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Past President’s perspective
It’s January 1, 2022, as I write, and my CHEST presidency came to an end last night as the fireworks lit up the sky. With COVID-19 waxing and waning across the United States and around the world, I have been a wartime president. CHEST has not been able to do a number of the things that we would normally have done in person, including that there has not been an in-person CHEST annual meeting during my entire presidency. We have, nonetheless, achieved some important things that I will share with you.
If you’re a typical CHEST member, you probably don’t spend a lot of time wondering about CHEST’s finances, nor should you. Nevertheless, CHEST – your organization – does have to be fiscally responsible if we desire to continue our educational and research missions, and that is the job of your Board of Regents, your presidents, and your professional staff at the CHEST headquarters. I’m happy to tell you that your organization is in healthy financial condition, in spite of a challenging economic environment and, being forced into remote, online annual meetings and board reviews for 2 years. What that means to us and to you is that we get to maintain and improve our full array of educational activities, including our annual meeting, our journal, our board reviews, our hands-on courses at the CHEST headquarters, and our web content. And, we get to accelerate our advocacy activities for our patients and for the clinical folks who care for them (us!). CHEST is primed for emerging from this pandemic stronger, because we have had to make the most of every dollar we have, and more innovative, because that’s how we have done it. We are ready for new ways of interacting and for innovative new ways of delivering education, sponsoring research, fostering networking, and leading in the clinical arena of chest medicine.
During my time as CHEST President, many of us have become progressively more aware of the blatant inequities that continue in society – and, yes, even in medicine. Perhaps more than anything, it both saddens and angers me when anyone values or devalues someone else’s life because of the color of their skin, who they feel attracted to or love, the sex they were born with or their knowledge that nature gave them the wrong physical characteristics for their gender, what physical impairments they have, where they were born, where they were educated - or not, what language is their first language, or what opportunities they were presented with in their lives. Everyone deserves the opportunity to be who and what they are and to be respected for who they are, and everyone deserves the opportunity to excel. The strongest collaborations have diverse constituents with unified goals, and I want for CHEST to be among the strongest of professional collaborations. It has been deeply important to me during my presidency to champion these values, and we have worked hard to make CHEST an inclusive and diverse organization. Much remains to be done, but we did make some good progress this year.
We established a spirometry working group to look at the science around race-based adjustments for normal values, to call out if there are mistakes or omissions in that approach, and to propose the work that needs to be done to correct them. We invited the American Thoracic Society and the Canadian Thoracic Society to join us in this effort. Race is a social construct, not a physiologic principle, and some data suggest that apparent differences in physiology could actually reflect differences in socioeconomic status of study participants. In similar work, our nephrology colleagues demonstrated that apparent differences in normal glomerular filtration rate (GFR) are related to socio-economic and health care access issues; they called for labs to no longer report race-based norms for creatinine and GFR values. Our colleagues believe that race-based GFR norms have harmed patients by promoting delay in treatments aimed at preventing dialysis or by causing delays in the initiation of dialysis. In our world, asbestos companies have argued that African American and other populations of color should receive lower asbestosis settlements on the basis that they began with lower predicted lung function and, therefore, had been less damaged by exposure to asbestos. I am very interested to see our working group’s output. I think it could result in landmark changes in our evaluation and treatment of patients with lung diseases.
A very important undertaking for us this year was a top to bottom analysis of our own practices around diversity, equity, and inclusion. We started by taking lessons from the CHEST Foundation-sponsored listening tour across the nation. Many of our patients of color lack adequate access to the care they need, which informs our efforts in advocacy and health policy. We also learned that, as a profession, we have not earned the trust of our patients of color, and we must take steps to remedy that. CHEST began this effort by developing the First 5 Minutes program, which teaches all of us how to take the first moments of our interactions with patients to enhance our empathy and to establish trusting relationships with them. You will hear more about this program in the months to come.
CHEST is dedicated to ensuring that all of our members have equitable opportunities to take part in our learning activities, both as participants and as developers. Likewise, we want any member who desires to advance in our organization to have wide open opportunity to develop and use their skills. We hired a consulting firm who specializes in aiding nonprofits with their diversity, equity, and inclusion goals to help us find our weaknesses in that area. They spent several months interviewing members at all stages of their careers and in a variety of job types, with the goal of determining what it is like to be a CHEST member of color, a woman, a member of the LGBTQIA community, or a member of any group that has been made to feel “other.” We are currently working to turn their findings into concrete steps to make CHEST the most diverse and inclusive medical society possible. Finally, our consultants are helping us to ensure that the people we hire to work for our organization full time have equitable opportunities in their workplace, and that CHEST headquarters feels inclusive and is diverse for them.
COVID-19 rages on. In fact, daily case numbers at this writing are skyrocketing, higher than at any time during the pandemic, and hospitalization rates, while lower than with some of the previous waves, are following. Many of us are stressed, and in many of our ICUs, we have fewer nurses than we did at the outset of the pandemic. The CHEST COVID-19 task force continues on the job, though, with fresh content to match the current circumstances. These dedicated individuals, who I recognized with a Presidential Citation for 2021, have worked since the early days of the pandemic to scour the literature and the landscape to find the right data and the right experts to inform the topical infographics, reviews, webinars, and podcasts that are freely available to all and are posted on the CHEST website. I hope that you have availed yourself of the material there, and, if not, you have missed some valuable learning opportunities. Missed them in real time, that is; they are all on the site for you to use at will. We are optimistic that someday soon, there will be less of a need for the COVID-19 task force, but the members are all ready to continue their work until that time comes..
I’ve highlighted just a few of the higher profile things that CHEST achieved in 2021. It would be impossible for me to cover all that CHEST has accomplished this past year. My sources tell me that during my presidency, we generated, signed on, or declined to join nearly 100 advocacy statements on topics ranging from recall of home CPAP machines to access to appropriate supplemental oxygen for patients with interstitial lung disease, to the acquisition of a nebulizer company by a tobacco company. We held successful board review sessions and repeated our all online, yet interactive, version of the CHEST annual meeting, with more than 4,000 total attendees– not as large as an in-person meeting, but not terribly far off, either. I will add that our program chairs and their committee pivoted from a meeting in Vancouver to a meeting in Orlando to, with only 6 weeks’ notice, a meeting in the ether. We are fortunate to have worked with such talented and dedicated individuals, and all of us owe them a lot for their efforts.
If, as I say, I have been a wartime president, then the worldwide viral pandemic that directly affects those of us in chest medicine has been the war. In spite of the current tsunami of cases, I am optimistic that the war ends relatively soon. CHEST will not simply return to normalcy, though. Dr. David Schulman, a brilliant and innovative educator, has taken the leadership reins of the organization, and I foresee exhilarating times ahead.
We are making it through a challenging environment, and CHEST is stronger for it. I will look forward to seeing all of you in Nashville, when we, at long last, can look one another in the eye, shake one another’s hand, and enjoy the experience of the CHEST annual meeting together. And if you don’t mind me asking, when you see me in Nashville, will you please do exactly that?
It’s January 1, 2022, as I write, and my CHEST presidency came to an end last night as the fireworks lit up the sky. With COVID-19 waxing and waning across the United States and around the world, I have been a wartime president. CHEST has not been able to do a number of the things that we would normally have done in person, including that there has not been an in-person CHEST annual meeting during my entire presidency. We have, nonetheless, achieved some important things that I will share with you.
If you’re a typical CHEST member, you probably don’t spend a lot of time wondering about CHEST’s finances, nor should you. Nevertheless, CHEST – your organization – does have to be fiscally responsible if we desire to continue our educational and research missions, and that is the job of your Board of Regents, your presidents, and your professional staff at the CHEST headquarters. I’m happy to tell you that your organization is in healthy financial condition, in spite of a challenging economic environment and, being forced into remote, online annual meetings and board reviews for 2 years. What that means to us and to you is that we get to maintain and improve our full array of educational activities, including our annual meeting, our journal, our board reviews, our hands-on courses at the CHEST headquarters, and our web content. And, we get to accelerate our advocacy activities for our patients and for the clinical folks who care for them (us!). CHEST is primed for emerging from this pandemic stronger, because we have had to make the most of every dollar we have, and more innovative, because that’s how we have done it. We are ready for new ways of interacting and for innovative new ways of delivering education, sponsoring research, fostering networking, and leading in the clinical arena of chest medicine.
During my time as CHEST President, many of us have become progressively more aware of the blatant inequities that continue in society – and, yes, even in medicine. Perhaps more than anything, it both saddens and angers me when anyone values or devalues someone else’s life because of the color of their skin, who they feel attracted to or love, the sex they were born with or their knowledge that nature gave them the wrong physical characteristics for their gender, what physical impairments they have, where they were born, where they were educated - or not, what language is their first language, or what opportunities they were presented with in their lives. Everyone deserves the opportunity to be who and what they are and to be respected for who they are, and everyone deserves the opportunity to excel. The strongest collaborations have diverse constituents with unified goals, and I want for CHEST to be among the strongest of professional collaborations. It has been deeply important to me during my presidency to champion these values, and we have worked hard to make CHEST an inclusive and diverse organization. Much remains to be done, but we did make some good progress this year.
We established a spirometry working group to look at the science around race-based adjustments for normal values, to call out if there are mistakes or omissions in that approach, and to propose the work that needs to be done to correct them. We invited the American Thoracic Society and the Canadian Thoracic Society to join us in this effort. Race is a social construct, not a physiologic principle, and some data suggest that apparent differences in physiology could actually reflect differences in socioeconomic status of study participants. In similar work, our nephrology colleagues demonstrated that apparent differences in normal glomerular filtration rate (GFR) are related to socio-economic and health care access issues; they called for labs to no longer report race-based norms for creatinine and GFR values. Our colleagues believe that race-based GFR norms have harmed patients by promoting delay in treatments aimed at preventing dialysis or by causing delays in the initiation of dialysis. In our world, asbestos companies have argued that African American and other populations of color should receive lower asbestosis settlements on the basis that they began with lower predicted lung function and, therefore, had been less damaged by exposure to asbestos. I am very interested to see our working group’s output. I think it could result in landmark changes in our evaluation and treatment of patients with lung diseases.
A very important undertaking for us this year was a top to bottom analysis of our own practices around diversity, equity, and inclusion. We started by taking lessons from the CHEST Foundation-sponsored listening tour across the nation. Many of our patients of color lack adequate access to the care they need, which informs our efforts in advocacy and health policy. We also learned that, as a profession, we have not earned the trust of our patients of color, and we must take steps to remedy that. CHEST began this effort by developing the First 5 Minutes program, which teaches all of us how to take the first moments of our interactions with patients to enhance our empathy and to establish trusting relationships with them. You will hear more about this program in the months to come.
CHEST is dedicated to ensuring that all of our members have equitable opportunities to take part in our learning activities, both as participants and as developers. Likewise, we want any member who desires to advance in our organization to have wide open opportunity to develop and use their skills. We hired a consulting firm who specializes in aiding nonprofits with their diversity, equity, and inclusion goals to help us find our weaknesses in that area. They spent several months interviewing members at all stages of their careers and in a variety of job types, with the goal of determining what it is like to be a CHEST member of color, a woman, a member of the LGBTQIA community, or a member of any group that has been made to feel “other.” We are currently working to turn their findings into concrete steps to make CHEST the most diverse and inclusive medical society possible. Finally, our consultants are helping us to ensure that the people we hire to work for our organization full time have equitable opportunities in their workplace, and that CHEST headquarters feels inclusive and is diverse for them.
COVID-19 rages on. In fact, daily case numbers at this writing are skyrocketing, higher than at any time during the pandemic, and hospitalization rates, while lower than with some of the previous waves, are following. Many of us are stressed, and in many of our ICUs, we have fewer nurses than we did at the outset of the pandemic. The CHEST COVID-19 task force continues on the job, though, with fresh content to match the current circumstances. These dedicated individuals, who I recognized with a Presidential Citation for 2021, have worked since the early days of the pandemic to scour the literature and the landscape to find the right data and the right experts to inform the topical infographics, reviews, webinars, and podcasts that are freely available to all and are posted on the CHEST website. I hope that you have availed yourself of the material there, and, if not, you have missed some valuable learning opportunities. Missed them in real time, that is; they are all on the site for you to use at will. We are optimistic that someday soon, there will be less of a need for the COVID-19 task force, but the members are all ready to continue their work until that time comes..
I’ve highlighted just a few of the higher profile things that CHEST achieved in 2021. It would be impossible for me to cover all that CHEST has accomplished this past year. My sources tell me that during my presidency, we generated, signed on, or declined to join nearly 100 advocacy statements on topics ranging from recall of home CPAP machines to access to appropriate supplemental oxygen for patients with interstitial lung disease, to the acquisition of a nebulizer company by a tobacco company. We held successful board review sessions and repeated our all online, yet interactive, version of the CHEST annual meeting, with more than 4,000 total attendees– not as large as an in-person meeting, but not terribly far off, either. I will add that our program chairs and their committee pivoted from a meeting in Vancouver to a meeting in Orlando to, with only 6 weeks’ notice, a meeting in the ether. We are fortunate to have worked with such talented and dedicated individuals, and all of us owe them a lot for their efforts.
If, as I say, I have been a wartime president, then the worldwide viral pandemic that directly affects those of us in chest medicine has been the war. In spite of the current tsunami of cases, I am optimistic that the war ends relatively soon. CHEST will not simply return to normalcy, though. Dr. David Schulman, a brilliant and innovative educator, has taken the leadership reins of the organization, and I foresee exhilarating times ahead.
We are making it through a challenging environment, and CHEST is stronger for it. I will look forward to seeing all of you in Nashville, when we, at long last, can look one another in the eye, shake one another’s hand, and enjoy the experience of the CHEST annual meeting together. And if you don’t mind me asking, when you see me in Nashville, will you please do exactly that?
It’s January 1, 2022, as I write, and my CHEST presidency came to an end last night as the fireworks lit up the sky. With COVID-19 waxing and waning across the United States and around the world, I have been a wartime president. CHEST has not been able to do a number of the things that we would normally have done in person, including that there has not been an in-person CHEST annual meeting during my entire presidency. We have, nonetheless, achieved some important things that I will share with you.
If you’re a typical CHEST member, you probably don’t spend a lot of time wondering about CHEST’s finances, nor should you. Nevertheless, CHEST – your organization – does have to be fiscally responsible if we desire to continue our educational and research missions, and that is the job of your Board of Regents, your presidents, and your professional staff at the CHEST headquarters. I’m happy to tell you that your organization is in healthy financial condition, in spite of a challenging economic environment and, being forced into remote, online annual meetings and board reviews for 2 years. What that means to us and to you is that we get to maintain and improve our full array of educational activities, including our annual meeting, our journal, our board reviews, our hands-on courses at the CHEST headquarters, and our web content. And, we get to accelerate our advocacy activities for our patients and for the clinical folks who care for them (us!). CHEST is primed for emerging from this pandemic stronger, because we have had to make the most of every dollar we have, and more innovative, because that’s how we have done it. We are ready for new ways of interacting and for innovative new ways of delivering education, sponsoring research, fostering networking, and leading in the clinical arena of chest medicine.
During my time as CHEST President, many of us have become progressively more aware of the blatant inequities that continue in society – and, yes, even in medicine. Perhaps more than anything, it both saddens and angers me when anyone values or devalues someone else’s life because of the color of their skin, who they feel attracted to or love, the sex they were born with or their knowledge that nature gave them the wrong physical characteristics for their gender, what physical impairments they have, where they were born, where they were educated - or not, what language is their first language, or what opportunities they were presented with in their lives. Everyone deserves the opportunity to be who and what they are and to be respected for who they are, and everyone deserves the opportunity to excel. The strongest collaborations have diverse constituents with unified goals, and I want for CHEST to be among the strongest of professional collaborations. It has been deeply important to me during my presidency to champion these values, and we have worked hard to make CHEST an inclusive and diverse organization. Much remains to be done, but we did make some good progress this year.
We established a spirometry working group to look at the science around race-based adjustments for normal values, to call out if there are mistakes or omissions in that approach, and to propose the work that needs to be done to correct them. We invited the American Thoracic Society and the Canadian Thoracic Society to join us in this effort. Race is a social construct, not a physiologic principle, and some data suggest that apparent differences in physiology could actually reflect differences in socioeconomic status of study participants. In similar work, our nephrology colleagues demonstrated that apparent differences in normal glomerular filtration rate (GFR) are related to socio-economic and health care access issues; they called for labs to no longer report race-based norms for creatinine and GFR values. Our colleagues believe that race-based GFR norms have harmed patients by promoting delay in treatments aimed at preventing dialysis or by causing delays in the initiation of dialysis. In our world, asbestos companies have argued that African American and other populations of color should receive lower asbestosis settlements on the basis that they began with lower predicted lung function and, therefore, had been less damaged by exposure to asbestos. I am very interested to see our working group’s output. I think it could result in landmark changes in our evaluation and treatment of patients with lung diseases.
A very important undertaking for us this year was a top to bottom analysis of our own practices around diversity, equity, and inclusion. We started by taking lessons from the CHEST Foundation-sponsored listening tour across the nation. Many of our patients of color lack adequate access to the care they need, which informs our efforts in advocacy and health policy. We also learned that, as a profession, we have not earned the trust of our patients of color, and we must take steps to remedy that. CHEST began this effort by developing the First 5 Minutes program, which teaches all of us how to take the first moments of our interactions with patients to enhance our empathy and to establish trusting relationships with them. You will hear more about this program in the months to come.
CHEST is dedicated to ensuring that all of our members have equitable opportunities to take part in our learning activities, both as participants and as developers. Likewise, we want any member who desires to advance in our organization to have wide open opportunity to develop and use their skills. We hired a consulting firm who specializes in aiding nonprofits with their diversity, equity, and inclusion goals to help us find our weaknesses in that area. They spent several months interviewing members at all stages of their careers and in a variety of job types, with the goal of determining what it is like to be a CHEST member of color, a woman, a member of the LGBTQIA community, or a member of any group that has been made to feel “other.” We are currently working to turn their findings into concrete steps to make CHEST the most diverse and inclusive medical society possible. Finally, our consultants are helping us to ensure that the people we hire to work for our organization full time have equitable opportunities in their workplace, and that CHEST headquarters feels inclusive and is diverse for them.
COVID-19 rages on. In fact, daily case numbers at this writing are skyrocketing, higher than at any time during the pandemic, and hospitalization rates, while lower than with some of the previous waves, are following. Many of us are stressed, and in many of our ICUs, we have fewer nurses than we did at the outset of the pandemic. The CHEST COVID-19 task force continues on the job, though, with fresh content to match the current circumstances. These dedicated individuals, who I recognized with a Presidential Citation for 2021, have worked since the early days of the pandemic to scour the literature and the landscape to find the right data and the right experts to inform the topical infographics, reviews, webinars, and podcasts that are freely available to all and are posted on the CHEST website. I hope that you have availed yourself of the material there, and, if not, you have missed some valuable learning opportunities. Missed them in real time, that is; they are all on the site for you to use at will. We are optimistic that someday soon, there will be less of a need for the COVID-19 task force, but the members are all ready to continue their work until that time comes..
