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Two different radiation boost strategies reduce local failures in NSCLC
The European PET-Boost trial finds that both of two strategies for delivering a radiation boost to locally advanced non–small cell lung cancer (NSCLC) tumors improve local control relative to that seen historically. Results were reported at the European Society for Radiology and Oncology 2020 Online Congress.
“From previous studies, we know that local recurrences have an important negative impact on survival,” said presenting author Saskia A. Cooke, an MD, PhD candidate in the department of Radiation Oncology Research, the Netherlands Cancer Institute, Amsterdam.
In addition, research shows that, despite advances in drug therapy, the most common site of progression in this population is intrathoracic.
“These results further underline the need to develop treatment strategies which effectively prevent intrathoracic and local recurrences,” Ms. Cooke said.
PET-Boost is a multicenter, randomized trial that enrolled patients with inoperable stage II or III NSCLC and a primary tumor measuring 4 cm or greater.
“The study was a phase 2 ‘pick the winner’ trial, which, by design, does not compare the two arms to one another but to a historic rate of outcome,” Ms. Cooke explained.
The patients were randomized evenly to receive the standard 66 Gy of radiotherapy given in 24 fractions of 2.75 Gy with one of two dose-escalation strategies: a boost to the whole primary tumor or a boost to only the tumor area having high metabolic activity, with a maximum standard uptake value (SUVmax) of at least 50% on the pretreatment FDG-PET scan.
For each patient, both plans were created before randomization, with the dose escalated as high as possible up to an organ-at-risk constraint, Ms. Cooke noted.
“A key element is that the two plans were made isotoxic by equaling the mean lung dose, and in both arms, the dose was delivered integrated into the 24 fractions, so without prolongation of the overall treatment time,” she said.
The trial’s goal was to improve the 1-year rate of freedom from local failure from the 70% seen historically with conventional chemoradiotherapy to 85%.
The trial was stopped early because of slow accrual, after enrollment of 107 patients, Ms. Cooke reported. The large majority received concurrent or sequential chemotherapy with their radiotherapy.
With a median follow-up of 12.6 months for the endpoint, the 1-year rate of freedom from local failure as determined on centrally reviewed CT scans was 97% with the whole-tumor boost and 91% with the PET-directed boost. The 2-year rates were 89% and 82%, respectively.
With a median follow-up of 61 months for the endpoint, the 1-year rate of overall survival was 77% with the whole-tumor boost and 62% with the PET-directed boost. The 2-year rates were 46% and 43%, respectively.
The two boost strategies increased acute and late toxicity over that seen historically, but not to unacceptable levels, as reported previously (Radiother Oncol. 2019;131:166-73).
“In this PET-Boost trial, using hypofractionated personalized dose escalation led to a very good local control rate, which, in both arms, was more than 90% at 1 year,” Ms. Cooke summarized.
In fact, values compare favorably with those seen in the phase 3 RTOG 0617 trial using conventional chemoradiotherapy and dose escalation, even though patients in that trial had smaller tumors.
“Survival, especially in the group treated with the homogeneous boost, was actually similar to the RTOG 0617 high-dose arm and also quite similar to the 1-year survival in the placebo arm of the PACIFIC trial,” she added. The somewhat poorer survival at 2 years in PET-Boost was likely related, in part, to the large tumor volumes and the mediastinal radiation dose, she speculated.
The investigators are now evaluating specific sites of failure and extrathoracic recurrences, as well as assessing associations of toxicity with organ-at-risk doses and quality of life.
“While further results of the trial are awaited, so far, we do believe that in selected patients with locally advanced NSCLC, hypofractionated dose escalation to the tumor is a very important subject for future research,” Ms. Cooke said.
The investigators plan to carry the whole-tumor boost strategy forward because it yields similar efficacy but is easier to plan.
Not ready for prime time
“Overall, this study conceptually is well designed as it is forward thinking and uses imaging to personalize radiation treatment, going to higher doses to active areas of disease based on FDG-PET imaging,” Arya Amini, MD, assistant clinical professor in the department of radiation oncology, City of Hope Comprehensive Cancer Center, Duarte, Calif., said in an interview.
However, he cautioned, local failure is challenging to assess at 1 year because of radiation-induced changes. In fact, more than a quarter of study patients had scans that were not evaluable for this reason. Furthermore, rates of late cardiac toxicity and esophageal stenosis are unknown.
“Longer-term follow-up is needed as the current data does not support dose escalation in unresectable lung cancer, specifically stage III NSCLC, based on RTOG 0617,” Dr. Amini said. “However, the overall survival detriment from dose escalation in RTOG 0617 could have been due to poor radiation techniques and toxicities including cardiac side effects, which we now better understand. The PET-Boost trial focuses on delivering higher doses of hypofractionated radiation based on PET, which essentially leads to a smaller area getting a radiation boost, which, in turn, should have less side effects.”
“This area of work will continue to be more exciting as more tumor-targeting radiotracers can be utilized with PET,” he predicted. “One of the future avenues in radiation oncology is incorporating novel imaging modalities including tumor-specific radiotracers with PET scans, for example, to dose-paint disease, delivering higher doses to more active parts of the primary and lymph nodes, while reducing doses to less active areas, which potentially could lead to higher rates of local control with minimal side effects.”
