“There are relatively few people that do this at this time,” he added in an interview, pointing out that among those who do, most are obstetricians/gynecologists.

A bit of digging into ANCHOR’s backstory revealed that this was a point of contention at the study’s onset. While physicians participating in the study received extensive training in high-resolution anoscopy, ob/gyns were the fastest to achieve competency and/or had the most prior experience, namely because of their experience in cervical cancer screening in women.

But initial objections by the American Board of Obstetricians and Gynecologists (which at the time, insisted that its members only treat women and threatened to remove their certification if they participated in the research), almost threw a wrench into the study’s start, according to a report in The New York Times. While rational minds prevailed and the board reversed its earlier statements, lack of ample training in the procedure may signal future barriers to treatment.

Another challenge lies in how study findings might be applicable to other groups outside of the HIV/AIDS population, such as people with other forms of immunosuppression who have HSIL, or even healthy women or men who are at risk as a result of penetrative/nonpenetrative sexual or nonsexual (for example, vaginal discharge to the anus) contact.

Although he was unable to share specifics at this time, Dr. Palefsky said that when they designed the ANCHOR study, they were aware that “merely showing efficacy wouldn’t necessarily be sufficient for establishing a standard of care, where[as] other pieces of information undoubtedly would be considered by entities that make guidelines” (for example, an examination of adverse events, risks/benefits, and factors that influence quality of life).

“With that in mind, we are doing a quality-of-life study and, in fact, have [collaborated on], developed, and validated what I think is the first anal disease-specific, quality of life instrument,” Dr. Palefsky said. “The work is still ongoing because we did not complete enrollment in the study, but we are continuing it as part of the follow up.”

Study investigators have also collected samples for a biorepository of specimens that will hopefully facilitate a better understanding of the molecular events driving progression from precancer to cancer. “A lot of people with HIV have these high-grade lesions,” Dr. Palefsky said. “If we were able to identify who’s at highest risk of all of them, that would be very important, because we prefer not to treat everybody with high-grade disease,” he noted, adding that the “underlying hope is that the biomarkers we find in the setting will also be relevant for other HPV-related cancers,” especially in women.

Dr. Yarchoan concurred. “One of the challenges is going to be to digest this information and see how to use it to potentially address the growing problem of females with HIV,” he said.

Dr. Palefsky, Dr. Sparano, and Dr. Yarchoan have disclosed no relevant financial relationships.

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

At Wayne State University’s Stress, Trauma, and Anxiety Research Clinic (STARC) in Michigan, researchers are developing novel interventions for treating some very ancient phobias hardwired into the human brain. By using augmented reality as means of conducting exposure therapy, STARC researchers – including Shantanu Madaboosi, Rakesh Ramaswamy, and Lana Grasser – and STARC director Arash Javanbakht, MD, have produced compelling evidence that they can free patients of their often debilitating fears of spiders, dogs, and snakes. Yet their work doesn’t stop there, and research into treating anxiety and posttraumatic stress disorder among first responders and others with high-stress occupations is ongoing.

This news organization spoke with Dr. Javanbakht, a psychiatrist, about the technological advances that have made this work possible; the future of remote-based psychiatry; and his tarantula colleague, Tony.
 

Augmenting exposure therapy

How did you begin using artificial intelligence as a way of delivering exposure therapy?

Exposure therapy is a very effective treatment for phobias, obsessive-compulsive disorder, and PTSD. But the problem we had is that, if someone comes to me and says they’re afraid of dogs, snakes, or spiders, I don’t have those in my office. Or, if its social phobia, I can’t create those scenarios. So, despite being such an effective treatment, it’s not utilized as much as it should be.

Several years ago, I saw a TED talk by the CEO of an augmented reality company who happened to be a neuroscientist. I thought the concept was amazing, because it offered a way to overcome those limitations.

Mixed augmented reality allows us to bring all those feared objects to the clinic. I can bring my Labrador to the office for someone who’s afraid of dogs, and they can get the exposure to that one dog. But we know good exposure therapy needs to be generalizable, with as many different breeds of dogs as possible, and is context dependent. If the patient sees a dog in their neighborhood, their fear response may come back. Doing it in a real-life context, and offering as many contexts as possible, makes it more effective.

Augmented reality allows all of these options because you can have as many different types of virtual objects as you want, and the difference between augmented reality and virtual reality is that augmented reality happens in a real-life context. You wear the goggles and you can walk around the environment and track the object, so the context is more realistic.
 

When did you begin researching augmented reality as a clinical tool?

I became a faculty member here in 2015, right out of my residency training, and I think it was around 2016 or 2017 that we began this work.

I’m very much involved in exposure therapy, utilize it myself, train others, and research how it works and changes the brain. I knew the ins and outs and what would make a better exposure therapy, based on my knowledge of neuroscience.

We spend time thinking about how we can apply these neuroscientific principles in software that can also be easily used by a not very technologically savvy therapist. Because that has been a big barrier when it comes to technology and human use in medicine.

Initially, we had a company create the software for us, but we’ve since brought all the programming inside.

The cool thing about these augmented reality devices is that they have excellent surface mapping. As soon as the person wears the goggles, it automatically maps the surfaces and provides a 3D view of the patient’s environment on the therapist’s computer. Say you’re treating a patient with a fear of spiders. Through drop-down menus, the therapist can choose what type of spider, its color and size, where it should be placed, and the motion. I can choose to move the spider from 6 feet away on the floor to the walls to the ceiling.
 

Virtual phobias, real fear

A big question for a lot of people was if the spiders are virtual, will they be scary, because it has to be realistic enough to create a fear response for the therapy to work. We use a couple of wires that you can put on a person’s finger and hook them up to a tablet or a cell phone. This provides an online measure of a person’s autonomic sympathetic response.

Like a lie detector test?

Exactly. We put that on their fingers and exposed them to a real-life tarantula and to our virtual tarantulas, and the fear response was no different. That means these do create an objective fear reaction in the body.

We also had people who said, “I know this is not real. I won’t be scared.” And when we started the therapy, it was with a tiny spider 5 meters away from them, and they’d lift their legs off the floor.

With the treatment, we’d come to one room and start with a very little spider, far from them. Then gradually we move them up to bigger, more diverse types of spiders, which are moving around. The patient comes near and tries to touch them.

Then at some point, I’d put a spiderweb on the door, put a few spiders on that, open the door, and have the patient walk through it. They kept walking through this spiderweb.

When they were desensitized to these spiders in this context – and as I said, context is important – we’d go to another room. This was darker, more like a basement, and we’d continue the same thing. That would actually take much less time because they already had desensitized a lot.

In our field, sense of control is very important, especially for when a patient goes home. So at the end, I’d leave the room and talk to the patient via a baby monitor. The patient was surrounded by 20 tarantulas, without the prompt moving around the environment.

Now that they’re desensitized to my virtual spiders, the question is, how would that apply to a real spider? So, we had a real live tarantula, whose name was Tony Stark, because we’re the STARC lab. We’d put Tony at the end of a long hallway before the treatment and see how close the patients could get to him.

Everybody who got the treatment was able to touch the tank containing the tarantula. It was only one treatment session; nobody’s was longer than 1 hour, and the average treatment time was 38 minutes.
 

That’s pretty effective.

It’s pretty good, compared with other studies. And I believe this is because of all the components I mentioned: being able to use your real environment; combining it with the real tarantula; the variety of the types of the feared objects; and, of course, giving the patient a sense of autonomy at the end.

Then we had to see how prolonged the effects are. We had them come in 1 week and 1 month after the treatment. I’d remind them of the principles of good exposure therapy and ask them to keep practicing at home between the sessions, looking at pictures and videos. But we never tested who did or did not do it.

After 1 week and 1 month, the effects were either the same or better. A larger number of people at 1 month were able to touch the tarantula than right after treatment.
 

Treating PTSD in first responders

Did you start with spiders and dogs because those are common fears?

We started with spiders because that worked with the initial goal of creating a prototype. Spiders’ behavior is simple enough for the programming, which takes a lot of time. Another reason for choosing spiders was that we had a lot of other studies of real and virtual reality exposure therapy to compare against.

I think another reason for our success is that, when you do real exposure therapy, you have just one scared tarantula in the corner of their tank, and they don’t listen to you. But my spiders listen to me and do exactly what I tell them.

After our initial success, we obtained more funds to expand it to other phobias. The cool thing is that we don’t need separate software for different phobias. You can choose dogs or snakes, add it to the person’s environment, and decide their behaviors.

We just started a clinical trial using dogs, and another group in Turkey is running a clinical trial with dogs. Eastern Michigan University is working with spiders. And a clinic at the University of Nebraska Medical Center is going to start using them in real-world clinics, not for research.

We have another project whose goal is helping reduce the impact of trauma and also treating PTSD in first responders, who are exposed to a lot of horrible things. Rates of PTSD are around 20%-30% among cops, firefighters, and EMS personnel.

They commonly find it very painful being in crowds because the fight-or-flight instinct in the brain is constantly screening for any sign of threat in their environment. We’re working on them walking into an empty room wearing the goggles, and then their therapist can scale the stimulus up and down.

There’ll be two people in front of you talking to each other, and then another group comes in, and people get louder. People can look at you and talk to you. There’s kids running, Fourth of July fireworks, and other things that might bother someone who’s been involved in gun- or explosion-related traumas. You gradually scale up when the person is next to their therapist.

Another thing we’re doing is related to cardiopulmonary resuscitation. If a young person dies in a CPR situation, that is really painful and traumatic. So, for exposure therapy to that, we’re creating a difficult CPR scenario when that person may die. The responder wears the goggles and basically watches a group of people doing CPR while standing next to a therapist who can help them navigate it and then scale it off.

Another goal is combining this with telemedicine, where the person can do it in their real-life environment. Imagine a person with military trauma. You can put them back in the barracks, connected with their psychiatrists via telemedicine. Then we would put humans in military fatigues near them and have them interact with them to feel comfortable with that situation.
 

What else is next for you and your group?

The next biggest challenge that we’re tackling is PTSD, because of course creating human-encounter scenarios is much more complicated than spiders and dogs. We’re in the midst of developing this so we can basically bring it to people’s homes.

We’ve been working with some military personnel to see if we can basically give a device to a veteran with PTSD, so they can go home and practice on their own.

There’s another possibility for training. Let’s take the example of a police force, which can have a lot of difficulties and mistakes because of lack of exposure and training. They can wear these goggles, get fully geared up, and be placed in encounters with people of different backgrounds, of different severity, with people who could be severely mentally ill or present different challenges for the officers.

Those situations can teach them a lot. I’m the creator of this thing, but even I’m often surprised by how realistic this technology can be. I find myself interacting with avatars the same way I would if they were real humans. I actually had one of my colleagues, when we started launching the programming with the dogs, immediately jump back. It’s just like the animal brain reacts to them.
 

Last question: Do you actually interact with Tony, the tarantula?

Oh, Tony is my friend. Unfortunately, he’s not with our lab at this moment. He’s on a sabbatical at Eastern Michigan University for their clinical trials. But yes, I’ve held him. He’s very friendly.

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

At Wayne State University’s Stress, Trauma, and Anxiety Research Clinic (STARC) in Michigan, researchers are developing novel interventions for treating some very ancient phobias hardwired into the human brain. By using augmented reality as means of conducting exposure therapy, STARC researchers – including Shantanu Madaboosi, Rakesh Ramaswamy, and Lana Grasser – and STARC director Arash Javanbakht, MD, have produced compelling evidence that they can free patients of their often debilitating fears of spiders, dogs, and snakes. Yet their work doesn’t stop there, and research into treating anxiety and posttraumatic stress disorder among first responders and others with high-stress occupations is ongoing.

This news organization spoke with Dr. Javanbakht, a psychiatrist, about the technological advances that have made this work possible; the future of remote-based psychiatry; and his tarantula colleague, Tony.
 

Augmenting exposure therapy

How did you begin using artificial intelligence as a way of delivering exposure therapy?

Exposure therapy is a very effective treatment for phobias, obsessive-compulsive disorder, and PTSD. But the problem we had is that, if someone comes to me and says they’re afraid of dogs, snakes, or spiders, I don’t have those in my office. Or, if its social phobia, I can’t create those scenarios. So, despite being such an effective treatment, it’s not utilized as much as it should be.

Several years ago, I saw a TED talk by the CEO of an augmented reality company who happened to be a neuroscientist. I thought the concept was amazing, because it offered a way to overcome those limitations.

Mixed augmented reality allows us to bring all those feared objects to the clinic. I can bring my Labrador to the office for someone who’s afraid of dogs, and they can get the exposure to that one dog. But we know good exposure therapy needs to be generalizable, with as many different breeds of dogs as possible, and is context dependent. If the patient sees a dog in their neighborhood, their fear response may come back. Doing it in a real-life context, and offering as many contexts as possible, makes it more effective.

Augmented reality allows all of these options because you can have as many different types of virtual objects as you want, and the difference between augmented reality and virtual reality is that augmented reality happens in a real-life context. You wear the goggles and you can walk around the environment and track the object, so the context is more realistic.
 

When did you begin researching augmented reality as a clinical tool?

I became a faculty member here in 2015, right out of my residency training, and I think it was around 2016 or 2017 that we began this work.

I’m very much involved in exposure therapy, utilize it myself, train others, and research how it works and changes the brain. I knew the ins and outs and what would make a better exposure therapy, based on my knowledge of neuroscience.

We spend time thinking about how we can apply these neuroscientific principles in software that can also be easily used by a not very technologically savvy therapist. Because that has been a big barrier when it comes to technology and human use in medicine.

Initially, we had a company create the software for us, but we’ve since brought all the programming inside.

The cool thing about these augmented reality devices is that they have excellent surface mapping. As soon as the person wears the goggles, it automatically maps the surfaces and provides a 3D view of the patient’s environment on the therapist’s computer. Say you’re treating a patient with a fear of spiders. Through drop-down menus, the therapist can choose what type of spider, its color and size, where it should be placed, and the motion. I can choose to move the spider from 6 feet away on the floor to the walls to the ceiling.
 

Virtual phobias, real fear

A big question for a lot of people was if the spiders are virtual, will they be scary, because it has to be realistic enough to create a fear response for the therapy to work. We use a couple of wires that you can put on a person’s finger and hook them up to a tablet or a cell phone. This provides an online measure of a person’s autonomic sympathetic response.

Like a lie detector test?

Exactly. We put that on their fingers and exposed them to a real-life tarantula and to our virtual tarantulas, and the fear response was no different. That means these do create an objective fear reaction in the body.

We also had people who said, “I know this is not real. I won’t be scared.” And when we started the therapy, it was with a tiny spider 5 meters away from them, and they’d lift their legs off the floor.

With the treatment, we’d come to one room and start with a very little spider, far from them. Then gradually we move them up to bigger, more diverse types of spiders, which are moving around. The patient comes near and tries to touch them.

Then at some point, I’d put a spiderweb on the door, put a few spiders on that, open the door, and have the patient walk through it. They kept walking through this spiderweb.

When they were desensitized to these spiders in this context – and as I said, context is important – we’d go to another room. This was darker, more like a basement, and we’d continue the same thing. That would actually take much less time because they already had desensitized a lot.

In our field, sense of control is very important, especially for when a patient goes home. So at the end, I’d leave the room and talk to the patient via a baby monitor. The patient was surrounded by 20 tarantulas, without the prompt moving around the environment.

Now that they’re desensitized to my virtual spiders, the question is, how would that apply to a real spider? So, we had a real live tarantula, whose name was Tony Stark, because we’re the STARC lab. We’d put Tony at the end of a long hallway before the treatment and see how close the patients could get to him.

Everybody who got the treatment was able to touch the tank containing the tarantula. It was only one treatment session; nobody’s was longer than 1 hour, and the average treatment time was 38 minutes.
 

That’s pretty effective.

It’s pretty good, compared with other studies. And I believe this is because of all the components I mentioned: being able to use your real environment; combining it with the real tarantula; the variety of the types of the feared objects; and, of course, giving the patient a sense of autonomy at the end.

Then we had to see how prolonged the effects are. We had them come in 1 week and 1 month after the treatment. I’d remind them of the principles of good exposure therapy and ask them to keep practicing at home between the sessions, looking at pictures and videos. But we never tested who did or did not do it.

After 1 week and 1 month, the effects were either the same or better. A larger number of people at 1 month were able to touch the tarantula than right after treatment.
 

Treating PTSD in first responders

Did you start with spiders and dogs because those are common fears?

We started with spiders because that worked with the initial goal of creating a prototype. Spiders’ behavior is simple enough for the programming, which takes a lot of time. Another reason for choosing spiders was that we had a lot of other studies of real and virtual reality exposure therapy to compare against.

I think another reason for our success is that, when you do real exposure therapy, you have just one scared tarantula in the corner of their tank, and they don’t listen to you. But my spiders listen to me and do exactly what I tell them.

After our initial success, we obtained more funds to expand it to other phobias. The cool thing is that we don’t need separate software for different phobias. You can choose dogs or snakes, add it to the person’s environment, and decide their behaviors.

We just started a clinical trial using dogs, and another group in Turkey is running a clinical trial with dogs. Eastern Michigan University is working with spiders. And a clinic at the University of Nebraska Medical Center is going to start using them in real-world clinics, not for research.

We have another project whose goal is helping reduce the impact of trauma and also treating PTSD in first responders, who are exposed to a lot of horrible things. Rates of PTSD are around 20%-30% among cops, firefighters, and EMS personnel.

They commonly find it very painful being in crowds because the fight-or-flight instinct in the brain is constantly screening for any sign of threat in their environment. We’re working on them walking into an empty room wearing the goggles, and then their therapist can scale the stimulus up and down.

There’ll be two people in front of you talking to each other, and then another group comes in, and people get louder. People can look at you and talk to you. There’s kids running, Fourth of July fireworks, and other things that might bother someone who’s been involved in gun- or explosion-related traumas. You gradually scale up when the person is next to their therapist.

Another thing we’re doing is related to cardiopulmonary resuscitation. If a young person dies in a CPR situation, that is really painful and traumatic. So, for exposure therapy to that, we’re creating a difficult CPR scenario when that person may die. The responder wears the goggles and basically watches a group of people doing CPR while standing next to a therapist who can help them navigate it and then scale it off.

Another goal is combining this with telemedicine, where the person can do it in their real-life environment. Imagine a person with military trauma. You can put them back in the barracks, connected with their psychiatrists via telemedicine. Then we would put humans in military fatigues near them and have them interact with them to feel comfortable with that situation.
 

What else is next for you and your group?

The next biggest challenge that we’re tackling is PTSD, because of course creating human-encounter scenarios is much more complicated than spiders and dogs. We’re in the midst of developing this so we can basically bring it to people’s homes.

We’ve been working with some military personnel to see if we can basically give a device to a veteran with PTSD, so they can go home and practice on their own.

There’s another possibility for training. Let’s take the example of a police force, which can have a lot of difficulties and mistakes because of lack of exposure and training. They can wear these goggles, get fully geared up, and be placed in encounters with people of different backgrounds, of different severity, with people who could be severely mentally ill or present different challenges for the officers.

Those situations can teach them a lot. I’m the creator of this thing, but even I’m often surprised by how realistic this technology can be. I find myself interacting with avatars the same way I would if they were real humans. I actually had one of my colleagues, when we started launching the programming with the dogs, immediately jump back. It’s just like the animal brain reacts to them.
 

Last question: Do you actually interact with Tony, the tarantula?

Oh, Tony is my friend. Unfortunately, he’s not with our lab at this moment. He’s on a sabbatical at Eastern Michigan University for their clinical trials. But yes, I’ve held him. He’s very friendly.

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

At Wayne State University’s Stress, Trauma, and Anxiety Research Clinic (STARC) in Michigan, researchers are developing novel interventions for treating some very ancient phobias hardwired into the human brain. By using augmented reality as means of conducting exposure therapy, STARC researchers – including Shantanu Madaboosi, Rakesh Ramaswamy, and Lana Grasser – and STARC director Arash Javanbakht, MD, have produced compelling evidence that they can free patients of their often debilitating fears of spiders, dogs, and snakes. Yet their work doesn’t stop there, and research into treating anxiety and posttraumatic stress disorder among first responders and others with high-stress occupations is ongoing.