I’ve highlighted just a few of the higher profile things that CHEST achieved in 2021. It would be impossible for me to cover all that CHEST has accomplished this past year. My sources tell me that during my presidency, we generated, signed on, or declined to join nearly 100 advocacy statements on topics ranging from recall of home CPAP machines to access to appropriate supplemental oxygen for patients with interstitial lung disease, to the acquisition of a nebulizer company by a tobacco company. We held successful board review sessions and repeated our all online, yet interactive, version of the CHEST annual meeting, with more than 4,000 total attendees– not as large as an in-person meeting, but not terribly far off, either. I will add that our program chairs and their committee pivoted from a meeting in Vancouver to a meeting in Orlando to, with only 6 weeks’ notice, a meeting in the ether. We are fortunate to have worked with such talented and dedicated individuals, and all of us owe them a lot for their efforts.
If, as I say, I have been a wartime president, then the worldwide viral pandemic that directly affects those of us in chest medicine has been the war. In spite of the current tsunami of cases, I am optimistic that the war ends relatively soon. CHEST will not simply return to normalcy, though. Dr. David Schulman, a brilliant and innovative educator, has taken the leadership reins of the organization, and I foresee exhilarating times ahead.
We are making it through a challenging environment, and CHEST is stronger for it. I will look forward to seeing all of you in Nashville, when we, at long last, can look one another in the eye, shake one another’s hand, and enjoy the experience of the CHEST annual meeting together. And if you don’t mind me asking, when you see me in Nashville, will you please do exactly that?
The gap in cosmeceuticals education
Starting this month, I will be joining Dr. Leslie S. Baumann as a cocontributor to the Cosmeceutical Critique column, and since this is my first column, I would like to formally introduce myself. I am a cosmetic and general dermatologist in private practice in Miami and a longtime skin care enthusiast. My path toward becoming a dermatologist began when I was working in New York City, my hometown, as a scientific researcher, fulfilling my passion for scientific inquiry. After realizing that I most enjoyed applying discoveries made in the lab directly to patient care, I decided to pursue medical school at New York University before completing a dermatology residency at the University of Miami, serving as Chief Resident during my final year. Although I was born and raised in New York, staying in Miami was an obvious decision for me. In addition to the tropical weather and amazing lifestyle, the medical community in Miami supports adventure, creativity, and innovation, which are key aspects that drew me to the University of Miami and continue to drive my personal evolution in private practice.
I now practice at Baumann Cosmetic & Research Institute alongside my mentor, Dr. Baumann. I truly have my dream job – I get to talk skin care and do a wide array of cosmetics procedures, perform skin surgeries, and solve complex medical dermatology cases all in a day’s work. My career sits at the intersection of my passions for science, critical thinking, beauty, aesthetics, and most importantly, engaging with patients.
For my first column, I want to , and I will provide a simple framework to approach the design of skin care regimens and utilization of cosmeceuticals in practice.
The focus of a dermatology residency is on medical and surgical skills. We become experts in diagnosing and treating conditions ranging from life-threatening drug reactions like Stevens-Johnson Syndrome to complex diseases like dermatomyositis, utilizing medications and treatments ranging from cyclosporine and methotrexate to biologics and intravenous immunoglobulin, and performing advanced skin surgeries utilizing flaps and grafts to repair defects.
The discipline of cosmetic dermatology, let alone cosmeceuticals, accounts for a fraction of our didactic and hands-on training. I completed a top dermatology residency program that prepared me to treat any dermatologic condition; however, I honestly felt like I didn’t have a strong understanding of cosmeceuticals and skin care and how to integrate them with prescription therapies when I completed residency, which is a sentiment shared by residents across the country. I remember a study break while preparing for my final board exam when I went into a tailspin for an entire day trying to decode an ingredient list of a new “antiaging serum” and researching its mechanisms of action and the clinical data supporting the active ingredients in the serum, which included bakuchiol and a blend of peptides. As a dermatologist who likes to treat and provide recommendations based on scientific rationale and data to deliver the highest level of care, I admit that I felt insecure not being as knowledgeable about cosmeceuticals as I was about more complex dermatology treatments. As both a cosmetic and general dermatologist, discussing skin care and cosmeceuticals independent of or in conjunction with medical management occurs daily, and I recognized that becoming an expert in this area is essential to becoming a top, well-rounded dermatologist.
A gap in cosmeceutical education in dermatology residency
Multiple studies have established that the field of cosmetic dermatology comprises a fraction of dermatology residency training. In 2013, Kirby et al. published a survey of dermatology instructors and chief residents across the country and found that only 67% of responders reported having received formal lectures on cosmetic dermatology.1 In 2014, Bauer et al. published a survey of dermatology program directors assessing attitudes toward cosmetic dermatology and reported that only 38% of program directors believed that cosmetic dermatology should be a necessary aspect of residency training.2 A survey sent to dermatology residents published in 2012 found that among respondents, more than 58% of residency programs have an “encouraging or somewhat encouraging” attitude toward teaching cosmetic dermatology, yet 22% of programs had a “somewhat discouraging” or “discouraging” attitude.3 While these noted studies have focused on procedural aspects of cosmetic dermatology training, Feetham et al. surveyed dermatology residents and faculty to assess attitudes toward and training on skin care and cosmeceuticals specifically. Among resident respondents, most (74.5%) reported their education on skin care and cosmeceuticals has been “too little or nonexistent” during residency and 76.5% “agree or strongly agree” that it should be part of their education.4 In contrast, 60% of faculty reported resident education on skin care and cosmeceuticals is “just the right amount or too much” (P < .001).
In my personal experience as a resident, discussing skin care was emphasized when treating patients with eczema, contact dermatitis, acne, and hair disorders, but otherwise, the majority of skin care discussions relied on having a stock list of recommended cleansers, moisturizers, and sunscreens. In regards to cosmeceuticals for facial skin specifically, there were only a handful of instances in which alternative ingredients, such as vitamin C for hyperpigmentation, were discussed and specific brands were mentioned. Upon reflection, I wish I had more opportunity to see the clinical benefits of cosmeceuticals first hand, just like when I observe dupilumab clear patients with severe atopic dermatitis, rather than reading about it in textbooks and journals.
While one hypothesis for programs’ limited attention given to cosmetic training may be that it detracts from medical training, the survey by Bauer et al. found that residents did not feel less prepared (94.9%) or less interested (97.4%) in medical dermatology as a result of their cosmetic training.2 In addition, providers in an academic dermatology residency may limit discussions of skin care because of the high patient volume and because extensive skin care discussions will not impact insurance billings. Academic dermatology programs often service patients with more financial constraints, which further limits OTC cosmeceutical discussions. In my residency experience, I had the opportunity to regularly treat more severe and rare dermatologic cases than those I encounter in private practice; therefore, I spent more time focusing on systemic therapies, with fewer opportunities to dedicate time to cosmeceuticals.
Why skin care and cosmeceuticals should be an essential aspect of residency training
Discussing skin care and cosmeceuticals is a valuable aspect of medical and general dermatology, not just aesthetic dermatology. When treating general dermatologic conditions, guidance on proper skin care can improve both adherence and efficacy of medical treatments. For example, an acne study by de Lucas et al. demonstrated that adherence to adjuvant treatment of acne (such as the use of moisturizers) was associated not only with a 2.4-fold increase in the probability of adherence to pharmacological treatment, but also with a significant reduction in acne severity.5 Aside from skin care, cosmeceuticals themselves have efficacy in treating general dermatologic conditions. In the treatment of acne, topical niacinamide, a popular cosmeceutical ingredient, has been shown to have sebosuppressive and anti-inflammatory effects, addressing key aspects of acne pathogenesis.6 A double-blind study by Draelos et al. reported topical 2% niacinamide was effective in reducing the rate of sebum excretion in 50 Japanese patients over 4 weeks.6 In several double-blind studies that have compared twice daily application of 4% nicotinamide gel with the same application of 1% clindamycin gel in moderate inflammatory acne over 8 weeks, nicotinamide gel reduced the number of inflammatory papules and acne lesions to a level comparable with clindamycin gel.6 These studies support the use of niacinamide cosmeceutical products as an adjunctive treatment for acne.
With increased clinical data supporting cosmeceuticals, it can be expected that some cosmeceuticals will substitute traditional prescription medications in the dermatologists’ arsenal. For example, hydroquinone – both prescription strength and OTC 2% – is a workhorse in treating melasma; however, there is increasing interest in hydroquinone-free treatments, especially since OTC cosmeceuticals containing 2% hydroquinone were banned in 2020 because of safety concerns. Dermatologists will therefore need to provide guidance about hydroquinone alternatives for skin lightening, including soy, licorice extracts, kojic acid, arbutin, niacinamide, N-acetylglucosamine, and vitamin C, among others.7 Utilizing knowledge of a cosmeceutical’s mechanisms of action and clinical data, the dermatologist is in the best position to guide patients toward optimal ingredients and dispel cosmeceutical myths. Given that cosmeceuticals are not regulated by the Food and Drug Administration, it is even more important that the dermatologist serves as an authority on cosmeceuticals.
How to become a master skin care and cosmeceutical prescriber
A common pitfall I have observed among practitioners less experienced with aesthetic-focused skin care and cosmeceuticals is adapting a one-size-fits-all approach. In the one-size-fits-all approach, every patient concerned about aging gets the same vitamin C serum and retinoid, and every patient with hyperpigmentation gets the same hydroquinone prescription, for example. This approach, however, does not take into account unique differences in patients’ skin. Below
is the basic skin care framework that I follow, taught to me by Dr. Baumann. It utilizes an individualized approach based on the patient’s skin qualities to achieve optimal results.
Determine the patient’s skin type (dry vs. oily; sensitive vs. not sensitive; pigmentation issues vs. no hyperpigmentation; wrinkled and mature vs. nonwrinkled) and identify concerns (e.g., dark spots, redness, acne, dehydration).
Separate products into categories of cleansers, eye creams, moisturizers, sun protection, and treatments. Treatments refers to any additional products in a skin care regimen intended to ameliorate a particular condition (e.g., vitamin C for hyperpigmentation, retinoids for fine lines).
Choose products for each category in step 2 (cleansers, eye creams, moisturizers, sun protection, treatments) that are complementary to the patient’s skin type (determined in step 1) and aid the patient in meeting their particular skin goals. For example, a salicylic acid cleanser would be beneficial for a patient with oily skin and acne, but this same cleanser may be too drying and irritating for an acne patient with dry skin.
Ensure that chosen ingredients and products work together harmoniously. For example, while the acne patient may benefit from a salicylic acid cleanser and retinoid cream, using them in succession initially may be overly drying for some patients.
Spend the time to make sure patients understand the appropriate order of application and recognize when efficacy of a product is impacted by another product in the regimen. For example, a low pH cleanser can increase penetration of an ascorbic acid product that follows it in the regimen.
After establishing a basic skin care framework, the next step for beginners is learning about ingredients and their mechanisms of action and familiarizing themselves with scientific and clinical studies. Until cosmeceuticals become an integral part of the training curriculum, dermatologists can gain knowledge independently by reading literature and studies on cosmeceutical active ingredients and experimenting with consumer products. I look forward to regularly contributing to this column to further our awareness and understanding of the mechanisms of and data supporting cosmeceuticals so that we can better guide our patients.
Please feel free to email me at [email protected] or message me on Instagram @DrChloeGoldman with ideas that you would like me to address in this column.
Dr. Goldman is a dermatologist in private practice in Miami, and specializes in cosmetic and general dermatology. She practices at Baumann Cosmetic & Research Institute and is also opening a new general dermatology practice. Dr. Goldman receives compensation to create social media content for Replenix, a skin care company. She has no other relevant disclosures.
References
1. Kirby JS et al. J Am Acad Dermatol. 2013;68(2):e23-8.
2. Bauer et al. JAMA Dermatol. 2014;150(2):125-9.
3. Group A et al. Dermatol Surg. 2012;38(12):1975-80.
4. Feetham HJ et al. J Cosmet Dermatol. 2018;17(2):220-6.
5. de Lucas R et al. BMC Dermatol. 2015;15:17.
6. Araviiskaia E and Dreno BJ. Eur Acad Dermatol Venereol. 2016;30(6):926-35.
7. Leyden JJ et al. J Eur Acad Dermatol Venereol. 2011;25(10):1140-5.
Starting this month, I will be joining Dr. Leslie S. Baumann as a cocontributor to the Cosmeceutical Critique column, and since this is my first column, I would like to formally introduce myself. I am a cosmetic and general dermatologist in private practice in Miami and a longtime skin care enthusiast. My path toward becoming a dermatologist began when I was working in New York City, my hometown, as a scientific researcher, fulfilling my passion for scientific inquiry. After realizing that I most enjoyed applying discoveries made in the lab directly to patient care, I decided to pursue medical school at New York University before completing a dermatology residency at the University of Miami, serving as Chief Resident during my final year. Although I was born and raised in New York, staying in Miami was an obvious decision for me. In addition to the tropical weather and amazing lifestyle, the medical community in Miami supports adventure, creativity, and innovation, which are key aspects that drew me to the University of Miami and continue to drive my personal evolution in private practice.
I now practice at Baumann Cosmetic & Research Institute alongside my mentor, Dr. Baumann. I truly have my dream job – I get to talk skin care and do a wide array of cosmetics procedures, perform skin surgeries, and solve complex medical dermatology cases all in a day’s work. My career sits at the intersection of my passions for science, critical thinking, beauty, aesthetics, and most importantly, engaging with patients.
For my first column, I want to , and I will provide a simple framework to approach the design of skin care regimens and utilization of cosmeceuticals in practice.
The focus of a dermatology residency is on medical and surgical skills. We become experts in diagnosing and treating conditions ranging from life-threatening drug reactions like Stevens-Johnson Syndrome to complex diseases like dermatomyositis, utilizing medications and treatments ranging from cyclosporine and methotrexate to biologics and intravenous immunoglobulin, and performing advanced skin surgeries utilizing flaps and grafts to repair defects.
The discipline of cosmetic dermatology, let alone cosmeceuticals, accounts for a fraction of our didactic and hands-on training. I completed a top dermatology residency program that prepared me to treat any dermatologic condition; however, I honestly felt like I didn’t have a strong understanding of cosmeceuticals and skin care and how to integrate them with prescription therapies when I completed residency, which is a sentiment shared by residents across the country. I remember a study break while preparing for my final board exam when I went into a tailspin for an entire day trying to decode an ingredient list of a new “antiaging serum” and researching its mechanisms of action and the clinical data supporting the active ingredients in the serum, which included bakuchiol and a blend of peptides. As a dermatologist who likes to treat and provide recommendations based on scientific rationale and data to deliver the highest level of care, I admit that I felt insecure not being as knowledgeable about cosmeceuticals as I was about more complex dermatology treatments. As both a cosmetic and general dermatologist, discussing skin care and cosmeceuticals independent of or in conjunction with medical management occurs daily, and I recognized that becoming an expert in this area is essential to becoming a top, well-rounded dermatologist.
A gap in cosmeceutical education in dermatology residency
Multiple studies have established that the field of cosmetic dermatology comprises a fraction of dermatology residency training. In 2013, Kirby et al. published a survey of dermatology instructors and chief residents across the country and found that only 67% of responders reported having received formal lectures on cosmetic dermatology.1 In 2014, Bauer et al. published a survey of dermatology program directors assessing attitudes toward cosmetic dermatology and reported that only 38% of program directors believed that cosmetic dermatology should be a necessary aspect of residency training.2 A survey sent to dermatology residents published in 2012 found that among respondents, more than 58% of residency programs have an “encouraging or somewhat encouraging” attitude toward teaching cosmetic dermatology, yet 22% of programs had a “somewhat discouraging” or “discouraging” attitude.3 While these noted studies have focused on procedural aspects of cosmetic dermatology training, Feetham et al. surveyed dermatology residents and faculty to assess attitudes toward and training on skin care and cosmeceuticals specifically. Among resident respondents, most (74.5%) reported their education on skin care and cosmeceuticals has been “too little or nonexistent” during residency and 76.5% “agree or strongly agree” that it should be part of their education.4 In contrast, 60% of faculty reported resident education on skin care and cosmeceuticals is “just the right amount or too much” (P < .001).
In my personal experience as a resident, discussing skin care was emphasized when treating patients with eczema, contact dermatitis, acne, and hair disorders, but otherwise, the majority of skin care discussions relied on having a stock list of recommended cleansers, moisturizers, and sunscreens. In regards to cosmeceuticals for facial skin specifically, there were only a handful of instances in which alternative ingredients, such as vitamin C for hyperpigmentation, were discussed and specific brands were mentioned. Upon reflection, I wish I had more opportunity to see the clinical benefits of cosmeceuticals first hand, just like when I observe dupilumab clear patients with severe atopic dermatitis, rather than reading about it in textbooks and journals.
While one hypothesis for programs’ limited attention given to cosmetic training may be that it detracts from medical training, the survey by Bauer et al. found that residents did not feel less prepared (94.9%) or less interested (97.4%) in medical dermatology as a result of their cosmetic training.2 In addition, providers in an academic dermatology residency may limit discussions of skin care because of the high patient volume and because extensive skin care discussions will not impact insurance billings. Academic dermatology programs often service patients with more financial constraints, which further limits OTC cosmeceutical discussions. In my residency experience, I had the opportunity to regularly treat more severe and rare dermatologic cases than those I encounter in private practice; therefore, I spent more time focusing on systemic therapies, with fewer opportunities to dedicate time to cosmeceuticals.
Why skin care and cosmeceuticals should be an essential aspect of residency training
Discussing skin care and cosmeceuticals is a valuable aspect of medical and general dermatology, not just aesthetic dermatology. When treating general dermatologic conditions, guidance on proper skin care can improve both adherence and efficacy of medical treatments. For example, an acne study by de Lucas et al. demonstrated that adherence to adjuvant treatment of acne (such as the use of moisturizers) was associated not only with a 2.4-fold increase in the probability of adherence to pharmacological treatment, but also with a significant reduction in acne severity.5 Aside from skin care, cosmeceuticals themselves have efficacy in treating general dermatologic conditions. In the treatment of acne, topical niacinamide, a popular cosmeceutical ingredient, has been shown to have sebosuppressive and anti-inflammatory effects, addressing key aspects of acne pathogenesis.6 A double-blind study by Draelos et al. reported topical 2% niacinamide was effective in reducing the rate of sebum excretion in 50 Japanese patients over 4 weeks.6 In several double-blind studies that have compared twice daily application of 4% nicotinamide gel with the same application of 1% clindamycin gel in moderate inflammatory acne over 8 weeks, nicotinamide gel reduced the number of inflammatory papules and acne lesions to a level comparable with clindamycin gel.6 These studies support the use of niacinamide cosmeceutical products as an adjunctive treatment for acne.
