User login
Case: Patient with statin-associated muscle symptoms
A 66-year-old woman is discharged from the hospital after an MI. Her discharge medications include atorvastatin 40 mg, lisinopril 20 mg, acetylsalicylic acid 81 mg, and clopidogrel 75 mg. At this patient’s follow-up appointment, she mentions that she has muscle pain and stiffness in both legs and her back. Her labs include thyroid-stimulating hormone of 2.0 and vitamin D of 40. She stops the atorvastatin for 2 weeks with resolution of her symptoms.
Which treatment recommendation would you make for this patient?
A. Restart atorvastatin
B. Start rosuvastatin twice a week
C. Start ezetimibe
D. Start a PCSK9 inhibitor
We often see high-risk cardiovascular disease patients who are concerned about muscle side effects brought on by statins. I think we all can agree that this patient needs aggressive medical therapy for prevention of secondary cardiovascular events. I would restart her atorvastatin.
Neilsen and Nordestgaard found that early statin discontinuation rates increased from 6% in 1995 to 18% in 2010.1
Early statin discontinuation correlated with negative statin-related news stories, their paper states. This suggests either an increased awareness of side effects or a possible nocebo effect.
Statin rechallenge results
Joy and colleagues reported the results on eight patients who had developed myalgias within 3 weeks of starting a statin. These patients, who received placebo or statin, completed an N-of-1 trial with three double-blind, crossover comparisons separated by 3-week washout periods.
Patients were evaluated pain on a visual analog scale (VAS). For each N-of-1 trial there was no statistically significant difference in pain or myalgia score between those who took statin and placebo. Five of the eight patients chose to continue on statins at the end of the trial.
Herrett and colleagues performed a more extensive series of N-of-1 trials involving 200 patients who had stopped or were considering stopping statins because of muscle symptoms.3 Participants either received 2 months of atorvastatin 20 mg or placebo for 2-month blocks six times. They rated their muscle symptoms on a VAS at the end of each block. There was no difference in muscle symptom scores between the statin and placebo periods.
Wood and colleagues took it a step further, when they studied an N-of-1 trial that included statin, placebo, and no treatment.4 Each participant received four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles. Each month they used treatment from the bottles based on random sequence and reported daily symptom scores. The mean symptom intensity was 8.0 during no-tablet months, 15.4 during placebo months (P < .001, compared with no-tablet months), and 16.3 during statin months (P < .001, compared with no-tablet months; P = .39, compared with placebo).
Taylor and colleagues studied 120 patients who had prior statin-associated muscle complaints.5 Each patient received either simvastatin 20 mg or placebo for 4 weeks, and then were switched for an additional 4 weeks. A total of 43 patients (36%) had pain on simvastatin but not placebo, 21 (17%) had no pain with either treatment, 21 (17%) reported pain with both treatments, and 35 (29%) had pain with placebo but not simvastatin. These studies support the concept of nocebo effect in patients who have muscle symptoms on statins.
So what should be done? Brennan and Roy did a retrospective study of 118 patients referred to a lipid clinic as being statin intolerant to two or more statins.6 Most of the patients were able to tolerate a statin: 71% tolerated same statin rechallenge, 53% tolerated statin switch, and 57% tolerated a nonstatin therapy.
In the Prosisa study, only 27% of patients who reported statin-associated muscle symptoms had reappearance of muscle symptoms after rechallenge with a statin.7
Research implications
Rechallenge with the same statin seems to be a reasonable first step, followed by switching to a different statin. I also share the concept of nocebo effect with my patients, and tell them I believe they have an excellent chance of tolerating the statin.
Pearl: The majority of patients with muscle symptoms while taking a statin likely have a nocebo effect, and are likely to tolerate rechallenge with the same statin.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.
References
1. Nielsen SF and Nordestgaard BG. Eur Heart J. 2016;37:908-16.
2. Joy TR et al. Ann Intern Med. 2014;160:301-10.
3. Herrett E et al. BMJ. 2021 Feb 24;372:n135.
4. Wood FA et al. N Engl J Med 2020;383:2182-4.
5. Taylor BA et al. Atherosclerosis. 2017;256:100-4.
6. Brennen ET and Roy TR. Can J Card. 2017;33(5):666-73.
7. Bonaiti Fet al. Atherosclerosis. 2020;315:E13-4.
A 66-year-old woman is discharged from the hospital after an MI. Her discharge medications include atorvastatin 40 mg, lisinopril 20 mg, acetylsalicylic acid 81 mg, and clopidogrel 75 mg. At this patient’s follow-up appointment, she mentions that she has muscle pain and stiffness in both legs and her back. Her labs include thyroid-stimulating hormone of 2.0 and vitamin D of 40. She stops the atorvastatin for 2 weeks with resolution of her symptoms.
Which treatment recommendation would you make for this patient?
A. Restart atorvastatin
B. Start rosuvastatin twice a week
C. Start ezetimibe
D. Start a PCSK9 inhibitor
We often see high-risk cardiovascular disease patients who are concerned about muscle side effects brought on by statins. I think we all can agree that this patient needs aggressive medical therapy for prevention of secondary cardiovascular events. I would restart her atorvastatin.
Neilsen and Nordestgaard found that early statin discontinuation rates increased from 6% in 1995 to 18% in 2010.1
Early statin discontinuation correlated with negative statin-related news stories, their paper states. This suggests either an increased awareness of side effects or a possible nocebo effect.
Statin rechallenge results
Joy and colleagues reported the results on eight patients who had developed myalgias within 3 weeks of starting a statin. These patients, who received placebo or statin, completed an N-of-1 trial with three double-blind, crossover comparisons separated by 3-week washout periods.
Patients were evaluated pain on a visual analog scale (VAS). For each N-of-1 trial there was no statistically significant difference in pain or myalgia score between those who took statin and placebo. Five of the eight patients chose to continue on statins at the end of the trial.
Herrett and colleagues performed a more extensive series of N-of-1 trials involving 200 patients who had stopped or were considering stopping statins because of muscle symptoms.3 Participants either received 2 months of atorvastatin 20 mg or placebo for 2-month blocks six times. They rated their muscle symptoms on a VAS at the end of each block. There was no difference in muscle symptom scores between the statin and placebo periods.
Wood and colleagues took it a step further, when they studied an N-of-1 trial that included statin, placebo, and no treatment.4 Each participant received four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles. Each month they used treatment from the bottles based on random sequence and reported daily symptom scores. The mean symptom intensity was 8.0 during no-tablet months, 15.4 during placebo months (P < .001, compared with no-tablet months), and 16.3 during statin months (P < .001, compared with no-tablet months; P = .39, compared with placebo).
Taylor and colleagues studied 120 patients who had prior statin-associated muscle complaints.5 Each patient received either simvastatin 20 mg or placebo for 4 weeks, and then were switched for an additional 4 weeks. A total of 43 patients (36%) had pain on simvastatin but not placebo, 21 (17%) had no pain with either treatment, 21 (17%) reported pain with both treatments, and 35 (29%) had pain with placebo but not simvastatin. These studies support the concept of nocebo effect in patients who have muscle symptoms on statins.
So what should be done? Brennan and Roy did a retrospective study of 118 patients referred to a lipid clinic as being statin intolerant to two or more statins.6 Most of the patients were able to tolerate a statin: 71% tolerated same statin rechallenge, 53% tolerated statin switch, and 57% tolerated a nonstatin therapy.
In the Prosisa study, only 27% of patients who reported statin-associated muscle symptoms had reappearance of muscle symptoms after rechallenge with a statin.7
Research implications
Rechallenge with the same statin seems to be a reasonable first step, followed by switching to a different statin. I also share the concept of nocebo effect with my patients, and tell them I believe they have an excellent chance of tolerating the statin.
Pearl: The majority of patients with muscle symptoms while taking a statin likely have a nocebo effect, and are likely to tolerate rechallenge with the same statin.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.
References
1. Nielsen SF and Nordestgaard BG. Eur Heart J. 2016;37:908-16.
2. Joy TR et al. Ann Intern Med. 2014;160:301-10.
3. Herrett E et al. BMJ. 2021 Feb 24;372:n135.
4. Wood FA et al. N Engl J Med 2020;383:2182-4.
5. Taylor BA et al. Atherosclerosis. 2017;256:100-4.
6. Brennen ET and Roy TR. Can J Card. 2017;33(5):666-73.
7. Bonaiti Fet al. Atherosclerosis. 2020;315:E13-4.
A 66-year-old woman is discharged from the hospital after an MI. Her discharge medications include atorvastatin 40 mg, lisinopril 20 mg, acetylsalicylic acid 81 mg, and clopidogrel 75 mg. At this patient’s follow-up appointment, she mentions that she has muscle pain and stiffness in both legs and her back. Her labs include thyroid-stimulating hormone of 2.0 and vitamin D of 40. She stops the atorvastatin for 2 weeks with resolution of her symptoms.
Which treatment recommendation would you make for this patient?
A. Restart atorvastatin
B. Start rosuvastatin twice a week
C. Start ezetimibe
D. Start a PCSK9 inhibitor
We often see high-risk cardiovascular disease patients who are concerned about muscle side effects brought on by statins. I think we all can agree that this patient needs aggressive medical therapy for prevention of secondary cardiovascular events. I would restart her atorvastatin.
Neilsen and Nordestgaard found that early statin discontinuation rates increased from 6% in 1995 to 18% in 2010.1
Early statin discontinuation correlated with negative statin-related news stories, their paper states. This suggests either an increased awareness of side effects or a possible nocebo effect.
Statin rechallenge results
Joy and colleagues reported the results on eight patients who had developed myalgias within 3 weeks of starting a statin. These patients, who received placebo or statin, completed an N-of-1 trial with three double-blind, crossover comparisons separated by 3-week washout periods.
Patients were evaluated pain on a visual analog scale (VAS). For each N-of-1 trial there was no statistically significant difference in pain or myalgia score between those who took statin and placebo. Five of the eight patients chose to continue on statins at the end of the trial.
Herrett and colleagues performed a more extensive series of N-of-1 trials involving 200 patients who had stopped or were considering stopping statins because of muscle symptoms.3 Participants either received 2 months of atorvastatin 20 mg or placebo for 2-month blocks six times. They rated their muscle symptoms on a VAS at the end of each block. There was no difference in muscle symptom scores between the statin and placebo periods.
Wood and colleagues took it a step further, when they studied an N-of-1 trial that included statin, placebo, and no treatment.4 Each participant received four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles. Each month they used treatment from the bottles based on random sequence and reported daily symptom scores. The mean symptom intensity was 8.0 during no-tablet months, 15.4 during placebo months (P < .001, compared with no-tablet months), and 16.3 during statin months (P < .001, compared with no-tablet months; P = .39, compared with placebo).
Taylor and colleagues studied 120 patients who had prior statin-associated muscle complaints.5 Each patient received either simvastatin 20 mg or placebo for 4 weeks, and then were switched for an additional 4 weeks. A total of 43 patients (36%) had pain on simvastatin but not placebo, 21 (17%) had no pain with either treatment, 21 (17%) reported pain with both treatments, and 35 (29%) had pain with placebo but not simvastatin. These studies support the concept of nocebo effect in patients who have muscle symptoms on statins.
So what should be done? Brennan and Roy did a retrospective study of 118 patients referred to a lipid clinic as being statin intolerant to two or more statins.6 Most of the patients were able to tolerate a statin: 71% tolerated same statin rechallenge, 53% tolerated statin switch, and 57% tolerated a nonstatin therapy.
In the Prosisa study, only 27% of patients who reported statin-associated muscle symptoms had reappearance of muscle symptoms after rechallenge with a statin.7
Research implications
Rechallenge with the same statin seems to be a reasonable first step, followed by switching to a different statin. I also share the concept of nocebo effect with my patients, and tell them I believe they have an excellent chance of tolerating the statin.
Pearl: The majority of patients with muscle symptoms while taking a statin likely have a nocebo effect, and are likely to tolerate rechallenge with the same statin.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.
References
1. Nielsen SF and Nordestgaard BG. Eur Heart J. 2016;37:908-16.
2. Joy TR et al. Ann Intern Med. 2014;160:301-10.
3. Herrett E et al. BMJ. 2021 Feb 24;372:n135.
4. Wood FA et al. N Engl J Med 2020;383:2182-4.
5. Taylor BA et al. Atherosclerosis. 2017;256:100-4.
6. Brennen ET and Roy TR. Can J Card. 2017;33(5):666-73.
7. Bonaiti Fet al. Atherosclerosis. 2020;315:E13-4.
Addressing vaccine hesitancy with patients
Breakthrough with empathy and compassion
The COVID-19 pandemic is a worldwide tragedy. In the beginning there was a lack of testing, personal protective equipment, COVID tests, and support for health care workers and patients. As 2020 came to a close, the world was given a glimpse of hope with the development of a vaccine against the deadly virus. Many world citizens celebrated the scientific accomplishment and began to breathe a sigh of relief that there was an end in sight. However, the development and distribution of the COVID-19 vaccine revealed a new challenge, vaccine hesitancy.
Community members, young healthy people, and even critically ill hospitalized patients who have the fortune of surviving acute illness are hesitant to the COVID-19 vaccine. I recently cared for a critically ill young patient who was intubated for days with status asthmaticus, one of the worst cases I’d ever seen. She was extubated and made a full recovery. Prior to discharge I asked if she wanted the first dose of the COVID-19 vaccine and she said, “No.” I was shocked. This was an otherwise healthy 30-something-year-old who was lucky enough to survive without any underlying infection in the setting of severe obstructive lung disease. A co-infection with COVID-19 would be disastrous and increase her mortality. I had a long talk at the bedside and asked the reason for her hesitancy. Her answer left me speechless, “I don’t know, I just don’t want to.” I ultimately convinced her that contracting COVID-19 would be a fate worse than she could imagine, and she agreed to the vaccine prior to discharge. This interaction made me ponder – “why are our patients, friends, and family members hesitant about receiving a lifesaving vaccine, especially when they are aware of how sick they or others can become without it?”