This news organization spoke with Dr. Javanbakht, a psychiatrist, about the technological advances that have made this work possible; the future of remote-based psychiatry; and his tarantula colleague, Tony.
 

Augmenting exposure therapy

How did you begin using artificial intelligence as a way of delivering exposure therapy?

Exposure therapy is a very effective treatment for phobias, obsessive-compulsive disorder, and PTSD. But the problem we had is that, if someone comes to me and says they’re afraid of dogs, snakes, or spiders, I don’t have those in my office. Or, if its social phobia, I can’t create those scenarios. So, despite being such an effective treatment, it’s not utilized as much as it should be.

Several years ago, I saw a TED talk by the CEO of an augmented reality company who happened to be a neuroscientist. I thought the concept was amazing, because it offered a way to overcome those limitations.

Mixed augmented reality allows us to bring all those feared objects to the clinic. I can bring my Labrador to the office for someone who’s afraid of dogs, and they can get the exposure to that one dog. But we know good exposure therapy needs to be generalizable, with as many different breeds of dogs as possible, and is context dependent. If the patient sees a dog in their neighborhood, their fear response may come back. Doing it in a real-life context, and offering as many contexts as possible, makes it more effective.

Augmented reality allows all of these options because you can have as many different types of virtual objects as you want, and the difference between augmented reality and virtual reality is that augmented reality happens in a real-life context. You wear the goggles and you can walk around the environment and track the object, so the context is more realistic.
 

When did you begin researching augmented reality as a clinical tool?

I became a faculty member here in 2015, right out of my residency training, and I think it was around 2016 or 2017 that we began this work.

I’m very much involved in exposure therapy, utilize it myself, train others, and research how it works and changes the brain. I knew the ins and outs and what would make a better exposure therapy, based on my knowledge of neuroscience.

We spend time thinking about how we can apply these neuroscientific principles in software that can also be easily used by a not very technologically savvy therapist. Because that has been a big barrier when it comes to technology and human use in medicine.

Initially, we had a company create the software for us, but we’ve since brought all the programming inside.

The cool thing about these augmented reality devices is that they have excellent surface mapping. As soon as the person wears the goggles, it automatically maps the surfaces and provides a 3D view of the patient’s environment on the therapist’s computer. Say you’re treating a patient with a fear of spiders. Through drop-down menus, the therapist can choose what type of spider, its color and size, where it should be placed, and the motion. I can choose to move the spider from 6 feet away on the floor to the walls to the ceiling.
 

Virtual phobias, real fear

A big question for a lot of people was if the spiders are virtual, will they be scary, because it has to be realistic enough to create a fear response for the therapy to work. We use a couple of wires that you can put on a person’s finger and hook them up to a tablet or a cell phone. This provides an online measure of a person’s autonomic sympathetic response.

Like a lie detector test?

Exactly. We put that on their fingers and exposed them to a real-life tarantula and to our virtual tarantulas, and the fear response was no different. That means these do create an objective fear reaction in the body.

We also had people who said, “I know this is not real. I won’t be scared.” And when we started the therapy, it was with a tiny spider 5 meters away from them, and they’d lift their legs off the floor.

With the treatment, we’d come to one room and start with a very little spider, far from them. Then gradually we move them up to bigger, more diverse types of spiders, which are moving around. The patient comes near and tries to touch them.

Then at some point, I’d put a spiderweb on the door, put a few spiders on that, open the door, and have the patient walk through it. They kept walking through this spiderweb.

When they were desensitized to these spiders in this context – and as I said, context is important – we’d go to another room. This was darker, more like a basement, and we’d continue the same thing. That would actually take much less time because they already had desensitized a lot.

In our field, sense of control is very important, especially for when a patient goes home. So at the end, I’d leave the room and talk to the patient via a baby monitor. The patient was surrounded by 20 tarantulas, without the prompt moving around the environment.

Now that they’re desensitized to my virtual spiders, the question is, how would that apply to a real spider? So, we had a real live tarantula, whose name was Tony Stark, because we’re the STARC lab. We’d put Tony at the end of a long hallway before the treatment and see how close the patients could get to him.

Everybody who got the treatment was able to touch the tank containing the tarantula. It was only one treatment session; nobody’s was longer than 1 hour, and the average treatment time was 38 minutes.
 

That’s pretty effective.

It’s pretty good, compared with other studies. And I believe this is because of all the components I mentioned: being able to use your real environment; combining it with the real tarantula; the variety of the types of the feared objects; and, of course, giving the patient a sense of autonomy at the end.

Then we had to see how prolonged the effects are. We had them come in 1 week and 1 month after the treatment. I’d remind them of the principles of good exposure therapy and ask them to keep practicing at home between the sessions, looking at pictures and videos. But we never tested who did or did not do it.

After 1 week and 1 month, the effects were either the same or better. A larger number of people at 1 month were able to touch the tarantula than right after treatment.
 

Treating PTSD in first responders

Did you start with spiders and dogs because those are common fears?

We started with spiders because that worked with the initial goal of creating a prototype. Spiders’ behavior is simple enough for the programming, which takes a lot of time. Another reason for choosing spiders was that we had a lot of other studies of real and virtual reality exposure therapy to compare against.

I think another reason for our success is that, when you do real exposure therapy, you have just one scared tarantula in the corner of their tank, and they don’t listen to you. But my spiders listen to me and do exactly what I tell them.

After our initial success, we obtained more funds to expand it to other phobias. The cool thing is that we don’t need separate software for different phobias. You can choose dogs or snakes, add it to the person’s environment, and decide their behaviors.

We just started a clinical trial using dogs, and another group in Turkey is running a clinical trial with dogs. Eastern Michigan University is working with spiders. And a clinic at the University of Nebraska Medical Center is going to start using them in real-world clinics, not for research.

We have another project whose goal is helping reduce the impact of trauma and also treating PTSD in first responders, who are exposed to a lot of horrible things. Rates of PTSD are around 20%-30% among cops, firefighters, and EMS personnel.

They commonly find it very painful being in crowds because the fight-or-flight instinct in the brain is constantly screening for any sign of threat in their environment. We’re working on them walking into an empty room wearing the goggles, and then their therapist can scale the stimulus up and down.

There’ll be two people in front of you talking to each other, and then another group comes in, and people get louder. People can look at you and talk to you. There’s kids running, Fourth of July fireworks, and other things that might bother someone who’s been involved in gun- or explosion-related traumas. You gradually scale up when the person is next to their therapist.

Another thing we’re doing is related to cardiopulmonary resuscitation. If a young person dies in a CPR situation, that is really painful and traumatic. So, for exposure therapy to that, we’re creating a difficult CPR scenario when that person may die. The responder wears the goggles and basically watches a group of people doing CPR while standing next to a therapist who can help them navigate it and then scale it off.

Another goal is combining this with telemedicine, where the person can do it in their real-life environment. Imagine a person with military trauma. You can put them back in the barracks, connected with their psychiatrists via telemedicine. Then we would put humans in military fatigues near them and have them interact with them to feel comfortable with that situation.
 

What else is next for you and your group?

The next biggest challenge that we’re tackling is PTSD, because of course creating human-encounter scenarios is much more complicated than spiders and dogs. We’re in the midst of developing this so we can basically bring it to people’s homes.

We’ve been working with some military personnel to see if we can basically give a device to a veteran with PTSD, so they can go home and practice on their own.

There’s another possibility for training. Let’s take the example of a police force, which can have a lot of difficulties and mistakes because of lack of exposure and training. They can wear these goggles, get fully geared up, and be placed in encounters with people of different backgrounds, of different severity, with people who could be severely mentally ill or present different challenges for the officers.

Those situations can teach them a lot. I’m the creator of this thing, but even I’m often surprised by how realistic this technology can be. I find myself interacting with avatars the same way I would if they were real humans. I actually had one of my colleagues, when we started launching the programming with the dogs, immediately jump back. It’s just like the animal brain reacts to them.
 

Last question: Do you actually interact with Tony, the tarantula?

Oh, Tony is my friend. Unfortunately, he’s not with our lab at this moment. He’s on a sabbatical at Eastern Michigan University for their clinical trials. But yes, I’ve held him. He’s very friendly.

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

For parents living in poverty, “diaper math” is a familiar and distressingly pressing daily calculation. Babies in the U.S. go through 6-10 disposable diapers a day, at an average cost of $70-$80 a month. Name-brand diapers with high-end absorption sell for as much as a half a dollar each, and can result in upwards of $120 a month in expenses.

One in every three American families cannot afford enough diapers to keep their infants and toddlers clean, dry, and healthy, according to the National Diaper Bank Network. For many parents, that leads to wrenching choices: diapers, food, or rent?

The COVID-19 pandemic has exacerbated the situation, both by expanding unemployment rolls and by causing supply chain disruptions that have triggered higher prices for a multitude of products, including diapers. Diaper banks – community-funded programs that offer free diapers to low-income families – distributed 86% more diapers on average in 2020 than in 2019, according to the National Diaper Bank Network. In some locations, distribution increased by as much as 800%.

Yet no federal program helps parents pay for this childhood essential. The government’s food assistance program does not cover diapers, nor do most state-level public aid programs.

California is the only state to directly fund diapers for families, but support is limited. CalWORKS, a financial assistance program for families with children, provides $30 per month to help families pay for diapers for children under age 3. Federal policy shifts also may be in the works: Democratic lawmakers are pushing to include $200 million for diaper distribution in the massive budget reconciliation package.

Without adequate resources, low-income parents are left scrambling for ways to get the most use out of each diaper. This stressful undertaking is the subject of a recent article in American Sociological Review by Jennifer Randles, PhD, professor of sociology at California State University–Fresno. In 2018, Randles conducted phone interviews with 70 mothers in California over nine months. She tried to recruit fathers as well, but only two men responded.

Dr. Randles spoke with KHN’s Jenny Gold about how the cost of diapers weighs on low-income moms, and the “inventive mothering” many low-income women adopt to shield their children from the harms of poverty. The conversation has been edited for length and clarity.

Q: How do diapers play into day-to-day anxieties for low-income mothers?

In my sample, half of the mothers told me that they worried more about diapers than they worried about food or housing.

I started to ask mothers, “Can you tell me how many diapers you have on hand right now?” Almost every one told me with exact specificity how many they had – 5 or 7 or 12. And they knew exactly how long that number of diapers would last, based on how often their children defecated and urinated, if their kid was sick, if they had a diaper rash at the time. So just all the emotional and cognitive labor that goes into keeping such careful track of diaper supplies.

They were worrying and figuring out, “OK, I’m down to almost my last diaper. What do I do now? Do I go find some cans [to sell]? Do I go sell some things in my house? Who in my social network might have some extra cash right now?” I talked to moms who sell blood plasma just to get their infants diapers.

Q: What coping strategies stood out to you?

Those of us who study diapers often call them diaper-stretching strategies. One was leaving on a diaper a little bit longer than someone might otherwise leave it on and letting it get completely full. Some mothers figured out if they bought a [more expensive] diaper that held more and leaked less, they could leave the diaper on longer.

They would also do things like letting the baby go diaperless, especially when they were at home and felt like they wouldn’t be judged for letting their baby go without a diaper. And they used every household good you can imagine to make makeshift diapers. Mothers are using cloth, sheets, and pillowcases. They’re using things that are disposable like paper towels with duct tape. They’re making diapers out their own period supplies or adult incontinence supplies when they can get a sample.

One of the questions I often get is, “Why don’t they just use cloth?” A lot of the mothers that I spoke with had tried cloth diapers and they found that they were very cost- and labor-prohibitive. If you pay for a full startup set of cloth diapers, you’re looking at anywhere from $500 to $1,000. And these moms never had that much money. Most of them didn’t have in-home washers and dryers. Some of them didn’t even have homes or consistent access to water, and it’s illegal in a lot of laundromats and public laundry facilities to wash your old diapers. So the same conditions that would prevent moms from being able to readily afford disposable diapers are the same conditions that keep them from being able to use cloth.

Q: You found that, for many women, the concept of being a good mother is wrapped up in diapering. Why is that?

Diapers and managing diapers was so fundamental to their identity as good moms. Most of the mothers in my sample went without their own food. They weren’t paying a cellphone bill or buying their own medicine or their own menstrual supplies, as a way of saving diaper money.

I talked to a lot of moms who said, when your baby is hungry, that’s horrible. Obviously, you do everything to prevent that. But there’s something about a diaper that covers this vulnerable part of a very young baby’s body, this very delicate skin. And being able to do something to meet this human need that we all have, and to maintain dignity and cleanliness.

A lot of the moms had been through the welfare system, and so they’re living in this constant fear [of losing their children]. This is especially true among mothers of color, who are much more likely to get wrapped up in the child welfare system. People can’t necessarily see when your baby’s hungry. But people can see a saggy diaper. That’s going to be one of the things that tags you as a bad mom.

Q: Was your work on diapers influenced by your experience as a parent?

When I was doing these interviews, my daughter was about 2 or 3. So still in diapers. When my daughter peed during a diaper change, I thought, “Oh, I can just toss that one. Here, let me get another clean one.” That’s a really easy choice. For me. That’s a crisis for the mothers I interviewed. Many of them told me they have an anxiety attack with every diaper change.

Q: Do you see a clear policy solution to diaper stress?

What’s kind of ironic is how much physical, emotional, and cognitive labor goes into managing something that society and lawmakers don’t even recognize. Diapers are still not really recognized as a basic need, as evidenced by the fact that they’re still taxed in 35 states.

I think what California is doing is an excellent start. And I think diaper banks are a fabulous type of community-based organization that are filling a huge need that is not being filled by safety net policies. So, public support for diaper banks.

The direct cash aid part of the social safety net has been all but dismantled in the last 25 years. California is pretty generous. But there are some states where just the cost of diapers alone would use almost half of the average state TANF [Temporary Assistance for Needy Families] benefit for a family of three. I think we really do have to address the fact that the value of cash aid buys so much less than it used to.

Q: Your body of work on marriage and families is fascinating and unusual. Is there a single animating question behind your research?

The common thread is: How do our safety net policies support low-income families’ parenting goals? And do they equalize the conditions of parenting? I think of it as a reproductive justice issue. The ability to have a child or to not have a child, and then to parent that child in conditions where the child’s basic needs are met.

We like to say that we’re child and family friendly. The diaper issue is just one of many, many issues where we don’t really put our money or our policies where our mouth is, in terms of supporting families and supporting children. I think my work is trying to get people to think more collectively about having a social responsibility to all families and to each other. No country, but especially the richest country on the planet, should have one in three very young children not having one of their basic needs met.

I interviewed one dad who was incarcerated because he wrote a bad check. And as he described it to me, he had a certain amount of money, and they needed both diapers and milk for the baby. And I’ll never forget, he said, “I didn’t make a good choice, but I made the right one.”

These are not fancy shoes. These are not name-brand clothes. This was a dad needing both milk and diapers. I don’t think it gets much more basic than that.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

For parents living in poverty, “diaper math” is a familiar and distressingly pressing daily calculation. Babies in the U.S. go through 6-10 disposable diapers a day, at an average cost of $70-$80 a month. Name-brand diapers with high-end absorption sell for as much as a half a dollar each, and can result in upwards of $120 a month in expenses.

One in every three American families cannot afford enough diapers to keep their infants and toddlers clean, dry, and healthy, according to the National Diaper Bank Network. For many parents, that leads to wrenching choices: diapers, food, or rent?

The COVID-19 pandemic has exacerbated the situation, both by expanding unemployment rolls and by causing supply chain disruptions that have triggered higher prices for a multitude of products, including diapers. Diaper banks – community-funded programs that offer free diapers to low-income families – distributed 86% more diapers on average in 2020 than in 2019, according to the National Diaper Bank Network. In some locations, distribution increased by as much as 800%.

Yet no federal program helps parents pay for this childhood essential. The government’s food assistance program does not cover diapers, nor do most state-level public aid programs.

California is the only state to directly fund diapers for families, but support is limited. CalWORKS, a financial assistance program for families with children, provides $30 per month to help families pay for diapers for children under age 3. Federal policy shifts also may be in the works: Democratic lawmakers are pushing to include $200 million for diaper distribution in the massive budget reconciliation package.

Without adequate resources, low-income parents are left scrambling for ways to get the most use out of each diaper. This stressful undertaking is the subject of a recent article in American Sociological Review by Jennifer Randles, PhD, professor of sociology at California State University–Fresno. In 2018, Randles conducted phone interviews with 70 mothers in California over nine months. She tried to recruit fathers as well, but only two men responded.

Dr. Randles spoke with KHN’s Jenny Gold about how the cost of diapers weighs on low-income moms, and the “inventive mothering” many low-income women adopt to shield their children from the harms of poverty. The conversation has been edited for length and clarity.

Q: How do diapers play into day-to-day anxieties for low-income mothers?

In my sample, half of the mothers told me that they worried more about diapers than they worried about food or housing.

I started to ask mothers, “Can you tell me how many diapers you have on hand right now?” Almost every one told me with exact specificity how many they had – 5 or 7 or 12. And they knew exactly how long that number of diapers would last, based on how often their children defecated and urinated, if their kid was sick, if they had a diaper rash at the time. So just all the emotional and cognitive labor that goes into keeping such careful track of diaper supplies.

They were worrying and figuring out, “OK, I’m down to almost my last diaper. What do I do now? Do I go find some cans [to sell]? Do I go sell some things in my house? Who in my social network might have some extra cash right now?” I talked to moms who sell blood plasma just to get their infants diapers.

Q: What coping strategies stood out to you?

Those of us who study diapers often call them diaper-stretching strategies. One was leaving on a diaper a little bit longer than someone might otherwise leave it on and letting it get completely full. Some mothers figured out if they bought a [more expensive] diaper that held more and leaked less, they could leave the diaper on longer.

They would also do things like letting the baby go diaperless, especially when they were at home and felt like they wouldn’t be judged for letting their baby go without a diaper. And they used every household good you can imagine to make makeshift diapers. Mothers are using cloth, sheets, and pillowcases. They’re using things that are disposable like paper towels with duct tape. They’re making diapers out their own period supplies or adult incontinence supplies when they can get a sample.

One of the questions I often get is, “Why don’t they just use cloth?” A lot of the mothers that I spoke with had tried cloth diapers and they found that they were very cost- and labor-prohibitive. If you pay for a full startup set of cloth diapers, you’re looking at anywhere from $500 to $1,000. And these moms never had that much money. Most of them didn’t have in-home washers and dryers. Some of them didn’t even have homes or consistent access to water, and it’s illegal in a lot of laundromats and public laundry facilities to wash your old diapers. So the same conditions that would prevent moms from being able to readily afford disposable diapers are the same conditions that keep them from being able to use cloth.

Q: You found that, for many women, the concept of being a good mother is wrapped up in diapering. Why is that?

Diapers and managing diapers was so fundamental to their identity as good moms. Most of the mothers in my sample went without their own food. They weren’t paying a cellphone bill or buying their own medicine or their own menstrual supplies, as a way of saving diaper money.

I talked to a lot of moms who said, when your baby is hungry, that’s horrible. Obviously, you do everything to prevent that. But there’s something about a diaper that covers this vulnerable part of a very young baby’s body, this very delicate skin. And being able to do something to meet this human need that we all have, and to maintain dignity and cleanliness.

A lot of the moms had been through the welfare system, and so they’re living in this constant fear [of losing their children]. This is especially true among mothers of color, who are much more likely to get wrapped up in the child welfare system. People can’t necessarily see when your baby’s hungry. But people can see a saggy diaper. That’s going to be one of the things that tags you as a bad mom.

Q: Was your work on diapers influenced by your experience as a parent?

When I was doing these interviews, my daughter was about 2 or 3. So still in diapers. When my daughter peed during a diaper change, I thought, “Oh, I can just toss that one. Here, let me get another clean one.” That’s a really easy choice. For me. That’s a crisis for the mothers I interviewed. Many of them told me they have an anxiety attack with every diaper change.

Q: Do you see a clear policy solution to diaper stress?

What’s kind of ironic is how much physical, emotional, and cognitive labor goes into managing something that society and lawmakers don’t even recognize. Diapers are still not really recognized as a basic need, as evidenced by the fact that they’re still taxed in 35 states.