With increased clinical data supporting cosmeceuticals, it can be expected that some cosmeceuticals will substitute traditional prescription medications in the dermatologists’ arsenal. For example, hydroquinone – both prescription strength and OTC 2% – is a workhorse in treating melasma; however, there is increasing interest in hydroquinone-free treatments, especially since OTC cosmeceuticals containing 2% hydroquinone were banned in 2020 because of safety concerns. Dermatologists will therefore need to provide guidance about hydroquinone alternatives for skin lightening, including soy, licorice extracts, kojic acid, arbutin, niacinamide, N-acetylglucosamine, and vitamin C, among others.7 Utilizing knowledge of a cosmeceutical’s mechanisms of action and clinical data, the dermatologist is in the best position to guide patients toward optimal ingredients and dispel cosmeceutical myths. Given that cosmeceuticals are not regulated by the Food and Drug Administration, it is even more important that the dermatologist serves as an authority on cosmeceuticals.
How to become a master skin care and cosmeceutical prescriber
A common pitfall I have observed among practitioners less experienced with aesthetic-focused skin care and cosmeceuticals is adapting a one-size-fits-all approach. In the one-size-fits-all approach, every patient concerned about aging gets the same vitamin C serum and retinoid, and every patient with hyperpigmentation gets the same hydroquinone prescription, for example. This approach, however, does not take into account unique differences in patients’ skin. Below
is the basic skin care framework that I follow, taught to me by Dr. Baumann. It utilizes an individualized approach based on the patient’s skin qualities to achieve optimal results.
Determine the patient’s skin type (dry vs. oily; sensitive vs. not sensitive; pigmentation issues vs. no hyperpigmentation; wrinkled and mature vs. nonwrinkled) and identify concerns (e.g., dark spots, redness, acne, dehydration).
Separate products into categories of cleansers, eye creams, moisturizers, sun protection, and treatments. Treatments refers to any additional products in a skin care regimen intended to ameliorate a particular condition (e.g., vitamin C for hyperpigmentation, retinoids for fine lines).
Choose products for each category in step 2 (cleansers, eye creams, moisturizers, sun protection, treatments) that are complementary to the patient’s skin type (determined in step 1) and aid the patient in meeting their particular skin goals. For example, a salicylic acid cleanser would be beneficial for a patient with oily skin and acne, but this same cleanser may be too drying and irritating for an acne patient with dry skin.
Ensure that chosen ingredients and products work together harmoniously. For example, while the acne patient may benefit from a salicylic acid cleanser and retinoid cream, using them in succession initially may be overly drying for some patients.
Spend the time to make sure patients understand the appropriate order of application and recognize when efficacy of a product is impacted by another product in the regimen. For example, a low pH cleanser can increase penetration of an ascorbic acid product that follows it in the regimen.
After establishing a basic skin care framework, the next step for beginners is learning about ingredients and their mechanisms of action and familiarizing themselves with scientific and clinical studies. Until cosmeceuticals become an integral part of the training curriculum, dermatologists can gain knowledge independently by reading literature and studies on cosmeceutical active ingredients and experimenting with consumer products. I look forward to regularly contributing to this column to further our awareness and understanding of the mechanisms of and data supporting cosmeceuticals so that we can better guide our patients.
Please feel free to email me at [email protected] or message me on Instagram @DrChloeGoldman with ideas that you would like me to address in this column.
Dr. Goldman is a dermatologist in private practice in Miami, and specializes in cosmetic and general dermatology. She practices at Baumann Cosmetic & Research Institute and is also opening a new general dermatology practice. Dr. Goldman receives compensation to create social media content for Replenix, a skin care company. She has no other relevant disclosures.
References
1. Kirby JS et al. J Am Acad Dermatol. 2013;68(2):e23-8.
2. Bauer et al. JAMA Dermatol. 2014;150(2):125-9.
3. Group A et al. Dermatol Surg. 2012;38(12):1975-80.
4. Feetham HJ et al. J Cosmet Dermatol. 2018;17(2):220-6.
5. de Lucas R et al. BMC Dermatol. 2015;15:17.
6. Araviiskaia E and Dreno BJ. Eur Acad Dermatol Venereol. 2016;30(6):926-35.
7. Leyden JJ et al. J Eur Acad Dermatol Venereol. 2011;25(10):1140-5.
Starting this month, I will be joining Dr. Leslie S. Baumann as a cocontributor to the Cosmeceutical Critique column, and since this is my first column, I would like to formally introduce myself. I am a cosmetic and general dermatologist in private practice in Miami and a longtime skin care enthusiast. My path toward becoming a dermatologist began when I was working in New York City, my hometown, as a scientific researcher, fulfilling my passion for scientific inquiry. After realizing that I most enjoyed applying discoveries made in the lab directly to patient care, I decided to pursue medical school at New York University before completing a dermatology residency at the University of Miami, serving as Chief Resident during my final year. Although I was born and raised in New York, staying in Miami was an obvious decision for me. In addition to the tropical weather and amazing lifestyle, the medical community in Miami supports adventure, creativity, and innovation, which are key aspects that drew me to the University of Miami and continue to drive my personal evolution in private practice.
I now practice at Baumann Cosmetic & Research Institute alongside my mentor, Dr. Baumann. I truly have my dream job – I get to talk skin care and do a wide array of cosmetics procedures, perform skin surgeries, and solve complex medical dermatology cases all in a day’s work. My career sits at the intersection of my passions for science, critical thinking, beauty, aesthetics, and most importantly, engaging with patients.
For my first column, I want to , and I will provide a simple framework to approach the design of skin care regimens and utilization of cosmeceuticals in practice.
The focus of a dermatology residency is on medical and surgical skills. We become experts in diagnosing and treating conditions ranging from life-threatening drug reactions like Stevens-Johnson Syndrome to complex diseases like dermatomyositis, utilizing medications and treatments ranging from cyclosporine and methotrexate to biologics and intravenous immunoglobulin, and performing advanced skin surgeries utilizing flaps and grafts to repair defects.
The discipline of cosmetic dermatology, let alone cosmeceuticals, accounts for a fraction of our didactic and hands-on training. I completed a top dermatology residency program that prepared me to treat any dermatologic condition; however, I honestly felt like I didn’t have a strong understanding of cosmeceuticals and skin care and how to integrate them with prescription therapies when I completed residency, which is a sentiment shared by residents across the country. I remember a study break while preparing for my final board exam when I went into a tailspin for an entire day trying to decode an ingredient list of a new “antiaging serum” and researching its mechanisms of action and the clinical data supporting the active ingredients in the serum, which included bakuchiol and a blend of peptides. As a dermatologist who likes to treat and provide recommendations based on scientific rationale and data to deliver the highest level of care, I admit that I felt insecure not being as knowledgeable about cosmeceuticals as I was about more complex dermatology treatments. As both a cosmetic and general dermatologist, discussing skin care and cosmeceuticals independent of or in conjunction with medical management occurs daily, and I recognized that becoming an expert in this area is essential to becoming a top, well-rounded dermatologist.
A gap in cosmeceutical education in dermatology residency
Multiple studies have established that the field of cosmetic dermatology comprises a fraction of dermatology residency training. In 2013, Kirby et al. published a survey of dermatology instructors and chief residents across the country and found that only 67% of responders reported having received formal lectures on cosmetic dermatology.1 In 2014, Bauer et al. published a survey of dermatology program directors assessing attitudes toward cosmetic dermatology and reported that only 38% of program directors believed that cosmetic dermatology should be a necessary aspect of residency training.2 A survey sent to dermatology residents published in 2012 found that among respondents, more than 58% of residency programs have an “encouraging or somewhat encouraging” attitude toward teaching cosmetic dermatology, yet 22% of programs had a “somewhat discouraging” or “discouraging” attitude.3 While these noted studies have focused on procedural aspects of cosmetic dermatology training, Feetham et al. surveyed dermatology residents and faculty to assess attitudes toward and training on skin care and cosmeceuticals specifically. Among resident respondents, most (74.5%) reported their education on skin care and cosmeceuticals has been “too little or nonexistent” during residency and 76.5% “agree or strongly agree” that it should be part of their education.4 In contrast, 60% of faculty reported resident education on skin care and cosmeceuticals is “just the right amount or too much” (P < .001).
In my personal experience as a resident, discussing skin care was emphasized when treating patients with eczema, contact dermatitis, acne, and hair disorders, but otherwise, the majority of skin care discussions relied on having a stock list of recommended cleansers, moisturizers, and sunscreens. In regards to cosmeceuticals for facial skin specifically, there were only a handful of instances in which alternative ingredients, such as vitamin C for hyperpigmentation, were discussed and specific brands were mentioned. Upon reflection, I wish I had more opportunity to see the clinical benefits of cosmeceuticals first hand, just like when I observe dupilumab clear patients with severe atopic dermatitis, rather than reading about it in textbooks and journals.
While one hypothesis for programs’ limited attention given to cosmetic training may be that it detracts from medical training, the survey by Bauer et al. found that residents did not feel less prepared (94.9%) or less interested (97.4%) in medical dermatology as a result of their cosmetic training.2 In addition, providers in an academic dermatology residency may limit discussions of skin care because of the high patient volume and because extensive skin care discussions will not impact insurance billings. Academic dermatology programs often service patients with more financial constraints, which further limits OTC cosmeceutical discussions. In my residency experience, I had the opportunity to regularly treat more severe and rare dermatologic cases than those I encounter in private practice; therefore, I spent more time focusing on systemic therapies, with fewer opportunities to dedicate time to cosmeceuticals.
Why skin care and cosmeceuticals should be an essential aspect of residency training
Discussing skin care and cosmeceuticals is a valuable aspect of medical and general dermatology, not just aesthetic dermatology. When treating general dermatologic conditions, guidance on proper skin care can improve both adherence and efficacy of medical treatments. For example, an acne study by de Lucas et al. demonstrated that adherence to adjuvant treatment of acne (such as the use of moisturizers) was associated not only with a 2.4-fold increase in the probability of adherence to pharmacological treatment, but also with a significant reduction in acne severity.5 Aside from skin care, cosmeceuticals themselves have efficacy in treating general dermatologic conditions. In the treatment of acne, topical niacinamide, a popular cosmeceutical ingredient, has been shown to have sebosuppressive and anti-inflammatory effects, addressing key aspects of acne pathogenesis.6 A double-blind study by Draelos et al. reported topical 2% niacinamide was effective in reducing the rate of sebum excretion in 50 Japanese patients over 4 weeks.6 In several double-blind studies that have compared twice daily application of 4% nicotinamide gel with the same application of 1% clindamycin gel in moderate inflammatory acne over 8 weeks, nicotinamide gel reduced the number of inflammatory papules and acne lesions to a level comparable with clindamycin gel.6 These studies support the use of niacinamide cosmeceutical products as an adjunctive treatment for acne.
With increased clinical data supporting cosmeceuticals, it can be expected that some cosmeceuticals will substitute traditional prescription medications in the dermatologists’ arsenal. For example, hydroquinone – both prescription strength and OTC 2% – is a workhorse in treating melasma; however, there is increasing interest in hydroquinone-free treatments, especially since OTC cosmeceuticals containing 2% hydroquinone were banned in 2020 because of safety concerns. Dermatologists will therefore need to provide guidance about hydroquinone alternatives for skin lightening, including soy, licorice extracts, kojic acid, arbutin, niacinamide, N-acetylglucosamine, and vitamin C, among others.7 Utilizing knowledge of a cosmeceutical’s mechanisms of action and clinical data, the dermatologist is in the best position to guide patients toward optimal ingredients and dispel cosmeceutical myths. Given that cosmeceuticals are not regulated by the Food and Drug Administration, it is even more important that the dermatologist serves as an authority on cosmeceuticals.
How to become a master skin care and cosmeceutical prescriber
A common pitfall I have observed among practitioners less experienced with aesthetic-focused skin care and cosmeceuticals is adapting a one-size-fits-all approach. In the one-size-fits-all approach, every patient concerned about aging gets the same vitamin C serum and retinoid, and every patient with hyperpigmentation gets the same hydroquinone prescription, for example. This approach, however, does not take into account unique differences in patients’ skin. Below
is the basic skin care framework that I follow, taught to me by Dr. Baumann. It utilizes an individualized approach based on the patient’s skin qualities to achieve optimal results.
Determine the patient’s skin type (dry vs. oily; sensitive vs. not sensitive; pigmentation issues vs. no hyperpigmentation; wrinkled and mature vs. nonwrinkled) and identify concerns (e.g., dark spots, redness, acne, dehydration).
Separate products into categories of cleansers, eye creams, moisturizers, sun protection, and treatments. Treatments refers to any additional products in a skin care regimen intended to ameliorate a particular condition (e.g., vitamin C for hyperpigmentation, retinoids for fine lines).
Choose products for each category in step 2 (cleansers, eye creams, moisturizers, sun protection, treatments) that are complementary to the patient’s skin type (determined in step 1) and aid the patient in meeting their particular skin goals. For example, a salicylic acid cleanser would be beneficial for a patient with oily skin and acne, but this same cleanser may be too drying and irritating for an acne patient with dry skin.
Ensure that chosen ingredients and products work together harmoniously. For example, while the acne patient may benefit from a salicylic acid cleanser and retinoid cream, using them in succession initially may be overly drying for some patients.
Spend the time to make sure patients understand the appropriate order of application and recognize when efficacy of a product is impacted by another product in the regimen. For example, a low pH cleanser can increase penetration of an ascorbic acid product that follows it in the regimen.
After establishing a basic skin care framework, the next step for beginners is learning about ingredients and their mechanisms of action and familiarizing themselves with scientific and clinical studies. Until cosmeceuticals become an integral part of the training curriculum, dermatologists can gain knowledge independently by reading literature and studies on cosmeceutical active ingredients and experimenting with consumer products. I look forward to regularly contributing to this column to further our awareness and understanding of the mechanisms of and data supporting cosmeceuticals so that we can better guide our patients.
Please feel free to email me at [email protected] or message me on Instagram @DrChloeGoldman with ideas that you would like me to address in this column.
Dr. Goldman is a dermatologist in private practice in Miami, and specializes in cosmetic and general dermatology. She practices at Baumann Cosmetic & Research Institute and is also opening a new general dermatology practice. Dr. Goldman receives compensation to create social media content for Replenix, a skin care company. She has no other relevant disclosures.
References
1. Kirby JS et al. J Am Acad Dermatol. 2013;68(2):e23-8.
2. Bauer et al. JAMA Dermatol. 2014;150(2):125-9.
3. Group A et al. Dermatol Surg. 2012;38(12):1975-80.
4. Feetham HJ et al. J Cosmet Dermatol. 2018;17(2):220-6.
5. de Lucas R et al. BMC Dermatol. 2015;15:17.
6. Araviiskaia E and Dreno BJ. Eur Acad Dermatol Venereol. 2016;30(6):926-35.
7. Leyden JJ et al. J Eur Acad Dermatol Venereol. 2011;25(10):1140-5.
Obstetrical care for gender diverse patients: A summary from the SMFM annual meeting
The purpose of this commentary is to provide a brief summary of discussions centering around reproductive health experiences and obstetrical care for gender-diverse patients from the recent Society of Maternal & Fetal Medicine meeting. Two presentations featured patient perspectives combined with physician lectures to provide a comprehensive outlook on unique reproductive care needs for this growing population.
One of the speakers, Trystan Reese, is a transgender activist, educator, and transgender male who chose to carry his own pregnancy and subsequently delivered his son in 2017. During the summit, he described many barriers that he faced during his pregnancy and offered providers suggestions on how to improve the care for members of the gender-diverse community seeking to start a family.
We often think of conception and pregnancy as experiences unique to one gender. This is simply not the case. In discussing preconceptual care and pregnancy, it is paramount for providers to make the distinction between gender identity and natal sex. Gender identity is an internal sense of self in relation to natal sex. Depending on this intrinsic feeling, people may identify as cisgender, transgender, or as a gender outside of the standard binary. Natal sex describes biologic characteristics such as chromosomal makeup, reproductive anatomy, and secondary sexual changes. In keeping these distinctions in mind, pregnancy is therefore exclusive to a person’s natal sex, not gender identity. One of the biggest challenges in caring for transgender patients who desire pregnancy, is the psychological distress related to the gendered notions surrounding this experience.1
There are many ways in which patients encounter unintentional marginalization within the medical system. For example, many electronic medical record systems don’t allow for pronouns or give error messages if the patient’s gender identity is different from their sex assigned at birth. Patients who attend prenatal appointments or birth classes are given documents that center around cisgender women and heterosexual relationships. The labor and delivery wards themselves typically include language such as “maternity,” and birth certificates have distinct “mother” and “father” denotations.1 Insurance coverage for prenatal care and delivery can be problematic if a patient who is assigned female at birth has changed their gender marker to “male” on their insurance card.
Many of these roadblocks can be ameliorated by utilizing more inclusive terminology. Terms such as “maternal” can be replaced with “pregnant patients, parent, or patients giving birth.” Names of maternity wards can be altered to perinatal units, which is more inclusive and more descriptive of the wide variety of patients that may experience childbirth and parenthood.1 Introducing “you-centered” language can also be helpful. Instead of saying “women may find ...” providers can try saying “patients may find ...” or “individuals may find.”1
Most of the medical and obstetrical care of gender-diverse patients is routine. Prenatal labs, aneuploidy screening, ultrasounds, and fetal surveillance do not differ between transgender and cisgender patients. However, the experience of pregnancy itself can significantly heighten feelings of dysphoria as it inherently leads to patients confronting aspects of their biological sex.2 Because of the teratogenic nature of testosterone, patients are required to stop taking testosterone prior to conception and for the duration of pregnancy. This can also heighten dysphoria and lead to increased rates of anxiety and depression.3
Many transgender patients can safely achieve a normal vaginal birth.4 A small survey of 41 people demonstrated that more transgender men who had taken testosterone were delivered by cesarean section (36% vs. 19%).3 Staff training is an important aspect of caring for a transgender patient in labor to ensure that all members of the labor unit are cognizant of appropriate name and pronoun usage. Another interesting, although unsurprising, fact is that many transgender gestational parents chose a community-based (out-of-hospital) birth according to a 2014 study.1 This is predominantly because of the discrimination patients face when delivering within a hospital setting.
Postpartum depression screening should be conducted prior to patients leaving the hospital and individualized during postpartum appointments. Reinitiation of testosterone can occur 4-6 weeks after delivery.1
While pregnancy can pose some unique challenges to gender-diverse individuals, these intricacies are not insurmountable. The result of pregnancy, regardless of one’s gender identity, is the same – parenthood. One patient’s description of his experience was particularly poignant: “Pregnancy and childbirth were very male experiences for me. When I birthed my children, I was born into fatherhood.”1 It is up to all providers to modify clinical settings, as well as our patient interactions and use of language, if we are to provide inclusion in obstetrics.1,5
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Brandt JS et al. “Understanding intersections: Care for transgender and gender diverse patient populations.” SMFM 2022 annual meeting. 2022 Feb 2.
2. Hoffkling A et al. BMC Pregnancy Childbirth. 2017 Nov 8;17(Suppl 2):332.
3. Light AD et al. Obstet Gynecol. 2014;124:1120-7.
4. Moseson H et al. Int J Transgend Health. 2021 Nov 17;22(1-2):30-41.
5. Brandt JS et al. Obstetrical care for trans*person, in “Trans*gynecology: Managing transgender patients in obstetrics and gynecology practice.” (Cambridge, England: Cambridge University Press, 2022).