The trial was sponsored by The Netherlands Cancer Institute. Ms. Cooke and Dr. Amini disclosed no conflicts of interest.
SOURCE: Lalezari F et al. ESTRO 2020. Abstract OC-0609.
The European PET-Boost trial finds that both of two strategies for delivering a radiation boost to locally advanced non–small cell lung cancer (NSCLC) tumors improve local control relative to that seen historically. Results were reported at the European Society for Radiology and Oncology 2020 Online Congress.
“From previous studies, we know that local recurrences have an important negative impact on survival,” said presenting author Saskia A. Cooke, an MD, PhD candidate in the department of Radiation Oncology Research, the Netherlands Cancer Institute, Amsterdam.
In addition, research shows that, despite advances in drug therapy, the most common site of progression in this population is intrathoracic.
“These results further underline the need to develop treatment strategies which effectively prevent intrathoracic and local recurrences,” Ms. Cooke said.
PET-Boost is a multicenter, randomized trial that enrolled patients with inoperable stage II or III NSCLC and a primary tumor measuring 4 cm or greater.
“The study was a phase 2 ‘pick the winner’ trial, which, by design, does not compare the two arms to one another but to a historic rate of outcome,” Ms. Cooke explained.
The patients were randomized evenly to receive the standard 66 Gy of radiotherapy given in 24 fractions of 2.75 Gy with one of two dose-escalation strategies: a boost to the whole primary tumor or a boost to only the tumor area having high metabolic activity, with a maximum standard uptake value (SUVmax) of at least 50% on the pretreatment FDG-PET scan.
For each patient, both plans were created before randomization, with the dose escalated as high as possible up to an organ-at-risk constraint, Ms. Cooke noted.
“A key element is that the two plans were made isotoxic by equaling the mean lung dose, and in both arms, the dose was delivered integrated into the 24 fractions, so without prolongation of the overall treatment time,” she said.
The trial’s goal was to improve the 1-year rate of freedom from local failure from the 70% seen historically with conventional chemoradiotherapy to 85%.
The trial was stopped early because of slow accrual, after enrollment of 107 patients, Ms. Cooke reported. The large majority received concurrent or sequential chemotherapy with their radiotherapy.
With a median follow-up of 12.6 months for the endpoint, the 1-year rate of freedom from local failure as determined on centrally reviewed CT scans was 97% with the whole-tumor boost and 91% with the PET-directed boost. The 2-year rates were 89% and 82%, respectively.
With a median follow-up of 61 months for the endpoint, the 1-year rate of overall survival was 77% with the whole-tumor boost and 62% with the PET-directed boost. The 2-year rates were 46% and 43%, respectively.
The two boost strategies increased acute and late toxicity over that seen historically, but not to unacceptable levels, as reported previously (Radiother Oncol. 2019;131:166-73).
“In this PET-Boost trial, using hypofractionated personalized dose escalation led to a very good local control rate, which, in both arms, was more than 90% at 1 year,” Ms. Cooke summarized.
In fact, values compare favorably with those seen in the phase 3 RTOG 0617 trial using conventional chemoradiotherapy and dose escalation, even though patients in that trial had smaller tumors.
“Survival, especially in the group treated with the homogeneous boost, was actually similar to the RTOG 0617 high-dose arm and also quite similar to the 1-year survival in the placebo arm of the PACIFIC trial,” she added. The somewhat poorer survival at 2 years in PET-Boost was likely related, in part, to the large tumor volumes and the mediastinal radiation dose, she speculated.
The investigators are now evaluating specific sites of failure and extrathoracic recurrences, as well as assessing associations of toxicity with organ-at-risk doses and quality of life.
“While further results of the trial are awaited, so far, we do believe that in selected patients with locally advanced NSCLC, hypofractionated dose escalation to the tumor is a very important subject for future research,” Ms. Cooke said.
The investigators plan to carry the whole-tumor boost strategy forward because it yields similar efficacy but is easier to plan.
Not ready for prime time
“Overall, this study conceptually is well designed as it is forward thinking and uses imaging to personalize radiation treatment, going to higher doses to active areas of disease based on FDG-PET imaging,” Arya Amini, MD, assistant clinical professor in the department of radiation oncology, City of Hope Comprehensive Cancer Center, Duarte, Calif., said in an interview.
However, he cautioned, local failure is challenging to assess at 1 year because of radiation-induced changes. In fact, more than a quarter of study patients had scans that were not evaluable for this reason. Furthermore, rates of late cardiac toxicity and esophageal stenosis are unknown.
“Longer-term follow-up is needed as the current data does not support dose escalation in unresectable lung cancer, specifically stage III NSCLC, based on RTOG 0617,” Dr. Amini said. “However, the overall survival detriment from dose escalation in RTOG 0617 could have been due to poor radiation techniques and toxicities including cardiac side effects, which we now better understand. The PET-Boost trial focuses on delivering higher doses of hypofractionated radiation based on PET, which essentially leads to a smaller area getting a radiation boost, which, in turn, should have less side effects.”