I think what California is doing is an excellent start. And I think diaper banks are a fabulous type of community-based organization that are filling a huge need that is not being filled by safety net policies. So, public support for diaper banks.

The direct cash aid part of the social safety net has been all but dismantled in the last 25 years. California is pretty generous. But there are some states where just the cost of diapers alone would use almost half of the average state TANF [Temporary Assistance for Needy Families] benefit for a family of three. I think we really do have to address the fact that the value of cash aid buys so much less than it used to.

Q: Your body of work on marriage and families is fascinating and unusual. Is there a single animating question behind your research?

The common thread is: How do our safety net policies support low-income families’ parenting goals? And do they equalize the conditions of parenting? I think of it as a reproductive justice issue. The ability to have a child or to not have a child, and then to parent that child in conditions where the child’s basic needs are met.

We like to say that we’re child and family friendly. The diaper issue is just one of many, many issues where we don’t really put our money or our policies where our mouth is, in terms of supporting families and supporting children. I think my work is trying to get people to think more collectively about having a social responsibility to all families and to each other. No country, but especially the richest country on the planet, should have one in three very young children not having one of their basic needs met.

I interviewed one dad who was incarcerated because he wrote a bad check. And as he described it to me, he had a certain amount of money, and they needed both diapers and milk for the baby. And I’ll never forget, he said, “I didn’t make a good choice, but I made the right one.”

These are not fancy shoes. These are not name-brand clothes. This was a dad needing both milk and diapers. I don’t think it gets much more basic than that.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

For parents living in poverty, “diaper math” is a familiar and distressingly pressing daily calculation. Babies in the U.S. go through 6-10 disposable diapers a day, at an average cost of $70-$80 a month. Name-brand diapers with high-end absorption sell for as much as a half a dollar each, and can result in upwards of $120 a month in expenses.

One in every three American families cannot afford enough diapers to keep their infants and toddlers clean, dry, and healthy, according to the National Diaper Bank Network. For many parents, that leads to wrenching choices: diapers, food, or rent?

The COVID-19 pandemic has exacerbated the situation, both by expanding unemployment rolls and by causing supply chain disruptions that have triggered higher prices for a multitude of products, including diapers. Diaper banks – community-funded programs that offer free diapers to low-income families – distributed 86% more diapers on average in 2020 than in 2019, according to the National Diaper Bank Network. In some locations, distribution increased by as much as 800%.

Yet no federal program helps parents pay for this childhood essential. The government’s food assistance program does not cover diapers, nor do most state-level public aid programs.

California is the only state to directly fund diapers for families, but support is limited. CalWORKS, a financial assistance program for families with children, provides $30 per month to help families pay for diapers for children under age 3. Federal policy shifts also may be in the works: Democratic lawmakers are pushing to include $200 million for diaper distribution in the massive budget reconciliation package.

Without adequate resources, low-income parents are left scrambling for ways to get the most use out of each diaper. This stressful undertaking is the subject of a recent article in American Sociological Review by Jennifer Randles, PhD, professor of sociology at California State University–Fresno. In 2018, Randles conducted phone interviews with 70 mothers in California over nine months. She tried to recruit fathers as well, but only two men responded.

Dr. Randles spoke with KHN’s Jenny Gold about how the cost of diapers weighs on low-income moms, and the “inventive mothering” many low-income women adopt to shield their children from the harms of poverty. The conversation has been edited for length and clarity.

Q: How do diapers play into day-to-day anxieties for low-income mothers?

In my sample, half of the mothers told me that they worried more about diapers than they worried about food or housing.

I started to ask mothers, “Can you tell me how many diapers you have on hand right now?” Almost every one told me with exact specificity how many they had – 5 or 7 or 12. And they knew exactly how long that number of diapers would last, based on how often their children defecated and urinated, if their kid was sick, if they had a diaper rash at the time. So just all the emotional and cognitive labor that goes into keeping such careful track of diaper supplies.

They were worrying and figuring out, “OK, I’m down to almost my last diaper. What do I do now? Do I go find some cans [to sell]? Do I go sell some things in my house? Who in my social network might have some extra cash right now?” I talked to moms who sell blood plasma just to get their infants diapers.

Q: What coping strategies stood out to you?

Those of us who study diapers often call them diaper-stretching strategies. One was leaving on a diaper a little bit longer than someone might otherwise leave it on and letting it get completely full. Some mothers figured out if they bought a [more expensive] diaper that held more and leaked less, they could leave the diaper on longer.

They would also do things like letting the baby go diaperless, especially when they were at home and felt like they wouldn’t be judged for letting their baby go without a diaper. And they used every household good you can imagine to make makeshift diapers. Mothers are using cloth, sheets, and pillowcases. They’re using things that are disposable like paper towels with duct tape. They’re making diapers out their own period supplies or adult incontinence supplies when they can get a sample.

One of the questions I often get is, “Why don’t they just use cloth?” A lot of the mothers that I spoke with had tried cloth diapers and they found that they were very cost- and labor-prohibitive. If you pay for a full startup set of cloth diapers, you’re looking at anywhere from $500 to $1,000. And these moms never had that much money. Most of them didn’t have in-home washers and dryers. Some of them didn’t even have homes or consistent access to water, and it’s illegal in a lot of laundromats and public laundry facilities to wash your old diapers. So the same conditions that would prevent moms from being able to readily afford disposable diapers are the same conditions that keep them from being able to use cloth.

Q: You found that, for many women, the concept of being a good mother is wrapped up in diapering. Why is that?

Diapers and managing diapers was so fundamental to their identity as good moms. Most of the mothers in my sample went without their own food. They weren’t paying a cellphone bill or buying their own medicine or their own menstrual supplies, as a way of saving diaper money.

I talked to a lot of moms who said, when your baby is hungry, that’s horrible. Obviously, you do everything to prevent that. But there’s something about a diaper that covers this vulnerable part of a very young baby’s body, this very delicate skin. And being able to do something to meet this human need that we all have, and to maintain dignity and cleanliness.

A lot of the moms had been through the welfare system, and so they’re living in this constant fear [of losing their children]. This is especially true among mothers of color, who are much more likely to get wrapped up in the child welfare system. People can’t necessarily see when your baby’s hungry. But people can see a saggy diaper. That’s going to be one of the things that tags you as a bad mom.

Q: Was your work on diapers influenced by your experience as a parent?

When I was doing these interviews, my daughter was about 2 or 3. So still in diapers. When my daughter peed during a diaper change, I thought, “Oh, I can just toss that one. Here, let me get another clean one.” That’s a really easy choice. For me. That’s a crisis for the mothers I interviewed. Many of them told me they have an anxiety attack with every diaper change.

Q: Do you see a clear policy solution to diaper stress?

What’s kind of ironic is how much physical, emotional, and cognitive labor goes into managing something that society and lawmakers don’t even recognize. Diapers are still not really recognized as a basic need, as evidenced by the fact that they’re still taxed in 35 states.

I think what California is doing is an excellent start. And I think diaper banks are a fabulous type of community-based organization that are filling a huge need that is not being filled by safety net policies. So, public support for diaper banks.

The direct cash aid part of the social safety net has been all but dismantled in the last 25 years. California is pretty generous. But there are some states where just the cost of diapers alone would use almost half of the average state TANF [Temporary Assistance for Needy Families] benefit for a family of three. I think we really do have to address the fact that the value of cash aid buys so much less than it used to.

Q: Your body of work on marriage and families is fascinating and unusual. Is there a single animating question behind your research?

The common thread is: How do our safety net policies support low-income families’ parenting goals? And do they equalize the conditions of parenting? I think of it as a reproductive justice issue. The ability to have a child or to not have a child, and then to parent that child in conditions where the child’s basic needs are met.

We like to say that we’re child and family friendly. The diaper issue is just one of many, many issues where we don’t really put our money or our policies where our mouth is, in terms of supporting families and supporting children. I think my work is trying to get people to think more collectively about having a social responsibility to all families and to each other. No country, but especially the richest country on the planet, should have one in three very young children not having one of their basic needs met.

I interviewed one dad who was incarcerated because he wrote a bad check. And as he described it to me, he had a certain amount of money, and they needed both diapers and milk for the baby. And I’ll never forget, he said, “I didn’t make a good choice, but I made the right one.”

These are not fancy shoes. These are not name-brand clothes. This was a dad needing both milk and diapers. I don’t think it gets much more basic than that.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anesthesiologists charge private insurers more than 300% above Medicare rates, a markup that is higher than that of 16 other specialties, according to a study released by the Urban Institute.

The Washington-based nonprofit institute found that the lowest markups were in psychiatry, ophthalmology, ob.gyn., family medicine, gastroenterology, and internal medicine, at 110%-120% of Medicare rates. Dermatology on average charged just 90% of Medicare rates.

In the middle are cardiology and cardiovascular surgery (130%), urology (130%), general surgery, surgical and radiation oncology (all at 140%), and orthopedics (150%).

At the top end were radiology (180%), neurosurgery (220%), emergency and critical care (250%), and anesthesiology (330%).

The wide variation in payments could be cited in support of the idea of applying Medicare rates across all physician specialties, say the study authors. Although lowering practitioner payments might lead to savings, it “will also create more pushback from providers, especially if these rates are introduced in the employer market,” write researchers Stacey McMorrow, PhD, Robert A. Berenson, MD, and John Holahan, PhD.

It is not known whether lowering commercial payment rates might decrease patient access, they write.

The authors also note that specialties in which the potential for a fee reduction was greatest were also the specialties for which baseline compensation was highest – from $350,000 annually for emergency physicians to $800,000 a year for neurosurgeons. Annual compensation for ob.gyns., dermatologists, and opthalmologists is about $350,000 a year, which suggests that “these specialties are similarly well compensated by both Medicare and commercial insurers,” the authors write.

The investigators assessed the top 20 procedure codes by expenditure in each of 17 physician specialties. They estimated the commercial-to-Medicare payment ratio for each service and constructed weighted averages across services for each specialty at the national level and for 12 states for which data for all the specialties and services were available.

The researchers analyzed claims from the FAIR Health database between March 2019 and March 2020. That database represents 60 insurers covering 150 million people.

Pediatric and geriatric specialties, nonphysician practitioners, out-of-network clinicians, and ambulatory surgery center claims were excluded. Codes with modifiers, J codes, and clinical laboratory services were also not included.

The charges used in the study were not the actual contracted rates. The authors instead used “imputed allowed amounts” for each claim line. That method was used to protect the confidentiality of the negotiated rates.

With regard to all specialties, the lowest compensated services were procedures, evaluation and management, and tests, which received 140%-150% of the Medicare rate. Treatments and imaging were marked up 160%. Anesthesia was reimbursed at a rate 330% higher than the rate Medicare would pay.

The authors also assessed geographic variation for the 12 states for which they had data.

Similar to findings in other studies, the researchers found that the markup was lowest in Pennsylvania (120%) and highest in Wisconsin (260%). The U.S. average was 160%. California and Missouri were at 150%; Michigan was right at the average.

For physicians in Illinois, Louisiana, Colorado, Texas, and New York, markups were 170%-180% over the Medicare rate. Markups for clinicians in New Jersey (190%) and Arizona (200%) were closest to the Wisconsin rate.

The authors note some study limitations, including the fact that they excluded out-of-network practitioners, “and such payments may disproportionately affect certain specialties.”

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

Anesthesiologists charge private insurers more than 300% above Medicare rates, a markup that is higher than that of 16 other specialties, according to a study released by the Urban Institute.

The Washington-based nonprofit institute found that the lowest markups were in psychiatry, ophthalmology, ob.gyn., family medicine, gastroenterology, and internal medicine, at 110%-120% of Medicare rates. Dermatology on average charged just 90% of Medicare rates.

In the middle are cardiology and cardiovascular surgery (130%), urology (130%), general surgery, surgical and radiation oncology (all at 140%), and orthopedics (150%).

At the top end were radiology (180%), neurosurgery (220%), emergency and critical care (250%), and anesthesiology (330%).

The wide variation in payments could be cited in support of the idea of applying Medicare rates across all physician specialties, say the study authors. Although lowering practitioner payments might lead to savings, it “will also create more pushback from providers, especially if these rates are introduced in the employer market,” write researchers Stacey McMorrow, PhD, Robert A. Berenson, MD, and John Holahan, PhD.

It is not known whether lowering commercial payment rates might decrease patient access, they write.

The authors also note that specialties in which the potential for a fee reduction was greatest were also the specialties for which baseline compensation was highest – from $350,000 annually for emergency physicians to $800,000 a year for neurosurgeons. Annual compensation for ob.gyns., dermatologists, and opthalmologists is about $350,000 a year, which suggests that “these specialties are similarly well compensated by both Medicare and commercial insurers,” the authors write.

The investigators assessed the top 20 procedure codes by expenditure in each of 17 physician specialties. They estimated the commercial-to-Medicare payment ratio for each service and constructed weighted averages across services for each specialty at the national level and for 12 states for which data for all the specialties and services were available.

The researchers analyzed claims from the FAIR Health database between March 2019 and March 2020. That database represents 60 insurers covering 150 million people.

Pediatric and geriatric specialties, nonphysician practitioners, out-of-network clinicians, and ambulatory surgery center claims were excluded. Codes with modifiers, J codes, and clinical laboratory services were also not included.

The charges used in the study were not the actual contracted rates. The authors instead used “imputed allowed amounts” for each claim line. That method was used to protect the confidentiality of the negotiated rates.

With regard to all specialties, the lowest compensated services were procedures, evaluation and management, and tests, which received 140%-150% of the Medicare rate. Treatments and imaging were marked up 160%. Anesthesia was reimbursed at a rate 330% higher than the rate Medicare would pay.

The authors also assessed geographic variation for the 12 states for which they had data.

Similar to findings in other studies, the researchers found that the markup was lowest in Pennsylvania (120%) and highest in Wisconsin (260%). The U.S. average was 160%. California and Missouri were at 150%; Michigan was right at the average.

For physicians in Illinois, Louisiana, Colorado, Texas, and New York, markups were 170%-180% over the Medicare rate. Markups for clinicians in New Jersey (190%) and Arizona (200%) were closest to the Wisconsin rate.

The authors note some study limitations, including the fact that they excluded out-of-network practitioners, “and such payments may disproportionately affect certain specialties.”

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

Anesthesiologists charge private insurers more than 300% above Medicare rates, a markup that is higher than that of 16 other specialties, according to a study released by the Urban Institute.

The Washington-based nonprofit institute found that the lowest markups were in psychiatry, ophthalmology, ob.gyn., family medicine, gastroenterology, and internal medicine, at 110%-120% of Medicare rates. Dermatology on average charged just 90% of Medicare rates.

In the middle are cardiology and cardiovascular surgery (130%), urology (130%), general surgery, surgical and radiation oncology (all at 140%), and orthopedics (150%).

At the top end were radiology (180%), neurosurgery (220%), emergency and critical care (250%), and anesthesiology (330%).

The wide variation in payments could be cited in support of the idea of applying Medicare rates across all physician specialties, say the study authors. Although lowering practitioner payments might lead to savings, it “will also create more pushback from providers, especially if these rates are introduced in the employer market,” write researchers Stacey McMorrow, PhD, Robert A. Berenson, MD, and John Holahan, PhD.

It is not known whether lowering commercial payment rates might decrease patient access, they write.

The authors also note that specialties in which the potential for a fee reduction was greatest were also the specialties for which baseline compensation was highest – from $350,000 annually for emergency physicians to $800,000 a year for neurosurgeons. Annual compensation for ob.gyns., dermatologists, and opthalmologists is about $350,000 a year, which suggests that “these specialties are similarly well compensated by both Medicare and commercial insurers,” the authors write.

The investigators assessed the top 20 procedure codes by expenditure in each of 17 physician specialties. They estimated the commercial-to-Medicare payment ratio for each service and constructed weighted averages across services for each specialty at the national level and for 12 states for which data for all the specialties and services were available.

The researchers analyzed claims from the FAIR Health database between March 2019 and March 2020. That database represents 60 insurers covering 150 million people.

Pediatric and geriatric specialties, nonphysician practitioners, out-of-network clinicians, and ambulatory surgery center claims were excluded. Codes with modifiers, J codes, and clinical laboratory services were also not included.

The charges used in the study were not the actual contracted rates. The authors instead used “imputed allowed amounts” for each claim line. That method was used to protect the confidentiality of the negotiated rates.

With regard to all specialties, the lowest compensated services were procedures, evaluation and management, and tests, which received 140%-150% of the Medicare rate. Treatments and imaging were marked up 160%. Anesthesia was reimbursed at a rate 330% higher than the rate Medicare would pay.

The authors also assessed geographic variation for the 12 states for which they had data.

Similar to findings in other studies, the researchers found that the markup was lowest in Pennsylvania (120%) and highest in Wisconsin (260%). The U.S. average was 160%. California and Missouri were at 150%; Michigan was right at the average.

For physicians in Illinois, Louisiana, Colorado, Texas, and New York, markups were 170%-180% over the Medicare rate. Markups for clinicians in New Jersey (190%) and Arizona (200%) were closest to the Wisconsin rate.

The authors note some study limitations, including the fact that they excluded out-of-network practitioners, “and such payments may disproportionately affect certain specialties.”

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

Years ago, when rheumatologist Leonard Sigal, MD, was undertaking research on Lyme disease and treating patients with the condition at the Robert Wood Johnson Medical School, New Brunswick, N.J., a regular stream of abuse and threats became the usual background noise of his work. He didn’t get used to it, but it never stopped.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“I was accused of incredibly heinous crimes,” Dr. Sigal said in an interview. “I was accused of lying, cheating, of doing things to make money that were against the public interest and against the interest of patients in general.”

It’s an experience many doctors who treat Lyme disease have endured, so much so that some infectious disease doctors aren’t comfortable treating patients with Lyme disease, according to Timothy Flanigan, MD, a professor of infectious disease at Brown University, Providence, R.I.

But it wasn’t until Dr. Sigal left academia in 2003 that he realized the toll all that background abuse had been taking on him.

“It was a breath of fresh air,” he said. “I didn’t have to go into clinic and argue with people. I didn’t have to read articles in the newspaper that made no sense whatsoever. I didn’t have to hear through second and third parties how such and such was saying horrible things about me. I didn’t have to fight anymore. When I was in industry and working on stuff that had nothing to do with Lyme disease, I realized what a relief it was not to have that burden.”

So the last thing Dr. Sigal expected after all these years was to find himself named in a lawsuit alleging that he was part of a conspiracy to deny patients of what they claimed was appropriate treatment for Lyme disease. Yet, that’s exactly what happened in November 2017, when a group of 24 patients with Lyme disease, led by Texas resident Lisa Torrey, filed a lawsuit against the Infectious Diseases Society of America, eight insurance companies, and 7 of the doctors involved in producing the IDSA guidelines on Lyme disease diagnosis and management. Dr. Sigal himself had not even participated in writing the guidelines. He simply reviewed them, made a few grammatical suggestions, and said they looked good. Over the next 4 years, however, he and his fellow defendants rode an emotional roller coaster of seemingly endless motions, amendments, and other legal developments, waiting to find out whether they would owe millions of dollars for simply summarizing – or just reviewing – the available medical literature on Lyme disease.

“There were times I was on the verge of real anger. I was frustrated. There were times I was frightened, and, occasionally, I would just think of it as being silly. But when I thought of it as being silly, I had to remember I was being sued in Texas, because who knows what’s going to happen,” Dr. Sigal said. “It’s not as though I was being sued in a jurisdiction where anybody knew about Lyme disease. There are examples of physicians who are convicted of doing things they didn’t do because they were sued in the wrong jurisdiction.”

Several individuals who spoke with this news organization on condition of anonymity said that the district court where the suit was filed is notorious for being especially friendly to plaintiffs. But in legal rulings issued on Sept. 1 and Sept. 20, 2021, a federal judge in Texas dismissed all the patient group’s claims. The plaintiffs filed an appeal on Oct. 19. It’s unclear whether that has any reasonable chance of success.

“One of the things this court case does is validate the fact that our [guidelines] process is a legitimate process and there isn’t outside influence from insurance companies or pharma firms,” Daniel McQuillen, MD, president of IDSA, said in an interview. “We don’t really want anything other than to be vindicated, which we were, 100%.”