According to the World Health Organization, vaccine hesitancy refers to a delay in acceptance or refusal of vaccines despite availability of vaccine services. Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence.1 No vaccine is 100% effective. However, throughout history, the work of scientists and doctors to create vaccines saved millions of lives and revolutionized global health. Arguably, the single most life-saving innovation in the history of medicine, vaccines have eradicated smallpox, protected against whooping cough (1914), diphtheria (1926), tetanus (1938), influenza (1945) and mumps (1948), polio (1955), measles (1963), and rubella (1969), and worldwide vaccination rates increased dramatically thanks to successful global health campaigns.2 However, there was a paradox of vaccine success. As terrifying diseases decreased in prevalence, so did the fear of these diseases and their effects – paralysis, brain damage, blindness, and death. This gave birth to a new challenge in modern medicine, vaccine hesitancy – a privilege of first world nations.
Vaccines saved countless lives and improved health and wellbeing around the world for decades. However, to prevent the morbidity and mortality associated with vaccine-preventable diseases and their complications, and optimize control of vaccine-preventable diseases in communities, high vaccination rates must be achieved. Enter the COVID-19 pandemic, the creation of the COVID-19 vaccine, and vaccine hesitancy.
The question we ask ourselves as health care providers is ‘how do we convince the skeptics and those opposed to vaccination to take the vaccine?’ The answer is complicated. If you are like me, you’ve had many conversations with people – friends, patients, family members, who are resistant to the vaccine. Very often the facts are not well received, and those discussions end in argument, high emotions, and broken relationships. With the delta variant of COVID-19 on the rise, spreading aggressively among the unvaccinated, and increased hospitalizations, we foresee the reoccurrence of overwhelmed health systems and a continued death toll.
The new paradox we are faced with is that people choose to believe fiction versus fact, despite the real life evidence of the severe health effects and increased deaths related to COVID-19. Do these skeptics simply have a cavalier attitude towards not only their own life, but the lives of others? Or, is there something deeper? It is not enough to tell people that the vaccines are proven safe3 and are more widely available than ever. It is not enough to tell people that they can die of COVID-19 – they already know that. Emotional pleas to family members are falling on deaf ears. This past month, when asking patients why they don’t want the vaccine, many have no real legitimate health-related reason and respond with a simple, “I don’t want to.” So, how do we get through to the unvaccinated?
A compassionate approach
We navigate these difficult conversations over time with the approach of compassion and empathy, not hostility or bullying. As health care providers, we start by being good empathic listeners. Similar to when we have advance care planning and code status conversations, we cannot enter the dialogue with our intention, beliefs, or formulated goals for that person. We have to listen without judgement to the wide range of reasons why others are reluctant or unwilling to get the vaccine – historical mistrust, political identity, religious reasons, short-term side effects that may cause them to lose a day or two of work – and understand that for each person their reasons are different. The point is to not assume that you know or understand what barriers and beliefs they have towards vaccination, but to meet them at their point of view and listen while keeping your own emotions level and steady.
Identifying the reason for vaccine hesitancy is the first step to getting the unvaccinated closer to vaccination. Ask open ended questions: “Can you help me understand, what is your hesitancy to the vaccine?”; “What about the vaccine worries you?”; “What have you heard about/know about the COVID-19 vaccine?”; or “Can you tell me more about why you feel that way?” As meticulous as it sounds, we have to go back to the basics of patient interviewing.
It is important to remember that this is not a debate and escalation to arguments will certainly backfire. Think about any time you disagreed with someone on a topic. Did criticizing, blaming, and shaming ever convince you to change your beliefs or behaviors? The likely answer is, “No.” Avoid the “backfire effect”– which is when giving people facts disproving their “incorrect” beliefs can actually reinforce those beliefs. The more people are confronted with facts at odds with their opinions, the stronger they cling to those opinions. If you want them to change their mind, you cannot approach the conversation as a debate. You are having this vaccine discussion to try to meet the other person where they are, understand their position, and talk with them, and not at them, about their concerns.
As leaders in health care, we have to be willing to give up control and lead with empathy. We have to show others that we hear them, believe their concerns, and acknowledge that their beliefs are valid to them as individuals. Even if you disagree, this is not the place to let anger, disappointment, or resentment take a front seat. This is about balance, and highlighting the autonomy in decision making that the other person has to make a choice. Be humble in these conversations and avoid condescending tones or statements.
We already know that you are a caring health care provider. As hospitalists, we are frontline providers who have seen unnecessary deaths and illness due to COVID-19. You are passionate and motivated because you are committed to your oath to save lives. However, you have to check your own feelings and remember that you are not speaking with an unvaccinated person to make them get vaccinated, but rather to understand their cognitive process and hopefully walk with them down a path that provides them with a clarity of options they truly have. Extend empathy and they will see your motivation is rooted in good-heartedness and a concern for their wellbeing.
If someone admits to reasons for avoiding vaccination that are not rooted in any fact, then guide them to the best resources. Our health care system recently released a COVID-19 fact versus myth handout called Trust the Facts. This could be the kind of vetted resource you offer. Guide them to accredited websites, such as the World Health Organization, the Center for Disease Control, or their local and state departments of health to help debunk fiction by reviewing it with them. Discuss myths such as, ‘the vaccine will cause infertility,’ ‘the vaccine will give me COVID,’ ‘the vaccine was rushed and is not safe,’ ‘the vaccine is not needed if I am young and healthy,’ ‘the vaccine has a microchip,’ etc. Knowledge is power and disinformation is deadly, but how facts are presented will make the biggest difference in how others receive them, so remember your role is not to argue with these statements, but rather to provide perspective without agreeing or disagreeing.
Respond to their concerns with statements such as, “I hear you…it sounds like you are worried/fearful/mistrusting about the side effects/safety/efficacy of the vaccine…can we talk more about that?” Ask them where these concerns come from – the news, social media, an article, word of mouth, friends, or family. Ask them about the information they have and show genuine interest that you want to see it from their perspective. This is the key to compassionate and empathic dialogue – you relinquish your intentions.
Once you know or unveil their reasons for hesitancy, ask them what they would like to see with regards to COVID-19 and ending the pandemic. Would they like to get back to a new normal, to visit family members, to travel once again, to not have to wear masks and quarantine? What do they want for themselves, their families, communities, the country, or even the world? The goal is to find something in our shared humanity, to connect on a deeper level so they start to open up and let down walls, and find something you both see eye-to-eye on. Know your audience and speak to what serves them. To effectively persuade someone to come around to your point of view starts with recognizing the root of the disagreement and trying to overcome it before trying to change the person’s mind, understanding both the logic and the emotion that’s driving their decision making.4
Building trust
Reminding patients, friends or family members that their health and well-being means a lot to you can also be a strategy to keeping the conversation open and friendly. Sharing stories as hospitalists caring for many critically ill COVID patients or patients who died alone due to COVID-19, and the trauma you experienced as a health care provider feeling paralyzed by the limitations of modern medicine against the deadly virus, will only serve to humanize you in such an interaction.
Building trust will also increase vaccine willingness. This will require a concerted effort by scientists, doctors, and health care systems to engage with community leaders and members. To address hesitancy, the people we serve have to hear those local, personal, and relatable stories about vaccinations, and how it benefits not just themselves, but others around them in their community. As part of the #VaxUp campaign in Virginia, community and physician leaders shared their stories of hesitancy and motivation surrounding the vaccine. These are real people in the community discussing why getting vaccinated is so important and what helped them make an informed decision. I discussed my own hesitancy and concerns and also tackled a few vaccine myths.
As vaccinated health care workers or community leaders, you are living proof of the benefits of getting the COVID vaccine. Focus on the positives but also be honest. If your second shot gave you fevers, chills, or myalgias, then admit it and share how you overcame these expected reactions. Refocus on the safety of the vaccine and the fact that it is freely available to all people. Maybe the person you are speaking with doesn’t know where or how to get an appointment to get vaccinated. Help them find the nearest place to get an appointment and identify barriers they may have in transportation, child, or senior care to leave home safely to get vaccinated, or physical conditions that are preventing them from receiving the vaccine. Share that being vaccinated protects you from contracting the virus and spreading it to loved ones. Focus on how a fully vaccinated community and country can open up opportunities to heal and connect as a society, spend time with family/friends in another county or state, hold a newborn grandchild, or even travel outside the U.S.
There is no guarantee that you will be able to persuade someone to get vaccinated. It’s possible the outcome of your conversation will not result in the other person changing their mind in that moment. That doesn’t mean that you failed, because you started the dialogue and planted the seed. If you are a vaccinated health care provider, your words have influence and power, and we are obliged by our positions to have responsibility for the health of our communities. Don’t be discouraged, as it is through caring, compassionate, respectful, and empathic conversations that your influence will make the most difference in these relationships as you continue to advocate for all human life.
Dr. Williams is vice president of the Hampton Roads chapter of the Society of Hospital Medicine. She is a hospitalist at Sentara Careplex Hospital in Hampton, Va., where she also serves as vice president of the Medical Executive Committee.
References
1. World Health Organization. Report of the SAGE working group on vaccine hesitancy. Oct 2014. https://www.who.int/immunization/sage/meetings/2014/october/1_Report_WORKING_GROUP_vaccine_hesitancy_final.pdf
2. Hsu JL. A brief history of vaccines: Smallpox to the present. S D Med. 2013;Spec no:33-7. PMID: 23444589.
3. Chiu A, Bever L. Are they experimental? Can they alter DNA? Experts tackle lingering coronavirus vaccine fears. The Washington Post. 2021 May 14. https://www.washingtonpost.com/lifestyle/2021/05/14/safe-fast-vaccine-fear-infertility-dna/
4. Huang L. Edge: Turning Adversity into Advantage. New York: Portfolio/Penguin, 2020.
Breakthrough with empathy and compassion
Breakthrough with empathy and compassion
The COVID-19 pandemic is a worldwide tragedy. In the beginning there was a lack of testing, personal protective equipment, COVID tests, and support for health care workers and patients. As 2020 came to a close, the world was given a glimpse of hope with the development of a vaccine against the deadly virus. Many world citizens celebrated the scientific accomplishment and began to breathe a sigh of relief that there was an end in sight. However, the development and distribution of the COVID-19 vaccine revealed a new challenge, vaccine hesitancy.
Community members, young healthy people, and even critically ill hospitalized patients who have the fortune of surviving acute illness are hesitant to the COVID-19 vaccine. I recently cared for a critically ill young patient who was intubated for days with status asthmaticus, one of the worst cases I’d ever seen. She was extubated and made a full recovery. Prior to discharge I asked if she wanted the first dose of the COVID-19 vaccine and she said, “No.” I was shocked. This was an otherwise healthy 30-something-year-old who was lucky enough to survive without any underlying infection in the setting of severe obstructive lung disease. A co-infection with COVID-19 would be disastrous and increase her mortality. I had a long talk at the bedside and asked the reason for her hesitancy. Her answer left me speechless, “I don’t know, I just don’t want to.” I ultimately convinced her that contracting COVID-19 would be a fate worse than she could imagine, and she agreed to the vaccine prior to discharge. This interaction made me ponder – “why are our patients, friends, and family members hesitant about receiving a lifesaving vaccine, especially when they are aware of how sick they or others can become without it?”
According to the World Health Organization, vaccine hesitancy refers to a delay in acceptance or refusal of vaccines despite availability of vaccine services. Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence.1 No vaccine is 100% effective. However, throughout history, the work of scientists and doctors to create vaccines saved millions of lives and revolutionized global health. Arguably, the single most life-saving innovation in the history of medicine, vaccines have eradicated smallpox, protected against whooping cough (1914), diphtheria (1926), tetanus (1938), influenza (1945) and mumps (1948), polio (1955), measles (1963), and rubella (1969), and worldwide vaccination rates increased dramatically thanks to successful global health campaigns.2 However, there was a paradox of vaccine success. As terrifying diseases decreased in prevalence, so did the fear of these diseases and their effects – paralysis, brain damage, blindness, and death. This gave birth to a new challenge in modern medicine, vaccine hesitancy – a privilege of first world nations.
Vaccines saved countless lives and improved health and wellbeing around the world for decades. However, to prevent the morbidity and mortality associated with vaccine-preventable diseases and their complications, and optimize control of vaccine-preventable diseases in communities, high vaccination rates must be achieved. Enter the COVID-19 pandemic, the creation of the COVID-19 vaccine, and vaccine hesitancy.
The question we ask ourselves as health care providers is ‘how do we convince the skeptics and those opposed to vaccination to take the vaccine?’ The answer is complicated. If you are like me, you’ve had many conversations with people – friends, patients, family members, who are resistant to the vaccine. Very often the facts are not well received, and those discussions end in argument, high emotions, and broken relationships. With the delta variant of COVID-19 on the rise, spreading aggressively among the unvaccinated, and increased hospitalizations, we foresee the reoccurrence of overwhelmed health systems and a continued death toll.
The new paradox we are faced with is that people choose to believe fiction versus fact, despite the real life evidence of the severe health effects and increased deaths related to COVID-19. Do these skeptics simply have a cavalier attitude towards not only their own life, but the lives of others? Or, is there something deeper? It is not enough to tell people that the vaccines are proven safe3 and are more widely available than ever. It is not enough to tell people that they can die of COVID-19 – they already know that. Emotional pleas to family members are falling on deaf ears. This past month, when asking patients why they don’t want the vaccine, many have no real legitimate health-related reason and respond with a simple, “I don’t want to.” So, how do we get through to the unvaccinated?
A compassionate approach
We navigate these difficult conversations over time with the approach of compassion and empathy, not hostility or bullying. As health care providers, we start by being good empathic listeners. Similar to when we have advance care planning and code status conversations, we cannot enter the dialogue with our intention, beliefs, or formulated goals for that person. We have to listen without judgement to the wide range of reasons why others are reluctant or unwilling to get the vaccine – historical mistrust, political identity, religious reasons, short-term side effects that may cause them to lose a day or two of work – and understand that for each person their reasons are different. The point is to not assume that you know or understand what barriers and beliefs they have towards vaccination, but to meet them at their point of view and listen while keeping your own emotions level and steady.
Identifying the reason for vaccine hesitancy is the first step to getting the unvaccinated closer to vaccination. Ask open ended questions: “Can you help me understand, what is your hesitancy to the vaccine?”; “What about the vaccine worries you?”; “What have you heard about/know about the COVID-19 vaccine?”; or “Can you tell me more about why you feel that way?” As meticulous as it sounds, we have to go back to the basics of patient interviewing.
