Cheryl K. Lee, MD, an Assistant Professor Of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.  

Dr. Lee reported no disclosures.

You have been treating COVID-19 patients since before the US Food and Drug Administration (FDA) granted emergency authorization to 3 pharma vaccine producers. But now you have patients, on oxygen or under observation, who have foregone vaccination. What do you think about that?

This question raises a good point that is often missed: how the unvaccinated are often portrayed. The reasons these patients remain unvaccinated are not necessarily uniform.

What we know based on attitude surveys done by the Kaiser Family Foundation¹ is that people are vaccine hesitant for varied reasons. And this finding isn’t unique. The pediatric literature shows that those who are opposed to childhood vaccination do not share the same motivations.² Yes, some are strident about their beliefs against vaccination, usually in concert with popularized myths. Many unvaccinated people are hesitant based on misconceptions, do not have access to a clinician who can answer their questions, can’t afford to lose a day of work due to the vaccine’s expected side effects, or understandably mistrust the healthcare community based on personal or historical context.

What do the unvaccinated have in common? Education levels, income levels?

We know from surveys³ that generally, more men than women are hesitant. Those who are uninsured or underinsured⁴ and those of lower socioeconomic status are more hesitant than their counterparts. It's changing a bit, but those who are in minority communities, Black and Latinx communities, are more likely to be unvaccinated compared to other groups. Even in Chicago, where we have a relatively good vaccination rate (59%),⁵ Black and Latinx communities are under vaccinated as compared to those who are White or Asian. The reasons for this are complex and include historical disinvestment in communities and decreased access to medical care. Some wonderful agencies are pairing up with community leaders in target neighborhoods to address this equity gap.

What do you say to these patients, if anything, about their status?

It’s not what you might expect. At first, I listen. I find that most are well-intentioned people trying to make the right decision for themselves and their family. It is, therefore, helpful to hear what their motivations and fears are first, before delving into facts. Furthermore, although facts are wonderful and necessary, what is more persuasive is a personal anecdote. I will tell folks my personal story about deciding to be vaccinated. I talk about how I found accurate information about the vaccine and what a relief it was afterwards to know that I would be safe, especially as a mom. I even talk about feeling tired and achy after the second shot, which means that the vaccine is working. I joke that it is the only time I’ve felt so relieved to feel sick. Last, I often say that it’s okay to feel scared or apprehensive, and that they deserve to get the best information. What’s important is that these conversations feel genuine.

Can you share an anecdote or two?

A few months ago, I took care of an unvaccinated gentleman who was in the hospital for a chronic medical condition. Before this hospitalization, his personal physicians had tried to convince him to get the vaccine over a period of several months.

It would have been easy to assume that he would remain unvaccinated and that I should put my energy into convincing someone else. However, I found him surprisingly open to discussion, and we were able to have many conversations about what he'd heard from nonmedical sources. We bonded over the sheer volume of available information and how difficult it is to know what is true. We then walked through what was truth vs fiction, and I tailored the discussion to how the vaccine could specifically improve his quality of life and his family's. He confided that what made his decision more difficult was the fact that he hadn’t met anyone who had gotten the vaccine among his friends and family. He ultimately did decide to get vaccinated, along with a family member. We made the appointment for the week after he was discharged. What a feeling it was to get a text message from his clinic physician saying that he got his first shot and that it went great!

I wasn’t the only physician who had spoken to this patient about getting vaccinated; others had done the same before he came to the hospital. It is a good reminder that each conversation can act like a gentle nudge in the right direction.

In terms of the data on the unvaccinated–reasons they stay away, what their backgrounds are and so forth–how close do those data play out in real life?

It is not advisable to assume why someone would be unvaccinated based on first impressions. I find the reasons are highly specific to that individual, ranging from false impressions about fertility to concerns about missing work. In my experience, several patients simply wanted to get more facts from a healthcare worker directly before signing up. Pregnancy is particularly important to talk about, considering how devastating the Delta variant has been to this group of women. One gentleman that I spoke to was worried about affecting his wife’s pregnancy with the vaccine. We know now that vaccines are safe and prevent pregnant patients from getting seriously ill and dying, but that knowledge isn’t widely known to the public. So many kind and well-meaning people have foregone vaccination because they're concerned about doing anything to upset the pregnancy.

How long, generally, does it take for unvaccinated patients to discuss the reasons for their choice?

It takes time, and that's a real barrier for many healthcare professionals, especially in a clinic setting where the luxury of extra time is nonexistent. How much time differs for everyone, and usually a change of heart takes more than one conversation.

Truly, the first conversation is just to listen, to understand their hesitation, and to develop trust. For anyone to really hear what I have to say, they must trust that what I'm saying is solely motivated by caring about what happens to them and their family.

One gentleman said something pointed during our first conversation: Thank you for listening. When I tell people I am not vaccinated I can feel them judging me, that they've already decided what to think of me.

I always tell people that they have good questions because they do. I respect the fact that they're feeling open enough to share what they're hearing or what they're afraid of. It's a privilege for me to be involved in that conversation.

What advice would you give other hospitalists in terms of treating and counseling patients who are unvaccinated?

Every hospitalization, whether it’s COVID-related or not, is an opportunity to speak with those who are still unvaccinated. Every encounter can be used to further the conversation about vaccines, by increasing their trust in the healthcare community, answering their questions, and providing facts in place of confusion. Using those opportunities is the best way to get us out of this pandemic.

That said, it's been a long two years, so it's okay if physicians don't have the emotional bandwidth or the time to have these discussions. Maybe save that conversation for another day. But for some providers, perhaps knowing that those who are unvaccinated can change and that anxiety could be preventing some from getting their shot will motivate them to start these conversations with their patients.

Cheryl K. Lee, MD, an Assistant Professor Of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.  

Dr. Lee reported no disclosures.

You have been treating COVID-19 patients since before the US Food and Drug Administration (FDA) granted emergency authorization to 3 pharma vaccine producers. But now you have patients, on oxygen or under observation, who have foregone vaccination. What do you think about that?

This question raises a good point that is often missed: how the unvaccinated are often portrayed. The reasons these patients remain unvaccinated are not necessarily uniform.

What we know based on attitude surveys done by the Kaiser Family Foundation¹ is that people are vaccine hesitant for varied reasons. And this finding isn’t unique. The pediatric literature shows that those who are opposed to childhood vaccination do not share the same motivations.² Yes, some are strident about their beliefs against vaccination, usually in concert with popularized myths. Many unvaccinated people are hesitant based on misconceptions, do not have access to a clinician who can answer their questions, can’t afford to lose a day of work due to the vaccine’s expected side effects, or understandably mistrust the healthcare community based on personal or historical context.

What do the unvaccinated have in common? Education levels, income levels?

We know from surveys³ that generally, more men than women are hesitant. Those who are uninsured or underinsured⁴ and those of lower socioeconomic status are more hesitant than their counterparts. It's changing a bit, but those who are in minority communities, Black and Latinx communities, are more likely to be unvaccinated compared to other groups. Even in Chicago, where we have a relatively good vaccination rate (59%),⁵ Black and Latinx communities are under vaccinated as compared to those who are White or Asian. The reasons for this are complex and include historical disinvestment in communities and decreased access to medical care. Some wonderful agencies are pairing up with community leaders in target neighborhoods to address this equity gap.

What do you say to these patients, if anything, about their status?

It’s not what you might expect. At first, I listen. I find that most are well-intentioned people trying to make the right decision for themselves and their family. It is, therefore, helpful to hear what their motivations and fears are first, before delving into facts. Furthermore, although facts are wonderful and necessary, what is more persuasive is a personal anecdote. I will tell folks my personal story about deciding to be vaccinated. I talk about how I found accurate information about the vaccine and what a relief it was afterwards to know that I would be safe, especially as a mom. I even talk about feeling tired and achy after the second shot, which means that the vaccine is working. I joke that it is the only time I’ve felt so relieved to feel sick. Last, I often say that it’s okay to feel scared or apprehensive, and that they deserve to get the best information. What’s important is that these conversations feel genuine.

Can you share an anecdote or two?

A few months ago, I took care of an unvaccinated gentleman who was in the hospital for a chronic medical condition. Before this hospitalization, his personal physicians had tried to convince him to get the vaccine over a period of several months.

It would have been easy to assume that he would remain unvaccinated and that I should put my energy into convincing someone else. However, I found him surprisingly open to discussion, and we were able to have many conversations about what he'd heard from nonmedical sources. We bonded over the sheer volume of available information and how difficult it is to know what is true. We then walked through what was truth vs fiction, and I tailored the discussion to how the vaccine could specifically improve his quality of life and his family's. He confided that what made his decision more difficult was the fact that he hadn’t met anyone who had gotten the vaccine among his friends and family. He ultimately did decide to get vaccinated, along with a family member. We made the appointment for the week after he was discharged. What a feeling it was to get a text message from his clinic physician saying that he got his first shot and that it went great!

I wasn’t the only physician who had spoken to this patient about getting vaccinated; others had done the same before he came to the hospital. It is a good reminder that each conversation can act like a gentle nudge in the right direction.

In terms of the data on the unvaccinated–reasons they stay away, what their backgrounds are and so forth–how close do those data play out in real life?

It is not advisable to assume why someone would be unvaccinated based on first impressions. I find the reasons are highly specific to that individual, ranging from false impressions about fertility to concerns about missing work. In my experience, several patients simply wanted to get more facts from a healthcare worker directly before signing up. Pregnancy is particularly important to talk about, considering how devastating the Delta variant has been to this group of women. One gentleman that I spoke to was worried about affecting his wife’s pregnancy with the vaccine. We know now that vaccines are safe and prevent pregnant patients from getting seriously ill and dying, but that knowledge isn’t widely known to the public. So many kind and well-meaning people have foregone vaccination because they're concerned about doing anything to upset the pregnancy.

How long, generally, does it take for unvaccinated patients to discuss the reasons for their choice?

It takes time, and that's a real barrier for many healthcare professionals, especially in a clinic setting where the luxury of extra time is nonexistent. How much time differs for everyone, and usually a change of heart takes more than one conversation.

Truly, the first conversation is just to listen, to understand their hesitation, and to develop trust. For anyone to really hear what I have to say, they must trust that what I'm saying is solely motivated by caring about what happens to them and their family.

One gentleman said something pointed during our first conversation: Thank you for listening. When I tell people I am not vaccinated I can feel them judging me, that they've already decided what to think of me.

I always tell people that they have good questions because they do. I respect the fact that they're feeling open enough to share what they're hearing or what they're afraid of. It's a privilege for me to be involved in that conversation.

What advice would you give other hospitalists in terms of treating and counseling patients who are unvaccinated?

Every hospitalization, whether it’s COVID-related or not, is an opportunity to speak with those who are still unvaccinated. Every encounter can be used to further the conversation about vaccines, by increasing their trust in the healthcare community, answering their questions, and providing facts in place of confusion. Using those opportunities is the best way to get us out of this pandemic.

That said, it's been a long two years, so it's okay if physicians don't have the emotional bandwidth or the time to have these discussions. Maybe save that conversation for another day. But for some providers, perhaps knowing that those who are unvaccinated can change and that anxiety could be preventing some from getting their shot will motivate them to start these conversations with their patients.

Cheryl K. Lee, MD, an Assistant Professor Of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.  

Dr. Lee reported no disclosures.

You have been treating COVID-19 patients since before the US Food and Drug Administration (FDA) granted emergency authorization to 3 pharma vaccine producers. But now you have patients, on oxygen or under observation, who have foregone vaccination. What do you think about that?

This question raises a good point that is often missed: how the unvaccinated are often portrayed. The reasons these patients remain unvaccinated are not necessarily uniform.

What we know based on attitude surveys done by the Kaiser Family Foundation¹ is that people are vaccine hesitant for varied reasons. And this finding isn’t unique. The pediatric literature shows that those who are opposed to childhood vaccination do not share the same motivations.² Yes, some are strident about their beliefs against vaccination, usually in concert with popularized myths. Many unvaccinated people are hesitant based on misconceptions, do not have access to a clinician who can answer their questions, can’t afford to lose a day of work due to the vaccine’s expected side effects, or understandably mistrust the healthcare community based on personal or historical context.

What do the unvaccinated have in common? Education levels, income levels?

We know from surveys³ that generally, more men than women are hesitant. Those who are uninsured or underinsured⁴ and those of lower socioeconomic status are more hesitant than their counterparts. It's changing a bit, but those who are in minority communities, Black and Latinx communities, are more likely to be unvaccinated compared to other groups. Even in Chicago, where we have a relatively good vaccination rate (59%),⁵ Black and Latinx communities are under vaccinated as compared to those who are White or Asian. The reasons for this are complex and include historical disinvestment in communities and decreased access to medical care. Some wonderful agencies are pairing up with community leaders in target neighborhoods to address this equity gap.

What do you say to these patients, if anything, about their status?

It’s not what you might expect. At first, I listen. I find that most are well-intentioned people trying to make the right decision for themselves and their family. It is, therefore, helpful to hear what their motivations and fears are first, before delving into facts. Furthermore, although facts are wonderful and necessary, what is more persuasive is a personal anecdote. I will tell folks my personal story about deciding to be vaccinated. I talk about how I found accurate information about the vaccine and what a relief it was afterwards to know that I would be safe, especially as a mom. I even talk about feeling tired and achy after the second shot, which means that the vaccine is working. I joke that it is the only time I’ve felt so relieved to feel sick. Last, I often say that it’s okay to feel scared or apprehensive, and that they deserve to get the best information. What’s important is that these conversations feel genuine.

Can you share an anecdote or two?

A few months ago, I took care of an unvaccinated gentleman who was in the hospital for a chronic medical condition. Before this hospitalization, his personal physicians had tried to convince him to get the vaccine over a period of several months.

It would have been easy to assume that he would remain unvaccinated and that I should put my energy into convincing someone else. However, I found him surprisingly open to discussion, and we were able to have many conversations about what he'd heard from nonmedical sources. We bonded over the sheer volume of available information and how difficult it is to know what is true. We then walked through what was truth vs fiction, and I tailored the discussion to how the vaccine could specifically improve his quality of life and his family's. He confided that what made his decision more difficult was the fact that he hadn’t met anyone who had gotten the vaccine among his friends and family. He ultimately did decide to get vaccinated, along with a family member. We made the appointment for the week after he was discharged. What a feeling it was to get a text message from his clinic physician saying that he got his first shot and that it went great!

I wasn’t the only physician who had spoken to this patient about getting vaccinated; others had done the same before he came to the hospital. It is a good reminder that each conversation can act like a gentle nudge in the right direction.

In terms of the data on the unvaccinated–reasons they stay away, what their backgrounds are and so forth–how close do those data play out in real life?

It is not advisable to assume why someone would be unvaccinated based on first impressions. I find the reasons are highly specific to that individual, ranging from false impressions about fertility to concerns about missing work. In my experience, several patients simply wanted to get more facts from a healthcare worker directly before signing up. Pregnancy is particularly important to talk about, considering how devastating the Delta variant has been to this group of women. One gentleman that I spoke to was worried about affecting his wife’s pregnancy with the vaccine. We know now that vaccines are safe and prevent pregnant patients from getting seriously ill and dying, but that knowledge isn’t widely known to the public. So many kind and well-meaning people have foregone vaccination because they're concerned about doing anything to upset the pregnancy.

How long, generally, does it take for unvaccinated patients to discuss the reasons for their choice?

It takes time, and that's a real barrier for many healthcare professionals, especially in a clinic setting where the luxury of extra time is nonexistent. How much time differs for everyone, and usually a change of heart takes more than one conversation.

Truly, the first conversation is just to listen, to understand their hesitation, and to develop trust. For anyone to really hear what I have to say, they must trust that what I'm saying is solely motivated by caring about what happens to them and their family.

One gentleman said something pointed during our first conversation: Thank you for listening. When I tell people I am not vaccinated I can feel them judging me, that they've already decided what to think of me.

I always tell people that they have good questions because they do. I respect the fact that they're feeling open enough to share what they're hearing or what they're afraid of. It's a privilege for me to be involved in that conversation.

What advice would you give other hospitalists in terms of treating and counseling patients who are unvaccinated?

Every hospitalization, whether it’s COVID-related or not, is an opportunity to speak with those who are still unvaccinated. Every encounter can be used to further the conversation about vaccines, by increasing their trust in the healthcare community, answering their questions, and providing facts in place of confusion. Using those opportunities is the best way to get us out of this pandemic.

That said, it's been a long two years, so it's okay if physicians don't have the emotional bandwidth or the time to have these discussions. Maybe save that conversation for another day. But for some providers, perhaps knowing that those who are unvaccinated can change and that anxiety could be preventing some from getting their shot will motivate them to start these conversations with their patients.

Thanksgiving has long been my favorite holiday: a chance to reconnect with family and friends as well as time for reflection, gratitude, and hope. While Thanksgiving 2020 (sadly) was spent eating takeout turkey on the couch due to the pandemic, I am hopeful that Thanksgiving 2021 will for most of us bring a return to the holiday traditions that sustain us.

In this month’s issue of GIHN, we highlight several important studies impacting frontline clinical practice. Relevant to patients with liver disease, we highlight work evaluating the potential supra-additive effects of alcohol intake and obesity in impacting cirrhosis incidence and assessing the comparative performance of non-invasive screening tests in detecting NASH-related fibrosis. Another study of note, relevant to clinical management of GERD, suggests that combinations of abnormal pH-impedance monitoring metrics may predict PPI nonresponders better than individual metrics and could be used to identify patients more likely to respond to invasive GERD management.