But that vindication came with a cost, both emotional and financial. Although IDSA’s insurance covered many of its legal costs, “it’s not a trivial expense,” Dr. McQuillen said. “We’re left with a baseless lawsuit with no facts that went on for 4 years, and our [medical] society basically bore all that expense, which isn’t really particularly fair.”
 

‘Preposterous’ accusations

The lawsuit alleged that the IDSA, the seven named physicians, and the insurance companies had “engaged in a decades-long conspiracy to deny the existence and prevent treatment of chronic Lyme disease.” The patient group claimed that the doctors knew that many patients with Lyme disease do not respond to short-term antibiotic treatment and instead need “long-term antibiotic treatment until the symptoms are resolved,” an assertion not supported by the scientific evidence.

What many patients call “chronic Lyme disease” is termed posttreatment Lyme disease syndrome (PTDLS), a constellation of symptoms that include pain, fatigue, and cognitive difficulties that some people experience after a 2- to 4-week course of antibiotics for Lyme disease. It took years of patient advocacy before the Centers for Disease Control and Prevention recognized PTLDS as a condition, but awareness of it has been increasing, said Dr. Flanigan, who was not involved in the lawsuit but treats patients with Lyme disease and PTLDS.

“Long haulers and sequelae of COVID have really opened the eyes of many practitioners that these long-term inflammatory conditions are real and very challenging to treat, and we need to work with patients to help them improve their health,” Dr. Flanigan said. “It’s a sad commentary on our society that the difficulty in treating patients with posttreatment Lyme disease syndrome, or what is commonly referred to by patients as chronic Lyme, ends up in a lawsuit in court.” He said he’s glad the lawsuit was dismissed but added that “there’s a crying need for additional high-quality, evidence-based research to help patients who are suffering from posttreatment Lyme disease syndrome.”

Patients fought for broader recognition of their condition, and some of them organized. They came up with their own ideas of what was causing their symptoms to persist. One that especially took hold was that infection from Borrelia burgdorferi, the bacteria that causes Lyme disease, persists after initial antibiotic treatment, causing so-called chronic Lyme disease. The cause of PTLDS is still under investigation, and the evidence does not support the idea of a persistent bacterial infection. Multiple studies from the National Institutes of Health have shown that long-term use of antibiotics does not benefit patients who continue to experience symptoms after initial treatment. Several studies have shown that severe adverse effects can result from extended intravenous antibiotic treatment, including death.

Nevertheless, the plaintiffs in the lawsuit argued that the insurance companies “enlisted the help of doctors who were researching Lyme disease – the IDSA panelists – and paid them large fees to develop arbitrary guidelines for testing Lyme disease,” thereby enabling the insurance companies to deny coverage for long-term antibiotic treatment to patients.

“The assertions were just preposterous,” Dr. McQuillen said.

In addition to the conspiracy charge, the plaintiffs brought additional accusations to the lawsuit over the years, including racketeering and claims that the guidelines contain false representations regarding Lyme disease testing and treatment. The plaintiffs claimed that the guidelines didn’t acknowledge that treatment can fail and included false information about how to test for Lyme disease. In reality, however, the guidelines do acknowledge that not all patients respond to the recommended 2- to 4-week course of antibiotics and that some diagnoses should be made clinically rather than on the basis of testing.

Regardless, guidelines are not stipulations. They’re a summation of the medical and scientific findings on Lyme disease based on careful review of hundreds of studies.

“They make really clear that adherence to the guidelines [is] voluntary. They aren’t a standard of care from which deviation of care is a problem,” Dr. McQuillen said. “You take those guidelines and apply it to the patient in front of you, and you see what fits best for that patient, because not every patient is going to fit into guidelines.”

Further, the authors said that IDSA vets their recommendations for any potential conflicts of interest in accordance with the organization’s guidelines practices.

“The point of the guidelines is to have people on the committee who don’t care what the guidelines are as long as we have good patient care,” Dr. McQuillen said.

Choosing to fight

Malpractice insurance does not cover this kind of lawsuit, because the doctors named in it did not personally treat any of the patients who filed it. Thus, the doctors were at risk of losing thousands, or millions, of dollars in legal fees, even if they ultimately prevail. Several of the physicians’ academic and health care institutions stepped in to cover some fees, and IDSA covered the rest in a joint defense.

“The IDSA provided me a lawyer at no cost to me, and I felt protected by them,” Dr. Sigal said. “They took care of me and made sure I was safe, and I am grateful to them for that.”

Dr. McQuillen said the expenses exceeded what the organization’s umbrella insurance covered. The physicians had invested their time and effort into the guidelines without any financial compensation.

“They’ve basically put a lot of sweat equity into producing guidelines” that follow the organization’s practices and ethics, Dr. McQuillen said. “To leave them out on an island by themselves is just not the right thing to do. We wouldn’t do that for any of our members who did something on behalf of our society.”

IDSA could have chosen to settle the lawsuit, as the insurance companies did.

“None of us on the board felt that was the right thing to do, because we believe in the process, and the science is right, and you shouldn’t be able to try to change that by having a lawsuit that’s baseless,” Dr. McQuillen said.

Several of the doctors named in the suit spoke with this news organization off the record about the exhaustion, frustration, and general suffering the suit has caused them over the past several years, including ongoing harassment that targeted their families and often became quite personal. But none expressed any wish that IDSA had chosen the faster, cheaper, easier route of settling.

“I love the organization for having done this rather than caving and paying,” Dr. Sigal said. “They showed real moral character, real integrity in fighting this suit, because they had done nothing wrong.”

Fighting the suit was about more than standing by the science, though. It’s essential to ensure physicians continue to conduct research and write clinical guidelines, even about ambiguous or controversial topics, said Raymond J. Dattwyler, MD, a professor of microbiology, immunology, and medicine at New York Medical College, Valhalla, who wrote the treatment part of the guidelines and was named in the suit.

“I was really surprised that someone would sue for scientific guidelines, because guidelines are common across medicine, and they’re just a roadmap to help practicing physicians understand how to handle evaluation or treatment of any number of particular problems,” Dr. Dattwyler said in an interview. But he wasn’t surprised that IDSA chose to fight the accusations, “because the principle involved is so compelling. It’s really standing up for all medical societies, and it’s very important to have guidelines. For the health and welfare of the American public, you need to have good information readily available to the practicing physicians.”

If the patient group had won in a settlement, it could potentially have led to less rigorous guidelines from other medical organizations, which would have had an adverse effect on public health, Dr. Dattwyler said. Such a chilling effect could reverberate far beyond the management of Lyme disease.

“One of the problems with our legal system is anybody can sue anybody, but it costs so much to defend yourself,” Dr. Dattwyler said. “This lawsuit costs millions, so that’s chilling. That’s going to inhibit guidelines, and it’s not only guidelines for infectious disease but it’s guidelines for cancer, guidelines for allergic diseases, guidelines for any number of things.”

To an extent, the threats and harassment that patient groups have directed toward different doctors have already had a chilling effect.

“For the people who gave of their time in good faith to generate these guidelines to get harassed everywhere, all the time, sometimes at home, sometimes at their place of work, it’s just unfair,” Dr. McQuillen said. “It also might discourage people from working in research to try to figure out better diagnostics or get a vaccine that actually works. Even if you really find it incredibly interesting, if laying over you is the threat that someone is going to sue you baselessly, and you’re going to have to put the time and effort into defending that, not to mention the money, I can’t see how that would be considered a positive that would encourage you to do it. In some ways, attacking people that are trying to help may drive them away from trying to help.

“At the same time, professional disagreements among practitioners – including a small minority who do treat patients with lengthy courses of antibiotics – can ultimately harm patient care, Dr. Flanigan said.

“There’s a lot of energy being expended fighting among different care providers, and often the individual needs of the patients seem to be not addressed,” Dr. Flanigan said. “The discord between different approaches often seems more important than spending time with the individual patient and trying to find a tailored approach to treatment which can benefit the patient best.”

At the same time, Dr. Sigal said he believes most of the clinicians who use non–evidence-based treatments for their patients do so because they genuinely believe it’s the right thing to do.

“I think they’re motivated by the same concerns that I have, and that is, I need to do what’s best for my patient,” Dr. Sigal said. Ultimately, the evidence should lead the way. “The only arbiter we possibly have in deciding these things is the medical scientific literature,” he added, “and if you can’t subscribe to that, then this way lies madness.”

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

Years ago, when rheumatologist Leonard Sigal, MD, was undertaking research on Lyme disease and treating patients with the condition at the Robert Wood Johnson Medical School, New Brunswick, N.J., a regular stream of abuse and threats became the usual background noise of his work. He didn’t get used to it, but it never stopped.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“I was accused of incredibly heinous crimes,” Dr. Sigal said in an interview. “I was accused of lying, cheating, of doing things to make money that were against the public interest and against the interest of patients in general.”

It’s an experience many doctors who treat Lyme disease have endured, so much so that some infectious disease doctors aren’t comfortable treating patients with Lyme disease, according to Timothy Flanigan, MD, a professor of infectious disease at Brown University, Providence, R.I.

But it wasn’t until Dr. Sigal left academia in 2003 that he realized the toll all that background abuse had been taking on him.

“It was a breath of fresh air,” he said. “I didn’t have to go into clinic and argue with people. I didn’t have to read articles in the newspaper that made no sense whatsoever. I didn’t have to hear through second and third parties how such and such was saying horrible things about me. I didn’t have to fight anymore. When I was in industry and working on stuff that had nothing to do with Lyme disease, I realized what a relief it was not to have that burden.”

So the last thing Dr. Sigal expected after all these years was to find himself named in a lawsuit alleging that he was part of a conspiracy to deny patients of what they claimed was appropriate treatment for Lyme disease. Yet, that’s exactly what happened in November 2017, when a group of 24 patients with Lyme disease, led by Texas resident Lisa Torrey, filed a lawsuit against the Infectious Diseases Society of America, eight insurance companies, and 7 of the doctors involved in producing the IDSA guidelines on Lyme disease diagnosis and management. Dr. Sigal himself had not even participated in writing the guidelines. He simply reviewed them, made a few grammatical suggestions, and said they looked good. Over the next 4 years, however, he and his fellow defendants rode an emotional roller coaster of seemingly endless motions, amendments, and other legal developments, waiting to find out whether they would owe millions of dollars for simply summarizing – or just reviewing – the available medical literature on Lyme disease.

“There were times I was on the verge of real anger. I was frustrated. There were times I was frightened, and, occasionally, I would just think of it as being silly. But when I thought of it as being silly, I had to remember I was being sued in Texas, because who knows what’s going to happen,” Dr. Sigal said. “It’s not as though I was being sued in a jurisdiction where anybody knew about Lyme disease. There are examples of physicians who are convicted of doing things they didn’t do because they were sued in the wrong jurisdiction.”

Several individuals who spoke with this news organization on condition of anonymity said that the district court where the suit was filed is notorious for being especially friendly to plaintiffs. But in legal rulings issued on Sept. 1 and Sept. 20, 2021, a federal judge in Texas dismissed all the patient group’s claims. The plaintiffs filed an appeal on Oct. 19. It’s unclear whether that has any reasonable chance of success.

“One of the things this court case does is validate the fact that our [guidelines] process is a legitimate process and there isn’t outside influence from insurance companies or pharma firms,” Daniel McQuillen, MD, president of IDSA, said in an interview. “We don’t really want anything other than to be vindicated, which we were, 100%.”

But that vindication came with a cost, both emotional and financial. Although IDSA’s insurance covered many of its legal costs, “it’s not a trivial expense,” Dr. McQuillen said. “We’re left with a baseless lawsuit with no facts that went on for 4 years, and our [medical] society basically bore all that expense, which isn’t really particularly fair.”
 

‘Preposterous’ accusations

The lawsuit alleged that the IDSA, the seven named physicians, and the insurance companies had “engaged in a decades-long conspiracy to deny the existence and prevent treatment of chronic Lyme disease.” The patient group claimed that the doctors knew that many patients with Lyme disease do not respond to short-term antibiotic treatment and instead need “long-term antibiotic treatment until the symptoms are resolved,” an assertion not supported by the scientific evidence.

What many patients call “chronic Lyme disease” is termed posttreatment Lyme disease syndrome (PTDLS), a constellation of symptoms that include pain, fatigue, and cognitive difficulties that some people experience after a 2- to 4-week course of antibiotics for Lyme disease. It took years of patient advocacy before the Centers for Disease Control and Prevention recognized PTLDS as a condition, but awareness of it has been increasing, said Dr. Flanigan, who was not involved in the lawsuit but treats patients with Lyme disease and PTLDS.

“Long haulers and sequelae of COVID have really opened the eyes of many practitioners that these long-term inflammatory conditions are real and very challenging to treat, and we need to work with patients to help them improve their health,” Dr. Flanigan said. “It’s a sad commentary on our society that the difficulty in treating patients with posttreatment Lyme disease syndrome, or what is commonly referred to by patients as chronic Lyme, ends up in a lawsuit in court.” He said he’s glad the lawsuit was dismissed but added that “there’s a crying need for additional high-quality, evidence-based research to help patients who are suffering from posttreatment Lyme disease syndrome.”

Patients fought for broader recognition of their condition, and some of them organized. They came up with their own ideas of what was causing their symptoms to persist. One that especially took hold was that infection from Borrelia burgdorferi, the bacteria that causes Lyme disease, persists after initial antibiotic treatment, causing so-called chronic Lyme disease. The cause of PTLDS is still under investigation, and the evidence does not support the idea of a persistent bacterial infection. Multiple studies from the National Institutes of Health have shown that long-term use of antibiotics does not benefit patients who continue to experience symptoms after initial treatment. Several studies have shown that severe adverse effects can result from extended intravenous antibiotic treatment, including death.

Nevertheless, the plaintiffs in the lawsuit argued that the insurance companies “enlisted the help of doctors who were researching Lyme disease – the IDSA panelists – and paid them large fees to develop arbitrary guidelines for testing Lyme disease,” thereby enabling the insurance companies to deny coverage for long-term antibiotic treatment to patients.

“The assertions were just preposterous,” Dr. McQuillen said.

In addition to the conspiracy charge, the plaintiffs brought additional accusations to the lawsuit over the years, including racketeering and claims that the guidelines contain false representations regarding Lyme disease testing and treatment. The plaintiffs claimed that the guidelines didn’t acknowledge that treatment can fail and included false information about how to test for Lyme disease. In reality, however, the guidelines do acknowledge that not all patients respond to the recommended 2- to 4-week course of antibiotics and that some diagnoses should be made clinically rather than on the basis of testing.

Regardless, guidelines are not stipulations. They’re a summation of the medical and scientific findings on Lyme disease based on careful review of hundreds of studies.

“They make really clear that adherence to the guidelines [is] voluntary. They aren’t a standard of care from which deviation of care is a problem,” Dr. McQuillen said. “You take those guidelines and apply it to the patient in front of you, and you see what fits best for that patient, because not every patient is going to fit into guidelines.”

Further, the authors said that IDSA vets their recommendations for any potential conflicts of interest in accordance with the organization’s guidelines practices.

“The point of the guidelines is to have people on the committee who don’t care what the guidelines are as long as we have good patient care,” Dr. McQuillen said.

Choosing to fight

Malpractice insurance does not cover this kind of lawsuit, because the doctors named in it did not personally treat any of the patients who filed it. Thus, the doctors were at risk of losing thousands, or millions, of dollars in legal fees, even if they ultimately prevail. Several of the physicians’ academic and health care institutions stepped in to cover some fees, and IDSA covered the rest in a joint defense.

“The IDSA provided me a lawyer at no cost to me, and I felt protected by them,” Dr. Sigal said. “They took care of me and made sure I was safe, and I am grateful to them for that.”

Dr. McQuillen said the expenses exceeded what the organization’s umbrella insurance covered. The physicians had invested their time and effort into the guidelines without any financial compensation.

“They’ve basically put a lot of sweat equity into producing guidelines” that follow the organization’s practices and ethics, Dr. McQuillen said. “To leave them out on an island by themselves is just not the right thing to do. We wouldn’t do that for any of our members who did something on behalf of our society.”

IDSA could have chosen to settle the lawsuit, as the insurance companies did.

“None of us on the board felt that was the right thing to do, because we believe in the process, and the science is right, and you shouldn’t be able to try to change that by having a lawsuit that’s baseless,” Dr. McQuillen said.

Several of the doctors named in the suit spoke with this news organization off the record about the exhaustion, frustration, and general suffering the suit has caused them over the past several years, including ongoing harassment that targeted their families and often became quite personal. But none expressed any wish that IDSA had chosen the faster, cheaper, easier route of settling.

“I love the organization for having done this rather than caving and paying,” Dr. Sigal said. “They showed real moral character, real integrity in fighting this suit, because they had done nothing wrong.”

Fighting the suit was about more than standing by the science, though. It’s essential to ensure physicians continue to conduct research and write clinical guidelines, even about ambiguous or controversial topics, said Raymond J. Dattwyler, MD, a professor of microbiology, immunology, and medicine at New York Medical College, Valhalla, who wrote the treatment part of the guidelines and was named in the suit.

“I was really surprised that someone would sue for scientific guidelines, because guidelines are common across medicine, and they’re just a roadmap to help practicing physicians understand how to handle evaluation or treatment of any number of particular problems,” Dr. Dattwyler said in an interview. But he wasn’t surprised that IDSA chose to fight the accusations, “because the principle involved is so compelling. It’s really standing up for all medical societies, and it’s very important to have guidelines. For the health and welfare of the American public, you need to have good information readily available to the practicing physicians.”

If the patient group had won in a settlement, it could potentially have led to less rigorous guidelines from other medical organizations, which would have had an adverse effect on public health, Dr. Dattwyler said. Such a chilling effect could reverberate far beyond the management of Lyme disease.

“One of the problems with our legal system is anybody can sue anybody, but it costs so much to defend yourself,” Dr. Dattwyler said. “This lawsuit costs millions, so that’s chilling. That’s going to inhibit guidelines, and it’s not only guidelines for infectious disease but it’s guidelines for cancer, guidelines for allergic diseases, guidelines for any number of things.”

To an extent, the threats and harassment that patient groups have directed toward different doctors have already had a chilling effect.

“For the people who gave of their time in good faith to generate these guidelines to get harassed everywhere, all the time, sometimes at home, sometimes at their place of work, it’s just unfair,” Dr. McQuillen said. “It also might discourage people from working in research to try to figure out better diagnostics or get a vaccine that actually works. Even if you really find it incredibly interesting, if laying over you is the threat that someone is going to sue you baselessly, and you’re going to have to put the time and effort into defending that, not to mention the money, I can’t see how that would be considered a positive that would encourage you to do it. In some ways, attacking people that are trying to help may drive them away from trying to help.

“At the same time, professional disagreements among practitioners – including a small minority who do treat patients with lengthy courses of antibiotics – can ultimately harm patient care, Dr. Flanigan said.

“There’s a lot of energy being expended fighting among different care providers, and often the individual needs of the patients seem to be not addressed,” Dr. Flanigan said. “The discord between different approaches often seems more important than spending time with the individual patient and trying to find a tailored approach to treatment which can benefit the patient best.”

At the same time, Dr. Sigal said he believes most of the clinicians who use non–evidence-based treatments for their patients do so because they genuinely believe it’s the right thing to do.

“I think they’re motivated by the same concerns that I have, and that is, I need to do what’s best for my patient,” Dr. Sigal said. Ultimately, the evidence should lead the way. “The only arbiter we possibly have in deciding these things is the medical scientific literature,” he added, “and if you can’t subscribe to that, then this way lies madness.”

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

Years ago, when rheumatologist Leonard Sigal, MD, was undertaking research on Lyme disease and treating patients with the condition at the Robert Wood Johnson Medical School, New Brunswick, N.J., a regular stream of abuse and threats became the usual background noise of his work. He didn’t get used to it, but it never stopped.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“I was accused of incredibly heinous crimes,” Dr. Sigal said in an interview. “I was accused of lying, cheating, of doing things to make money that were against the public interest and against the interest of patients in general.”

It’s an experience many doctors who treat Lyme disease have endured, so much so that some infectious disease doctors aren’t comfortable treating patients with Lyme disease, according to Timothy Flanigan, MD, a professor of infectious disease at Brown University, Providence, R.I.