It is important to remember that this is not a debate and escalation to arguments will certainly backfire. Think about any time you disagreed with someone on a topic. Did criticizing, blaming, and shaming ever convince you to change your beliefs or behaviors? The likely answer is, “No.” Avoid the “backfire effect”– which is when giving people facts disproving their “incorrect” beliefs can actually reinforce those beliefs. The more people are confronted with facts at odds with their opinions, the stronger they cling to those opinions. If you want them to change their mind, you cannot approach the conversation as a debate. You are having this vaccine discussion to try to meet the other person where they are, understand their position, and talk with them, and not at them, about their concerns.
As leaders in health care, we have to be willing to give up control and lead with empathy. We have to show others that we hear them, believe their concerns, and acknowledge that their beliefs are valid to them as individuals. Even if you disagree, this is not the place to let anger, disappointment, or resentment take a front seat. This is about balance, and highlighting the autonomy in decision making that the other person has to make a choice. Be humble in these conversations and avoid condescending tones or statements.
We already know that you are a caring health care provider. As hospitalists, we are frontline providers who have seen unnecessary deaths and illness due to COVID-19. You are passionate and motivated because you are committed to your oath to save lives. However, you have to check your own feelings and remember that you are not speaking with an unvaccinated person to make them get vaccinated, but rather to understand their cognitive process and hopefully walk with them down a path that provides them with a clarity of options they truly have. Extend empathy and they will see your motivation is rooted in good-heartedness and a concern for their wellbeing.
If someone admits to reasons for avoiding vaccination that are not rooted in any fact, then guide them to the best resources. Our health care system recently released a COVID-19 fact versus myth handout called Trust the Facts. This could be the kind of vetted resource you offer. Guide them to accredited websites, such as the World Health Organization, the Center for Disease Control, or their local and state departments of health to help debunk fiction by reviewing it with them. Discuss myths such as, ‘the vaccine will cause infertility,’ ‘the vaccine will give me COVID,’ ‘the vaccine was rushed and is not safe,’ ‘the vaccine is not needed if I am young and healthy,’ ‘the vaccine has a microchip,’ etc. Knowledge is power and disinformation is deadly, but how facts are presented will make the biggest difference in how others receive them, so remember your role is not to argue with these statements, but rather to provide perspective without agreeing or disagreeing.
Respond to their concerns with statements such as, “I hear you…it sounds like you are worried/fearful/mistrusting about the side effects/safety/efficacy of the vaccine…can we talk more about that?” Ask them where these concerns come from – the news, social media, an article, word of mouth, friends, or family. Ask them about the information they have and show genuine interest that you want to see it from their perspective. This is the key to compassionate and empathic dialogue – you relinquish your intentions.
Once you know or unveil their reasons for hesitancy, ask them what they would like to see with regards to COVID-19 and ending the pandemic. Would they like to get back to a new normal, to visit family members, to travel once again, to not have to wear masks and quarantine? What do they want for themselves, their families, communities, the country, or even the world? The goal is to find something in our shared humanity, to connect on a deeper level so they start to open up and let down walls, and find something you both see eye-to-eye on. Know your audience and speak to what serves them. To effectively persuade someone to come around to your point of view starts with recognizing the root of the disagreement and trying to overcome it before trying to change the person’s mind, understanding both the logic and the emotion that’s driving their decision making.4
Building trust
Reminding patients, friends or family members that their health and well-being means a lot to you can also be a strategy to keeping the conversation open and friendly. Sharing stories as hospitalists caring for many critically ill COVID patients or patients who died alone due to COVID-19, and the trauma you experienced as a health care provider feeling paralyzed by the limitations of modern medicine against the deadly virus, will only serve to humanize you in such an interaction.
Building trust will also increase vaccine willingness. This will require a concerted effort by scientists, doctors, and health care systems to engage with community leaders and members. To address hesitancy, the people we serve have to hear those local, personal, and relatable stories about vaccinations, and how it benefits not just themselves, but others around them in their community. As part of the #VaxUp campaign in Virginia, community and physician leaders shared their stories of hesitancy and motivation surrounding the vaccine. These are real people in the community discussing why getting vaccinated is so important and what helped them make an informed decision. I discussed my own hesitancy and concerns and also tackled a few vaccine myths.
As vaccinated health care workers or community leaders, you are living proof of the benefits of getting the COVID vaccine. Focus on the positives but also be honest. If your second shot gave you fevers, chills, or myalgias, then admit it and share how you overcame these expected reactions. Refocus on the safety of the vaccine and the fact that it is freely available to all people. Maybe the person you are speaking with doesn’t know where or how to get an appointment to get vaccinated. Help them find the nearest place to get an appointment and identify barriers they may have in transportation, child, or senior care to leave home safely to get vaccinated, or physical conditions that are preventing them from receiving the vaccine. Share that being vaccinated protects you from contracting the virus and spreading it to loved ones. Focus on how a fully vaccinated community and country can open up opportunities to heal and connect as a society, spend time with family/friends in another county or state, hold a newborn grandchild, or even travel outside the U.S.
There is no guarantee that you will be able to persuade someone to get vaccinated. It’s possible the outcome of your conversation will not result in the other person changing their mind in that moment. That doesn’t mean that you failed, because you started the dialogue and planted the seed. If you are a vaccinated health care provider, your words have influence and power, and we are obliged by our positions to have responsibility for the health of our communities. Don’t be discouraged, as it is through caring, compassionate, respectful, and empathic conversations that your influence will make the most difference in these relationships as you continue to advocate for all human life.
Dr. Williams is vice president of the Hampton Roads chapter of the Society of Hospital Medicine. She is a hospitalist at Sentara Careplex Hospital in Hampton, Va., where she also serves as vice president of the Medical Executive Committee.
References
1. World Health Organization. Report of the SAGE working group on vaccine hesitancy. Oct 2014. https://www.who.int/immunization/sage/meetings/2014/october/1_Report_WORKING_GROUP_vaccine_hesitancy_final.pdf
2. Hsu JL. A brief history of vaccines: Smallpox to the present. S D Med. 2013;Spec no:33-7. PMID: 23444589.
3. Chiu A, Bever L. Are they experimental? Can they alter DNA? Experts tackle lingering coronavirus vaccine fears. The Washington Post. 2021 May 14. https://www.washingtonpost.com/lifestyle/2021/05/14/safe-fast-vaccine-fear-infertility-dna/
4. Huang L. Edge: Turning Adversity into Advantage. New York: Portfolio/Penguin, 2020.
The COVID-19 pandemic is a worldwide tragedy. In the beginning there was a lack of testing, personal protective equipment, COVID tests, and support for health care workers and patients. As 2020 came to a close, the world was given a glimpse of hope with the development of a vaccine against the deadly virus. Many world citizens celebrated the scientific accomplishment and began to breathe a sigh of relief that there was an end in sight. However, the development and distribution of the COVID-19 vaccine revealed a new challenge, vaccine hesitancy.
Community members, young healthy people, and even critically ill hospitalized patients who have the fortune of surviving acute illness are hesitant to the COVID-19 vaccine. I recently cared for a critically ill young patient who was intubated for days with status asthmaticus, one of the worst cases I’d ever seen. She was extubated and made a full recovery. Prior to discharge I asked if she wanted the first dose of the COVID-19 vaccine and she said, “No.” I was shocked. This was an otherwise healthy 30-something-year-old who was lucky enough to survive without any underlying infection in the setting of severe obstructive lung disease. A co-infection with COVID-19 would be disastrous and increase her mortality. I had a long talk at the bedside and asked the reason for her hesitancy. Her answer left me speechless, “I don’t know, I just don’t want to.” I ultimately convinced her that contracting COVID-19 would be a fate worse than she could imagine, and she agreed to the vaccine prior to discharge. This interaction made me ponder – “why are our patients, friends, and family members hesitant about receiving a lifesaving vaccine, especially when they are aware of how sick they or others can become without it?”
According to the World Health Organization, vaccine hesitancy refers to a delay in acceptance or refusal of vaccines despite availability of vaccine services. Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence.1 No vaccine is 100% effective. However, throughout history, the work of scientists and doctors to create vaccines saved millions of lives and revolutionized global health. Arguably, the single most life-saving innovation in the history of medicine, vaccines have eradicated smallpox, protected against whooping cough (1914), diphtheria (1926), tetanus (1938), influenza (1945) and mumps (1948), polio (1955), measles (1963), and rubella (1969), and worldwide vaccination rates increased dramatically thanks to successful global health campaigns.2 However, there was a paradox of vaccine success. As terrifying diseases decreased in prevalence, so did the fear of these diseases and their effects – paralysis, brain damage, blindness, and death. This gave birth to a new challenge in modern medicine, vaccine hesitancy – a privilege of first world nations.
Vaccines saved countless lives and improved health and wellbeing around the world for decades. However, to prevent the morbidity and mortality associated with vaccine-preventable diseases and their complications, and optimize control of vaccine-preventable diseases in communities, high vaccination rates must be achieved. Enter the COVID-19 pandemic, the creation of the COVID-19 vaccine, and vaccine hesitancy.
The question we ask ourselves as health care providers is ‘how do we convince the skeptics and those opposed to vaccination to take the vaccine?’ The answer is complicated. If you are like me, you’ve had many conversations with people – friends, patients, family members, who are resistant to the vaccine. Very often the facts are not well received, and those discussions end in argument, high emotions, and broken relationships. With the delta variant of COVID-19 on the rise, spreading aggressively among the unvaccinated, and increased hospitalizations, we foresee the reoccurrence of overwhelmed health systems and a continued death toll.
The new paradox we are faced with is that people choose to believe fiction versus fact, despite the real life evidence of the severe health effects and increased deaths related to COVID-19. Do these skeptics simply have a cavalier attitude towards not only their own life, but the lives of others? Or, is there something deeper? It is not enough to tell people that the vaccines are proven safe3 and are more widely available than ever. It is not enough to tell people that they can die of COVID-19 – they already know that. Emotional pleas to family members are falling on deaf ears. This past month, when asking patients why they don’t want the vaccine, many have no real legitimate health-related reason and respond with a simple, “I don’t want to.” So, how do we get through to the unvaccinated?
A compassionate approach
We navigate these difficult conversations over time with the approach of compassion and empathy, not hostility or bullying. As health care providers, we start by being good empathic listeners. Similar to when we have advance care planning and code status conversations, we cannot enter the dialogue with our intention, beliefs, or formulated goals for that person. We have to listen without judgement to the wide range of reasons why others are reluctant or unwilling to get the vaccine – historical mistrust, political identity, religious reasons, short-term side effects that may cause them to lose a day or two of work – and understand that for each person their reasons are different. The point is to not assume that you know or understand what barriers and beliefs they have towards vaccination, but to meet them at their point of view and listen while keeping your own emotions level and steady.
Identifying the reason for vaccine hesitancy is the first step to getting the unvaccinated closer to vaccination. Ask open ended questions: “Can you help me understand, what is your hesitancy to the vaccine?”; “What about the vaccine worries you?”; “What have you heard about/know about the COVID-19 vaccine?”; or “Can you tell me more about why you feel that way?” As meticulous as it sounds, we have to go back to the basics of patient interviewing.
It is important to remember that this is not a debate and escalation to arguments will certainly backfire. Think about any time you disagreed with someone on a topic. Did criticizing, blaming, and shaming ever convince you to change your beliefs or behaviors? The likely answer is, “No.” Avoid the “backfire effect”– which is when giving people facts disproving their “incorrect” beliefs can actually reinforce those beliefs. The more people are confronted with facts at odds with their opinions, the stronger they cling to those opinions. If you want them to change their mind, you cannot approach the conversation as a debate. You are having this vaccine discussion to try to meet the other person where they are, understand their position, and talk with them, and not at them, about their concerns.
As leaders in health care, we have to be willing to give up control and lead with empathy. We have to show others that we hear them, believe their concerns, and acknowledge that their beliefs are valid to them as individuals. Even if you disagree, this is not the place to let anger, disappointment, or resentment take a front seat. This is about balance, and highlighting the autonomy in decision making that the other person has to make a choice. Be humble in these conversations and avoid condescending tones or statements.
We already know that you are a caring health care provider. As hospitalists, we are frontline providers who have seen unnecessary deaths and illness due to COVID-19. You are passionate and motivated because you are committed to your oath to save lives. However, you have to check your own feelings and remember that you are not speaking with an unvaccinated person to make them get vaccinated, but rather to understand their cognitive process and hopefully walk with them down a path that provides them with a clarity of options they truly have. Extend empathy and they will see your motivation is rooted in good-heartedness and a concern for their wellbeing.
If someone admits to reasons for avoiding vaccination that are not rooted in any fact, then guide them to the best resources. Our health care system recently released a COVID-19 fact versus myth handout called Trust the Facts. This could be the kind of vetted resource you offer. Guide them to accredited websites, such as the World Health Organization, the Center for Disease Control, or their local and state departments of health to help debunk fiction by reviewing it with them. Discuss myths such as, ‘the vaccine will cause infertility,’ ‘the vaccine will give me COVID,’ ‘the vaccine was rushed and is not safe,’ ‘the vaccine is not needed if I am young and healthy,’ ‘the vaccine has a microchip,’ etc. Knowledge is power and disinformation is deadly, but how facts are presented will make the biggest difference in how others receive them, so remember your role is not to argue with these statements, but rather to provide perspective without agreeing or disagreeing.
Respond to their concerns with statements such as, “I hear you…it sounds like you are worried/fearful/mistrusting about the side effects/safety/efficacy of the vaccine…can we talk more about that?” Ask them where these concerns come from – the news, social media, an article, word of mouth, friends, or family. Ask them about the information they have and show genuine interest that you want to see it from their perspective. This is the key to compassionate and empathic dialogue – you relinquish your intentions.