The purpose of this commentary is to provide a brief summary of discussions centering around reproductive health experiences and obstetrical care for gender-diverse patients from the recent Society of Maternal & Fetal Medicine meeting. Two presentations featured patient perspectives combined with physician lectures to provide a comprehensive outlook on unique reproductive care needs for this growing population.
One of the speakers, Trystan Reese, is a transgender activist, educator, and transgender male who chose to carry his own pregnancy and subsequently delivered his son in 2017. During the summit, he described many barriers that he faced during his pregnancy and offered providers suggestions on how to improve the care for members of the gender-diverse community seeking to start a family.
We often think of conception and pregnancy as experiences unique to one gender. This is simply not the case. In discussing preconceptual care and pregnancy, it is paramount for providers to make the distinction between gender identity and natal sex. Gender identity is an internal sense of self in relation to natal sex. Depending on this intrinsic feeling, people may identify as cisgender, transgender, or as a gender outside of the standard binary. Natal sex describes biologic characteristics such as chromosomal makeup, reproductive anatomy, and secondary sexual changes. In keeping these distinctions in mind, pregnancy is therefore exclusive to a person’s natal sex, not gender identity. One of the biggest challenges in caring for transgender patients who desire pregnancy, is the psychological distress related to the gendered notions surrounding this experience.1
There are many ways in which patients encounter unintentional marginalization within the medical system. For example, many electronic medical record systems don’t allow for pronouns or give error messages if the patient’s gender identity is different from their sex assigned at birth. Patients who attend prenatal appointments or birth classes are given documents that center around cisgender women and heterosexual relationships. The labor and delivery wards themselves typically include language such as “maternity,” and birth certificates have distinct “mother” and “father” denotations.1 Insurance coverage for prenatal care and delivery can be problematic if a patient who is assigned female at birth has changed their gender marker to “male” on their insurance card.
Many of these roadblocks can be ameliorated by utilizing more inclusive terminology. Terms such as “maternal” can be replaced with “pregnant patients, parent, or patients giving birth.” Names of maternity wards can be altered to perinatal units, which is more inclusive and more descriptive of the wide variety of patients that may experience childbirth and parenthood.1 Introducing “you-centered” language can also be helpful. Instead of saying “women may find ...” providers can try saying “patients may find ...” or “individuals may find.”1
Most of the medical and obstetrical care of gender-diverse patients is routine. Prenatal labs, aneuploidy screening, ultrasounds, and fetal surveillance do not differ between transgender and cisgender patients. However, the experience of pregnancy itself can significantly heighten feelings of dysphoria as it inherently leads to patients confronting aspects of their biological sex.2 Because of the teratogenic nature of testosterone, patients are required to stop taking testosterone prior to conception and for the duration of pregnancy. This can also heighten dysphoria and lead to increased rates of anxiety and depression.3
Many transgender patients can safely achieve a normal vaginal birth.4 A small survey of 41 people demonstrated that more transgender men who had taken testosterone were delivered by cesarean section (36% vs. 19%).3 Staff training is an important aspect of caring for a transgender patient in labor to ensure that all members of the labor unit are cognizant of appropriate name and pronoun usage. Another interesting, although unsurprising, fact is that many transgender gestational parents chose a community-based (out-of-hospital) birth according to a 2014 study.1 This is predominantly because of the discrimination patients face when delivering within a hospital setting.
Postpartum depression screening should be conducted prior to patients leaving the hospital and individualized during postpartum appointments. Reinitiation of testosterone can occur 4-6 weeks after delivery.1
While pregnancy can pose some unique challenges to gender-diverse individuals, these intricacies are not insurmountable. The result of pregnancy, regardless of one’s gender identity, is the same – parenthood. One patient’s description of his experience was particularly poignant: “Pregnancy and childbirth were very male experiences for me. When I birthed my children, I was born into fatherhood.”1 It is up to all providers to modify clinical settings, as well as our patient interactions and use of language, if we are to provide inclusion in obstetrics.1,5
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Brandt JS et al. “Understanding intersections: Care for transgender and gender diverse patient populations.” SMFM 2022 annual meeting. 2022 Feb 2.
2. Hoffkling A et al. BMC Pregnancy Childbirth. 2017 Nov 8;17(Suppl 2):332.
3. Light AD et al. Obstet Gynecol. 2014;124:1120-7.
4. Moseson H et al. Int J Transgend Health. 2021 Nov 17;22(1-2):30-41.
5. Brandt JS et al. Obstetrical care for trans*person, in “Trans*gynecology: Managing transgender patients in obstetrics and gynecology practice.” (Cambridge, England: Cambridge University Press, 2022).
The purpose of this commentary is to provide a brief summary of discussions centering around reproductive health experiences and obstetrical care for gender-diverse patients from the recent Society of Maternal & Fetal Medicine meeting. Two presentations featured patient perspectives combined with physician lectures to provide a comprehensive outlook on unique reproductive care needs for this growing population.
One of the speakers, Trystan Reese, is a transgender activist, educator, and transgender male who chose to carry his own pregnancy and subsequently delivered his son in 2017. During the summit, he described many barriers that he faced during his pregnancy and offered providers suggestions on how to improve the care for members of the gender-diverse community seeking to start a family.
We often think of conception and pregnancy as experiences unique to one gender. This is simply not the case. In discussing preconceptual care and pregnancy, it is paramount for providers to make the distinction between gender identity and natal sex. Gender identity is an internal sense of self in relation to natal sex. Depending on this intrinsic feeling, people may identify as cisgender, transgender, or as a gender outside of the standard binary. Natal sex describes biologic characteristics such as chromosomal makeup, reproductive anatomy, and secondary sexual changes. In keeping these distinctions in mind, pregnancy is therefore exclusive to a person’s natal sex, not gender identity. One of the biggest challenges in caring for transgender patients who desire pregnancy, is the psychological distress related to the gendered notions surrounding this experience.1
There are many ways in which patients encounter unintentional marginalization within the medical system. For example, many electronic medical record systems don’t allow for pronouns or give error messages if the patient’s gender identity is different from their sex assigned at birth. Patients who attend prenatal appointments or birth classes are given documents that center around cisgender women and heterosexual relationships. The labor and delivery wards themselves typically include language such as “maternity,” and birth certificates have distinct “mother” and “father” denotations.1 Insurance coverage for prenatal care and delivery can be problematic if a patient who is assigned female at birth has changed their gender marker to “male” on their insurance card.
Many of these roadblocks can be ameliorated by utilizing more inclusive terminology. Terms such as “maternal” can be replaced with “pregnant patients, parent, or patients giving birth.” Names of maternity wards can be altered to perinatal units, which is more inclusive and more descriptive of the wide variety of patients that may experience childbirth and parenthood.1 Introducing “you-centered” language can also be helpful. Instead of saying “women may find ...” providers can try saying “patients may find ...” or “individuals may find.”1
Most of the medical and obstetrical care of gender-diverse patients is routine. Prenatal labs, aneuploidy screening, ultrasounds, and fetal surveillance do not differ between transgender and cisgender patients. However, the experience of pregnancy itself can significantly heighten feelings of dysphoria as it inherently leads to patients confronting aspects of their biological sex.2 Because of the teratogenic nature of testosterone, patients are required to stop taking testosterone prior to conception and for the duration of pregnancy. This can also heighten dysphoria and lead to increased rates of anxiety and depression.3
Many transgender patients can safely achieve a normal vaginal birth.4 A small survey of 41 people demonstrated that more transgender men who had taken testosterone were delivered by cesarean section (36% vs. 19%).3 Staff training is an important aspect of caring for a transgender patient in labor to ensure that all members of the labor unit are cognizant of appropriate name and pronoun usage. Another interesting, although unsurprising, fact is that many transgender gestational parents chose a community-based (out-of-hospital) birth according to a 2014 study.1 This is predominantly because of the discrimination patients face when delivering within a hospital setting.
Postpartum depression screening should be conducted prior to patients leaving the hospital and individualized during postpartum appointments. Reinitiation of testosterone can occur 4-6 weeks after delivery.1
While pregnancy can pose some unique challenges to gender-diverse individuals, these intricacies are not insurmountable. The result of pregnancy, regardless of one’s gender identity, is the same – parenthood. One patient’s description of his experience was particularly poignant: “Pregnancy and childbirth were very male experiences for me. When I birthed my children, I was born into fatherhood.”1 It is up to all providers to modify clinical settings, as well as our patient interactions and use of language, if we are to provide inclusion in obstetrics.1,5
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Brandt JS et al. “Understanding intersections: Care for transgender and gender diverse patient populations.” SMFM 2022 annual meeting. 2022 Feb 2.
2. Hoffkling A et al. BMC Pregnancy Childbirth. 2017 Nov 8;17(Suppl 2):332.
3. Light AD et al. Obstet Gynecol. 2014;124:1120-7.
4. Moseson H et al. Int J Transgend Health. 2021 Nov 17;22(1-2):30-41.
5. Brandt JS et al. Obstetrical care for trans*person, in “Trans*gynecology: Managing transgender patients in obstetrics and gynecology practice.” (Cambridge, England: Cambridge University Press, 2022).
Why is vitamin D hype so impervious to evidence?
The vitamin D story exudes teaching points: It offers a master class in critical appraisal, connecting the concepts of biologic plausibility, flawed surrogate markers, confounded observational studies, and slews of randomized controlled trials (RCTs) showing no benefits on health outcomes.
Yet despite the utter lack of benefit seen in trials, the hype continues. And the pandemic has only enhanced this hype as an onslaught of papers have reported the association of low vitamin D levels and COVID-19 disease.
My questions are simple: Why doesn’t the evidence persuade people? How many nonsignificant trials do we need before researchers stop studying vitamin D, doctors stop (routinely) measuring levels, and patients stop wasting money on the unhelpful supplement? What are the implications for this lack of persuasion?
Before exploring these questions, I want to set out that symptomatic vitamin deficiencies of any sort ought to be corrected.
Biologic plausibility and the pull of observational studies
It has long been known that vitamin D is crucial for bone health and that it can be produced in the skin with sun exposure. In the last decade, however, experts note that nearly every tissue and cell in our body has a vitamin D receptor. It then follows that if this many cells in the body can activate vitamin D, it must be vital for cardiovascular health, immune function, cancer prevention: basically, everything health related.
Oodles of observational studies have found that low serum levels of vitamin D correlate with higher mortality from all causes, cancer, cardiovascular disease, and now even COVID-19. Yet no matter the amount of statistical adjustment in these studies, we cannot know whether these associations are due to true causality.
The major issue is confounding: That is, people with low vitamin D levels have other conditions or diseases that lead to higher rates of ill health. Consider a patient with obesity, arthritis, and cognitive decline; this person is unlikely to do much exercise in the sun and may have low vitamin D levels. The low vitamin D level is simply a marker of overall poor health.
The randomized controlled trials tell a clear story
There are hundreds of vitamin D RCTs. The results simplify into one sentence: Vitamin D supplements do not improve health outcomes.
Here is a short summary of some recent studies.
VITAL, a massive (N > 25,000) RCT with 5 years of follow-up, compared vitamin D supplements to placebo and found no differences in the primary endpoints of cancer or cardiac events. Rates of death from any cause were nearly identical. Crucially, in subgroup analyses, the effects did not vary according to vitamin D levels at baseline.
The D-Health investigators randomly assigned more than 21,000 adults to vitamin D or placebo and after 5.7 years of follow-up reported no differences in the primary endpoint of overall mortality. There also were no differences in cardiovascular disease mortality.
Then you have the Mendelian randomized studies, which some have called nature’s RCT. These studies take advantage of the fact that some people are born with gene variations that predispose to low vitamin D levels. More than 60 Mendelian randomization studies have evaluated the consequences of lifelong genetically lowered vitamin D levels on various outcomes; most of these have found null effects.
Then there are the meta-analyses and systematic reviews. I loved the conclusion of this review of systematic reviews from the BMJ (emphasis mine):
“Despite a few hundred systematic reviews and meta-analyses, highly convincing evidence of a clear role of vitamin D does not exist for any outcome, but associations with a selection of outcomes are probable.”
The failure to persuade
My original plan was to emphasize the power of the RCT. Despite strong associations of low vitamin D levels with poor outcomes, the trials show no benefit to treatment. This strongly suggests (or nearly proves) that low vitamin D levels are akin to premature ventricular complexes after myocardial infarction: a marker for risk but not a target for therapy.
But I now see the more important issue as why scientists, funders, clinicians, and patients are not persuaded by clear evidence. Every day in clinic I see patients on vitamin D supplements; the journals keep publishing vitamin D studies. The proponents of vitamin D remain positive. And lately there is outsized attention and hope that vitamin D will mitigate SARS-CoV2 infection – based only on observational data.
You might argue against this point by saying vitamin D is natural and relatively innocuous, so who cares?
I offer three rebuttals to that point: Opportunity costs, distraction, and the insidious danger of poor critical appraisal skills. If you are burning money on vitamin D research, there is less available to study other important issues. If a patient is distracted by low vitamin D levels, she may pay less attention to her high body mass index or hypertension. And on the matter of critical appraisal, trust in medicine requires clinicians to be competent in critical appraisal. And these days, what could be more important than trust in medical professionals?
One major reason for the failure of persuasion of evidence is spin – or language that distracts from the primary endpoint. Here are two (of many) examples:
A meta-analysis of 50 vitamin D trials set out to study mortality. The authors found no significant difference in that primary endpoint. But the second sentence in their conclusion was that vitamin D supplements reduced the risk for cancer deaths by 15%. That’s a secondary endpoint in a study with nonsignificance in the primary endpoint. That is spin. This meta-analysis was completed before the Australian D-Health trial found that cancer deaths were 15% higher in the vitamin D arm, a difference that did not reach statistical significance.
The following example is worse: The authors of the VITAL trial, which found that vitamin D supplements had no effect on the primary endpoint of invasive cancer or cardiovascular disease, published a secondary analysis of the trial looking at a different endpoint: A composite incidence of metastatic and fatal invasive total cancer. They reported a 0.4% lower rate for the vitamin D group, a difference that barely made statistical significance at a P value of .04.
But everyone knows the dangers of reanalyzing data with a new endpoint after you have seen the data. What’s more, even if this were a reasonable post hoc analysis, the results are neither clinically meaningful nor statistically robust. Yet the fatally flawed paper has been viewed 60,000 times and picked up by 48 news outlets.
Another way to distract from nonsignificant primary outcomes is to nitpick the trials. The vitamin D dose wasn’t high enough, for instance. This might persuade me if there were one or two vitamin D trials, but there are hundreds of trials and meta-analyses, and their results are consistently null.
Conclusion: No, it is not hopeless
A nihilist would argue that fighting spin is futile. They would say you can’t fight incentives and business models. The incentive structure to publish is strong, and the journals and media know vitamin D studies garner attention – which is their currency.
I am not a nihilist and believe strongly that we must continue to teach critical appraisal and numerical literacy.
In fact, I would speculate that decades of poor critical appraisal by the medical profession have fostered outsized hope and created erroneous norms.
Imagine a counter-factual world in which clinicians have taught society that the human body is unlike an engine that can be repaired by fixing one part (i.e., the vitamin D level), that magic bullets (insulin) are rare, that most treatments fail, or that you can’t rely on association studies to prove efficacy.
In this world, people would be immune from spin and hype.
The norm would be that pills, supplements, and procedures are not what delivers good health. What delivers health is an amalgam of good luck, healthy habits, and lots of time spent outside playing in the sun.
Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
The vitamin D story exudes teaching points: It offers a master class in critical appraisal, connecting the concepts of biologic plausibility, flawed surrogate markers, confounded observational studies, and slews of randomized controlled trials (RCTs) showing no benefits on health outcomes.
Yet despite the utter lack of benefit seen in trials, the hype continues. And the pandemic has only enhanced this hype as an onslaught of papers have reported the association of low vitamin D levels and COVID-19 disease.
My questions are simple: Why doesn’t the evidence persuade people? How many nonsignificant trials do we need before researchers stop studying vitamin D, doctors stop (routinely) measuring levels, and patients stop wasting money on the unhelpful supplement? What are the implications for this lack of persuasion?
Before exploring these questions, I want to set out that symptomatic vitamin deficiencies of any sort ought to be corrected.
Biologic plausibility and the pull of observational studies
It has long been known that vitamin D is crucial for bone health and that it can be produced in the skin with sun exposure. In the last decade, however, experts note that nearly every tissue and cell in our body has a vitamin D receptor. It then follows that if this many cells in the body can activate vitamin D, it must be vital for cardiovascular health, immune function, cancer prevention: basically, everything health related.
Oodles of observational studies have found that low serum levels of vitamin D correlate with higher mortality from all causes, cancer, cardiovascular disease, and now even COVID-19. Yet no matter the amount of statistical adjustment in these studies, we cannot know whether these associations are due to true causality.
The major issue is confounding: That is, people with low vitamin D levels have other conditions or diseases that lead to higher rates of ill health. Consider a patient with obesity, arthritis, and cognitive decline; this person is unlikely to do much exercise in the sun and may have low vitamin D levels. The low vitamin D level is simply a marker of overall poor health.
The randomized controlled trials tell a clear story
There are hundreds of vitamin D RCTs. The results simplify into one sentence: Vitamin D supplements do not improve health outcomes.
Here is a short summary of some recent studies.
VITAL, a massive (N > 25,000) RCT with 5 years of follow-up, compared vitamin D supplements to placebo and found no differences in the primary endpoints of cancer or cardiac events. Rates of death from any cause were nearly identical. Crucially, in subgroup analyses, the effects did not vary according to vitamin D levels at baseline.
The D-Health investigators randomly assigned more than 21,000 adults to vitamin D or placebo and after 5.7 years of follow-up reported no differences in the primary endpoint of overall mortality. There also were no differences in cardiovascular disease mortality.
Then you have the Mendelian randomized studies, which some have called nature’s RCT. These studies take advantage of the fact that some people are born with gene variations that predispose to low vitamin D levels. More than 60 Mendelian randomization studies have evaluated the consequences of lifelong genetically lowered vitamin D levels on various outcomes; most of these have found null effects.
Then there are the meta-analyses and systematic reviews. I loved the conclusion of this review of systematic reviews from the BMJ (emphasis mine):
“Despite a few hundred systematic reviews and meta-analyses, highly convincing evidence of a clear role of vitamin D does not exist for any outcome, but associations with a selection of outcomes are probable.”
The failure to persuade
My original plan was to emphasize the power of the RCT. Despite strong associations of low vitamin D levels with poor outcomes, the trials show no benefit to treatment. This strongly suggests (or nearly proves) that low vitamin D levels are akin to premature ventricular complexes after myocardial infarction: a marker for risk but not a target for therapy.
But I now see the more important issue as why scientists, funders, clinicians, and patients are not persuaded by clear evidence. Every day in clinic I see patients on vitamin D supplements; the journals keep publishing vitamin D studies. The proponents of vitamin D remain positive. And lately there is outsized attention and hope that vitamin D will mitigate SARS-CoV2 infection – based only on observational data.
You might argue against this point by saying vitamin D is natural and relatively innocuous, so who cares?