But it wasn’t until Dr. Sigal left academia in 2003 that he realized the toll all that background abuse had been taking on him.

“It was a breath of fresh air,” he said. “I didn’t have to go into clinic and argue with people. I didn’t have to read articles in the newspaper that made no sense whatsoever. I didn’t have to hear through second and third parties how such and such was saying horrible things about me. I didn’t have to fight anymore. When I was in industry and working on stuff that had nothing to do with Lyme disease, I realized what a relief it was not to have that burden.”

So the last thing Dr. Sigal expected after all these years was to find himself named in a lawsuit alleging that he was part of a conspiracy to deny patients of what they claimed was appropriate treatment for Lyme disease. Yet, that’s exactly what happened in November 2017, when a group of 24 patients with Lyme disease, led by Texas resident Lisa Torrey, filed a lawsuit against the Infectious Diseases Society of America, eight insurance companies, and 7 of the doctors involved in producing the IDSA guidelines on Lyme disease diagnosis and management. Dr. Sigal himself had not even participated in writing the guidelines. He simply reviewed them, made a few grammatical suggestions, and said they looked good. Over the next 4 years, however, he and his fellow defendants rode an emotional roller coaster of seemingly endless motions, amendments, and other legal developments, waiting to find out whether they would owe millions of dollars for simply summarizing – or just reviewing – the available medical literature on Lyme disease.

“There were times I was on the verge of real anger. I was frustrated. There were times I was frightened, and, occasionally, I would just think of it as being silly. But when I thought of it as being silly, I had to remember I was being sued in Texas, because who knows what’s going to happen,” Dr. Sigal said. “It’s not as though I was being sued in a jurisdiction where anybody knew about Lyme disease. There are examples of physicians who are convicted of doing things they didn’t do because they were sued in the wrong jurisdiction.”

Several individuals who spoke with this news organization on condition of anonymity said that the district court where the suit was filed is notorious for being especially friendly to plaintiffs. But in legal rulings issued on Sept. 1 and Sept. 20, 2021, a federal judge in Texas dismissed all the patient group’s claims. The plaintiffs filed an appeal on Oct. 19. It’s unclear whether that has any reasonable chance of success.

“One of the things this court case does is validate the fact that our [guidelines] process is a legitimate process and there isn’t outside influence from insurance companies or pharma firms,” Daniel McQuillen, MD, president of IDSA, said in an interview. “We don’t really want anything other than to be vindicated, which we were, 100%.”

But that vindication came with a cost, both emotional and financial. Although IDSA’s insurance covered many of its legal costs, “it’s not a trivial expense,” Dr. McQuillen said. “We’re left with a baseless lawsuit with no facts that went on for 4 years, and our [medical] society basically bore all that expense, which isn’t really particularly fair.”
 

‘Preposterous’ accusations

The lawsuit alleged that the IDSA, the seven named physicians, and the insurance companies had “engaged in a decades-long conspiracy to deny the existence and prevent treatment of chronic Lyme disease.” The patient group claimed that the doctors knew that many patients with Lyme disease do not respond to short-term antibiotic treatment and instead need “long-term antibiotic treatment until the symptoms are resolved,” an assertion not supported by the scientific evidence.

What many patients call “chronic Lyme disease” is termed posttreatment Lyme disease syndrome (PTDLS), a constellation of symptoms that include pain, fatigue, and cognitive difficulties that some people experience after a 2- to 4-week course of antibiotics for Lyme disease. It took years of patient advocacy before the Centers for Disease Control and Prevention recognized PTLDS as a condition, but awareness of it has been increasing, said Dr. Flanigan, who was not involved in the lawsuit but treats patients with Lyme disease and PTLDS.

“Long haulers and sequelae of COVID have really opened the eyes of many practitioners that these long-term inflammatory conditions are real and very challenging to treat, and we need to work with patients to help them improve their health,” Dr. Flanigan said. “It’s a sad commentary on our society that the difficulty in treating patients with posttreatment Lyme disease syndrome, or what is commonly referred to by patients as chronic Lyme, ends up in a lawsuit in court.” He said he’s glad the lawsuit was dismissed but added that “there’s a crying need for additional high-quality, evidence-based research to help patients who are suffering from posttreatment Lyme disease syndrome.”

Patients fought for broader recognition of their condition, and some of them organized. They came up with their own ideas of what was causing their symptoms to persist. One that especially took hold was that infection from Borrelia burgdorferi, the bacteria that causes Lyme disease, persists after initial antibiotic treatment, causing so-called chronic Lyme disease. The cause of PTLDS is still under investigation, and the evidence does not support the idea of a persistent bacterial infection. Multiple studies from the National Institutes of Health have shown that long-term use of antibiotics does not benefit patients who continue to experience symptoms after initial treatment. Several studies have shown that severe adverse effects can result from extended intravenous antibiotic treatment, including death.

Nevertheless, the plaintiffs in the lawsuit argued that the insurance companies “enlisted the help of doctors who were researching Lyme disease – the IDSA panelists – and paid them large fees to develop arbitrary guidelines for testing Lyme disease,” thereby enabling the insurance companies to deny coverage for long-term antibiotic treatment to patients.

“The assertions were just preposterous,” Dr. McQuillen said.

In addition to the conspiracy charge, the plaintiffs brought additional accusations to the lawsuit over the years, including racketeering and claims that the guidelines contain false representations regarding Lyme disease testing and treatment. The plaintiffs claimed that the guidelines didn’t acknowledge that treatment can fail and included false information about how to test for Lyme disease. In reality, however, the guidelines do acknowledge that not all patients respond to the recommended 2- to 4-week course of antibiotics and that some diagnoses should be made clinically rather than on the basis of testing.

Regardless, guidelines are not stipulations. They’re a summation of the medical and scientific findings on Lyme disease based on careful review of hundreds of studies.

“They make really clear that adherence to the guidelines [is] voluntary. They aren’t a standard of care from which deviation of care is a problem,” Dr. McQuillen said. “You take those guidelines and apply it to the patient in front of you, and you see what fits best for that patient, because not every patient is going to fit into guidelines.”

Further, the authors said that IDSA vets their recommendations for any potential conflicts of interest in accordance with the organization’s guidelines practices.

“The point of the guidelines is to have people on the committee who don’t care what the guidelines are as long as we have good patient care,” Dr. McQuillen said.

Choosing to fight

Malpractice insurance does not cover this kind of lawsuit, because the doctors named in it did not personally treat any of the patients who filed it. Thus, the doctors were at risk of losing thousands, or millions, of dollars in legal fees, even if they ultimately prevail. Several of the physicians’ academic and health care institutions stepped in to cover some fees, and IDSA covered the rest in a joint defense.

“The IDSA provided me a lawyer at no cost to me, and I felt protected by them,” Dr. Sigal said. “They took care of me and made sure I was safe, and I am grateful to them for that.”

Dr. McQuillen said the expenses exceeded what the organization’s umbrella insurance covered. The physicians had invested their time and effort into the guidelines without any financial compensation.

“They’ve basically put a lot of sweat equity into producing guidelines” that follow the organization’s practices and ethics, Dr. McQuillen said. “To leave them out on an island by themselves is just not the right thing to do. We wouldn’t do that for any of our members who did something on behalf of our society.”

IDSA could have chosen to settle the lawsuit, as the insurance companies did.

“None of us on the board felt that was the right thing to do, because we believe in the process, and the science is right, and you shouldn’t be able to try to change that by having a lawsuit that’s baseless,” Dr. McQuillen said.

Several of the doctors named in the suit spoke with this news organization off the record about the exhaustion, frustration, and general suffering the suit has caused them over the past several years, including ongoing harassment that targeted their families and often became quite personal. But none expressed any wish that IDSA had chosen the faster, cheaper, easier route of settling.

“I love the organization for having done this rather than caving and paying,” Dr. Sigal said. “They showed real moral character, real integrity in fighting this suit, because they had done nothing wrong.”

Fighting the suit was about more than standing by the science, though. It’s essential to ensure physicians continue to conduct research and write clinical guidelines, even about ambiguous or controversial topics, said Raymond J. Dattwyler, MD, a professor of microbiology, immunology, and medicine at New York Medical College, Valhalla, who wrote the treatment part of the guidelines and was named in the suit.

“I was really surprised that someone would sue for scientific guidelines, because guidelines are common across medicine, and they’re just a roadmap to help practicing physicians understand how to handle evaluation or treatment of any number of particular problems,” Dr. Dattwyler said in an interview. But he wasn’t surprised that IDSA chose to fight the accusations, “because the principle involved is so compelling. It’s really standing up for all medical societies, and it’s very important to have guidelines. For the health and welfare of the American public, you need to have good information readily available to the practicing physicians.”

If the patient group had won in a settlement, it could potentially have led to less rigorous guidelines from other medical organizations, which would have had an adverse effect on public health, Dr. Dattwyler said. Such a chilling effect could reverberate far beyond the management of Lyme disease.

“One of the problems with our legal system is anybody can sue anybody, but it costs so much to defend yourself,” Dr. Dattwyler said. “This lawsuit costs millions, so that’s chilling. That’s going to inhibit guidelines, and it’s not only guidelines for infectious disease but it’s guidelines for cancer, guidelines for allergic diseases, guidelines for any number of things.”

To an extent, the threats and harassment that patient groups have directed toward different doctors have already had a chilling effect.

“For the people who gave of their time in good faith to generate these guidelines to get harassed everywhere, all the time, sometimes at home, sometimes at their place of work, it’s just unfair,” Dr. McQuillen said. “It also might discourage people from working in research to try to figure out better diagnostics or get a vaccine that actually works. Even if you really find it incredibly interesting, if laying over you is the threat that someone is going to sue you baselessly, and you’re going to have to put the time and effort into defending that, not to mention the money, I can’t see how that would be considered a positive that would encourage you to do it. In some ways, attacking people that are trying to help may drive them away from trying to help.

“At the same time, professional disagreements among practitioners – including a small minority who do treat patients with lengthy courses of antibiotics – can ultimately harm patient care, Dr. Flanigan said.

“There’s a lot of energy being expended fighting among different care providers, and often the individual needs of the patients seem to be not addressed,” Dr. Flanigan said. “The discord between different approaches often seems more important than spending time with the individual patient and trying to find a tailored approach to treatment which can benefit the patient best.”

At the same time, Dr. Sigal said he believes most of the clinicians who use non–evidence-based treatments for their patients do so because they genuinely believe it’s the right thing to do.

“I think they’re motivated by the same concerns that I have, and that is, I need to do what’s best for my patient,” Dr. Sigal said. Ultimately, the evidence should lead the way. “The only arbiter we possibly have in deciding these things is the medical scientific literature,” he added, “and if you can’t subscribe to that, then this way lies madness.”

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

The pandemic exacerbated the financial struggles of many primary care practices, and some still have not recovered from COVID-19–related losses, according to experts and the results of recent surveys by the Primary Care Collaborative (PCC).

Fewer than 30% (26.4%) of primary care clinicians report that their practices are financially healthy, according to the latest results from a periodic survey by the PCC. An earlier survey by the PCC suggests clinicians’ confidence in the financial viability of their practices has significantly declined since last year, when compared with the new survey’s results. When the older survey was taken between Sept. 4 and Sept. 8 of 2020, only 35% of primary care clinicians said that revenue and pay were significantly lower than they were before the pandemic.

Submissions to the new PCC survey were collected between Aug. 13 and Aug. 17 of 2021 and included 1,263 respondents from 49 states, the District of Columbia, and two territories. The PCC and the Larry A. Green Center have been regularly surveying primary care clinicians to better understand the impact of COVID-19 throughout the pandemic.

PCC President and CEO Ann Greiner said in an interview that the drop over a year follows a trend.

Though primary care faced struggles before the pandemic, the COVID-19 effect has been striking and cumulative, she noted.

“[Primary care practices] were healthier prepandemic,” said Ms. Greiner. “The precipitous drop in revenue when stay-at-home orders went into effect had a very big effect though pay structure and lack of investment in primary care was a problem long before COVID-19.”

COVID-19 has exacerbated all that ails primary care, and has increased fears of viability of primary care offices, she said.

Ms. Greiner pointed to a report from Health Affairs, that projected in 2020 that primary care would lose $65,000 in revenue per full-time physician by the end of the year for a total shortfall of $15 billion, following steep drops in office visits and fees for services from March to May, 2020.

In July of this year, she said, PCC’s survey found that, “Four in 10 clinicians worry that primary care will be gone in 5 years and one-fifth of respondents expect to leave the profession within the next three.”

The July PCC survey also showed that 13% of primary care clinicians said they have discussed selling their practice and cite high-level burnout/exhaustion as a main challenge for the next 6 months.

Robert L. Phillips, MD, a Virginia-based physician who oversees research for the American Board of Family Medicine, said, “Practices in our national primary care practice registry (PRIME) saw visit volumes drop 40% in the 2-3 months around the start of the pandemic and had not seen them return to normal as of June of this year. This means most remain financially underwater.”


 

End to paycheck protection hurt practices

Conrad L. Flick, MD, managing partner of Family Medical Associates in Raleigh, N.C., said the end of the federal Paycheck Protection Program (PPP) at the end of 2020 caused further distress to primary care and could also help explain the drop in healthy practices that PCC’s survey from last year suggested.

“Many of us who struggled financially as the pandemic hit last year were really worried. PPP certainly shored that up for a lot of us. But now it’s no longer here,” he said.

Dr. Flick said his 10-clinician independent practice is financially sound and he credits that to having the PPP loan, shared savings from an accountable care organization, and holding some profit over from last year to this year.

His practice had to cut two nurse practitioners this year when volume did not return to prepandemic levels.

“The PPP loan let us keep [those NPs] employed through spring, but we were hoping the volume would come back. Come spring this year the volume hasn’t come back, and we couldn’t afford to keep the office at full staff,” he said.

The way primary care physicians are paid is what makes them so vulnerable in a pandemic, he explained.

“Our revenue is purely based on how many people I can get through my office at a given period of time. We don’t have ways to generate revenue and build a cushion.”

Family physician L. Allen Dobson, MD, said the survey results may have become even more grim in the last year, because primary care practices, especially small practices, have not recovered from the 2020 losses and effects have snowballed.

Even though primary care offices have largely reopened and many patients have returned to in-person visits, he said, physicians are dealing with uncertainties of COVID-19 surges and variants and are having trouble recruiting and maintaining staff.

Revenue that should have come to primary care practices in testing and distributing vaccines instead went elsewhere to larger vaccination sites and retail clinics, noted Dr. Dobson, who is chair of the board of managers of Community Care Physicians Network in Mount Pleasant, N.C., which provides assistance with administrative tasks to small and solo primary care practices.
 

COVID-19 brought ‘accelerated change’

COVID-19 brought “an accelerated change,” in decreasing revenue, Dr. Dobson said.

Small primary care practices have followed the rules of changing to electronic health records, getting patient-centered medical home certification, and documenting quality improvement measures, but they have not reaped the financial benefits from these changes, he explained.

A report commissioned by the Physician Advocacy Institute found that the pandemic accelerated a long national trend of hospitals and corporate entities acquiring physician practices and employing physicians.

From January 2019 to January 2021, these entities acquired 20,900 additional physician practices and 48,000 additional physicians left independent practice for employment by hospital systems or other corporate entities.

Further straining practices is a thinning workforce, with 21% or respondents to the most recent PCC survey having said they were unable to hire clinicians for open positions and 54% saying they are unable to hire staff for open positions.

One respondent to the PCC survey from Utah said, “We need more support. It’s a moral injury to have our pay cut and be severely understaffed. Most of the burden of educating patients and getting them vaccinated has fallen to primary care and we are already overwhelmed with taking care of patients with worsening mental and physical health.”

According to Bruce Landon, MD, MBA, professor of health care policy at the Harvard Medical School’s Center for Primary Care, Boston, another source of financial strain for primary care practices is that they are having difficulty attracting doctors, nurses, and administrators.

These practices often need to increase pay for those positions to recruit people, and they are leaving many positions unfilled, Dr. Landon explained.

Plus, COVID-19 introduced costs for personal protective equipment (PPE) and cleaning products, and those expenses generally have not been reimbursed, Dr. Landon said.
 

Uncertainty around telemedicine

A new risk for primary care is a decline in telemedicine payments at a time when practices are still relying on telemedicine for revenue.

In the most recent PCC report, 40% of clinicians said they use telemedicine for at least a fifth of all office visits.

Even though most practices have reopened there’s still a fair amount of telemedicine and that will continue, Dr. Landon said in an interview.

In March of 2020, the Centers for Medicare & Medicaid Services lifted restrictions and that helped physicians with getting reimbursed for the services as they would office visits. But some commercial payers are starting to back off full payment for telemedicine, Dr. Landon noted.

“At some point the feds will probably start to do that with Medicare. I think that’s a mistake. [Telemedicine] has been one of the silver linings of this cloud of the pandemic,” he said.

If prepandemic payment regulations are restored, 41% of clinicians said, in the most recent PCC survey, that they worry their practices will no longer be able to support telemedicine.
 

Possible safety nets

Dr. Landon said that one thing that’s also clear is that some form of primary care capitation payment is necessary, at least for some of the work in primary care.

The practices that had capitation as part of payment were the ones who were most easily able to handle the pandemic because they didn’t see the immediate drop in revenue that fee-for-service practices saw, he noted.

“If we have a next pandemic, having a steady revenue stream to support primary care is really important and having a different way to pay for primary care is probably the best way to do that,” he said. “These longer-term strategies are going to be really crucial if we want to have a primary care system 10 years from now.”

Ms. Greiner, Dr. Flick, Dr. Phillips, Dr. Dobson, and Dr. Landon report no relevant financial relationships.

The pandemic exacerbated the financial struggles of many primary care practices, and some still have not recovered from COVID-19–related losses, according to experts and the results of recent surveys by the Primary Care Collaborative (PCC).

Fewer than 30% (26.4%) of primary care clinicians report that their practices are financially healthy, according to the latest results from a periodic survey by the PCC. An earlier survey by the PCC suggests clinicians’ confidence in the financial viability of their practices has significantly declined since last year, when compared with the new survey’s results. When the older survey was taken between Sept. 4 and Sept. 8 of 2020, only 35% of primary care clinicians said that revenue and pay were significantly lower than they were before the pandemic.

Submissions to the new PCC survey were collected between Aug. 13 and Aug. 17 of 2021 and included 1,263 respondents from 49 states, the District of Columbia, and two territories. The PCC and the Larry A. Green Center have been regularly surveying primary care clinicians to better understand the impact of COVID-19 throughout the pandemic.

PCC President and CEO Ann Greiner said in an interview that the drop over a year follows a trend.

Though primary care faced struggles before the pandemic, the COVID-19 effect has been striking and cumulative, she noted.

“[Primary care practices] were healthier prepandemic,” said Ms. Greiner. “The precipitous drop in revenue when stay-at-home orders went into effect had a very big effect though pay structure and lack of investment in primary care was a problem long before COVID-19.”

COVID-19 has exacerbated all that ails primary care, and has increased fears of viability of primary care offices, she said.

Ms. Greiner pointed to a report from Health Affairs, that projected in 2020 that primary care would lose $65,000 in revenue per full-time physician by the end of the year for a total shortfall of $15 billion, following steep drops in office visits and fees for services from March to May, 2020.

In July of this year, she said, PCC’s survey found that, “Four in 10 clinicians worry that primary care will be gone in 5 years and one-fifth of respondents expect to leave the profession within the next three.”

The July PCC survey also showed that 13% of primary care clinicians said they have discussed selling their practice and cite high-level burnout/exhaustion as a main challenge for the next 6 months.

Robert L. Phillips, MD, a Virginia-based physician who oversees research for the American Board of Family Medicine, said, “Practices in our national primary care practice registry (PRIME) saw visit volumes drop 40% in the 2-3 months around the start of the pandemic and had not seen them return to normal as of June of this year. This means most remain financially underwater.”


 

End to paycheck protection hurt practices

Conrad L. Flick, MD, managing partner of Family Medical Associates in Raleigh, N.C., said the end of the federal Paycheck Protection Program (PPP) at the end of 2020 caused further distress to primary care and could also help explain the drop in healthy practices that PCC’s survey from last year suggested.

“Many of us who struggled financially as the pandemic hit last year were really worried. PPP certainly shored that up for a lot of us. But now it’s no longer here,” he said.