“This area of work will continue to be more exciting as more tumor-targeting radiotracers can be utilized with PET,” he predicted. “One of the future avenues in radiation oncology is incorporating novel imaging modalities including tumor-specific radiotracers with PET scans, for example, to dose-paint disease, delivering higher doses to more active parts of the primary and lymph nodes, while reducing doses to less active areas, which potentially could lead to higher rates of local control with minimal side effects.”
The trial was sponsored by The Netherlands Cancer Institute. Ms. Cooke and Dr. Amini disclosed no conflicts of interest.
SOURCE: Lalezari F et al. ESTRO 2020. Abstract OC-0609.
The European PET-Boost trial finds that both of two strategies for delivering a radiation boost to locally advanced non–small cell lung cancer (NSCLC) tumors improve local control relative to that seen historically. Results were reported at the European Society for Radiology and Oncology 2020 Online Congress.
“From previous studies, we know that local recurrences have an important negative impact on survival,” said presenting author Saskia A. Cooke, an MD, PhD candidate in the department of Radiation Oncology Research, the Netherlands Cancer Institute, Amsterdam.
In addition, research shows that, despite advances in drug therapy, the most common site of progression in this population is intrathoracic.
“These results further underline the need to develop treatment strategies which effectively prevent intrathoracic and local recurrences,” Ms. Cooke said.
PET-Boost is a multicenter, randomized trial that enrolled patients with inoperable stage II or III NSCLC and a primary tumor measuring 4 cm or greater.
“The study was a phase 2 ‘pick the winner’ trial, which, by design, does not compare the two arms to one another but to a historic rate of outcome,” Ms. Cooke explained.
The patients were randomized evenly to receive the standard 66 Gy of radiotherapy given in 24 fractions of 2.75 Gy with one of two dose-escalation strategies: a boost to the whole primary tumor or a boost to only the tumor area having high metabolic activity, with a maximum standard uptake value (SUVmax) of at least 50% on the pretreatment FDG-PET scan.
For each patient, both plans were created before randomization, with the dose escalated as high as possible up to an organ-at-risk constraint, Ms. Cooke noted.
“A key element is that the two plans were made isotoxic by equaling the mean lung dose, and in both arms, the dose was delivered integrated into the 24 fractions, so without prolongation of the overall treatment time,” she said.
The trial’s goal was to improve the 1-year rate of freedom from local failure from the 70% seen historically with conventional chemoradiotherapy to 85%.
The trial was stopped early because of slow accrual, after enrollment of 107 patients, Ms. Cooke reported. The large majority received concurrent or sequential chemotherapy with their radiotherapy.
With a median follow-up of 12.6 months for the endpoint, the 1-year rate of freedom from local failure as determined on centrally reviewed CT scans was 97% with the whole-tumor boost and 91% with the PET-directed boost. The 2-year rates were 89% and 82%, respectively.
With a median follow-up of 61 months for the endpoint, the 1-year rate of overall survival was 77% with the whole-tumor boost and 62% with the PET-directed boost. The 2-year rates were 46% and 43%, respectively.
The two boost strategies increased acute and late toxicity over that seen historically, but not to unacceptable levels, as reported previously (Radiother Oncol. 2019;131:166-73).
“In this PET-Boost trial, using hypofractionated personalized dose escalation led to a very good local control rate, which, in both arms, was more than 90% at 1 year,” Ms. Cooke summarized.
In fact, values compare favorably with those seen in the phase 3 RTOG 0617 trial using conventional chemoradiotherapy and dose escalation, even though patients in that trial had smaller tumors.
“Survival, especially in the group treated with the homogeneous boost, was actually similar to the RTOG 0617 high-dose arm and also quite similar to the 1-year survival in the placebo arm of the PACIFIC trial,” she added. The somewhat poorer survival at 2 years in PET-Boost was likely related, in part, to the large tumor volumes and the mediastinal radiation dose, she speculated.
The investigators are now evaluating specific sites of failure and extrathoracic recurrences, as well as assessing associations of toxicity with organ-at-risk doses and quality of life.
“While further results of the trial are awaited, so far, we do believe that in selected patients with locally advanced NSCLC, hypofractionated dose escalation to the tumor is a very important subject for future research,” Ms. Cooke said.
The investigators plan to carry the whole-tumor boost strategy forward because it yields similar efficacy but is easier to plan.
Not ready for prime time
“Overall, this study conceptually is well designed as it is forward thinking and uses imaging to personalize radiation treatment, going to higher doses to active areas of disease based on FDG-PET imaging,” Arya Amini, MD, assistant clinical professor in the department of radiation oncology, City of Hope Comprehensive Cancer Center, Duarte, Calif., said in an interview.
However, he cautioned, local failure is challenging to assess at 1 year because of radiation-induced changes. In fact, more than a quarter of study patients had scans that were not evaluable for this reason. Furthermore, rates of late cardiac toxicity and esophageal stenosis are unknown.