I offer three rebuttals to that point: Opportunity costs, distraction, and the insidious danger of poor critical appraisal skills. If you are burning money on vitamin D research, there is less available to study other important issues. If a patient is distracted by low vitamin D levels, she may pay less attention to her high body mass index or hypertension. And on the matter of critical appraisal, trust in medicine requires clinicians to be competent in critical appraisal. And these days, what could be more important than trust in medical professionals?
One major reason for the failure of persuasion of evidence is spin – or language that distracts from the primary endpoint. Here are two (of many) examples:
A meta-analysis of 50 vitamin D trials set out to study mortality. The authors found no significant difference in that primary endpoint. But the second sentence in their conclusion was that vitamin D supplements reduced the risk for cancer deaths by 15%. That’s a secondary endpoint in a study with nonsignificance in the primary endpoint. That is spin. This meta-analysis was completed before the Australian D-Health trial found that cancer deaths were 15% higher in the vitamin D arm, a difference that did not reach statistical significance.
The following example is worse: The authors of the VITAL trial, which found that vitamin D supplements had no effect on the primary endpoint of invasive cancer or cardiovascular disease, published a secondary analysis of the trial looking at a different endpoint: A composite incidence of metastatic and fatal invasive total cancer. They reported a 0.4% lower rate for the vitamin D group, a difference that barely made statistical significance at a P value of .04.
But everyone knows the dangers of reanalyzing data with a new endpoint after you have seen the data. What’s more, even if this were a reasonable post hoc analysis, the results are neither clinically meaningful nor statistically robust. Yet the fatally flawed paper has been viewed 60,000 times and picked up by 48 news outlets.
Another way to distract from nonsignificant primary outcomes is to nitpick the trials. The vitamin D dose wasn’t high enough, for instance. This might persuade me if there were one or two vitamin D trials, but there are hundreds of trials and meta-analyses, and their results are consistently null.
Conclusion: No, it is not hopeless
A nihilist would argue that fighting spin is futile. They would say you can’t fight incentives and business models. The incentive structure to publish is strong, and the journals and media know vitamin D studies garner attention – which is their currency.
I am not a nihilist and believe strongly that we must continue to teach critical appraisal and numerical literacy.
In fact, I would speculate that decades of poor critical appraisal by the medical profession have fostered outsized hope and created erroneous norms.
Imagine a counter-factual world in which clinicians have taught society that the human body is unlike an engine that can be repaired by fixing one part (i.e., the vitamin D level), that magic bullets (insulin) are rare, that most treatments fail, or that you can’t rely on association studies to prove efficacy.
In this world, people would be immune from spin and hype.
The norm would be that pills, supplements, and procedures are not what delivers good health. What delivers health is an amalgam of good luck, healthy habits, and lots of time spent outside playing in the sun.
Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
The vitamin D story exudes teaching points: It offers a master class in critical appraisal, connecting the concepts of biologic plausibility, flawed surrogate markers, confounded observational studies, and slews of randomized controlled trials (RCTs) showing no benefits on health outcomes.
Yet despite the utter lack of benefit seen in trials, the hype continues. And the pandemic has only enhanced this hype as an onslaught of papers have reported the association of low vitamin D levels and COVID-19 disease.
My questions are simple: Why doesn’t the evidence persuade people? How many nonsignificant trials do we need before researchers stop studying vitamin D, doctors stop (routinely) measuring levels, and patients stop wasting money on the unhelpful supplement? What are the implications for this lack of persuasion?
Before exploring these questions, I want to set out that symptomatic vitamin deficiencies of any sort ought to be corrected.
Biologic plausibility and the pull of observational studies
It has long been known that vitamin D is crucial for bone health and that it can be produced in the skin with sun exposure. In the last decade, however, experts note that nearly every tissue and cell in our body has a vitamin D receptor. It then follows that if this many cells in the body can activate vitamin D, it must be vital for cardiovascular health, immune function, cancer prevention: basically, everything health related.
Oodles of observational studies have found that low serum levels of vitamin D correlate with higher mortality from all causes, cancer, cardiovascular disease, and now even COVID-19. Yet no matter the amount of statistical adjustment in these studies, we cannot know whether these associations are due to true causality.
The major issue is confounding: That is, people with low vitamin D levels have other conditions or diseases that lead to higher rates of ill health. Consider a patient with obesity, arthritis, and cognitive decline; this person is unlikely to do much exercise in the sun and may have low vitamin D levels. The low vitamin D level is simply a marker of overall poor health.
The randomized controlled trials tell a clear story
There are hundreds of vitamin D RCTs. The results simplify into one sentence: Vitamin D supplements do not improve health outcomes.
Here is a short summary of some recent studies.
VITAL, a massive (N > 25,000) RCT with 5 years of follow-up, compared vitamin D supplements to placebo and found no differences in the primary endpoints of cancer or cardiac events. Rates of death from any cause were nearly identical. Crucially, in subgroup analyses, the effects did not vary according to vitamin D levels at baseline.
The D-Health investigators randomly assigned more than 21,000 adults to vitamin D or placebo and after 5.7 years of follow-up reported no differences in the primary endpoint of overall mortality. There also were no differences in cardiovascular disease mortality.
Then you have the Mendelian randomized studies, which some have called nature’s RCT. These studies take advantage of the fact that some people are born with gene variations that predispose to low vitamin D levels. More than 60 Mendelian randomization studies have evaluated the consequences of lifelong genetically lowered vitamin D levels on various outcomes; most of these have found null effects.
Then there are the meta-analyses and systematic reviews. I loved the conclusion of this review of systematic reviews from the BMJ (emphasis mine):
“Despite a few hundred systematic reviews and meta-analyses, highly convincing evidence of a clear role of vitamin D does not exist for any outcome, but associations with a selection of outcomes are probable.”
The failure to persuade
My original plan was to emphasize the power of the RCT. Despite strong associations of low vitamin D levels with poor outcomes, the trials show no benefit to treatment. This strongly suggests (or nearly proves) that low vitamin D levels are akin to premature ventricular complexes after myocardial infarction: a marker for risk but not a target for therapy.
But I now see the more important issue as why scientists, funders, clinicians, and patients are not persuaded by clear evidence. Every day in clinic I see patients on vitamin D supplements; the journals keep publishing vitamin D studies. The proponents of vitamin D remain positive. And lately there is outsized attention and hope that vitamin D will mitigate SARS-CoV2 infection – based only on observational data.
You might argue against this point by saying vitamin D is natural and relatively innocuous, so who cares?
I offer three rebuttals to that point: Opportunity costs, distraction, and the insidious danger of poor critical appraisal skills. If you are burning money on vitamin D research, there is less available to study other important issues. If a patient is distracted by low vitamin D levels, she may pay less attention to her high body mass index or hypertension. And on the matter of critical appraisal, trust in medicine requires clinicians to be competent in critical appraisal. And these days, what could be more important than trust in medical professionals?
One major reason for the failure of persuasion of evidence is spin – or language that distracts from the primary endpoint. Here are two (of many) examples:
A meta-analysis of 50 vitamin D trials set out to study mortality. The authors found no significant difference in that primary endpoint. But the second sentence in their conclusion was that vitamin D supplements reduced the risk for cancer deaths by 15%. That’s a secondary endpoint in a study with nonsignificance in the primary endpoint. That is spin. This meta-analysis was completed before the Australian D-Health trial found that cancer deaths were 15% higher in the vitamin D arm, a difference that did not reach statistical significance.
The following example is worse: The authors of the VITAL trial, which found that vitamin D supplements had no effect on the primary endpoint of invasive cancer or cardiovascular disease, published a secondary analysis of the trial looking at a different endpoint: A composite incidence of metastatic and fatal invasive total cancer. They reported a 0.4% lower rate for the vitamin D group, a difference that barely made statistical significance at a P value of .04.
But everyone knows the dangers of reanalyzing data with a new endpoint after you have seen the data. What’s more, even if this were a reasonable post hoc analysis, the results are neither clinically meaningful nor statistically robust. Yet the fatally flawed paper has been viewed 60,000 times and picked up by 48 news outlets.
Another way to distract from nonsignificant primary outcomes is to nitpick the trials. The vitamin D dose wasn’t high enough, for instance. This might persuade me if there were one or two vitamin D trials, but there are hundreds of trials and meta-analyses, and their results are consistently null.
Conclusion: No, it is not hopeless
A nihilist would argue that fighting spin is futile. They would say you can’t fight incentives and business models. The incentive structure to publish is strong, and the journals and media know vitamin D studies garner attention – which is their currency.
I am not a nihilist and believe strongly that we must continue to teach critical appraisal and numerical literacy.
In fact, I would speculate that decades of poor critical appraisal by the medical profession have fostered outsized hope and created erroneous norms.
Imagine a counter-factual world in which clinicians have taught society that the human body is unlike an engine that can be repaired by fixing one part (i.e., the vitamin D level), that magic bullets (insulin) are rare, that most treatments fail, or that you can’t rely on association studies to prove efficacy.
In this world, people would be immune from spin and hype.
The norm would be that pills, supplements, and procedures are not what delivers good health. What delivers health is an amalgam of good luck, healthy habits, and lots of time spent outside playing in the sun.
Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
Practice valuation
.
Too often, physicians are not receiving a fair return on the equity they have worked so hard to build over several decades, either because they have waited too long and must accept what is offered, or because they simply take the buyer’s word for their practice’s value. Don’t put yourself in either of those positions, and don’t entertain any offers until you obtain an objective appraisal from a neutral party.
Of course, a medical practice is trickier to value than an ordinary business, and usually requires the services of an experienced professional appraiser. Entire books have been written about the process, so I can’t hope to cover it completely in 750 words; but three basic yardsticks are essential for determining the equity, or book value, of a practice:
- Tangible assets. Equipment, cash, accounts receivable, and other property owned by the practice.
- Liabilities. Accounts payable, outstanding loans, and anything else owed to others.
- Intangible assets. Sometimes called “good will” – the reputation of the physicians, the location and name recognition of the practice, the loyalty and volume of patients, and other, well, intangibles.
Valuing tangible assets is comparatively straightforward, but there are several ways to do it, and when reviewing a practice appraisal you should ask which of them was used. Depreciated value is the book value of equipment and supplies as determined by their purchase price, less the amount their value has decreased since purchase. Remaining useful life value estimates how long the equipment can be expected to last. Market (or replacement) value is the amount it would cost on the open market to replace all equipment and supplies.
Intangible assets are more difficult to value. Many components are analyzed, including location, interior and exterior decor, accessibility to patients, age and functional status of equipment, systems in place to promote efficiency, reasons why patients come back (if in fact they do), and the overall reputation of the practice in the community. Other important factors include the “payer mix” (what percentage pays cash, how many third-party contracts are in place and how well they pay, etcetera), the extent and strength of the referral base, and the presence of supplemental income streams, such as clinical research.
It is also important to determine to what extent intangible assets are transferable. For example, unique skills with a laser, neurotoxins, or filler substances, or extraordinary personal charisma, may increase your practice’s value to you, but they are worthless to the next owner, and he or she will be unwilling to pay for them unless your services become part of the deal.
Once again there are many ways to estimate intangible asset value, and once again you should ask which were used. Cash flow analysis works on the assumption that cash flow is a measure of intangible value. Capitalization of earnings puts a value, or capitalization, on the practice’s income streams using a variety of assumptions. Guideline comparison uses various databases to compare your practice with other, similar ones that have changed hands in the past.
Two newer techniques that some consider a better estimate of intangible assets are the replacement method, which estimates the costs of starting the practice over again in the current market; and the excess earnings method, which measures how far above average your practice’s earnings (and thus its overall value) are.
Asset-based valuation is the most popular, but by no means the only method available. Income-based valuation looks at the source and strength of a practice’s income stream as a creator of value, as well as whether or not its income stream under a different owner would mirror its present one. This in turn becomes the basis for an understanding of the fair market value of both tangible and intangible assets. Market valuation combines the asset-based and income-based approaches, along with an analysis of sales and mergers of comparable practices in the community, to determine the value of a practice in its local market.
Whatever methods are used, it is important that the appraisal be done by an experienced and independent financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation is supplied to support the conclusions reached. This is especially important if the appraisal will be relied upon in the sale or merger of the practice.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
.
Too often, physicians are not receiving a fair return on the equity they have worked so hard to build over several decades, either because they have waited too long and must accept what is offered, or because they simply take the buyer’s word for their practice’s value. Don’t put yourself in either of those positions, and don’t entertain any offers until you obtain an objective appraisal from a neutral party.
Of course, a medical practice is trickier to value than an ordinary business, and usually requires the services of an experienced professional appraiser. Entire books have been written about the process, so I can’t hope to cover it completely in 750 words; but three basic yardsticks are essential for determining the equity, or book value, of a practice:
- Tangible assets. Equipment, cash, accounts receivable, and other property owned by the practice.
- Liabilities. Accounts payable, outstanding loans, and anything else owed to others.
- Intangible assets. Sometimes called “good will” – the reputation of the physicians, the location and name recognition of the practice, the loyalty and volume of patients, and other, well, intangibles.
Valuing tangible assets is comparatively straightforward, but there are several ways to do it, and when reviewing a practice appraisal you should ask which of them was used. Depreciated value is the book value of equipment and supplies as determined by their purchase price, less the amount their value has decreased since purchase. Remaining useful life value estimates how long the equipment can be expected to last. Market (or replacement) value is the amount it would cost on the open market to replace all equipment and supplies.
Intangible assets are more difficult to value. Many components are analyzed, including location, interior and exterior decor, accessibility to patients, age and functional status of equipment, systems in place to promote efficiency, reasons why patients come back (if in fact they do), and the overall reputation of the practice in the community. Other important factors include the “payer mix” (what percentage pays cash, how many third-party contracts are in place and how well they pay, etcetera), the extent and strength of the referral base, and the presence of supplemental income streams, such as clinical research.
It is also important to determine to what extent intangible assets are transferable. For example, unique skills with a laser, neurotoxins, or filler substances, or extraordinary personal charisma, may increase your practice’s value to you, but they are worthless to the next owner, and he or she will be unwilling to pay for them unless your services become part of the deal.
Once again there are many ways to estimate intangible asset value, and once again you should ask which were used. Cash flow analysis works on the assumption that cash flow is a measure of intangible value. Capitalization of earnings puts a value, or capitalization, on the practice’s income streams using a variety of assumptions. Guideline comparison uses various databases to compare your practice with other, similar ones that have changed hands in the past.
Two newer techniques that some consider a better estimate of intangible assets are the replacement method, which estimates the costs of starting the practice over again in the current market; and the excess earnings method, which measures how far above average your practice’s earnings (and thus its overall value) are.
Asset-based valuation is the most popular, but by no means the only method available. Income-based valuation looks at the source and strength of a practice’s income stream as a creator of value, as well as whether or not its income stream under a different owner would mirror its present one. This in turn becomes the basis for an understanding of the fair market value of both tangible and intangible assets. Market valuation combines the asset-based and income-based approaches, along with an analysis of sales and mergers of comparable practices in the community, to determine the value of a practice in its local market.
Whatever methods are used, it is important that the appraisal be done by an experienced and independent financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation is supplied to support the conclusions reached. This is especially important if the appraisal will be relied upon in the sale or merger of the practice.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
.
Too often, physicians are not receiving a fair return on the equity they have worked so hard to build over several decades, either because they have waited too long and must accept what is offered, or because they simply take the buyer’s word for their practice’s value. Don’t put yourself in either of those positions, and don’t entertain any offers until you obtain an objective appraisal from a neutral party.
Of course, a medical practice is trickier to value than an ordinary business, and usually requires the services of an experienced professional appraiser. Entire books have been written about the process, so I can’t hope to cover it completely in 750 words; but three basic yardsticks are essential for determining the equity, or book value, of a practice:
- Tangible assets. Equipment, cash, accounts receivable, and other property owned by the practice.
- Liabilities. Accounts payable, outstanding loans, and anything else owed to others.
- Intangible assets. Sometimes called “good will” – the reputation of the physicians, the location and name recognition of the practice, the loyalty and volume of patients, and other, well, intangibles.
Valuing tangible assets is comparatively straightforward, but there are several ways to do it, and when reviewing a practice appraisal you should ask which of them was used. Depreciated value is the book value of equipment and supplies as determined by their purchase price, less the amount their value has decreased since purchase. Remaining useful life value estimates how long the equipment can be expected to last. Market (or replacement) value is the amount it would cost on the open market to replace all equipment and supplies.
Intangible assets are more difficult to value. Many components are analyzed, including location, interior and exterior decor, accessibility to patients, age and functional status of equipment, systems in place to promote efficiency, reasons why patients come back (if in fact they do), and the overall reputation of the practice in the community. Other important factors include the “payer mix” (what percentage pays cash, how many third-party contracts are in place and how well they pay, etcetera), the extent and strength of the referral base, and the presence of supplemental income streams, such as clinical research.
It is also important to determine to what extent intangible assets are transferable. For example, unique skills with a laser, neurotoxins, or filler substances, or extraordinary personal charisma, may increase your practice’s value to you, but they are worthless to the next owner, and he or she will be unwilling to pay for them unless your services become part of the deal.
Once again there are many ways to estimate intangible asset value, and once again you should ask which were used. Cash flow analysis works on the assumption that cash flow is a measure of intangible value. Capitalization of earnings puts a value, or capitalization, on the practice’s income streams using a variety of assumptions. Guideline comparison uses various databases to compare your practice with other, similar ones that have changed hands in the past.
Two newer techniques that some consider a better estimate of intangible assets are the replacement method, which estimates the costs of starting the practice over again in the current market; and the excess earnings method, which measures how far above average your practice’s earnings (and thus its overall value) are.
Asset-based valuation is the most popular, but by no means the only method available. Income-based valuation looks at the source and strength of a practice’s income stream as a creator of value, as well as whether or not its income stream under a different owner would mirror its present one. This in turn becomes the basis for an understanding of the fair market value of both tangible and intangible assets. Market valuation combines the asset-based and income-based approaches, along with an analysis of sales and mergers of comparable practices in the community, to determine the value of a practice in its local market.
Whatever methods are used, it is important that the appraisal be done by an experienced and independent financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation is supplied to support the conclusions reached. This is especially important if the appraisal will be relied upon in the sale or merger of the practice.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
To a perfect day
Motionless, every Olympic skater starts off perfectly. Once the music starts, it’s up to them whether they will continue on perfectly or not. In this way, you’re just like an Olympic skater. Each day, a skating program. The music starts the moment your foot touches the floor in the morning. It’s up to you if the rest of the day will continue on flawlessly or not. To this point, I’ve yet to have a perfect day.
If I’m honest, my “perfect day” streak typically ends once I’ve made coffee. By then, I’ll have spilled a few grains of grounds or clinked mugs together when taking one from the cupboard. (D’oh!) Hardly ever can I make it to backing out of the driveway, let alone through a patient encounter. I’ve had a few procedures that when complete I’ve thought, “well, that looks great.” I can remember encounters that went brilliantly despite a high technical difficulty. I’ve also tagged a 7-iron shot 160 downwind yards to within inches of the cup. But I’ve hardly ever done anything in my life perfectly.