Dr. Flick said his 10-clinician independent practice is financially sound and he credits that to having the PPP loan, shared savings from an accountable care organization, and holding some profit over from last year to this year.

His practice had to cut two nurse practitioners this year when volume did not return to prepandemic levels.

“The PPP loan let us keep [those NPs] employed through spring, but we were hoping the volume would come back. Come spring this year the volume hasn’t come back, and we couldn’t afford to keep the office at full staff,” he said.

The way primary care physicians are paid is what makes them so vulnerable in a pandemic, he explained.

“Our revenue is purely based on how many people I can get through my office at a given period of time. We don’t have ways to generate revenue and build a cushion.”

Family physician L. Allen Dobson, MD, said the survey results may have become even more grim in the last year, because primary care practices, especially small practices, have not recovered from the 2020 losses and effects have snowballed.

Even though primary care offices have largely reopened and many patients have returned to in-person visits, he said, physicians are dealing with uncertainties of COVID-19 surges and variants and are having trouble recruiting and maintaining staff.

Revenue that should have come to primary care practices in testing and distributing vaccines instead went elsewhere to larger vaccination sites and retail clinics, noted Dr. Dobson, who is chair of the board of managers of Community Care Physicians Network in Mount Pleasant, N.C., which provides assistance with administrative tasks to small and solo primary care practices.
 

COVID-19 brought ‘accelerated change’

COVID-19 brought “an accelerated change,” in decreasing revenue, Dr. Dobson said.

Small primary care practices have followed the rules of changing to electronic health records, getting patient-centered medical home certification, and documenting quality improvement measures, but they have not reaped the financial benefits from these changes, he explained.

A report commissioned by the Physician Advocacy Institute found that the pandemic accelerated a long national trend of hospitals and corporate entities acquiring physician practices and employing physicians.

From January 2019 to January 2021, these entities acquired 20,900 additional physician practices and 48,000 additional physicians left independent practice for employment by hospital systems or other corporate entities.

Further straining practices is a thinning workforce, with 21% or respondents to the most recent PCC survey having said they were unable to hire clinicians for open positions and 54% saying they are unable to hire staff for open positions.

One respondent to the PCC survey from Utah said, “We need more support. It’s a moral injury to have our pay cut and be severely understaffed. Most of the burden of educating patients and getting them vaccinated has fallen to primary care and we are already overwhelmed with taking care of patients with worsening mental and physical health.”

According to Bruce Landon, MD, MBA, professor of health care policy at the Harvard Medical School’s Center for Primary Care, Boston, another source of financial strain for primary care practices is that they are having difficulty attracting doctors, nurses, and administrators.

These practices often need to increase pay for those positions to recruit people, and they are leaving many positions unfilled, Dr. Landon explained.

Plus, COVID-19 introduced costs for personal protective equipment (PPE) and cleaning products, and those expenses generally have not been reimbursed, Dr. Landon said.
 

Uncertainty around telemedicine

A new risk for primary care is a decline in telemedicine payments at a time when practices are still relying on telemedicine for revenue.

In the most recent PCC report, 40% of clinicians said they use telemedicine for at least a fifth of all office visits.

Even though most practices have reopened there’s still a fair amount of telemedicine and that will continue, Dr. Landon said in an interview.

In March of 2020, the Centers for Medicare & Medicaid Services lifted restrictions and that helped physicians with getting reimbursed for the services as they would office visits. But some commercial payers are starting to back off full payment for telemedicine, Dr. Landon noted.

“At some point the feds will probably start to do that with Medicare. I think that’s a mistake. [Telemedicine] has been one of the silver linings of this cloud of the pandemic,” he said.

If prepandemic payment regulations are restored, 41% of clinicians said, in the most recent PCC survey, that they worry their practices will no longer be able to support telemedicine.
 

Possible safety nets

Dr. Landon said that one thing that’s also clear is that some form of primary care capitation payment is necessary, at least for some of the work in primary care.

The practices that had capitation as part of payment were the ones who were most easily able to handle the pandemic because they didn’t see the immediate drop in revenue that fee-for-service practices saw, he noted.

“If we have a next pandemic, having a steady revenue stream to support primary care is really important and having a different way to pay for primary care is probably the best way to do that,” he said. “These longer-term strategies are going to be really crucial if we want to have a primary care system 10 years from now.”

Ms. Greiner, Dr. Flick, Dr. Phillips, Dr. Dobson, and Dr. Landon report no relevant financial relationships.

The pandemic exacerbated the financial struggles of many primary care practices, and some still have not recovered from COVID-19–related losses, according to experts and the results of recent surveys by the Primary Care Collaborative (PCC).

Fewer than 30% (26.4%) of primary care clinicians report that their practices are financially healthy, according to the latest results from a periodic survey by the PCC. An earlier survey by the PCC suggests clinicians’ confidence in the financial viability of their practices has significantly declined since last year, when compared with the new survey’s results. When the older survey was taken between Sept. 4 and Sept. 8 of 2020, only 35% of primary care clinicians said that revenue and pay were significantly lower than they were before the pandemic.

Submissions to the new PCC survey were collected between Aug. 13 and Aug. 17 of 2021 and included 1,263 respondents from 49 states, the District of Columbia, and two territories. The PCC and the Larry A. Green Center have been regularly surveying primary care clinicians to better understand the impact of COVID-19 throughout the pandemic.

PCC President and CEO Ann Greiner said in an interview that the drop over a year follows a trend.

Though primary care faced struggles before the pandemic, the COVID-19 effect has been striking and cumulative, she noted.

“[Primary care practices] were healthier prepandemic,” said Ms. Greiner. “The precipitous drop in revenue when stay-at-home orders went into effect had a very big effect though pay structure and lack of investment in primary care was a problem long before COVID-19.”

COVID-19 has exacerbated all that ails primary care, and has increased fears of viability of primary care offices, she said.

Ms. Greiner pointed to a report from Health Affairs, that projected in 2020 that primary care would lose $65,000 in revenue per full-time physician by the end of the year for a total shortfall of $15 billion, following steep drops in office visits and fees for services from March to May, 2020.

In July of this year, she said, PCC’s survey found that, “Four in 10 clinicians worry that primary care will be gone in 5 years and one-fifth of respondents expect to leave the profession within the next three.”

The July PCC survey also showed that 13% of primary care clinicians said they have discussed selling their practice and cite high-level burnout/exhaustion as a main challenge for the next 6 months.

Robert L. Phillips, MD, a Virginia-based physician who oversees research for the American Board of Family Medicine, said, “Practices in our national primary care practice registry (PRIME) saw visit volumes drop 40% in the 2-3 months around the start of the pandemic and had not seen them return to normal as of June of this year. This means most remain financially underwater.”


 

End to paycheck protection hurt practices

Conrad L. Flick, MD, managing partner of Family Medical Associates in Raleigh, N.C., said the end of the federal Paycheck Protection Program (PPP) at the end of 2020 caused further distress to primary care and could also help explain the drop in healthy practices that PCC’s survey from last year suggested.

“Many of us who struggled financially as the pandemic hit last year were really worried. PPP certainly shored that up for a lot of us. But now it’s no longer here,” he said.

Dr. Flick said his 10-clinician independent practice is financially sound and he credits that to having the PPP loan, shared savings from an accountable care organization, and holding some profit over from last year to this year.

His practice had to cut two nurse practitioners this year when volume did not return to prepandemic levels.

“The PPP loan let us keep [those NPs] employed through spring, but we were hoping the volume would come back. Come spring this year the volume hasn’t come back, and we couldn’t afford to keep the office at full staff,” he said.

The way primary care physicians are paid is what makes them so vulnerable in a pandemic, he explained.

“Our revenue is purely based on how many people I can get through my office at a given period of time. We don’t have ways to generate revenue and build a cushion.”

Family physician L. Allen Dobson, MD, said the survey results may have become even more grim in the last year, because primary care practices, especially small practices, have not recovered from the 2020 losses and effects have snowballed.

Even though primary care offices have largely reopened and many patients have returned to in-person visits, he said, physicians are dealing with uncertainties of COVID-19 surges and variants and are having trouble recruiting and maintaining staff.

Revenue that should have come to primary care practices in testing and distributing vaccines instead went elsewhere to larger vaccination sites and retail clinics, noted Dr. Dobson, who is chair of the board of managers of Community Care Physicians Network in Mount Pleasant, N.C., which provides assistance with administrative tasks to small and solo primary care practices.
 

COVID-19 brought ‘accelerated change’

COVID-19 brought “an accelerated change,” in decreasing revenue, Dr. Dobson said.

Small primary care practices have followed the rules of changing to electronic health records, getting patient-centered medical home certification, and documenting quality improvement measures, but they have not reaped the financial benefits from these changes, he explained.

A report commissioned by the Physician Advocacy Institute found that the pandemic accelerated a long national trend of hospitals and corporate entities acquiring physician practices and employing physicians.

From January 2019 to January 2021, these entities acquired 20,900 additional physician practices and 48,000 additional physicians left independent practice for employment by hospital systems or other corporate entities.

Further straining practices is a thinning workforce, with 21% or respondents to the most recent PCC survey having said they were unable to hire clinicians for open positions and 54% saying they are unable to hire staff for open positions.

One respondent to the PCC survey from Utah said, “We need more support. It’s a moral injury to have our pay cut and be severely understaffed. Most of the burden of educating patients and getting them vaccinated has fallen to primary care and we are already overwhelmed with taking care of patients with worsening mental and physical health.”

According to Bruce Landon, MD, MBA, professor of health care policy at the Harvard Medical School’s Center for Primary Care, Boston, another source of financial strain for primary care practices is that they are having difficulty attracting doctors, nurses, and administrators.

These practices often need to increase pay for those positions to recruit people, and they are leaving many positions unfilled, Dr. Landon explained.

Plus, COVID-19 introduced costs for personal protective equipment (PPE) and cleaning products, and those expenses generally have not been reimbursed, Dr. Landon said.
 

Uncertainty around telemedicine

A new risk for primary care is a decline in telemedicine payments at a time when practices are still relying on telemedicine for revenue.

In the most recent PCC report, 40% of clinicians said they use telemedicine for at least a fifth of all office visits.

Even though most practices have reopened there’s still a fair amount of telemedicine and that will continue, Dr. Landon said in an interview.

In March of 2020, the Centers for Medicare & Medicaid Services lifted restrictions and that helped physicians with getting reimbursed for the services as they would office visits. But some commercial payers are starting to back off full payment for telemedicine, Dr. Landon noted.

“At some point the feds will probably start to do that with Medicare. I think that’s a mistake. [Telemedicine] has been one of the silver linings of this cloud of the pandemic,” he said.

If prepandemic payment regulations are restored, 41% of clinicians said, in the most recent PCC survey, that they worry their practices will no longer be able to support telemedicine.
 

Possible safety nets

Dr. Landon said that one thing that’s also clear is that some form of primary care capitation payment is necessary, at least for some of the work in primary care.

The practices that had capitation as part of payment were the ones who were most easily able to handle the pandemic because they didn’t see the immediate drop in revenue that fee-for-service practices saw, he noted.

“If we have a next pandemic, having a steady revenue stream to support primary care is really important and having a different way to pay for primary care is probably the best way to do that,” he said. “These longer-term strategies are going to be really crucial if we want to have a primary care system 10 years from now.”

Ms. Greiner, Dr. Flick, Dr. Phillips, Dr. Dobson, and Dr. Landon report no relevant financial relationships.

A new analysis has shown disparities in cardiovascular risk factors between Black and White adults in the United States, disparities that may be largely attributable to social determinants of health.

Investigators analyzed 20 years of data on over 50,500 U.S. adults drawn from the National Health and Nutrition Examination Surveys (NHANES) and found that, in the overall population, body mass index and hemoglobin A1c were significantly increased between 1999 and 2018, while serum total cholesterol and cigarette smoking were significantly decreased. Mean systolic blood pressure decreased between 1999 and 2010, but then increased after 2010.

The mean age- and sex-adjusted estimated 10-year risk for atherosclerotic cardiovascular disease (ASCVD) was consistently higher in Black participants vs. White participants, but the difference was attenuated after further adjusting for education, income, home ownership, employment, health insurance, and access to health care.

“These findings are helpful to guide the development of national public health policies for targeted interventions aimed at eliminating health disparities,” Jiang He, MD, PhD, Joseph S. Copes Chair and professor of epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

“Interventions on social determinants of cardiovascular health should be tested in rigorous designed intervention trials,” said Dr. He, director of the Tulane University Translational Science Institute.

The study was published online Oct. 5 in JAMA.
 

‘Flattened’ CVD mortality?

Recent data show that the CVD mortality rate flattened, while the total number of cardiovascular deaths increased in the U.S. general population from 2010 to 2018, “but the reasons for this deceleration in the decline of CVD mortality are not entirely understood,” Dr. He said.

Moreover, “racial and ethnic differences in CVD mortality persist in the U.S. general population [but] the secular trends of cardiovascular risk factors among U.S. subpopulations with various racial and ethnic backgrounds and socioeconomic status are [also] not well understood,” he added. The effects of social determinants of health, such as education, income, home ownership, employment, health insurance, and access to health care on racial/ethnic differences in CVD risk, “are not well documented.”

To investigate these questions, the researchers drew on data from NHANES, a series of cross-sectional surveys in nationally representative samples of the U.S. population aged 20 years and older. The surveys are conducted in 2-year cycles and include data from 10 cycles conducted from 1999-2000 to 2017-2018 (n = 50,571, mean age 49.0-51.8 years; 48.2%-51.3% female).

Every 2 years, participants provided sociodemographic information, including age, race/ethnicity, sex, education, income, employment, housing, health insurance, and access to health care, as well as medical history and medication use. They underwent a physical examination that included weight and height, blood pressure, lipid levels, plasma glucose, and hemoglobin A1c.
 

Social determinants of health

Between 1999-2000 and 2017-2018, age- and sex-adjusted mean BMI and hemoglobin A1c increased, while mean serum total cholesterol and prevalence of smoking decreased (all P < .001).

Participants with at least a college education or high family income had “consistently lower levels” of cardiovascular risk factors. And although the mean age- and sex-adjusted 10-year risk for ASCVD was significantly higher in non-Hispanic Black vs. non-Hispanic White participants (difference, 1.4% [1.0%-1.7%] in 1999-2008 and 2.0% [1.7%-2.4%] in 2009-2018), the difference was attenuated (by –0.3% in 1999-2008 and 0.7% in 2009-2018) after the researchers further adjusted for education, income, home ownership, employment, health insurance, and access to health care.

The differences in cardiovascular risk factors between Black and White participants “may have been moderated by social determinants of health,” the authors noted.
 

Provide appropriate education

Commenting on the study in an interview, Mary Ann McLaughlin, MD, MPH, associate professor of medicine, cardiology, Icahn School of Medicine at Mount Sinai, New York, pointed out that two important cardiovascular risk factors associated with being overweight – hypertension and diabetes – remained higher in the Black population compared with the White population in this analysis.

“Physicians and health care systems should provide appropriate education and resources regarding risk factor modification regarding diet, exercise, and blood pressure control,” advised Dr. McLaughlin, who was not involved with the study.

“Importantly, smoking rates and cholesterol levels are lower in the Black population, compared to the White population, when adjusted for many important socioeconomic factors,” she pointed out.

Dr. McLaughlin added that other “important social determinants of health, such as neighborhood and access to healthy food, were not measured and should be addressed by physicians when optimizing cardiovascular risk.”

The research reported in this publication was supported by the National Heart, Lung, and Blood Institute and by the National Institute of General Medical Sciences. One of the researchers, Joshua D. Bundy, PhD, was supported by a grant from the National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. He and the other coauthors and Dr. McLaughlin reported no relevant financial relationships.
 

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

A new analysis has shown disparities in cardiovascular risk factors between Black and White adults in the United States, disparities that may be largely attributable to social determinants of health.

Investigators analyzed 20 years of data on over 50,500 U.S. adults drawn from the National Health and Nutrition Examination Surveys (NHANES) and found that, in the overall population, body mass index and hemoglobin A1c were significantly increased between 1999 and 2018, while serum total cholesterol and cigarette smoking were significantly decreased. Mean systolic blood pressure decreased between 1999 and 2010, but then increased after 2010.

The mean age- and sex-adjusted estimated 10-year risk for atherosclerotic cardiovascular disease (ASCVD) was consistently higher in Black participants vs. White participants, but the difference was attenuated after further adjusting for education, income, home ownership, employment, health insurance, and access to health care.

“These findings are helpful to guide the development of national public health policies for targeted interventions aimed at eliminating health disparities,” Jiang He, MD, PhD, Joseph S. Copes Chair and professor of epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

“Interventions on social determinants of cardiovascular health should be tested in rigorous designed intervention trials,” said Dr. He, director of the Tulane University Translational Science Institute.

The study was published online Oct. 5 in JAMA.
 

‘Flattened’ CVD mortality?

Recent data show that the CVD mortality rate flattened, while the total number of cardiovascular deaths increased in the U.S. general population from 2010 to 2018, “but the reasons for this deceleration in the decline of CVD mortality are not entirely understood,” Dr. He said.

Moreover, “racial and ethnic differences in CVD mortality persist in the U.S. general population [but] the secular trends of cardiovascular risk factors among U.S. subpopulations with various racial and ethnic backgrounds and socioeconomic status are [also] not well understood,” he added. The effects of social determinants of health, such as education, income, home ownership, employment, health insurance, and access to health care on racial/ethnic differences in CVD risk, “are not well documented.”

To investigate these questions, the researchers drew on data from NHANES, a series of cross-sectional surveys in nationally representative samples of the U.S. population aged 20 years and older. The surveys are conducted in 2-year cycles and include data from 10 cycles conducted from 1999-2000 to 2017-2018 (n = 50,571, mean age 49.0-51.8 years; 48.2%-51.3% female).

Every 2 years, participants provided sociodemographic information, including age, race/ethnicity, sex, education, income, employment, housing, health insurance, and access to health care, as well as medical history and medication use. They underwent a physical examination that included weight and height, blood pressure, lipid levels, plasma glucose, and hemoglobin A1c.
 

Social determinants of health

Between 1999-2000 and 2017-2018, age- and sex-adjusted mean BMI and hemoglobin A1c increased, while mean serum total cholesterol and prevalence of smoking decreased (all P < .001).

Participants with at least a college education or high family income had “consistently lower levels” of cardiovascular risk factors. And although the mean age- and sex-adjusted 10-year risk for ASCVD was significantly higher in non-Hispanic Black vs. non-Hispanic White participants (difference, 1.4% [1.0%-1.7%] in 1999-2008 and 2.0% [1.7%-2.4%] in 2009-2018), the difference was attenuated (by –0.3% in 1999-2008 and 0.7% in 2009-2018) after the researchers further adjusted for education, income, home ownership, employment, health insurance, and access to health care.

The differences in cardiovascular risk factors between Black and White participants “may have been moderated by social determinants of health,” the authors noted.
 

Provide appropriate education

Commenting on the study in an interview, Mary Ann McLaughlin, MD, MPH, associate professor of medicine, cardiology, Icahn School of Medicine at Mount Sinai, New York, pointed out that two important cardiovascular risk factors associated with being overweight – hypertension and diabetes – remained higher in the Black population compared with the White population in this analysis.

“Physicians and health care systems should provide appropriate education and resources regarding risk factor modification regarding diet, exercise, and blood pressure control,” advised Dr. McLaughlin, who was not involved with the study.

“Importantly, smoking rates and cholesterol levels are lower in the Black population, compared to the White population, when adjusted for many important socioeconomic factors,” she pointed out.

Dr. McLaughlin added that other “important social determinants of health, such as neighborhood and access to healthy food, were not measured and should be addressed by physicians when optimizing cardiovascular risk.”

The research reported in this publication was supported by the National Heart, Lung, and Blood Institute and by the National Institute of General Medical Sciences. One of the researchers, Joshua D. Bundy, PhD, was supported by a grant from the National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. He and the other coauthors and Dr. McLaughlin reported no relevant financial relationships.
 

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

A new analysis has shown disparities in cardiovascular risk factors between Black and White adults in the United States, disparities that may be largely attributable to social determinants of health.