“Longer-term follow-up is needed as the current data does not support dose escalation in unresectable lung cancer, specifically stage III NSCLC, based on RTOG 0617,” Dr. Amini said. “However, the overall survival detriment from dose escalation in RTOG 0617 could have been due to poor radiation techniques and toxicities including cardiac side effects, which we now better understand. The PET-Boost trial focuses on delivering higher doses of hypofractionated radiation based on PET, which essentially leads to a smaller area getting a radiation boost, which, in turn, should have less side effects.”
“This area of work will continue to be more exciting as more tumor-targeting radiotracers can be utilized with PET,” he predicted. “One of the future avenues in radiation oncology is incorporating novel imaging modalities including tumor-specific radiotracers with PET scans, for example, to dose-paint disease, delivering higher doses to more active parts of the primary and lymph nodes, while reducing doses to less active areas, which potentially could lead to higher rates of local control with minimal side effects.”
The trial was sponsored by The Netherlands Cancer Institute. Ms. Cooke and Dr. Amini disclosed no conflicts of interest.
SOURCE: Lalezari F et al. ESTRO 2020. Abstract OC-0609.
FROM ESTRO 2020
CMS finalizes 2021 physician pay rule with E/M changes
Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests. While gastroenterology is estimated to experience a 4% cut, other fields are expecting cuts up to 10%.
The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.
CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule takes effect on Jan. 1, 2021, within a 30-day period instead of the usual 60-day time frame.
The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.
“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”
In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.
Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).
In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%). The changes also would lead to an expected 4% decrease for gastroenterology. The GI societies are among the groups pressing Congress to intercede.
CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.
The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.
In a statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”
By AMA’s calculations, CMS’s planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Dr. Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Dr. Bailey said will result in “simpler and more flexible” coding and documentation.
The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.
In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on Jan. 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020. AGA has been advocating for passage of this bill before the end of the 116th Congress and urges GIs to contact their lawmakers to prevent these cuts to specialty care. While the GI societies are in support of the bill, they have expressed concerns regarding the financial cliff H.R. 8702 would create. With the payment cuts pushed to 2023, this financial cliff would require physicians to return to Congress to prevent future cuts once the 2-year delay is up.
The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.
Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.
“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
“Long overdue”
But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.
In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”
This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.
In a tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”
The American Academy of Family Physicians joined ACP in a Nov. 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last-minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”
In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.
“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”
Based on reporting from Medscape.com.
Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests. While gastroenterology is estimated to experience a 4% cut, other fields are expecting cuts up to 10%.
The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.
CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule takes effect on Jan. 1, 2021, within a 30-day period instead of the usual 60-day time frame.
The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.
“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”
In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.
Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).
In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%). The changes also would lead to an expected 4% decrease for gastroenterology. The GI societies are among the groups pressing Congress to intercede.
CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.
The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.
In a statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”
By AMA’s calculations, CMS’s planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Dr. Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Dr. Bailey said will result in “simpler and more flexible” coding and documentation.
The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.
In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on Jan. 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020. AGA has been advocating for passage of this bill before the end of the 116th Congress and urges GIs to contact their lawmakers to prevent these cuts to specialty care. While the GI societies are in support of the bill, they have expressed concerns regarding the financial cliff H.R. 8702 would create. With the payment cuts pushed to 2023, this financial cliff would require physicians to return to Congress to prevent future cuts once the 2-year delay is up.
The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.
Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.
“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
“Long overdue”
But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.
In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”
This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.
In a tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”
The American Academy of Family Physicians joined ACP in a Nov. 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last-minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”
In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.
“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”
Based on reporting from Medscape.com.
Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests. While gastroenterology is estimated to experience a 4% cut, other fields are expecting cuts up to 10%.
The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.
CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule takes effect on Jan. 1, 2021, within a 30-day period instead of the usual 60-day time frame.
The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.
“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”
In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.
Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).
In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%). The changes also would lead to an expected 4% decrease for gastroenterology. The GI societies are among the groups pressing Congress to intercede.
CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.
The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.
In a statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”
By AMA’s calculations, CMS’s planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Dr. Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Dr. Bailey said will result in “simpler and more flexible” coding and documentation.
The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.
In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on Jan. 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020. AGA has been advocating for passage of this bill before the end of the 116th Congress and urges GIs to contact their lawmakers to prevent these cuts to specialty care. While the GI societies are in support of the bill, they have expressed concerns regarding the financial cliff H.R. 8702 would create. With the payment cuts pushed to 2023, this financial cliff would require physicians to return to Congress to prevent future cuts once the 2-year delay is up.
The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.
Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.
“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
“Long overdue”
But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.
In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”
This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.
In a tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”
The American Academy of Family Physicians joined ACP in a Nov. 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last-minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”
In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.
“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”
Based on reporting from Medscape.com.
Swedish registry study finds atopic dermatitis significantly associated with autoimmune diseases
in a case control study derived from Swedish national health care registry data.