We also wish to acknowledge in this issue the outstanding work that AGA and its fellow societies do on behalf of the gastroenterology community in developing and harmonizing ACGME Reporting Milestones for GI and Transplant Hepatology fellowship programs to assist with trainee assessment. Our fellowship trainees represent the future of our profession, and it is of critical importance that we train competent, compassionate professionals who will provide outstanding clinical care to our patients. Kudos to the team, including Dr. Brijen Shah, GI & Hepatology News associate editor Dr. Janice Jou, and others, for their hard work on Milestones 2.0!

Megan A. Adams, MD, JD, MSc
Editor in Chief

Thanksgiving has long been my favorite holiday: a chance to reconnect with family and friends as well as time for reflection, gratitude, and hope. While Thanksgiving 2020 (sadly) was spent eating takeout turkey on the couch due to the pandemic, I am hopeful that Thanksgiving 2021 will for most of us bring a return to the holiday traditions that sustain us.

In this month’s issue of GIHN, we highlight several important studies impacting frontline clinical practice. Relevant to patients with liver disease, we highlight work evaluating the potential supra-additive effects of alcohol intake and obesity in impacting cirrhosis incidence and assessing the comparative performance of non-invasive screening tests in detecting NASH-related fibrosis. Another study of note, relevant to clinical management of GERD, suggests that combinations of abnormal pH-impedance monitoring metrics may predict PPI nonresponders better than individual metrics and could be used to identify patients more likely to respond to invasive GERD management.

We also wish to acknowledge in this issue the outstanding work that AGA and its fellow societies do on behalf of the gastroenterology community in developing and harmonizing ACGME Reporting Milestones for GI and Transplant Hepatology fellowship programs to assist with trainee assessment. Our fellowship trainees represent the future of our profession, and it is of critical importance that we train competent, compassionate professionals who will provide outstanding clinical care to our patients. Kudos to the team, including Dr. Brijen Shah, GI & Hepatology News associate editor Dr. Janice Jou, and others, for their hard work on Milestones 2.0!

Megan A. Adams, MD, JD, MSc
Editor in Chief

Thanksgiving has long been my favorite holiday: a chance to reconnect with family and friends as well as time for reflection, gratitude, and hope. While Thanksgiving 2020 (sadly) was spent eating takeout turkey on the couch due to the pandemic, I am hopeful that Thanksgiving 2021 will for most of us bring a return to the holiday traditions that sustain us.

In this month’s issue of GIHN, we highlight several important studies impacting frontline clinical practice. Relevant to patients with liver disease, we highlight work evaluating the potential supra-additive effects of alcohol intake and obesity in impacting cirrhosis incidence and assessing the comparative performance of non-invasive screening tests in detecting NASH-related fibrosis. Another study of note, relevant to clinical management of GERD, suggests that combinations of abnormal pH-impedance monitoring metrics may predict PPI nonresponders better than individual metrics and could be used to identify patients more likely to respond to invasive GERD management.

We also wish to acknowledge in this issue the outstanding work that AGA and its fellow societies do on behalf of the gastroenterology community in developing and harmonizing ACGME Reporting Milestones for GI and Transplant Hepatology fellowship programs to assist with trainee assessment. Our fellowship trainees represent the future of our profession, and it is of critical importance that we train competent, compassionate professionals who will provide outstanding clinical care to our patients. Kudos to the team, including Dr. Brijen Shah, GI & Hepatology News associate editor Dr. Janice Jou, and others, for their hard work on Milestones 2.0!

Megan A. Adams, MD, JD, MSc
Editor in Chief

Biosimilar medications have received significant attention recently in the treatment of rheumatoid arthritis (RA), though the effects of switching from the reference drug to a biosimilar is not known. The study by Fleischmann et al¹ looks at the safety and efficacy, as well as immunogenicity, of biosimilar adalimumab (ADL-PF) compared to the reference ADL-EU (European Union sourced adalimumab) in a randomized double-blind study. Patients were randomized to start and continue ADL-PF or start ADL-EU and switch to ADL-PF at week 26 or 52. Immunogenicity was measured using anti-drug antibodies (ADA). American College of Rheumatology (ACR20) response rates were similar among all groups, while ACR50 and ACR70 response rates were numerically lower in the week 52 switch group. ADA development was comparable between groups. Data were analyzed using descriptive statistics, but overall, safety, efficacy, and immunogenicity were similar between patients maintained on ADL-PF and those switched from ADL-EU at week 26 or 52.

Statins have long been associated with musculoskeletal symptoms in patients, but have also been postulated to have anti-inflammatory and immunomodulatory effects. Complicating the relationship is the knowledge that inflammation increases cardiovascular risk in RA patients. In a case-control study, Peterson et al² used an administrative database to examine the influence of statin use on development of RA. Cases were identified based on ICD-9 coding as well as a prescription for methotrexate after diagnosis. They were matched 1:1 with controls based on demographics and year of diagnosis. Statin use was evaluated. Statin use was associated with a small increase in risk of RA, which was diminished after adjusting for hyperlipidemia; a trend towards increase in risk with higher dose and duration of statin use was not statistically significant. Beyond this, the reduced risk after adjustment for hyperlipidemia is hard to interpret as an explanation of cause or effect of autoimmunity, and, given the small magnitude of increases and decreases in risk, may not be clinically meaningful.

In addition to patients with RA having a higher burden of cardiovascular disease necessitating use of statins, they also have a high risk of progressive secondary osteoarthritis requiring joint replacement surgery. Chang et al³ used a national claims-based dataset from China to examine risk of total knee or hip replacement (TKR and THR, respectively) in patients with RA. From 2000-2013 (ie, the onset of the biologic era), TKR and THR rates were examined in a cohort of biologic disease-modifying antirheumatic drug (bDMARD) users compared to conventional synthetic DMARD (csDMARD) users. Adjusted hazard ratios (HR) were lower for both TKD and THR in bDMARD users. Though RA activity was not examined, combined with the knowledge of the association of disease severity with bDMARD use, this study lends evidence to the benefits of more aggressive treatment.

Finally, much is made of the link between bDMARD and targeted synthetic DMARD use and malignancy due to reduced immunosurveillance, but concrete evidence is conflicting. Wetzman et al⁴ performed a systematic review of studies of patients with inflammatory arthritis (RA, psoriatic arthritis, and Ankylosing spondylitis) looking at cancer relapse or occurrence of new cancer. An increase in skin cancers (HR 1.32) was noted, but reassuringly no other increase in risk of recurrent or new cancer was seen.

References

1. Fleischmann R et al. Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira®) or continuing biosimilar therapy: week 52–92 data from a randomized, double-blind, phase 3 trialArthritis Res Ther. 2021(Sep 25);23:248.
2. Peterson MN et al. Risk of rheumatoid arthritis diagnosis in statin users in a large nationwide US study. Arthritis Res Ther. 2021(Sep 18):23:244.
3. Chang YS et al. Effects of biologics on reducing the risks of total knee replacement and total hip replacement in rheumatoid arthritis. Rheumatology (Oxford). 2021(Sep 17):keab671.
4. Wetzman A et al. Risk of cancer after initiation of targeted therapies in patients with rheumatoid arthritis and a prior cancer: systematic review with meta-analysis. Arthritis Care Res (Hoboken). 2021(Sep 21): acr.24784.

Biosimilar medications have received significant attention recently in the treatment of rheumatoid arthritis (RA), though the effects of switching from the reference drug to a biosimilar is not known. The study by Fleischmann et al¹ looks at the safety and efficacy, as well as immunogenicity, of biosimilar adalimumab (ADL-PF) compared to the reference ADL-EU (European Union sourced adalimumab) in a randomized double-blind study. Patients were randomized to start and continue ADL-PF or start ADL-EU and switch to ADL-PF at week 26 or 52. Immunogenicity was measured using anti-drug antibodies (ADA). American College of Rheumatology (ACR20) response rates were similar among all groups, while ACR50 and ACR70 response rates were numerically lower in the week 52 switch group. ADA development was comparable between groups. Data were analyzed using descriptive statistics, but overall, safety, efficacy, and immunogenicity were similar between patients maintained on ADL-PF and those switched from ADL-EU at week 26 or 52.

Statins have long been associated with musculoskeletal symptoms in patients, but have also been postulated to have anti-inflammatory and immunomodulatory effects. Complicating the relationship is the knowledge that inflammation increases cardiovascular risk in RA patients. In a case-control study, Peterson et al² used an administrative database to examine the influence of statin use on development of RA. Cases were identified based on ICD-9 coding as well as a prescription for methotrexate after diagnosis. They were matched 1:1 with controls based on demographics and year of diagnosis. Statin use was evaluated. Statin use was associated with a small increase in risk of RA, which was diminished after adjusting for hyperlipidemia; a trend towards increase in risk with higher dose and duration of statin use was not statistically significant. Beyond this, the reduced risk after adjustment for hyperlipidemia is hard to interpret as an explanation of cause or effect of autoimmunity, and, given the small magnitude of increases and decreases in risk, may not be clinically meaningful.

In addition to patients with RA having a higher burden of cardiovascular disease necessitating use of statins, they also have a high risk of progressive secondary osteoarthritis requiring joint replacement surgery. Chang et al³ used a national claims-based dataset from China to examine risk of total knee or hip replacement (TKR and THR, respectively) in patients with RA. From 2000-2013 (ie, the onset of the biologic era), TKR and THR rates were examined in a cohort of biologic disease-modifying antirheumatic drug (bDMARD) users compared to conventional synthetic DMARD (csDMARD) users. Adjusted hazard ratios (HR) were lower for both TKD and THR in bDMARD users. Though RA activity was not examined, combined with the knowledge of the association of disease severity with bDMARD use, this study lends evidence to the benefits of more aggressive treatment.

Finally, much is made of the link between bDMARD and targeted synthetic DMARD use and malignancy due to reduced immunosurveillance, but concrete evidence is conflicting. Wetzman et al⁴ performed a systematic review of studies of patients with inflammatory arthritis (RA, psoriatic arthritis, and Ankylosing spondylitis) looking at cancer relapse or occurrence of new cancer. An increase in skin cancers (HR 1.32) was noted, but reassuringly no other increase in risk of recurrent or new cancer was seen.

References

1. Fleischmann R et al. Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira®) or continuing biosimilar therapy: week 52–92 data from a randomized, double-blind, phase 3 trialArthritis Res Ther. 2021(Sep 25);23:248.
2. Peterson MN et al. Risk of rheumatoid arthritis diagnosis in statin users in a large nationwide US study. Arthritis Res Ther. 2021(Sep 18):23:244.
3. Chang YS et al. Effects of biologics on reducing the risks of total knee replacement and total hip replacement in rheumatoid arthritis. Rheumatology (Oxford). 2021(Sep 17):keab671.
4. Wetzman A et al. Risk of cancer after initiation of targeted therapies in patients with rheumatoid arthritis and a prior cancer: systematic review with meta-analysis. Arthritis Care Res (Hoboken). 2021(Sep 21): acr.24784.

Biosimilar medications have received significant attention recently in the treatment of rheumatoid arthritis (RA), though the effects of switching from the reference drug to a biosimilar is not known. The study by Fleischmann et al¹ looks at the safety and efficacy, as well as immunogenicity, of biosimilar adalimumab (ADL-PF) compared to the reference ADL-EU (European Union sourced adalimumab) in a randomized double-blind study. Patients were randomized to start and continue ADL-PF or start ADL-EU and switch to ADL-PF at week 26 or 52. Immunogenicity was measured using anti-drug antibodies (ADA). American College of Rheumatology (ACR20) response rates were similar among all groups, while ACR50 and ACR70 response rates were numerically lower in the week 52 switch group. ADA development was comparable between groups. Data were analyzed using descriptive statistics, but overall, safety, efficacy, and immunogenicity were similar between patients maintained on ADL-PF and those switched from ADL-EU at week 26 or 52.

Statins have long been associated with musculoskeletal symptoms in patients, but have also been postulated to have anti-inflammatory and immunomodulatory effects. Complicating the relationship is the knowledge that inflammation increases cardiovascular risk in RA patients. In a case-control study, Peterson et al² used an administrative database to examine the influence of statin use on development of RA. Cases were identified based on ICD-9 coding as well as a prescription for methotrexate after diagnosis. They were matched 1:1 with controls based on demographics and year of diagnosis. Statin use was evaluated. Statin use was associated with a small increase in risk of RA, which was diminished after adjusting for hyperlipidemia; a trend towards increase in risk with higher dose and duration of statin use was not statistically significant. Beyond this, the reduced risk after adjustment for hyperlipidemia is hard to interpret as an explanation of cause or effect of autoimmunity, and, given the small magnitude of increases and decreases in risk, may not be clinically meaningful.

In addition to patients with RA having a higher burden of cardiovascular disease necessitating use of statins, they also have a high risk of progressive secondary osteoarthritis requiring joint replacement surgery. Chang et al³ used a national claims-based dataset from China to examine risk of total knee or hip replacement (TKR and THR, respectively) in patients with RA. From 2000-2013 (ie, the onset of the biologic era), TKR and THR rates were examined in a cohort of biologic disease-modifying antirheumatic drug (bDMARD) users compared to conventional synthetic DMARD (csDMARD) users. Adjusted hazard ratios (HR) were lower for both TKD and THR in bDMARD users. Though RA activity was not examined, combined with the knowledge of the association of disease severity with bDMARD use, this study lends evidence to the benefits of more aggressive treatment.

Finally, much is made of the link between bDMARD and targeted synthetic DMARD use and malignancy due to reduced immunosurveillance, but concrete evidence is conflicting. Wetzman et al⁴ performed a systematic review of studies of patients with inflammatory arthritis (RA, psoriatic arthritis, and Ankylosing spondylitis) looking at cancer relapse or occurrence of new cancer. An increase in skin cancers (HR 1.32) was noted, but reassuringly no other increase in risk of recurrent or new cancer was seen.

References

1. Fleischmann R et al. Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira®) or continuing biosimilar therapy: week 52–92 data from a randomized, double-blind, phase 3 trialArthritis Res Ther. 2021(Sep 25);23:248.
2. Peterson MN et al. Risk of rheumatoid arthritis diagnosis in statin users in a large nationwide US study. Arthritis Res Ther. 2021(Sep 18):23:244.
3. Chang YS et al. Effects of biologics on reducing the risks of total knee replacement and total hip replacement in rheumatoid arthritis. Rheumatology (Oxford). 2021(Sep 17):keab671.
4. Wetzman A et al. Risk of cancer after initiation of targeted therapies in patients with rheumatoid arthritis and a prior cancer: systematic review with meta-analysis. Arthritis Care Res (Hoboken). 2021(Sep 21): acr.24784.

There have been quite a few papers published in October that have provided further insights into psoriatic arthritis (PsA). Understanding risk factors for developing PsA in patients with psoriasis is of ongoing interest, but there is limited data on the relationship between the severity of psoriasis and the risk of developing PsA especially in the USA population. Using the Optum electronic health records (EHR) database, Merola et al¹ assessed the incidence, prevalence, and predictors of PsA among 114,868 patients with psoriasis between January 1, 2009, and March 31, 2019. The severity of psoriasis was determined by treatment received during the 1 year after psoriasis diagnosis as follows: mild (89.3%) topicals and phototherapy only; moderate (5.5%) nonbiologic systemic therapies (acitretin, apremilast, cyclosporine, methotrexate), and severe (5.2%) biologic therapies (adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, ustekinumab). They found that the overall incidence of PsA was 2.9 (95% CI 2.9-3.0) events per 100 patient-years of follow up (PY). The incidence (100 PY, 95% CI) by severity was lowest (2.1 [95% CI 2.1-2.1]) in the mild, higher in the moderate (9.9 [95% CI 9.5-10.4]), and highest (17.6 [95% CI 16.9-18.3]) in the severe psoriasis category. The study thus confirms that patients with more severe psoriasis have higher risk of developing PsA.

The effect of treatment of psoriasis on the development of PsA is also have great interest. Recent studies² have indicated that biologic treatment of psoriasis may reduce the incidence of PsA. However, Meer et al³ in a retrospective cohort study using of 1,93,709 patients with psoriasis without PsA in the Optum Insights EHR database report that biologic use was associated with the development of PsA among patients with psoriasis. After propensity score matching, the hazard ratio was 2.14 (95% CI 2.00-2.28) for patients on biologics compared to those on oral therapy or phototherapy. Such studies are influenced by confounding factors ,by indication, and protopathic bias and hence prospective studies are warranted.

Better treatment outcomes are likely if patient priorities are taken into account when choosing a therapy. However, there are few studies addressing this issue. Sumpton et al⁴ conducted a discrete choice experiment in patients with PsA in Sydney, Australia, to assess preferences for different attributes of biologics. They identified the following attributes in order of preference: oral route (compared to subcutaneous and intravenous routes), avoiding severe side effects, increasing ability to attend to normal activities, avoiding infections, improvement in enthesitis pain, improvement in psoriasis, increasing chance of remission and improvement in joint pain. Thus, patients valued ease of administration, avoiding side effects, and physical function more when choosing a therapy. With increased availability of treatment choices, developing decision support systems that facilitate shared decision making between patients and clinicians is required to improve care of PsA patients.

Ultrasound is increasingly being used at the point of care in rheumatology, but until now ultrasound was not used as a primary outcome in a clinical trial. In the first randomized, placebo-controlled, phase III study using power Doppler ultrasound (PDUS) D’Agostino et al⁵ demonstrated that treatment with secukinumab (dosed according to psoriasis severity) led to statistically significant improvement in synovitis measured using the Global European League Against Rheumatism and Outcome Measures in Rheumatoid Arthritis Clinical Trials Synovitis Score (GLOESS) compared to placebo. Thus, secukinumab, an IL-17A inhibitor, reduces synovitis as detected by ultrasound as well as symptoms and clinical signs of PsA.