Once you know or unveil their reasons for hesitancy, ask them what they would like to see with regards to COVID-19 and ending the pandemic. Would they like to get back to a new normal, to visit family members, to travel once again, to not have to wear masks and quarantine? What do they want for themselves, their families, communities, the country, or even the world? The goal is to find something in our shared humanity, to connect on a deeper level so they start to open up and let down walls, and find something you both see eye-to-eye on. Know your audience and speak to what serves them. To effectively persuade someone to come around to your point of view starts with recognizing the root of the disagreement and trying to overcome it before trying to change the person’s mind, understanding both the logic and the emotion that’s driving their decision making.4
Building trust
Reminding patients, friends or family members that their health and well-being means a lot to you can also be a strategy to keeping the conversation open and friendly. Sharing stories as hospitalists caring for many critically ill COVID patients or patients who died alone due to COVID-19, and the trauma you experienced as a health care provider feeling paralyzed by the limitations of modern medicine against the deadly virus, will only serve to humanize you in such an interaction.
Building trust will also increase vaccine willingness. This will require a concerted effort by scientists, doctors, and health care systems to engage with community leaders and members. To address hesitancy, the people we serve have to hear those local, personal, and relatable stories about vaccinations, and how it benefits not just themselves, but others around them in their community. As part of the #VaxUp campaign in Virginia, community and physician leaders shared their stories of hesitancy and motivation surrounding the vaccine. These are real people in the community discussing why getting vaccinated is so important and what helped them make an informed decision. I discussed my own hesitancy and concerns and also tackled a few vaccine myths.
As vaccinated health care workers or community leaders, you are living proof of the benefits of getting the COVID vaccine. Focus on the positives but also be honest. If your second shot gave you fevers, chills, or myalgias, then admit it and share how you overcame these expected reactions. Refocus on the safety of the vaccine and the fact that it is freely available to all people. Maybe the person you are speaking with doesn’t know where or how to get an appointment to get vaccinated. Help them find the nearest place to get an appointment and identify barriers they may have in transportation, child, or senior care to leave home safely to get vaccinated, or physical conditions that are preventing them from receiving the vaccine. Share that being vaccinated protects you from contracting the virus and spreading it to loved ones. Focus on how a fully vaccinated community and country can open up opportunities to heal and connect as a society, spend time with family/friends in another county or state, hold a newborn grandchild, or even travel outside the U.S.
There is no guarantee that you will be able to persuade someone to get vaccinated. It’s possible the outcome of your conversation will not result in the other person changing their mind in that moment. That doesn’t mean that you failed, because you started the dialogue and planted the seed. If you are a vaccinated health care provider, your words have influence and power, and we are obliged by our positions to have responsibility for the health of our communities. Don’t be discouraged, as it is through caring, compassionate, respectful, and empathic conversations that your influence will make the most difference in these relationships as you continue to advocate for all human life.
Dr. Williams is vice president of the Hampton Roads chapter of the Society of Hospital Medicine. She is a hospitalist at Sentara Careplex Hospital in Hampton, Va., where she also serves as vice president of the Medical Executive Committee.
References
1. World Health Organization. Report of the SAGE working group on vaccine hesitancy. Oct 2014. https://www.who.int/immunization/sage/meetings/2014/october/1_Report_WORKING_GROUP_vaccine_hesitancy_final.pdf
2. Hsu JL. A brief history of vaccines: Smallpox to the present. S D Med. 2013;Spec no:33-7. PMID: 23444589.
3. Chiu A, Bever L. Are they experimental? Can they alter DNA? Experts tackle lingering coronavirus vaccine fears. The Washington Post. 2021 May 14. https://www.washingtonpost.com/lifestyle/2021/05/14/safe-fast-vaccine-fear-infertility-dna/
4. Huang L. Edge: Turning Adversity into Advantage. New York: Portfolio/Penguin, 2020.
Working without a net
My first hospital consult was also on my first day of practice, in July, 1998.
I was in a small room, subleased from an oncology group. My schedule, as first day schedules are, was sparse.
Around noon one of the oncology docs asked me to come to his exam room, so I went across the hall. There he had a lady in her late 50s, with known metastatic cancer. He’d brought her in for a few days of worsening headaches and diplopia, and my 10-second neurological exam showed dysconjugate gaze and dysarthria. He said he was admitting her to the hospital, and asked if I’d consult on her.
I hung out in the hospital’s MRI control room later that day, waiting for her images to come up. I was nervous, maybe even a little scared. In spite of having survived medical school, residency, and fellowship, I was worried I’d screwed up the case, somehow. If the MRI was normal, I’d look like an idiot. My career would be over, on day one. No one would ever consult me again.
Of course, the MRI showed a brainstem metastasis (in addition to other places), and my initial differential was correct. Good for me, terrible for the patient. I ordered Decadron, called the oncologist, spoke to the patient and her family, and went home. I followed her for maybe a another few days, mainly because I didn’t know what the protocol was for signing off.
Self-doubt is common in all fields, especially when starting out, but probably strongest in medicine. A lot depends on us getting the right answer – quickly – in cases like that one. In my case this was compounded by its being my first day of practice. There was no attending I could call for help. I was working without a net.
But the years of training paid off, I got the case right, and moved on. Twenty-three years later it seems silly that I was so worried. Nowadays I order the MRI, move to the next patient, and try not to think about it until the results come back or a nurse calls with a status change. If my initial impression is wrong, I move down the differential list.
But
It’s what makes us better doctors.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
My first hospital consult was also on my first day of practice, in July, 1998.
I was in a small room, subleased from an oncology group. My schedule, as first day schedules are, was sparse.
Around noon one of the oncology docs asked me to come to his exam room, so I went across the hall. There he had a lady in her late 50s, with known metastatic cancer. He’d brought her in for a few days of worsening headaches and diplopia, and my 10-second neurological exam showed dysconjugate gaze and dysarthria. He said he was admitting her to the hospital, and asked if I’d consult on her.
I hung out in the hospital’s MRI control room later that day, waiting for her images to come up. I was nervous, maybe even a little scared. In spite of having survived medical school, residency, and fellowship, I was worried I’d screwed up the case, somehow. If the MRI was normal, I’d look like an idiot. My career would be over, on day one. No one would ever consult me again.
Of course, the MRI showed a brainstem metastasis (in addition to other places), and my initial differential was correct. Good for me, terrible for the patient. I ordered Decadron, called the oncologist, spoke to the patient and her family, and went home. I followed her for maybe a another few days, mainly because I didn’t know what the protocol was for signing off.
Self-doubt is common in all fields, especially when starting out, but probably strongest in medicine. A lot depends on us getting the right answer – quickly – in cases like that one. In my case this was compounded by its being my first day of practice. There was no attending I could call for help. I was working without a net.
But the years of training paid off, I got the case right, and moved on. Twenty-three years later it seems silly that I was so worried. Nowadays I order the MRI, move to the next patient, and try not to think about it until the results come back or a nurse calls with a status change. If my initial impression is wrong, I move down the differential list.
But
It’s what makes us better doctors.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
My first hospital consult was also on my first day of practice, in July, 1998.
I was in a small room, subleased from an oncology group. My schedule, as first day schedules are, was sparse.
Around noon one of the oncology docs asked me to come to his exam room, so I went across the hall. There he had a lady in her late 50s, with known metastatic cancer. He’d brought her in for a few days of worsening headaches and diplopia, and my 10-second neurological exam showed dysconjugate gaze and dysarthria. He said he was admitting her to the hospital, and asked if I’d consult on her.
I hung out in the hospital’s MRI control room later that day, waiting for her images to come up. I was nervous, maybe even a little scared. In spite of having survived medical school, residency, and fellowship, I was worried I’d screwed up the case, somehow. If the MRI was normal, I’d look like an idiot. My career would be over, on day one. No one would ever consult me again.
Of course, the MRI showed a brainstem metastasis (in addition to other places), and my initial differential was correct. Good for me, terrible for the patient. I ordered Decadron, called the oncologist, spoke to the patient and her family, and went home. I followed her for maybe a another few days, mainly because I didn’t know what the protocol was for signing off.
Self-doubt is common in all fields, especially when starting out, but probably strongest in medicine. A lot depends on us getting the right answer – quickly – in cases like that one. In my case this was compounded by its being my first day of practice. There was no attending I could call for help. I was working without a net.
But the years of training paid off, I got the case right, and moved on. Twenty-three years later it seems silly that I was so worried. Nowadays I order the MRI, move to the next patient, and try not to think about it until the results come back or a nurse calls with a status change. If my initial impression is wrong, I move down the differential list.
But
It’s what makes us better doctors.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Is Nissen fundoplication the best we can do?
As an esophagologist that does not perform fundoplication, LINX, or TIF, I find it difficult to debate the merits of one procedure over another based on my experience. In fact, I have always stated that it is difficult to assess a procedure or test that one has not used. That being said, maybe the fact that I have not performed these procedures makes me more objective and I can only use my experience with patients and the data to make the case that we need options beyond Nissen fundoplication.
The recent VA Randomized trial in refractory GERD published by Spechler and colleagues once again highlighted the fact that there are some patients that require a mechanical solution to reflux disease.1 In this study, the authors carefully defined a patient population with refractory GERD and showed that Nissen fundoplication was superior to medical management in patients who did not respond to proton pump inhibitors. However, of the 27 patients who underwent fundoplication, one patient had major complications which required a repeat operation and prolonged hospital stay. These findings highlight the main problem with Nissen fundoplication. Dr. Watson elegantly argued in his assertion during our debate that Nissen and fundoplication are not the same. In this position, he was noting the side effects associated with Nissen fundoplication,2 and he focused his argument on the comparison between a partial wrap versus LINX and TIF to level the playing field. On that note, I agree with Dr. Watson that a well-done partial fundoplication is a great option for patients with a mechanical problem.
Nonetheless, Redo operations have an escalating risk of severe debilitating consequences and we should do everything possible to reduce that risk.3 The LINX and the TIF procedure have data to support their effectiveness, and the initial studies a more favorable side effect profile.4,5 The ability to perform these procedures in patients with hiatal hernia and the fact that these approaches do not exclude the possibility of fundoplication in the future make them an attractive alternative.
In the end, more rigorous comparative studies should be performed to truly determine which approach is better. Although we have good surgical and medical options, we all recognize that they are not perfect and we should not settle on the current state of GERD management.
John E. Pandolfino, MD, MSCI, is the Hans Popper Professor of Medicine and Division Chief, Gastroenterology and Hepatology at Northwestern University, Chicago. He disclosed relationships with Ethicon/Johnson & Johnson, Endogastric Solutions, and Medtronic. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2021.
References
1. Spechler SJ et al. N Engl J Med. 2019 Oct 17;381[16]:1513-23.
2. Yadlapati R et al. Am J Gastroenterol. 2018 Aug;113[8]:1137-47.
3. Singhal S et al. J Gastrointest Surg. 2018 Feb;22[2]:177-86.
4. Ganz RA et al. Clin Gastroenterol Hepatol. 2016 May;14(5):671-7.
Endosc Int Open. 2019 May;7(5):E647-E654
As an esophagologist that does not perform fundoplication, LINX, or TIF, I find it difficult to debate the merits of one procedure over another based on my experience. In fact, I have always stated that it is difficult to assess a procedure or test that one has not used. That being said, maybe the fact that I have not performed these procedures makes me more objective and I can only use my experience with patients and the data to make the case that we need options beyond Nissen fundoplication.
The recent VA Randomized trial in refractory GERD published by Spechler and colleagues once again highlighted the fact that there are some patients that require a mechanical solution to reflux disease.1 In this study, the authors carefully defined a patient population with refractory GERD and showed that Nissen fundoplication was superior to medical management in patients who did not respond to proton pump inhibitors. However, of the 27 patients who underwent fundoplication, one patient had major complications which required a repeat operation and prolonged hospital stay. These findings highlight the main problem with Nissen fundoplication. Dr. Watson elegantly argued in his assertion during our debate that Nissen and fundoplication are not the same. In this position, he was noting the side effects associated with Nissen fundoplication,2 and he focused his argument on the comparison between a partial wrap versus LINX and TIF to level the playing field. On that note, I agree with Dr. Watson that a well-done partial fundoplication is a great option for patients with a mechanical problem.
Nonetheless, Redo operations have an escalating risk of severe debilitating consequences and we should do everything possible to reduce that risk.3 The LINX and the TIF procedure have data to support their effectiveness, and the initial studies a more favorable side effect profile.4,5 The ability to perform these procedures in patients with hiatal hernia and the fact that these approaches do not exclude the possibility of fundoplication in the future make them an attractive alternative.
In the end, more rigorous comparative studies should be performed to truly determine which approach is better. Although we have good surgical and medical options, we all recognize that they are not perfect and we should not settle on the current state of GERD management.
John E. Pandolfino, MD, MSCI, is the Hans Popper Professor of Medicine and Division Chief, Gastroenterology and Hepatology at Northwestern University, Chicago. He disclosed relationships with Ethicon/Johnson & Johnson, Endogastric Solutions, and Medtronic. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2021.
References
1. Spechler SJ et al. N Engl J Med. 2019 Oct 17;381[16]:1513-23.
2. Yadlapati R et al. Am J Gastroenterol. 2018 Aug;113[8]:1137-47.
3. Singhal S et al. J Gastrointest Surg. 2018 Feb;22[2]:177-86.
4. Ganz RA et al. Clin Gastroenterol Hepatol. 2016 May;14(5):671-7.
Endosc Int Open. 2019 May;7(5):E647-E654
As an esophagologist that does not perform fundoplication, LINX, or TIF, I find it difficult to debate the merits of one procedure over another based on my experience. In fact, I have always stated that it is difficult to assess a procedure or test that one has not used. That being said, maybe the fact that I have not performed these procedures makes me more objective and I can only use my experience with patients and the data to make the case that we need options beyond Nissen fundoplication.
The recent VA Randomized trial in refractory GERD published by Spechler and colleagues once again highlighted the fact that there are some patients that require a mechanical solution to reflux disease.1 In this study, the authors carefully defined a patient population with refractory GERD and showed that Nissen fundoplication was superior to medical management in patients who did not respond to proton pump inhibitors. However, of the 27 patients who underwent fundoplication, one patient had major complications which required a repeat operation and prolonged hospital stay. These findings highlight the main problem with Nissen fundoplication. Dr. Watson elegantly argued in his assertion during our debate that Nissen and fundoplication are not the same. In this position, he was noting the side effects associated with Nissen fundoplication,2 and he focused his argument on the comparison between a partial wrap versus LINX and TIF to level the playing field. On that note, I agree with Dr. Watson that a well-done partial fundoplication is a great option for patients with a mechanical problem.
