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How to explain physician compounding to legislators
In Ohio, new limits on drug compounding in physicians’ offices went into effect in April and have become a real hindrance to care for dermatology patients. The State of Ohio Board of Pharmacy has defined compounding as combining two or more prescription drugs and has required that physicians who perform this “compounding” must obtain a “Terminal Distributor of Dangerous Drugs” license. Ohio is the “test state,” and these rules, unless vigorously opposed, will be coming to your state.
[polldaddy:9779752]
The rules state that “compounded” drugs used within 6 hours of preparation must be prepared in a designated clean medication area with proper hand hygiene and the use of powder-free gloves. “Compounded” drugs that are used more than 6 hours after preparation, require a designated clean room with access limited to authorized personnel, environmental control devices such as a laminar flow hood, and additional equipment and training of personnel to maintain an aseptic environment. A separate license is required for each office location.
The state pharmacy boards are eager to restrict physicians – as well as dentists and veterinarians – and to collect annual licensing fees. Additionally, according to an article from the Ohio State Medical Association, noncompliant physicians can be fined by the pharmacy board.
We are talking big money, power, and dreams of clinical relevancy (and billable activities) here.
What can dermatologists do to prevent this regulatory overreach? I encourage you to plan a visit to your state representative, where you can demonstrate how these restrictions affect you and your patients – an exercise that should be both fun and compelling. All you need to illustrate your case is a simple kit that includes a syringe (but no needles in the statehouse!), a bottle of lidocaine with epinephrine, a bottle of 8.4% bicarbonate, alcohol pads, and gloves.
First, explain to your audience that there is a skin cancer epidemic with more than 5.4 million new cases a year and that, over the past 20 years, the incidence of skin cancer has doubled and is projected to double again over the next 20 years. Further, explain that dermatologists treat more than 70% of these cases in the office setting, under local anesthesia, at a huge cost savings to the public and government (it costs an average of 12 times as much to remove these cancers in the outpatient department at the hospital). Remember, states foot most of the bill for Medicaid and Medicare gap indigent coverage.
Take the bottle of lidocaine with epinephrine and open the syringe pack (Staffers love this demonstration; everyone is fascinated with shots.). Put on your gloves, wipe the top of the lidocaine bottle with an alcohol swab, and explain that this medicine is the anesthetic preferred for skin cancer surgery. Explain how it not only numbs the skin, but also causes vasoconstriction, so that the cancer can be easily and safely removed in the office.
Then explain that, in order for the epinephrine to be stable, the solution has to be very acidic (a pH of 4.2, in fact). Explain that this makes it burn like hell unless you add 0.1 cc per cc of 8.4% bicarbonate, in which case the perceived pain on a 10-point scale will drop from 8 to 2. Then pick up the bottle of bicarbonate and explain that you will no longer be able to mix these two components anymore without a “Terminal Distributor of Dangerous Drugs” license because your state pharmacy board considers this compounding. Your representative is likely to give you looks of astonishment, disbelief, and then a dawning realization of the absurdity of the situation.
Follow-up questions may include “Why can’t you buy buffered lidocaine with epinephrine from the compounding pharmacy?” Easy answer: because each patient needs an individual prescription, and you may not know in advance which patient will need it, and how much the patient will need, and it becomes unstable once it has been buffered. It also will cost the patient $45 per 5-cc syringe, and it will be degraded by the time the patient returns from the compounding pharmacy. Explain further that it costs you only 84 cents to make a 5-cc syringe of buffered lidocaine; that some patients may need as many as 10 syringes; and that these costs are all included in the surgery (free!) if the physician draws it up in the office.
A simple summary is – less pain, less cost – and no history of infections or complications.
It is an eye-opener when you demonstrate how ridiculous the compounding rules being imposed are for physicians and patients. I’ve used this demonstration at the state and federal legislative level, and more recently, at the Food and Drug Administration.
If you get the chance, when a state legislator is in your office, become an advocate for your patients and fellow physicians. Make sure physician offices are excluded from these definitions of com
This column was updated June 22, 2017.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@frontlinemedcom.com.
In Ohio, new limits on drug compounding in physicians’ offices went into effect in April and have become a real hindrance to care for dermatology patients. The State of Ohio Board of Pharmacy has defined compounding as combining two or more prescription drugs and has required that physicians who perform this “compounding” must obtain a “Terminal Distributor of Dangerous Drugs” license. Ohio is the “test state,” and these rules, unless vigorously opposed, will be coming to your state.
[polldaddy:9779752]
The rules state that “compounded” drugs used within 6 hours of preparation must be prepared in a designated clean medication area with proper hand hygiene and the use of powder-free gloves. “Compounded” drugs that are used more than 6 hours after preparation, require a designated clean room with access limited to authorized personnel, environmental control devices such as a laminar flow hood, and additional equipment and training of personnel to maintain an aseptic environment. A separate license is required for each office location.
The state pharmacy boards are eager to restrict physicians – as well as dentists and veterinarians – and to collect annual licensing fees. Additionally, according to an article from the Ohio State Medical Association, noncompliant physicians can be fined by the pharmacy board.
We are talking big money, power, and dreams of clinical relevancy (and billable activities) here.
What can dermatologists do to prevent this regulatory overreach? I encourage you to plan a visit to your state representative, where you can demonstrate how these restrictions affect you and your patients – an exercise that should be both fun and compelling. All you need to illustrate your case is a simple kit that includes a syringe (but no needles in the statehouse!), a bottle of lidocaine with epinephrine, a bottle of 8.4% bicarbonate, alcohol pads, and gloves.
First, explain to your audience that there is a skin cancer epidemic with more than 5.4 million new cases a year and that, over the past 20 years, the incidence of skin cancer has doubled and is projected to double again over the next 20 years. Further, explain that dermatologists treat more than 70% of these cases in the office setting, under local anesthesia, at a huge cost savings to the public and government (it costs an average of 12 times as much to remove these cancers in the outpatient department at the hospital). Remember, states foot most of the bill for Medicaid and Medicare gap indigent coverage.
Take the bottle of lidocaine with epinephrine and open the syringe pack (Staffers love this demonstration; everyone is fascinated with shots.). Put on your gloves, wipe the top of the lidocaine bottle with an alcohol swab, and explain that this medicine is the anesthetic preferred for skin cancer surgery. Explain how it not only numbs the skin, but also causes vasoconstriction, so that the cancer can be easily and safely removed in the office.
Then explain that, in order for the epinephrine to be stable, the solution has to be very acidic (a pH of 4.2, in fact). Explain that this makes it burn like hell unless you add 0.1 cc per cc of 8.4% bicarbonate, in which case the perceived pain on a 10-point scale will drop from 8 to 2. Then pick up the bottle of bicarbonate and explain that you will no longer be able to mix these two components anymore without a “Terminal Distributor of Dangerous Drugs” license because your state pharmacy board considers this compounding. Your representative is likely to give you looks of astonishment, disbelief, and then a dawning realization of the absurdity of the situation.
Follow-up questions may include “Why can’t you buy buffered lidocaine with epinephrine from the compounding pharmacy?” Easy answer: because each patient needs an individual prescription, and you may not know in advance which patient will need it, and how much the patient will need, and it becomes unstable once it has been buffered. It also will cost the patient $45 per 5-cc syringe, and it will be degraded by the time the patient returns from the compounding pharmacy. Explain further that it costs you only 84 cents to make a 5-cc syringe of buffered lidocaine; that some patients may need as many as 10 syringes; and that these costs are all included in the surgery (free!) if the physician draws it up in the office.
A simple summary is – less pain, less cost – and no history of infections or complications.
It is an eye-opener when you demonstrate how ridiculous the compounding rules being imposed are for physicians and patients. I’ve used this demonstration at the state and federal legislative level, and more recently, at the Food and Drug Administration.
If you get the chance, when a state legislator is in your office, become an advocate for your patients and fellow physicians. Make sure physician offices are excluded from these definitions of com
This column was updated June 22, 2017.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@frontlinemedcom.com.
In Ohio, new limits on drug compounding in physicians’ offices went into effect in April and have become a real hindrance to care for dermatology patients. The State of Ohio Board of Pharmacy has defined compounding as combining two or more prescription drugs and has required that physicians who perform this “compounding” must obtain a “Terminal Distributor of Dangerous Drugs” license. Ohio is the “test state,” and these rules, unless vigorously opposed, will be coming to your state.
[polldaddy:9779752]
The rules state that “compounded” drugs used within 6 hours of preparation must be prepared in a designated clean medication area with proper hand hygiene and the use of powder-free gloves. “Compounded” drugs that are used more than 6 hours after preparation, require a designated clean room with access limited to authorized personnel, environmental control devices such as a laminar flow hood, and additional equipment and training of personnel to maintain an aseptic environment. A separate license is required for each office location.
The state pharmacy boards are eager to restrict physicians – as well as dentists and veterinarians – and to collect annual licensing fees. Additionally, according to an article from the Ohio State Medical Association, noncompliant physicians can be fined by the pharmacy board.
We are talking big money, power, and dreams of clinical relevancy (and billable activities) here.
What can dermatologists do to prevent this regulatory overreach? I encourage you to plan a visit to your state representative, where you can demonstrate how these restrictions affect you and your patients – an exercise that should be both fun and compelling. All you need to illustrate your case is a simple kit that includes a syringe (but no needles in the statehouse!), a bottle of lidocaine with epinephrine, a bottle of 8.4% bicarbonate, alcohol pads, and gloves.
First, explain to your audience that there is a skin cancer epidemic with more than 5.4 million new cases a year and that, over the past 20 years, the incidence of skin cancer has doubled and is projected to double again over the next 20 years. Further, explain that dermatologists treat more than 70% of these cases in the office setting, under local anesthesia, at a huge cost savings to the public and government (it costs an average of 12 times as much to remove these cancers in the outpatient department at the hospital). Remember, states foot most of the bill for Medicaid and Medicare gap indigent coverage.
Take the bottle of lidocaine with epinephrine and open the syringe pack (Staffers love this demonstration; everyone is fascinated with shots.). Put on your gloves, wipe the top of the lidocaine bottle with an alcohol swab, and explain that this medicine is the anesthetic preferred for skin cancer surgery. Explain how it not only numbs the skin, but also causes vasoconstriction, so that the cancer can be easily and safely removed in the office.
Then explain that, in order for the epinephrine to be stable, the solution has to be very acidic (a pH of 4.2, in fact). Explain that this makes it burn like hell unless you add 0.1 cc per cc of 8.4% bicarbonate, in which case the perceived pain on a 10-point scale will drop from 8 to 2. Then pick up the bottle of bicarbonate and explain that you will no longer be able to mix these two components anymore without a “Terminal Distributor of Dangerous Drugs” license because your state pharmacy board considers this compounding. Your representative is likely to give you looks of astonishment, disbelief, and then a dawning realization of the absurdity of the situation.
Follow-up questions may include “Why can’t you buy buffered lidocaine with epinephrine from the compounding pharmacy?” Easy answer: because each patient needs an individual prescription, and you may not know in advance which patient will need it, and how much the patient will need, and it becomes unstable once it has been buffered. It also will cost the patient $45 per 5-cc syringe, and it will be degraded by the time the patient returns from the compounding pharmacy. Explain further that it costs you only 84 cents to make a 5-cc syringe of buffered lidocaine; that some patients may need as many as 10 syringes; and that these costs are all included in the surgery (free!) if the physician draws it up in the office.
A simple summary is – less pain, less cost – and no history of infections or complications.
It is an eye-opener when you demonstrate how ridiculous the compounding rules being imposed are for physicians and patients. I’ve used this demonstration at the state and federal legislative level, and more recently, at the Food and Drug Administration.
If you get the chance, when a state legislator is in your office, become an advocate for your patients and fellow physicians. Make sure physician offices are excluded from these definitions of com
This column was updated June 22, 2017.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@frontlinemedcom.com.
Treating Barrett’s Esophagus: Comparing EMR and ESD
Dear colleagues,
Many of us diagnose and treat patients with Barrett’s esophagus, estimated to affect up to 5.6% of the US adult population. There has been an expanding array of tools to help diagnose and effectively treat Barrett’s esophagus with dysplasia and malignancy. In particular, endoscopic submucosal dissection (ESD) has emerged as an important method for treating early cancer in the gastrointestinal tract.
But how do we incorporate ESD into our algorithm for management, especially with the popularity and effectiveness of endoscopic mucosal resection (EMR)? In this issue of Perspectives we aim to provide context for the use of ESD, as compared with EMR. Dr. Silvio de Melo discusses his preferred EMR technique and its many advantages in the management of BE, including for residual or refractory areas. In contrast, Dr. Mohamed Othman reviews the power of ESD and when we should consider this approach over EMR. We hope these discussions will facilitate your care for patients with Barrett’s esophagus.
We also welcome your thoughts on this topic — join the conversation on X at @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.
Endoscopic Mucosal Resection: The ‘Workhorse’ for Patient Care
BY SILVIO W. DE MELO JR, MD, AGAF
Barrett’s esophagus (BE) remains an important clinical problem, being one of the modifiable risk factors for esophageal adenocarcinoma. The care for BE is complex and requires several steps to correctly formulate a therapeutic plan. It starts with a proper endoscopic examination. It is recommended to spend at least 1 minute inspecting and evaluating every centimeter of the salmon-colored epithelium, looking for change in vascular pattern, erosions/ulcers, nodules, and/or masses. After the inspection, random biopsies every 1-2 cm plus targeted biopsies will guide you. It is still controversial if the addition of other sampling strategies, such as brushings or confocal endomicroscopy, is needed.
The introduction of radiofrequency ablation (RFA) was paramount in popularizing the treatment options for BE and sunsetting the previous dominant modality, photodynamic therapy (PDT). RFA proved to have a superior clinical efficacy in replacing the intestinal metaplasia/BE with neosquamous epithelium while boosting a much better safety profile, compared with PDT. However, RFA is most efficacious for “flat BE” and it is not an effective, nor recommended, method to treat nodular BE or early cancer, such as carcinoma in situ or nodular high-grade dysplasia. Endoscopic mucosal resection (EMR) is utilized to overcome those limitations.
There are several techniques utilized for EMR:
- The lift and snare technique.
- The snare-in-cap technique.
- The Band-snare technique.
The free-hand submucosal lift and snare is not frequently used in the esophagus. It is difficult to maintain visualization while being confident that one has the whole lesion inside the snare and that the distal (anal side) part of the lesion is free of any unwanted tissue (to minimize complications such as perforations or unwelcomed gastric resections). It is difficult after the first resection to lift an adjacent area, as the fluid easily leaks from the first resected spot, thus removing larger lesions in piece-meal fashion is challenging. This technique can be used in small (in my personal experience, less than 5 mm) lesions, but, given that there are better and safer alternatives, I almost never use this technique for my esophageal EMR cases. I prefer to use the band-snare technique even for lesions under 5 mm.
The snare-in-cap technique has been utilized in the esophagus. In this technique, a cap is attached to the distal end of the scope and the size of the resection is determined by the size of the cap, usually under 1.5 cm. Because of the risk of perforation without previous lifting, it is required that the lesion is lifted with a submucosal fluid, saline or any Food and Drug Administration–approved EMR solution. The lesion is then suctioned inside the cap where the snare had been previously opened inside the cap, the snare is closed, and the tissue is resected. The same limitations regarding the inability to remove larger lesions (greater than 1.5 cm) because of the challenge in lifting the adjacent area applies here. However, the perforation risk for this technique is higher than the traditional lift and the band and snare techniques. Thus, this technique has fallen out of favor for most endoscopists.
The third technique (band-snare EMR) is the one that most endoscopists use for endoscopic mucosal resection. It is a small variation of the already time-tested and very familiar procedure of esophageal variceal band ligation (EVL). There are multiple commercially available kits for esophageal EMR. The kit contains the chamber with the bands and a proprietary hexagonal snare used to resect the specimen.
The advantages of this technique are:
- It is widely commercially available.
- It builds on a familiar procedure, EVL, therefore the learning curve is short.
- The set-up is quick and the procedure can be completed safely and effectively.
- There is no need for injecting the submucosal with a lifting solution.
- Despite the band having a size limitation of 1 cm, one can remove larger lesions by repeating the band and resect process, using the rosette technique.