What does it mean to be perfect? Well, there have been 23 perfect baseball games. In 1972, the Miami Dolphins had the only perfect NFL season, 14-0 (although my 2007 Patriots went 18-0 before losing to the – ugh – Giants). Every year, several hundred students score a perfect 1600 on the SAT. In an underground vault somewhere in France is a perfect sphere, a perfectly spherical 1-kg mass of pure silicon. There are at least 51 perfect numbers. And model Bella Hadid’s exactly 1.62-ratioed face is said to be perfectly beautiful. But yet, U.S. skater Nathan Chen’s seemingly flawless 113.97-point short program in Beijing, still imperfect.
Attempting a perfect day or perfect surgery or a perfect pour over coffee is a fun game, but perfectionism has an insidious side. Some of us feel this way every day: We must do it exactly right, every time. Even an insignificant imperfection or error feels like failure. A 3.90 GPA is a fail. 515 on the MCAT, not nearly good enough. For them, the burden of perfection is crushing. It is hard for some to recognize that even if your performance could not be improved, the outcome can still be flawed. A chip in the ice, a patient showing up late, an interviewer with an agenda, a missed referee call can all flub up an otherwise flawless day. It isn’t necessary to abandon hope, all ye who live in the real world. Although achieving perfection is usually impossible, reward comes from the pursuit of perfection, not from holding it. It is called perfectionistic striving and in contrast to perfectionistic concerns, it is associated with resilience and positive mood. To do so you must combine giving your all with acceptance of whatever the outcome.
Keith Jarrett is one of the greatest jazz pianists of all time. He is a true perfectionist, precise in his standards and exacting in expectations. In 1975 in Cologne, Germany, he agreed to play at the behest of a teenage girl who arranged to have him perform at the opera house. Except, there was a miscommunication and only a small, broken rehearsal piano was available. As the story goes, she approached him as he waited to be taken back to his hotel, the concert was canceled and she somehow convinced him to play on the nearly unplayable instrument. The result is the Köln Concert, one of the greatest jazz performances in history. It was perfectly imperfect.
Yes, even the 1-kg sphere has femtogram quantities of other elements mixed in – the universal standard for perfect is itself, imperfect. It doesn’t matter. It’s the pursuit of such that makes life worthwhile. There’s always tomorrow. Have your coffee grinders ready.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
Motionless, every Olympic skater starts off perfectly. Once the music starts, it’s up to them whether they will continue on perfectly or not. In this way, you’re just like an Olympic skater. Each day, a skating program. The music starts the moment your foot touches the floor in the morning. It’s up to you if the rest of the day will continue on flawlessly or not. To this point, I’ve yet to have a perfect day.
If I’m honest, my “perfect day” streak typically ends once I’ve made coffee. By then, I’ll have spilled a few grains of grounds or clinked mugs together when taking one from the cupboard. (D’oh!) Hardly ever can I make it to backing out of the driveway, let alone through a patient encounter. I’ve had a few procedures that when complete I’ve thought, “well, that looks great.” I can remember encounters that went brilliantly despite a high technical difficulty. I’ve also tagged a 7-iron shot 160 downwind yards to within inches of the cup. But I’ve hardly ever done anything in my life perfectly.
What does it mean to be perfect? Well, there have been 23 perfect baseball games. In 1972, the Miami Dolphins had the only perfect NFL season, 14-0 (although my 2007 Patriots went 18-0 before losing to the – ugh – Giants). Every year, several hundred students score a perfect 1600 on the SAT. In an underground vault somewhere in France is a perfect sphere, a perfectly spherical 1-kg mass of pure silicon. There are at least 51 perfect numbers. And model Bella Hadid’s exactly 1.62-ratioed face is said to be perfectly beautiful. But yet, U.S. skater Nathan Chen’s seemingly flawless 113.97-point short program in Beijing, still imperfect.
Attempting a perfect day or perfect surgery or a perfect pour over coffee is a fun game, but perfectionism has an insidious side. Some of us feel this way every day: We must do it exactly right, every time. Even an insignificant imperfection or error feels like failure. A 3.90 GPA is a fail. 515 on the MCAT, not nearly good enough. For them, the burden of perfection is crushing. It is hard for some to recognize that even if your performance could not be improved, the outcome can still be flawed. A chip in the ice, a patient showing up late, an interviewer with an agenda, a missed referee call can all flub up an otherwise flawless day. It isn’t necessary to abandon hope, all ye who live in the real world. Although achieving perfection is usually impossible, reward comes from the pursuit of perfection, not from holding it. It is called perfectionistic striving and in contrast to perfectionistic concerns, it is associated with resilience and positive mood. To do so you must combine giving your all with acceptance of whatever the outcome.
Keith Jarrett is one of the greatest jazz pianists of all time. He is a true perfectionist, precise in his standards and exacting in expectations. In 1975 in Cologne, Germany, he agreed to play at the behest of a teenage girl who arranged to have him perform at the opera house. Except, there was a miscommunication and only a small, broken rehearsal piano was available. As the story goes, she approached him as he waited to be taken back to his hotel, the concert was canceled and she somehow convinced him to play on the nearly unplayable instrument. The result is the Köln Concert, one of the greatest jazz performances in history. It was perfectly imperfect.
Yes, even the 1-kg sphere has femtogram quantities of other elements mixed in – the universal standard for perfect is itself, imperfect. It doesn’t matter. It’s the pursuit of such that makes life worthwhile. There’s always tomorrow. Have your coffee grinders ready.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
Motionless, every Olympic skater starts off perfectly. Once the music starts, it’s up to them whether they will continue on perfectly or not. In this way, you’re just like an Olympic skater. Each day, a skating program. The music starts the moment your foot touches the floor in the morning. It’s up to you if the rest of the day will continue on flawlessly or not. To this point, I’ve yet to have a perfect day.
If I’m honest, my “perfect day” streak typically ends once I’ve made coffee. By then, I’ll have spilled a few grains of grounds or clinked mugs together when taking one from the cupboard. (D’oh!) Hardly ever can I make it to backing out of the driveway, let alone through a patient encounter. I’ve had a few procedures that when complete I’ve thought, “well, that looks great.” I can remember encounters that went brilliantly despite a high technical difficulty. I’ve also tagged a 7-iron shot 160 downwind yards to within inches of the cup. But I’ve hardly ever done anything in my life perfectly.
What does it mean to be perfect? Well, there have been 23 perfect baseball games. In 1972, the Miami Dolphins had the only perfect NFL season, 14-0 (although my 2007 Patriots went 18-0 before losing to the – ugh – Giants). Every year, several hundred students score a perfect 1600 on the SAT. In an underground vault somewhere in France is a perfect sphere, a perfectly spherical 1-kg mass of pure silicon. There are at least 51 perfect numbers. And model Bella Hadid’s exactly 1.62-ratioed face is said to be perfectly beautiful. But yet, U.S. skater Nathan Chen’s seemingly flawless 113.97-point short program in Beijing, still imperfect.
Attempting a perfect day or perfect surgery or a perfect pour over coffee is a fun game, but perfectionism has an insidious side. Some of us feel this way every day: We must do it exactly right, every time. Even an insignificant imperfection or error feels like failure. A 3.90 GPA is a fail. 515 on the MCAT, not nearly good enough. For them, the burden of perfection is crushing. It is hard for some to recognize that even if your performance could not be improved, the outcome can still be flawed. A chip in the ice, a patient showing up late, an interviewer with an agenda, a missed referee call can all flub up an otherwise flawless day. It isn’t necessary to abandon hope, all ye who live in the real world. Although achieving perfection is usually impossible, reward comes from the pursuit of perfection, not from holding it. It is called perfectionistic striving and in contrast to perfectionistic concerns, it is associated with resilience and positive mood. To do so you must combine giving your all with acceptance of whatever the outcome.
Keith Jarrett is one of the greatest jazz pianists of all time. He is a true perfectionist, precise in his standards and exacting in expectations. In 1975 in Cologne, Germany, he agreed to play at the behest of a teenage girl who arranged to have him perform at the opera house. Except, there was a miscommunication and only a small, broken rehearsal piano was available. As the story goes, she approached him as he waited to be taken back to his hotel, the concert was canceled and she somehow convinced him to play on the nearly unplayable instrument. The result is the Köln Concert, one of the greatest jazz performances in history. It was perfectly imperfect.
Yes, even the 1-kg sphere has femtogram quantities of other elements mixed in – the universal standard for perfect is itself, imperfect. It doesn’t matter. It’s the pursuit of such that makes life worthwhile. There’s always tomorrow. Have your coffee grinders ready.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
A 19-month-old vaccinated female with 2 days of rash
Acute hemorrhagic edema of infancy (AHEI) is a leukocytoclastic vasculitis that typically affects children between 4 months and 2 years of age.1 Etiology is unknown but the majority of cases are preceded by infections, vaccinations, or certain medications.2
AHEI is a self-limited disease that runs a benign course with spontaneous resolution within days to 3 weeks.3 Classic presentation involves acute onset of fever, purpura, ecchymosis, and inflammatory edema. Edema is often the first sign, and may involve the face, ears, scrotum, or extremities. Hemorrhagic lesions may vary in size but often coalesce and present in a distinctive “cockade” or rosette pattern with scalloped borders. Systemic manifestations are rare, but renal and joint involvement may occur.4 Despite the dramatic and sometimes extensive appearance of the dermatologic manifestations, patients with AHEI are usually not in significant distress.
Diagnosis is clinical, but skin biopsy may show leukocytoclastic vasculitis of the superficial small vessels with infiltrations of neutrophils, extravasation of red blood cells, and fibrinoid necrosis.5 In most cases, immunofluorescence is negative for perivascular IgA deposition. Treatment is symptomatic as the disease resolves spontaneously. Recurrence is uncommon but may occur, and usually occurs early.
What is on the differential?
Kawasaki disease. Similar to AHEI, patients with Kawasaki disease also may present with facial and extremity edema. However, patients with Kawasaki disease appear sicker, have associated lymphadenopathy, conjunctivitis, and fever longer than 5 days. The lack of elevated inflammatory markers, acute-onset, classic dermatologic lesions, and nontoxic appearance in our patient rule out Kawasaki disease and make AHEI more likely.
IgA vasculitis/Henoch-Schönlein purpura. The distinction between AHEI and Henoch-Schönlein purpura is among the most challenging. AHEI commonly afflicts younger children ranging from 4 months to 2 years, whereas Henoch-Schönlein purpura occurs in older children from 3 to 6 years of age. Visceral involvement is rare in AHEI, but frequently presents in Henoch-Schönlein purpura with gastrointestinal and renal complications. Although our patient had both mild renal involvement and a distribution primarily on the buttocks and lower limbs, similar to the classic distribution of Henoch-Schönlein purpura, the younger age and lack of gastrointestinal and arthritic manifestations make AHEI more likely.
Gianotti-Crosti syndrome. Gianotti-Crosti syndrome, also known as papulovesicular acrodermatitis of childhood, mainly affects children between the ages of 6 months and 12 years. Like AHEI, Gianotti-Crosti is a self-limiting condition likely triggered by viral infection or immunization. However, Gianotti-Crosti is characterized by a papular rash that may last for several weeks. Neither AHEI nor Gianotti-Crosti are pruritic, but patients with Gianotti-Crosti tend to have either inguinal or axillary lymphadenopathy. Our patient’s large, coalescing dusky red patches and edematous plaques without lymphadenopathy are more consistent with AHEI.
Erythema multiforme. Erythema multiforme is an acute, immune-mediated condition characterized by distinctive target-like lesions on the skin often accompanied by erosions or bullae. Unlike AHEI, erythema multiforme can involve the oral, genital, and/or ocular mucosae. Erythema multiforme is rare before the age of 4 years. Although the targetoid or annular purpuric configuration of erythema multiforme may present similarly to AHEI in some cases, the young age of our patient and the lack of mucosal involvement make AHEI more likely.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Ms. Kleinman is a pediatric dermatology research associate at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Neither Dr. Matiz nor Ms. Kleinman has any relevant financial disclosures.
References
1. Savino F et al. Pediatr Dermatol. 2013;30(6):e149-e152.
2. Carboni E et al. F1000Res. 2019;8:1771. 2019 Oct 17.
3. Fiore E et al. J Am Acad Dermatol. 2008;59(4):684-95.
4. Watanabe T and Sato Y. Pediatr Nephrol. 2007;22(11):1979-81.
5. Cunha DF et al. Autops Case Rep. 2015;5(3):37-41.
Acute hemorrhagic edema of infancy (AHEI) is a leukocytoclastic vasculitis that typically affects children between 4 months and 2 years of age.1 Etiology is unknown but the majority of cases are preceded by infections, vaccinations, or certain medications.2
AHEI is a self-limited disease that runs a benign course with spontaneous resolution within days to 3 weeks.3 Classic presentation involves acute onset of fever, purpura, ecchymosis, and inflammatory edema. Edema is often the first sign, and may involve the face, ears, scrotum, or extremities. Hemorrhagic lesions may vary in size but often coalesce and present in a distinctive “cockade” or rosette pattern with scalloped borders. Systemic manifestations are rare, but renal and joint involvement may occur.4 Despite the dramatic and sometimes extensive appearance of the dermatologic manifestations, patients with AHEI are usually not in significant distress.
Diagnosis is clinical, but skin biopsy may show leukocytoclastic vasculitis of the superficial small vessels with infiltrations of neutrophils, extravasation of red blood cells, and fibrinoid necrosis.5 In most cases, immunofluorescence is negative for perivascular IgA deposition. Treatment is symptomatic as the disease resolves spontaneously. Recurrence is uncommon but may occur, and usually occurs early.
What is on the differential?
Kawasaki disease. Similar to AHEI, patients with Kawasaki disease also may present with facial and extremity edema. However, patients with Kawasaki disease appear sicker, have associated lymphadenopathy, conjunctivitis, and fever longer than 5 days. The lack of elevated inflammatory markers, acute-onset, classic dermatologic lesions, and nontoxic appearance in our patient rule out Kawasaki disease and make AHEI more likely.
IgA vasculitis/Henoch-Schönlein purpura. The distinction between AHEI and Henoch-Schönlein purpura is among the most challenging. AHEI commonly afflicts younger children ranging from 4 months to 2 years, whereas Henoch-Schönlein purpura occurs in older children from 3 to 6 years of age. Visceral involvement is rare in AHEI, but frequently presents in Henoch-Schönlein purpura with gastrointestinal and renal complications. Although our patient had both mild renal involvement and a distribution primarily on the buttocks and lower limbs, similar to the classic distribution of Henoch-Schönlein purpura, the younger age and lack of gastrointestinal and arthritic manifestations make AHEI more likely.
Gianotti-Crosti syndrome. Gianotti-Crosti syndrome, also known as papulovesicular acrodermatitis of childhood, mainly affects children between the ages of 6 months and 12 years. Like AHEI, Gianotti-Crosti is a self-limiting condition likely triggered by viral infection or immunization. However, Gianotti-Crosti is characterized by a papular rash that may last for several weeks. Neither AHEI nor Gianotti-Crosti are pruritic, but patients with Gianotti-Crosti tend to have either inguinal or axillary lymphadenopathy. Our patient’s large, coalescing dusky red patches and edematous plaques without lymphadenopathy are more consistent with AHEI.
Erythema multiforme. Erythema multiforme is an acute, immune-mediated condition characterized by distinctive target-like lesions on the skin often accompanied by erosions or bullae. Unlike AHEI, erythema multiforme can involve the oral, genital, and/or ocular mucosae. Erythema multiforme is rare before the age of 4 years. Although the targetoid or annular purpuric configuration of erythema multiforme may present similarly to AHEI in some cases, the young age of our patient and the lack of mucosal involvement make AHEI more likely.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Ms. Kleinman is a pediatric dermatology research associate at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Neither Dr. Matiz nor Ms. Kleinman has any relevant financial disclosures.
References
1. Savino F et al. Pediatr Dermatol. 2013;30(6):e149-e152.
2. Carboni E et al. F1000Res. 2019;8:1771. 2019 Oct 17.
3. Fiore E et al. J Am Acad Dermatol. 2008;59(4):684-95.
4. Watanabe T and Sato Y. Pediatr Nephrol. 2007;22(11):1979-81.
5. Cunha DF et al. Autops Case Rep. 2015;5(3):37-41.
Acute hemorrhagic edema of infancy (AHEI) is a leukocytoclastic vasculitis that typically affects children between 4 months and 2 years of age.1 Etiology is unknown but the majority of cases are preceded by infections, vaccinations, or certain medications.2
AHEI is a self-limited disease that runs a benign course with spontaneous resolution within days to 3 weeks.3 Classic presentation involves acute onset of fever, purpura, ecchymosis, and inflammatory edema. Edema is often the first sign, and may involve the face, ears, scrotum, or extremities. Hemorrhagic lesions may vary in size but often coalesce and present in a distinctive “cockade” or rosette pattern with scalloped borders. Systemic manifestations are rare, but renal and joint involvement may occur.4 Despite the dramatic and sometimes extensive appearance of the dermatologic manifestations, patients with AHEI are usually not in significant distress.
Diagnosis is clinical, but skin biopsy may show leukocytoclastic vasculitis of the superficial small vessels with infiltrations of neutrophils, extravasation of red blood cells, and fibrinoid necrosis.5 In most cases, immunofluorescence is negative for perivascular IgA deposition. Treatment is symptomatic as the disease resolves spontaneously. Recurrence is uncommon but may occur, and usually occurs early.
What is on the differential?
Kawasaki disease. Similar to AHEI, patients with Kawasaki disease also may present with facial and extremity edema. However, patients with Kawasaki disease appear sicker, have associated lymphadenopathy, conjunctivitis, and fever longer than 5 days. The lack of elevated inflammatory markers, acute-onset, classic dermatologic lesions, and nontoxic appearance in our patient rule out Kawasaki disease and make AHEI more likely.
IgA vasculitis/Henoch-Schönlein purpura. The distinction between AHEI and Henoch-Schönlein purpura is among the most challenging. AHEI commonly afflicts younger children ranging from 4 months to 2 years, whereas Henoch-Schönlein purpura occurs in older children from 3 to 6 years of age. Visceral involvement is rare in AHEI, but frequently presents in Henoch-Schönlein purpura with gastrointestinal and renal complications. Although our patient had both mild renal involvement and a distribution primarily on the buttocks and lower limbs, similar to the classic distribution of Henoch-Schönlein purpura, the younger age and lack of gastrointestinal and arthritic manifestations make AHEI more likely.
Gianotti-Crosti syndrome. Gianotti-Crosti syndrome, also known as papulovesicular acrodermatitis of childhood, mainly affects children between the ages of 6 months and 12 years. Like AHEI, Gianotti-Crosti is a self-limiting condition likely triggered by viral infection or immunization. However, Gianotti-Crosti is characterized by a papular rash that may last for several weeks. Neither AHEI nor Gianotti-Crosti are pruritic, but patients with Gianotti-Crosti tend to have either inguinal or axillary lymphadenopathy. Our patient’s large, coalescing dusky red patches and edematous plaques without lymphadenopathy are more consistent with AHEI.