References

1. Merola JF et al. Incidence and Prevalence of Psoriatic Arthritis in Patients With Psoriasis Stratified by Psoriasis Disease Severity: Retrospective Analysis of a US Electronic Health Records Database. J Am Acad Dermatol. 2021(Sep 18):S0190-9622(21)02494-4.
2. Acosta Felquer ML et al. Treating the skin with biologics in patients with psoriasis decreases the incidence of psoriatic arthritis. Ann Rheum Dis. 2021 (Jul 19):annrheumdis-2021-220865.
3. Meer E et al. Does biologic therapy impact the development of PsA among patients with psoriasis? Ann Rheum Dis. 2021(Oct 6):annrheumdis-2021-220761.
4. Sumpton D et al. Preferences for biologic treatment in patients with psoriatic arthritis: a discrete choice experiment. Arthritis Care Res (Hoboken). 2021(Sep 13):acr.24782
5. D'Agostino MA et al. Response to secukinumab on synovitis using power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE. Rheumatology (Oxford). 2021(Sep 16):keab628.

There have been quite a few papers published in October that have provided further insights into psoriatic arthritis (PsA). Understanding risk factors for developing PsA in patients with psoriasis is of ongoing interest, but there is limited data on the relationship between the severity of psoriasis and the risk of developing PsA especially in the USA population. Using the Optum electronic health records (EHR) database, Merola et al¹ assessed the incidence, prevalence, and predictors of PsA among 114,868 patients with psoriasis between January 1, 2009, and March 31, 2019. The severity of psoriasis was determined by treatment received during the 1 year after psoriasis diagnosis as follows: mild (89.3%) topicals and phototherapy only; moderate (5.5%) nonbiologic systemic therapies (acitretin, apremilast, cyclosporine, methotrexate), and severe (5.2%) biologic therapies (adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, ustekinumab). They found that the overall incidence of PsA was 2.9 (95% CI 2.9-3.0) events per 100 patient-years of follow up (PY). The incidence (100 PY, 95% CI) by severity was lowest (2.1 [95% CI 2.1-2.1]) in the mild, higher in the moderate (9.9 [95% CI 9.5-10.4]), and highest (17.6 [95% CI 16.9-18.3]) in the severe psoriasis category. The study thus confirms that patients with more severe psoriasis have higher risk of developing PsA.

The effect of treatment of psoriasis on the development of PsA is also have great interest. Recent studies² have indicated that biologic treatment of psoriasis may reduce the incidence of PsA. However, Meer et al³ in a retrospective cohort study using of 1,93,709 patients with psoriasis without PsA in the Optum Insights EHR database report that biologic use was associated with the development of PsA among patients with psoriasis. After propensity score matching, the hazard ratio was 2.14 (95% CI 2.00-2.28) for patients on biologics compared to those on oral therapy or phototherapy. Such studies are influenced by confounding factors ,by indication, and protopathic bias and hence prospective studies are warranted.

Better treatment outcomes are likely if patient priorities are taken into account when choosing a therapy. However, there are few studies addressing this issue. Sumpton et al⁴ conducted a discrete choice experiment in patients with PsA in Sydney, Australia, to assess preferences for different attributes of biologics. They identified the following attributes in order of preference: oral route (compared to subcutaneous and intravenous routes), avoiding severe side effects, increasing ability to attend to normal activities, avoiding infections, improvement in enthesitis pain, improvement in psoriasis, increasing chance of remission and improvement in joint pain. Thus, patients valued ease of administration, avoiding side effects, and physical function more when choosing a therapy. With increased availability of treatment choices, developing decision support systems that facilitate shared decision making between patients and clinicians is required to improve care of PsA patients.

Ultrasound is increasingly being used at the point of care in rheumatology, but until now ultrasound was not used as a primary outcome in a clinical trial. In the first randomized, placebo-controlled, phase III study using power Doppler ultrasound (PDUS) D’Agostino et al⁵ demonstrated that treatment with secukinumab (dosed according to psoriasis severity) led to statistically significant improvement in synovitis measured using the Global European League Against Rheumatism and Outcome Measures in Rheumatoid Arthritis Clinical Trials Synovitis Score (GLOESS) compared to placebo. Thus, secukinumab, an IL-17A inhibitor, reduces synovitis as detected by ultrasound as well as symptoms and clinical signs of PsA.

References

1. Merola JF et al. Incidence and Prevalence of Psoriatic Arthritis in Patients With Psoriasis Stratified by Psoriasis Disease Severity: Retrospective Analysis of a US Electronic Health Records Database. J Am Acad Dermatol. 2021(Sep 18):S0190-9622(21)02494-4.
2. Acosta Felquer ML et al. Treating the skin with biologics in patients with psoriasis decreases the incidence of psoriatic arthritis. Ann Rheum Dis. 2021 (Jul 19):annrheumdis-2021-220865.
3. Meer E et al. Does biologic therapy impact the development of PsA among patients with psoriasis? Ann Rheum Dis. 2021(Oct 6):annrheumdis-2021-220761.
4. Sumpton D et al. Preferences for biologic treatment in patients with psoriatic arthritis: a discrete choice experiment. Arthritis Care Res (Hoboken). 2021(Sep 13):acr.24782
5. D'Agostino MA et al. Response to secukinumab on synovitis using power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE. Rheumatology (Oxford). 2021(Sep 16):keab628.

There have been quite a few papers published in October that have provided further insights into psoriatic arthritis (PsA). Understanding risk factors for developing PsA in patients with psoriasis is of ongoing interest, but there is limited data on the relationship between the severity of psoriasis and the risk of developing PsA especially in the USA population. Using the Optum electronic health records (EHR) database, Merola et al¹ assessed the incidence, prevalence, and predictors of PsA among 114,868 patients with psoriasis between January 1, 2009, and March 31, 2019. The severity of psoriasis was determined by treatment received during the 1 year after psoriasis diagnosis as follows: mild (89.3%) topicals and phototherapy only; moderate (5.5%) nonbiologic systemic therapies (acitretin, apremilast, cyclosporine, methotrexate), and severe (5.2%) biologic therapies (adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, ustekinumab). They found that the overall incidence of PsA was 2.9 (95% CI 2.9-3.0) events per 100 patient-years of follow up (PY). The incidence (100 PY, 95% CI) by severity was lowest (2.1 [95% CI 2.1-2.1]) in the mild, higher in the moderate (9.9 [95% CI 9.5-10.4]), and highest (17.6 [95% CI 16.9-18.3]) in the severe psoriasis category. The study thus confirms that patients with more severe psoriasis have higher risk of developing PsA.

The effect of treatment of psoriasis on the development of PsA is also have great interest. Recent studies² have indicated that biologic treatment of psoriasis may reduce the incidence of PsA. However, Meer et al³ in a retrospective cohort study using of 1,93,709 patients with psoriasis without PsA in the Optum Insights EHR database report that biologic use was associated with the development of PsA among patients with psoriasis. After propensity score matching, the hazard ratio was 2.14 (95% CI 2.00-2.28) for patients on biologics compared to those on oral therapy or phototherapy. Such studies are influenced by confounding factors ,by indication, and protopathic bias and hence prospective studies are warranted.

Better treatment outcomes are likely if patient priorities are taken into account when choosing a therapy. However, there are few studies addressing this issue. Sumpton et al⁴ conducted a discrete choice experiment in patients with PsA in Sydney, Australia, to assess preferences for different attributes of biologics. They identified the following attributes in order of preference: oral route (compared to subcutaneous and intravenous routes), avoiding severe side effects, increasing ability to attend to normal activities, avoiding infections, improvement in enthesitis pain, improvement in psoriasis, increasing chance of remission and improvement in joint pain. Thus, patients valued ease of administration, avoiding side effects, and physical function more when choosing a therapy. With increased availability of treatment choices, developing decision support systems that facilitate shared decision making between patients and clinicians is required to improve care of PsA patients.

Ultrasound is increasingly being used at the point of care in rheumatology, but until now ultrasound was not used as a primary outcome in a clinical trial. In the first randomized, placebo-controlled, phase III study using power Doppler ultrasound (PDUS) D’Agostino et al⁵ demonstrated that treatment with secukinumab (dosed according to psoriasis severity) led to statistically significant improvement in synovitis measured using the Global European League Against Rheumatism and Outcome Measures in Rheumatoid Arthritis Clinical Trials Synovitis Score (GLOESS) compared to placebo. Thus, secukinumab, an IL-17A inhibitor, reduces synovitis as detected by ultrasound as well as symptoms and clinical signs of PsA.

References

1. Merola JF et al. Incidence and Prevalence of Psoriatic Arthritis in Patients With Psoriasis Stratified by Psoriasis Disease Severity: Retrospective Analysis of a US Electronic Health Records Database. J Am Acad Dermatol. 2021(Sep 18):S0190-9622(21)02494-4.
2. Acosta Felquer ML et al. Treating the skin with biologics in patients with psoriasis decreases the incidence of psoriatic arthritis. Ann Rheum Dis. 2021 (Jul 19):annrheumdis-2021-220865.
3. Meer E et al. Does biologic therapy impact the development of PsA among patients with psoriasis? Ann Rheum Dis. 2021(Oct 6):annrheumdis-2021-220761.
4. Sumpton D et al. Preferences for biologic treatment in patients with psoriatic arthritis: a discrete choice experiment. Arthritis Care Res (Hoboken). 2021(Sep 13):acr.24782
5. D'Agostino MA et al. Response to secukinumab on synovitis using power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE. Rheumatology (Oxford). 2021(Sep 16):keab628.

While this month’s journal scan for clinical research reviews in exocrine pancreatic insufficiency (EPI) may not reveal a landmark paper, there certainly are novel findings worthy of note.  In particular researchers Halabitska and Babinets¹ from Ternopil National Medical University in Ukraine¹ looked at the impact of NSAID use on fecal elastase and nutritional parameters in patients with baseline EPI.

The researchers’ primary aim is based on the idea that osteoarthritis (OA) accounts for a significant global disease burden, particularly in advanced age with other concomitant comorbidities, yet most attention is paid to the study of peptic ulcer disease (PUD) and nonsteroidal anti-inflammatory drug (NSAID)-related enteropathies of the gastrointestinal tract after NSAID use. Researchers state, “however, no studies have been found to study the effect of NSAIDs on the progression of EPI and the development of trophological disorders, especially under conditions of primary OA comorbidity with diseases accompanied by EPI.”

This study included 87 adult patients with primary OA along with EPI and 30 healthy controls. The patients in the interventional group received a 14-day course of NSAIDs which are officially recommended for the treatment of pain in primary OA (15 mg/day meloxicam, 200 mg/day nimesulide, 150 mg/day diclofenac sodium).  Fecal α-elastase levels were analyzed before and after NSAID treatment in patients with primary OA and concomitant EPI. After NSAID treatment, there was a statistically significant decrease in EPI levels, which was most pronounced in the subgroup of patients with EPI from chronic pancreatitis. Further, the levels of trophologic parameters (magnesium, calcium, iron, zinc, selenium, albumin, and vitamins A, E, and K) decreased significantly after NSAID treatment (all P < .05).

The authors concluded that NSAID use likely worsens EPI and nutritional parameters in patients with primary osteoarthritis with concomitant EPI at baseline. This is potentially practice changing, which might suggest that a closer monitoring of EPI parameters during a course of NSAID treatment is needed. Patients with EPI are of course already at risk of fat soluble vitamin deficiencies, and it may provide only more reason to check and replenish micronutrients and vitamin levels after a course of NSAID therapy. 

References

1. Halabitska IM et al. Different consequences of the treatment of osteoarthritis in gastrointestinal comorbidity with exocrine pancreatic insufficiency. Fam Med Prim Care Rev. 2021 (Oct 5);23(4):10.5114/fmpcr.2021.108207.

While this month’s journal scan for clinical research reviews in exocrine pancreatic insufficiency (EPI) may not reveal a landmark paper, there certainly are novel findings worthy of note.  In particular researchers Halabitska and Babinets¹ from Ternopil National Medical University in Ukraine¹ looked at the impact of NSAID use on fecal elastase and nutritional parameters in patients with baseline EPI.

The researchers’ primary aim is based on the idea that osteoarthritis (OA) accounts for a significant global disease burden, particularly in advanced age with other concomitant comorbidities, yet most attention is paid to the study of peptic ulcer disease (PUD) and nonsteroidal anti-inflammatory drug (NSAID)-related enteropathies of the gastrointestinal tract after NSAID use. Researchers state, “however, no studies have been found to study the effect of NSAIDs on the progression of EPI and the development of trophological disorders, especially under conditions of primary OA comorbidity with diseases accompanied by EPI.”

This study included 87 adult patients with primary OA along with EPI and 30 healthy controls. The patients in the interventional group received a 14-day course of NSAIDs which are officially recommended for the treatment of pain in primary OA (15 mg/day meloxicam, 200 mg/day nimesulide, 150 mg/day diclofenac sodium).  Fecal α-elastase levels were analyzed before and after NSAID treatment in patients with primary OA and concomitant EPI. After NSAID treatment, there was a statistically significant decrease in EPI levels, which was most pronounced in the subgroup of patients with EPI from chronic pancreatitis. Further, the levels of trophologic parameters (magnesium, calcium, iron, zinc, selenium, albumin, and vitamins A, E, and K) decreased significantly after NSAID treatment (all P < .05).

The authors concluded that NSAID use likely worsens EPI and nutritional parameters in patients with primary osteoarthritis with concomitant EPI at baseline. This is potentially practice changing, which might suggest that a closer monitoring of EPI parameters during a course of NSAID treatment is needed. Patients with EPI are of course already at risk of fat soluble vitamin deficiencies, and it may provide only more reason to check and replenish micronutrients and vitamin levels after a course of NSAID therapy. 

References

1. Halabitska IM et al. Different consequences of the treatment of osteoarthritis in gastrointestinal comorbidity with exocrine pancreatic insufficiency. Fam Med Prim Care Rev. 2021 (Oct 5);23(4):10.5114/fmpcr.2021.108207.

While this month’s journal scan for clinical research reviews in exocrine pancreatic insufficiency (EPI) may not reveal a landmark paper, there certainly are novel findings worthy of note.  In particular researchers Halabitska and Babinets¹ from Ternopil National Medical University in Ukraine¹ looked at the impact of NSAID use on fecal elastase and nutritional parameters in patients with baseline EPI.

The researchers’ primary aim is based on the idea that osteoarthritis (OA) accounts for a significant global disease burden, particularly in advanced age with other concomitant comorbidities, yet most attention is paid to the study of peptic ulcer disease (PUD) and nonsteroidal anti-inflammatory drug (NSAID)-related enteropathies of the gastrointestinal tract after NSAID use. Researchers state, “however, no studies have been found to study the effect of NSAIDs on the progression of EPI and the development of trophological disorders, especially under conditions of primary OA comorbidity with diseases accompanied by EPI.”

This study included 87 adult patients with primary OA along with EPI and 30 healthy controls. The patients in the interventional group received a 14-day course of NSAIDs which are officially recommended for the treatment of pain in primary OA (15 mg/day meloxicam, 200 mg/day nimesulide, 150 mg/day diclofenac sodium).  Fecal α-elastase levels were analyzed before and after NSAID treatment in patients with primary OA and concomitant EPI. After NSAID treatment, there was a statistically significant decrease in EPI levels, which was most pronounced in the subgroup of patients with EPI from chronic pancreatitis. Further, the levels of trophologic parameters (magnesium, calcium, iron, zinc, selenium, albumin, and vitamins A, E, and K) decreased significantly after NSAID treatment (all P < .05).

The authors concluded that NSAID use likely worsens EPI and nutritional parameters in patients with primary osteoarthritis with concomitant EPI at baseline. This is potentially practice changing, which might suggest that a closer monitoring of EPI parameters during a course of NSAID treatment is needed. Patients with EPI are of course already at risk of fat soluble vitamin deficiencies, and it may provide only more reason to check and replenish micronutrients and vitamin levels after a course of NSAID therapy. 

References

1. Halabitska IM et al. Different consequences of the treatment of osteoarthritis in gastrointestinal comorbidity with exocrine pancreatic insufficiency. Fam Med Prim Care Rev. 2021 (Oct 5);23(4):10.5114/fmpcr.2021.108207.

Dear colleagues and friends,

I am fortunate to receive the baton from Charles Kahi, MD, in facilitating the fascinating and timely debates that have characterized the AGA Perspective series. Favorable reimbursement changes and the need for social distancing fast-tracked telemedicine, a care delivery model that had been slowly evolving.

In this month’s Perspective column, Dr. Hernaez and Dr. Vaughn discuss the pros and cons of telemedicine in GI. Is it the new office visit? Or simply just good enough for when we really need it? I look forward to hearing your thoughts and experiences on the AGA Community forum as well as by email ([email protected]).
 

Gyanprakash A. Ketwaroo, MD, is assistant professor of medicine at Baylor College of Medicine, Houston. He is an associate editor for GI & Hepatology News.