Band-snare EMR also has limitations:
- There are only six bands on each chamber. Depending on the size of the lesion, one may need to use multiple kits.
- It is not suitable for en bloc resection of lesions greater than 1 cm.
My experience with band EMR is that we can complete the procedure in under 1 hour. The dreaded complication of perforation occurs in under 1% of cases, most bleeding episodes can easily be controlled endoscopically, and the risk of post-EMR stricture is minimal. Therefore, band EMR is the most used technique for esophageal endoscopic resections.
Esophageal EMR is also effective for other indications in BE therapy, such as residual and recurrent BE. Band-snare EMR can be used for an en bloc resection or rosette technique for the areas resistant to ablation therapies with great success and safety.
From a financial standpoint, comparing EMR with endoscopic submucosal dissection (ESD), EMR is the superior strategy given that EMR is widely available, has a much shorter learning curve, has a greater safety profile, is applicable to a wider variety of indications, and has a more favorable return on investment. EMR should be the workhorse for the care of patients with BE, reserving ESD for specific indications.
In summary, there is no “one-size-fits-all” endoscopic therapy in the care of BE. Most Barrett’s patients can be successfully treated with a combination of ablation plus EMR, reserving ESD for select cases.
Dr. de Melo is section chief of gastroenterology at the Orlando VA Healthcare System, Orlando, Florida. He declares no conflicts of interest.
ESD Over EMR for Resecting Esophageal Lesions
BY MOHAMED O. OTHMAN, MD, AGAF
Although endoscopic submucosal dissection (ESD) is the preferred endoscopic resection method in the East, the adoption of this technique in the West, particularly in the United States, has faced many hurdles. Many endoscopists who routinely perform piecemeal endoscopic mucosal resection (EMR) question the utility of ESD, arguing that EMR is just as effective. While this may hold true in certain situations, the global trend in the endoscopic treatment of early esophageal squamous cell carcinoma, nodular Barrett’s esophagus (BE), and early esophageal adenocarcinoma (EAC) has clearly shifted toward ESD. In this perspective, I will summarize why ESD is preferred over EMR for these indications and explore why ESD has yet to gain widespread adoption in the United States.
The superiority of ESD over EMR has been well established in multiple publications from both Eastern and Western literature. Mejia-Perez et al, in a multicenter cohort study from eight centers in North America, compared outcomes of ESD vs EMR for BE with high-grade dysplasia (HGD) or T1a adenocarcinoma in 243 patients. ESD achieved significantly higher en bloc resection rates (89% vs 43%) and R0 resection rates (73% vs 56%), compared with EMR, along with a substantially lower recurrence/residual disease rate on follow-up (3.5% in the ESD group vs 31.4% in EMR group). Additionally, more patients required repeat endoscopic resection after EMR to treat residual or recurrent disease (EMR, 24.2% vs ESD, 3.5%; P < .001).
Han et al conducted a meta-analysis of 22 studies comparing ESD and EMR for early esophageal neoplasia, including both squamous cell carcinoma (SCC) and BE-associated lesions. ESD was associated with significantly higher curative resection rates than EMR (OR, 9.74; 95% CI, 4.83-19.62; P < .0001). Of note, lesion size was a critical factor in determining the advantage of ESD. For lesions ≤ 10 mm, curative resection rates were comparable between ESD and EMR. However, for lesions > 10 mm, ESD achieved significantly higher curative resection rates. This size-based recommendation has been adopted by the American Society of Gastrointestinal Endoscopy (ASGE) in their recent guidelines on ESD indications for esophageal lesions. ASGE guidelines favors ESD over EMR for SCC lesions > 15 mm and for nodular BE with dysplasia or early EAC > 20 mm.
ESD is particularly beneficial in patients who develop early adenocarcinoma after RFA or EMR. Mesureur et al evaluated the efficacy of salvage ESD for Barrett’s recurrence or residual BE following RFA. In their multicenter retrospective study of 56 patients, salvage ESD achieved an en bloc resection rate of 89.3%, despite significant fibrosis, with an R0 resection rate of 66%. At a median follow-up of 14 months, most patients remained in endoscopic remission without the need for esophagectomy.
Combining ESD with RFA has also been shown to accelerate the eradication of BE with dysplasia while reducing the number of required sessions. Our group demonstrated the high efficacy of ESD followed by RFA in 18 patients, most of whom had long-segment BE with HGD or EAC. On average, patients required only one to two RFA sessions after ESD to achieve complete eradication of intestinal metaplasia (CE-IM). Over a median follow-up of 42.5 months (IQR, 28-59.25), complete eradication of early esophageal cancer was achieved in 13 patients (100%), eradication of dysplasia in 15 patients (100%), and CE-IM in 14 patients (77.8%).
Despite the overwhelming evidence supporting ESD and the strong endorsement from professional societies, adoption in the West continues to lag. Several factors contribute to this gap. First, ESD has a steep learning curve. Our data showed that, on average, an untutored practitioner achieved competency after 150-250 procedures, a finding corroborated by other US groups.
Second, there is no specific CPT code for ESD in the United States. Physicians are forced to bill the procedure as EMR or use an unlisted code, resulting in reimbursement that does not reflect the time and complexity of the procedure. Our group showed that physician reimbursement for ESD is highly variable, ranging from $50 to $800 per case, depending on insurance type.
Third, the increasing emphasis on productivity and RVU generation in academic settings has hindered the growth of ESD training in many institutions. Still, the outlook for ESD in the United States remains encouraging. Multiple industry-sponsored training courses are held annually, and professional societies are investing heavily in expanding access to structured education in ESD. Industry is also innovating devices that improve procedural efficiency and safety. Adopting novel approaches, such as traction-assisted ESD, has made the technique more appealing to endoscopists concerned about long procedure times. For example, our group proposed a standardized esophageal ESD technique that incorporates specimen self-retraction. This method improves both safety and speed and has helped address several procedural challenges. We’ve demonstrated that consistency in technique can substantially expedite esophageal ESD.
Fast forward 5 years: We anticipate a dedicated CPT code for ESD, broader access to advanced resection tools, and an expanding number of fellowships offering structured ESD training. These developments are poised to eliminate many of the current barriers. In summary, with robust data supporting the efficacy of ESD in early esophageal cancer, the focus in the United States should shift toward mastering and integrating the technique, rather than dismissing it in favor of piecemeal EMR.
Dr. Othman is chief of the gastroenterology and hepatology section at Baylor College of Medicine and Medicine Subspecialities Service Line Chief at Baylor St Luke’s Medical Center, both in Houston. He declares no conflicts of interest.
Dear colleagues,
Many of us diagnose and treat patients with Barrett’s esophagus, estimated to affect up to 5.6% of the US adult population. There has been an expanding array of tools to help diagnose and effectively treat Barrett’s esophagus with dysplasia and malignancy. In particular, endoscopic submucosal dissection (ESD) has emerged as an important method for treating early cancer in the gastrointestinal tract.
But how do we incorporate ESD into our algorithm for management, especially with the popularity and effectiveness of endoscopic mucosal resection (EMR)? In this issue of Perspectives we aim to provide context for the use of ESD, as compared with EMR. Dr. Silvio de Melo discusses his preferred EMR technique and its many advantages in the management of BE, including for residual or refractory areas. In contrast, Dr. Mohamed Othman reviews the power of ESD and when we should consider this approach over EMR. We hope these discussions will facilitate your care for patients with Barrett’s esophagus.
We also welcome your thoughts on this topic — join the conversation on X at @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.
Endoscopic Mucosal Resection: The ‘Workhorse’ for Patient Care
BY SILVIO W. DE MELO JR, MD, AGAF
Barrett’s esophagus (BE) remains an important clinical problem, being one of the modifiable risk factors for esophageal adenocarcinoma. The care for BE is complex and requires several steps to correctly formulate a therapeutic plan. It starts with a proper endoscopic examination. It is recommended to spend at least 1 minute inspecting and evaluating every centimeter of the salmon-colored epithelium, looking for change in vascular pattern, erosions/ulcers, nodules, and/or masses. After the inspection, random biopsies every 1-2 cm plus targeted biopsies will guide you. It is still controversial if the addition of other sampling strategies, such as brushings or confocal endomicroscopy, is needed.
The introduction of radiofrequency ablation (RFA) was paramount in popularizing the treatment options for BE and sunsetting the previous dominant modality, photodynamic therapy (PDT). RFA proved to have a superior clinical efficacy in replacing the intestinal metaplasia/BE with neosquamous epithelium while boosting a much better safety profile, compared with PDT. However, RFA is most efficacious for “flat BE” and it is not an effective, nor recommended, method to treat nodular BE or early cancer, such as carcinoma in situ or nodular high-grade dysplasia. Endoscopic mucosal resection (EMR) is utilized to overcome those limitations.
There are several techniques utilized for EMR:
- The lift and snare technique.
- The snare-in-cap technique.
- The Band-snare technique.
The free-hand submucosal lift and snare is not frequently used in the esophagus. It is difficult to maintain visualization while being confident that one has the whole lesion inside the snare and that the distal (anal side) part of the lesion is free of any unwanted tissue (to minimize complications such as perforations or unwelcomed gastric resections). It is difficult after the first resection to lift an adjacent area, as the fluid easily leaks from the first resected spot, thus removing larger lesions in piece-meal fashion is challenging. This technique can be used in small (in my personal experience, less than 5 mm) lesions, but, given that there are better and safer alternatives, I almost never use this technique for my esophageal EMR cases. I prefer to use the band-snare technique even for lesions under 5 mm.
The snare-in-cap technique has been utilized in the esophagus. In this technique, a cap is attached to the distal end of the scope and the size of the resection is determined by the size of the cap, usually under 1.5 cm. Because of the risk of perforation without previous lifting, it is required that the lesion is lifted with a submucosal fluid, saline or any Food and Drug Administration–approved EMR solution. The lesion is then suctioned inside the cap where the snare had been previously opened inside the cap, the snare is closed, and the tissue is resected. The same limitations regarding the inability to remove larger lesions (greater than 1.5 cm) because of the challenge in lifting the adjacent area applies here. However, the perforation risk for this technique is higher than the traditional lift and the band and snare techniques. Thus, this technique has fallen out of favor for most endoscopists.
The third technique (band-snare EMR) is the one that most endoscopists use for endoscopic mucosal resection. It is a small variation of the already time-tested and very familiar procedure of esophageal variceal band ligation (EVL). There are multiple commercially available kits for esophageal EMR. The kit contains the chamber with the bands and a proprietary hexagonal snare used to resect the specimen.
The advantages of this technique are:
- It is widely commercially available.
- It builds on a familiar procedure, EVL, therefore the learning curve is short.
- The set-up is quick and the procedure can be completed safely and effectively.
- There is no need for injecting the submucosal with a lifting solution.
- Despite the band having a size limitation of 1 cm, one can remove larger lesions by repeating the band and resect process, using the rosette technique.
Band-snare EMR also has limitations:
- There are only six bands on each chamber. Depending on the size of the lesion, one may need to use multiple kits.
- It is not suitable for en bloc resection of lesions greater than 1 cm.
My experience with band EMR is that we can complete the procedure in under 1 hour. The dreaded complication of perforation occurs in under 1% of cases, most bleeding episodes can easily be controlled endoscopically, and the risk of post-EMR stricture is minimal. Therefore, band EMR is the most used technique for esophageal endoscopic resections.
Esophageal EMR is also effective for other indications in BE therapy, such as residual and recurrent BE. Band-snare EMR can be used for an en bloc resection or rosette technique for the areas resistant to ablation therapies with great success and safety.
From a financial standpoint, comparing EMR with endoscopic submucosal dissection (ESD), EMR is the superior strategy given that EMR is widely available, has a much shorter learning curve, has a greater safety profile, is applicable to a wider variety of indications, and has a more favorable return on investment. EMR should be the workhorse for the care of patients with BE, reserving ESD for specific indications.
In summary, there is no “one-size-fits-all” endoscopic therapy in the care of BE. Most Barrett’s patients can be successfully treated with a combination of ablation plus EMR, reserving ESD for select cases.
Dr. de Melo is section chief of gastroenterology at the Orlando VA Healthcare System, Orlando, Florida. He declares no conflicts of interest.
ESD Over EMR for Resecting Esophageal Lesions
BY MOHAMED O. OTHMAN, MD, AGAF
Although endoscopic submucosal dissection (ESD) is the preferred endoscopic resection method in the East, the adoption of this technique in the West, particularly in the United States, has faced many hurdles. Many endoscopists who routinely perform piecemeal endoscopic mucosal resection (EMR) question the utility of ESD, arguing that EMR is just as effective. While this may hold true in certain situations, the global trend in the endoscopic treatment of early esophageal squamous cell carcinoma, nodular Barrett’s esophagus (BE), and early esophageal adenocarcinoma (EAC) has clearly shifted toward ESD. In this perspective, I will summarize why ESD is preferred over EMR for these indications and explore why ESD has yet to gain widespread adoption in the United States.
The superiority of ESD over EMR has been well established in multiple publications from both Eastern and Western literature. Mejia-Perez et al, in a multicenter cohort study from eight centers in North America, compared outcomes of ESD vs EMR for BE with high-grade dysplasia (HGD) or T1a adenocarcinoma in 243 patients. ESD achieved significantly higher en bloc resection rates (89% vs 43%) and R0 resection rates (73% vs 56%), compared with EMR, along with a substantially lower recurrence/residual disease rate on follow-up (3.5% in the ESD group vs 31.4% in EMR group). Additionally, more patients required repeat endoscopic resection after EMR to treat residual or recurrent disease (EMR, 24.2% vs ESD, 3.5%; P < .001).
Han et al conducted a meta-analysis of 22 studies comparing ESD and EMR for early esophageal neoplasia, including both squamous cell carcinoma (SCC) and BE-associated lesions. ESD was associated with significantly higher curative resection rates than EMR (OR, 9.74; 95% CI, 4.83-19.62; P < .0001). Of note, lesion size was a critical factor in determining the advantage of ESD. For lesions ≤ 10 mm, curative resection rates were comparable between ESD and EMR. However, for lesions > 10 mm, ESD achieved significantly higher curative resection rates. This size-based recommendation has been adopted by the American Society of Gastrointestinal Endoscopy (ASGE) in their recent guidelines on ESD indications for esophageal lesions. ASGE guidelines favors ESD over EMR for SCC lesions > 15 mm and for nodular BE with dysplasia or early EAC > 20 mm.
ESD is particularly beneficial in patients who develop early adenocarcinoma after RFA or EMR. Mesureur et al evaluated the efficacy of salvage ESD for Barrett’s recurrence or residual BE following RFA. In their multicenter retrospective study of 56 patients, salvage ESD achieved an en bloc resection rate of 89.3%, despite significant fibrosis, with an R0 resection rate of 66%. At a median follow-up of 14 months, most patients remained in endoscopic remission without the need for esophagectomy.
Combining ESD with RFA has also been shown to accelerate the eradication of BE with dysplasia while reducing the number of required sessions. Our group demonstrated the high efficacy of ESD followed by RFA in 18 patients, most of whom had long-segment BE with HGD or EAC. On average, patients required only one to two RFA sessions after ESD to achieve complete eradication of intestinal metaplasia (CE-IM). Over a median follow-up of 42.5 months (IQR, 28-59.25), complete eradication of early esophageal cancer was achieved in 13 patients (100%), eradication of dysplasia in 15 patients (100%), and CE-IM in 14 patients (77.8%).
Despite the overwhelming evidence supporting ESD and the strong endorsement from professional societies, adoption in the West continues to lag. Several factors contribute to this gap. First, ESD has a steep learning curve. Our data showed that, on average, an untutored practitioner achieved competency after 150-250 procedures, a finding corroborated by other US groups.
Second, there is no specific CPT code for ESD in the United States. Physicians are forced to bill the procedure as EMR or use an unlisted code, resulting in reimbursement that does not reflect the time and complexity of the procedure. Our group showed that physician reimbursement for ESD is highly variable, ranging from $50 to $800 per case, depending on insurance type.