Nonetheless, Redo operations have an escalating risk of severe debilitating consequences and we should do everything possible to reduce that risk.3 The LINX and the TIF procedure have data to support their effectiveness, and the initial studies a more favorable side effect profile.4,5 The ability to perform these procedures in patients with hiatal hernia and the fact that these approaches do not exclude the possibility of fundoplication in the future make them an attractive alternative.
In the end, more rigorous comparative studies should be performed to truly determine which approach is better. Although we have good surgical and medical options, we all recognize that they are not perfect and we should not settle on the current state of GERD management.
John E. Pandolfino, MD, MSCI, is the Hans Popper Professor of Medicine and Division Chief, Gastroenterology and Hepatology at Northwestern University, Chicago. He disclosed relationships with Ethicon/Johnson & Johnson, Endogastric Solutions, and Medtronic. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2021.
References
1. Spechler SJ et al. N Engl J Med. 2019 Oct 17;381[16]:1513-23.
2. Yadlapati R et al. Am J Gastroenterol. 2018 Aug;113[8]:1137-47.
3. Singhal S et al. J Gastrointest Surg. 2018 Feb;22[2]:177-86.
4. Ganz RA et al. Clin Gastroenterol Hepatol. 2016 May;14(5):671-7.
Endosc Int Open. 2019 May;7(5):E647-E654
Should magnesium be used for COPD exacerbations?
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major driver of disease-related morbidity. Their prevention and treatment are a focus of COPD management. Antibiotics, corticosteroids, and nebulized bronchodilators are all given to patients with AECOPD, and while the supporting data aren’t perfect, there’s little debate surrounding their use. These medications are well known to most physicians; we’re comfortable with their efficacy and aware of their side effects. They are nothing if not familiar.
What about magnesium (Mg), though? Apparently, in the emergency room (ER) it is part of the standard AECOPD cocktail. I would argue that Mg is familiar to most too; every internal medicine trainee in the United States is taught to infuse 2 g of Mg intravenously for any inpatient (ICU or otherwise) with a serum level <2.0 mg/dL. In fact, “electrolyte protocols” are part of the order sets at most hospitals where I’ve worked. Mg is infused reflexively when it drops below certain levels.
I’m less familiar with using Mg in the setting of an AECOPD, though. A recent online post by an academic ER physician (Richard Pescatore, DO) urged caution in this setting. He argues that too many in the ER are embracing the “Dutch Hypothesis” and treating asthma and COPD as the same disease. Dr. Pescatore believes that Mg works for asthma exacerbations because asthma is a disease of smooth muscle and large airways, while COPD is not. COPD, he says, is a disease of the small airways, largely resulting from parenchymal distortions due to emphysema. Therefore, Mg, which is thought to act on the smooth muscle surrounding the large airways, won’t be beneficial for AECOPD and may even cause harm.
Data are lacking
What data exist for using Mg for AECOPD? The best randomized controlled trial (RCT) I could find was published in 1995 and is cited in the reader’s rebuttal. The trial found a significant improvement in peak expiratory flow rate (PEFR) with Mg and a nonsignificant reduction in hospitalizations.
A poorly done systematic review of RCTs using Mg for AECOPD was published in 2014, and in 2020 the Agency for Healthcare Research and Quality (AHRQ) included Mg in its well-executed meta-analysis of pharmacologic treatments for AECOPD. Data across the four to five Mg RCTs included in each of the reviews (study inclusion criteria were slightly different) could not be combined. All RCTs were small, and only soft outcomes like PEFR and forced expiratory volume in 1 second (FEV1) seemed to improve with Mg. No adverse events were noted, but this should be interpreted with caution given that many studies did not report on adverse events at all.
A small RCT published this year (after both systematic reviews were completed) showed that using intravenous magnesium sulfate had no significant effect on FEV1, vital signs, or symptoms.
In summary, the data aren’t great. Mg doesn’t show up at all as a treatment option in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report on COPD, and the authors of the AHRQ review concluded that large, high-quality RCTs are needed to assess the impact of Mg in AECOPD. Although I didn’t do an extensive review of Mg for asthma exacerbations, it’s not clear that the data here are much better. Mg gets an honorable mention (add for severe exacerbations when there’s inadequate response to standard treatments) in both the 2007 National Heart, Lung, and Blood Institute (NHLBI) guideline and the 2019 Global Initiative for Asthma (GINA) guide. The 2020 update to the 2007 NHLBI guideline is more targeted in its review and does not cover Mg as a treatment option. On the basis of my anecdotal clinical experience and on networking with airway experts, I do think Mg is used more often for asthma than for AECOPD.
Final thoughts on using Mg for AECOPD
All that being said, is it reasonable to use Mg for AECOPD? I think so. I’d stick to using it for severe cases where conventional treatments have failed, just like the NHLBI and GINA advise for asthma. I’d also limit it to 2-3 g, which is the dosing range employed by several of the existing AECOPD RCTs. The assertion that Mg may be harmful in AECOPD because COPD affects the small airways, and asthma does not, is misguided. Both affect the small airways. Furthermore, none of our inhaled therapies reach the small airways, so one can’t argue against using Mg because it only targets larger airways without abandoning albuterol and ipratropium as well. I don’t think anyone would advise that. Given what we now know about asthma and COPD phenotypes and asthma-COPD overlap, I’d caution against pedantic theories about response to therapies.
Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He has received research grants from Fisher-Paykel and has received payments from the American College of Chest Physicians.
A version of this article first appeared on Medscape.com.
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major driver of disease-related morbidity. Their prevention and treatment are a focus of COPD management. Antibiotics, corticosteroids, and nebulized bronchodilators are all given to patients with AECOPD, and while the supporting data aren’t perfect, there’s little debate surrounding their use. These medications are well known to most physicians; we’re comfortable with their efficacy and aware of their side effects. They are nothing if not familiar.
What about magnesium (Mg), though? Apparently, in the emergency room (ER) it is part of the standard AECOPD cocktail. I would argue that Mg is familiar to most too; every internal medicine trainee in the United States is taught to infuse 2 g of Mg intravenously for any inpatient (ICU or otherwise) with a serum level <2.0 mg/dL. In fact, “electrolyte protocols” are part of the order sets at most hospitals where I’ve worked. Mg is infused reflexively when it drops below certain levels.
I’m less familiar with using Mg in the setting of an AECOPD, though. A recent online post by an academic ER physician (Richard Pescatore, DO) urged caution in this setting. He argues that too many in the ER are embracing the “Dutch Hypothesis” and treating asthma and COPD as the same disease. Dr. Pescatore believes that Mg works for asthma exacerbations because asthma is a disease of smooth muscle and large airways, while COPD is not. COPD, he says, is a disease of the small airways, largely resulting from parenchymal distortions due to emphysema. Therefore, Mg, which is thought to act on the smooth muscle surrounding the large airways, won’t be beneficial for AECOPD and may even cause harm.
Data are lacking
What data exist for using Mg for AECOPD? The best randomized controlled trial (RCT) I could find was published in 1995 and is cited in the reader’s rebuttal. The trial found a significant improvement in peak expiratory flow rate (PEFR) with Mg and a nonsignificant reduction in hospitalizations.
A poorly done systematic review of RCTs using Mg for AECOPD was published in 2014, and in 2020 the Agency for Healthcare Research and Quality (AHRQ) included Mg in its well-executed meta-analysis of pharmacologic treatments for AECOPD. Data across the four to five Mg RCTs included in each of the reviews (study inclusion criteria were slightly different) could not be combined. All RCTs were small, and only soft outcomes like PEFR and forced expiratory volume in 1 second (FEV1) seemed to improve with Mg. No adverse events were noted, but this should be interpreted with caution given that many studies did not report on adverse events at all.
A small RCT published this year (after both systematic reviews were completed) showed that using intravenous magnesium sulfate had no significant effect on FEV1, vital signs, or symptoms.
In summary, the data aren’t great. Mg doesn’t show up at all as a treatment option in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report on COPD, and the authors of the AHRQ review concluded that large, high-quality RCTs are needed to assess the impact of Mg in AECOPD. Although I didn’t do an extensive review of Mg for asthma exacerbations, it’s not clear that the data here are much better. Mg gets an honorable mention (add for severe exacerbations when there’s inadequate response to standard treatments) in both the 2007 National Heart, Lung, and Blood Institute (NHLBI) guideline and the 2019 Global Initiative for Asthma (GINA) guide. The 2020 update to the 2007 NHLBI guideline is more targeted in its review and does not cover Mg as a treatment option. On the basis of my anecdotal clinical experience and on networking with airway experts, I do think Mg is used more often for asthma than for AECOPD.
Final thoughts on using Mg for AECOPD
All that being said, is it reasonable to use Mg for AECOPD? I think so. I’d stick to using it for severe cases where conventional treatments have failed, just like the NHLBI and GINA advise for asthma. I’d also limit it to 2-3 g, which is the dosing range employed by several of the existing AECOPD RCTs. The assertion that Mg may be harmful in AECOPD because COPD affects the small airways, and asthma does not, is misguided. Both affect the small airways. Furthermore, none of our inhaled therapies reach the small airways, so one can’t argue against using Mg because it only targets larger airways without abandoning albuterol and ipratropium as well. I don’t think anyone would advise that. Given what we now know about asthma and COPD phenotypes and asthma-COPD overlap, I’d caution against pedantic theories about response to therapies.
Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He has received research grants from Fisher-Paykel and has received payments from the American College of Chest Physicians.
A version of this article first appeared on Medscape.com.
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major driver of disease-related morbidity. Their prevention and treatment are a focus of COPD management. Antibiotics, corticosteroids, and nebulized bronchodilators are all given to patients with AECOPD, and while the supporting data aren’t perfect, there’s little debate surrounding their use. These medications are well known to most physicians; we’re comfortable with their efficacy and aware of their side effects. They are nothing if not familiar.
What about magnesium (Mg), though? Apparently, in the emergency room (ER) it is part of the standard AECOPD cocktail. I would argue that Mg is familiar to most too; every internal medicine trainee in the United States is taught to infuse 2 g of Mg intravenously for any inpatient (ICU or otherwise) with a serum level <2.0 mg/dL. In fact, “electrolyte protocols” are part of the order sets at most hospitals where I’ve worked. Mg is infused reflexively when it drops below certain levels.
I’m less familiar with using Mg in the setting of an AECOPD, though. A recent online post by an academic ER physician (Richard Pescatore, DO) urged caution in this setting. He argues that too many in the ER are embracing the “Dutch Hypothesis” and treating asthma and COPD as the same disease. Dr. Pescatore believes that Mg works for asthma exacerbations because asthma is a disease of smooth muscle and large airways, while COPD is not. COPD, he says, is a disease of the small airways, largely resulting from parenchymal distortions due to emphysema. Therefore, Mg, which is thought to act on the smooth muscle surrounding the large airways, won’t be beneficial for AECOPD and may even cause harm.
Data are lacking
What data exist for using Mg for AECOPD? The best randomized controlled trial (RCT) I could find was published in 1995 and is cited in the reader’s rebuttal. The trial found a significant improvement in peak expiratory flow rate (PEFR) with Mg and a nonsignificant reduction in hospitalizations.
A poorly done systematic review of RCTs using Mg for AECOPD was published in 2014, and in 2020 the Agency for Healthcare Research and Quality (AHRQ) included Mg in its well-executed meta-analysis of pharmacologic treatments for AECOPD. Data across the four to five Mg RCTs included in each of the reviews (study inclusion criteria were slightly different) could not be combined. All RCTs were small, and only soft outcomes like PEFR and forced expiratory volume in 1 second (FEV1) seemed to improve with Mg. No adverse events were noted, but this should be interpreted with caution given that many studies did not report on adverse events at all.
A small RCT published this year (after both systematic reviews were completed) showed that using intravenous magnesium sulfate had no significant effect on FEV1, vital signs, or symptoms.
In summary, the data aren’t great. Mg doesn’t show up at all as a treatment option in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report on COPD, and the authors of the AHRQ review concluded that large, high-quality RCTs are needed to assess the impact of Mg in AECOPD. Although I didn’t do an extensive review of Mg for asthma exacerbations, it’s not clear that the data here are much better. Mg gets an honorable mention (add for severe exacerbations when there’s inadequate response to standard treatments) in both the 2007 National Heart, Lung, and Blood Institute (NHLBI) guideline and the 2019 Global Initiative for Asthma (GINA) guide. The 2020 update to the 2007 NHLBI guideline is more targeted in its review and does not cover Mg as a treatment option. On the basis of my anecdotal clinical experience and on networking with airway experts, I do think Mg is used more often for asthma than for AECOPD.
Final thoughts on using Mg for AECOPD
All that being said, is it reasonable to use Mg for AECOPD? I think so. I’d stick to using it for severe cases where conventional treatments have failed, just like the NHLBI and GINA advise for asthma. I’d also limit it to 2-3 g, which is the dosing range employed by several of the existing AECOPD RCTs. The assertion that Mg may be harmful in AECOPD because COPD affects the small airways, and asthma does not, is misguided. Both affect the small airways. Furthermore, none of our inhaled therapies reach the small airways, so one can’t argue against using Mg because it only targets larger airways without abandoning albuterol and ipratropium as well. I don’t think anyone would advise that. Given what we now know about asthma and COPD phenotypes and asthma-COPD overlap, I’d caution against pedantic theories about response to therapies.
Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He has received research grants from Fisher-Paykel and has received payments from the American College of Chest Physicians.
A version of this article first appeared on Medscape.com.
The postpandemic path forward for GI research
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the alarming impact of COVID-19 on the biomedical research community. The Institute has taken steps to address the pandemic’s immediate challenges, such as supporting COVID-19 research within its mission and implementing policies that ease grantees’ concerns about funding and lost time. The NIDDK has also sought to balance the needs brought about by the pandemic with its responsibility to continue research on the many diseases and conditions in the NIDDK’s purview.
The NIDDK continues to support most research through unsolicited R01 awards. It also continues to support organized consortia that aim to improve our understanding and treatment of digestive diseases; research centers that provide valuable sources of collaboration among researchers investigating digestive diseases and/or nutrition and obesity; and programs that encourage transitions to different career levels.