It holds promise

BY RUBEN HERNAEZ, MD, MPH, PHD

It was around January 2020, when COVID-19 was something far, far away, and not particularly worrisome. I was performing a routine care visit of one of my out-of-state patients waitlisted for a liver transplant. All was going fine until he stated, “Hey doc, while I appreciate your time and visits, these travels to Houston are quite inconvenient for my family and me: It is a logistical ordeal, and my wife is always afraid of catching something in the airplane. Could you do the same remotely such as a videoconference?” And just like that, it sparked my interest in how to maintain his liver transplant care from a distance. The Federation of State Medical Boards defines telemedicine as “the practice of medicine using electronic communication, information technology, or other means between a physician in one location, and a patient in another location, with or without an intervening health care provider.¹ What my patient was asking was to use a mode of telemedicine – a video visit – to receive the same quality of care. He brought up three critical points that I will discuss further: access to specialty care (such as transplant hepatology), reduction of costs (time and money), and improved patient satisfaction.

Arora and colleagues pioneered the Extension for Community Healthcare Outcomes (ECHO) project, providing complex specialty medical care to underserved populations through a model of team-based interdisciplinary development in hepatitis C infection treatment in underserved communities, with cure rates similar to the university settings.¹ The University of Michigan–Veterans Affairs Medical Center used a similar approach, called Specialty Care Access Network–Extension of Community Healthcare Outcome (SCAN‐ECHO). They showed that telemedicine improved survival in 513 patients evaluated in this program compared to regular care (hazard ratio [HR]of 0.54, 95% confidence interval 0.36‐0.81, P = .003).² So the evidence backs my patient’s request in providing advanced medical care using a telemedicine platform.

An extra benefit of telemedicine in the current climate crisis is reducing the carbon footprint: There’s no need to travel. Telemedicine has been shown to be cost effective: A study of claims data from Jefferson Health reported that patients who received care from an on-demand telemedicine program had net cost savings per telemedicine visit between $19 and $121 per visit compared with traditional in-person visits.³ Using telemonitoring, a form of telemedicine, Bloom et al. showed in 100 simulated patients with cirrhosis and ascites over a 6-month horizon that standard of care was $167,500 more expensive than telemonitoring. The net savings of telemonitoring was always superior in different clinical scenarios.⁴

Further, our patients significantly decrease travel time (almost instant), improve compliance with medical appointments (more flexibility), and no more headaches related to parking or getting lost around the medical campus. Not surprisingly, these perks from telemedicine are associated with patient-reported outcomes. Reed and colleagues reported patients’ experience with video telemedicine visits in Kaiser Permanente Northern California (n = 1,274) and showed that “67% generally needed to make one or more arrangements to attend an in-person office visit (55% time off from work, 29% coverage for another activity or responsibility, 15% child care or caregiving, and 10% another person to accompany them)”; in contrast, 87% reported a video visit as “more convenient for me,” and 93% stated that “my video visit adequately addressed my needs.”⁵ In liver transplantation, John et al. showed that, in the Veterans Health Administration, telehealth was associated with a significantly shorter time on the liver transplant waitlist (138.8 vs. 249 days), reduction in the time from referral to evaluation (HR, 0.15; 95% CI, 0.09-0.21; P < .01) and listing (HR, 0.26; 95% CI, 0.12-0.40; P < .01) in a study of 232 patients with advanced cirrhosis.⁶

So, should I change my approach to patients undergoing care for chronic liver/gastrointestinal diseases? I think so. Telemedicine and its tools provide clear benefits to our patients by increasing access to care, time and money savings, and satisfaction. I am fortunate to work within the largest healthcare network in the Nation – the Veterans Health Administration – and therefore, I can cross state lines to provide medical care/advice using the video-visit tool (VA VideoConnect). One could argue that some patients might find it challenging to access telemedicine appointments, but with adequate coaching or support from our teams, telemedicine visits are a click away.

Going back to my patient, I embraced his request and coached him on using VA VideoConnect. We can continue his waitlist medical care in the following months despite the COVID-19 pandemic using telemedicine. I can assess his asterixis and ascites via his cellphone; his primary care team fills in the vitals and labs to complete a virtual visit. There’s no question in my mind that telemedicine is here to stay and that we will continue to adapt e-health tools into video visits (for example, integrating vitals, measurement of frailty, and remote monitoring). The future of our specialty is here, and I envision we will eventually have home-based hospitalizations with daily virtual rounds.
 

Dr. Hernaez is with the section of gastroenterology and the Center for Innovations in Quality, Effectiveness, and Safety at the Michael E. DeBakey Veterans Affairs Medical Center and in the section of gastroenterology and hepatology in the department of medicine at Baylor College of Medicine, both in Houston. He has no relevant conflicts of interest.

References

1. Arora S et al. N Engl J Med. 2011 Jun 9;364(23):2199-207.

2. Su GL et al. Hepatology. 2018 Dec;68(6):2317-24.

3. Nord G et al. Am J Emerg Med. 2019 May;37(5):890-4.

4. Bloom PP et al. Dig Dis Sci. 2021. doi: 10.1007/s10620-021-07013-2.

5. Reed ME et al. Ann Intern Med. 2019 Aug;171:222-4.

6. John BV et al. Clin Gastroenterol Hepatol. 2020 Jul;18:1822-30.e4.

It has its limits

BY BYRON P. VAUGHN, MD, MS

The post-pandemic world will include telehealth. Technology disrupts business as usual and often brings positive change. But there are consequences. To employ telehealth into routine care equitably and effectively within a gastroenterology practice, we should consider two general questions: “Was the care I provided the same quality as if the patient was seen in person?” and more broadly, “am I satisfied with my practice’s implementation of telehealth?” This perspective will highlight several areas affecting gastroenterology care: lack of physical exam, disproportionate impact on certain populations, development of a patient-provider relationship, impact on physician well-being, and potential financial ramifications. We will all have to adapt to telemedicine to some extent. Understanding the trade-offs of this technology can help us position effectively in a gastroenterology practice.

Perhaps the most obvious limitation of telemedicine is the lack of vital signs and physical exam. Determining if a patient is “sick or not” is often one of the first lessons trainees learn overnight. Vital signs and physical exam are crucial in the complex triaging that occurs when evaluating for diagnoses with potentially urgent interventions. While most outpatient gastroenterology clinics are not evaluating an acute abdomen, in the correct context, the physical exam provides important nuance and often reassurance. My personal estimate is that 90% of a diagnosis is based on the history. But without physical contact, providers may increase costly downstream diagnostic testing or referrals to the emergency department. Increasing use of at-home or wearable health technology could help but requires system investments in infrastructure to implement.

Telemedicine requires a baseline level of equipment and knowledge to participate. A variety of populations will have either a knowledge gap or technology gap. Lack of rural high-speed Internet can lead to poor video quality, inhibiting effective communication and frustrating both provider and patient. In urban areas, there is a drastic wealth divide, and some groups may have difficulty obtaining sufficient equipment to complete a video visit. Even with adequate infrastructure and equipment, certain groups may be disadvantaged because of a lack of the technological savvy or literacy needed to navigate a virtual visit. The addition of interpreter services adds complexity to communication on top of the virtual interaction. These technology and knowledge gaps can produce confusion and potentially lead to worse care.¹ Careful selection of appropriate patients for telemedicine is essential. Is the quality of care over a virtual visit the same for a business executive as that of a non-English speaking refugee?

The term “webside manner” precedes the pandemic but will be important in the lexicon of doctor-patient relationships moving forward. We routinely train physicians about the importance of small actions to improve our bedside manner, such as sitting down, reacting to body language, and making eye contact. First impressions matter in relationship building. For many of my established IBD patients, I can easily hop into a comfortable repertoire in person, virtually, or even on the phone. In addition, I know these people well enough to trust that I am providing the same level of care regardless of visit medium. However, a new patient virtual encounter requires nuance. I have met new patients while they are driving (I requested the patient park!), in public places, and at work. Despite instructions given to patients about the appropriate location for a virtual visit, the patient location is not in our control. For some patients this may increase the comfort of the visit. However, for others, it can lead to distractions or potentially limit the amount of information a patient is willing to share. Forming a patient-provider relationship virtually will require a new set of skills and specific training for many practitioners.

Telehealth can contribute to provider burnout. While a busy in-person clinic can be exhausting, I have found I can be more exhausted after a half-day of virtual clinic. There is an element of human connection that is difficult to replace online.² On top of that loss, video visits are more psychologically demanding than in-person interactions. I also spend more time in a chair, have fewer coffee breaks, and have fewer professional interactions with the clinic staff and professional colleagues. Several other micro-stressors exist in virtual care that may make “Zoom fatigue” a real occupational hazard.³

Lastly, there are implications on reimbursement with telehealth. In Minnesota, a 2015 telemedicine law required private and state employee health plans to provide the same coverage for telemedicine as in-person visits, although patients had to drive to a clinic or facility to use secure telehealth equipment and have vital signs taken. With the pandemic, this stipulation is waived, and it seems likely to become permanent. However, reimbursement questions will arise, as there is a perception that a 30-minute telephone call should not cost as much as a 30-minute in-person visit, regardless of the content of the conversation.

We will have to learn to move forward with telehealth. The strength of telehealth is likely in patients with chronic, well controlled diseases, who have frequent interactions with health care. Examples of this include (although certainly are not limited to) established patients with well-controlled IBD, non-cirrhotic liver disease, and irritable bowel syndrome. Triaging patients who need in-person evaluation, ensuring patient and provider well-being, and creating a financially sustainable model of care are yet unresolved issues. Providers will likely vary in their personal acceptance of telehealth and will need to advocate within their own systems to obtain a hybrid model of telehealth that maximizes quality of care with job satisfaction.
 

Dr. Vaughn is associate professor of medicine and codirector of the inflammatory bowel disease program in the division of gastroenterology, hepatology, and nutrition at University of Minnesota, Minneapolis. He has received consulting fees from Prometheus and research support from Roche, Takeda, Celgene, Diasorin, and Crestovo.

References

1. George S et al. Stud Health Technol Inform. 2013;192:946.

2. Blank S. “What’s missing from Zoom reminds us what it means to be human,” 2020 Apr 27, Medium.

3. Williams N. Occup Med (Lond). 2021 Apr. doi: 10.1093/occmed/kqab041.

Dear colleagues and friends,

I am fortunate to receive the baton from Charles Kahi, MD, in facilitating the fascinating and timely debates that have characterized the AGA Perspective series. Favorable reimbursement changes and the need for social distancing fast-tracked telemedicine, a care delivery model that had been slowly evolving.

In this month’s Perspective column, Dr. Hernaez and Dr. Vaughn discuss the pros and cons of telemedicine in GI. Is it the new office visit? Or simply just good enough for when we really need it? I look forward to hearing your thoughts and experiences on the AGA Community forum as well as by email ([email protected]).
 

Gyanprakash A. Ketwaroo, MD, is assistant professor of medicine at Baylor College of Medicine, Houston. He is an associate editor for GI & Hepatology News.

It holds promise

BY RUBEN HERNAEZ, MD, MPH, PHD

It was around January 2020, when COVID-19 was something far, far away, and not particularly worrisome. I was performing a routine care visit of one of my out-of-state patients waitlisted for a liver transplant. All was going fine until he stated, “Hey doc, while I appreciate your time and visits, these travels to Houston are quite inconvenient for my family and me: It is a logistical ordeal, and my wife is always afraid of catching something in the airplane. Could you do the same remotely such as a videoconference?” And just like that, it sparked my interest in how to maintain his liver transplant care from a distance. The Federation of State Medical Boards defines telemedicine as “the practice of medicine using electronic communication, information technology, or other means between a physician in one location, and a patient in another location, with or without an intervening health care provider.¹ What my patient was asking was to use a mode of telemedicine – a video visit – to receive the same quality of care. He brought up three critical points that I will discuss further: access to specialty care (such as transplant hepatology), reduction of costs (time and money), and improved patient satisfaction.

Arora and colleagues pioneered the Extension for Community Healthcare Outcomes (ECHO) project, providing complex specialty medical care to underserved populations through a model of team-based interdisciplinary development in hepatitis C infection treatment in underserved communities, with cure rates similar to the university settings.¹ The University of Michigan–Veterans Affairs Medical Center used a similar approach, called Specialty Care Access Network–Extension of Community Healthcare Outcome (SCAN‐ECHO). They showed that telemedicine improved survival in 513 patients evaluated in this program compared to regular care (hazard ratio [HR]of 0.54, 95% confidence interval 0.36‐0.81, P = .003).² So the evidence backs my patient’s request in providing advanced medical care using a telemedicine platform.

An extra benefit of telemedicine in the current climate crisis is reducing the carbon footprint: There’s no need to travel. Telemedicine has been shown to be cost effective: A study of claims data from Jefferson Health reported that patients who received care from an on-demand telemedicine program had net cost savings per telemedicine visit between $19 and $121 per visit compared with traditional in-person visits.³ Using telemonitoring, a form of telemedicine, Bloom et al. showed in 100 simulated patients with cirrhosis and ascites over a 6-month horizon that standard of care was $167,500 more expensive than telemonitoring. The net savings of telemonitoring was always superior in different clinical scenarios.⁴

Further, our patients significantly decrease travel time (almost instant), improve compliance with medical appointments (more flexibility), and no more headaches related to parking or getting lost around the medical campus. Not surprisingly, these perks from telemedicine are associated with patient-reported outcomes. Reed and colleagues reported patients’ experience with video telemedicine visits in Kaiser Permanente Northern California (n = 1,274) and showed that “67% generally needed to make one or more arrangements to attend an in-person office visit (55% time off from work, 29% coverage for another activity or responsibility, 15% child care or caregiving, and 10% another person to accompany them)”; in contrast, 87% reported a video visit as “more convenient for me,” and 93% stated that “my video visit adequately addressed my needs.”⁵ In liver transplantation, John et al. showed that, in the Veterans Health Administration, telehealth was associated with a significantly shorter time on the liver transplant waitlist (138.8 vs. 249 days), reduction in the time from referral to evaluation (HR, 0.15; 95% CI, 0.09-0.21; P < .01) and listing (HR, 0.26; 95% CI, 0.12-0.40; P < .01) in a study of 232 patients with advanced cirrhosis.⁶

So, should I change my approach to patients undergoing care for chronic liver/gastrointestinal diseases? I think so. Telemedicine and its tools provide clear benefits to our patients by increasing access to care, time and money savings, and satisfaction. I am fortunate to work within the largest healthcare network in the Nation – the Veterans Health Administration – and therefore, I can cross state lines to provide medical care/advice using the video-visit tool (VA VideoConnect). One could argue that some patients might find it challenging to access telemedicine appointments, but with adequate coaching or support from our teams, telemedicine visits are a click away.

Going back to my patient, I embraced his request and coached him on using VA VideoConnect. We can continue his waitlist medical care in the following months despite the COVID-19 pandemic using telemedicine. I can assess his asterixis and ascites via his cellphone; his primary care team fills in the vitals and labs to complete a virtual visit. There’s no question in my mind that telemedicine is here to stay and that we will continue to adapt e-health tools into video visits (for example, integrating vitals, measurement of frailty, and remote monitoring). The future of our specialty is here, and I envision we will eventually have home-based hospitalizations with daily virtual rounds.
 

Dr. Hernaez is with the section of gastroenterology and the Center for Innovations in Quality, Effectiveness, and Safety at the Michael E. DeBakey Veterans Affairs Medical Center and in the section of gastroenterology and hepatology in the department of medicine at Baylor College of Medicine, both in Houston. He has no relevant conflicts of interest.

References

1. Arora S et al. N Engl J Med. 2011 Jun 9;364(23):2199-207.

2. Su GL et al. Hepatology. 2018 Dec;68(6):2317-24.

3. Nord G et al. Am J Emerg Med. 2019 May;37(5):890-4.

4. Bloom PP et al. Dig Dis Sci. 2021. doi: 10.1007/s10620-021-07013-2.

5. Reed ME et al. Ann Intern Med. 2019 Aug;171:222-4.

6. John BV et al. Clin Gastroenterol Hepatol. 2020 Jul;18:1822-30.e4.

It has its limits

BY BYRON P. VAUGHN, MD, MS

The post-pandemic world will include telehealth. Technology disrupts business as usual and often brings positive change. But there are consequences. To employ telehealth into routine care equitably and effectively within a gastroenterology practice, we should consider two general questions: “Was the care I provided the same quality as if the patient was seen in person?” and more broadly, “am I satisfied with my practice’s implementation of telehealth?” This perspective will highlight several areas affecting gastroenterology care: lack of physical exam, disproportionate impact on certain populations, development of a patient-provider relationship, impact on physician well-being, and potential financial ramifications. We will all have to adapt to telemedicine to some extent. Understanding the trade-offs of this technology can help us position effectively in a gastroenterology practice.

Perhaps the most obvious limitation of telemedicine is the lack of vital signs and physical exam. Determining if a patient is “sick or not” is often one of the first lessons trainees learn overnight. Vital signs and physical exam are crucial in the complex triaging that occurs when evaluating for diagnoses with potentially urgent interventions. While most outpatient gastroenterology clinics are not evaluating an acute abdomen, in the correct context, the physical exam provides important nuance and often reassurance. My personal estimate is that 90% of a diagnosis is based on the history. But without physical contact, providers may increase costly downstream diagnostic testing or referrals to the emergency department. Increasing use of at-home or wearable health technology could help but requires system investments in infrastructure to implement.