Third, the increasing emphasis on productivity and RVU generation in academic settings has hindered the growth of ESD training in many institutions. Still, the outlook for ESD in the United States remains encouraging. Multiple industry-sponsored training courses are held annually, and professional societies are investing heavily in expanding access to structured education in ESD. Industry is also innovating devices that improve procedural efficiency and safety. Adopting novel approaches, such as traction-assisted ESD, has made the technique more appealing to endoscopists concerned about long procedure times. For example, our group proposed a standardized esophageal ESD technique that incorporates specimen self-retraction. This method improves both safety and speed and has helped address several procedural challenges. We’ve demonstrated that consistency in technique can substantially expedite esophageal ESD.
Fast forward 5 years: We anticipate a dedicated CPT code for ESD, broader access to advanced resection tools, and an expanding number of fellowships offering structured ESD training. These developments are poised to eliminate many of the current barriers. In summary, with robust data supporting the efficacy of ESD in early esophageal cancer, the focus in the United States should shift toward mastering and integrating the technique, rather than dismissing it in favor of piecemeal EMR.
Dr. Othman is chief of the gastroenterology and hepatology section at Baylor College of Medicine and Medicine Subspecialities Service Line Chief at Baylor St Luke’s Medical Center, both in Houston. He declares no conflicts of interest.
Dear colleagues,
Many of us diagnose and treat patients with Barrett’s esophagus, estimated to affect up to 5.6% of the US adult population. There has been an expanding array of tools to help diagnose and effectively treat Barrett’s esophagus with dysplasia and malignancy. In particular, endoscopic submucosal dissection (ESD) has emerged as an important method for treating early cancer in the gastrointestinal tract.
But how do we incorporate ESD into our algorithm for management, especially with the popularity and effectiveness of endoscopic mucosal resection (EMR)? In this issue of Perspectives we aim to provide context for the use of ESD, as compared with EMR. Dr. Silvio de Melo discusses his preferred EMR technique and its many advantages in the management of BE, including for residual or refractory areas. In contrast, Dr. Mohamed Othman reviews the power of ESD and when we should consider this approach over EMR. We hope these discussions will facilitate your care for patients with Barrett’s esophagus.
We also welcome your thoughts on this topic — join the conversation on X at @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.
Endoscopic Mucosal Resection: The ‘Workhorse’ for Patient Care
BY SILVIO W. DE MELO JR, MD, AGAF
Barrett’s esophagus (BE) remains an important clinical problem, being one of the modifiable risk factors for esophageal adenocarcinoma. The care for BE is complex and requires several steps to correctly formulate a therapeutic plan. It starts with a proper endoscopic examination. It is recommended to spend at least 1 minute inspecting and evaluating every centimeter of the salmon-colored epithelium, looking for change in vascular pattern, erosions/ulcers, nodules, and/or masses. After the inspection, random biopsies every 1-2 cm plus targeted biopsies will guide you. It is still controversial if the addition of other sampling strategies, such as brushings or confocal endomicroscopy, is needed.
The introduction of radiofrequency ablation (RFA) was paramount in popularizing the treatment options for BE and sunsetting the previous dominant modality, photodynamic therapy (PDT). RFA proved to have a superior clinical efficacy in replacing the intestinal metaplasia/BE with neosquamous epithelium while boosting a much better safety profile, compared with PDT. However, RFA is most efficacious for “flat BE” and it is not an effective, nor recommended, method to treat nodular BE or early cancer, such as carcinoma in situ or nodular high-grade dysplasia. Endoscopic mucosal resection (EMR) is utilized to overcome those limitations.
There are several techniques utilized for EMR:
- The lift and snare technique.
- The snare-in-cap technique.
- The Band-snare technique.
The free-hand submucosal lift and snare is not frequently used in the esophagus. It is difficult to maintain visualization while being confident that one has the whole lesion inside the snare and that the distal (anal side) part of the lesion is free of any unwanted tissue (to minimize complications such as perforations or unwelcomed gastric resections). It is difficult after the first resection to lift an adjacent area, as the fluid easily leaks from the first resected spot, thus removing larger lesions in piece-meal fashion is challenging. This technique can be used in small (in my personal experience, less than 5 mm) lesions, but, given that there are better and safer alternatives, I almost never use this technique for my esophageal EMR cases. I prefer to use the band-snare technique even for lesions under 5 mm.
The snare-in-cap technique has been utilized in the esophagus. In this technique, a cap is attached to the distal end of the scope and the size of the resection is determined by the size of the cap, usually under 1.5 cm. Because of the risk of perforation without previous lifting, it is required that the lesion is lifted with a submucosal fluid, saline or any Food and Drug Administration–approved EMR solution. The lesion is then suctioned inside the cap where the snare had been previously opened inside the cap, the snare is closed, and the tissue is resected. The same limitations regarding the inability to remove larger lesions (greater than 1.5 cm) because of the challenge in lifting the adjacent area applies here. However, the perforation risk for this technique is higher than the traditional lift and the band and snare techniques. Thus, this technique has fallen out of favor for most endoscopists.
The third technique (band-snare EMR) is the one that most endoscopists use for endoscopic mucosal resection. It is a small variation of the already time-tested and very familiar procedure of esophageal variceal band ligation (EVL). There are multiple commercially available kits for esophageal EMR. The kit contains the chamber with the bands and a proprietary hexagonal snare used to resect the specimen.
The advantages of this technique are:
- It is widely commercially available.
- It builds on a familiar procedure, EVL, therefore the learning curve is short.
- The set-up is quick and the procedure can be completed safely and effectively.
- There is no need for injecting the submucosal with a lifting solution.
- Despite the band having a size limitation of 1 cm, one can remove larger lesions by repeating the band and resect process, using the rosette technique.
Band-snare EMR also has limitations:
- There are only six bands on each chamber. Depending on the size of the lesion, one may need to use multiple kits.
- It is not suitable for en bloc resection of lesions greater than 1 cm.
My experience with band EMR is that we can complete the procedure in under 1 hour. The dreaded complication of perforation occurs in under 1% of cases, most bleeding episodes can easily be controlled endoscopically, and the risk of post-EMR stricture is minimal. Therefore, band EMR is the most used technique for esophageal endoscopic resections.
Esophageal EMR is also effective for other indications in BE therapy, such as residual and recurrent BE. Band-snare EMR can be used for an en bloc resection or rosette technique for the areas resistant to ablation therapies with great success and safety.
From a financial standpoint, comparing EMR with endoscopic submucosal dissection (ESD), EMR is the superior strategy given that EMR is widely available, has a much shorter learning curve, has a greater safety profile, is applicable to a wider variety of indications, and has a more favorable return on investment. EMR should be the workhorse for the care of patients with BE, reserving ESD for specific indications.
In summary, there is no “one-size-fits-all” endoscopic therapy in the care of BE. Most Barrett’s patients can be successfully treated with a combination of ablation plus EMR, reserving ESD for select cases.
Dr. de Melo is section chief of gastroenterology at the Orlando VA Healthcare System, Orlando, Florida. He declares no conflicts of interest.
ESD Over EMR for Resecting Esophageal Lesions
BY MOHAMED O. OTHMAN, MD, AGAF
Although endoscopic submucosal dissection (ESD) is the preferred endoscopic resection method in the East, the adoption of this technique in the West, particularly in the United States, has faced many hurdles. Many endoscopists who routinely perform piecemeal endoscopic mucosal resection (EMR) question the utility of ESD, arguing that EMR is just as effective. While this may hold true in certain situations, the global trend in the endoscopic treatment of early esophageal squamous cell carcinoma, nodular Barrett’s esophagus (BE), and early esophageal adenocarcinoma (EAC) has clearly shifted toward ESD. In this perspective, I will summarize why ESD is preferred over EMR for these indications and explore why ESD has yet to gain widespread adoption in the United States.
The superiority of ESD over EMR has been well established in multiple publications from both Eastern and Western literature. Mejia-Perez et al, in a multicenter cohort study from eight centers in North America, compared outcomes of ESD vs EMR for BE with high-grade dysplasia (HGD) or T1a adenocarcinoma in 243 patients. ESD achieved significantly higher en bloc resection rates (89% vs 43%) and R0 resection rates (73% vs 56%), compared with EMR, along with a substantially lower recurrence/residual disease rate on follow-up (3.5% in the ESD group vs 31.4% in EMR group). Additionally, more patients required repeat endoscopic resection after EMR to treat residual or recurrent disease (EMR, 24.2% vs ESD, 3.5%; P < .001).
Han et al conducted a meta-analysis of 22 studies comparing ESD and EMR for early esophageal neoplasia, including both squamous cell carcinoma (SCC) and BE-associated lesions. ESD was associated with significantly higher curative resection rates than EMR (OR, 9.74; 95% CI, 4.83-19.62; P < .0001). Of note, lesion size was a critical factor in determining the advantage of ESD. For lesions ≤ 10 mm, curative resection rates were comparable between ESD and EMR. However, for lesions > 10 mm, ESD achieved significantly higher curative resection rates. This size-based recommendation has been adopted by the American Society of Gastrointestinal Endoscopy (ASGE) in their recent guidelines on ESD indications for esophageal lesions. ASGE guidelines favors ESD over EMR for SCC lesions > 15 mm and for nodular BE with dysplasia or early EAC > 20 mm.
ESD is particularly beneficial in patients who develop early adenocarcinoma after RFA or EMR. Mesureur et al evaluated the efficacy of salvage ESD for Barrett’s recurrence or residual BE following RFA. In their multicenter retrospective study of 56 patients, salvage ESD achieved an en bloc resection rate of 89.3%, despite significant fibrosis, with an R0 resection rate of 66%. At a median follow-up of 14 months, most patients remained in endoscopic remission without the need for esophagectomy.
Combining ESD with RFA has also been shown to accelerate the eradication of BE with dysplasia while reducing the number of required sessions. Our group demonstrated the high efficacy of ESD followed by RFA in 18 patients, most of whom had long-segment BE with HGD or EAC. On average, patients required only one to two RFA sessions after ESD to achieve complete eradication of intestinal metaplasia (CE-IM). Over a median follow-up of 42.5 months (IQR, 28-59.25), complete eradication of early esophageal cancer was achieved in 13 patients (100%), eradication of dysplasia in 15 patients (100%), and CE-IM in 14 patients (77.8%).
Despite the overwhelming evidence supporting ESD and the strong endorsement from professional societies, adoption in the West continues to lag. Several factors contribute to this gap. First, ESD has a steep learning curve. Our data showed that, on average, an untutored practitioner achieved competency after 150-250 procedures, a finding corroborated by other US groups.
Second, there is no specific CPT code for ESD in the United States. Physicians are forced to bill the procedure as EMR or use an unlisted code, resulting in reimbursement that does not reflect the time and complexity of the procedure. Our group showed that physician reimbursement for ESD is highly variable, ranging from $50 to $800 per case, depending on insurance type.
Third, the increasing emphasis on productivity and RVU generation in academic settings has hindered the growth of ESD training in many institutions. Still, the outlook for ESD in the United States remains encouraging. Multiple industry-sponsored training courses are held annually, and professional societies are investing heavily in expanding access to structured education in ESD. Industry is also innovating devices that improve procedural efficiency and safety. Adopting novel approaches, such as traction-assisted ESD, has made the technique more appealing to endoscopists concerned about long procedure times. For example, our group proposed a standardized esophageal ESD technique that incorporates specimen self-retraction. This method improves both safety and speed and has helped address several procedural challenges. We’ve demonstrated that consistency in technique can substantially expedite esophageal ESD.
Fast forward 5 years: We anticipate a dedicated CPT code for ESD, broader access to advanced resection tools, and an expanding number of fellowships offering structured ESD training. These developments are poised to eliminate many of the current barriers. In summary, with robust data supporting the efficacy of ESD in early esophageal cancer, the focus in the United States should shift toward mastering and integrating the technique, rather than dismissing it in favor of piecemeal EMR.
Dr. Othman is chief of the gastroenterology and hepatology section at Baylor College of Medicine and Medicine Subspecialities Service Line Chief at Baylor St Luke’s Medical Center, both in Houston. He declares no conflicts of interest.
Building Your Referral Base
In this video, Lisa Mathew, MD, of South Denver Gastroenterology in Denver, Colorado, and Raja Taunk, MD, of Anne Arundel Gastroenterology Associates, in Annapolis, Maryland, share insights on private practice gastroenterology and offer tips on building your practice – specifically improving your referral base.
In this video, Lisa Mathew, MD, of South Denver Gastroenterology in Denver, Colorado, and Raja Taunk, MD, of Anne Arundel Gastroenterology Associates, in Annapolis, Maryland, share insights on private practice gastroenterology and offer tips on building your practice – specifically improving your referral base.
In this video, Lisa Mathew, MD, of South Denver Gastroenterology in Denver, Colorado, and Raja Taunk, MD, of Anne Arundel Gastroenterology Associates, in Annapolis, Maryland, share insights on private practice gastroenterology and offer tips on building your practice – specifically improving your referral base.
A Threat to Scientific Progress
The United States has long been recognized as a global leader in biomedical research and scientific discovery, with federal research and development (R&D) funding serving as the bedrock of national innovation. Substantial federal investment in biomedical research has stemmed from a recognition of its importance in fueling critical discoveries that improve patient care and the health of our communities.
In the United States, academic institutions play a key role in conducting research in the national interest and collaborating with industry, with most of the federal research funding distributed by the National Institutes of Health, National Science Foundation, and other agencies awarded to university-based academic investigators. In a 2014 report, the National Academies of Sciences, Engineering and Medicine identified three pillars of a highly productive research system: a talented and interconnected workforce, adequate and dependable resources, and world-class basic research in all major areas of science.
A series of recent, short-sighted federal policy decisions threaten the future of scientific discovery by eroding these pillars. Decisions to freeze previously awarded federal grant funding, delay grant review panels, fire federal scientists, and propose crippling cuts to indirect cost rates (among others) have sent shock waves through the research community and already have led some prominent research institutions to cut staff and divert resources away from groundbreaking research. While the acute effects of these changes are just beginning to be felt, it is the long-term effects of these decisions on future medical and scientific discovery that will be most devastating to society.
In our April issue, we highlight important research advancements in inflammatory bowel disease presented at February’s Congress of the European Crohn’s and Colitis Organisation (ECCO) in Berlin. In this month’s Member Spotlight, Abigail Meyers, MPAS, PA-C, outlines her impactful work as a member of AGA’s newly formed Nurse Practitioner and Physician Assistant Task Force and shares how her personal journey as a patient with inflammatory bowel disease allows her to be a more powerful advocate for important issues impacting other patients with this condition.
Megan A. Adams, MD, JD, MSc
Editor in Chief
The United States has long been recognized as a global leader in biomedical research and scientific discovery, with federal research and development (R&D) funding serving as the bedrock of national innovation. Substantial federal investment in biomedical research has stemmed from a recognition of its importance in fueling critical discoveries that improve patient care and the health of our communities.
In the United States, academic institutions play a key role in conducting research in the national interest and collaborating with industry, with most of the federal research funding distributed by the National Institutes of Health, National Science Foundation, and other agencies awarded to university-based academic investigators. In a 2014 report, the National Academies of Sciences, Engineering and Medicine identified three pillars of a highly productive research system: a talented and interconnected workforce, adequate and dependable resources, and world-class basic research in all major areas of science.
A series of recent, short-sighted federal policy decisions threaten the future of scientific discovery by eroding these pillars. Decisions to freeze previously awarded federal grant funding, delay grant review panels, fire federal scientists, and propose crippling cuts to indirect cost rates (among others) have sent shock waves through the research community and already have led some prominent research institutions to cut staff and divert resources away from groundbreaking research. While the acute effects of these changes are just beginning to be felt, it is the long-term effects of these decisions on future medical and scientific discovery that will be most devastating to society.
In our April issue, we highlight important research advancements in inflammatory bowel disease presented at February’s Congress of the European Crohn’s and Colitis Organisation (ECCO) in Berlin. In this month’s Member Spotlight, Abigail Meyers, MPAS, PA-C, outlines her impactful work as a member of AGA’s newly formed Nurse Practitioner and Physician Assistant Task Force and shares how her personal journey as a patient with inflammatory bowel disease allows her to be a more powerful advocate for important issues impacting other patients with this condition.