Investigators analyzed 20 years of data on over 50,500 U.S. adults drawn from the National Health and Nutrition Examination Surveys (NHANES) and found that, in the overall population, body mass index and hemoglobin A1c were significantly increased between 1999 and 2018, while serum total cholesterol and cigarette smoking were significantly decreased. Mean systolic blood pressure decreased between 1999 and 2010, but then increased after 2010.

The mean age- and sex-adjusted estimated 10-year risk for atherosclerotic cardiovascular disease (ASCVD) was consistently higher in Black participants vs. White participants, but the difference was attenuated after further adjusting for education, income, home ownership, employment, health insurance, and access to health care.

“These findings are helpful to guide the development of national public health policies for targeted interventions aimed at eliminating health disparities,” Jiang He, MD, PhD, Joseph S. Copes Chair and professor of epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

“Interventions on social determinants of cardiovascular health should be tested in rigorous designed intervention trials,” said Dr. He, director of the Tulane University Translational Science Institute.

The study was published online Oct. 5 in JAMA.
 

‘Flattened’ CVD mortality?

Recent data show that the CVD mortality rate flattened, while the total number of cardiovascular deaths increased in the U.S. general population from 2010 to 2018, “but the reasons for this deceleration in the decline of CVD mortality are not entirely understood,” Dr. He said.

Moreover, “racial and ethnic differences in CVD mortality persist in the U.S. general population [but] the secular trends of cardiovascular risk factors among U.S. subpopulations with various racial and ethnic backgrounds and socioeconomic status are [also] not well understood,” he added. The effects of social determinants of health, such as education, income, home ownership, employment, health insurance, and access to health care on racial/ethnic differences in CVD risk, “are not well documented.”

To investigate these questions, the researchers drew on data from NHANES, a series of cross-sectional surveys in nationally representative samples of the U.S. population aged 20 years and older. The surveys are conducted in 2-year cycles and include data from 10 cycles conducted from 1999-2000 to 2017-2018 (n = 50,571, mean age 49.0-51.8 years; 48.2%-51.3% female).

Every 2 years, participants provided sociodemographic information, including age, race/ethnicity, sex, education, income, employment, housing, health insurance, and access to health care, as well as medical history and medication use. They underwent a physical examination that included weight and height, blood pressure, lipid levels, plasma glucose, and hemoglobin A1c.
 

Social determinants of health

Between 1999-2000 and 2017-2018, age- and sex-adjusted mean BMI and hemoglobin A1c increased, while mean serum total cholesterol and prevalence of smoking decreased (all P < .001).

Participants with at least a college education or high family income had “consistently lower levels” of cardiovascular risk factors. And although the mean age- and sex-adjusted 10-year risk for ASCVD was significantly higher in non-Hispanic Black vs. non-Hispanic White participants (difference, 1.4% [1.0%-1.7%] in 1999-2008 and 2.0% [1.7%-2.4%] in 2009-2018), the difference was attenuated (by –0.3% in 1999-2008 and 0.7% in 2009-2018) after the researchers further adjusted for education, income, home ownership, employment, health insurance, and access to health care.

The differences in cardiovascular risk factors between Black and White participants “may have been moderated by social determinants of health,” the authors noted.
 

Provide appropriate education

Commenting on the study in an interview, Mary Ann McLaughlin, MD, MPH, associate professor of medicine, cardiology, Icahn School of Medicine at Mount Sinai, New York, pointed out that two important cardiovascular risk factors associated with being overweight – hypertension and diabetes – remained higher in the Black population compared with the White population in this analysis.

“Physicians and health care systems should provide appropriate education and resources regarding risk factor modification regarding diet, exercise, and blood pressure control,” advised Dr. McLaughlin, who was not involved with the study.

“Importantly, smoking rates and cholesterol levels are lower in the Black population, compared to the White population, when adjusted for many important socioeconomic factors,” she pointed out.

Dr. McLaughlin added that other “important social determinants of health, such as neighborhood and access to healthy food, were not measured and should be addressed by physicians when optimizing cardiovascular risk.”

The research reported in this publication was supported by the National Heart, Lung, and Blood Institute and by the National Institute of General Medical Sciences. One of the researchers, Joshua D. Bundy, PhD, was supported by a grant from the National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. He and the other coauthors and Dr. McLaughlin reported no relevant financial relationships.
 

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

Respected psychiatrist and psychoanalyst Irwin Marcus, MD, died on October 3. He was 102. Dedicated to his profession, Dr. Marcus was seeing patients until earlier this year. His long and illustrious career included creating and founding programs and organizations wherever he saw a need.

Among his many professional accomplishments, Dr. Marcus helped found the child and adolescent psychiatry program at Tulane University School of Medicine, New Orleans, and was one of the founders and a past president of the New Orleans Psychoanalytic Institute.

Dr. Marcus was also former chairman of the psychiatric department at Touro Infirmary and clinical professor emeritus at Louisiana State University Medical School, both in New Orleans.

“He initiated a number of traditions that are still important to us – community outreach, treating underserved youth, and strong interdisciplinary relationships,” Charles H. Zeanah, Jr., MD, current Mary Peters Sellars-Polchow chair of psychiatry at Tulane, told this news organization.

Dr. Marcus also continued to treat adult patients by phone and at his home until mid-June of this year. He had also started writing a children’s book.

It was his “tremendous work ethic” and creativity that kept him working past the age of 100, his wife, Angela Hill, a former news anchor, said in an interview.

Even vision loss resulting from macular degeneration and long-standing hearing problems did not stop him, she noted.

“He was always thinking creatively; he was always thinking intellectually,” said Ms. Hill. “That was, to me, the marvel of him.”
 

Wartime service, brain-trauma clinic

Born in Chicago in 1919, Dr. Marcus studied first at the Illinois Institute of Technology before transferring to the University of Illinois School of Medicine.

Neurosurgery was an early interest, and Dr. Marcus undertook his medical residency at Cook County Hospital in Chicago. The day after the bombing of Pearl Harbor, he enlisted in the U.S. Army.

During World War II, Dr. Marcus served in the Army Medical Corps and treated brain injuries and other wounds before he was badly injured himself and had to return to the United States for treatment.

After his recovery, he worked at an army medical facility in El Paso, Texas. On the basis of his earlier experiences, he founded a clinic there to diagnose and treat brain trauma.

After the war, Dr. Marcus continued his studies at Columbia University’s College of Physicians and Surgeons, in New York. Soon, his focus became psychiatry, child psychiatry, and psychoanalysis.

In 1951, Dr. Marcus accepted a position at Tulane. He created the Family Study Unit there the following year. Dr. Zeanah noted that the original name was chosen out of concern over the stigma associated with the term “child psychiatry.”

However, the environment changed relatively quickly, and the unit soon became known as Tulane Child Psychiatry.
 

Research, books, helmet patent

Dr. Marcus received Tulane’s first research grant in child psychiatry from the National Institute of Mental Health to investigate the potential mechanisms behind accident-prone children. That interest was inspired by his own clinical experience.

The findings, which were published in Monographs of the Society for Research in Child Development, showed that being accident prone was a nonspecific response to stressors from multiple sources, including a temperamental disposition, parent-child conflict, and family conflict.

To provide care to young patients, Dr. Marcus collaborated with the Children’s Bureau, the Jewish Children’s Home, the German Protestant’s Orphan Asylum, and Associated Catholic Charities.
 

‘He saved my life’

In 2002, Dr. Marcus participated in the 50th anniversary celebration of Tulane’s child psychiatry program. He returned in 2009 for what would be his final grand rounds presentation, which included an inspiring interview with Dr. Zeanah.

“He talked about the early history of child psychiatry, the things that he’d been trying to do, and some of the challenges that he faced,” Dr. Zeanah said.

Dr. Marcus’s former patients often told Ms. Hill how much he had helped them, she said.

“People would walk up and say, ‘Angela, Irwin won’t tell you this, but he saved my life,’” said Ms. Hill. “A couple walked up at a restaurant, and both of them said, ‘He saved our family.’”

Throughout his professional life, Dr. Marcus continued to strive toward growth and providing aid, she added.

“That is the bottom line of Irwin Marcus: All of his work was to help,” said Ms. Hill.

A version of this article first appeared on Medscape.

Respected psychiatrist and psychoanalyst Irwin Marcus, MD, died on October 3. He was 102. Dedicated to his profession, Dr. Marcus was seeing patients until earlier this year. His long and illustrious career included creating and founding programs and organizations wherever he saw a need.

Among his many professional accomplishments, Dr. Marcus helped found the child and adolescent psychiatry program at Tulane University School of Medicine, New Orleans, and was one of the founders and a past president of the New Orleans Psychoanalytic Institute.

Dr. Marcus was also former chairman of the psychiatric department at Touro Infirmary and clinical professor emeritus at Louisiana State University Medical School, both in New Orleans.

“He initiated a number of traditions that are still important to us – community outreach, treating underserved youth, and strong interdisciplinary relationships,” Charles H. Zeanah, Jr., MD, current Mary Peters Sellars-Polchow chair of psychiatry at Tulane, told this news organization.

Dr. Marcus also continued to treat adult patients by phone and at his home until mid-June of this year. He had also started writing a children’s book.

It was his “tremendous work ethic” and creativity that kept him working past the age of 100, his wife, Angela Hill, a former news anchor, said in an interview.

Even vision loss resulting from macular degeneration and long-standing hearing problems did not stop him, she noted.

“He was always thinking creatively; he was always thinking intellectually,” said Ms. Hill. “That was, to me, the marvel of him.”
 

Wartime service, brain-trauma clinic

Born in Chicago in 1919, Dr. Marcus studied first at the Illinois Institute of Technology before transferring to the University of Illinois School of Medicine.

Neurosurgery was an early interest, and Dr. Marcus undertook his medical residency at Cook County Hospital in Chicago. The day after the bombing of Pearl Harbor, he enlisted in the U.S. Army.

During World War II, Dr. Marcus served in the Army Medical Corps and treated brain injuries and other wounds before he was badly injured himself and had to return to the United States for treatment.

After his recovery, he worked at an army medical facility in El Paso, Texas. On the basis of his earlier experiences, he founded a clinic there to diagnose and treat brain trauma.

After the war, Dr. Marcus continued his studies at Columbia University’s College of Physicians and Surgeons, in New York. Soon, his focus became psychiatry, child psychiatry, and psychoanalysis.

In 1951, Dr. Marcus accepted a position at Tulane. He created the Family Study Unit there the following year. Dr. Zeanah noted that the original name was chosen out of concern over the stigma associated with the term “child psychiatry.”

However, the environment changed relatively quickly, and the unit soon became known as Tulane Child Psychiatry.
 

Research, books, helmet patent

Dr. Marcus received Tulane’s first research grant in child psychiatry from the National Institute of Mental Health to investigate the potential mechanisms behind accident-prone children. That interest was inspired by his own clinical experience.

The findings, which were published in Monographs of the Society for Research in Child Development, showed that being accident prone was a nonspecific response to stressors from multiple sources, including a temperamental disposition, parent-child conflict, and family conflict.

To provide care to young patients, Dr. Marcus collaborated with the Children’s Bureau, the Jewish Children’s Home, the German Protestant’s Orphan Asylum, and Associated Catholic Charities.
 

‘He saved my life’

In 2002, Dr. Marcus participated in the 50th anniversary celebration of Tulane’s child psychiatry program. He returned in 2009 for what would be his final grand rounds presentation, which included an inspiring interview with Dr. Zeanah.

“He talked about the early history of child psychiatry, the things that he’d been trying to do, and some of the challenges that he faced,” Dr. Zeanah said.

Dr. Marcus’s former patients often told Ms. Hill how much he had helped them, she said.

“People would walk up and say, ‘Angela, Irwin won’t tell you this, but he saved my life,’” said Ms. Hill. “A couple walked up at a restaurant, and both of them said, ‘He saved our family.’”

Throughout his professional life, Dr. Marcus continued to strive toward growth and providing aid, she added.

“That is the bottom line of Irwin Marcus: All of his work was to help,” said Ms. Hill.

A version of this article first appeared on Medscape.

Respected psychiatrist and psychoanalyst Irwin Marcus, MD, died on October 3. He was 102. Dedicated to his profession, Dr. Marcus was seeing patients until earlier this year. His long and illustrious career included creating and founding programs and organizations wherever he saw a need.

Among his many professional accomplishments, Dr. Marcus helped found the child and adolescent psychiatry program at Tulane University School of Medicine, New Orleans, and was one of the founders and a past president of the New Orleans Psychoanalytic Institute.

Dr. Marcus was also former chairman of the psychiatric department at Touro Infirmary and clinical professor emeritus at Louisiana State University Medical School, both in New Orleans.

“He initiated a number of traditions that are still important to us – community outreach, treating underserved youth, and strong interdisciplinary relationships,” Charles H. Zeanah, Jr., MD, current Mary Peters Sellars-Polchow chair of psychiatry at Tulane, told this news organization.

Dr. Marcus also continued to treat adult patients by phone and at his home until mid-June of this year. He had also started writing a children’s book.

It was his “tremendous work ethic” and creativity that kept him working past the age of 100, his wife, Angela Hill, a former news anchor, said in an interview.

Even vision loss resulting from macular degeneration and long-standing hearing problems did not stop him, she noted.

“He was always thinking creatively; he was always thinking intellectually,” said Ms. Hill. “That was, to me, the marvel of him.”
 

Wartime service, brain-trauma clinic

Born in Chicago in 1919, Dr. Marcus studied first at the Illinois Institute of Technology before transferring to the University of Illinois School of Medicine.

Neurosurgery was an early interest, and Dr. Marcus undertook his medical residency at Cook County Hospital in Chicago. The day after the bombing of Pearl Harbor, he enlisted in the U.S. Army.

During World War II, Dr. Marcus served in the Army Medical Corps and treated brain injuries and other wounds before he was badly injured himself and had to return to the United States for treatment.

After his recovery, he worked at an army medical facility in El Paso, Texas. On the basis of his earlier experiences, he founded a clinic there to diagnose and treat brain trauma.

After the war, Dr. Marcus continued his studies at Columbia University’s College of Physicians and Surgeons, in New York. Soon, his focus became psychiatry, child psychiatry, and psychoanalysis.

In 1951, Dr. Marcus accepted a position at Tulane. He created the Family Study Unit there the following year. Dr. Zeanah noted that the original name was chosen out of concern over the stigma associated with the term “child psychiatry.”

However, the environment changed relatively quickly, and the unit soon became known as Tulane Child Psychiatry.
 

Research, books, helmet patent

Dr. Marcus received Tulane’s first research grant in child psychiatry from the National Institute of Mental Health to investigate the potential mechanisms behind accident-prone children. That interest was inspired by his own clinical experience.

The findings, which were published in Monographs of the Society for Research in Child Development, showed that being accident prone was a nonspecific response to stressors from multiple sources, including a temperamental disposition, parent-child conflict, and family conflict.

To provide care to young patients, Dr. Marcus collaborated with the Children’s Bureau, the Jewish Children’s Home, the German Protestant’s Orphan Asylum, and Associated Catholic Charities.
 

‘He saved my life’

In 2002, Dr. Marcus participated in the 50th anniversary celebration of Tulane’s child psychiatry program. He returned in 2009 for what would be his final grand rounds presentation, which included an inspiring interview with Dr. Zeanah.

“He talked about the early history of child psychiatry, the things that he’d been trying to do, and some of the challenges that he faced,” Dr. Zeanah said.

Dr. Marcus’s former patients often told Ms. Hill how much he had helped them, she said.

“People would walk up and say, ‘Angela, Irwin won’t tell you this, but he saved my life,’” said Ms. Hill. “A couple walked up at a restaurant, and both of them said, ‘He saved our family.’”

Throughout his professional life, Dr. Marcus continued to strive toward growth and providing aid, she added.

“That is the bottom line of Irwin Marcus: All of his work was to help,” said Ms. Hill.

A version of this article first appeared on Medscape.

The use of robotically assisted surgical devices for benign and malignant tumors is here to stay, but the decision to perform robot-assisted surgery should be driven by clinical outcomes, not convenience, physicians say.

“The problem in minimally invasive surgery, especially in cancer surgery, is that the concept has been flip-flopped,” said Hooman Noorchashm, MD, PhD, a retired cardiothoracic surgeon turned patient advocate. “The main purpose of surgery should be removal of diseased tissue or repair of damaged tissue with adequate safety. The size of the incision on that triage scheme is secondary.”

In 2013, Dr. Noorchashm’s wife, Amy Reed, MD, an anesthesiologist, had a hysterectomy for treatment of severe uterine fibroids. The surgery was performed with a laparoscopic power morcellator, which led to the dissemination of cells from a previously undetected abdominal lesion. She was later diagnosed with stage 4 leiomyosarcoma and died in May 2017.

Dr. Noorchashm said the problem with robotic surgery isn’t the technology itself or how it’s used, but why it’s used in the first place. “Not only was there an extreme level of laxity with respect to the malignant potential of fibroids, but also that the size of the incision supersedes the safety of the procedure.”

The ultimate goal of oncologic surgery is to achieve an en bloc resection with clean surgical margins and removal of the tumor intact, Dr. Noorchashm said. The only scientific way of showing the benefits or therapeutic equivalence of new technology is through noninferiority comparison trials.
 

Robotic surgery inching toward $14 billion in revenue by 2028

Although robotic surgical technology has been in use since the 1990s, the technology is still considered to be its infancy. The first Food and Drug Administration–approved robotics platform, the da Vinci Surgical System (Intuitive Surgical) was approved by the FDA in 2000. And, now, with its patent expiring in 2022, competitors will be developing and launching new products for abdominal and colorectal surgery, partial knee replacements, cardiovascular procedures, head and neck surgery, and spinal procedures.

Robotic surgery is a rapidly expanding area with new product launches announced daily. In August 2021, the market research firm Grand View Research, reported the surgical robot marketplace is projected to reach $14 billion by 2028, up from $3.6 billion this year.

“This new era of robotic-assisted surgery attracts both surgeons and patients. Robotic surgery has reshaped our surgeries over the last 2 decades, and robots are now used in almost in every surgical field. Still, as surgeons, we continue to look – with great interest – to new robotic companies that may be able to provide better robots in a more cost-effective manner,” wrote urologists Ahmad Almujalhem and Koon Ho Rha in a review published in the journal BJUI Compass.

However, the authors wrote that, although the market is competitive, cost remains an issue, as are competing interests. In addition, many companies are creating replicas of existing technologies instead of focusing on new designs and new technology. “Although the da Vinci system propelled many robots to market, there has been no significant improvement in the console,” they added.

The technology is attractive to both surgeons and patients. “Surgeons are attracted to newer technologies, better vision, and easier learning curves. Patients are also attracted to robotic surgery, as this technology is considered state of the art and is associated with reduced pain and scar size,” the authors wrote.
 

Outcomes depend on many variables

In terms of outcomes, the literature is mixed. It largely depends on a number of variables from the site of surgery, the type of cancer, technology used, and the surgeon’s skill.

Jung Mogg Kim, MD, PhD, a microbiologist with Hanyang University, Seoul, South Korea, published a systemic review and meta-analysis of 27 clinical reports in PLoS ONE assessing clinical outcomes. They found that robot-assisted laparoscopic surgery did not result in statistically superior outcomes, compared with conventional laparoscopic surgery, except for lower estimated blood loss with robots. Operative time and total complications rates were “significantly more favorable” with conventional laparoscopic procedures.

Thomas E. Ahlering, MD, a robotic prostatectomy specialist at the University of California, Irvine, explained that the success or failure of robot-assisted surgery can be highly dependent on the body site and tumor type.

“The oncologic outcome, as long as the surgeon is up to speed, is not going to be better, but the goal is to be as good,” he said in an interview.

In most cases, Dr. Ahlering said, the goal of surgery is to remove a viable tumor with clean margins while leaving the organ intact. But in prostate surgery, the goal is to remove the entire organ while trying to preserve urinary continence and sexual function.

“One of the biggest benefits of the robot is that we’re able to use it in a laparoscopic environment meaning that we need a pneumoperitoneum [which] dramatically decreases bleeding. In prostate cancer, the area is so highly vascular that bleeding is a major issue,” he said.

The same benefits of reduced bleeding, improved visualization, and precision are also seen with robotic-assisted surgery for renal cancer, he noted.