Telemedicine requires a baseline level of equipment and knowledge to participate. A variety of populations will have either a knowledge gap or technology gap. Lack of rural high-speed Internet can lead to poor video quality, inhibiting effective communication and frustrating both provider and patient. In urban areas, there is a drastic wealth divide, and some groups may have difficulty obtaining sufficient equipment to complete a video visit. Even with adequate infrastructure and equipment, certain groups may be disadvantaged because of a lack of the technological savvy or literacy needed to navigate a virtual visit. The addition of interpreter services adds complexity to communication on top of the virtual interaction. These technology and knowledge gaps can produce confusion and potentially lead to worse care.¹ Careful selection of appropriate patients for telemedicine is essential. Is the quality of care over a virtual visit the same for a business executive as that of a non-English speaking refugee?

The term “webside manner” precedes the pandemic but will be important in the lexicon of doctor-patient relationships moving forward. We routinely train physicians about the importance of small actions to improve our bedside manner, such as sitting down, reacting to body language, and making eye contact. First impressions matter in relationship building. For many of my established IBD patients, I can easily hop into a comfortable repertoire in person, virtually, or even on the phone. In addition, I know these people well enough to trust that I am providing the same level of care regardless of visit medium. However, a new patient virtual encounter requires nuance. I have met new patients while they are driving (I requested the patient park!), in public places, and at work. Despite instructions given to patients about the appropriate location for a virtual visit, the patient location is not in our control. For some patients this may increase the comfort of the visit. However, for others, it can lead to distractions or potentially limit the amount of information a patient is willing to share. Forming a patient-provider relationship virtually will require a new set of skills and specific training for many practitioners.

Telehealth can contribute to provider burnout. While a busy in-person clinic can be exhausting, I have found I can be more exhausted after a half-day of virtual clinic. There is an element of human connection that is difficult to replace online.² On top of that loss, video visits are more psychologically demanding than in-person interactions. I also spend more time in a chair, have fewer coffee breaks, and have fewer professional interactions with the clinic staff and professional colleagues. Several other micro-stressors exist in virtual care that may make “Zoom fatigue” a real occupational hazard.³

Lastly, there are implications on reimbursement with telehealth. In Minnesota, a 2015 telemedicine law required private and state employee health plans to provide the same coverage for telemedicine as in-person visits, although patients had to drive to a clinic or facility to use secure telehealth equipment and have vital signs taken. With the pandemic, this stipulation is waived, and it seems likely to become permanent. However, reimbursement questions will arise, as there is a perception that a 30-minute telephone call should not cost as much as a 30-minute in-person visit, regardless of the content of the conversation.

We will have to learn to move forward with telehealth. The strength of telehealth is likely in patients with chronic, well controlled diseases, who have frequent interactions with health care. Examples of this include (although certainly are not limited to) established patients with well-controlled IBD, non-cirrhotic liver disease, and irritable bowel syndrome. Triaging patients who need in-person evaluation, ensuring patient and provider well-being, and creating a financially sustainable model of care are yet unresolved issues. Providers will likely vary in their personal acceptance of telehealth and will need to advocate within their own systems to obtain a hybrid model of telehealth that maximizes quality of care with job satisfaction.
 

Dr. Vaughn is associate professor of medicine and codirector of the inflammatory bowel disease program in the division of gastroenterology, hepatology, and nutrition at University of Minnesota, Minneapolis. He has received consulting fees from Prometheus and research support from Roche, Takeda, Celgene, Diasorin, and Crestovo.

References

1. George S et al. Stud Health Technol Inform. 2013;192:946.

2. Blank S. “What’s missing from Zoom reminds us what it means to be human,” 2020 Apr 27, Medium.

3. Williams N. Occup Med (Lond). 2021 Apr. doi: 10.1093/occmed/kqab041.

Dear colleagues and friends,

I am fortunate to receive the baton from Charles Kahi, MD, in facilitating the fascinating and timely debates that have characterized the AGA Perspective series. Favorable reimbursement changes and the need for social distancing fast-tracked telemedicine, a care delivery model that had been slowly evolving.

In this month’s Perspective column, Dr. Hernaez and Dr. Vaughn discuss the pros and cons of telemedicine in GI. Is it the new office visit? Or simply just good enough for when we really need it? I look forward to hearing your thoughts and experiences on the AGA Community forum as well as by email ([email protected]).
 

Gyanprakash A. Ketwaroo, MD, is assistant professor of medicine at Baylor College of Medicine, Houston. He is an associate editor for GI & Hepatology News.

It holds promise

BY RUBEN HERNAEZ, MD, MPH, PHD

It was around January 2020, when COVID-19 was something far, far away, and not particularly worrisome. I was performing a routine care visit of one of my out-of-state patients waitlisted for a liver transplant. All was going fine until he stated, “Hey doc, while I appreciate your time and visits, these travels to Houston are quite inconvenient for my family and me: It is a logistical ordeal, and my wife is always afraid of catching something in the airplane. Could you do the same remotely such as a videoconference?” And just like that, it sparked my interest in how to maintain his liver transplant care from a distance. The Federation of State Medical Boards defines telemedicine as “the practice of medicine using electronic communication, information technology, or other means between a physician in one location, and a patient in another location, with or without an intervening health care provider.¹ What my patient was asking was to use a mode of telemedicine – a video visit – to receive the same quality of care. He brought up three critical points that I will discuss further: access to specialty care (such as transplant hepatology), reduction of costs (time and money), and improved patient satisfaction.

Arora and colleagues pioneered the Extension for Community Healthcare Outcomes (ECHO) project, providing complex specialty medical care to underserved populations through a model of team-based interdisciplinary development in hepatitis C infection treatment in underserved communities, with cure rates similar to the university settings.¹ The University of Michigan–Veterans Affairs Medical Center used a similar approach, called Specialty Care Access Network–Extension of Community Healthcare Outcome (SCAN‐ECHO). They showed that telemedicine improved survival in 513 patients evaluated in this program compared to regular care (hazard ratio [HR]of 0.54, 95% confidence interval 0.36‐0.81, P = .003).² So the evidence backs my patient’s request in providing advanced medical care using a telemedicine platform.

An extra benefit of telemedicine in the current climate crisis is reducing the carbon footprint: There’s no need to travel. Telemedicine has been shown to be cost effective: A study of claims data from Jefferson Health reported that patients who received care from an on-demand telemedicine program had net cost savings per telemedicine visit between $19 and $121 per visit compared with traditional in-person visits.³ Using telemonitoring, a form of telemedicine, Bloom et al. showed in 100 simulated patients with cirrhosis and ascites over a 6-month horizon that standard of care was $167,500 more expensive than telemonitoring. The net savings of telemonitoring was always superior in different clinical scenarios.⁴

Further, our patients significantly decrease travel time (almost instant), improve compliance with medical appointments (more flexibility), and no more headaches related to parking or getting lost around the medical campus. Not surprisingly, these perks from telemedicine are associated with patient-reported outcomes. Reed and colleagues reported patients’ experience with video telemedicine visits in Kaiser Permanente Northern California (n = 1,274) and showed that “67% generally needed to make one or more arrangements to attend an in-person office visit (55% time off from work, 29% coverage for another activity or responsibility, 15% child care or caregiving, and 10% another person to accompany them)”; in contrast, 87% reported a video visit as “more convenient for me,” and 93% stated that “my video visit adequately addressed my needs.”⁵ In liver transplantation, John et al. showed that, in the Veterans Health Administration, telehealth was associated with a significantly shorter time on the liver transplant waitlist (138.8 vs. 249 days), reduction in the time from referral to evaluation (HR, 0.15; 95% CI, 0.09-0.21; P < .01) and listing (HR, 0.26; 95% CI, 0.12-0.40; P < .01) in a study of 232 patients with advanced cirrhosis.⁶

So, should I change my approach to patients undergoing care for chronic liver/gastrointestinal diseases? I think so. Telemedicine and its tools provide clear benefits to our patients by increasing access to care, time and money savings, and satisfaction. I am fortunate to work within the largest healthcare network in the Nation – the Veterans Health Administration – and therefore, I can cross state lines to provide medical care/advice using the video-visit tool (VA VideoConnect). One could argue that some patients might find it challenging to access telemedicine appointments, but with adequate coaching or support from our teams, telemedicine visits are a click away.

Going back to my patient, I embraced his request and coached him on using VA VideoConnect. We can continue his waitlist medical care in the following months despite the COVID-19 pandemic using telemedicine. I can assess his asterixis and ascites via his cellphone; his primary care team fills in the vitals and labs to complete a virtual visit. There’s no question in my mind that telemedicine is here to stay and that we will continue to adapt e-health tools into video visits (for example, integrating vitals, measurement of frailty, and remote monitoring). The future of our specialty is here, and I envision we will eventually have home-based hospitalizations with daily virtual rounds.
 

Dr. Hernaez is with the section of gastroenterology and the Center for Innovations in Quality, Effectiveness, and Safety at the Michael E. DeBakey Veterans Affairs Medical Center and in the section of gastroenterology and hepatology in the department of medicine at Baylor College of Medicine, both in Houston. He has no relevant conflicts of interest.

References

1. Arora S et al. N Engl J Med. 2011 Jun 9;364(23):2199-207.

2. Su GL et al. Hepatology. 2018 Dec;68(6):2317-24.

3. Nord G et al. Am J Emerg Med. 2019 May;37(5):890-4.

4. Bloom PP et al. Dig Dis Sci. 2021. doi: 10.1007/s10620-021-07013-2.

5. Reed ME et al. Ann Intern Med. 2019 Aug;171:222-4.

6. John BV et al. Clin Gastroenterol Hepatol. 2020 Jul;18:1822-30.e4.

It has its limits

BY BYRON P. VAUGHN, MD, MS

The post-pandemic world will include telehealth. Technology disrupts business as usual and often brings positive change. But there are consequences. To employ telehealth into routine care equitably and effectively within a gastroenterology practice, we should consider two general questions: “Was the care I provided the same quality as if the patient was seen in person?” and more broadly, “am I satisfied with my practice’s implementation of telehealth?” This perspective will highlight several areas affecting gastroenterology care: lack of physical exam, disproportionate impact on certain populations, development of a patient-provider relationship, impact on physician well-being, and potential financial ramifications. We will all have to adapt to telemedicine to some extent. Understanding the trade-offs of this technology can help us position effectively in a gastroenterology practice.

Perhaps the most obvious limitation of telemedicine is the lack of vital signs and physical exam. Determining if a patient is “sick or not” is often one of the first lessons trainees learn overnight. Vital signs and physical exam are crucial in the complex triaging that occurs when evaluating for diagnoses with potentially urgent interventions. While most outpatient gastroenterology clinics are not evaluating an acute abdomen, in the correct context, the physical exam provides important nuance and often reassurance. My personal estimate is that 90% of a diagnosis is based on the history. But without physical contact, providers may increase costly downstream diagnostic testing or referrals to the emergency department. Increasing use of at-home or wearable health technology could help but requires system investments in infrastructure to implement.

Telemedicine requires a baseline level of equipment and knowledge to participate. A variety of populations will have either a knowledge gap or technology gap. Lack of rural high-speed Internet can lead to poor video quality, inhibiting effective communication and frustrating both provider and patient. In urban areas, there is a drastic wealth divide, and some groups may have difficulty obtaining sufficient equipment to complete a video visit. Even with adequate infrastructure and equipment, certain groups may be disadvantaged because of a lack of the technological savvy or literacy needed to navigate a virtual visit. The addition of interpreter services adds complexity to communication on top of the virtual interaction. These technology and knowledge gaps can produce confusion and potentially lead to worse care.¹ Careful selection of appropriate patients for telemedicine is essential. Is the quality of care over a virtual visit the same for a business executive as that of a non-English speaking refugee?

The term “webside manner” precedes the pandemic but will be important in the lexicon of doctor-patient relationships moving forward. We routinely train physicians about the importance of small actions to improve our bedside manner, such as sitting down, reacting to body language, and making eye contact. First impressions matter in relationship building. For many of my established IBD patients, I can easily hop into a comfortable repertoire in person, virtually, or even on the phone. In addition, I know these people well enough to trust that I am providing the same level of care regardless of visit medium. However, a new patient virtual encounter requires nuance. I have met new patients while they are driving (I requested the patient park!), in public places, and at work. Despite instructions given to patients about the appropriate location for a virtual visit, the patient location is not in our control. For some patients this may increase the comfort of the visit. However, for others, it can lead to distractions or potentially limit the amount of information a patient is willing to share. Forming a patient-provider relationship virtually will require a new set of skills and specific training for many practitioners.

Telehealth can contribute to provider burnout. While a busy in-person clinic can be exhausting, I have found I can be more exhausted after a half-day of virtual clinic. There is an element of human connection that is difficult to replace online.² On top of that loss, video visits are more psychologically demanding than in-person interactions. I also spend more time in a chair, have fewer coffee breaks, and have fewer professional interactions with the clinic staff and professional colleagues. Several other micro-stressors exist in virtual care that may make “Zoom fatigue” a real occupational hazard.³

Lastly, there are implications on reimbursement with telehealth. In Minnesota, a 2015 telemedicine law required private and state employee health plans to provide the same coverage for telemedicine as in-person visits, although patients had to drive to a clinic or facility to use secure telehealth equipment and have vital signs taken. With the pandemic, this stipulation is waived, and it seems likely to become permanent. However, reimbursement questions will arise, as there is a perception that a 30-minute telephone call should not cost as much as a 30-minute in-person visit, regardless of the content of the conversation.

We will have to learn to move forward with telehealth. The strength of telehealth is likely in patients with chronic, well controlled diseases, who have frequent interactions with health care. Examples of this include (although certainly are not limited to) established patients with well-controlled IBD, non-cirrhotic liver disease, and irritable bowel syndrome. Triaging patients who need in-person evaluation, ensuring patient and provider well-being, and creating a financially sustainable model of care are yet unresolved issues. Providers will likely vary in their personal acceptance of telehealth and will need to advocate within their own systems to obtain a hybrid model of telehealth that maximizes quality of care with job satisfaction.
 

Dr. Vaughn is associate professor of medicine and codirector of the inflammatory bowel disease program in the division of gastroenterology, hepatology, and nutrition at University of Minnesota, Minneapolis. He has received consulting fees from Prometheus and research support from Roche, Takeda, Celgene, Diasorin, and Crestovo.

References

1. George S et al. Stud Health Technol Inform. 2013;192:946.

2. Blank S. “What’s missing from Zoom reminds us what it means to be human,” 2020 Apr 27, Medium.

3. Williams N. Occup Med (Lond). 2021 Apr. doi: 10.1093/occmed/kqab041.

There are multiple benefits and few harms from sharing clinical notes in patients with mental illness, results of a poll of international experts show.

As of April 5, 2021, new federal rules in the United States mandate that all patients are offered online access to their electronic health record. 

“Given that sharing notes in psychiatry is likely to be more complicated than in some other specialties, we were unsure whether experts would consider the practice more harmful than beneficial,” Charlotte Blease, PhD, of Beth Israel Deaconess Medical Center in Boston, told this news organization.

“However, the results of our poll suggest clinicians’ anxieties about sharing mental health notes with patients may be misplaced. We found clear consensus among experts that the benefits of online access to clinical notes could outweigh the risks,” Dr. Blease said in a news release.

The study was published online in PLOS ONE.

Empowering patients

Investigators used an online Delphi poll, an established methodology used to investigate emerging health care policy – including in psychiatry – to solicit the views of an international panel of experts on the mental health effects of sharing clinical notes.

The panel included clinicians, chief medical information officers, patient advocates, and informatics experts with extensive experience and research knowledge about patient access to mental health notes.

There was consensus among the panel that offering online access to mental health notes could enhance patients’ understanding about their diagnosis, care plan, and rationale for treatments.

There was also consensus that access to clinical notes could enhance patient recall about what was communicated and improve mental health patients’ sense of control over their health care.

The panel also agreed that blocking mental health notes could lead to greater harms including increased feelings of stigmatization.

Confirmatory findings

The poll results support an earlier study by Dr. Blease and colleagues that evaluated the experiences of patients in accessing their online clinical notes. 

Among these patients with major depressive disorder, schizophrenia, schizoaffective disorder, or bipolar-related disorder, “access helped to clarify why medications had been prescribed, improved understanding about side effects, and 20% of patients reported doing a better job taking their meds as prescribed,” said Dr. Blease.

However, the expert panel in the Delphi poll predicted that with “open notes” some patients might demand changes to their clinical notes, and that mental health clinicians might be less detailed/accurate in documenting negative aspects of the patient relationship, details about patients’ personalities, or symptoms of paranoia in patients.

“If some patients feel more judged or offended by what they read, this may undermine the therapeutic relationship. We also need more research into the experiences of patients hospitalized for their care,” she added.

“In some clinical cases where there is more focus on emergency care than in forming a therapeutic relationship, for example emergency department visits, we know almost nothing about the risks and benefits associated with OpenNotes,” senior author John Torous, MD, with Beth Israel Deaconess Medical Center and Harvard Medical School, said in an interview.

“One thing is clear,” Dr. Blease said. “Patient access to their online medical records is now mainstream, and we need more clinician education on how to write notes that patients will read, and more guidance among patients on the benefits and risks of accessing their notes.”

Support for this research was provided by a J. F. Keane Scholar Award and a Swedish Research Council on Health, Working Life, and Welfare grant. The authors have disclosed no relevant financial relationships.

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

There are multiple benefits and few harms from sharing clinical notes in patients with mental illness, results of a poll of international experts show.

As of April 5, 2021, new federal rules in the United States mandate that all patients are offered online access to their electronic health record. 

“Given that sharing notes in psychiatry is likely to be more complicated than in some other specialties, we were unsure whether experts would consider the practice more harmful than beneficial,” Charlotte Blease, PhD, of Beth Israel Deaconess Medical Center in Boston, told this news organization.