Atopic dermatitis (AD) is known to be associated with other atopic conditions, and there is increasing evidence it is associated with some nonatopic conditions, including some cancers, cardiovascular disease, and neuropsychiatric disorders, according to Lina U. Ivert, MD, of the dermatology and venereology unit at the Karolinska Institutet, Stockholm, and coauthors. There are also some data indicating that autoimmune diseases, particularly those involving the skin and gastrointestinal tract, are more common in people with AD.
The aim of their study, published in the British Journal of Dermatology, was to investigate a wide spectrum of autoimmune diseases for associations with AD in a large-scale, population-based study using Swedish registers. Findings could lead to better monitoring of comorbidities and deeper understanding of disease burden and AD pathophysiology, they noted.
Large-scale study
With data from the Swedish Board of Health and Welfare’s National Patient Register on inpatient diagnoses since 1964 and specialist outpatient visits since 2001, the investigators included all patients aged 15 years and older with AD diagnoses (104,832) and matched them with controls from the general population (1,022,435). The authors noted that the large number of people included in the analysis allowed for robust estimates, and underscored that 80% of the AD patients included had received their diagnosis in a dermatology department, which reduces the risk of misclassification.
Association with autoimmune disease
The investigators found an association between AD and autoimmune disease, with an adjusted odds ratio) of 1.97 (95% confidence interval, 1.93-2.01). The association was present with several organ systems, particularly the skin and gastrointestinal tract, and with connective tissue diseases. The strongest associations with autoimmune skin diseases were found for dermatitis herpetiformis (aOR, 9.76; 95% CI, 8.10-11.8), alopecia areata (aOR, 5.11; 95% CI, 4.75-5.49), and chronic urticaria (aOR, 4.82; 95% CI, 4.48-5.19).
AD was associated with gastrointestinal diseases, including celiac disease (aOR, 1.96; 95% CI, 1.84-2.09), Crohn disease (aOR 1.83; CI, 1.71-1.96), and ulcerative colitis (aOR 1.58; 95% CI, 1.49-1.68).
Connective tissue diseases significantly associated with AD included systemic lupus erythematosus (aOR, 1.65; 95% CI, 1.42-1.90), ankylosing spondylitis (aOR, 1.46; 95% CI, 1.29-1.66), and RA (aOR, 1.44; 95% CI,1.34-1.54]). Hematologic or hepatic autoimmune disease associations with AD were not observed.
Stronger association with multiple diseases
The association between AD and two or more autoimmune diseases was significantly stronger than the association between AD and having one autoimmune disease. For example, the OR for AD among people with three to five autoimmune diseases was 3.33 (95% CI, 2.86-3.87), and was stronger in men (OR, 3.96; 95% CI, 2.92-5.37) than in women (OR, 3.14; 95% CI, 2.63-3.74).
Sex differences
In the study overall, the association with AD and autoimmune diseases was stronger in men (aOR, 2.18; 95% CI, 2.10-2.25), compared with women (aOR, 1.89; 95% CI, 1.85-1.93), but this “sex difference was only statistically significant between AD and RA and between AD and Celiac disease,” they noted.
Associations between AD and dermatomyositis, systemic scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves disease, multiple sclerosis, and polymyalgia rheumatica were found only in women. Dr. Ivert and coauthors observed that “women are in general more likely to develop autoimmune diseases, and 80% of patients with autoimmune diseases are women.”
Provocative questions
Commenting on the findings, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology, George Washington University, Washington, said, “At a high level, it is important for clinicians to recognize that atopic dermatitis is a systemic immune-mediated disease. AD is associated with higher rates of comorbid autoimmune disease, similar to psoriasis and other chronic inflammatory skin diseases.”
“At this point, there is nothing immediately actionable about these results,” noted Dr. Silverberg, who was not an author of this study. “That said, in my mind, they raise some provocative questions: What is the difference between AD in adults who do versus those who do not get comorbid autoimmune disease? Does AD then present differently? Does it respond to the same therapies? These will have to be the subject of future research.”
The study was funded by the Swedish Asthma and Allergy Association Research Foundation, Hudfonden (the Welander-Finsen Foundation), and the Swedish Society for Dermatology and Venereology. The authors disclosed no conflicts of interest.
SOURCE: Ivert LU et al. Br J Dermatol. 2020 Oct 22. doi: 10.1111/bjd.19624.
in a case control study derived from Swedish national health care registry data.
Atopic dermatitis (AD) is known to be associated with other atopic conditions, and there is increasing evidence it is associated with some nonatopic conditions, including some cancers, cardiovascular disease, and neuropsychiatric disorders, according to Lina U. Ivert, MD, of the dermatology and venereology unit at the Karolinska Institutet, Stockholm, and coauthors. There are also some data indicating that autoimmune diseases, particularly those involving the skin and gastrointestinal tract, are more common in people with AD.
The aim of their study, published in the British Journal of Dermatology, was to investigate a wide spectrum of autoimmune diseases for associations with AD in a large-scale, population-based study using Swedish registers. Findings could lead to better monitoring of comorbidities and deeper understanding of disease burden and AD pathophysiology, they noted.