Erythema multiforme. Erythema multiforme is an acute, immune-mediated condition characterized by distinctive target-like lesions on the skin often accompanied by erosions or bullae. Unlike AHEI, erythema multiforme can involve the oral, genital, and/or ocular mucosae. Erythema multiforme is rare before the age of 4 years. Although the targetoid or annular purpuric configuration of erythema multiforme may present similarly to AHEI in some cases, the young age of our patient and the lack of mucosal involvement make AHEI more likely.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Ms. Kleinman is a pediatric dermatology research associate at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Neither Dr. Matiz nor Ms. Kleinman has any relevant financial disclosures.
References
1. Savino F et al. Pediatr Dermatol. 2013;30(6):e149-e152.
2. Carboni E et al. F1000Res. 2019;8:1771. 2019 Oct 17.
3. Fiore E et al. J Am Acad Dermatol. 2008;59(4):684-95.
4. Watanabe T and Sato Y. Pediatr Nephrol. 2007;22(11):1979-81.
5. Cunha DF et al. Autops Case Rep. 2015;5(3):37-41.
A 34-year-old male presented with 10 days of a pruritic rash
Less frequently observable infectious agents associated with EM are Mycoplasma pneumoniae, Histoplasma capsulatum, and parapoxvirus (orf). Rarely, EM is triggered by drug eruption or systemic disease. Individuals of all age groups and races can be affected by EM. However, it is predominantly observed in young adult patients (20-40 years of age), and there is a male predominance.
Patients typically present with the abrupt onset of symmetrical red papules that evolve into typical and atypical targetoid lesions. Lesions evolve in 48-72 hours, favoring acrofacial sites that then spread down towards the trunk. Systemic symptoms such as fever and arthralgia may accompany the skin lesions.1-3
Erythema multiforme is recognized in two forms: EM minor and EM major. Both forms share the same characteristic of target lesions. However, the presence of mucosal involvement distinguishes the two. Mucosal involvement is absent or mild in EM minor, while mucosal involvement in EM major is often severe.2,3 Painful bullous lesions are commonly present in the mouth, genital, and ocular mucous membranes. Severe symptoms can often result in difficulty eating and drinking.
Diagnosis is largely clinical. Further histologic study may accompany diagnoses to exclude differential diagnosis. In EM, direct immunofluorescence (DIF) is negative. Histopathology reveals apoptosis of individual keratinocytes.1,2
Therapeutic treatment for painful bullous lesions in the mouth involve antiseptic rinses and anesthetic solutions. Preventive treatment for patients with HSV-associated EM recurrence includes oral acyclovir or valacyclovir.2
In this patient, a punch biopsy was performed, confirming the diagnosis. A DIF was negative, and a chest x-ray was negative. Treatment was initiated with oral acyclovir, doxycycline, and a prednisone taper. In addition, topical clobetasol propionate and magic mouthwash (Maalox/lidocaine/nystatin) was prescribed. The patient was placed on daily suppressive valacyclovir to prevent frequent recurrence of EM.
This case and photo were submitted by Ms. Pham, the University of California, Los Angeles, and Dr. Sateesh, San Diego Family Dermatology. Dr. Bilu-Martin edited the column.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Hafsi W and Badri T. Erythema Multiforme, in “StatPearls [Internet].” Treasure Island, Fla.: StatPearls Publishing, 2022 Jan.
2. Bolognia J et al. Dermatology. St. Louis: Mosby/Elsevier, 2008.
3. Oakley A. Erythema Multiforme. DermNet NZ. 2015 Oct.
Less frequently observable infectious agents associated with EM are Mycoplasma pneumoniae, Histoplasma capsulatum, and parapoxvirus (orf). Rarely, EM is triggered by drug eruption or systemic disease. Individuals of all age groups and races can be affected by EM. However, it is predominantly observed in young adult patients (20-40 years of age), and there is a male predominance.
Patients typically present with the abrupt onset of symmetrical red papules that evolve into typical and atypical targetoid lesions. Lesions evolve in 48-72 hours, favoring acrofacial sites that then spread down towards the trunk. Systemic symptoms such as fever and arthralgia may accompany the skin lesions.1-3
Erythema multiforme is recognized in two forms: EM minor and EM major. Both forms share the same characteristic of target lesions. However, the presence of mucosal involvement distinguishes the two. Mucosal involvement is absent or mild in EM minor, while mucosal involvement in EM major is often severe.2,3 Painful bullous lesions are commonly present in the mouth, genital, and ocular mucous membranes. Severe symptoms can often result in difficulty eating and drinking.
Diagnosis is largely clinical. Further histologic study may accompany diagnoses to exclude differential diagnosis. In EM, direct immunofluorescence (DIF) is negative. Histopathology reveals apoptosis of individual keratinocytes.1,2
Therapeutic treatment for painful bullous lesions in the mouth involve antiseptic rinses and anesthetic solutions. Preventive treatment for patients with HSV-associated EM recurrence includes oral acyclovir or valacyclovir.2
In this patient, a punch biopsy was performed, confirming the diagnosis. A DIF was negative, and a chest x-ray was negative. Treatment was initiated with oral acyclovir, doxycycline, and a prednisone taper. In addition, topical clobetasol propionate and magic mouthwash (Maalox/lidocaine/nystatin) was prescribed. The patient was placed on daily suppressive valacyclovir to prevent frequent recurrence of EM.
This case and photo were submitted by Ms. Pham, the University of California, Los Angeles, and Dr. Sateesh, San Diego Family Dermatology. Dr. Bilu-Martin edited the column.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Hafsi W and Badri T. Erythema Multiforme, in “StatPearls [Internet].” Treasure Island, Fla.: StatPearls Publishing, 2022 Jan.
2. Bolognia J et al. Dermatology. St. Louis: Mosby/Elsevier, 2008.
3. Oakley A. Erythema Multiforme. DermNet NZ. 2015 Oct.
Less frequently observable infectious agents associated with EM are Mycoplasma pneumoniae, Histoplasma capsulatum, and parapoxvirus (orf). Rarely, EM is triggered by drug eruption or systemic disease. Individuals of all age groups and races can be affected by EM. However, it is predominantly observed in young adult patients (20-40 years of age), and there is a male predominance.
Patients typically present with the abrupt onset of symmetrical red papules that evolve into typical and atypical targetoid lesions. Lesions evolve in 48-72 hours, favoring acrofacial sites that then spread down towards the trunk. Systemic symptoms such as fever and arthralgia may accompany the skin lesions.1-3
Erythema multiforme is recognized in two forms: EM minor and EM major. Both forms share the same characteristic of target lesions. However, the presence of mucosal involvement distinguishes the two. Mucosal involvement is absent or mild in EM minor, while mucosal involvement in EM major is often severe.2,3 Painful bullous lesions are commonly present in the mouth, genital, and ocular mucous membranes. Severe symptoms can often result in difficulty eating and drinking.
Diagnosis is largely clinical. Further histologic study may accompany diagnoses to exclude differential diagnosis. In EM, direct immunofluorescence (DIF) is negative. Histopathology reveals apoptosis of individual keratinocytes.1,2
Therapeutic treatment for painful bullous lesions in the mouth involve antiseptic rinses and anesthetic solutions. Preventive treatment for patients with HSV-associated EM recurrence includes oral acyclovir or valacyclovir.2
In this patient, a punch biopsy was performed, confirming the diagnosis. A DIF was negative, and a chest x-ray was negative. Treatment was initiated with oral acyclovir, doxycycline, and a prednisone taper. In addition, topical clobetasol propionate and magic mouthwash (Maalox/lidocaine/nystatin) was prescribed. The patient was placed on daily suppressive valacyclovir to prevent frequent recurrence of EM.
This case and photo were submitted by Ms. Pham, the University of California, Los Angeles, and Dr. Sateesh, San Diego Family Dermatology. Dr. Bilu-Martin edited the column.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Hafsi W and Badri T. Erythema Multiforme, in “StatPearls [Internet].” Treasure Island, Fla.: StatPearls Publishing, 2022 Jan.
2. Bolognia J et al. Dermatology. St. Louis: Mosby/Elsevier, 2008.
3. Oakley A. Erythema Multiforme. DermNet NZ. 2015 Oct.
Blind optimism only works in fantasy football. Time to get realistic
In the age of COVID, what exactly does it mean to be optimistic? I get this question quite a bit from virtually everyone I meet in one form or another through my work with the George Washington Resiliency and Well-Being Center in Washington, D.C. Giving a lecture on resilience and staying positive can be a significant challenge. Especially when we wake up to the news that 1 of every 100 older Americans has died secondary to COVID. The mind doesn’t really know how to process this type of loss. It is hard to maintain any form of a positive attitude when you’re still struggling just to accept the magnitude of what humanity has experienced over the past 2 years.
In “Resilience: The Science of Mastering Life’s Greatest Challenges,” (Cambridge, England: Cambridge University Press, 2018), Steven M. Southwick, MD, and Dennis S. Charney, MD, identify 10 critical factors associated with very resilient individuals. The authors based their work on science, personal experience, and interviews of people who have literally been through hell and back. One of the critical factors they identified is optimism.
“Optimism ignites resilience, providing energy to power the other resilience factors. It facilitates an active and creative approach to coping with challenging situations.”
Dr. Southwick and Dr. Charney are a lot smarter than me and far more patient to weave all this data together into a coherent story about optimism. Sounds like a damn good factor to focus a lecture on in my book! Slight problem: In my experience, many health professionals are already expert optimists. They literally eat, sleep, and sincerely breathe this stuff. So if we are going to talk about optimism, then we need to discuss realistic optimism.
How does realistic optimism differ from, say, blind optimism? Dr. Southwick and Dr. Charney’s review of the literature points to three features worthy of highlighting.
Realistic vs. blind optimism: Take-home points
- In realistic optimism, we notice the negative but don’t stay engaged with it. Realistic optimists moved on from problems that were not solvable.
- Blind optimism can lead to underestimating risk, overestimating abilities, and inadequate preparation.
Growing up in northeast Ohio, I can absolutely embrace the concept of realistic optimism. It’s overcast in Cleveland 8 months out of the year. To hope for 3 sunny days in a row in April is genuinely a fools’ errand. So you learn over time, the sun will shine; you just have to at times wait 3-4 months for it to occur.
From a skill perspective, realistic optimism could be conceptualized as a great mix of radical acceptance, emotion regulation, and focused problem solving. This is all fine, but to be realistically optimistic, we must first stop wishing for a better tomorrow. You may say, I don’t wish for or see rainbows and unicorns, et cetera, et cetera. Okay, so you don’t verbalize your wishes, but on a small level, you may engage in wishful thinking. Here are a few wishful thoughts that I would daydream about, which were not realistically optimistic at various points:
- “Once we get enough COVID-19 tests, things will improve.”
- “All we need to do is get vaccines, and then the new normal is right there.”
- “Once everyone gets the booster, then we got this thing beat.”
At this point, you could argue that I was engaged in blind optimism. I consider the above statements blind for a couple of reasons. They weren’t balanced (both positive and negative), didn’t have a clear definition of the outcome, and were more focused on external events I couldn’t control. These statements were the equivalent of wishes, and I don’t have a magic lamp with a genie, so I need to let go of my wishful thinking first. Let me rephrase that: I need to forcefully toss it into the sea of COVID variants and start figuring out how I’m going to tread water for another 6-12 months. So with this in mind, here are my initial thoughts on ways to navigate the next year of the pandemic:
- A multilayered form of protection gives me the best chance to survive the next 6 months of the pandemic.
- It will take time, but I’ll process the loss associated with a workplace that will never be the same.
- Until we have positivity test rates lower than 2% across the globe, COVID will remain a substantial disruption to humanity.
- I can’t bring back missed graduation or the first day of school, but I can share ways that I’ve countered and survived loneliness in my life with my children.
Okay, this is the starting point – hopefully not pessimistic, or blindly optimistic, just realistic. Now I can address other important topics, such as planning to rebuild my disappointing fantasy football team. I was No. 1 in our GW department of psychiatry fantasy football league until my star running back Derrick Henry went down. My residents will become attendings and still give me grief about this for many years to follow, and that is a very good thing.
Everyone be well and safe.
Dr. Norris is associate dean of student affairs; associate professor, department of psychiatry, George Washington University; chief wellness officer, GW Hospital, GW Medical Faculty Associates, and the GW School of Medicine and Health Sciences (GWU Medical Enterprise), Washington. He has disclosed having no relevant financial relationships. A version of this article first appeared on Medscape.com.
In the age of COVID, what exactly does it mean to be optimistic? I get this question quite a bit from virtually everyone I meet in one form or another through my work with the George Washington Resiliency and Well-Being Center in Washington, D.C. Giving a lecture on resilience and staying positive can be a significant challenge. Especially when we wake up to the news that 1 of every 100 older Americans has died secondary to COVID. The mind doesn’t really know how to process this type of loss. It is hard to maintain any form of a positive attitude when you’re still struggling just to accept the magnitude of what humanity has experienced over the past 2 years.
In “Resilience: The Science of Mastering Life’s Greatest Challenges,” (Cambridge, England: Cambridge University Press, 2018), Steven M. Southwick, MD, and Dennis S. Charney, MD, identify 10 critical factors associated with very resilient individuals. The authors based their work on science, personal experience, and interviews of people who have literally been through hell and back. One of the critical factors they identified is optimism.
“Optimism ignites resilience, providing energy to power the other resilience factors. It facilitates an active and creative approach to coping with challenging situations.”
Dr. Southwick and Dr. Charney are a lot smarter than me and far more patient to weave all this data together into a coherent story about optimism. Sounds like a damn good factor to focus a lecture on in my book! Slight problem: In my experience, many health professionals are already expert optimists. They literally eat, sleep, and sincerely breathe this stuff. So if we are going to talk about optimism, then we need to discuss realistic optimism.
How does realistic optimism differ from, say, blind optimism? Dr. Southwick and Dr. Charney’s review of the literature points to three features worthy of highlighting.
Realistic vs. blind optimism: Take-home points
- In realistic optimism, we notice the negative but don’t stay engaged with it. Realistic optimists moved on from problems that were not solvable.
- Blind optimism can lead to underestimating risk, overestimating abilities, and inadequate preparation.
Growing up in northeast Ohio, I can absolutely embrace the concept of realistic optimism. It’s overcast in Cleveland 8 months out of the year. To hope for 3 sunny days in a row in April is genuinely a fools’ errand. So you learn over time, the sun will shine; you just have to at times wait 3-4 months for it to occur.
From a skill perspective, realistic optimism could be conceptualized as a great mix of radical acceptance, emotion regulation, and focused problem solving. This is all fine, but to be realistically optimistic, we must first stop wishing for a better tomorrow. You may say, I don’t wish for or see rainbows and unicorns, et cetera, et cetera. Okay, so you don’t verbalize your wishes, but on a small level, you may engage in wishful thinking. Here are a few wishful thoughts that I would daydream about, which were not realistically optimistic at various points:
- “Once we get enough COVID-19 tests, things will improve.”
- “All we need to do is get vaccines, and then the new normal is right there.”
- “Once everyone gets the booster, then we got this thing beat.”
At this point, you could argue that I was engaged in blind optimism. I consider the above statements blind for a couple of reasons. They weren’t balanced (both positive and negative), didn’t have a clear definition of the outcome, and were more focused on external events I couldn’t control. These statements were the equivalent of wishes, and I don’t have a magic lamp with a genie, so I need to let go of my wishful thinking first. Let me rephrase that: I need to forcefully toss it into the sea of COVID variants and start figuring out how I’m going to tread water for another 6-12 months. So with this in mind, here are my initial thoughts on ways to navigate the next year of the pandemic:
- A multilayered form of protection gives me the best chance to survive the next 6 months of the pandemic.
- It will take time, but I’ll process the loss associated with a workplace that will never be the same.
- Until we have positivity test rates lower than 2% across the globe, COVID will remain a substantial disruption to humanity.
- I can’t bring back missed graduation or the first day of school, but I can share ways that I’ve countered and survived loneliness in my life with my children.
Okay, this is the starting point – hopefully not pessimistic, or blindly optimistic, just realistic. Now I can address other important topics, such as planning to rebuild my disappointing fantasy football team. I was No. 1 in our GW department of psychiatry fantasy football league until my star running back Derrick Henry went down. My residents will become attendings and still give me grief about this for many years to follow, and that is a very good thing.
Everyone be well and safe.
Dr. Norris is associate dean of student affairs; associate professor, department of psychiatry, George Washington University; chief wellness officer, GW Hospital, GW Medical Faculty Associates, and the GW School of Medicine and Health Sciences (GWU Medical Enterprise), Washington. He has disclosed having no relevant financial relationships. A version of this article first appeared on Medscape.com.
In the age of COVID, what exactly does it mean to be optimistic? I get this question quite a bit from virtually everyone I meet in one form or another through my work with the George Washington Resiliency and Well-Being Center in Washington, D.C. Giving a lecture on resilience and staying positive can be a significant challenge. Especially when we wake up to the news that 1 of every 100 older Americans has died secondary to COVID. The mind doesn’t really know how to process this type of loss. It is hard to maintain any form of a positive attitude when you’re still struggling just to accept the magnitude of what humanity has experienced over the past 2 years.
In “Resilience: The Science of Mastering Life’s Greatest Challenges,” (Cambridge, England: Cambridge University Press, 2018), Steven M. Southwick, MD, and Dennis S. Charney, MD, identify 10 critical factors associated with very resilient individuals. The authors based their work on science, personal experience, and interviews of people who have literally been through hell and back. One of the critical factors they identified is optimism.
“Optimism ignites resilience, providing energy to power the other resilience factors. It facilitates an active and creative approach to coping with challenging situations.”
Dr. Southwick and Dr. Charney are a lot smarter than me and far more patient to weave all this data together into a coherent story about optimism. Sounds like a damn good factor to focus a lecture on in my book! Slight problem: In my experience, many health professionals are already expert optimists. They literally eat, sleep, and sincerely breathe this stuff. So if we are going to talk about optimism, then we need to discuss realistic optimism.
How does realistic optimism differ from, say, blind optimism? Dr. Southwick and Dr. Charney’s review of the literature points to three features worthy of highlighting.
Realistic vs. blind optimism: Take-home points
- In realistic optimism, we notice the negative but don’t stay engaged with it. Realistic optimists moved on from problems that were not solvable.
- Blind optimism can lead to underestimating risk, overestimating abilities, and inadequate preparation.
Growing up in northeast Ohio, I can absolutely embrace the concept of realistic optimism. It’s overcast in Cleveland 8 months out of the year. To hope for 3 sunny days in a row in April is genuinely a fools’ errand. So you learn over time, the sun will shine; you just have to at times wait 3-4 months for it to occur.
From a skill perspective, realistic optimism could be conceptualized as a great mix of radical acceptance, emotion regulation, and focused problem solving. This is all fine, but to be realistically optimistic, we must first stop wishing for a better tomorrow. You may say, I don’t wish for or see rainbows and unicorns, et cetera, et cetera. Okay, so you don’t verbalize your wishes, but on a small level, you may engage in wishful thinking. Here are a few wishful thoughts that I would daydream about, which were not realistically optimistic at various points:
- “Once we get enough COVID-19 tests, things will improve.”
- “All we need to do is get vaccines, and then the new normal is right there.”
- “Once everyone gets the booster, then we got this thing beat.”