“However, the results of our poll suggest clinicians’ anxieties about sharing mental health notes with patients may be misplaced. We found clear consensus among experts that the benefits of online access to clinical notes could outweigh the risks,” Dr. Blease said in a news release.

The study was published online in PLOS ONE.

Empowering patients

Investigators used an online Delphi poll, an established methodology used to investigate emerging health care policy – including in psychiatry – to solicit the views of an international panel of experts on the mental health effects of sharing clinical notes.

The panel included clinicians, chief medical information officers, patient advocates, and informatics experts with extensive experience and research knowledge about patient access to mental health notes.

There was consensus among the panel that offering online access to mental health notes could enhance patients’ understanding about their diagnosis, care plan, and rationale for treatments.

There was also consensus that access to clinical notes could enhance patient recall about what was communicated and improve mental health patients’ sense of control over their health care.

The panel also agreed that blocking mental health notes could lead to greater harms including increased feelings of stigmatization.

Confirmatory findings

The poll results support an earlier study by Dr. Blease and colleagues that evaluated the experiences of patients in accessing their online clinical notes. 

Among these patients with major depressive disorder, schizophrenia, schizoaffective disorder, or bipolar-related disorder, “access helped to clarify why medications had been prescribed, improved understanding about side effects, and 20% of patients reported doing a better job taking their meds as prescribed,” said Dr. Blease.

However, the expert panel in the Delphi poll predicted that with “open notes” some patients might demand changes to their clinical notes, and that mental health clinicians might be less detailed/accurate in documenting negative aspects of the patient relationship, details about patients’ personalities, or symptoms of paranoia in patients.

“If some patients feel more judged or offended by what they read, this may undermine the therapeutic relationship. We also need more research into the experiences of patients hospitalized for their care,” she added.

“In some clinical cases where there is more focus on emergency care than in forming a therapeutic relationship, for example emergency department visits, we know almost nothing about the risks and benefits associated with OpenNotes,” senior author John Torous, MD, with Beth Israel Deaconess Medical Center and Harvard Medical School, said in an interview.

“One thing is clear,” Dr. Blease said. “Patient access to their online medical records is now mainstream, and we need more clinician education on how to write notes that patients will read, and more guidance among patients on the benefits and risks of accessing their notes.”

Support for this research was provided by a J. F. Keane Scholar Award and a Swedish Research Council on Health, Working Life, and Welfare grant. The authors have disclosed no relevant financial relationships.

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

There are multiple benefits and few harms from sharing clinical notes in patients with mental illness, results of a poll of international experts show.

As of April 5, 2021, new federal rules in the United States mandate that all patients are offered online access to their electronic health record. 

“Given that sharing notes in psychiatry is likely to be more complicated than in some other specialties, we were unsure whether experts would consider the practice more harmful than beneficial,” Charlotte Blease, PhD, of Beth Israel Deaconess Medical Center in Boston, told this news organization.

“However, the results of our poll suggest clinicians’ anxieties about sharing mental health notes with patients may be misplaced. We found clear consensus among experts that the benefits of online access to clinical notes could outweigh the risks,” Dr. Blease said in a news release.

The study was published online in PLOS ONE.

Empowering patients

Investigators used an online Delphi poll, an established methodology used to investigate emerging health care policy – including in psychiatry – to solicit the views of an international panel of experts on the mental health effects of sharing clinical notes.

The panel included clinicians, chief medical information officers, patient advocates, and informatics experts with extensive experience and research knowledge about patient access to mental health notes.

There was consensus among the panel that offering online access to mental health notes could enhance patients’ understanding about their diagnosis, care plan, and rationale for treatments.

There was also consensus that access to clinical notes could enhance patient recall about what was communicated and improve mental health patients’ sense of control over their health care.

The panel also agreed that blocking mental health notes could lead to greater harms including increased feelings of stigmatization.

Confirmatory findings

The poll results support an earlier study by Dr. Blease and colleagues that evaluated the experiences of patients in accessing their online clinical notes. 

Among these patients with major depressive disorder, schizophrenia, schizoaffective disorder, or bipolar-related disorder, “access helped to clarify why medications had been prescribed, improved understanding about side effects, and 20% of patients reported doing a better job taking their meds as prescribed,” said Dr. Blease.

However, the expert panel in the Delphi poll predicted that with “open notes” some patients might demand changes to their clinical notes, and that mental health clinicians might be less detailed/accurate in documenting negative aspects of the patient relationship, details about patients’ personalities, or symptoms of paranoia in patients.

“If some patients feel more judged or offended by what they read, this may undermine the therapeutic relationship. We also need more research into the experiences of patients hospitalized for their care,” she added.

“In some clinical cases where there is more focus on emergency care than in forming a therapeutic relationship, for example emergency department visits, we know almost nothing about the risks and benefits associated with OpenNotes,” senior author John Torous, MD, with Beth Israel Deaconess Medical Center and Harvard Medical School, said in an interview.

“One thing is clear,” Dr. Blease said. “Patient access to their online medical records is now mainstream, and we need more clinician education on how to write notes that patients will read, and more guidance among patients on the benefits and risks of accessing their notes.”

Support for this research was provided by a J. F. Keane Scholar Award and a Swedish Research Council on Health, Working Life, and Welfare grant. The authors have disclosed no relevant financial relationships.

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

Medical transition in transgender patients

I just read the article “Writing letters for transgender patients undergoing medical transition” by Dr. Amy Riese (Pearls, Current Psychiatry, August 2021, p. 51-52). I very much appreciate this topic being brought into the light and her excellent guidelines for patients who suffer from gender dysphoria and require medical transition.

I would like to use her piece as an opportunity to highlight what has become a chasm in psychiatric care. Dr. Riese’s article was on the letter itself and not the assessment of a patient with possible gender dysphoria, but assessment is barely mentioned, and is the single most important part of a gender transition process. Assessment has become the huge chasm in treatment. In my community, both personally and professionally, I have witnessed very little assessment taking place, yet a lot of transitioning is happening.

Concerned and caring family members take their child (or self-present if the patient is an adult) to gender specialists for their expertise. What is happening during these evaluations are brief conversations during which the gender specialist accepts a patient’s (sometimes a minor’s) self-diagnosis of gender dysphoria. There is discussion of the importance of being gender-affirming, and the beginning of a discussion of hormone therapy. During these discussions of hormone therapy, there is very little disclosure of some of the untoward effects. I understand this is a generalization, and there are some gender specialists who are doing excellent, thorough assessments. But this is what I am seeing in my community, to the point that I have no local specialists to whom I feel comfortable sending my patients who may have gender dysphoria.

During discussions, some of the significant medical outcomes of hormone therapy (immunosuppression, loss of bone density, sterility, increased risk of certain types of cancer, etc.) are not mentioned, or are mentioned in passing. Clinicians have begun using euphemisms such as “top surgery” or “upper body surgery,” as used in Dr. Riese’s article, rather than the medically accurate term, which is “bilateral mastectomy.” These behaviors are being manifested by mostly well-meaning clinicians, and start the process of ushering a patient down a one-way street toward a medical transition.

In April of this year, a prestigious institution in my state did a training on aspects of treating transgender and nonbinary youth. The training advocated giving less information to transgender youth regarding the effects of treatment on fertility, arguing that giving adequate information would disrupt the normal course of development. However, we are allowing these same youth to consent for treatment.

This is a very destructive phenomenon, and only time will tell what the psychiatric outcomes will be for patients who medically transition who did not have an adequate assessment. After so much loss under the auspices of treatment, one would hope that at the very least, these children and young adults would be in a better place psychologically, that they would finally be happy and fulfilled in their new reality, that their mental anguish would evaporate, and with it, their risk of suicide. And this may be true if the patient had gender dysphoria.

But what about the patients who did not have an adequate assessment, whose self-diagnosis was accepted without question, the gender-affirming model immediately implemented, and referrals quickly made for medical treatment? For those patients, once everything has been done, every hormone taken, every surgery performed, but still not male enough, not convincingly male in every aspect, now what? Where does one go from there?

Only time will tell what the psychiatric outcomes will be for these patients, who are primarily youth and young adults at this point. What about the psychological pain that brought them to identify as transgender in the first place? Since the patient was colluded with in the diagnosis of gender dysphoria, that pain was never identified and addressed. What will the suicide rate be of these fully transitioned patients who never had gender dysphoria?

And what shall become of the clinicians who treated them without pause or careful consideration, who bypassed informed consent, treating teens as if they had the judgment and psychological maturity of an adult? What will be their defense when the malpractice lawsuits begin to mount against them, when patients and their families emerge on the other side of the medical transition to find that life, identity, intimacy, and the most basic biological functions have been altered forever based on the capricious and suggestible whims of children?

According to the DSM-5, the prevalence of gender dysphoria is very low. Even if we were to double the DSM-5 estimate, it is still very low. As psychiatrists, we are leaders in the mental health field, and need to set the tone and guide nonphysician clinicians toward extremely careful assessment of these patients.

While Dr. Riese gives excellent information about how to write a letter for a patient who needs transition, far fewer of these letters should be written. The upward trend in the numbers of patients receiving a diagnosis, and subsequently letters, is largely imposed by clinicians who disregard the DSM-5 and fail to apply critical thought to this assessments.

Medical transition in transgender patients

I just read the article “Writing letters for transgender patients undergoing medical transition” by Dr. Amy Riese (Pearls, Current Psychiatry, August 2021, p. 51-52). I very much appreciate this topic being brought into the light and her excellent guidelines for patients who suffer from gender dysphoria and require medical transition.

I would like to use her piece as an opportunity to highlight what has become a chasm in psychiatric care. Dr. Riese’s article was on the letter itself and not the assessment of a patient with possible gender dysphoria, but assessment is barely mentioned, and is the single most important part of a gender transition process. Assessment has become the huge chasm in treatment. In my community, both personally and professionally, I have witnessed very little assessment taking place, yet a lot of transitioning is happening.

Concerned and caring family members take their child (or self-present if the patient is an adult) to gender specialists for their expertise. What is happening during these evaluations are brief conversations during which the gender specialist accepts a patient’s (sometimes a minor’s) self-diagnosis of gender dysphoria. There is discussion of the importance of being gender-affirming, and the beginning of a discussion of hormone therapy. During these discussions of hormone therapy, there is very little disclosure of some of the untoward effects. I understand this is a generalization, and there are some gender specialists who are doing excellent, thorough assessments. But this is what I am seeing in my community, to the point that I have no local specialists to whom I feel comfortable sending my patients who may have gender dysphoria.

During discussions, some of the significant medical outcomes of hormone therapy (immunosuppression, loss of bone density, sterility, increased risk of certain types of cancer, etc.) are not mentioned, or are mentioned in passing. Clinicians have begun using euphemisms such as “top surgery” or “upper body surgery,” as used in Dr. Riese’s article, rather than the medically accurate term, which is “bilateral mastectomy.” These behaviors are being manifested by mostly well-meaning clinicians, and start the process of ushering a patient down a one-way street toward a medical transition.

In April of this year, a prestigious institution in my state did a training on aspects of treating transgender and nonbinary youth. The training advocated giving less information to transgender youth regarding the effects of treatment on fertility, arguing that giving adequate information would disrupt the normal course of development. However, we are allowing these same youth to consent for treatment.

This is a very destructive phenomenon, and only time will tell what the psychiatric outcomes will be for patients who medically transition who did not have an adequate assessment. After so much loss under the auspices of treatment, one would hope that at the very least, these children and young adults would be in a better place psychologically, that they would finally be happy and fulfilled in their new reality, that their mental anguish would evaporate, and with it, their risk of suicide. And this may be true if the patient had gender dysphoria.

But what about the patients who did not have an adequate assessment, whose self-diagnosis was accepted without question, the gender-affirming model immediately implemented, and referrals quickly made for medical treatment? For those patients, once everything has been done, every hormone taken, every surgery performed, but still not male enough, not convincingly male in every aspect, now what? Where does one go from there?

Only time will tell what the psychiatric outcomes will be for these patients, who are primarily youth and young adults at this point. What about the psychological pain that brought them to identify as transgender in the first place? Since the patient was colluded with in the diagnosis of gender dysphoria, that pain was never identified and addressed. What will the suicide rate be of these fully transitioned patients who never had gender dysphoria?

And what shall become of the clinicians who treated them without pause or careful consideration, who bypassed informed consent, treating teens as if they had the judgment and psychological maturity of an adult? What will be their defense when the malpractice lawsuits begin to mount against them, when patients and their families emerge on the other side of the medical transition to find that life, identity, intimacy, and the most basic biological functions have been altered forever based on the capricious and suggestible whims of children?

According to the DSM-5, the prevalence of gender dysphoria is very low. Even if we were to double the DSM-5 estimate, it is still very low. As psychiatrists, we are leaders in the mental health field, and need to set the tone and guide nonphysician clinicians toward extremely careful assessment of these patients.

While Dr. Riese gives excellent information about how to write a letter for a patient who needs transition, far fewer of these letters should be written. The upward trend in the numbers of patients receiving a diagnosis, and subsequently letters, is largely imposed by clinicians who disregard the DSM-5 and fail to apply critical thought to this assessments.

Medical transition in transgender patients

I just read the article “Writing letters for transgender patients undergoing medical transition” by Dr. Amy Riese (Pearls, Current Psychiatry, August 2021, p. 51-52). I very much appreciate this topic being brought into the light and her excellent guidelines for patients who suffer from gender dysphoria and require medical transition.

I would like to use her piece as an opportunity to highlight what has become a chasm in psychiatric care. Dr. Riese’s article was on the letter itself and not the assessment of a patient with possible gender dysphoria, but assessment is barely mentioned, and is the single most important part of a gender transition process. Assessment has become the huge chasm in treatment. In my community, both personally and professionally, I have witnessed very little assessment taking place, yet a lot of transitioning is happening.

Concerned and caring family members take their child (or self-present if the patient is an adult) to gender specialists for their expertise. What is happening during these evaluations are brief conversations during which the gender specialist accepts a patient’s (sometimes a minor’s) self-diagnosis of gender dysphoria. There is discussion of the importance of being gender-affirming, and the beginning of a discussion of hormone therapy. During these discussions of hormone therapy, there is very little disclosure of some of the untoward effects. I understand this is a generalization, and there are some gender specialists who are doing excellent, thorough assessments. But this is what I am seeing in my community, to the point that I have no local specialists to whom I feel comfortable sending my patients who may have gender dysphoria.

During discussions, some of the significant medical outcomes of hormone therapy (immunosuppression, loss of bone density, sterility, increased risk of certain types of cancer, etc.) are not mentioned, or are mentioned in passing. Clinicians have begun using euphemisms such as “top surgery” or “upper body surgery,” as used in Dr. Riese’s article, rather than the medically accurate term, which is “bilateral mastectomy.” These behaviors are being manifested by mostly well-meaning clinicians, and start the process of ushering a patient down a one-way street toward a medical transition.

In April of this year, a prestigious institution in my state did a training on aspects of treating transgender and nonbinary youth. The training advocated giving less information to transgender youth regarding the effects of treatment on fertility, arguing that giving adequate information would disrupt the normal course of development. However, we are allowing these same youth to consent for treatment.

This is a very destructive phenomenon, and only time will tell what the psychiatric outcomes will be for patients who medically transition who did not have an adequate assessment. After so much loss under the auspices of treatment, one would hope that at the very least, these children and young adults would be in a better place psychologically, that they would finally be happy and fulfilled in their new reality, that their mental anguish would evaporate, and with it, their risk of suicide. And this may be true if the patient had gender dysphoria.

But what about the patients who did not have an adequate assessment, whose self-diagnosis was accepted without question, the gender-affirming model immediately implemented, and referrals quickly made for medical treatment? For those patients, once everything has been done, every hormone taken, every surgery performed, but still not male enough, not convincingly male in every aspect, now what? Where does one go from there?

Only time will tell what the psychiatric outcomes will be for these patients, who are primarily youth and young adults at this point. What about the psychological pain that brought them to identify as transgender in the first place? Since the patient was colluded with in the diagnosis of gender dysphoria, that pain was never identified and addressed. What will the suicide rate be of these fully transitioned patients who never had gender dysphoria?

And what shall become of the clinicians who treated them without pause or careful consideration, who bypassed informed consent, treating teens as if they had the judgment and psychological maturity of an adult? What will be their defense when the malpractice lawsuits begin to mount against them, when patients and their families emerge on the other side of the medical transition to find that life, identity, intimacy, and the most basic biological functions have been altered forever based on the capricious and suggestible whims of children?

According to the DSM-5, the prevalence of gender dysphoria is very low. Even if we were to double the DSM-5 estimate, it is still very low. As psychiatrists, we are leaders in the mental health field, and need to set the tone and guide nonphysician clinicians toward extremely careful assessment of these patients.

While Dr. Riese gives excellent information about how to write a letter for a patient who needs transition, far fewer of these letters should be written. The upward trend in the numbers of patients receiving a diagnosis, and subsequently letters, is largely imposed by clinicians who disregard the DSM-5 and fail to apply critical thought to this assessments.

A novel investigational allogeneic stem cell–derived treatment resulted in near reversal of type 1 diabetes in a patient who had lived with the condition for about 40 years.

CIPhotos/Getty Images

The patient was the first in Vertex Pharmaceuticals’ phase 1/2 multicenter, single-arm, open-label clinical trial of the insulin-producing islet cell therapy VX-880 for patients with type 1 diabetes who have impaired hypoglycemic awareness and severe hypoglycemia.

The cells are delivered by infusion into the hepatic portal vein. As of now, chronic immunosuppression is required to prevent rejection, but several approaches are being studied to overcome the limitation.