Large-scale study
With data from the Swedish Board of Health and Welfare’s National Patient Register on inpatient diagnoses since 1964 and specialist outpatient visits since 2001, the investigators included all patients aged 15 years and older with AD diagnoses (104,832) and matched them with controls from the general population (1,022,435). The authors noted that the large number of people included in the analysis allowed for robust estimates, and underscored that 80% of the AD patients included had received their diagnosis in a dermatology department, which reduces the risk of misclassification.
Association with autoimmune disease
The investigators found an association between AD and autoimmune disease, with an adjusted odds ratio) of 1.97 (95% confidence interval, 1.93-2.01). The association was present with several organ systems, particularly the skin and gastrointestinal tract, and with connective tissue diseases. The strongest associations with autoimmune skin diseases were found for dermatitis herpetiformis (aOR, 9.76; 95% CI, 8.10-11.8), alopecia areata (aOR, 5.11; 95% CI, 4.75-5.49), and chronic urticaria (aOR, 4.82; 95% CI, 4.48-5.19).
AD was associated with gastrointestinal diseases, including celiac disease (aOR, 1.96; 95% CI, 1.84-2.09), Crohn disease (aOR 1.83; CI, 1.71-1.96), and ulcerative colitis (aOR 1.58; 95% CI, 1.49-1.68).
Connective tissue diseases significantly associated with AD included systemic lupus erythematosus (aOR, 1.65; 95% CI, 1.42-1.90), ankylosing spondylitis (aOR, 1.46; 95% CI, 1.29-1.66), and RA (aOR, 1.44; 95% CI,1.34-1.54]). Hematologic or hepatic autoimmune disease associations with AD were not observed.
Stronger association with multiple diseases
The association between AD and two or more autoimmune diseases was significantly stronger than the association between AD and having one autoimmune disease. For example, the OR for AD among people with three to five autoimmune diseases was 3.33 (95% CI, 2.86-3.87), and was stronger in men (OR, 3.96; 95% CI, 2.92-5.37) than in women (OR, 3.14; 95% CI, 2.63-3.74).
Sex differences
In the study overall, the association with AD and autoimmune diseases was stronger in men (aOR, 2.18; 95% CI, 2.10-2.25), compared with women (aOR, 1.89; 95% CI, 1.85-1.93), but this “sex difference was only statistically significant between AD and RA and between AD and Celiac disease,” they noted.
Associations between AD and dermatomyositis, systemic scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves disease, multiple sclerosis, and polymyalgia rheumatica were found only in women. Dr. Ivert and coauthors observed that “women are in general more likely to develop autoimmune diseases, and 80% of patients with autoimmune diseases are women.”
Provocative questions
Commenting on the findings, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology, George Washington University, Washington, said, “At a high level, it is important for clinicians to recognize that atopic dermatitis is a systemic immune-mediated disease. AD is associated with higher rates of comorbid autoimmune disease, similar to psoriasis and other chronic inflammatory skin diseases.”
“At this point, there is nothing immediately actionable about these results,” noted Dr. Silverberg, who was not an author of this study. “That said, in my mind, they raise some provocative questions: What is the difference between AD in adults who do versus those who do not get comorbid autoimmune disease? Does AD then present differently? Does it respond to the same therapies? These will have to be the subject of future research.”
The study was funded by the Swedish Asthma and Allergy Association Research Foundation, Hudfonden (the Welander-Finsen Foundation), and the Swedish Society for Dermatology and Venereology. The authors disclosed no conflicts of interest.
SOURCE: Ivert LU et al. Br J Dermatol. 2020 Oct 22. doi: 10.1111/bjd.19624.
in a case control study derived from Swedish national health care registry data.
Atopic dermatitis (AD) is known to be associated with other atopic conditions, and there is increasing evidence it is associated with some nonatopic conditions, including some cancers, cardiovascular disease, and neuropsychiatric disorders, according to Lina U. Ivert, MD, of the dermatology and venereology unit at the Karolinska Institutet, Stockholm, and coauthors. There are also some data indicating that autoimmune diseases, particularly those involving the skin and gastrointestinal tract, are more common in people with AD.
The aim of their study, published in the British Journal of Dermatology, was to investigate a wide spectrum of autoimmune diseases for associations with AD in a large-scale, population-based study using Swedish registers. Findings could lead to better monitoring of comorbidities and deeper understanding of disease burden and AD pathophysiology, they noted.
Large-scale study
With data from the Swedish Board of Health and Welfare’s National Patient Register on inpatient diagnoses since 1964 and specialist outpatient visits since 2001, the investigators included all patients aged 15 years and older with AD diagnoses (104,832) and matched them with controls from the general population (1,022,435). The authors noted that the large number of people included in the analysis allowed for robust estimates, and underscored that 80% of the AD patients included had received their diagnosis in a dermatology department, which reduces the risk of misclassification.
Association with autoimmune disease
The investigators found an association between AD and autoimmune disease, with an adjusted odds ratio) of 1.97 (95% confidence interval, 1.93-2.01). The association was present with several organ systems, particularly the skin and gastrointestinal tract, and with connective tissue diseases. The strongest associations with autoimmune skin diseases were found for dermatitis herpetiformis (aOR, 9.76; 95% CI, 8.10-11.8), alopecia areata (aOR, 5.11; 95% CI, 4.75-5.49), and chronic urticaria (aOR, 4.82; 95% CI, 4.48-5.19).