At this point, you could argue that I was engaged in blind optimism. I consider the above statements blind for a couple of reasons. They weren’t balanced (both positive and negative), didn’t have a clear definition of the outcome, and were more focused on external events I couldn’t control. These statements were the equivalent of wishes, and I don’t have a magic lamp with a genie, so I need to let go of my wishful thinking first. Let me rephrase that: I need to forcefully toss it into the sea of COVID variants and start figuring out how I’m going to tread water for another 6-12 months. So with this in mind, here are my initial thoughts on ways to navigate the next year of the pandemic:
- A multilayered form of protection gives me the best chance to survive the next 6 months of the pandemic.
- It will take time, but I’ll process the loss associated with a workplace that will never be the same.
- Until we have positivity test rates lower than 2% across the globe, COVID will remain a substantial disruption to humanity.
- I can’t bring back missed graduation or the first day of school, but I can share ways that I’ve countered and survived loneliness in my life with my children.
Okay, this is the starting point – hopefully not pessimistic, or blindly optimistic, just realistic. Now I can address other important topics, such as planning to rebuild my disappointing fantasy football team. I was No. 1 in our GW department of psychiatry fantasy football league until my star running back Derrick Henry went down. My residents will become attendings and still give me grief about this for many years to follow, and that is a very good thing.
Everyone be well and safe.
Dr. Norris is associate dean of student affairs; associate professor, department of psychiatry, George Washington University; chief wellness officer, GW Hospital, GW Medical Faculty Associates, and the GW School of Medicine and Health Sciences (GWU Medical Enterprise), Washington. He has disclosed having no relevant financial relationships. A version of this article first appeared on Medscape.com.
Inhaled corticosteroids for COVID-19
Since the onset of the pandemic, the role for corticosteroids (CS) as a therapy for COVID-19 has evolved. Initially, there was reluctance to use oral corticosteroids (OCS) outside of COVID-19-related sepsis or acute respiratory distress syndrome (ARDS). This was in keeping with community-acquired pneumonia (CAP) guidelines (Metlay JP, et al.Am J Respir Crit Care Med. 2019; 200:e45-e67) and reflected concerns that OCS might worsen outcomes in viral pneumonias. At my hospital, the reluctance to use OCS was extended to inhaled corticosteroids (ICS), with early protocols advising cessation in patients with COVID-19.
In fairness, the hesitation to use ICS was short-lived and reflected attempts to provide reasonable guidance during the early pandemic data vacuum. Over time, OCS therapy has gained acceptance as a treatment for moderate-to-severe COVID-19. On top of this, the relationship between COVID-19 and asthma has proved to be complicated. It seemed intuitive that asthmatics would fair worse in the face of a highly transmissible respiratory pathogen. Data on COVID-19 and asthma provide a mixed picture, though. It also appears that the interaction varies by phenotype (Zhu Z, et al. J Allergy Clin Immunol. 2020;146:327-329).
Improvements with OCS and the complicated interaction between COVID-19 and asthma led some to speculate that ICS, the primary treatment for asthma, may actually be protective. There is biologic plausibility to support this concept. Generally, we’ve seen a variety of immunomodulators show efficacy against moderate or severe disease. Specific to ICS, data have shown a down-regulation in COVID-19 gene expression and reduction in proteins required by the virus for cell entry. This includes a reduction in the evil, much maligned ACE-2 receptor (Peters M, et al. Am J Respir Crit Care Med. 2020;202:83-90).
Like much with COVID-19, the initial asthma phenotype and ICS data were observational and hypothesis- generating, at best. More recently, a series of randomized trials has tested the effects of ICS in patients with milder forms of COVID-19. The data are promising and are worth a thorough review by all physicians caring for COVID-19 outside of the hospital.
The STOIC trial (Ramakrishnan S, et al. Lancet Respir Med. 2021;9:763–772) randomized 146 patients to budesonide via dry powder inhaler (DPI), 800 ug twice per day (BID), versus usual care. The primary outcome was clinical deterioration, defined as presentation to acute or emergency care or need for hospitalization. There was a number of secondary outcomes designed to assess time-to-recovery, predominantly by self-report via questionnaires. The results were nothing short of spectacular. There was a significant difference in the primary outcome with a number-needed to treat (NNT) of only 8 to prevent one instance of COVID-19 deterioration. A number of the secondary outcomes reached significance, as well.
The PRINCIPLE trial, only available in preprint form (https://tinyurl.com/mr4cah7j), also randomized patients to budesonide via ICS vs usual care. PRINCIPLE is one of those cool, adaptive platform trials designed to evaluate multiple therapies simultaneously that have gained popularity in the pandemic era. These trials include predefined criteria for success and futility that allow treatments to be added and others to be dropped. The dosage of budesonide was identical to that in STOIC, and, again, it was delivered via DPI. By design, patients were older with co-morbidities, and there were two primary outcomes. The first was a composite of hospitalization and death, and the second was time to recovery.
The PRINCIPLE preprint is only an interim analysis. There were 751 and 1,028 patients who received budesonide and usual care, respectively. Time to recovery was significantly shorter in the budesonide group, but budesonide failed to meet their prespecified criteria for reducing hospitalization/death. The authors noted that the composite outcome of hospitalization or death did not occur at the rates originally anticipated, presumably due to high vaccination rates. This may have led to type II error.
In a third trial published online in November (Clemency BM, et al. JAMA Intern Med. 2021;10.1001/jamainternmed.2021.6759), patients were randomized to 640 micrograms per day of the ICS ciclesonide. Delivery was via metered-dose inhaler (MDI) for a total duration of 30 days. Unlike the STOIC and PRINCIPLE trials, this one wasn’t open label. It was blinded and placebo-controlled. The investigators found no difference in their primary outcome, time to resolution of symptoms. Ciclesonide did reduce the composite secondary outcome of ED visits or hospital admissions. The number needed to treat was 23.
Please indulge me while I overreact. It seems we’ve got a positive signal in all three. In the era of the Omnicron variant and limited health resources, a widely available therapy that curtails symptoms and prevents acute care visits and hospitalizations could have a tremendous impact. It doesn’t require administration in a clinic and, in theory, efficacy shouldn’t be affected by future mutations of the virus.
A more sober look mutes my enthusiasm. First, as the authors of the ciclesonide article note, open-label trials tracking subjective outcomes via self-assessment can be prone to bias. The ciclesonide trial was double-blinded and didn’t find a difference in time to symptom resolution, only the two open-label trials did. Second, the largest study (PRINCIPLE) didn’t show a difference in escalation of care.
Given, they defined “escalation” as hospitalization or death, and vaccines and patient selection (enrolled only outpatients with mild disease) made proving a statistical reduction difficult. However, in the text they state there wasn’t an improvement in “health care services use” either. In essence, the largest trial showed no change in escalation of care, and the trial with the best design did not show reduction in symptoms.
Although three randomized trials are enough for the inevitable meta-analysis that’ll be published soon; don’t expect it to shed much light. Combining data won’t be particularly helpful because the PRINCIPLE trial is larger than the other two combined, so its results will dominate any statistical analysis of combined data. Not to worry though – there are several more ICS COVID-19 trials underway (NCT04355637, NCT04331054, NCT04193878, NCT04330586, NCT04331054, NCT04331470, NCT04355637, NCT04356495, and NCT04381364). Providers will have to decide for themselves whether what we have so far is sufficient to change practice.
Dr. Holley is Program Director, Pulmonary and Critical Care Medicine Fellowship; and Associate Professor of Medicine USU, Walter Reed National Military Medical Center, Bethesda, Maryland. He also serves as Section Editor for Pulmonary Perspectives®.
Since the onset of the pandemic, the role for corticosteroids (CS) as a therapy for COVID-19 has evolved. Initially, there was reluctance to use oral corticosteroids (OCS) outside of COVID-19-related sepsis or acute respiratory distress syndrome (ARDS). This was in keeping with community-acquired pneumonia (CAP) guidelines (Metlay JP, et al.Am J Respir Crit Care Med. 2019; 200:e45-e67) and reflected concerns that OCS might worsen outcomes in viral pneumonias. At my hospital, the reluctance to use OCS was extended to inhaled corticosteroids (ICS), with early protocols advising cessation in patients with COVID-19.
In fairness, the hesitation to use ICS was short-lived and reflected attempts to provide reasonable guidance during the early pandemic data vacuum. Over time, OCS therapy has gained acceptance as a treatment for moderate-to-severe COVID-19. On top of this, the relationship between COVID-19 and asthma has proved to be complicated. It seemed intuitive that asthmatics would fair worse in the face of a highly transmissible respiratory pathogen. Data on COVID-19 and asthma provide a mixed picture, though. It also appears that the interaction varies by phenotype (Zhu Z, et al. J Allergy Clin Immunol. 2020;146:327-329).
Improvements with OCS and the complicated interaction between COVID-19 and asthma led some to speculate that ICS, the primary treatment for asthma, may actually be protective. There is biologic plausibility to support this concept. Generally, we’ve seen a variety of immunomodulators show efficacy against moderate or severe disease. Specific to ICS, data have shown a down-regulation in COVID-19 gene expression and reduction in proteins required by the virus for cell entry. This includes a reduction in the evil, much maligned ACE-2 receptor (Peters M, et al. Am J Respir Crit Care Med. 2020;202:83-90).
Like much with COVID-19, the initial asthma phenotype and ICS data were observational and hypothesis- generating, at best. More recently, a series of randomized trials has tested the effects of ICS in patients with milder forms of COVID-19. The data are promising and are worth a thorough review by all physicians caring for COVID-19 outside of the hospital.
The STOIC trial (Ramakrishnan S, et al. Lancet Respir Med. 2021;9:763–772) randomized 146 patients to budesonide via dry powder inhaler (DPI), 800 ug twice per day (BID), versus usual care. The primary outcome was clinical deterioration, defined as presentation to acute or emergency care or need for hospitalization. There was a number of secondary outcomes designed to assess time-to-recovery, predominantly by self-report via questionnaires. The results were nothing short of spectacular. There was a significant difference in the primary outcome with a number-needed to treat (NNT) of only 8 to prevent one instance of COVID-19 deterioration. A number of the secondary outcomes reached significance, as well.
The PRINCIPLE trial, only available in preprint form (https://tinyurl.com/mr4cah7j), also randomized patients to budesonide via ICS vs usual care. PRINCIPLE is one of those cool, adaptive platform trials designed to evaluate multiple therapies simultaneously that have gained popularity in the pandemic era. These trials include predefined criteria for success and futility that allow treatments to be added and others to be dropped. The dosage of budesonide was identical to that in STOIC, and, again, it was delivered via DPI. By design, patients were older with co-morbidities, and there were two primary outcomes. The first was a composite of hospitalization and death, and the second was time to recovery.
The PRINCIPLE preprint is only an interim analysis. There were 751 and 1,028 patients who received budesonide and usual care, respectively. Time to recovery was significantly shorter in the budesonide group, but budesonide failed to meet their prespecified criteria for reducing hospitalization/death. The authors noted that the composite outcome of hospitalization or death did not occur at the rates originally anticipated, presumably due to high vaccination rates. This may have led to type II error.
In a third trial published online in November (Clemency BM, et al. JAMA Intern Med. 2021;10.1001/jamainternmed.2021.6759), patients were randomized to 640 micrograms per day of the ICS ciclesonide. Delivery was via metered-dose inhaler (MDI) for a total duration of 30 days. Unlike the STOIC and PRINCIPLE trials, this one wasn’t open label. It was blinded and placebo-controlled. The investigators found no difference in their primary outcome, time to resolution of symptoms. Ciclesonide did reduce the composite secondary outcome of ED visits or hospital admissions. The number needed to treat was 23.
Please indulge me while I overreact. It seems we’ve got a positive signal in all three. In the era of the Omnicron variant and limited health resources, a widely available therapy that curtails symptoms and prevents acute care visits and hospitalizations could have a tremendous impact. It doesn’t require administration in a clinic and, in theory, efficacy shouldn’t be affected by future mutations of the virus.
A more sober look mutes my enthusiasm. First, as the authors of the ciclesonide article note, open-label trials tracking subjective outcomes via self-assessment can be prone to bias. The ciclesonide trial was double-blinded and didn’t find a difference in time to symptom resolution, only the two open-label trials did. Second, the largest study (PRINCIPLE) didn’t show a difference in escalation of care.
Given, they defined “escalation” as hospitalization or death, and vaccines and patient selection (enrolled only outpatients with mild disease) made proving a statistical reduction difficult. However, in the text they state there wasn’t an improvement in “health care services use” either. In essence, the largest trial showed no change in escalation of care, and the trial with the best design did not show reduction in symptoms.
Although three randomized trials are enough for the inevitable meta-analysis that’ll be published soon; don’t expect it to shed much light. Combining data won’t be particularly helpful because the PRINCIPLE trial is larger than the other two combined, so its results will dominate any statistical analysis of combined data. Not to worry though – there are several more ICS COVID-19 trials underway (NCT04355637, NCT04331054, NCT04193878, NCT04330586, NCT04331054, NCT04331470, NCT04355637, NCT04356495, and NCT04381364). Providers will have to decide for themselves whether what we have so far is sufficient to change practice.
Dr. Holley is Program Director, Pulmonary and Critical Care Medicine Fellowship; and Associate Professor of Medicine USU, Walter Reed National Military Medical Center, Bethesda, Maryland. He also serves as Section Editor for Pulmonary Perspectives®.
Since the onset of the pandemic, the role for corticosteroids (CS) as a therapy for COVID-19 has evolved. Initially, there was reluctance to use oral corticosteroids (OCS) outside of COVID-19-related sepsis or acute respiratory distress syndrome (ARDS). This was in keeping with community-acquired pneumonia (CAP) guidelines (Metlay JP, et al.Am J Respir Crit Care Med. 2019; 200:e45-e67) and reflected concerns that OCS might worsen outcomes in viral pneumonias. At my hospital, the reluctance to use OCS was extended to inhaled corticosteroids (ICS), with early protocols advising cessation in patients with COVID-19.
In fairness, the hesitation to use ICS was short-lived and reflected attempts to provide reasonable guidance during the early pandemic data vacuum. Over time, OCS therapy has gained acceptance as a treatment for moderate-to-severe COVID-19. On top of this, the relationship between COVID-19 and asthma has proved to be complicated. It seemed intuitive that asthmatics would fair worse in the face of a highly transmissible respiratory pathogen. Data on COVID-19 and asthma provide a mixed picture, though. It also appears that the interaction varies by phenotype (Zhu Z, et al. J Allergy Clin Immunol. 2020;146:327-329).
Improvements with OCS and the complicated interaction between COVID-19 and asthma led some to speculate that ICS, the primary treatment for asthma, may actually be protective. There is biologic plausibility to support this concept. Generally, we’ve seen a variety of immunomodulators show efficacy against moderate or severe disease. Specific to ICS, data have shown a down-regulation in COVID-19 gene expression and reduction in proteins required by the virus for cell entry. This includes a reduction in the evil, much maligned ACE-2 receptor (Peters M, et al. Am J Respir Crit Care Med. 2020;202:83-90).
Like much with COVID-19, the initial asthma phenotype and ICS data were observational and hypothesis- generating, at best. More recently, a series of randomized trials has tested the effects of ICS in patients with milder forms of COVID-19. The data are promising and are worth a thorough review by all physicians caring for COVID-19 outside of the hospital.
The STOIC trial (Ramakrishnan S, et al. Lancet Respir Med. 2021;9:763–772) randomized 146 patients to budesonide via dry powder inhaler (DPI), 800 ug twice per day (BID), versus usual care. The primary outcome was clinical deterioration, defined as presentation to acute or emergency care or need for hospitalization. There was a number of secondary outcomes designed to assess time-to-recovery, predominantly by self-report via questionnaires. The results were nothing short of spectacular. There was a significant difference in the primary outcome with a number-needed to treat (NNT) of only 8 to prevent one instance of COVID-19 deterioration. A number of the secondary outcomes reached significance, as well.
The PRINCIPLE trial, only available in preprint form (https://tinyurl.com/mr4cah7j), also randomized patients to budesonide via ICS vs usual care. PRINCIPLE is one of those cool, adaptive platform trials designed to evaluate multiple therapies simultaneously that have gained popularity in the pandemic era. These trials include predefined criteria for success and futility that allow treatments to be added and others to be dropped. The dosage of budesonide was identical to that in STOIC, and, again, it was delivered via DPI. By design, patients were older with co-morbidities, and there were two primary outcomes. The first was a composite of hospitalization and death, and the second was time to recovery.
The PRINCIPLE preprint is only an interim analysis. There were 751 and 1,028 patients who received budesonide and usual care, respectively. Time to recovery was significantly shorter in the budesonide group, but budesonide failed to meet their prespecified criteria for reducing hospitalization/death. The authors noted that the composite outcome of hospitalization or death did not occur at the rates originally anticipated, presumably due to high vaccination rates. This may have led to type II error.
In a third trial published online in November (Clemency BM, et al. JAMA Intern Med. 2021;10.1001/jamainternmed.2021.6759), patients were randomized to 640 micrograms per day of the ICS ciclesonide. Delivery was via metered-dose inhaler (MDI) for a total duration of 30 days. Unlike the STOIC and PRINCIPLE trials, this one wasn’t open label. It was blinded and placebo-controlled. The investigators found no difference in their primary outcome, time to resolution of symptoms. Ciclesonide did reduce the composite secondary outcome of ED visits or hospital admissions. The number needed to treat was 23.
Please indulge me while I overreact. It seems we’ve got a positive signal in all three. In the era of the Omnicron variant and limited health resources, a widely available therapy that curtails symptoms and prevents acute care visits and hospitalizations could have a tremendous impact. It doesn’t require administration in a clinic and, in theory, efficacy shouldn’t be affected by future mutations of the virus.
A more sober look mutes my enthusiasm. First, as the authors of the ciclesonide article note, open-label trials tracking subjective outcomes via self-assessment can be prone to bias. The ciclesonide trial was double-blinded and didn’t find a difference in time to symptom resolution, only the two open-label trials did. Second, the largest study (PRINCIPLE) didn’t show a difference in escalation of care.
Given, they defined “escalation” as hospitalization or death, and vaccines and patient selection (enrolled only outpatients with mild disease) made proving a statistical reduction difficult. However, in the text they state there wasn’t an improvement in “health care services use” either. In essence, the largest trial showed no change in escalation of care, and the trial with the best design did not show reduction in symptoms.
Although three randomized trials are enough for the inevitable meta-analysis that’ll be published soon; don’t expect it to shed much light. Combining data won’t be particularly helpful because the PRINCIPLE trial is larger than the other two combined, so its results will dominate any statistical analysis of combined data. Not to worry though – there are several more ICS COVID-19 trials underway (NCT04355637, NCT04331054, NCT04193878, NCT04330586, NCT04331054, NCT04331470, NCT04355637, NCT04356495, and NCT04381364). Providers will have to decide for themselves whether what we have so far is sufficient to change practice.
Dr. Holley is Program Director, Pulmonary and Critical Care Medicine Fellowship; and Associate Professor of Medicine USU, Walter Reed National Military Medical Center, Bethesda, Maryland. He also serves as Section Editor for Pulmonary Perspectives®.