“There’s hope that this is a real advance. It’s been long awaited, and it looks really encouraging,” James Markmann, MD, PhD, the surgeon who performed the procedure, told this news organization.

The use of insulin-producing pancreatic beta cells derived from human pluripotent stem cells, first reported in 2014 by a team at the Harvard Stem Cell Institute, Boston, is seen as a major advance over use of cadaveric donor islet cells because stem cell–derived islets are available in unlimited and uncontaminated supplies.

Cadaveric donor islets are being used in products such as donislecel (CellTrans), which was endorsed by a Food and Drug Administration advisory committee in the summer for the treatment of type 1 diabetes that can’t be managed with current therapies.

The patient in the Vertex trial isn’t the first reported stem cell–derived islet recipient with type 1 diabetes, but these cells are the first to be transplanted into the liver.

“This Vertex patient stood out because the reduction in insulin requirement ... was so striking,” noted Dr. Markmann, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who has been transplanting islet cells from cadaveric donors into humans via the hepatic portal vein for over 20 years.

“Nobody knew what to expect, as it hadn’t been done before, but certainly the results in this patient are better than what I would have expected from a deceased donor islet transplant,” he added.

Asked to comment, A.M. James Shapiro, MD, agreed. “I think the most important finding is that a stem cell–derived islet is now transplanted into the liver of a patient safely, so far,” he said in an interview.

Dr. Shapiro is clinical director of the living donor and islet cell transplantation programs at the University of Alberta, Edmonton. He pioneered cadaveric donor islet cell transplantation more than 20 years ago with the watershed Edmonton Protocol.

‘Impressive finding ... bodes well for ongoing efforts’

Vertex announced the result by press release. The company plans to transplant another 16 patients, staggering them over time at multiple centers.

The first patient was treated with a single infusion of VX-880 at half the target dose (per protocol for the first two study subjects), along with standard immunosuppressive therapy. At 90 days, the patient’s C-peptide, a measure of endogenous insulin secretion, rose from undetectable to 280 pmol/L fasting and 560 pmol/L post mixed-meal tolerance testing.

Over the same period, the patient’s hemoglobin A1c dropped from 8.6% at baseline to 7.2%. And within 7 days, the individual’s daily exogenous insulin requirement dropped from an average of 34 units to just 2.9 units, a 91% decrease.

The patient had experienced five severe hypoglycemic episodes in the year prior to transplant. They experienced some mild hypoglycemia soon after the procedure while insulin doses were being adjusted, but none thereafter. 

Dr. Shapiro said in an interview: “I was absolutely thrilled to see the first patient results with high C-peptide and a 91% reduction in insulin. That’s a pretty impressive finding for half dosing in the very first patient in a trial. I think it bodes really well for ongoing efforts in this area by Vertex and by others that have similar kinds of cells. It’s very exciting.”

However, he cautioned, “we do need some longer-term data to be sure there’s no off-target growth or other concerns. But based on the purity of this product, that risk is likely to be low.”

And he noted, “I think we still have to address the challenges of setting this process up. A huge amount of work has gone into manufacturing the cell product for a single patient. I think it remains to be seen whether the same technology can be delivered at a larger scale ... i.e., being able to treat hundreds or thousands of patients.”

A blog post on the website of diabetes charity JDRF called the result “outstanding.” “It’s a big deal,” they added. However, they also cautioned: “There are a few things to keep in mind while assessing the data. One is that these are only results from a single person. Data are needed from many more to fully evaluate the potential of this therapy. The second is that this person only received half the target dose of cells.”

Dr. Shapiro is working with another company, ViaCyte, which has also developed stem cell–derived islets. In contrast to the Vertex product, which is fully differentiated and delivered to the liver, ViaCyte’s PEC-Direct product is comprised of stem cell-derived pancreatic islet progenitor cells that are implanted subcutaneously in a pouch, allowing for vascularization.

In a late-breaking poster at the annual scientific sessions of the American Diabetes Association in June 2021, ViaCyte reported on a patient given PEC-Direct. In that patient, stimulated C-peptide increased from 0.1 ng/mL at baseline to 0.8 ng/mL at week 39, and there was a drop in A1c from 7.4% to 6.6%, with no adverse events.

Immunosuppression: Which approach will come closer to cure?

Thus far, the requirement for lifelong immunosuppression has meant that any islet cell replacement approach, including with stem cell–derived islets, has been limited to use in people with type 1 diabetes who have hypoglycemic unawareness or severely unpredictable blood glucose levels.

Two broad approaches are simultaneously being explored to overcome the rejection problem: Encapsulation of the cells to protect them from the immune system, and genetic modification of the cells so that they don’t provoke the immune system in the first place.

In 2022, Vertex plans to file an investigational new drug application for an encapsulated islet cell program with the FDA.

Dr. Markmann believes the genetic modification approach is more promising. “I’m not a believer in encapsulation. I think the foreign body response is hard to overcome. I think the answer will ultimately be genetically modifying the [cell] lines. ... The cell could express something that would potentially turn off the lymphocytes or interfere with the lymphocytes trying to attack them.”

Moreover, he said, “you don’t have to get rid of immunosuppression completely. It’s all [a] risk-benefit [equation]. Even if you could get it down to a single less-toxic [immunosuppressive] agent that would be a huge step.”

Dr. Shapiro commented: “All efforts and eyes are laser-focused on developing cells or approaches that will allow transplantation of this kind of stem cell without any immunosuppression or with low-dose immunosuppression that could be regarded as being exceedingly low risk.”

“Then, and only then, I think we could offer this kind of treatment to children who are just diagnosed with diabetes or to [a bigger proportion of] patients with type 1 or type 2 diabetes. ... The science has to be done in a step-wise fashion,” he added.

Microencapsulation, Dr. Shapiro noted, “is a big challenge because the process of capturing the cells and putting them into a device is really injurious to their survival. ... That may or may not work.”

Dr. Shapiro and his Edmonton team are now embarking on a new trial with ViaCyte and CRISPR Therapeutics using gene-edited cells that contain two knock-in genes and two knock-out genes shown to be less immunogenic and anti-inflammatory in rodent models.

“They look to be promising. We’re going to start a first-in-human trial in the next few months with those cells to see if they really are able to withstand a transplant without the need for immunosuppression. That will be a very exciting trial in itself,” Dr. Shapiro said, noting that they expect to enroll the first patients in the next few months.

However, he cautioned, “first we have to make sure that the gene-edited product continues to function in patients in the way that the original product did, that the cells survive, and that the gene modifications are actually effective. ... Maybe other iterations will be needed.”

“I think, as we move forward, we will ultimately have a gene-edited stem cell–derived product that is immune evasive and will survive. So, I’m ... optimistic that this is not as long term as you might think, and it’s ... happening much more rapidly – at least in first-in-human trials to test safety and preliminary efficacy.”

Dr. Shapiro is a consultant for ViaCyte.

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

A novel investigational allogeneic stem cell–derived treatment resulted in near reversal of type 1 diabetes in a patient who had lived with the condition for about 40 years.

CIPhotos/Getty Images

The patient was the first in Vertex Pharmaceuticals’ phase 1/2 multicenter, single-arm, open-label clinical trial of the insulin-producing islet cell therapy VX-880 for patients with type 1 diabetes who have impaired hypoglycemic awareness and severe hypoglycemia.

The cells are delivered by infusion into the hepatic portal vein. As of now, chronic immunosuppression is required to prevent rejection, but several approaches are being studied to overcome the limitation.

“There’s hope that this is a real advance. It’s been long awaited, and it looks really encouraging,” James Markmann, MD, PhD, the surgeon who performed the procedure, told this news organization.

The use of insulin-producing pancreatic beta cells derived from human pluripotent stem cells, first reported in 2014 by a team at the Harvard Stem Cell Institute, Boston, is seen as a major advance over use of cadaveric donor islet cells because stem cell–derived islets are available in unlimited and uncontaminated supplies.

Cadaveric donor islets are being used in products such as donislecel (CellTrans), which was endorsed by a Food and Drug Administration advisory committee in the summer for the treatment of type 1 diabetes that can’t be managed with current therapies.

The patient in the Vertex trial isn’t the first reported stem cell–derived islet recipient with type 1 diabetes, but these cells are the first to be transplanted into the liver.

“This Vertex patient stood out because the reduction in insulin requirement ... was so striking,” noted Dr. Markmann, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who has been transplanting islet cells from cadaveric donors into humans via the hepatic portal vein for over 20 years.

“Nobody knew what to expect, as it hadn’t been done before, but certainly the results in this patient are better than what I would have expected from a deceased donor islet transplant,” he added.

Asked to comment, A.M. James Shapiro, MD, agreed. “I think the most important finding is that a stem cell–derived islet is now transplanted into the liver of a patient safely, so far,” he said in an interview.

Dr. Shapiro is clinical director of the living donor and islet cell transplantation programs at the University of Alberta, Edmonton. He pioneered cadaveric donor islet cell transplantation more than 20 years ago with the watershed Edmonton Protocol.

‘Impressive finding ... bodes well for ongoing efforts’

Vertex announced the result by press release. The company plans to transplant another 16 patients, staggering them over time at multiple centers.

The first patient was treated with a single infusion of VX-880 at half the target dose (per protocol for the first two study subjects), along with standard immunosuppressive therapy. At 90 days, the patient’s C-peptide, a measure of endogenous insulin secretion, rose from undetectable to 280 pmol/L fasting and 560 pmol/L post mixed-meal tolerance testing.

Over the same period, the patient’s hemoglobin A1c dropped from 8.6% at baseline to 7.2%. And within 7 days, the individual’s daily exogenous insulin requirement dropped from an average of 34 units to just 2.9 units, a 91% decrease.

The patient had experienced five severe hypoglycemic episodes in the year prior to transplant. They experienced some mild hypoglycemia soon after the procedure while insulin doses were being adjusted, but none thereafter. 

Dr. Shapiro said in an interview: “I was absolutely thrilled to see the first patient results with high C-peptide and a 91% reduction in insulin. That’s a pretty impressive finding for half dosing in the very first patient in a trial. I think it bodes really well for ongoing efforts in this area by Vertex and by others that have similar kinds of cells. It’s very exciting.”

However, he cautioned, “we do need some longer-term data to be sure there’s no off-target growth or other concerns. But based on the purity of this product, that risk is likely to be low.”

And he noted, “I think we still have to address the challenges of setting this process up. A huge amount of work has gone into manufacturing the cell product for a single patient. I think it remains to be seen whether the same technology can be delivered at a larger scale ... i.e., being able to treat hundreds or thousands of patients.”

A blog post on the website of diabetes charity JDRF called the result “outstanding.” “It’s a big deal,” they added. However, they also cautioned: “There are a few things to keep in mind while assessing the data. One is that these are only results from a single person. Data are needed from many more to fully evaluate the potential of this therapy. The second is that this person only received half the target dose of cells.”

Dr. Shapiro is working with another company, ViaCyte, which has also developed stem cell–derived islets. In contrast to the Vertex product, which is fully differentiated and delivered to the liver, ViaCyte’s PEC-Direct product is comprised of stem cell-derived pancreatic islet progenitor cells that are implanted subcutaneously in a pouch, allowing for vascularization.

In a late-breaking poster at the annual scientific sessions of the American Diabetes Association in June 2021, ViaCyte reported on a patient given PEC-Direct. In that patient, stimulated C-peptide increased from 0.1 ng/mL at baseline to 0.8 ng/mL at week 39, and there was a drop in A1c from 7.4% to 6.6%, with no adverse events.

Immunosuppression: Which approach will come closer to cure?

Thus far, the requirement for lifelong immunosuppression has meant that any islet cell replacement approach, including with stem cell–derived islets, has been limited to use in people with type 1 diabetes who have hypoglycemic unawareness or severely unpredictable blood glucose levels.

Two broad approaches are simultaneously being explored to overcome the rejection problem: Encapsulation of the cells to protect them from the immune system, and genetic modification of the cells so that they don’t provoke the immune system in the first place.

In 2022, Vertex plans to file an investigational new drug application for an encapsulated islet cell program with the FDA.

Dr. Markmann believes the genetic modification approach is more promising. “I’m not a believer in encapsulation. I think the foreign body response is hard to overcome. I think the answer will ultimately be genetically modifying the [cell] lines. ... The cell could express something that would potentially turn off the lymphocytes or interfere with the lymphocytes trying to attack them.”

Moreover, he said, “you don’t have to get rid of immunosuppression completely. It’s all [a] risk-benefit [equation]. Even if you could get it down to a single less-toxic [immunosuppressive] agent that would be a huge step.”

Dr. Shapiro commented: “All efforts and eyes are laser-focused on developing cells or approaches that will allow transplantation of this kind of stem cell without any immunosuppression or with low-dose immunosuppression that could be regarded as being exceedingly low risk.”

“Then, and only then, I think we could offer this kind of treatment to children who are just diagnosed with diabetes or to [a bigger proportion of] patients with type 1 or type 2 diabetes. ... The science has to be done in a step-wise fashion,” he added.

Microencapsulation, Dr. Shapiro noted, “is a big challenge because the process of capturing the cells and putting them into a device is really injurious to their survival. ... That may or may not work.”

Dr. Shapiro and his Edmonton team are now embarking on a new trial with ViaCyte and CRISPR Therapeutics using gene-edited cells that contain two knock-in genes and two knock-out genes shown to be less immunogenic and anti-inflammatory in rodent models.

“They look to be promising. We’re going to start a first-in-human trial in the next few months with those cells to see if they really are able to withstand a transplant without the need for immunosuppression. That will be a very exciting trial in itself,” Dr. Shapiro said, noting that they expect to enroll the first patients in the next few months.

However, he cautioned, “first we have to make sure that the gene-edited product continues to function in patients in the way that the original product did, that the cells survive, and that the gene modifications are actually effective. ... Maybe other iterations will be needed.”

“I think, as we move forward, we will ultimately have a gene-edited stem cell–derived product that is immune evasive and will survive. So, I’m ... optimistic that this is not as long term as you might think, and it’s ... happening much more rapidly – at least in first-in-human trials to test safety and preliminary efficacy.”

Dr. Shapiro is a consultant for ViaCyte.

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

A novel investigational allogeneic stem cell–derived treatment resulted in near reversal of type 1 diabetes in a patient who had lived with the condition for about 40 years.

CIPhotos/Getty Images

The patient was the first in Vertex Pharmaceuticals’ phase 1/2 multicenter, single-arm, open-label clinical trial of the insulin-producing islet cell therapy VX-880 for patients with type 1 diabetes who have impaired hypoglycemic awareness and severe hypoglycemia.

The cells are delivered by infusion into the hepatic portal vein. As of now, chronic immunosuppression is required to prevent rejection, but several approaches are being studied to overcome the limitation.

“There’s hope that this is a real advance. It’s been long awaited, and it looks really encouraging,” James Markmann, MD, PhD, the surgeon who performed the procedure, told this news organization.

The use of insulin-producing pancreatic beta cells derived from human pluripotent stem cells, first reported in 2014 by a team at the Harvard Stem Cell Institute, Boston, is seen as a major advance over use of cadaveric donor islet cells because stem cell–derived islets are available in unlimited and uncontaminated supplies.

Cadaveric donor islets are being used in products such as donislecel (CellTrans), which was endorsed by a Food and Drug Administration advisory committee in the summer for the treatment of type 1 diabetes that can’t be managed with current therapies.

The patient in the Vertex trial isn’t the first reported stem cell–derived islet recipient with type 1 diabetes, but these cells are the first to be transplanted into the liver.

“This Vertex patient stood out because the reduction in insulin requirement ... was so striking,” noted Dr. Markmann, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who has been transplanting islet cells from cadaveric donors into humans via the hepatic portal vein for over 20 years.

“Nobody knew what to expect, as it hadn’t been done before, but certainly the results in this patient are better than what I would have expected from a deceased donor islet transplant,” he added.

Asked to comment, A.M. James Shapiro, MD, agreed. “I think the most important finding is that a stem cell–derived islet is now transplanted into the liver of a patient safely, so far,” he said in an interview.

Dr. Shapiro is clinical director of the living donor and islet cell transplantation programs at the University of Alberta, Edmonton. He pioneered cadaveric donor islet cell transplantation more than 20 years ago with the watershed Edmonton Protocol.

‘Impressive finding ... bodes well for ongoing efforts’

Vertex announced the result by press release. The company plans to transplant another 16 patients, staggering them over time at multiple centers.

The first patient was treated with a single infusion of VX-880 at half the target dose (per protocol for the first two study subjects), along with standard immunosuppressive therapy. At 90 days, the patient’s C-peptide, a measure of endogenous insulin secretion, rose from undetectable to 280 pmol/L fasting and 560 pmol/L post mixed-meal tolerance testing.

Over the same period, the patient’s hemoglobin A1c dropped from 8.6% at baseline to 7.2%. And within 7 days, the individual’s daily exogenous insulin requirement dropped from an average of 34 units to just 2.9 units, a 91% decrease.

The patient had experienced five severe hypoglycemic episodes in the year prior to transplant. They experienced some mild hypoglycemia soon after the procedure while insulin doses were being adjusted, but none thereafter. 

Dr. Shapiro said in an interview: “I was absolutely thrilled to see the first patient results with high C-peptide and a 91% reduction in insulin. That’s a pretty impressive finding for half dosing in the very first patient in a trial. I think it bodes really well for ongoing efforts in this area by Vertex and by others that have similar kinds of cells. It’s very exciting.”