AD was associated with gastrointestinal diseases, including celiac disease (aOR, 1.96; 95% CI, 1.84-2.09), Crohn disease (aOR 1.83; CI, 1.71-1.96), and ulcerative colitis (aOR 1.58; 95% CI, 1.49-1.68).
Connective tissue diseases significantly associated with AD included systemic lupus erythematosus (aOR, 1.65; 95% CI, 1.42-1.90), ankylosing spondylitis (aOR, 1.46; 95% CI, 1.29-1.66), and RA (aOR, 1.44; 95% CI,1.34-1.54]). Hematologic or hepatic autoimmune disease associations with AD were not observed.
Stronger association with multiple diseases
The association between AD and two or more autoimmune diseases was significantly stronger than the association between AD and having one autoimmune disease. For example, the OR for AD among people with three to five autoimmune diseases was 3.33 (95% CI, 2.86-3.87), and was stronger in men (OR, 3.96; 95% CI, 2.92-5.37) than in women (OR, 3.14; 95% CI, 2.63-3.74).
Sex differences
In the study overall, the association with AD and autoimmune diseases was stronger in men (aOR, 2.18; 95% CI, 2.10-2.25), compared with women (aOR, 1.89; 95% CI, 1.85-1.93), but this “sex difference was only statistically significant between AD and RA and between AD and Celiac disease,” they noted.
Associations between AD and dermatomyositis, systemic scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves disease, multiple sclerosis, and polymyalgia rheumatica were found only in women. Dr. Ivert and coauthors observed that “women are in general more likely to develop autoimmune diseases, and 80% of patients with autoimmune diseases are women.”
Provocative questions
Commenting on the findings, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology, George Washington University, Washington, said, “At a high level, it is important for clinicians to recognize that atopic dermatitis is a systemic immune-mediated disease. AD is associated with higher rates of comorbid autoimmune disease, similar to psoriasis and other chronic inflammatory skin diseases.”
“At this point, there is nothing immediately actionable about these results,” noted Dr. Silverberg, who was not an author of this study. “That said, in my mind, they raise some provocative questions: What is the difference between AD in adults who do versus those who do not get comorbid autoimmune disease? Does AD then present differently? Does it respond to the same therapies? These will have to be the subject of future research.”
The study was funded by the Swedish Asthma and Allergy Association Research Foundation, Hudfonden (the Welander-Finsen Foundation), and the Swedish Society for Dermatology and Venereology. The authors disclosed no conflicts of interest.
SOURCE: Ivert LU et al. Br J Dermatol. 2020 Oct 22. doi: 10.1111/bjd.19624.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Analysis characterizes common wound microbes in epidermolysis bullosa
– in a retrospective analysis of over 700 wound cultures from 158 patients across the United States and Canada.
The findings from the EB Clinical Characterization and Outcomes Database speak to the value of surveillance cultures with routine testing for microbial resistance – including mupirocin resistance – and to the importance of antibiotic stewardship not only for oral antibiotics but for topicals as well, according to Laura E. Levin, MD, and Kimberly D. Morel, MD, of the departments of dermatology and pediatrics, Columbia University Irving Medical Center, New York, the lead and senior authors, respectively, of the paper recently published in Pediatric Dermatology.
Almost all of the 158 patients with at least one wound culture recorded in the database from the period of 2001-2018 had one or more positive culture results. Of 152 patients with positive cultures, 131 (86%) were positive for SA and 56 (37%) and 34 (22%) were positive for PA and GAS, respectively. Other bacteria isolated included Corynebacterium spp and Proteus spp. Nearly half (47%) of patients with SA-positive cultures had methicillin-resistant SA, and 68% had methicillin-susceptible SA. (Some patients grew both MSSA and MRSA at different points in time.)
Mupirocin-susceptibility testing was performed at only some of the 13 participating centers. Of 15 patients whose cultures had recorded SA mupirocin-susceptibility testing, 11 had cultures positive for mupirocin-susceptible SA and 6 (40%) had mupirocin-resistant SA isolates (2 patients grew both). Of these six patients, half had isolates that were also methicillin-resistant.
Mupirocin, a topical antibiotic, has been a cornerstone of decolonization regimens for MSSA and MRSA, but resistance has been demonstrated in other research as well and is not specific to EB, wrote Dr. Levin, Dr. Morel, and coauthors.
“Pediatric dermatologists often rely on topical antimicrobials in the treatment of patients’ open wounds to both prevent and treat infection, depending on the clinical scenario,” and surveillance cultures with routine testing for mupirocin resistance can help guide antibiotic choice and management strategies, Dr. Levin said in an interview.
More broadly, she added, “it’s helpful to know what bacteria are routinely colonizing wounds, not causing infection, versus those that are more likely to be associated with infection, chronic wounds, or the risk of developing skin cancer ... [to know] which wounds need to be treated more aggressively.”