The pandemic has shown in stark relief the devastating impact of health disparities. Because many NIDDK mission diseases place disparate burdens on minority groups and people with limited resources, the NIDDK remains committed to combating health disparities, whether pandemic related or not. The Institute recruits diverse study cohorts inclusive of those most affected. It seeks to open doors for young people from underrepresented groups through training, support, and inspiration to pursue research careers, such as through partnerships with organizations like the American Gastroenterological Association. The NIDDK is also implementing strategies to promote participant engagement, not only as study volunteers, but also in study design, recruitment, and consent. And, importantly, the Institute is supporting research to identify the causes of health disparities, including research on social determinants of health.
This year, the NIDDK embarked on the development of a 5-year Strategic Plan to develop a broad vision for accelerating research on diseases and conditions across its mission. This plan is meant to be overarching and will complement the NIDDK’s disease-specific planning efforts. The first draft of the plan is currently being developed based on the input received from a Strategic Plan Working Group (which includes several AGA members), a public Request for Information, and NIDDK’s Advisory Council. The draft will be available through the NIDDK website (niddk.nih.gov) for public comment.
By taking these actions, the NIDDK aims to continue reducing the burden of digestive diseases and improving health for all people.
Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health. He has no conflicts. Dr. Rodgers made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the alarming impact of COVID-19 on the biomedical research community. The Institute has taken steps to address the pandemic’s immediate challenges, such as supporting COVID-19 research within its mission and implementing policies that ease grantees’ concerns about funding and lost time. The NIDDK has also sought to balance the needs brought about by the pandemic with its responsibility to continue research on the many diseases and conditions in the NIDDK’s purview.
The NIDDK continues to support most research through unsolicited R01 awards. It also continues to support organized consortia that aim to improve our understanding and treatment of digestive diseases; research centers that provide valuable sources of collaboration among researchers investigating digestive diseases and/or nutrition and obesity; and programs that encourage transitions to different career levels.
The pandemic has shown in stark relief the devastating impact of health disparities. Because many NIDDK mission diseases place disparate burdens on minority groups and people with limited resources, the NIDDK remains committed to combating health disparities, whether pandemic related or not. The Institute recruits diverse study cohorts inclusive of those most affected. It seeks to open doors for young people from underrepresented groups through training, support, and inspiration to pursue research careers, such as through partnerships with organizations like the American Gastroenterological Association. The NIDDK is also implementing strategies to promote participant engagement, not only as study volunteers, but also in study design, recruitment, and consent. And, importantly, the Institute is supporting research to identify the causes of health disparities, including research on social determinants of health.
This year, the NIDDK embarked on the development of a 5-year Strategic Plan to develop a broad vision for accelerating research on diseases and conditions across its mission. This plan is meant to be overarching and will complement the NIDDK’s disease-specific planning efforts. The first draft of the plan is currently being developed based on the input received from a Strategic Plan Working Group (which includes several AGA members), a public Request for Information, and NIDDK’s Advisory Council. The draft will be available through the NIDDK website (niddk.nih.gov) for public comment.
By taking these actions, the NIDDK aims to continue reducing the burden of digestive diseases and improving health for all people.
Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health. He has no conflicts. Dr. Rodgers made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the alarming impact of COVID-19 on the biomedical research community. The Institute has taken steps to address the pandemic’s immediate challenges, such as supporting COVID-19 research within its mission and implementing policies that ease grantees’ concerns about funding and lost time. The NIDDK has also sought to balance the needs brought about by the pandemic with its responsibility to continue research on the many diseases and conditions in the NIDDK’s purview.
The NIDDK continues to support most research through unsolicited R01 awards. It also continues to support organized consortia that aim to improve our understanding and treatment of digestive diseases; research centers that provide valuable sources of collaboration among researchers investigating digestive diseases and/or nutrition and obesity; and programs that encourage transitions to different career levels.
The pandemic has shown in stark relief the devastating impact of health disparities. Because many NIDDK mission diseases place disparate burdens on minority groups and people with limited resources, the NIDDK remains committed to combating health disparities, whether pandemic related or not. The Institute recruits diverse study cohorts inclusive of those most affected. It seeks to open doors for young people from underrepresented groups through training, support, and inspiration to pursue research careers, such as through partnerships with organizations like the American Gastroenterological Association. The NIDDK is also implementing strategies to promote participant engagement, not only as study volunteers, but also in study design, recruitment, and consent. And, importantly, the Institute is supporting research to identify the causes of health disparities, including research on social determinants of health.
This year, the NIDDK embarked on the development of a 5-year Strategic Plan to develop a broad vision for accelerating research on diseases and conditions across its mission. This plan is meant to be overarching and will complement the NIDDK’s disease-specific planning efforts. The first draft of the plan is currently being developed based on the input received from a Strategic Plan Working Group (which includes several AGA members), a public Request for Information, and NIDDK’s Advisory Council. The draft will be available through the NIDDK website (niddk.nih.gov) for public comment.
By taking these actions, the NIDDK aims to continue reducing the burden of digestive diseases and improving health for all people.
Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health. He has no conflicts. Dr. Rodgers made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
The making of the Pfizer-BioNTech COVID-19 vaccine
Days after the World Health Organization declared the COVID-19 outbreak a global pandemic, Pfizer and BioNTech announced plans to codevelop a potential mRNA-based vaccine to help prevent COVID-19. The mRNA platform was selected given its potential for high potency and capacity for rapid development. A bold decision was made to invest in R&D and manufacturing at risk.
Two candidates, BNT162b1 and BNT162b2, quickly emerged as most promising. After extensive review of preclinical and early clinical data and in consultation with regulators, we advanced BNT162b2 into a global, Phase 2/3 efficacy trial in July 2020.
Enrollment was later expanded to increase diversity, and also to include adolescents 12 and older and people with chronic, stable HIV, Hepatitis C, or Hepatitis B.
In November 2020, we announced the results of our ongoing Phase 3 study with BNT162b2 demonstrating a vaccine efficacy rate of 95% against COVID-19 beginning 28 days after dose one. This result showed our ability to leverage decades of scientific expertise to execute a rigorous Phase 3 clinical program to make a potential vaccine available as quickly and safely as possible. The emergency use authorization that followed was a big step, but our research did not stop there.
Pfizer and BioNTech continue to evaluate data from the landmark trial, which ultimately enrolled 46,331 participants. We are also conducting trials in special populations, such as pregnant women and children under 12. To date, real-world evidence has demonstrated lower COVID-19 incidence in vaccinated individuals and has not shown escape of variant viruses from BNT162b2-mediated protection. Studies are ongoing to explore the effect of a third dose on immunity and to prepare in case a variant emerges that escapes protection.
We continue to identify improvements to increase production and are on track to deliver approximately 2.5 billion doses in 2021. Next generation ready-to-use and freeze-dried formulations are in development.
This pandemic sparked an unparalleled period of innovation, investment, and partnership with lessons learned that will help us prepare for future pandemics and accelerate R&D of therapeutic candidates for other debilitating and life-threatening conditions.
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration but has been authorized for emergency use to prevent COVID-19 in individuals 12+. See conditions of use: http://cvdvaccine.com
Dr. Dolsten is the Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer. He has no other conflicts. Dr. Dolsten made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
Days after the World Health Organization declared the COVID-19 outbreak a global pandemic, Pfizer and BioNTech announced plans to codevelop a potential mRNA-based vaccine to help prevent COVID-19. The mRNA platform was selected given its potential for high potency and capacity for rapid development. A bold decision was made to invest in R&D and manufacturing at risk.
Two candidates, BNT162b1 and BNT162b2, quickly emerged as most promising. After extensive review of preclinical and early clinical data and in consultation with regulators, we advanced BNT162b2 into a global, Phase 2/3 efficacy trial in July 2020.
Enrollment was later expanded to increase diversity, and also to include adolescents 12 and older and people with chronic, stable HIV, Hepatitis C, or Hepatitis B.
In November 2020, we announced the results of our ongoing Phase 3 study with BNT162b2 demonstrating a vaccine efficacy rate of 95% against COVID-19 beginning 28 days after dose one. This result showed our ability to leverage decades of scientific expertise to execute a rigorous Phase 3 clinical program to make a potential vaccine available as quickly and safely as possible. The emergency use authorization that followed was a big step, but our research did not stop there.
Pfizer and BioNTech continue to evaluate data from the landmark trial, which ultimately enrolled 46,331 participants. We are also conducting trials in special populations, such as pregnant women and children under 12. To date, real-world evidence has demonstrated lower COVID-19 incidence in vaccinated individuals and has not shown escape of variant viruses from BNT162b2-mediated protection. Studies are ongoing to explore the effect of a third dose on immunity and to prepare in case a variant emerges that escapes protection.
We continue to identify improvements to increase production and are on track to deliver approximately 2.5 billion doses in 2021. Next generation ready-to-use and freeze-dried formulations are in development.
This pandemic sparked an unparalleled period of innovation, investment, and partnership with lessons learned that will help us prepare for future pandemics and accelerate R&D of therapeutic candidates for other debilitating and life-threatening conditions.
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration but has been authorized for emergency use to prevent COVID-19 in individuals 12+. See conditions of use: http://cvdvaccine.com
Dr. Dolsten is the Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer. He has no other conflicts. Dr. Dolsten made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
Days after the World Health Organization declared the COVID-19 outbreak a global pandemic, Pfizer and BioNTech announced plans to codevelop a potential mRNA-based vaccine to help prevent COVID-19. The mRNA platform was selected given its potential for high potency and capacity for rapid development. A bold decision was made to invest in R&D and manufacturing at risk.
Two candidates, BNT162b1 and BNT162b2, quickly emerged as most promising. After extensive review of preclinical and early clinical data and in consultation with regulators, we advanced BNT162b2 into a global, Phase 2/3 efficacy trial in July 2020.
Enrollment was later expanded to increase diversity, and also to include adolescents 12 and older and people with chronic, stable HIV, Hepatitis C, or Hepatitis B.
In November 2020, we announced the results of our ongoing Phase 3 study with BNT162b2 demonstrating a vaccine efficacy rate of 95% against COVID-19 beginning 28 days after dose one. This result showed our ability to leverage decades of scientific expertise to execute a rigorous Phase 3 clinical program to make a potential vaccine available as quickly and safely as possible. The emergency use authorization that followed was a big step, but our research did not stop there.
Pfizer and BioNTech continue to evaluate data from the landmark trial, which ultimately enrolled 46,331 participants. We are also conducting trials in special populations, such as pregnant women and children under 12. To date, real-world evidence has demonstrated lower COVID-19 incidence in vaccinated individuals and has not shown escape of variant viruses from BNT162b2-mediated protection. Studies are ongoing to explore the effect of a third dose on immunity and to prepare in case a variant emerges that escapes protection.
We continue to identify improvements to increase production and are on track to deliver approximately 2.5 billion doses in 2021. Next generation ready-to-use and freeze-dried formulations are in development.
This pandemic sparked an unparalleled period of innovation, investment, and partnership with lessons learned that will help us prepare for future pandemics and accelerate R&D of therapeutic candidates for other debilitating and life-threatening conditions.
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration but has been authorized for emergency use to prevent COVID-19 in individuals 12+. See conditions of use: http://cvdvaccine.com
Dr. Dolsten is the Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer. He has no other conflicts. Dr. Dolsten made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.
How the 2022 proposed Medicare payment rules impact GI
In July 2021, the Centers for Medicare & Medicaid Services released the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgery Center (ASC) proposed rules for calendar year (CY) 2022. While the OPPS/ASC proposed rule was largely positive for gastroenterology, the PFS proposed rule was more of a mixed bag for practices.
No more colonoscopy coinsurance “loophole”: After nearly a decade of advocacy, the Removing Barriers to Colorectal Cancer Screening Act was finally signed into law this year and will take effect Jan. 1, 2023. The legislation phases out Medicare beneficiary cost-sharing obligations when a polyp or lesion is found and biopsied or removed as part of a screening colonoscopy or flexible sigmoidoscopy. The American Gastroenterological Association is pleased this will finally eliminate a surprise bill for patients and remove a barrier to colorectal cancer screening.
The phase out timeline is as follows:
- 80% payment for services furnished during CY 2022 (coinsurance, 20%).
- 85% payment for services furnished during CY 2023 through CY 2026 (coinsurance, 15%).
- 90% payment for services furnished during CY 2027 through CY 2029 (coinsurance, 10%).
- 100% payment for services furnished from CY 2030 onward (coinsurance, 0%).
Providers must continue to report HCPCS modifier “PT” in the hospital outpatient and ASC during the transition period to indicate that a planned colorectal cancer screening service converted to a diagnostic service.
Proposed 2022 PFS conversion factor could fall 3.75% unless Congress acts: The proposed 2022 PFS conversion factor is $33.58. The decrease reflects the expiration of the 3.75% payment increase provided by the Consolidated Appropriations Act. This congressional intervention averted a significant cut in Medicare physician payment that would have resulted in an almost 10% cut to GI services. The GI societies are working with Congress to avert cuts to physician payments next year as practices continue to recover from the pandemic.
GI procedure payments to increase 3% for hospital outpatient and ASCs: A 2.3% increase has been proposed for the conversion factors, resulting in $84.46 for hospitals and $50.04 for ASCs meeting quality reporting requirements. However, GI endoscopy procedure payments are expected to increase on average 3% in CY 2022.
Colon capsule endoscopy and POEM get new codes and payments: CMS accepted new CPT codes for colon capsule endoscopy (CCE) and peroral endoscopic myotomy (POEM) beginning Jan. 1, 2022.
CMS’s proposed CCE value of 2.41 physician work relative value units (wRVUs) reflects the recommendation of the American Medical Association RVS Update Committee (RUC), which is based on data from physicians who perform the procedure. The proposed national-level physician payments are $116.52 for the professional component and $664.21 for the technical component.
However, CMS did not accept the RUC’s recommendation of 15.50 wRVUs for POEM and, instead, proposed that POEM is similar in work to hemodialysis access CPT code 36819, which has a wRVU of 13.29 and a payment of $792.82. The RUC’s valuation of 15.50 wRVUs was based on data from nearly 120 physicians who perform POEM, and we are disappointed CMS chose to reject the robust survey data. The GI societies will defend the 15.50 wRVU in our comments.