Megan A. Adams, MD, JD, MSc
Editor in Chief
The United States has long been recognized as a global leader in biomedical research and scientific discovery, with federal research and development (R&D) funding serving as the bedrock of national innovation. Substantial federal investment in biomedical research has stemmed from a recognition of its importance in fueling critical discoveries that improve patient care and the health of our communities.
In the United States, academic institutions play a key role in conducting research in the national interest and collaborating with industry, with most of the federal research funding distributed by the National Institutes of Health, National Science Foundation, and other agencies awarded to university-based academic investigators. In a 2014 report, the National Academies of Sciences, Engineering and Medicine identified three pillars of a highly productive research system: a talented and interconnected workforce, adequate and dependable resources, and world-class basic research in all major areas of science.
A series of recent, short-sighted federal policy decisions threaten the future of scientific discovery by eroding these pillars. Decisions to freeze previously awarded federal grant funding, delay grant review panels, fire federal scientists, and propose crippling cuts to indirect cost rates (among others) have sent shock waves through the research community and already have led some prominent research institutions to cut staff and divert resources away from groundbreaking research. While the acute effects of these changes are just beginning to be felt, it is the long-term effects of these decisions on future medical and scientific discovery that will be most devastating to society.
In our April issue, we highlight important research advancements in inflammatory bowel disease presented at February’s Congress of the European Crohn’s and Colitis Organisation (ECCO) in Berlin. In this month’s Member Spotlight, Abigail Meyers, MPAS, PA-C, outlines her impactful work as a member of AGA’s newly formed Nurse Practitioner and Physician Assistant Task Force and shares how her personal journey as a patient with inflammatory bowel disease allows her to be a more powerful advocate for important issues impacting other patients with this condition.
Megan A. Adams, MD, JD, MSc
Editor in Chief
The Value of Public Service
Former Secretary of State Condoleezza Rice once said: “There is no greater challenge and there is no greater honor than to be in public service.” It has been a challenging few months for public servants, including the thousands of federal healthcare and public health workers who care for our veterans, provide critical services to underserved communities, work to fund high-impact biomedical research that improves health outcomes, and otherwise further important public health goals.
From the VA to the Department of Health & Human Services and its operating divisions, including the Centers for Disease Control and Prevention, National Institutes of Health, Centers for Medicare & Medicaid Services, and others, dedicated federal civil servants have had their work ethic, commitment, and productivity questioned in late-night emails from anonymous authors. They have been encouraged indiscriminately to resign and “move from [their] lower-productivity jobs in the public sector to higher-productivity jobs in the private sector,” and been subjected to vague threats of future job loss regardless of role, duration of service, performance, or political persuasion. This includes the roughly 30% of federal employees who are themselves US military veterans.
In essence, the message is that their work does not matter, and their service and sacrifice is not valued (which, of course, could not be further from the truth). These actions, along with a plethora of other divisive policies, not only threaten our democratic principles, but also serve to degrade our collective values and norms. We are at a “fork in the road” as a nation. I hope for the greater good that we can work together to uphold the value of public service, of community, of civility — both for the sake of our democracy and to preserve our nation’s health.
In our March issue, This month’s Member Spotlight features Dr. Pooja Singhal (Oklahoma Gastro Health and Wellness), who describes how she integrates wellness principles into her clinical practice, discusses the evolution of her interest in women’s digestive health, and shares how she serves her community outside of medicine.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Former Secretary of State Condoleezza Rice once said: “There is no greater challenge and there is no greater honor than to be in public service.” It has been a challenging few months for public servants, including the thousands of federal healthcare and public health workers who care for our veterans, provide critical services to underserved communities, work to fund high-impact biomedical research that improves health outcomes, and otherwise further important public health goals.
From the VA to the Department of Health & Human Services and its operating divisions, including the Centers for Disease Control and Prevention, National Institutes of Health, Centers for Medicare & Medicaid Services, and others, dedicated federal civil servants have had their work ethic, commitment, and productivity questioned in late-night emails from anonymous authors. They have been encouraged indiscriminately to resign and “move from [their] lower-productivity jobs in the public sector to higher-productivity jobs in the private sector,” and been subjected to vague threats of future job loss regardless of role, duration of service, performance, or political persuasion. This includes the roughly 30% of federal employees who are themselves US military veterans.
In essence, the message is that their work does not matter, and their service and sacrifice is not valued (which, of course, could not be further from the truth). These actions, along with a plethora of other divisive policies, not only threaten our democratic principles, but also serve to degrade our collective values and norms. We are at a “fork in the road” as a nation. I hope for the greater good that we can work together to uphold the value of public service, of community, of civility — both for the sake of our democracy and to preserve our nation’s health.
In our March issue, This month’s Member Spotlight features Dr. Pooja Singhal (Oklahoma Gastro Health and Wellness), who describes how she integrates wellness principles into her clinical practice, discusses the evolution of her interest in women’s digestive health, and shares how she serves her community outside of medicine.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Former Secretary of State Condoleezza Rice once said: “There is no greater challenge and there is no greater honor than to be in public service.” It has been a challenging few months for public servants, including the thousands of federal healthcare and public health workers who care for our veterans, provide critical services to underserved communities, work to fund high-impact biomedical research that improves health outcomes, and otherwise further important public health goals.
From the VA to the Department of Health & Human Services and its operating divisions, including the Centers for Disease Control and Prevention, National Institutes of Health, Centers for Medicare & Medicaid Services, and others, dedicated federal civil servants have had their work ethic, commitment, and productivity questioned in late-night emails from anonymous authors. They have been encouraged indiscriminately to resign and “move from [their] lower-productivity jobs in the public sector to higher-productivity jobs in the private sector,” and been subjected to vague threats of future job loss regardless of role, duration of service, performance, or political persuasion. This includes the roughly 30% of federal employees who are themselves US military veterans.
In essence, the message is that their work does not matter, and their service and sacrifice is not valued (which, of course, could not be further from the truth). These actions, along with a plethora of other divisive policies, not only threaten our democratic principles, but also serve to degrade our collective values and norms. We are at a “fork in the road” as a nation. I hope for the greater good that we can work together to uphold the value of public service, of community, of civility — both for the sake of our democracy and to preserve our nation’s health.
In our March issue, This month’s Member Spotlight features Dr. Pooja Singhal (Oklahoma Gastro Health and Wellness), who describes how she integrates wellness principles into her clinical practice, discusses the evolution of her interest in women’s digestive health, and shares how she serves her community outside of medicine.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Clinical Research in Early Career Academic Medicine
Conducting clinical research as an early career gastroenterologist can take on many forms and has varying definitions of success. This article focuses on key factors to consider and should be supplemented with mentorship tailored to personal interests, goals, and institutional criteria for success. In this article, we will discuss selected high-yield topics that assist in early-career research. We will briefly discuss 1. Defining your niche, 2. Collaboration, 3. Visibility, 4. Time management, 5. Funding, 6. Receiving mentorship, and 7. Providing mentorship. We will conclude with discussing several authors’ experience in the research lab of the first author (FELD Lab – Fostering Equity in Liver and Digestive disease).
Defining Your Niche
Defining your niche is an essential component of an early career, as when academicians must transition from a trainee, who is supporting the research of an established mentor, to defining their own subspeciality area of investigation. Early-career academics should build on their prior work, but should also explore their own passions and skill set to define what will be unique about their research program and contributions to the field. Of course, positioning oneself at the intersection of two or more seemingly unrelated fields opens much opportunity for large impact but comes at a cost of identifying mentorship and justifying the niche to funders.
Collaboration
Fostering a collaborative environment is essential for early-career physician-researchers. One effective approach is to establish collaboration circles with other early career academics. Expanding research endeavors beyond a single institution to a multi-center framework enriches both scope and impact. This collaborative approach not only amplifies the depth of research but also facilitates peer mentorship and sponsorship. Participation in such networks can significantly enhance scholarly output and broaden professional reach during this critical phase of academic progression. Furthermore, prioritizing the promotion of colleagues within these networks is crucial. Proactive sponsorship opportunities, such as inviting peers to present at institutional seminars, strengthen both individual and collective academic visibility.
Collaboration is also essential to foster between trainees involved in early-career investigators’ work. An interconnected lab environment ensures that trainees remain informed about concurrent projects, thereby fostering a culture of shared knowledge and optimized productivity. Encouraging trainees to spearhead research aligned with their interests, under mentor guidance, nurtures independent inquiry and leadership. By establishing explicit roles, responsibilities, and authorship agreements at the outset of collaborative projects, early career mentors can avoid future conflicts and preserve a collaborative culture within the lab. This structured approach cultivates a supportive ecosystem, advancing both individual and collective research achievements.
Visibility
Establishing visibility and developing name recognition are crucial components of career advancement for early-career academic physicians. By clearly defining their areas of expertise, faculty can position themselves as leaders within their discipline. Active participation in professional societies, both at the local and national level, engagement with interest groups, and frequent contributions to educational events can be effective strategies for gaining recognition. Leveraging social media platforms can be helpful in enhancing visibility by facilitating connections and promoting research to a broader audience.
Moreover, research visibility plays a vital role in academic promotion. A strong publication record, reflected by an increasing h-index, demonstrates the impact and relevance of one’s research. Self-citation, when appropriate, can reinforce the continuity and progression of scholarly contributions. While publishing in high-impact journals is desirable, adaptability in resubmitting to other journals following rejections ensures that research remains visible and accessible. It also clearly establishes by whom the work was first done, before someone else investigates the line of inquiry. Through a combination of strategic engagement and publication efforts, early-career physicians can effectively build their professional reputation and advance their academic careers.
Time Management
Time management is essential for any research, and particularly in early career when efficiency in clinical care duties is still being gained. Securing protected time for research is essential to develop a niche, build connections (both institutionally and beyond their institutions), and demonstrate productivity that can be utilized to support future grant efforts.
Similarly, using protected time efficiently is required. Without organization and planning, research time can be spent with scattered meetings and responding to various tasks that do not directly support your research. It is helpful to be introspective about the time of the day you are most productive in your research efforts and blocking off that time to focus on research tasks and minimizing distractions. Blocking monthly time for larger scale thinking and planning is also important. Weekly lab and individual one-on-one meetings also support time management for trainees and lab members, to ensure efficiency and progress. Additionally, robust clinical support is essential to ensure that research time remains protected and patient care moves forward. When negotiating for positions, and in regular meetings thereafter, it is important to advocate for sufficient clinical staffing such that non-physician tasks can be appropriately delegated to another member of the care team.
Funding
Securing adequate funding poses a significant challenge for all early-career physician-scientists, particularly because of the discrepancy between National Institutes of Health salary caps and the higher average salaries in academic gastroenterology. This financial gap can deter physicians from pursuing research-intensive careers altogether and can derail early investigators who do not obtain funding rapidly. To overcome this, early-career investigators may need to adopt flexible strategies, such as accepting a lower salary that aligns with grant funding limits or funneling incentive or bonus pay to research accounts. Alternatively, they can advocate for institutional support to bridge the salary gap, ensuring their research efforts remain financially viable.
Institutions committed to fostering research excellence may offer supplemental funding or bridge programs to retain talented physician-scientists, thereby mitigating the financial strain and encouraging long-term engagement in research. Regular meetings to review salary and support sources, including philanthropy, foundation grants, and other streams, should be undertaken with leadership to align the researcher’s timeline and available funding. If career development funding appears untenable, consideration of multi–principal investigator R01s or equivalent with senior established investigators can be a promising path.
Receiving Mentorship
Effective mentorship for early-career physician-scientists should be approached through a team-based model that leverages both internal and external mentors. Internal mentors, familiar with the specific culture, expectations, and advancement pathways of the institution, can provide invaluable guidance on navigating institutional metrics for success, such as promotion criteria, grant acquisition, and clinical-research balance. External mentors, on the other hand, bring a broader perspective by offering innovative career development strategies and solutions derived from experiences at their home institutions. This multimodal mentorship model ensures a well-rounded approach to professional growth.
All national gastroenterology societies, including the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy, and American Association for the Study of Liver Disease, offer structured early-career mentorship programs designed to connect emerging researchers with experienced leaders in the field (see below). These programs typically require a formal application process and are highly regarded for their exceptional quality and impact. Participation in such initiatives can significantly enhance career development by expanding networks, fostering interdisciplinary collaboration, and providing tailored guidance that complements institutional support. Integrating both internal and external mentorship opportunities ensures a robust and dynamic foundation for long-term success in academic medicine.
- AGA Career Compass (https://gastro.org/fellows-and-early-career/mentoring/)
- ACG Early Career Leadership Program (https://gi.org/acg-institute/early-career-leadership-program/)
- AGA-AASLD Academic Skills Workshop (https://gastro.org/news/applications-now-being-accepted-for-the-2024-aga-aasld-academic-skills-workshop/)
- AASLD Women’s Initiative Committee Leadership Program (https://www.aasld.org/promoting-leadership-potential-women-hepatology)
- Scrubs n Heels Mentorship Matrix (https://scrubsandheels.com/matrix/)
Providing Mentorship
The trainee authors on this manuscript describe in this section what has been helpful for them as mentees in the FELD research lab.
Student doctor Nguyen describes her experience as a lab member and things she finds most helpful as a medical student in the lab:
- Upon joining the team, a one-to-one meeting to discuss trainee’s personal and professional goals, and availability, was crucial to building the mentor-mentee relationship. Establishing this meaningful mentorship early on clarified expectations on both sides, built trust, and increased motivation. As a trainee, it is essential for me to see how my work aligns with a long-term goal and to receive ample guidance throughout the process.
- One of the most impactful experiences has been joining informal lunch sessions where trainees discussed data collection protocols and exchanged insights. In doing so, Dr. Feld has cultivated a lab culture that encourages curiosity, constructive feedback, and collaborative learning.
- To increase productivity, our team of trainees created a useful group message thread where we coordinated more sessions to collaborate. This coordination formed stronger relationships between team members and fostered a sense of shared purpose.
Dr. Cooper, a third year internal medicine resident, describes her experience as both a research mentee and a mentor to the junior trainees: “As a resident pursuing a career in academic gastroenterology and hepatology, I have found three key elements to be most helpful: intentional mentorship, structured meetings, and leadership development.”
- Intentional mentorship: Prior to joining the lab, I met with Dr. Feld to discuss my research experience and my goals. She took the time to understand these within the context of my training timeline and tailored project opportunities that aligned with my interests and were both feasible and impactful for my next steps. This intentional approach not only fostered a productive research experience but also established a mentor-mentee relationship built on genuine care for my growth and development.
- Regular meetings: Frequent lab meetings promote accountability, teamwork, and shared problem-solving skills. The open exchange of ideas fosters collaboration and joint problem solving to elevate the quality of our research. They are also an opportunity to observe key decision-making points during the research process and have been a great way to learn more about solid methodology.
- Supervised leadership: I have had ample time to lead discussions and coordinate projects among the junior trainees. These monitored leadership experiences promote project management skills, mentorship, and team dynamic awareness while maintaining the safety net of senior guidance. This model helped me transition from a trainee supporting others’ research to a more independent role, contributing to multi-disciplinary projects while mentoring junior members.
Conclusion
In conclusion, many exciting opportunities and notable barriers exist to establishing a clinical research laboratory in the early career. While excellence in each of the areas outlined may evolve, some aspects will come easier than others and with time, persistence, and a bit of luck, the research world will be a better place because of your contributions!
Dr. Feld is assistant professor of gastroenterology and hepatology and physician executive of Diversity, Equity, Inclusion and Belonging for the department of medicine at the University of Massachusetts (UMass) Chan Medical School, Worcester. Ms. Nguyen is a medical student at UMass Chan Medical School. Dr. Cooper is a resident physician at UMass Chan Medical School. Dr. Rabinowitz is an attending physician in the Inflammatory Bowel Disease Center at Beth Israel Deaconess Medical Center, Boston, Mass. Dr. Uchida is codirector of the Multidisciplinary Eosinophilic Gastrointestinal Disease Clinic at the University of Utah School of Medicine, Salt Lake City.
Conducting clinical research as an early career gastroenterologist can take on many forms and has varying definitions of success. This article focuses on key factors to consider and should be supplemented with mentorship tailored to personal interests, goals, and institutional criteria for success. In this article, we will discuss selected high-yield topics that assist in early-career research. We will briefly discuss 1. Defining your niche, 2. Collaboration, 3. Visibility, 4. Time management, 5. Funding, 6. Receiving mentorship, and 7. Providing mentorship. We will conclude with discussing several authors’ experience in the research lab of the first author (FELD Lab – Fostering Equity in Liver and Digestive disease).