He also emphasized that positive surgical margins, while less desirable than complete elimination of malignant cells, is not nearly as dire in prostate cancer as it is in surgery for other malignancies, such as soft-tissue sarcomas.

“The majority of cases are never going to recur, and if they do recur they essentially never lead to metastatic disease to bone, much less to prostate cancer–related death. The only thing they can do is slightly increase the PSA [prostate-specific antigen] recurrence,” he said.

Assuming that outcomes are comparable between an open procedure, conventional laparoscopic procedure, or robot-assisted approach, surgeons “will almost all go for the robot. It’s easier on the surgeon and it’s easier on the system,” Dr. Ahlering said.

In skilled hands for select patients, the use of a carefully researched and well-designed surgical assistive device can result in outcomes that are comparable with those seen in open surgical procedures, with robot-assisted surgery offering the possibility of less perioperative bleeding, lower postoperative morbidity, and faster recovery times.

“In our program we have been using robots to perform robotic radical prostatectomy and nephron-sparing surgery – partial nephrectomy and we’re also using them to perform intracorporeal bowel reconstruction and robotic radical cystectomy,” said Ashutosh Tewari, MD, of the Icahn School of Medicine at Mount Sinai, New York.

Robot-assisted surgery can be used “anywhere where you have to be selective, anywhere where you have to be reconstructive, anywhere where [assisted] vision can help, anywhere where the lack of bleeding will be of help to patients, and anywhere where a smaller incision can achieve the same goals,” Dr. Tewari said in an interview. Dr. Tewari’s Mount Sinai colleagues reported at the 2021 American Urological Association annual meeting, robotic-assisted salvage radical and partial nephrectomies were found to be safe and feasible procedures in patients with metachronous kidney tumors. For patients with early invasive cancer (stage pT1), oncologic outcomes with robotic-assisted partial nephrectomy were similar to those of patients who underwent radical surgery. The authors concluded that salvage robotic-assisted partial nephrectomy “can be considered in this group of patients due to the risk of future recurrences and need to preserve renal function.”

The National Comprehensive Cancer Network guideline for prostate cancer, updated in September 2021, states that “laparoscopic and robot-assisted radical prostatectomy are commonly used and are considered comparable to conventional approaches in experienced hands.”

In 2018, researchers in a multinational comparison trial reported that patients with cervical cancer who were randomly assigned to minimally invasive robot-assisted radical hysterectomy had significantly lower rates of both disease-free survival and overall survival than women randomized to open abdominal radical hysterectomy. The study results were published in the New England Journal of Medicine.

The use of robotically assisted surgical (RAS) devices could possibly create a “shielding layer” between the surgical team and patient reducing the risk of infection, according to Ajmal Zemmar, MD, PhD, FMH, a neurosurgeon with the University of Louisville (Ky.) Dr. Zemmar and colleagues recently published a perspective in Nature Machine Intelligence on trends in the use of surgical robots.

“In the operating theatre, robots can place intravascular lines, intubate the patient and manage the airway. The integration of a robot as a shielding layer, physically separating the health care worker and patient, is a powerful tool to combat the omnipresent fear of pathogen contamination and maintain surgical volumes,” Dr. Zemmar and colleagues wrote.
 

Surgical vs. clinical outcomes

In July 2021, this news organization reported that clinical trials of RAS for nipple-sparing mastectomy procedures were looking primarily at cosmetic or surgical outcomes and were not collecting cancer outcomes and if they were, it was secondary to cosmetic or surgical outcomes.

The FDA followed up by issuing a safety communication in August warning patients and providers that neither the safety nor efficacy of RAS for use in mastectomy procedures or treatment of breast cancer have been established.

“In addition, the FDA is aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies,” the communication stated.

Dr. Tewari disclosed relationships with various companies. Dr. Noorchashm had no relevant disclosures. Dr. Ahlering disclosed past funding or other considerations from Intuitive Robotics.

The use of robotically assisted surgical devices for benign and malignant tumors is here to stay, but the decision to perform robot-assisted surgery should be driven by clinical outcomes, not convenience, physicians say.

“The problem in minimally invasive surgery, especially in cancer surgery, is that the concept has been flip-flopped,” said Hooman Noorchashm, MD, PhD, a retired cardiothoracic surgeon turned patient advocate. “The main purpose of surgery should be removal of diseased tissue or repair of damaged tissue with adequate safety. The size of the incision on that triage scheme is secondary.”

In 2013, Dr. Noorchashm’s wife, Amy Reed, MD, an anesthesiologist, had a hysterectomy for treatment of severe uterine fibroids. The surgery was performed with a laparoscopic power morcellator, which led to the dissemination of cells from a previously undetected abdominal lesion. She was later diagnosed with stage 4 leiomyosarcoma and died in May 2017.

Dr. Noorchashm said the problem with robotic surgery isn’t the technology itself or how it’s used, but why it’s used in the first place. “Not only was there an extreme level of laxity with respect to the malignant potential of fibroids, but also that the size of the incision supersedes the safety of the procedure.”

The ultimate goal of oncologic surgery is to achieve an en bloc resection with clean surgical margins and removal of the tumor intact, Dr. Noorchashm said. The only scientific way of showing the benefits or therapeutic equivalence of new technology is through noninferiority comparison trials.
 

Robotic surgery inching toward $14 billion in revenue by 2028

Although robotic surgical technology has been in use since the 1990s, the technology is still considered to be its infancy. The first Food and Drug Administration–approved robotics platform, the da Vinci Surgical System (Intuitive Surgical) was approved by the FDA in 2000. And, now, with its patent expiring in 2022, competitors will be developing and launching new products for abdominal and colorectal surgery, partial knee replacements, cardiovascular procedures, head and neck surgery, and spinal procedures.

Robotic surgery is a rapidly expanding area with new product launches announced daily. In August 2021, the market research firm Grand View Research, reported the surgical robot marketplace is projected to reach $14 billion by 2028, up from $3.6 billion this year.

“This new era of robotic-assisted surgery attracts both surgeons and patients. Robotic surgery has reshaped our surgeries over the last 2 decades, and robots are now used in almost in every surgical field. Still, as surgeons, we continue to look – with great interest – to new robotic companies that may be able to provide better robots in a more cost-effective manner,” wrote urologists Ahmad Almujalhem and Koon Ho Rha in a review published in the journal BJUI Compass.

However, the authors wrote that, although the market is competitive, cost remains an issue, as are competing interests. In addition, many companies are creating replicas of existing technologies instead of focusing on new designs and new technology. “Although the da Vinci system propelled many robots to market, there has been no significant improvement in the console,” they added.

The technology is attractive to both surgeons and patients. “Surgeons are attracted to newer technologies, better vision, and easier learning curves. Patients are also attracted to robotic surgery, as this technology is considered state of the art and is associated with reduced pain and scar size,” the authors wrote.
 

Outcomes depend on many variables

In terms of outcomes, the literature is mixed. It largely depends on a number of variables from the site of surgery, the type of cancer, technology used, and the surgeon’s skill.

Jung Mogg Kim, MD, PhD, a microbiologist with Hanyang University, Seoul, South Korea, published a systemic review and meta-analysis of 27 clinical reports in PLoS ONE assessing clinical outcomes. They found that robot-assisted laparoscopic surgery did not result in statistically superior outcomes, compared with conventional laparoscopic surgery, except for lower estimated blood loss with robots. Operative time and total complications rates were “significantly more favorable” with conventional laparoscopic procedures.

Thomas E. Ahlering, MD, a robotic prostatectomy specialist at the University of California, Irvine, explained that the success or failure of robot-assisted surgery can be highly dependent on the body site and tumor type.

“The oncologic outcome, as long as the surgeon is up to speed, is not going to be better, but the goal is to be as good,” he said in an interview.

In most cases, Dr. Ahlering said, the goal of surgery is to remove a viable tumor with clean margins while leaving the organ intact. But in prostate surgery, the goal is to remove the entire organ while trying to preserve urinary continence and sexual function.

“One of the biggest benefits of the robot is that we’re able to use it in a laparoscopic environment meaning that we need a pneumoperitoneum [which] dramatically decreases bleeding. In prostate cancer, the area is so highly vascular that bleeding is a major issue,” he said.

The same benefits of reduced bleeding, improved visualization, and precision are also seen with robotic-assisted surgery for renal cancer, he noted.

He also emphasized that positive surgical margins, while less desirable than complete elimination of malignant cells, is not nearly as dire in prostate cancer as it is in surgery for other malignancies, such as soft-tissue sarcomas.

“The majority of cases are never going to recur, and if they do recur they essentially never lead to metastatic disease to bone, much less to prostate cancer–related death. The only thing they can do is slightly increase the PSA [prostate-specific antigen] recurrence,” he said.

Assuming that outcomes are comparable between an open procedure, conventional laparoscopic procedure, or robot-assisted approach, surgeons “will almost all go for the robot. It’s easier on the surgeon and it’s easier on the system,” Dr. Ahlering said.

In skilled hands for select patients, the use of a carefully researched and well-designed surgical assistive device can result in outcomes that are comparable with those seen in open surgical procedures, with robot-assisted surgery offering the possibility of less perioperative bleeding, lower postoperative morbidity, and faster recovery times.

“In our program we have been using robots to perform robotic radical prostatectomy and nephron-sparing surgery – partial nephrectomy and we’re also using them to perform intracorporeal bowel reconstruction and robotic radical cystectomy,” said Ashutosh Tewari, MD, of the Icahn School of Medicine at Mount Sinai, New York.

Robot-assisted surgery can be used “anywhere where you have to be selective, anywhere where you have to be reconstructive, anywhere where [assisted] vision can help, anywhere where the lack of bleeding will be of help to patients, and anywhere where a smaller incision can achieve the same goals,” Dr. Tewari said in an interview. Dr. Tewari’s Mount Sinai colleagues reported at the 2021 American Urological Association annual meeting, robotic-assisted salvage radical and partial nephrectomies were found to be safe and feasible procedures in patients with metachronous kidney tumors. For patients with early invasive cancer (stage pT1), oncologic outcomes with robotic-assisted partial nephrectomy were similar to those of patients who underwent radical surgery. The authors concluded that salvage robotic-assisted partial nephrectomy “can be considered in this group of patients due to the risk of future recurrences and need to preserve renal function.”

The National Comprehensive Cancer Network guideline for prostate cancer, updated in September 2021, states that “laparoscopic and robot-assisted radical prostatectomy are commonly used and are considered comparable to conventional approaches in experienced hands.”

In 2018, researchers in a multinational comparison trial reported that patients with cervical cancer who were randomly assigned to minimally invasive robot-assisted radical hysterectomy had significantly lower rates of both disease-free survival and overall survival than women randomized to open abdominal radical hysterectomy. The study results were published in the New England Journal of Medicine.

The use of robotically assisted surgical (RAS) devices could possibly create a “shielding layer” between the surgical team and patient reducing the risk of infection, according to Ajmal Zemmar, MD, PhD, FMH, a neurosurgeon with the University of Louisville (Ky.) Dr. Zemmar and colleagues recently published a perspective in Nature Machine Intelligence on trends in the use of surgical robots.

“In the operating theatre, robots can place intravascular lines, intubate the patient and manage the airway. The integration of a robot as a shielding layer, physically separating the health care worker and patient, is a powerful tool to combat the omnipresent fear of pathogen contamination and maintain surgical volumes,” Dr. Zemmar and colleagues wrote.
 

Surgical vs. clinical outcomes

In July 2021, this news organization reported that clinical trials of RAS for nipple-sparing mastectomy procedures were looking primarily at cosmetic or surgical outcomes and were not collecting cancer outcomes and if they were, it was secondary to cosmetic or surgical outcomes.

The FDA followed up by issuing a safety communication in August warning patients and providers that neither the safety nor efficacy of RAS for use in mastectomy procedures or treatment of breast cancer have been established.

“In addition, the FDA is aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies,” the communication stated.

Dr. Tewari disclosed relationships with various companies. Dr. Noorchashm had no relevant disclosures. Dr. Ahlering disclosed past funding or other considerations from Intuitive Robotics.

The use of robotically assisted surgical devices for benign and malignant tumors is here to stay, but the decision to perform robot-assisted surgery should be driven by clinical outcomes, not convenience, physicians say.

“The problem in minimally invasive surgery, especially in cancer surgery, is that the concept has been flip-flopped,” said Hooman Noorchashm, MD, PhD, a retired cardiothoracic surgeon turned patient advocate. “The main purpose of surgery should be removal of diseased tissue or repair of damaged tissue with adequate safety. The size of the incision on that triage scheme is secondary.”

In 2013, Dr. Noorchashm’s wife, Amy Reed, MD, an anesthesiologist, had a hysterectomy for treatment of severe uterine fibroids. The surgery was performed with a laparoscopic power morcellator, which led to the dissemination of cells from a previously undetected abdominal lesion. She was later diagnosed with stage 4 leiomyosarcoma and died in May 2017.

Dr. Noorchashm said the problem with robotic surgery isn’t the technology itself or how it’s used, but why it’s used in the first place. “Not only was there an extreme level of laxity with respect to the malignant potential of fibroids, but also that the size of the incision supersedes the safety of the procedure.”

The ultimate goal of oncologic surgery is to achieve an en bloc resection with clean surgical margins and removal of the tumor intact, Dr. Noorchashm said. The only scientific way of showing the benefits or therapeutic equivalence of new technology is through noninferiority comparison trials.
 

Robotic surgery inching toward $14 billion in revenue by 2028

Although robotic surgical technology has been in use since the 1990s, the technology is still considered to be its infancy. The first Food and Drug Administration–approved robotics platform, the da Vinci Surgical System (Intuitive Surgical) was approved by the FDA in 2000. And, now, with its patent expiring in 2022, competitors will be developing and launching new products for abdominal and colorectal surgery, partial knee replacements, cardiovascular procedures, head and neck surgery, and spinal procedures.

Robotic surgery is a rapidly expanding area with new product launches announced daily. In August 2021, the market research firm Grand View Research, reported the surgical robot marketplace is projected to reach $14 billion by 2028, up from $3.6 billion this year.

“This new era of robotic-assisted surgery attracts both surgeons and patients. Robotic surgery has reshaped our surgeries over the last 2 decades, and robots are now used in almost in every surgical field. Still, as surgeons, we continue to look – with great interest – to new robotic companies that may be able to provide better robots in a more cost-effective manner,” wrote urologists Ahmad Almujalhem and Koon Ho Rha in a review published in the journal BJUI Compass.

However, the authors wrote that, although the market is competitive, cost remains an issue, as are competing interests. In addition, many companies are creating replicas of existing technologies instead of focusing on new designs and new technology. “Although the da Vinci system propelled many robots to market, there has been no significant improvement in the console,” they added.

The technology is attractive to both surgeons and patients. “Surgeons are attracted to newer technologies, better vision, and easier learning curves. Patients are also attracted to robotic surgery, as this technology is considered state of the art and is associated with reduced pain and scar size,” the authors wrote.
 

Outcomes depend on many variables

In terms of outcomes, the literature is mixed. It largely depends on a number of variables from the site of surgery, the type of cancer, technology used, and the surgeon’s skill.

Jung Mogg Kim, MD, PhD, a microbiologist with Hanyang University, Seoul, South Korea, published a systemic review and meta-analysis of 27 clinical reports in PLoS ONE assessing clinical outcomes. They found that robot-assisted laparoscopic surgery did not result in statistically superior outcomes, compared with conventional laparoscopic surgery, except for lower estimated blood loss with robots. Operative time and total complications rates were “significantly more favorable” with conventional laparoscopic procedures.

Thomas E. Ahlering, MD, a robotic prostatectomy specialist at the University of California, Irvine, explained that the success or failure of robot-assisted surgery can be highly dependent on the body site and tumor type.

“The oncologic outcome, as long as the surgeon is up to speed, is not going to be better, but the goal is to be as good,” he said in an interview.

In most cases, Dr. Ahlering said, the goal of surgery is to remove a viable tumor with clean margins while leaving the organ intact. But in prostate surgery, the goal is to remove the entire organ while trying to preserve urinary continence and sexual function.

“One of the biggest benefits of the robot is that we’re able to use it in a laparoscopic environment meaning that we need a pneumoperitoneum [which] dramatically decreases bleeding. In prostate cancer, the area is so highly vascular that bleeding is a major issue,” he said.

The same benefits of reduced bleeding, improved visualization, and precision are also seen with robotic-assisted surgery for renal cancer, he noted.

He also emphasized that positive surgical margins, while less desirable than complete elimination of malignant cells, is not nearly as dire in prostate cancer as it is in surgery for other malignancies, such as soft-tissue sarcomas.

“The majority of cases are never going to recur, and if they do recur they essentially never lead to metastatic disease to bone, much less to prostate cancer–related death. The only thing they can do is slightly increase the PSA [prostate-specific antigen] recurrence,” he said.

Assuming that outcomes are comparable between an open procedure, conventional laparoscopic procedure, or robot-assisted approach, surgeons “will almost all go for the robot. It’s easier on the surgeon and it’s easier on the system,” Dr. Ahlering said.

In skilled hands for select patients, the use of a carefully researched and well-designed surgical assistive device can result in outcomes that are comparable with those seen in open surgical procedures, with robot-assisted surgery offering the possibility of less perioperative bleeding, lower postoperative morbidity, and faster recovery times.

“In our program we have been using robots to perform robotic radical prostatectomy and nephron-sparing surgery – partial nephrectomy and we’re also using them to perform intracorporeal bowel reconstruction and robotic radical cystectomy,” said Ashutosh Tewari, MD, of the Icahn School of Medicine at Mount Sinai, New York.

Robot-assisted surgery can be used “anywhere where you have to be selective, anywhere where you have to be reconstructive, anywhere where [assisted] vision can help, anywhere where the lack of bleeding will be of help to patients, and anywhere where a smaller incision can achieve the same goals,” Dr. Tewari said in an interview. Dr. Tewari’s Mount Sinai colleagues reported at the 2021 American Urological Association annual meeting, robotic-assisted salvage radical and partial nephrectomies were found to be safe and feasible procedures in patients with metachronous kidney tumors. For patients with early invasive cancer (stage pT1), oncologic outcomes with robotic-assisted partial nephrectomy were similar to those of patients who underwent radical surgery. The authors concluded that salvage robotic-assisted partial nephrectomy “can be considered in this group of patients due to the risk of future recurrences and need to preserve renal function.”

The National Comprehensive Cancer Network guideline for prostate cancer, updated in September 2021, states that “laparoscopic and robot-assisted radical prostatectomy are commonly used and are considered comparable to conventional approaches in experienced hands.”

In 2018, researchers in a multinational comparison trial reported that patients with cervical cancer who were randomly assigned to minimally invasive robot-assisted radical hysterectomy had significantly lower rates of both disease-free survival and overall survival than women randomized to open abdominal radical hysterectomy. The study results were published in the New England Journal of Medicine.

The use of robotically assisted surgical (RAS) devices could possibly create a “shielding layer” between the surgical team and patient reducing the risk of infection, according to Ajmal Zemmar, MD, PhD, FMH, a neurosurgeon with the University of Louisville (Ky.) Dr. Zemmar and colleagues recently published a perspective in Nature Machine Intelligence on trends in the use of surgical robots.

“In the operating theatre, robots can place intravascular lines, intubate the patient and manage the airway. The integration of a robot as a shielding layer, physically separating the health care worker and patient, is a powerful tool to combat the omnipresent fear of pathogen contamination and maintain surgical volumes,” Dr. Zemmar and colleagues wrote.
 

Surgical vs. clinical outcomes

In July 2021, this news organization reported that clinical trials of RAS for nipple-sparing mastectomy procedures were looking primarily at cosmetic or surgical outcomes and were not collecting cancer outcomes and if they were, it was secondary to cosmetic or surgical outcomes.

The FDA followed up by issuing a safety communication in August warning patients and providers that neither the safety nor efficacy of RAS for use in mastectomy procedures or treatment of breast cancer have been established.

“In addition, the FDA is aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies,” the communication stated.

Dr. Tewari disclosed relationships with various companies. Dr. Noorchashm had no relevant disclosures. Dr. Ahlering disclosed past funding or other considerations from Intuitive Robotics.

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.