The proposed facility fee for POEM is $3,160.76 in the hospital outpatient setting and $1,848.32 in the ASC. CMS’s proposed facility fee for colon capsule endoscopy is $814.44 in the hospital outpatient setting.
CMS moves physicians to MVPs and plans to phase out MIPS: CMS proposes to revise and phase out the Merit-Based Incentive Payment System (MIPS) and move physicians towards the MIPS Value Pathways (MVPs) system beginning in the 2023 performance year (PY). No GI MVPs were proposed for PY 2023. The GI societies are working with CMS as they develop MVPs to ensure any gastroenterology-related MVPs do not harm gastroenterologists.
CMS is statutorily required to weigh the MIPS Cost and Quality performance categories equally beginning with PY 2022. The proposed PY 2022 MIPS performance categories are:
- Quality: 30%.
- Cost: 30%.
- Promoting Interoperability: 25% (no change from 2021).
- Improvement Activities: 15% (no change from 2021).
CMS is also required by law beginning in 2022 to set the MIPS performance threshold to either the mean or median of the final scores for all MIPS eligible clinicians for a prior period. CMS proposes to use the mean final score from MIPS 2017 performance year/MIPS 2019 payment year, which would result in a performance threshold of 75 points and an additional performance threshold set at 89 points for exceptional performance.
CMS keeps all AGA-stewarded measures in MIPS 2022 program year: CMS has proposed to keep all AGA-stewarded measures in the MIPS program for the 2022 program year and accepted the substantive changes for the one-time screening for hepatitis C virus measure we received last year from the Physician Consortium for Performance Improvement. CMS proposed removal of the claims reporting option of American Society for Gastrointestinal Endoscopy–stewarded measure for photodocumentation of cecal intubation because it is topped-out; however, the registry version is still available in MIPS.
OQR Program includes colonoscopy measure for disparities reporting: CMS has identified six priority measures included in the Hospital Outpatient Quality Reporting (OQR) Program as candidate measures for disparities reporting stratified by dual eligibility, one of which is the Facility 7-Day Risk-Standardized Hospital Visit Rate After Outpatient Colonoscopy (OP-32).
The GI societies will jointly comment on issues in the 2022 PFS and OPPS/ASC proposed rules impacting gastroenterologists. We may also organize members to take action by submitting letters during the comment period, so watch your inbox for invitations to participate. We need your help to influence change.
Shivan Mehta, MD, MBA, is with the division of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and is an AGA adviser to the American Medical Association RVS Update Committee. David A. Leiman, MD, MSHP, is with the division of gastroenterology at Duke University, Durham, N.C., and is the chair of the AGA Quality Committee. Neither have conflicts to declare.
In July 2021, the Centers for Medicare & Medicaid Services released the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgery Center (ASC) proposed rules for calendar year (CY) 2022. While the OPPS/ASC proposed rule was largely positive for gastroenterology, the PFS proposed rule was more of a mixed bag for practices.
No more colonoscopy coinsurance “loophole”: After nearly a decade of advocacy, the Removing Barriers to Colorectal Cancer Screening Act was finally signed into law this year and will take effect Jan. 1, 2023. The legislation phases out Medicare beneficiary cost-sharing obligations when a polyp or lesion is found and biopsied or removed as part of a screening colonoscopy or flexible sigmoidoscopy. The American Gastroenterological Association is pleased this will finally eliminate a surprise bill for patients and remove a barrier to colorectal cancer screening.
The phase out timeline is as follows:
- 80% payment for services furnished during CY 2022 (coinsurance, 20%).
- 85% payment for services furnished during CY 2023 through CY 2026 (coinsurance, 15%).
- 90% payment for services furnished during CY 2027 through CY 2029 (coinsurance, 10%).
- 100% payment for services furnished from CY 2030 onward (coinsurance, 0%).
Providers must continue to report HCPCS modifier “PT” in the hospital outpatient and ASC during the transition period to indicate that a planned colorectal cancer screening service converted to a diagnostic service.
Proposed 2022 PFS conversion factor could fall 3.75% unless Congress acts: The proposed 2022 PFS conversion factor is $33.58. The decrease reflects the expiration of the 3.75% payment increase provided by the Consolidated Appropriations Act. This congressional intervention averted a significant cut in Medicare physician payment that would have resulted in an almost 10% cut to GI services. The GI societies are working with Congress to avert cuts to physician payments next year as practices continue to recover from the pandemic.
GI procedure payments to increase 3% for hospital outpatient and ASCs: A 2.3% increase has been proposed for the conversion factors, resulting in $84.46 for hospitals and $50.04 for ASCs meeting quality reporting requirements. However, GI endoscopy procedure payments are expected to increase on average 3% in CY 2022.
Colon capsule endoscopy and POEM get new codes and payments: CMS accepted new CPT codes for colon capsule endoscopy (CCE) and peroral endoscopic myotomy (POEM) beginning Jan. 1, 2022.
CMS’s proposed CCE value of 2.41 physician work relative value units (wRVUs) reflects the recommendation of the American Medical Association RVS Update Committee (RUC), which is based on data from physicians who perform the procedure. The proposed national-level physician payments are $116.52 for the professional component and $664.21 for the technical component.
However, CMS did not accept the RUC’s recommendation of 15.50 wRVUs for POEM and, instead, proposed that POEM is similar in work to hemodialysis access CPT code 36819, which has a wRVU of 13.29 and a payment of $792.82. The RUC’s valuation of 15.50 wRVUs was based on data from nearly 120 physicians who perform POEM, and we are disappointed CMS chose to reject the robust survey data. The GI societies will defend the 15.50 wRVU in our comments.
The proposed facility fee for POEM is $3,160.76 in the hospital outpatient setting and $1,848.32 in the ASC. CMS’s proposed facility fee for colon capsule endoscopy is $814.44 in the hospital outpatient setting.
CMS moves physicians to MVPs and plans to phase out MIPS: CMS proposes to revise and phase out the Merit-Based Incentive Payment System (MIPS) and move physicians towards the MIPS Value Pathways (MVPs) system beginning in the 2023 performance year (PY). No GI MVPs were proposed for PY 2023. The GI societies are working with CMS as they develop MVPs to ensure any gastroenterology-related MVPs do not harm gastroenterologists.
CMS is statutorily required to weigh the MIPS Cost and Quality performance categories equally beginning with PY 2022. The proposed PY 2022 MIPS performance categories are:
- Quality: 30%.
- Cost: 30%.
- Promoting Interoperability: 25% (no change from 2021).
- Improvement Activities: 15% (no change from 2021).
CMS is also required by law beginning in 2022 to set the MIPS performance threshold to either the mean or median of the final scores for all MIPS eligible clinicians for a prior period. CMS proposes to use the mean final score from MIPS 2017 performance year/MIPS 2019 payment year, which would result in a performance threshold of 75 points and an additional performance threshold set at 89 points for exceptional performance.
CMS keeps all AGA-stewarded measures in MIPS 2022 program year: CMS has proposed to keep all AGA-stewarded measures in the MIPS program for the 2022 program year and accepted the substantive changes for the one-time screening for hepatitis C virus measure we received last year from the Physician Consortium for Performance Improvement. CMS proposed removal of the claims reporting option of American Society for Gastrointestinal Endoscopy–stewarded measure for photodocumentation of cecal intubation because it is topped-out; however, the registry version is still available in MIPS.
OQR Program includes colonoscopy measure for disparities reporting: CMS has identified six priority measures included in the Hospital Outpatient Quality Reporting (OQR) Program as candidate measures for disparities reporting stratified by dual eligibility, one of which is the Facility 7-Day Risk-Standardized Hospital Visit Rate After Outpatient Colonoscopy (OP-32).
The GI societies will jointly comment on issues in the 2022 PFS and OPPS/ASC proposed rules impacting gastroenterologists. We may also organize members to take action by submitting letters during the comment period, so watch your inbox for invitations to participate. We need your help to influence change.
Shivan Mehta, MD, MBA, is with the division of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and is an AGA adviser to the American Medical Association RVS Update Committee. David A. Leiman, MD, MSHP, is with the division of gastroenterology at Duke University, Durham, N.C., and is the chair of the AGA Quality Committee. Neither have conflicts to declare.
In July 2021, the Centers for Medicare & Medicaid Services released the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS)/Ambulatory Surgery Center (ASC) proposed rules for calendar year (CY) 2022. While the OPPS/ASC proposed rule was largely positive for gastroenterology, the PFS proposed rule was more of a mixed bag for practices.
No more colonoscopy coinsurance “loophole”: After nearly a decade of advocacy, the Removing Barriers to Colorectal Cancer Screening Act was finally signed into law this year and will take effect Jan. 1, 2023. The legislation phases out Medicare beneficiary cost-sharing obligations when a polyp or lesion is found and biopsied or removed as part of a screening colonoscopy or flexible sigmoidoscopy. The American Gastroenterological Association is pleased this will finally eliminate a surprise bill for patients and remove a barrier to colorectal cancer screening.
The phase out timeline is as follows:
- 80% payment for services furnished during CY 2022 (coinsurance, 20%).
- 85% payment for services furnished during CY 2023 through CY 2026 (coinsurance, 15%).
- 90% payment for services furnished during CY 2027 through CY 2029 (coinsurance, 10%).
- 100% payment for services furnished from CY 2030 onward (coinsurance, 0%).
Providers must continue to report HCPCS modifier “PT” in the hospital outpatient and ASC during the transition period to indicate that a planned colorectal cancer screening service converted to a diagnostic service.
Proposed 2022 PFS conversion factor could fall 3.75% unless Congress acts: The proposed 2022 PFS conversion factor is $33.58. The decrease reflects the expiration of the 3.75% payment increase provided by the Consolidated Appropriations Act. This congressional intervention averted a significant cut in Medicare physician payment that would have resulted in an almost 10% cut to GI services. The GI societies are working with Congress to avert cuts to physician payments next year as practices continue to recover from the pandemic.
GI procedure payments to increase 3% for hospital outpatient and ASCs: A 2.3% increase has been proposed for the conversion factors, resulting in $84.46 for hospitals and $50.04 for ASCs meeting quality reporting requirements. However, GI endoscopy procedure payments are expected to increase on average 3% in CY 2022.
Colon capsule endoscopy and POEM get new codes and payments: CMS accepted new CPT codes for colon capsule endoscopy (CCE) and peroral endoscopic myotomy (POEM) beginning Jan. 1, 2022.
CMS’s proposed CCE value of 2.41 physician work relative value units (wRVUs) reflects the recommendation of the American Medical Association RVS Update Committee (RUC), which is based on data from physicians who perform the procedure. The proposed national-level physician payments are $116.52 for the professional component and $664.21 for the technical component.
However, CMS did not accept the RUC’s recommendation of 15.50 wRVUs for POEM and, instead, proposed that POEM is similar in work to hemodialysis access CPT code 36819, which has a wRVU of 13.29 and a payment of $792.82. The RUC’s valuation of 15.50 wRVUs was based on data from nearly 120 physicians who perform POEM, and we are disappointed CMS chose to reject the robust survey data. The GI societies will defend the 15.50 wRVU in our comments.
The proposed facility fee for POEM is $3,160.76 in the hospital outpatient setting and $1,848.32 in the ASC. CMS’s proposed facility fee for colon capsule endoscopy is $814.44 in the hospital outpatient setting.
CMS moves physicians to MVPs and plans to phase out MIPS: CMS proposes to revise and phase out the Merit-Based Incentive Payment System (MIPS) and move physicians towards the MIPS Value Pathways (MVPs) system beginning in the 2023 performance year (PY). No GI MVPs were proposed for PY 2023. The GI societies are working with CMS as they develop MVPs to ensure any gastroenterology-related MVPs do not harm gastroenterologists.
CMS is statutorily required to weigh the MIPS Cost and Quality performance categories equally beginning with PY 2022. The proposed PY 2022 MIPS performance categories are:
- Quality: 30%.
- Cost: 30%.
- Promoting Interoperability: 25% (no change from 2021).
- Improvement Activities: 15% (no change from 2021).
CMS is also required by law beginning in 2022 to set the MIPS performance threshold to either the mean or median of the final scores for all MIPS eligible clinicians for a prior period. CMS proposes to use the mean final score from MIPS 2017 performance year/MIPS 2019 payment year, which would result in a performance threshold of 75 points and an additional performance threshold set at 89 points for exceptional performance.
CMS keeps all AGA-stewarded measures in MIPS 2022 program year: CMS has proposed to keep all AGA-stewarded measures in the MIPS program for the 2022 program year and accepted the substantive changes for the one-time screening for hepatitis C virus measure we received last year from the Physician Consortium for Performance Improvement. CMS proposed removal of the claims reporting option of American Society for Gastrointestinal Endoscopy–stewarded measure for photodocumentation of cecal intubation because it is topped-out; however, the registry version is still available in MIPS.
OQR Program includes colonoscopy measure for disparities reporting: CMS has identified six priority measures included in the Hospital Outpatient Quality Reporting (OQR) Program as candidate measures for disparities reporting stratified by dual eligibility, one of which is the Facility 7-Day Risk-Standardized Hospital Visit Rate After Outpatient Colonoscopy (OP-32).
The GI societies will jointly comment on issues in the 2022 PFS and OPPS/ASC proposed rules impacting gastroenterologists. We may also organize members to take action by submitting letters during the comment period, so watch your inbox for invitations to participate. We need your help to influence change.
Shivan Mehta, MD, MBA, is with the division of gastroenterology and hepatology at the University of Pennsylvania, Philadelphia, and is an AGA adviser to the American Medical Association RVS Update Committee. David A. Leiman, MD, MSHP, is with the division of gastroenterology at Duke University, Durham, N.C., and is the chair of the AGA Quality Committee. Neither have conflicts to declare.
A long look at long haulers
With the number of pediatric infections with SARS-CoV-2 rising it is not surprising that children with persistent symptoms are beginning to accumulate. Who are these pediatric “long haulers” and do they differ from their adult counterparts? The answer is far from clear because the terms “long COVID” and “long hauler” are not well defined. But, I suspect we will find that they will be similar in most respects.
In a recent Guest Essay in the New York Times, two medical school professors attempt to inject some common sense into the long hauler phenomenon. (“The Truth About Long Covid is Complicated. Better Treatment Isn’t,” Adam Gaffney and Zackary Berger, The New York Times, Aug. 18, 2021).