Defining Your Niche
Defining your niche is an essential component of an early career, as when academicians must transition from a trainee, who is supporting the research of an established mentor, to defining their own subspeciality area of investigation. Early-career academics should build on their prior work, but should also explore their own passions and skill set to define what will be unique about their research program and contributions to the field. Of course, positioning oneself at the intersection of two or more seemingly unrelated fields opens much opportunity for large impact but comes at a cost of identifying mentorship and justifying the niche to funders.
Collaboration
Fostering a collaborative environment is essential for early-career physician-researchers. One effective approach is to establish collaboration circles with other early career academics. Expanding research endeavors beyond a single institution to a multi-center framework enriches both scope and impact. This collaborative approach not only amplifies the depth of research but also facilitates peer mentorship and sponsorship. Participation in such networks can significantly enhance scholarly output and broaden professional reach during this critical phase of academic progression. Furthermore, prioritizing the promotion of colleagues within these networks is crucial. Proactive sponsorship opportunities, such as inviting peers to present at institutional seminars, strengthen both individual and collective academic visibility.
Collaboration is also essential to foster between trainees involved in early-career investigators’ work. An interconnected lab environment ensures that trainees remain informed about concurrent projects, thereby fostering a culture of shared knowledge and optimized productivity. Encouraging trainees to spearhead research aligned with their interests, under mentor guidance, nurtures independent inquiry and leadership. By establishing explicit roles, responsibilities, and authorship agreements at the outset of collaborative projects, early career mentors can avoid future conflicts and preserve a collaborative culture within the lab. This structured approach cultivates a supportive ecosystem, advancing both individual and collective research achievements.
Visibility
Establishing visibility and developing name recognition are crucial components of career advancement for early-career academic physicians. By clearly defining their areas of expertise, faculty can position themselves as leaders within their discipline. Active participation in professional societies, both at the local and national level, engagement with interest groups, and frequent contributions to educational events can be effective strategies for gaining recognition. Leveraging social media platforms can be helpful in enhancing visibility by facilitating connections and promoting research to a broader audience.
Moreover, research visibility plays a vital role in academic promotion. A strong publication record, reflected by an increasing h-index, demonstrates the impact and relevance of one’s research. Self-citation, when appropriate, can reinforce the continuity and progression of scholarly contributions. While publishing in high-impact journals is desirable, adaptability in resubmitting to other journals following rejections ensures that research remains visible and accessible. It also clearly establishes by whom the work was first done, before someone else investigates the line of inquiry. Through a combination of strategic engagement and publication efforts, early-career physicians can effectively build their professional reputation and advance their academic careers.
Time Management
Time management is essential for any research, and particularly in early career when efficiency in clinical care duties is still being gained. Securing protected time for research is essential to develop a niche, build connections (both institutionally and beyond their institutions), and demonstrate productivity that can be utilized to support future grant efforts.
Similarly, using protected time efficiently is required. Without organization and planning, research time can be spent with scattered meetings and responding to various tasks that do not directly support your research. It is helpful to be introspective about the time of the day you are most productive in your research efforts and blocking off that time to focus on research tasks and minimizing distractions. Blocking monthly time for larger scale thinking and planning is also important. Weekly lab and individual one-on-one meetings also support time management for trainees and lab members, to ensure efficiency and progress. Additionally, robust clinical support is essential to ensure that research time remains protected and patient care moves forward. When negotiating for positions, and in regular meetings thereafter, it is important to advocate for sufficient clinical staffing such that non-physician tasks can be appropriately delegated to another member of the care team.
Funding
Securing adequate funding poses a significant challenge for all early-career physician-scientists, particularly because of the discrepancy between National Institutes of Health salary caps and the higher average salaries in academic gastroenterology. This financial gap can deter physicians from pursuing research-intensive careers altogether and can derail early investigators who do not obtain funding rapidly. To overcome this, early-career investigators may need to adopt flexible strategies, such as accepting a lower salary that aligns with grant funding limits or funneling incentive or bonus pay to research accounts. Alternatively, they can advocate for institutional support to bridge the salary gap, ensuring their research efforts remain financially viable.
Institutions committed to fostering research excellence may offer supplemental funding or bridge programs to retain talented physician-scientists, thereby mitigating the financial strain and encouraging long-term engagement in research. Regular meetings to review salary and support sources, including philanthropy, foundation grants, and other streams, should be undertaken with leadership to align the researcher’s timeline and available funding. If career development funding appears untenable, consideration of multi–principal investigator R01s or equivalent with senior established investigators can be a promising path.
Receiving Mentorship
Effective mentorship for early-career physician-scientists should be approached through a team-based model that leverages both internal and external mentors. Internal mentors, familiar with the specific culture, expectations, and advancement pathways of the institution, can provide invaluable guidance on navigating institutional metrics for success, such as promotion criteria, grant acquisition, and clinical-research balance. External mentors, on the other hand, bring a broader perspective by offering innovative career development strategies and solutions derived from experiences at their home institutions. This multimodal mentorship model ensures a well-rounded approach to professional growth.
All national gastroenterology societies, including the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy, and American Association for the Study of Liver Disease, offer structured early-career mentorship programs designed to connect emerging researchers with experienced leaders in the field (see below). These programs typically require a formal application process and are highly regarded for their exceptional quality and impact. Participation in such initiatives can significantly enhance career development by expanding networks, fostering interdisciplinary collaboration, and providing tailored guidance that complements institutional support. Integrating both internal and external mentorship opportunities ensures a robust and dynamic foundation for long-term success in academic medicine.
- AGA Career Compass (https://gastro.org/fellows-and-early-career/mentoring/)
- ACG Early Career Leadership Program (https://gi.org/acg-institute/early-career-leadership-program/)
- AGA-AASLD Academic Skills Workshop (https://gastro.org/news/applications-now-being-accepted-for-the-2024-aga-aasld-academic-skills-workshop/)
- AASLD Women’s Initiative Committee Leadership Program (https://www.aasld.org/promoting-leadership-potential-women-hepatology)
- Scrubs n Heels Mentorship Matrix (https://scrubsandheels.com/matrix/)
Providing Mentorship
The trainee authors on this manuscript describe in this section what has been helpful for them as mentees in the FELD research lab.
Student doctor Nguyen describes her experience as a lab member and things she finds most helpful as a medical student in the lab:
- Upon joining the team, a one-to-one meeting to discuss trainee’s personal and professional goals, and availability, was crucial to building the mentor-mentee relationship. Establishing this meaningful mentorship early on clarified expectations on both sides, built trust, and increased motivation. As a trainee, it is essential for me to see how my work aligns with a long-term goal and to receive ample guidance throughout the process.
- One of the most impactful experiences has been joining informal lunch sessions where trainees discussed data collection protocols and exchanged insights. In doing so, Dr. Feld has cultivated a lab culture that encourages curiosity, constructive feedback, and collaborative learning.
- To increase productivity, our team of trainees created a useful group message thread where we coordinated more sessions to collaborate. This coordination formed stronger relationships between team members and fostered a sense of shared purpose.
Dr. Cooper, a third year internal medicine resident, describes her experience as both a research mentee and a mentor to the junior trainees: “As a resident pursuing a career in academic gastroenterology and hepatology, I have found three key elements to be most helpful: intentional mentorship, structured meetings, and leadership development.”
- Intentional mentorship: Prior to joining the lab, I met with Dr. Feld to discuss my research experience and my goals. She took the time to understand these within the context of my training timeline and tailored project opportunities that aligned with my interests and were both feasible and impactful for my next steps. This intentional approach not only fostered a productive research experience but also established a mentor-mentee relationship built on genuine care for my growth and development.
- Regular meetings: Frequent lab meetings promote accountability, teamwork, and shared problem-solving skills. The open exchange of ideas fosters collaboration and joint problem solving to elevate the quality of our research. They are also an opportunity to observe key decision-making points during the research process and have been a great way to learn more about solid methodology.
- Supervised leadership: I have had ample time to lead discussions and coordinate projects among the junior trainees. These monitored leadership experiences promote project management skills, mentorship, and team dynamic awareness while maintaining the safety net of senior guidance. This model helped me transition from a trainee supporting others’ research to a more independent role, contributing to multi-disciplinary projects while mentoring junior members.
Conclusion
In conclusion, many exciting opportunities and notable barriers exist to establishing a clinical research laboratory in the early career. While excellence in each of the areas outlined may evolve, some aspects will come easier than others and with time, persistence, and a bit of luck, the research world will be a better place because of your contributions!
Dr. Feld is assistant professor of gastroenterology and hepatology and physician executive of Diversity, Equity, Inclusion and Belonging for the department of medicine at the University of Massachusetts (UMass) Chan Medical School, Worcester. Ms. Nguyen is a medical student at UMass Chan Medical School. Dr. Cooper is a resident physician at UMass Chan Medical School. Dr. Rabinowitz is an attending physician in the Inflammatory Bowel Disease Center at Beth Israel Deaconess Medical Center, Boston, Mass. Dr. Uchida is codirector of the Multidisciplinary Eosinophilic Gastrointestinal Disease Clinic at the University of Utah School of Medicine, Salt Lake City.
Conducting clinical research as an early career gastroenterologist can take on many forms and has varying definitions of success. This article focuses on key factors to consider and should be supplemented with mentorship tailored to personal interests, goals, and institutional criteria for success. In this article, we will discuss selected high-yield topics that assist in early-career research. We will briefly discuss 1. Defining your niche, 2. Collaboration, 3. Visibility, 4. Time management, 5. Funding, 6. Receiving mentorship, and 7. Providing mentorship. We will conclude with discussing several authors’ experience in the research lab of the first author (FELD Lab – Fostering Equity in Liver and Digestive disease).
Defining Your Niche
Defining your niche is an essential component of an early career, as when academicians must transition from a trainee, who is supporting the research of an established mentor, to defining their own subspeciality area of investigation. Early-career academics should build on their prior work, but should also explore their own passions and skill set to define what will be unique about their research program and contributions to the field. Of course, positioning oneself at the intersection of two or more seemingly unrelated fields opens much opportunity for large impact but comes at a cost of identifying mentorship and justifying the niche to funders.
Collaboration
Fostering a collaborative environment is essential for early-career physician-researchers. One effective approach is to establish collaboration circles with other early career academics. Expanding research endeavors beyond a single institution to a multi-center framework enriches both scope and impact. This collaborative approach not only amplifies the depth of research but also facilitates peer mentorship and sponsorship. Participation in such networks can significantly enhance scholarly output and broaden professional reach during this critical phase of academic progression. Furthermore, prioritizing the promotion of colleagues within these networks is crucial. Proactive sponsorship opportunities, such as inviting peers to present at institutional seminars, strengthen both individual and collective academic visibility.
Collaboration is also essential to foster between trainees involved in early-career investigators’ work. An interconnected lab environment ensures that trainees remain informed about concurrent projects, thereby fostering a culture of shared knowledge and optimized productivity. Encouraging trainees to spearhead research aligned with their interests, under mentor guidance, nurtures independent inquiry and leadership. By establishing explicit roles, responsibilities, and authorship agreements at the outset of collaborative projects, early career mentors can avoid future conflicts and preserve a collaborative culture within the lab. This structured approach cultivates a supportive ecosystem, advancing both individual and collective research achievements.
Visibility
Establishing visibility and developing name recognition are crucial components of career advancement for early-career academic physicians. By clearly defining their areas of expertise, faculty can position themselves as leaders within their discipline. Active participation in professional societies, both at the local and national level, engagement with interest groups, and frequent contributions to educational events can be effective strategies for gaining recognition. Leveraging social media platforms can be helpful in enhancing visibility by facilitating connections and promoting research to a broader audience.
Moreover, research visibility plays a vital role in academic promotion. A strong publication record, reflected by an increasing h-index, demonstrates the impact and relevance of one’s research. Self-citation, when appropriate, can reinforce the continuity and progression of scholarly contributions. While publishing in high-impact journals is desirable, adaptability in resubmitting to other journals following rejections ensures that research remains visible and accessible. It also clearly establishes by whom the work was first done, before someone else investigates the line of inquiry. Through a combination of strategic engagement and publication efforts, early-career physicians can effectively build their professional reputation and advance their academic careers.
Time Management
Time management is essential for any research, and particularly in early career when efficiency in clinical care duties is still being gained. Securing protected time for research is essential to develop a niche, build connections (both institutionally and beyond their institutions), and demonstrate productivity that can be utilized to support future grant efforts.
Similarly, using protected time efficiently is required. Without organization and planning, research time can be spent with scattered meetings and responding to various tasks that do not directly support your research. It is helpful to be introspective about the time of the day you are most productive in your research efforts and blocking off that time to focus on research tasks and minimizing distractions. Blocking monthly time for larger scale thinking and planning is also important. Weekly lab and individual one-on-one meetings also support time management for trainees and lab members, to ensure efficiency and progress. Additionally, robust clinical support is essential to ensure that research time remains protected and patient care moves forward. When negotiating for positions, and in regular meetings thereafter, it is important to advocate for sufficient clinical staffing such that non-physician tasks can be appropriately delegated to another member of the care team.
Funding
Securing adequate funding poses a significant challenge for all early-career physician-scientists, particularly because of the discrepancy between National Institutes of Health salary caps and the higher average salaries in academic gastroenterology. This financial gap can deter physicians from pursuing research-intensive careers altogether and can derail early investigators who do not obtain funding rapidly. To overcome this, early-career investigators may need to adopt flexible strategies, such as accepting a lower salary that aligns with grant funding limits or funneling incentive or bonus pay to research accounts. Alternatively, they can advocate for institutional support to bridge the salary gap, ensuring their research efforts remain financially viable.
Institutions committed to fostering research excellence may offer supplemental funding or bridge programs to retain talented physician-scientists, thereby mitigating the financial strain and encouraging long-term engagement in research. Regular meetings to review salary and support sources, including philanthropy, foundation grants, and other streams, should be undertaken with leadership to align the researcher’s timeline and available funding. If career development funding appears untenable, consideration of multi–principal investigator R01s or equivalent with senior established investigators can be a promising path.
Receiving Mentorship
Effective mentorship for early-career physician-scientists should be approached through a team-based model that leverages both internal and external mentors. Internal mentors, familiar with the specific culture, expectations, and advancement pathways of the institution, can provide invaluable guidance on navigating institutional metrics for success, such as promotion criteria, grant acquisition, and clinical-research balance. External mentors, on the other hand, bring a broader perspective by offering innovative career development strategies and solutions derived from experiences at their home institutions. This multimodal mentorship model ensures a well-rounded approach to professional growth.
All national gastroenterology societies, including the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy, and American Association for the Study of Liver Disease, offer structured early-career mentorship programs designed to connect emerging researchers with experienced leaders in the field (see below). These programs typically require a formal application process and are highly regarded for their exceptional quality and impact. Participation in such initiatives can significantly enhance career development by expanding networks, fostering interdisciplinary collaboration, and providing tailored guidance that complements institutional support. Integrating both internal and external mentorship opportunities ensures a robust and dynamic foundation for long-term success in academic medicine.
- AGA Career Compass (https://gastro.org/fellows-and-early-career/mentoring/)
- ACG Early Career Leadership Program (https://gi.org/acg-institute/early-career-leadership-program/)
- AGA-AASLD Academic Skills Workshop (https://gastro.org/news/applications-now-being-accepted-for-the-2024-aga-aasld-academic-skills-workshop/)
- AASLD Women’s Initiative Committee Leadership Program (https://www.aasld.org/promoting-leadership-potential-women-hepatology)
- Scrubs n Heels Mentorship Matrix (https://scrubsandheels.com/matrix/)
Providing Mentorship
The trainee authors on this manuscript describe in this section what has been helpful for them as mentees in the FELD research lab.
Student doctor Nguyen describes her experience as a lab member and things she finds most helpful as a medical student in the lab:
- Upon joining the team, a one-to-one meeting to discuss trainee’s personal and professional goals, and availability, was crucial to building the mentor-mentee relationship. Establishing this meaningful mentorship early on clarified expectations on both sides, built trust, and increased motivation. As a trainee, it is essential for me to see how my work aligns with a long-term goal and to receive ample guidance throughout the process.