However, he cautioned, “we do need some longer-term data to be sure there’s no off-target growth or other concerns. But based on the purity of this product, that risk is likely to be low.”

And he noted, “I think we still have to address the challenges of setting this process up. A huge amount of work has gone into manufacturing the cell product for a single patient. I think it remains to be seen whether the same technology can be delivered at a larger scale ... i.e., being able to treat hundreds or thousands of patients.”

A blog post on the website of diabetes charity JDRF called the result “outstanding.” “It’s a big deal,” they added. However, they also cautioned: “There are a few things to keep in mind while assessing the data. One is that these are only results from a single person. Data are needed from many more to fully evaluate the potential of this therapy. The second is that this person only received half the target dose of cells.”

Dr. Shapiro is working with another company, ViaCyte, which has also developed stem cell–derived islets. In contrast to the Vertex product, which is fully differentiated and delivered to the liver, ViaCyte’s PEC-Direct product is comprised of stem cell-derived pancreatic islet progenitor cells that are implanted subcutaneously in a pouch, allowing for vascularization.

In a late-breaking poster at the annual scientific sessions of the American Diabetes Association in June 2021, ViaCyte reported on a patient given PEC-Direct. In that patient, stimulated C-peptide increased from 0.1 ng/mL at baseline to 0.8 ng/mL at week 39, and there was a drop in A1c from 7.4% to 6.6%, with no adverse events.

Immunosuppression: Which approach will come closer to cure?

Thus far, the requirement for lifelong immunosuppression has meant that any islet cell replacement approach, including with stem cell–derived islets, has been limited to use in people with type 1 diabetes who have hypoglycemic unawareness or severely unpredictable blood glucose levels.

Two broad approaches are simultaneously being explored to overcome the rejection problem: Encapsulation of the cells to protect them from the immune system, and genetic modification of the cells so that they don’t provoke the immune system in the first place.

In 2022, Vertex plans to file an investigational new drug application for an encapsulated islet cell program with the FDA.

Dr. Markmann believes the genetic modification approach is more promising. “I’m not a believer in encapsulation. I think the foreign body response is hard to overcome. I think the answer will ultimately be genetically modifying the [cell] lines. ... The cell could express something that would potentially turn off the lymphocytes or interfere with the lymphocytes trying to attack them.”

Moreover, he said, “you don’t have to get rid of immunosuppression completely. It’s all [a] risk-benefit [equation]. Even if you could get it down to a single less-toxic [immunosuppressive] agent that would be a huge step.”

Dr. Shapiro commented: “All efforts and eyes are laser-focused on developing cells or approaches that will allow transplantation of this kind of stem cell without any immunosuppression or with low-dose immunosuppression that could be regarded as being exceedingly low risk.”

“Then, and only then, I think we could offer this kind of treatment to children who are just diagnosed with diabetes or to [a bigger proportion of] patients with type 1 or type 2 diabetes. ... The science has to be done in a step-wise fashion,” he added.

Microencapsulation, Dr. Shapiro noted, “is a big challenge because the process of capturing the cells and putting them into a device is really injurious to their survival. ... That may or may not work.”

Dr. Shapiro and his Edmonton team are now embarking on a new trial with ViaCyte and CRISPR Therapeutics using gene-edited cells that contain two knock-in genes and two knock-out genes shown to be less immunogenic and anti-inflammatory in rodent models.

“They look to be promising. We’re going to start a first-in-human trial in the next few months with those cells to see if they really are able to withstand a transplant without the need for immunosuppression. That will be a very exciting trial in itself,” Dr. Shapiro said, noting that they expect to enroll the first patients in the next few months.

However, he cautioned, “first we have to make sure that the gene-edited product continues to function in patients in the way that the original product did, that the cells survive, and that the gene modifications are actually effective. ... Maybe other iterations will be needed.”

“I think, as we move forward, we will ultimately have a gene-edited stem cell–derived product that is immune evasive and will survive. So, I’m ... optimistic that this is not as long term as you might think, and it’s ... happening much more rapidly – at least in first-in-human trials to test safety and preliminary efficacy.”

Dr. Shapiro is a consultant for ViaCyte.

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

Nearly two-thirds of Americans are not confident that they understood their doctor’s recommendations and the health information they discussed with their doctor after a visit, according to a new survey.

Confusion over health information and doctor advice is even higher among people who care for patients than among those who don’t provide care to their loved ones, the nationally representative survey from the AHIMA Foundation found.

The survey also shows that 80% of Americans – and an even higher portion of caregivers – are likely to research medical recommendations online after a doctor’s visit. But 1 in 4 people don’t know how to access their own medical records or find it difficult to do so.

The findings reflect the same low level of health literacy in the U.S. population that earlier surveys did. The results also indicate that little has changed since the Department of Health and Human Services released a National Action Plan to Improve Health Literacy in 2010.

That plan emphasized the need to develop and share accurate health information that helps people make decisions; to promote changes in the health care system that improve health information, communication, informed decision-making, and access to health services; and to increase the sharing and use of evidence-based health literacy practices.

According to the AHIMA Foundation report, 62% of Americans are not sure they understand their doctor’s advice and the health information discussed during a visit. Twenty-four percent say they don’t comprehend any of it, and 31% can’t remember what was said during the visit. Fifteen percent of those surveyed said they were more confused about their health than they were before the encounter with their doctor.
 

Caregivers have special issues

Forty-three percent of Americans are caregivers, the report notes, and 91% of those play an active role in managing someone else’s health. Millennials (65%) and Gen Xers (50%) are significantly more likely than Gen Zers (39%) and Boomers (20%) to be a caregiver.

Most caregivers have concerns about their loved ones’ ability to manage their own health. Most of them believe that doctors provide enough information, but 38% don’t believe a doctor can communicate effectively with the patient if the caregiver is not present.

Forty-three percent of caretakers don’t think their loved ones can understand medical information on their own. On the other hand, caregivers are more likely than people who don’t provide care to say the doctor confused them and to research the doctor’s advice after an appointment.

For many patients and caregivers, communications break down when they are with their health care provider. Twenty-two percent of Americans say they do not feel comfortable asking their doctor certain health questions. This inability to have a satisfactory dialogue with their doctor means that many patients leave their appointments without getting clear answers to their questions (24%) or without having an opportunity to ask any questions at all (17%).

This is not surprising, considering that a 2018 study found that doctors spend only 11 seconds, on average, listening to patients before interrupting them.
 

Depending on the internet

Overall, the AHIMA survey found, 42% of Americans research their doctor’s recommendations after an appointment. A higher percentage of caregivers than noncaregiver peers do so (47% vs. 38%). Eighty percent of respondents say they are “likely” to research their doctor’s advice online after a visit.

When they have a medical problem or a question about their condition, just as many Americans (59%) turn to the internet for an answer as contact their doctor directly, the survey found. Twenty-nine percent of the respondents consult friends, family, or colleagues; 23% look up medical records if they’re easily accessible; 19% ask pharmacists for advice; and 6% call an unspecified 800 number.

Americans feel secure in the health information they find on the internet. Among those who go online to look up information, 86% are confident that it is credible. And 42% report feeling relieved that they can find a lot of information about their health concerns. Respondents also say that the information they gather allows them to feel more confident in their doctor’s recommendations (35%) and that they feel better after having learned more on the internet than their doctor had told them (39%). Men are more likely than women to say that their confidence in their doctor’s recommendations increased after doing online research (40% vs. 30%).
 

Access to health records

Access to medical records would help people better understand their condition or diagnosis. But nearly half of Americans (48%) admit they don’t usually review their medical records until long after an appointment, and 52% say they rarely access their records at all.

One in four Americans say that they don’t know where to go to access their health information or that they didn’t find the process easy. More than half of those who have never had to find their records think the process would be difficult if they had to try.

Eighty-one percent of Americans use an online platform or portal to access their medical records or health information. Two-thirds of Americans who use an online portal trust that their medical information is kept safe and not shared with other people or organizations.

Four in five respondents agree that if they had access to all of their health information, including medical records, recommendations, conditions, and test results, they’d see an improvement in their health management. Fifty-nine percent of them believe they’d also be more confident about understanding their health, and 47% say they’d have greater trust in their doctor’s recommendations. Higher percentages of caregivers than noncaregivers say the same.

Younger people, those with a high school degree or less, and those who earn less than $50,000 are less likely than older, better educated, and more affluent people to understand their doctor’s health information and to ask questions of their providers.

People of color struggle with their relationships with doctors, are less satisfied than white people with the information they receive during visits, and are more likely than white peers to feel that if they had access to all their health information, they’d manage their health better and be more confident in their doctors’ recommendations, the survey found.

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

Nearly two-thirds of Americans are not confident that they understood their doctor’s recommendations and the health information they discussed with their doctor after a visit, according to a new survey.

Confusion over health information and doctor advice is even higher among people who care for patients than among those who don’t provide care to their loved ones, the nationally representative survey from the AHIMA Foundation found.

The survey also shows that 80% of Americans – and an even higher portion of caregivers – are likely to research medical recommendations online after a doctor’s visit. But 1 in 4 people don’t know how to access their own medical records or find it difficult to do so.

The findings reflect the same low level of health literacy in the U.S. population that earlier surveys did. The results also indicate that little has changed since the Department of Health and Human Services released a National Action Plan to Improve Health Literacy in 2010.

That plan emphasized the need to develop and share accurate health information that helps people make decisions; to promote changes in the health care system that improve health information, communication, informed decision-making, and access to health services; and to increase the sharing and use of evidence-based health literacy practices.

According to the AHIMA Foundation report, 62% of Americans are not sure they understand their doctor’s advice and the health information discussed during a visit. Twenty-four percent say they don’t comprehend any of it, and 31% can’t remember what was said during the visit. Fifteen percent of those surveyed said they were more confused about their health than they were before the encounter with their doctor.
 

Caregivers have special issues

Forty-three percent of Americans are caregivers, the report notes, and 91% of those play an active role in managing someone else’s health. Millennials (65%) and Gen Xers (50%) are significantly more likely than Gen Zers (39%) and Boomers (20%) to be a caregiver.

Most caregivers have concerns about their loved ones’ ability to manage their own health. Most of them believe that doctors provide enough information, but 38% don’t believe a doctor can communicate effectively with the patient if the caregiver is not present.

Forty-three percent of caretakers don’t think their loved ones can understand medical information on their own. On the other hand, caregivers are more likely than people who don’t provide care to say the doctor confused them and to research the doctor’s advice after an appointment.

For many patients and caregivers, communications break down when they are with their health care provider. Twenty-two percent of Americans say they do not feel comfortable asking their doctor certain health questions. This inability to have a satisfactory dialogue with their doctor means that many patients leave their appointments without getting clear answers to their questions (24%) or without having an opportunity to ask any questions at all (17%).

This is not surprising, considering that a 2018 study found that doctors spend only 11 seconds, on average, listening to patients before interrupting them.
 

Depending on the internet

Overall, the AHIMA survey found, 42% of Americans research their doctor’s recommendations after an appointment. A higher percentage of caregivers than noncaregiver peers do so (47% vs. 38%). Eighty percent of respondents say they are “likely” to research their doctor’s advice online after a visit.

When they have a medical problem or a question about their condition, just as many Americans (59%) turn to the internet for an answer as contact their doctor directly, the survey found. Twenty-nine percent of the respondents consult friends, family, or colleagues; 23% look up medical records if they’re easily accessible; 19% ask pharmacists for advice; and 6% call an unspecified 800 number.

Americans feel secure in the health information they find on the internet. Among those who go online to look up information, 86% are confident that it is credible. And 42% report feeling relieved that they can find a lot of information about their health concerns. Respondents also say that the information they gather allows them to feel more confident in their doctor’s recommendations (35%) and that they feel better after having learned more on the internet than their doctor had told them (39%). Men are more likely than women to say that their confidence in their doctor’s recommendations increased after doing online research (40% vs. 30%).
 

Access to health records

Access to medical records would help people better understand their condition or diagnosis. But nearly half of Americans (48%) admit they don’t usually review their medical records until long after an appointment, and 52% say they rarely access their records at all.

One in four Americans say that they don’t know where to go to access their health information or that they didn’t find the process easy. More than half of those who have never had to find their records think the process would be difficult if they had to try.

Eighty-one percent of Americans use an online platform or portal to access their medical records or health information. Two-thirds of Americans who use an online portal trust that their medical information is kept safe and not shared with other people or organizations.

Four in five respondents agree that if they had access to all of their health information, including medical records, recommendations, conditions, and test results, they’d see an improvement in their health management. Fifty-nine percent of them believe they’d also be more confident about understanding their health, and 47% say they’d have greater trust in their doctor’s recommendations. Higher percentages of caregivers than noncaregivers say the same.

Younger people, those with a high school degree or less, and those who earn less than $50,000 are less likely than older, better educated, and more affluent people to understand their doctor’s health information and to ask questions of their providers.

People of color struggle with their relationships with doctors, are less satisfied than white people with the information they receive during visits, and are more likely than white peers to feel that if they had access to all their health information, they’d manage their health better and be more confident in their doctors’ recommendations, the survey found.

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

Nearly two-thirds of Americans are not confident that they understood their doctor’s recommendations and the health information they discussed with their doctor after a visit, according to a new survey.

Confusion over health information and doctor advice is even higher among people who care for patients than among those who don’t provide care to their loved ones, the nationally representative survey from the AHIMA Foundation found.

The survey also shows that 80% of Americans – and an even higher portion of caregivers – are likely to research medical recommendations online after a doctor’s visit. But 1 in 4 people don’t know how to access their own medical records or find it difficult to do so.

The findings reflect the same low level of health literacy in the U.S. population that earlier surveys did. The results also indicate that little has changed since the Department of Health and Human Services released a National Action Plan to Improve Health Literacy in 2010.

That plan emphasized the need to develop and share accurate health information that helps people make decisions; to promote changes in the health care system that improve health information, communication, informed decision-making, and access to health services; and to increase the sharing and use of evidence-based health literacy practices.

According to the AHIMA Foundation report, 62% of Americans are not sure they understand their doctor’s advice and the health information discussed during a visit. Twenty-four percent say they don’t comprehend any of it, and 31% can’t remember what was said during the visit. Fifteen percent of those surveyed said they were more confused about their health than they were before the encounter with their doctor.
 

Caregivers have special issues

Forty-three percent of Americans are caregivers, the report notes, and 91% of those play an active role in managing someone else’s health. Millennials (65%) and Gen Xers (50%) are significantly more likely than Gen Zers (39%) and Boomers (20%) to be a caregiver.

Most caregivers have concerns about their loved ones’ ability to manage their own health. Most of them believe that doctors provide enough information, but 38% don’t believe a doctor can communicate effectively with the patient if the caregiver is not present.

Forty-three percent of caretakers don’t think their loved ones can understand medical information on their own. On the other hand, caregivers are more likely than people who don’t provide care to say the doctor confused them and to research the doctor’s advice after an appointment.

For many patients and caregivers, communications break down when they are with their health care provider. Twenty-two percent of Americans say they do not feel comfortable asking their doctor certain health questions. This inability to have a satisfactory dialogue with their doctor means that many patients leave their appointments without getting clear answers to their questions (24%) or without having an opportunity to ask any questions at all (17%).

This is not surprising, considering that a 2018 study found that doctors spend only 11 seconds, on average, listening to patients before interrupting them.
 

Depending on the internet

Overall, the AHIMA survey found, 42% of Americans research their doctor’s recommendations after an appointment. A higher percentage of caregivers than noncaregiver peers do so (47% vs. 38%). Eighty percent of respondents say they are “likely” to research their doctor’s advice online after a visit.

When they have a medical problem or a question about their condition, just as many Americans (59%) turn to the internet for an answer as contact their doctor directly, the survey found. Twenty-nine percent of the respondents consult friends, family, or colleagues; 23% look up medical records if they’re easily accessible; 19% ask pharmacists for advice; and 6% call an unspecified 800 number.

Americans feel secure in the health information they find on the internet. Among those who go online to look up information, 86% are confident that it is credible. And 42% report feeling relieved that they can find a lot of information about their health concerns. Respondents also say that the information they gather allows them to feel more confident in their doctor’s recommendations (35%) and that they feel better after having learned more on the internet than their doctor had told them (39%). Men are more likely than women to say that their confidence in their doctor’s recommendations increased after doing online research (40% vs. 30%).
 

Access to health records

Access to medical records would help people better understand their condition or diagnosis. But nearly half of Americans (48%) admit they don’t usually review their medical records until long after an appointment, and 52% say they rarely access their records at all.

One in four Americans say that they don’t know where to go to access their health information or that they didn’t find the process easy. More than half of those who have never had to find their records think the process would be difficult if they had to try.

Eighty-one percent of Americans use an online platform or portal to access their medical records or health information. Two-thirds of Americans who use an online portal trust that their medical information is kept safe and not shared with other people or organizations.

Four in five respondents agree that if they had access to all of their health information, including medical records, recommendations, conditions, and test results, they’d see an improvement in their health management. Fifty-nine percent of them believe they’d also be more confident about understanding their health, and 47% say they’d have greater trust in their doctor’s recommendations. Higher percentages of caregivers than noncaregivers say the same.

Younger people, those with a high school degree or less, and those who earn less than $50,000 are less likely than older, better educated, and more affluent people to understand their doctor’s health information and to ask questions of their providers.

People of color struggle with their relationships with doctors, are less satisfied than white people with the information they receive during visits, and are more likely than white peers to feel that if they had access to all their health information, they’d manage their health better and be more confident in their doctors’ recommendations, the survey found.

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