The authors divide the patients with long COVID into three categories. The first includes those who are complaining of persistent cough and fatigue for up to 3 months, a not unexpected course for patients recovering from a significant respiratory illness like pneumonia.
The second group comprises patients who developed acute respiratory distress syndrome during the course of their SARS-CoV-2 infection. These unfortunate individuals likely incurred lung damage that may have triggered renal damage and delirium and may never regain full function.
The third group of patients reports a wide variety of less specific symptoms including, but not limited to, severe fatigue, brain fog, shortness of breath, gastrointestinal symptoms, chronic pain, and palpitations.
The authors of the essay refer to several studies in which there was little if any correlation between these patients’ complaints and their antibody levels. In fact, one study of adolescents found that in a group with similar symptoms many of the individuals had no serologic evidence of SARS-CoV-2 infection.
Unfortunately, the lay public, the media, and some physicians make no distinction between these three groups and lump them all under the same long COVID umbrella. The resulting confusion seeds unwarranted anxiety among the first and third groups and may prevent some individuals from receiving the appropriate attention they deserve.
I suspect that like me, many of you see some similarities between this third group of long COVID patients and adolescents whose persistent symptoms don’t quite fit with their primary illness. Patients labeled as having post-concussion syndrome or “chronic Lyme disease” come immediately to mind. In both conditions, many of the patients had little if any evidence of severe insult from the initial event but continue to complain about a variety of symptoms including severe fatigue and brain fog.
We have done a very poor job of properly managing these patients. And there are a lot of them. A large part of the problem is labeling. In the old days one might have said these patients were having “psychosomatic” symptoms. But, while it may be an accurate description, like the term “retardation” it has been permanently tarnished. Fortunately, most of us are smart enough to avoid telling these patients that it is all in their heads.
However, convincing an individual that many of his symptoms may be the result of the psychological insult from the original disease compounded by other stresses and lifestyle factors can be a difficult sell. The task is made particularly difficult when there continue to be physicians who will miss or ignore the obvious and embark on therapeutic endeavors that are not only ineffective but can serve as a distraction from the real work of listening to and engaging these patients whose suffering may be just as real as that of those long haulers with structural damage.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
With the number of pediatric infections with SARS-CoV-2 rising it is not surprising that children with persistent symptoms are beginning to accumulate. Who are these pediatric “long haulers” and do they differ from their adult counterparts? The answer is far from clear because the terms “long COVID” and “long hauler” are not well defined. But, I suspect we will find that they will be similar in most respects.
In a recent Guest Essay in the New York Times, two medical school professors attempt to inject some common sense into the long hauler phenomenon. (“The Truth About Long Covid is Complicated. Better Treatment Isn’t,” Adam Gaffney and Zackary Berger, The New York Times, Aug. 18, 2021).
The authors divide the patients with long COVID into three categories. The first includes those who are complaining of persistent cough and fatigue for up to 3 months, a not unexpected course for patients recovering from a significant respiratory illness like pneumonia.
The second group comprises patients who developed acute respiratory distress syndrome during the course of their SARS-CoV-2 infection. These unfortunate individuals likely incurred lung damage that may have triggered renal damage and delirium and may never regain full function.
The third group of patients reports a wide variety of less specific symptoms including, but not limited to, severe fatigue, brain fog, shortness of breath, gastrointestinal symptoms, chronic pain, and palpitations.
The authors of the essay refer to several studies in which there was little if any correlation between these patients’ complaints and their antibody levels. In fact, one study of adolescents found that in a group with similar symptoms many of the individuals had no serologic evidence of SARS-CoV-2 infection.
Unfortunately, the lay public, the media, and some physicians make no distinction between these three groups and lump them all under the same long COVID umbrella. The resulting confusion seeds unwarranted anxiety among the first and third groups and may prevent some individuals from receiving the appropriate attention they deserve.
I suspect that like me, many of you see some similarities between this third group of long COVID patients and adolescents whose persistent symptoms don’t quite fit with their primary illness. Patients labeled as having post-concussion syndrome or “chronic Lyme disease” come immediately to mind. In both conditions, many of the patients had little if any evidence of severe insult from the initial event but continue to complain about a variety of symptoms including severe fatigue and brain fog.
We have done a very poor job of properly managing these patients. And there are a lot of them. A large part of the problem is labeling. In the old days one might have said these patients were having “psychosomatic” symptoms. But, while it may be an accurate description, like the term “retardation” it has been permanently tarnished. Fortunately, most of us are smart enough to avoid telling these patients that it is all in their heads.
However, convincing an individual that many of his symptoms may be the result of the psychological insult from the original disease compounded by other stresses and lifestyle factors can be a difficult sell. The task is made particularly difficult when there continue to be physicians who will miss or ignore the obvious and embark on therapeutic endeavors that are not only ineffective but can serve as a distraction from the real work of listening to and engaging these patients whose suffering may be just as real as that of those long haulers with structural damage.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
With the number of pediatric infections with SARS-CoV-2 rising it is not surprising that children with persistent symptoms are beginning to accumulate. Who are these pediatric “long haulers” and do they differ from their adult counterparts? The answer is far from clear because the terms “long COVID” and “long hauler” are not well defined. But, I suspect we will find that they will be similar in most respects.
In a recent Guest Essay in the New York Times, two medical school professors attempt to inject some common sense into the long hauler phenomenon. (“The Truth About Long Covid is Complicated. Better Treatment Isn’t,” Adam Gaffney and Zackary Berger, The New York Times, Aug. 18, 2021).
The authors divide the patients with long COVID into three categories. The first includes those who are complaining of persistent cough and fatigue for up to 3 months, a not unexpected course for patients recovering from a significant respiratory illness like pneumonia.
The second group comprises patients who developed acute respiratory distress syndrome during the course of their SARS-CoV-2 infection. These unfortunate individuals likely incurred lung damage that may have triggered renal damage and delirium and may never regain full function.
The third group of patients reports a wide variety of less specific symptoms including, but not limited to, severe fatigue, brain fog, shortness of breath, gastrointestinal symptoms, chronic pain, and palpitations.
The authors of the essay refer to several studies in which there was little if any correlation between these patients’ complaints and their antibody levels. In fact, one study of adolescents found that in a group with similar symptoms many of the individuals had no serologic evidence of SARS-CoV-2 infection.
Unfortunately, the lay public, the media, and some physicians make no distinction between these three groups and lump them all under the same long COVID umbrella. The resulting confusion seeds unwarranted anxiety among the first and third groups and may prevent some individuals from receiving the appropriate attention they deserve.
I suspect that like me, many of you see some similarities between this third group of long COVID patients and adolescents whose persistent symptoms don’t quite fit with their primary illness. Patients labeled as having post-concussion syndrome or “chronic Lyme disease” come immediately to mind. In both conditions, many of the patients had little if any evidence of severe insult from the initial event but continue to complain about a variety of symptoms including severe fatigue and brain fog.
We have done a very poor job of properly managing these patients. And there are a lot of them. A large part of the problem is labeling. In the old days one might have said these patients were having “psychosomatic” symptoms. But, while it may be an accurate description, like the term “retardation” it has been permanently tarnished. Fortunately, most of us are smart enough to avoid telling these patients that it is all in their heads.
However, convincing an individual that many of his symptoms may be the result of the psychological insult from the original disease compounded by other stresses and lifestyle factors can be a difficult sell. The task is made particularly difficult when there continue to be physicians who will miss or ignore the obvious and embark on therapeutic endeavors that are not only ineffective but can serve as a distraction from the real work of listening to and engaging these patients whose suffering may be just as real as that of those long haulers with structural damage.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Good news is no news
I’ve become kind of a hermit. At least, as much as someone who drives a car, goes to the store, and sees patients 5 days a week can be.
It seemed like the news was always dominated by another senseless mass shooting, an increasingly dysfunctional government, an environmental crisis going to hell (with us along for the ride), and endlessly escalating inflammatory political pundits (who always seem to get far more coverage than they deserve. Personally, I don’t think they deserve any, regardless of which side they’re on).
As things got worse, I became more obsessed with reading about them. I’d read the news on my iPad before bed, and when I first woke up, and several times a day at work.
It was driving me nuts. Perhaps it’s my personality to worry too much about these things. I was losing sleep and wasting valuable time at home and work.
I came to a decision. It was time to stop.
I deleted all my news apps and bookmarks. I’d go to lengths to avoid all news. If in a restaurant where a TV was on, I’d sit with my back to it. I stopped going to the doctor’s lounge (with its TVs constantly on a news network). When I had to wait to pick up my car at the shop, I sat outside and played games on my phone rather than use the waiting room with its blaring TV.
This doesn’t mean I’m completely unplugged. I still read interesting stories about science or history. I check the weather forecast. Family members occasionally send me amusing articles that I look at. I read online medical articles. I use the Internet to look things up. But I make a conscious effort not to look at headlines or other stuff on the periphery.
I’m not stupid or naive enough to believe that the insanity and acrimony won’t continue happening. But the bottom line is that obviously I can’t control or change it.
So I try not to let it upset me any more. If the only way to do that is to completely not read it and not know, I’m fine with that. After almost 50 years of reading news (I started when I was about 7, with my parent’s subscription to Newsweek), I’ve completely stopped.
Instead of reading the day’s events I now mindlessly play Toon Blast or read history books on my iPad before bed. Perhaps a waste of time, but no more so than getting upset, losing sleep, getting ulcers, and going gray over things I can’t control.
I have more time in the morning and my work day, since I’m not spending it scanning headlines.
Now my world is restricted to my family, friends, dogs, and job. Things I enjoy and have control over. Those around me have been told that I wish to discuss nothing about current events, and they respect that.
Now I sleep better, worry less (at least about those things), and have more time to focus on my immediate world. And that’s fine with me. It may be the way of the ostrich, but at this point in my life, that’s what I prefer.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve become kind of a hermit. At least, as much as someone who drives a car, goes to the store, and sees patients 5 days a week can be.
It seemed like the news was always dominated by another senseless mass shooting, an increasingly dysfunctional government, an environmental crisis going to hell (with us along for the ride), and endlessly escalating inflammatory political pundits (who always seem to get far more coverage than they deserve. Personally, I don’t think they deserve any, regardless of which side they’re on).
As things got worse, I became more obsessed with reading about them. I’d read the news on my iPad before bed, and when I first woke up, and several times a day at work.
It was driving me nuts. Perhaps it’s my personality to worry too much about these things. I was losing sleep and wasting valuable time at home and work.
I came to a decision. It was time to stop.
I deleted all my news apps and bookmarks. I’d go to lengths to avoid all news. If in a restaurant where a TV was on, I’d sit with my back to it. I stopped going to the doctor’s lounge (with its TVs constantly on a news network). When I had to wait to pick up my car at the shop, I sat outside and played games on my phone rather than use the waiting room with its blaring TV.
This doesn’t mean I’m completely unplugged. I still read interesting stories about science or history. I check the weather forecast. Family members occasionally send me amusing articles that I look at. I read online medical articles. I use the Internet to look things up. But I make a conscious effort not to look at headlines or other stuff on the periphery.
I’m not stupid or naive enough to believe that the insanity and acrimony won’t continue happening. But the bottom line is that obviously I can’t control or change it.
So I try not to let it upset me any more. If the only way to do that is to completely not read it and not know, I’m fine with that. After almost 50 years of reading news (I started when I was about 7, with my parent’s subscription to Newsweek), I’ve completely stopped.
Instead of reading the day’s events I now mindlessly play Toon Blast or read history books on my iPad before bed. Perhaps a waste of time, but no more so than getting upset, losing sleep, getting ulcers, and going gray over things I can’t control.
I have more time in the morning and my work day, since I’m not spending it scanning headlines.
Now my world is restricted to my family, friends, dogs, and job. Things I enjoy and have control over. Those around me have been told that I wish to discuss nothing about current events, and they respect that.
Now I sleep better, worry less (at least about those things), and have more time to focus on my immediate world. And that’s fine with me. It may be the way of the ostrich, but at this point in my life, that’s what I prefer.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve become kind of a hermit. At least, as much as someone who drives a car, goes to the store, and sees patients 5 days a week can be.
It seemed like the news was always dominated by another senseless mass shooting, an increasingly dysfunctional government, an environmental crisis going to hell (with us along for the ride), and endlessly escalating inflammatory political pundits (who always seem to get far more coverage than they deserve. Personally, I don’t think they deserve any, regardless of which side they’re on).
As things got worse, I became more obsessed with reading about them. I’d read the news on my iPad before bed, and when I first woke up, and several times a day at work.
It was driving me nuts. Perhaps it’s my personality to worry too much about these things. I was losing sleep and wasting valuable time at home and work.
I came to a decision. It was time to stop.
I deleted all my news apps and bookmarks. I’d go to lengths to avoid all news. If in a restaurant where a TV was on, I’d sit with my back to it. I stopped going to the doctor’s lounge (with its TVs constantly on a news network). When I had to wait to pick up my car at the shop, I sat outside and played games on my phone rather than use the waiting room with its blaring TV.
This doesn’t mean I’m completely unplugged. I still read interesting stories about science or history. I check the weather forecast. Family members occasionally send me amusing articles that I look at. I read online medical articles. I use the Internet to look things up. But I make a conscious effort not to look at headlines or other stuff on the periphery.
I’m not stupid or naive enough to believe that the insanity and acrimony won’t continue happening. But the bottom line is that obviously I can’t control or change it.
So I try not to let it upset me any more. If the only way to do that is to completely not read it and not know, I’m fine with that. After almost 50 years of reading news (I started when I was about 7, with my parent’s subscription to Newsweek), I’ve completely stopped.
Instead of reading the day’s events I now mindlessly play Toon Blast or read history books on my iPad before bed. Perhaps a waste of time, but no more so than getting upset, losing sleep, getting ulcers, and going gray over things I can’t control.
I have more time in the morning and my work day, since I’m not spending it scanning headlines.
Now my world is restricted to my family, friends, dogs, and job. Things I enjoy and have control over. Those around me have been told that I wish to discuss nothing about current events, and they respect that.
Now I sleep better, worry less (at least about those things), and have more time to focus on my immediate world. And that’s fine with me. It may be the way of the ostrich, but at this point in my life, that’s what I prefer.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.