- One of the most impactful experiences has been joining informal lunch sessions where trainees discussed data collection protocols and exchanged insights. In doing so, Dr. Feld has cultivated a lab culture that encourages curiosity, constructive feedback, and collaborative learning.
- To increase productivity, our team of trainees created a useful group message thread where we coordinated more sessions to collaborate. This coordination formed stronger relationships between team members and fostered a sense of shared purpose.
Dr. Cooper, a third year internal medicine resident, describes her experience as both a research mentee and a mentor to the junior trainees: “As a resident pursuing a career in academic gastroenterology and hepatology, I have found three key elements to be most helpful: intentional mentorship, structured meetings, and leadership development.”
- Intentional mentorship: Prior to joining the lab, I met with Dr. Feld to discuss my research experience and my goals. She took the time to understand these within the context of my training timeline and tailored project opportunities that aligned with my interests and were both feasible and impactful for my next steps. This intentional approach not only fostered a productive research experience but also established a mentor-mentee relationship built on genuine care for my growth and development.
- Regular meetings: Frequent lab meetings promote accountability, teamwork, and shared problem-solving skills. The open exchange of ideas fosters collaboration and joint problem solving to elevate the quality of our research. They are also an opportunity to observe key decision-making points during the research process and have been a great way to learn more about solid methodology.
- Supervised leadership: I have had ample time to lead discussions and coordinate projects among the junior trainees. These monitored leadership experiences promote project management skills, mentorship, and team dynamic awareness while maintaining the safety net of senior guidance. This model helped me transition from a trainee supporting others’ research to a more independent role, contributing to multi-disciplinary projects while mentoring junior members.
Conclusion
In conclusion, many exciting opportunities and notable barriers exist to establishing a clinical research laboratory in the early career. While excellence in each of the areas outlined may evolve, some aspects will come easier than others and with time, persistence, and a bit of luck, the research world will be a better place because of your contributions!
Dr. Feld is assistant professor of gastroenterology and hepatology and physician executive of Diversity, Equity, Inclusion and Belonging for the department of medicine at the University of Massachusetts (UMass) Chan Medical School, Worcester. Ms. Nguyen is a medical student at UMass Chan Medical School. Dr. Cooper is a resident physician at UMass Chan Medical School. Dr. Rabinowitz is an attending physician in the Inflammatory Bowel Disease Center at Beth Israel Deaconess Medical Center, Boston, Mass. Dr. Uchida is codirector of the Multidisciplinary Eosinophilic Gastrointestinal Disease Clinic at the University of Utah School of Medicine, Salt Lake City.
The Federal Trade Commission’s Non-Compete Ban
Non-compete agreements (NCAs) in physician contracts, also termed “restrictive covenants” or “covenants not to compete,” have become a hot topic recently because of the Federal Trade Commission’s (FTC’s) April 2024 ruling invalidating almost all NCAs. But in fact, NCAs have long been controversial, and no more so than in the realm of physician NCAs, which involve substantial policy concerns.
how it relates to a physician employment contract currently, and its possible evolution.
What is It?
Generally speaking, an NCA, usually in the form of an employment contract clause, is an agreement between the employer and the employee that the employee will not enter into post-contract competition with that employer within the limitations of a specific duration, scope of practice, and/or geography. NCAs have traditionally been regulated under state statutory law and common law and have been permitted based on policy considerations that attempt to balance competing employee and employer interests. Physicians should understand their states’ statutory treatment of an NCA.
NCAs protect important employer business interests, including the protection of proprietary information, safeguarding trade secrets, reducing employee turnover, and protecting patient lists. Employees, though, have limited mobility in changing professional positions, have less bargaining power with the employer, and may find themselves with limited options for comparable professional positions.
The NCA ostensibly appears to greatly benefit the employer’s interests over the employee’s; however, NCA protection of employer interests may also substantially benefit employees by encouraging substantial employer investment in employees whom the employer recognizes as a stable and likely long-term human resource, ultimately fostering increased employee satisfaction and innovation. Indeed, one concern with the FTC’s non-compete ban is the potential for significant underinvestment in information sharing and employee training, because employers would, without a NCA, be less likely to recoup those employee investments and would have limited ability to keep competitors from free-riding on investments in employees who leave and join competitors. Ultimately, this would lead to decreased market efficiency.
What is Its Status Today?
Regulation of NCAs, including physician NCAs, has traditionally been based on state statutory law and by common law. Perhaps because of the increasing use of the NCA in professional settings, the NCA has been increasingly scrutinized by courts and state legislatures in the last few decades, with an overall increasing focus on NCA reasonableness and appropriate fit in individual employment settings, and with an emphasis on employer demonstration of legitimate and significant business interests for using a NCA.
States have evolved differently in their treatment of NCAs; some states ban NCAs altogether while others allow them with varying interpretation and enforceability, frequently focused upon the NCA’s duration, scope, and geography. Similarly, in common law, courts will frequently invalidate NCAs that are found to be unreasonably overbroad, either geographically, temporally, and/or in regard to scope.
On April 23, 2024, however, the FTC altered this existing state of affairs by issuing a rule banning new NCAs in all employment situations after September 3, 2024. The rule also holds that existing NCAs are not enforceable, with a small carve-out for some senior executives. It applies to for-profit businesses, and some, but not all, non-profit organizations. The FTC’s stated intent is to reduce healthcare spending by increasing employee compensation and mobility. The FTC’s ban is likely meant to reduce transaction costs by increasing physician mobility.
There have been several lawsuits regarding the FTC ruling, challenging it on different grounds. The US District Court for the Northern District of Texas in Ryan LLC v. FTC issued first a preliminary injunction, then a final decision overturning the FTC’s rule. The Court held that the FTC had exceeded its statutory authority, and further, that the rule was arbitrary and capricious. It noted that the rule’s “categorical ban” has no equivalent in state law, is “unreasonably overbroad without a reasonable explanation,” “provides no evidence or reasoned basis,” does not “consider the positive benefits of non-compete agreements,” and does not “address alternatives to the Rule.” The Ryan Court reasoned that as an administrative agency, the FTC can only act as Congress authorizes by statute. On Oct. 18, 2024, the FTC appealed the Court’s decision to the Fifth Circuit Court of Appeals, seeking to reverse the holding setting aside its NCA ban.
The United States District Court for the Eastern District of Pennsylvania in ATS Tree Services LLC v. FTC denied the plaintiff’s motion to stay enforcement of the rule, refusing to issue a preliminary injunction preventing its implementation. As in Ryan, the ATS Tree Services LLC v. FTC plaintiffs argued that the FTC had exceeded its statutory authority in issuing the rule. However, the Plaintiff did not appeal the holding.
The US District Court for the Middle District of Florida in Properties of the Villages, Inc. v. FTCheld, like Ryan, that the rule exceeds the FTC’s statutory authority, noting the FTC’s prior lack of any NCA enforcement actions; however, its reasoning differed from Ryan. The Florida Court held that the FTC in fact has statutory authority to issue such rules; however, the Court held that the FTC could not enforce its rule because it violates the “major questions doctrine.” The “major questions doctrine” requires an agency such as the FTC to “point to clear congressional authorization” for any rule it issues that has “extraordinary ... economic and political significance,” as the NCA ban rule certainly does.
What is Its Future?
The FTC’s NCA ban remains unsettled. State legislatures, in response to the recent court holdings, are reassessing their statutory law regarding NCAs. The Ryan Court’s holding prevented the FTC’s rule from going into effect on September 4, 2024. The Texas and Florida court decisions are awaiting 5th and 11th Circuit Court of Appeals review, respectively. Assuming affirmation of either of the cases on appeal, a circuit split regarding the NCA ban may occur. The US Supreme Court may be called upon to determine the validity of the FTC rule banning NCAs. The Circuit Court decisions are likely to occur in 2025, and any Supreme Court decision would not likely occur until 2026. Meanwhile, state statutory law and common law still apply to NCAs, and the FTC may challenge the validity of NCAs on a case-by-case basis.
US antitrust law remains a potential remedy to scrutinize and restrain inappropriate business practices, including NCA-related abuses. The Sherman Act allows federal and state actors and private citizens, to sue for redress. Antitrust cases are typically considered using the “rule of reason” formulated by the Supreme Court in 1911, which requires plaintiffs show that defendant businesses possessing market power did in fact undertake anticompetitive conduct that had or likely had anticompetitive effects. In other words, the court in an antitrust case will require that the plaintiff show that the business actually had a significant controlling market presence in the geographic area; and further, that the plaintiff show that the business’ actions in fact had an anticompetitive effect, or likely had one. The latter can be found by showing an anticompetitive effect such as abusive pricing
The FTC’s ruling is legally and academically controversial and in fact may not withstand court scrutiny. The rule was put forth by the FTC as an ambitious rule to reduce healthcare spending. But businesses survive only if their revenue surpasses their costs, including personnel costs. Further, maximization of capitalization is attained when businesses require NCAs. Businesses invest heavily in recruiting, hiring, and training personnel, and increased personnel turnover increases these expenditures. NCAs arguably provide a collective benefit by ensuring force continuity, mitigating the risk of the loss of highly trained personnel with proprietary knowledge. NCAs also help a business maintain a skilled workforce, helping maximize business valuation. If FTC’s NCA ban rule were ultimately upheld, businesses would likely respond by instituting longer-term employee contracts, extended termination notice periods, and disincentives for employees who do not fully serve their contract length, including substantial financial disincentives. Business valuation might decrease, reducing investment incentives.
NCAs have long been a method of balancing the interests of employees and employers. They protect businesses’ confidential information, trade secrets, and patient lists, at some cost to employees pursuing new opportunities. The employee, though, is also provided with some benefit from the NCA, albeit indirect. State statutory law and courts have traditionally worked to ensure an appropriate delicate balance between interests, with courts generally finding unbalanced NCAs unenforceable.
For now, physicians should understand the policy considerations of and recognize the uncertainty surrounding NCAs, become familiar with their state’s statutory NCA law, review employment contracts carefully for NCA reasonableness, and seek legal advice if necessary.
Perhaps the FTC’s approach is the correct one for our future. Or perhaps the appropriate future of NCA interpretation and enforcement should continue to rest on state statutory law and common law, where antitrust enforcement is on a case-by-case basis, rather than FTC rulemaking. The results of high court decisions, state statutory law changes in response to the FTC rule, and perhaps US congressional action will provide the final answer.
Dr. Allen is based at the University of Oklahoma Health Sciences Center in Oklahoma City. He has declared no conflicts of interest in relation to this article.
Non-compete agreements (NCAs) in physician contracts, also termed “restrictive covenants” or “covenants not to compete,” have become a hot topic recently because of the Federal Trade Commission’s (FTC’s) April 2024 ruling invalidating almost all NCAs. But in fact, NCAs have long been controversial, and no more so than in the realm of physician NCAs, which involve substantial policy concerns.
how it relates to a physician employment contract currently, and its possible evolution.
What is It?
Generally speaking, an NCA, usually in the form of an employment contract clause, is an agreement between the employer and the employee that the employee will not enter into post-contract competition with that employer within the limitations of a specific duration, scope of practice, and/or geography. NCAs have traditionally been regulated under state statutory law and common law and have been permitted based on policy considerations that attempt to balance competing employee and employer interests. Physicians should understand their states’ statutory treatment of an NCA.
NCAs protect important employer business interests, including the protection of proprietary information, safeguarding trade secrets, reducing employee turnover, and protecting patient lists. Employees, though, have limited mobility in changing professional positions, have less bargaining power with the employer, and may find themselves with limited options for comparable professional positions.
The NCA ostensibly appears to greatly benefit the employer’s interests over the employee’s; however, NCA protection of employer interests may also substantially benefit employees by encouraging substantial employer investment in employees whom the employer recognizes as a stable and likely long-term human resource, ultimately fostering increased employee satisfaction and innovation. Indeed, one concern with the FTC’s non-compete ban is the potential for significant underinvestment in information sharing and employee training, because employers would, without a NCA, be less likely to recoup those employee investments and would have limited ability to keep competitors from free-riding on investments in employees who leave and join competitors. Ultimately, this would lead to decreased market efficiency.
What is Its Status Today?
Regulation of NCAs, including physician NCAs, has traditionally been based on state statutory law and by common law. Perhaps because of the increasing use of the NCA in professional settings, the NCA has been increasingly scrutinized by courts and state legislatures in the last few decades, with an overall increasing focus on NCA reasonableness and appropriate fit in individual employment settings, and with an emphasis on employer demonstration of legitimate and significant business interests for using a NCA.
States have evolved differently in their treatment of NCAs; some states ban NCAs altogether while others allow them with varying interpretation and enforceability, frequently focused upon the NCA’s duration, scope, and geography. Similarly, in common law, courts will frequently invalidate NCAs that are found to be unreasonably overbroad, either geographically, temporally, and/or in regard to scope.
On April 23, 2024, however, the FTC altered this existing state of affairs by issuing a rule banning new NCAs in all employment situations after September 3, 2024. The rule also holds that existing NCAs are not enforceable, with a small carve-out for some senior executives. It applies to for-profit businesses, and some, but not all, non-profit organizations. The FTC’s stated intent is to reduce healthcare spending by increasing employee compensation and mobility. The FTC’s ban is likely meant to reduce transaction costs by increasing physician mobility.
There have been several lawsuits regarding the FTC ruling, challenging it on different grounds. The US District Court for the Northern District of Texas in Ryan LLC v. FTC issued first a preliminary injunction, then a final decision overturning the FTC’s rule. The Court held that the FTC had exceeded its statutory authority, and further, that the rule was arbitrary and capricious. It noted that the rule’s “categorical ban” has no equivalent in state law, is “unreasonably overbroad without a reasonable explanation,” “provides no evidence or reasoned basis,” does not “consider the positive benefits of non-compete agreements,” and does not “address alternatives to the Rule.” The Ryan Court reasoned that as an administrative agency, the FTC can only act as Congress authorizes by statute. On Oct. 18, 2024, the FTC appealed the Court’s decision to the Fifth Circuit Court of Appeals, seeking to reverse the holding setting aside its NCA ban.
The United States District Court for the Eastern District of Pennsylvania in ATS Tree Services LLC v. FTC denied the plaintiff’s motion to stay enforcement of the rule, refusing to issue a preliminary injunction preventing its implementation. As in Ryan, the ATS Tree Services LLC v. FTC plaintiffs argued that the FTC had exceeded its statutory authority in issuing the rule. However, the Plaintiff did not appeal the holding.
The US District Court for the Middle District of Florida in Properties of the Villages, Inc. v. FTCheld, like Ryan, that the rule exceeds the FTC’s statutory authority, noting the FTC’s prior lack of any NCA enforcement actions; however, its reasoning differed from Ryan. The Florida Court held that the FTC in fact has statutory authority to issue such rules; however, the Court held that the FTC could not enforce its rule because it violates the “major questions doctrine.” The “major questions doctrine” requires an agency such as the FTC to “point to clear congressional authorization” for any rule it issues that has “extraordinary ... economic and political significance,” as the NCA ban rule certainly does.
What is Its Future?
The FTC’s NCA ban remains unsettled. State legislatures, in response to the recent court holdings, are reassessing their statutory law regarding NCAs. The Ryan Court’s holding prevented the FTC’s rule from going into effect on September 4, 2024. The Texas and Florida court decisions are awaiting 5th and 11th Circuit Court of Appeals review, respectively. Assuming affirmation of either of the cases on appeal, a circuit split regarding the NCA ban may occur. The US Supreme Court may be called upon to determine the validity of the FTC rule banning NCAs. The Circuit Court decisions are likely to occur in 2025, and any Supreme Court decision would not likely occur until 2026. Meanwhile, state statutory law and common law still apply to NCAs, and the FTC may challenge the validity of NCAs on a case-by-case basis.
US antitrust law remains a potential remedy to scrutinize and restrain inappropriate business practices, including NCA-related abuses. The Sherman Act allows federal and state actors and private citizens, to sue for redress. Antitrust cases are typically considered using the “rule of reason” formulated by the Supreme Court in 1911, which requires plaintiffs show that defendant businesses possessing market power did in fact undertake anticompetitive conduct that had or likely had anticompetitive effects. In other words, the court in an antitrust case will require that the plaintiff show that the business actually had a significant controlling market presence in the geographic area; and further, that the plaintiff show that the business’ actions in fact had an anticompetitive effect, or likely had one. The latter can be found by showing an anticompetitive effect such as abusive pricing
The FTC’s ruling is legally and academically controversial and in fact may not withstand court scrutiny. The rule was put forth by the FTC as an ambitious rule to reduce healthcare spending. But businesses survive only if their revenue surpasses their costs, including personnel costs. Further, maximization of capitalization is attained when businesses require NCAs. Businesses invest heavily in recruiting, hiring, and training personnel, and increased personnel turnover increases these expenditures. NCAs arguably provide a collective benefit by ensuring force continuity, mitigating the risk of the loss of highly trained personnel with proprietary knowledge. NCAs also help a business maintain a skilled workforce, helping maximize business valuation. If FTC’s NCA ban rule were ultimately upheld, businesses would likely respond by instituting longer-term employee contracts, extended termination notice periods, and disincentives for employees who do not fully serve their contract length, including substantial financial disincentives. Business valuation might decrease, reducing investment incentives.
NCAs have long been a method of balancing the interests of employees and employers. They protect businesses’ confidential information, trade secrets, and patient lists, at some cost to employees pursuing new opportunities. The employee, though, is also provided with some benefit from the NCA, albeit indirect. State statutory law and courts have traditionally worked to ensure an appropriate delicate balance between interests, with courts generally finding unbalanced NCAs unenforceable.
For now, physicians should understand the policy considerations of and recognize the uncertainty surrounding NCAs, become familiar with their state’s statutory NCA law, review employment contracts carefully for NCA reasonableness, and seek legal advice if necessary.
Perhaps the FTC’s approach is the correct one for our future. Or perhaps the appropriate future of NCA interpretation and enforcement should continue to rest on state statutory law and common law, where antitrust enforcement is on a case-by-case basis, rather than FTC rulemaking. The results of high court decisions, state statutory law changes in response to the FTC rule, and perhaps US congressional action will provide the final answer.
Dr. Allen is based at the University of Oklahoma Health Sciences Center in Oklahoma City. He has declared no conflicts of interest in relation to this article.
Non-compete agreements (NCAs) in physician contracts, also termed “restrictive covenants” or “covenants not to compete,” have become a hot topic recently because of the Federal Trade Commission’s (FTC’s) April 2024 ruling invalidating almost all NCAs. But in fact, NCAs have long been controversial, and no more so than in the realm of physician NCAs, which involve substantial policy concerns.
how it relates to a physician employment contract currently, and its possible evolution.
What is It?
Generally speaking, an NCA, usually in the form of an employment contract clause, is an agreement between the employer and the employee that the employee will not enter into post-contract competition with that employer within the limitations of a specific duration, scope of practice, and/or geography. NCAs have traditionally been regulated under state statutory law and common law and have been permitted based on policy considerations that attempt to balance competing employee and employer interests. Physicians should understand their states’ statutory treatment of an NCA.
NCAs protect important employer business interests, including the protection of proprietary information, safeguarding trade secrets, reducing employee turnover, and protecting patient lists. Employees, though, have limited mobility in changing professional positions, have less bargaining power with the employer, and may find themselves with limited options for comparable professional positions.
The NCA ostensibly appears to greatly benefit the employer’s interests over the employee’s; however, NCA protection of employer interests may also substantially benefit employees by encouraging substantial employer investment in employees whom the employer recognizes as a stable and likely long-term human resource, ultimately fostering increased employee satisfaction and innovation. Indeed, one concern with the FTC’s non-compete ban is the potential for significant underinvestment in information sharing and employee training, because employers would, without a NCA, be less likely to recoup those employee investments and would have limited ability to keep competitors from free-riding on investments in employees who leave and join competitors. Ultimately, this would lead to decreased market efficiency.
What is Its Status Today?
Regulation of NCAs, including physician NCAs, has traditionally been based on state statutory law and by common law. Perhaps because of the increasing use of the NCA in professional settings, the NCA has been increasingly scrutinized by courts and state legislatures in the last few decades, with an overall increasing focus on NCA reasonableness and appropriate fit in individual employment settings, and with an emphasis on employer demonstration of legitimate and significant business interests for using a NCA.
States have evolved differently in their treatment of NCAs; some states ban NCAs altogether while others allow them with varying interpretation and enforceability, frequently focused upon the NCA’s duration, scope, and geography. Similarly, in common law, courts will frequently invalidate NCAs that are found to be unreasonably overbroad, either geographically, temporally, and/or in regard to scope.
On April 23, 2024, however, the FTC altered this existing state of affairs by issuing a rule banning new NCAs in all employment situations after September 3, 2024. The rule also holds that existing NCAs are not enforceable, with a small carve-out for some senior executives. It applies to for-profit businesses, and some, but not all, non-profit organizations. The FTC’s stated intent is to reduce healthcare spending by increasing employee compensation and mobility. The FTC’s ban is likely meant to reduce transaction costs by increasing physician mobility.
There have been several lawsuits regarding the FTC ruling, challenging it on different grounds. The US District Court for the Northern District of Texas in Ryan LLC v. FTC issued first a preliminary injunction, then a final decision overturning the FTC’s rule. The Court held that the FTC had exceeded its statutory authority, and further, that the rule was arbitrary and capricious. It noted that the rule’s “categorical ban” has no equivalent in state law, is “unreasonably overbroad without a reasonable explanation,” “provides no evidence or reasoned basis,” does not “consider the positive benefits of non-compete agreements,” and does not “address alternatives to the Rule.” The Ryan Court reasoned that as an administrative agency, the FTC can only act as Congress authorizes by statute. On Oct. 18, 2024, the FTC appealed the Court’s decision to the Fifth Circuit Court of Appeals, seeking to reverse the holding setting aside its NCA ban.
The United States District Court for the Eastern District of Pennsylvania in ATS Tree Services LLC v. FTC denied the plaintiff’s motion to stay enforcement of the rule, refusing to issue a preliminary injunction preventing its implementation. As in Ryan, the ATS Tree Services LLC v. FTC plaintiffs argued that the FTC had exceeded its statutory authority in issuing the rule. However, the Plaintiff did not appeal the holding.
The US District Court for the Middle District of Florida in Properties of the Villages, Inc. v. FTCheld, like Ryan, that the rule exceeds the FTC’s statutory authority, noting the FTC’s prior lack of any NCA enforcement actions; however, its reasoning differed from Ryan. The Florida Court held that the FTC in fact has statutory authority to issue such rules; however, the Court held that the FTC could not enforce its rule because it violates the “major questions doctrine.” The “major questions doctrine” requires an agency such as the FTC to “point to clear congressional authorization” for any rule it issues that has “extraordinary ... economic and political significance,” as the NCA ban rule certainly does.
What is Its Future?
The FTC’s NCA ban remains unsettled. State legislatures, in response to the recent court holdings, are reassessing their statutory law regarding NCAs. The Ryan Court’s holding prevented the FTC’s rule from going into effect on September 4, 2024. The Texas and Florida court decisions are awaiting 5th and 11th Circuit Court of Appeals review, respectively. Assuming affirmation of either of the cases on appeal, a circuit split regarding the NCA ban may occur. The US Supreme Court may be called upon to determine the validity of the FTC rule banning NCAs. The Circuit Court decisions are likely to occur in 2025, and any Supreme Court decision would not likely occur until 2026. Meanwhile, state statutory law and common law still apply to NCAs, and the FTC may challenge the validity of NCAs on a case-by-case basis.
US antitrust law remains a potential remedy to scrutinize and restrain inappropriate business practices, including NCA-related abuses. The Sherman Act allows federal and state actors and private citizens, to sue for redress. Antitrust cases are typically considered using the “rule of reason” formulated by the Supreme Court in 1911, which requires plaintiffs show that defendant businesses possessing market power did in fact undertake anticompetitive conduct that had or likely had anticompetitive effects. In other words, the court in an antitrust case will require that the plaintiff show that the business actually had a significant controlling market presence in the geographic area; and further, that the plaintiff show that the business’ actions in fact had an anticompetitive effect, or likely had one. The latter can be found by showing an anticompetitive effect such as abusive pricing
The FTC’s ruling is legally and academically controversial and in fact may not withstand court scrutiny. The rule was put forth by the FTC as an ambitious rule to reduce healthcare spending. But businesses survive only if their revenue surpasses their costs, including personnel costs. Further, maximization of capitalization is attained when businesses require NCAs. Businesses invest heavily in recruiting, hiring, and training personnel, and increased personnel turnover increases these expenditures. NCAs arguably provide a collective benefit by ensuring force continuity, mitigating the risk of the loss of highly trained personnel with proprietary knowledge. NCAs also help a business maintain a skilled workforce, helping maximize business valuation. If FTC’s NCA ban rule were ultimately upheld, businesses would likely respond by instituting longer-term employee contracts, extended termination notice periods, and disincentives for employees who do not fully serve their contract length, including substantial financial disincentives. Business valuation might decrease, reducing investment incentives.
NCAs have long been a method of balancing the interests of employees and employers. They protect businesses’ confidential information, trade secrets, and patient lists, at some cost to employees pursuing new opportunities. The employee, though, is also provided with some benefit from the NCA, albeit indirect. State statutory law and courts have traditionally worked to ensure an appropriate delicate balance between interests, with courts generally finding unbalanced NCAs unenforceable.
For now, physicians should understand the policy considerations of and recognize the uncertainty surrounding NCAs, become familiar with their state’s statutory NCA law, review employment contracts carefully for NCA reasonableness, and seek legal advice if necessary.
Perhaps the FTC’s approach is the correct one for our future. Or perhaps the appropriate future of NCA interpretation and enforcement should continue to rest on state statutory law and common law, where antitrust enforcement is on a case-by-case basis, rather than FTC rulemaking. The results of high court decisions, state statutory law changes in response to the FTC rule, and perhaps US congressional action will provide the final answer.
Dr. Allen is based at the University of Oklahoma Health Sciences Center in Oklahoma City. He has declared no conflicts of interest in relation to this article.
Integrating Artificial Intelligence Into Private Practice
In this video, Vasu Appalaneni, MD, a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio,
In addition to her work at Dayton Gastroenterology, Dr. Appalaneni is executive vice president of clinical innovation at One GI, a gastroenterology management services organization that partners with gastroenterologists to help them manage and grow their independent gastroenterology practices. One GI is Dayton Gastroenterology’s parent company.
In this video, Vasu Appalaneni, MD, a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio,
In addition to her work at Dayton Gastroenterology, Dr. Appalaneni is executive vice president of clinical innovation at One GI, a gastroenterology management services organization that partners with gastroenterologists to help them manage and grow their independent gastroenterology practices. One GI is Dayton Gastroenterology’s parent company.
In this video, Vasu Appalaneni, MD, a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio,
In addition to her work at Dayton Gastroenterology, Dr. Appalaneni is executive vice president of clinical innovation at One GI, a gastroenterology management services organization that partners with gastroenterologists to help them manage and grow their independent gastroenterology practices. One GI is Dayton Gastroenterology’s parent company.
Healthcare AI: Balancing Safety and Innovation
Artificial intelligence (AI) applications are expanding rapidly in healthcare. AI powered tools are increasingly used in everyday medical practice, assisting clinicians with tasks such as diagnosis, treatment planning, data analysis, and patient monitoring, effectively integrating AI into routine clinical decision making. Despite its potential to fundamentally transform the practice of medicine and healthcare delivery, AI in healthcare remains largely unregulated, with a lack of common standards to guide responsible design, development, and adoption of AI-based tools to guide clinical care.
But this is changing. In mid-January, the US Department of Health & Human Services released its Strategic Plan for the Use of AI in Health, Human Services, and Public Health (available at www.healthit.gov), presenting an approach to catalyze innovation, promote trustworthy AI development, democratize technologies and resources, and cultivate AI-empowered workforces and organizational cultures. While there is no immediate regulatory impact, the plan does provide important insights into how the federal government thinks about AI, which will be a part of driving regulations in the future. As crucial stakeholders in the health AI universe and advocates for its responsible use in clinical practice, it is critical that we as clinicians keep abreast of developments in this rapidly evolving space.
In this month’s issue of GI & Hepatology News, we summarize a recent systematic review and meta-analysis highlighting worsening health disparities for Hispanic adults with MASLD. We also report the results of an industry-sponsored study comparing the real-world clinical effectiveness of GI Genius (an AI-driven tool) with that of standard colonoscopy.
In February’s Member Spotlight, we introduce you to international AGA member Dr. Tossapol Kerdsirichairat (clinical associate professor of gastroenterology at Bumrungrad International Hospital in Bangkok, Thailand), who shares his insights regarding the challenges and rewards of practicing gastroenterology at one of the largest private hospitals in Southeast Asia. ‘Tos’ is one of roughly 25% of AGA members who live and work outside the United States.
Finally, this month’s In Focus column from The New Gastroenterologist focuses on management of chronic constipation, a highly prevalent condition that significantly impacts the quality of life of many of our patients. We hope you enjoy this and all the exciting content in our February issue.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Artificial intelligence (AI) applications are expanding rapidly in healthcare. AI powered tools are increasingly used in everyday medical practice, assisting clinicians with tasks such as diagnosis, treatment planning, data analysis, and patient monitoring, effectively integrating AI into routine clinical decision making. Despite its potential to fundamentally transform the practice of medicine and healthcare delivery, AI in healthcare remains largely unregulated, with a lack of common standards to guide responsible design, development, and adoption of AI-based tools to guide clinical care.
But this is changing. In mid-January, the US Department of Health & Human Services released its Strategic Plan for the Use of AI in Health, Human Services, and Public Health (available at www.healthit.gov), presenting an approach to catalyze innovation, promote trustworthy AI development, democratize technologies and resources, and cultivate AI-empowered workforces and organizational cultures. While there is no immediate regulatory impact, the plan does provide important insights into how the federal government thinks about AI, which will be a part of driving regulations in the future. As crucial stakeholders in the health AI universe and advocates for its responsible use in clinical practice, it is critical that we as clinicians keep abreast of developments in this rapidly evolving space.
In this month’s issue of GI & Hepatology News, we summarize a recent systematic review and meta-analysis highlighting worsening health disparities for Hispanic adults with MASLD. We also report the results of an industry-sponsored study comparing the real-world clinical effectiveness of GI Genius (an AI-driven tool) with that of standard colonoscopy.
In February’s Member Spotlight, we introduce you to international AGA member Dr. Tossapol Kerdsirichairat (clinical associate professor of gastroenterology at Bumrungrad International Hospital in Bangkok, Thailand), who shares his insights regarding the challenges and rewards of practicing gastroenterology at one of the largest private hospitals in Southeast Asia. ‘Tos’ is one of roughly 25% of AGA members who live and work outside the United States.
Finally, this month’s In Focus column from The New Gastroenterologist focuses on management of chronic constipation, a highly prevalent condition that significantly impacts the quality of life of many of our patients. We hope you enjoy this and all the exciting content in our February issue.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Artificial intelligence (AI) applications are expanding rapidly in healthcare. AI powered tools are increasingly used in everyday medical practice, assisting clinicians with tasks such as diagnosis, treatment planning, data analysis, and patient monitoring, effectively integrating AI into routine clinical decision making. Despite its potential to fundamentally transform the practice of medicine and healthcare delivery, AI in healthcare remains largely unregulated, with a lack of common standards to guide responsible design, development, and adoption of AI-based tools to guide clinical care.
But this is changing. In mid-January, the US Department of Health & Human Services released its Strategic Plan for the Use of AI in Health, Human Services, and Public Health (available at www.healthit.gov), presenting an approach to catalyze innovation, promote trustworthy AI development, democratize technologies and resources, and cultivate AI-empowered workforces and organizational cultures. While there is no immediate regulatory impact, the plan does provide important insights into how the federal government thinks about AI, which will be a part of driving regulations in the future. As crucial stakeholders in the health AI universe and advocates for its responsible use in clinical practice, it is critical that we as clinicians keep abreast of developments in this rapidly evolving space.
In this month’s issue of GI & Hepatology News, we summarize a recent systematic review and meta-analysis highlighting worsening health disparities for Hispanic adults with MASLD. We also report the results of an industry-sponsored study comparing the real-world clinical effectiveness of GI Genius (an AI-driven tool) with that of standard colonoscopy.
In February’s Member Spotlight, we introduce you to international AGA member Dr. Tossapol Kerdsirichairat (clinical associate professor of gastroenterology at Bumrungrad International Hospital in Bangkok, Thailand), who shares his insights regarding the challenges and rewards of practicing gastroenterology at one of the largest private hospitals in Southeast Asia. ‘Tos’ is one of roughly 25% of AGA members who live and work outside the United States.
Finally, this month’s In Focus column from The New Gastroenterologist focuses on management of chronic constipation, a highly prevalent condition that significantly impacts the quality of life of many of our patients. We hope you enjoy this and all the exciting content in our February issue.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Atopic Dermatitis and Sleep Disturbances
Recently one of my keep-up-to-date apps alerted me to a study in Pediatric Dermatology on sleep and atopic dermatitis. When I chased down the abstract it was a shoulder-shrugging-so-what encounter. The authors reported that having a child with atopic dermatitis decreased the odds of a parent getting 7 hours of sleep a night and increased the odds that the parent was also taking sleep-aiding medications. The authors felt their data was meaningful enough to publish based on the size and the cross-sectional nature of their sample. However, anyone who has worked with families with atopic dermatitis shouldn’t be surprised at their findings.
Curious about what other investigators had discovered about the anecdotally obvious relationship between sleep and atopic dermatitis, I dug until I found a rather thorough discussion of the literature published in The Journal of Clinical Immunology Practice. These authors from the University of Rochester Medical School in New York begin by pointing out that, although 47%-80% of children with atopic dermatitis and 33%-90% of adults with atopic dermatitis have disturbed sleep, “literature on this topic remains sparse with most studies evaluating sleep as a secondary outcome using subjective measures.” They further note that sleep is one of the three most problematic symptoms for children with atopic dermatitis and their families.
Characterizing the Sleep Loss
Difficulty falling asleep, frequent and long waking, and excessive daytime sleepiness are the most common symptoms reported. In the few sleep laboratory studies that have been done there has been no significant decrease in sleep duration, which is a bit of a surprise. However, as expected, sleep-onset latency, more wake time after sleep onset, sleep fragmentation, and decreased sleep efficiency have been observed in the atopic dermatitis patients. In other studies of younger children, female gender and lower socioeconomic status seem to be associated with poor sleep quality.
Most studies found that in general the prevalence and severity of sleep disturbances increases with the severity of the disease. As the disease flares, increased bedtime resistance, nocturnal wakings and daytime sleepiness become more likely. These parentally reported associations have also been confirmed by sleep laboratory observations.
The sleep disturbances quickly become a family affair with 60% of siblings and parents reporting disturbed sleep. When the child with atopic dermatitis is having a flareup, nearly 90% of their parents report losing up to 2.5 hours of sleep. Not surprisingly sleep disturbances have been associated with behavioral and emotional problems including decreased happiness, poor cognitive performance, hyperactivity, and inattention. Mothers seem to bear the brunt of the problem and interpersonal conflicts and exhaustion are unfortunately not uncommon.
Probing the Causes
So why are atopic dermatitis patients and their families so prone to the ill effects of disturbed sleep? Although you might think it should be obvious, this review of the “sparse” literature doesn’t provide a satisfying answer. However, the authors provide three possible explanations.
The one with the least supporting evidence is circadian variations in the products of inflammation such as cytokines and their effect on melatonin production. The explanation which I think most of us have already considered is that pruritus disrupts sleep. This is the often-quoted itch-scratch feedback cycle which can release inflammatory mediators (“pruritogens”). However, the investigators have found that many studies report “conflicting results or only weak correlations.”
The third alternative posed by the authors is by far the most appealing and hinges on the assumption that, as with many other chronic conditions, atopic dermatitis renders the patient vulnerable to insomnia. “Nocturnal scratching disrupts sleep and sets the stage for cognitive and behavioral factors that reinforce insomnia as a conditioned response.” In other words, even after the “co-concurring condition” resolves insomnia related sleep behaviors continue. The investigators point to a study supporting this explanation which found that, even after a child’s skin cleared, his/her sleep arousals failed to return to normal suggesting that learned behavior patterns might be playing a role.
It may be a stretch to suggest that poor sleep hygiene might in and of itself cause atopic dermatitis, but it can’t be ruled out. At a minimum the current research suggests that there is a bidirectional relationship between sleep disturbances and atopic dermatitis.
Next Steps
The authors of this study urge that we be more creative in using already-existing portable and relatively low-cost sleep monitoring technology to better define this relationship. While that is a worthwhile avenue for research, I think we who see children (both primary care providers and dermatologists) now have enough evidence to move managing the sleep hygiene of our atopic dermatitis patients to the front burner, along with moisturizers and topical medications, without needing to do costly and time-consuming studies.
This means taking a thorough sleep history. If, in the rare cases where the child’s sleep habits are normal, the parents should be warned that falling off the sleep wagon is likely to exacerbate the child’s skin. If the history reveals an inefficient and dysfunctional bedtime routine or other symptoms of insomnia, advise the parents on how it can be improved. Then follow up at each visit if there has been no improvement. Sleep management can be time-consuming as well but it should be part of every primary care pediatrician’s toolbox. For the dermatologist who doesn’t feel comfortable managing sleep problems, a consultation with a pediatrician or a sleep specialist is in order.
The adult with atopic dermatitis is a somewhat different animal and a formal sleep study may be indicated. Cognitive-behavioral therapy might be helpful for adult population but the investigators could find no trials of its use in patients with atopic dermatitis.
Convincing the parents of an atopic dermatitis patient that their family’s disturbed sleep may not only be the result of his/her itchy skin but may be a preexisting compounding problem may not be an easy sell. I hope if you can be open to the strong possibility that disordered sleep is not just the effect but in some ways may be a likely contributor to your patients’ atopic dermatitis, you may become more effective in managing the disease.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Recently one of my keep-up-to-date apps alerted me to a study in Pediatric Dermatology on sleep and atopic dermatitis. When I chased down the abstract it was a shoulder-shrugging-so-what encounter. The authors reported that having a child with atopic dermatitis decreased the odds of a parent getting 7 hours of sleep a night and increased the odds that the parent was also taking sleep-aiding medications. The authors felt their data was meaningful enough to publish based on the size and the cross-sectional nature of their sample. However, anyone who has worked with families with atopic dermatitis shouldn’t be surprised at their findings.
Curious about what other investigators had discovered about the anecdotally obvious relationship between sleep and atopic dermatitis, I dug until I found a rather thorough discussion of the literature published in The Journal of Clinical Immunology Practice. These authors from the University of Rochester Medical School in New York begin by pointing out that, although 47%-80% of children with atopic dermatitis and 33%-90% of adults with atopic dermatitis have disturbed sleep, “literature on this topic remains sparse with most studies evaluating sleep as a secondary outcome using subjective measures.” They further note that sleep is one of the three most problematic symptoms for children with atopic dermatitis and their families.
Characterizing the Sleep Loss
Difficulty falling asleep, frequent and long waking, and excessive daytime sleepiness are the most common symptoms reported. In the few sleep laboratory studies that have been done there has been no significant decrease in sleep duration, which is a bit of a surprise. However, as expected, sleep-onset latency, more wake time after sleep onset, sleep fragmentation, and decreased sleep efficiency have been observed in the atopic dermatitis patients. In other studies of younger children, female gender and lower socioeconomic status seem to be associated with poor sleep quality.
Most studies found that in general the prevalence and severity of sleep disturbances increases with the severity of the disease. As the disease flares, increased bedtime resistance, nocturnal wakings and daytime sleepiness become more likely. These parentally reported associations have also been confirmed by sleep laboratory observations.
The sleep disturbances quickly become a family affair with 60% of siblings and parents reporting disturbed sleep. When the child with atopic dermatitis is having a flareup, nearly 90% of their parents report losing up to 2.5 hours of sleep. Not surprisingly sleep disturbances have been associated with behavioral and emotional problems including decreased happiness, poor cognitive performance, hyperactivity, and inattention. Mothers seem to bear the brunt of the problem and interpersonal conflicts and exhaustion are unfortunately not uncommon.
Probing the Causes
So why are atopic dermatitis patients and their families so prone to the ill effects of disturbed sleep? Although you might think it should be obvious, this review of the “sparse” literature doesn’t provide a satisfying answer. However, the authors provide three possible explanations.
The one with the least supporting evidence is circadian variations in the products of inflammation such as cytokines and their effect on melatonin production. The explanation which I think most of us have already considered is that pruritus disrupts sleep. This is the often-quoted itch-scratch feedback cycle which can release inflammatory mediators (“pruritogens”). However, the investigators have found that many studies report “conflicting results or only weak correlations.”
The third alternative posed by the authors is by far the most appealing and hinges on the assumption that, as with many other chronic conditions, atopic dermatitis renders the patient vulnerable to insomnia. “Nocturnal scratching disrupts sleep and sets the stage for cognitive and behavioral factors that reinforce insomnia as a conditioned response.” In other words, even after the “co-concurring condition” resolves insomnia related sleep behaviors continue. The investigators point to a study supporting this explanation which found that, even after a child’s skin cleared, his/her sleep arousals failed to return to normal suggesting that learned behavior patterns might be playing a role.
It may be a stretch to suggest that poor sleep hygiene might in and of itself cause atopic dermatitis, but it can’t be ruled out. At a minimum the current research suggests that there is a bidirectional relationship between sleep disturbances and atopic dermatitis.
Next Steps
The authors of this study urge that we be more creative in using already-existing portable and relatively low-cost sleep monitoring technology to better define this relationship. While that is a worthwhile avenue for research, I think we who see children (both primary care providers and dermatologists) now have enough evidence to move managing the sleep hygiene of our atopic dermatitis patients to the front burner, along with moisturizers and topical medications, without needing to do costly and time-consuming studies.
This means taking a thorough sleep history. If, in the rare cases where the child’s sleep habits are normal, the parents should be warned that falling off the sleep wagon is likely to exacerbate the child’s skin. If the history reveals an inefficient and dysfunctional bedtime routine or other symptoms of insomnia, advise the parents on how it can be improved. Then follow up at each visit if there has been no improvement. Sleep management can be time-consuming as well but it should be part of every primary care pediatrician’s toolbox. For the dermatologist who doesn’t feel comfortable managing sleep problems, a consultation with a pediatrician or a sleep specialist is in order.
The adult with atopic dermatitis is a somewhat different animal and a formal sleep study may be indicated. Cognitive-behavioral therapy might be helpful for adult population but the investigators could find no trials of its use in patients with atopic dermatitis.
Convincing the parents of an atopic dermatitis patient that their family’s disturbed sleep may not only be the result of his/her itchy skin but may be a preexisting compounding problem may not be an easy sell. I hope if you can be open to the strong possibility that disordered sleep is not just the effect but in some ways may be a likely contributor to your patients’ atopic dermatitis, you may become more effective in managing the disease.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Recently one of my keep-up-to-date apps alerted me to a study in Pediatric Dermatology on sleep and atopic dermatitis. When I chased down the abstract it was a shoulder-shrugging-so-what encounter. The authors reported that having a child with atopic dermatitis decreased the odds of a parent getting 7 hours of sleep a night and increased the odds that the parent was also taking sleep-aiding medications. The authors felt their data was meaningful enough to publish based on the size and the cross-sectional nature of their sample. However, anyone who has worked with families with atopic dermatitis shouldn’t be surprised at their findings.
Curious about what other investigators had discovered about the anecdotally obvious relationship between sleep and atopic dermatitis, I dug until I found a rather thorough discussion of the literature published in The Journal of Clinical Immunology Practice. These authors from the University of Rochester Medical School in New York begin by pointing out that, although 47%-80% of children with atopic dermatitis and 33%-90% of adults with atopic dermatitis have disturbed sleep, “literature on this topic remains sparse with most studies evaluating sleep as a secondary outcome using subjective measures.” They further note that sleep is one of the three most problematic symptoms for children with atopic dermatitis and their families.
Characterizing the Sleep Loss
Difficulty falling asleep, frequent and long waking, and excessive daytime sleepiness are the most common symptoms reported. In the few sleep laboratory studies that have been done there has been no significant decrease in sleep duration, which is a bit of a surprise. However, as expected, sleep-onset latency, more wake time after sleep onset, sleep fragmentation, and decreased sleep efficiency have been observed in the atopic dermatitis patients. In other studies of younger children, female gender and lower socioeconomic status seem to be associated with poor sleep quality.
Most studies found that in general the prevalence and severity of sleep disturbances increases with the severity of the disease. As the disease flares, increased bedtime resistance, nocturnal wakings and daytime sleepiness become more likely. These parentally reported associations have also been confirmed by sleep laboratory observations.
The sleep disturbances quickly become a family affair with 60% of siblings and parents reporting disturbed sleep. When the child with atopic dermatitis is having a flareup, nearly 90% of their parents report losing up to 2.5 hours of sleep. Not surprisingly sleep disturbances have been associated with behavioral and emotional problems including decreased happiness, poor cognitive performance, hyperactivity, and inattention. Mothers seem to bear the brunt of the problem and interpersonal conflicts and exhaustion are unfortunately not uncommon.
Probing the Causes
So why are atopic dermatitis patients and their families so prone to the ill effects of disturbed sleep? Although you might think it should be obvious, this review of the “sparse” literature doesn’t provide a satisfying answer. However, the authors provide three possible explanations.
The one with the least supporting evidence is circadian variations in the products of inflammation such as cytokines and their effect on melatonin production. The explanation which I think most of us have already considered is that pruritus disrupts sleep. This is the often-quoted itch-scratch feedback cycle which can release inflammatory mediators (“pruritogens”). However, the investigators have found that many studies report “conflicting results or only weak correlations.”
The third alternative posed by the authors is by far the most appealing and hinges on the assumption that, as with many other chronic conditions, atopic dermatitis renders the patient vulnerable to insomnia. “Nocturnal scratching disrupts sleep and sets the stage for cognitive and behavioral factors that reinforce insomnia as a conditioned response.” In other words, even after the “co-concurring condition” resolves insomnia related sleep behaviors continue. The investigators point to a study supporting this explanation which found that, even after a child’s skin cleared, his/her sleep arousals failed to return to normal suggesting that learned behavior patterns might be playing a role.
It may be a stretch to suggest that poor sleep hygiene might in and of itself cause atopic dermatitis, but it can’t be ruled out. At a minimum the current research suggests that there is a bidirectional relationship between sleep disturbances and atopic dermatitis.
Next Steps
The authors of this study urge that we be more creative in using already-existing portable and relatively low-cost sleep monitoring technology to better define this relationship. While that is a worthwhile avenue for research, I think we who see children (both primary care providers and dermatologists) now have enough evidence to move managing the sleep hygiene of our atopic dermatitis patients to the front burner, along with moisturizers and topical medications, without needing to do costly and time-consuming studies.
This means taking a thorough sleep history. If, in the rare cases where the child’s sleep habits are normal, the parents should be warned that falling off the sleep wagon is likely to exacerbate the child’s skin. If the history reveals an inefficient and dysfunctional bedtime routine or other symptoms of insomnia, advise the parents on how it can be improved. Then follow up at each visit if there has been no improvement. Sleep management can be time-consuming as well but it should be part of every primary care pediatrician’s toolbox. For the dermatologist who doesn’t feel comfortable managing sleep problems, a consultation with a pediatrician or a sleep specialist is in order.
The adult with atopic dermatitis is a somewhat different animal and a formal sleep study may be indicated. Cognitive-behavioral therapy might be helpful for adult population but the investigators could find no trials of its use in patients with atopic dermatitis.
Convincing the parents of an atopic dermatitis patient that their family’s disturbed sleep may not only be the result of his/her itchy skin but may be a preexisting compounding problem may not be an easy sell. I hope if you can be open to the strong possibility that disordered sleep is not just the effect but in some ways may be a likely contributor to your patients’ atopic dermatitis, you may become more effective in managing the disease.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.