A subset of patients with EB have been known to be at risk for squamous cell carcinoma, and research is implicating certain bacteria “as contributing to wound inflammation,” Dr. Morel said in an interview.
SCC was reported in 23 out of 717 patients in the database – but fewer than half of the patients with SCC had recorded wound cultures. The small numbers precluded the identification of microbes that may confer significant risk.
Correlating particular microbes with clinical features also will take more research. About half (57%) of the patients with recorded wound cultures had wounds with purulent exudate or other features of clinical infection. However, the presence or absence of clinical signs of infection was not temporally correlated with culture results in the database.
The 158 patients with recorded wound cultures had a mean age of 12.8 years and represented a range of EB subtypes.
PA was present in the wounds of patients as young as 1 month old, the authors noted. Investigators are “looking to further study PA and characterize clinical features ... to understand more about this microbe and its impact on patients with EB,” Dr. Morel said.
In the meantime, the analysis reaffirms the importance of antibiotic stewardship. Mupirocin is labeled to be used three times a day for a short period of time, but “tends to be prescribed and used less judiciously than intended,” Dr. Morel said. “It’s important [not to overuse it]. We have seen that patients’ culture results become sensitive to mupirocin again in the future when they avoid it for a period of time.”
The work was supported by the EB Research Partnership and EB Medical Research Foundation, as well as an NIH/NCATS grant. No investigator disclosures were listed.
SOURCE: Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14444.
– in a retrospective analysis of over 700 wound cultures from 158 patients across the United States and Canada.
The findings from the EB Clinical Characterization and Outcomes Database speak to the value of surveillance cultures with routine testing for microbial resistance – including mupirocin resistance – and to the importance of antibiotic stewardship not only for oral antibiotics but for topicals as well, according to Laura E. Levin, MD, and Kimberly D. Morel, MD, of the departments of dermatology and pediatrics, Columbia University Irving Medical Center, New York, the lead and senior authors, respectively, of the paper recently published in Pediatric Dermatology.
Almost all of the 158 patients with at least one wound culture recorded in the database from the period of 2001-2018 had one or more positive culture results. Of 152 patients with positive cultures, 131 (86%) were positive for SA and 56 (37%) and 34 (22%) were positive for PA and GAS, respectively. Other bacteria isolated included Corynebacterium spp and Proteus spp. Nearly half (47%) of patients with SA-positive cultures had methicillin-resistant SA, and 68% had methicillin-susceptible SA. (Some patients grew both MSSA and MRSA at different points in time.)
Mupirocin-susceptibility testing was performed at only some of the 13 participating centers. Of 15 patients whose cultures had recorded SA mupirocin-susceptibility testing, 11 had cultures positive for mupirocin-susceptible SA and 6 (40%) had mupirocin-resistant SA isolates (2 patients grew both). Of these six patients, half had isolates that were also methicillin-resistant.
Mupirocin, a topical antibiotic, has been a cornerstone of decolonization regimens for MSSA and MRSA, but resistance has been demonstrated in other research as well and is not specific to EB, wrote Dr. Levin, Dr. Morel, and coauthors.
“Pediatric dermatologists often rely on topical antimicrobials in the treatment of patients’ open wounds to both prevent and treat infection, depending on the clinical scenario,” and surveillance cultures with routine testing for mupirocin resistance can help guide antibiotic choice and management strategies, Dr. Levin said in an interview.
More broadly, she added, “it’s helpful to know what bacteria are routinely colonizing wounds, not causing infection, versus those that are more likely to be associated with infection, chronic wounds, or the risk of developing skin cancer ... [to know] which wounds need to be treated more aggressively.”
A subset of patients with EB have been known to be at risk for squamous cell carcinoma, and research is implicating certain bacteria “as contributing to wound inflammation,” Dr. Morel said in an interview.
SCC was reported in 23 out of 717 patients in the database – but fewer than half of the patients with SCC had recorded wound cultures. The small numbers precluded the identification of microbes that may confer significant risk.
Correlating particular microbes with clinical features also will take more research. About half (57%) of the patients with recorded wound cultures had wounds with purulent exudate or other features of clinical infection. However, the presence or absence of clinical signs of infection was not temporally correlated with culture results in the database.
The 158 patients with recorded wound cultures had a mean age of 12.8 years and represented a range of EB subtypes.
PA was present in the wounds of patients as young as 1 month old, the authors noted. Investigators are “looking to further study PA and characterize clinical features ... to understand more about this microbe and its impact on patients with EB,” Dr. Morel said.
In the meantime, the analysis reaffirms the importance of antibiotic stewardship. Mupirocin is labeled to be used three times a day for a short period of time, but “tends to be prescribed and used less judiciously than intended,” Dr. Morel said. “It’s important [not to overuse it]. We have seen that patients’ culture results become sensitive to mupirocin again in the future when they avoid it for a period of time.”
The work was supported by the EB Research Partnership and EB Medical Research Foundation, as well as an NIH/NCATS grant. No investigator disclosures were listed.
SOURCE: Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14444.
– in a retrospective analysis of over 700 wound cultures from 158 patients across the United States and Canada.
The findings from the EB Clinical Characterization and Outcomes Database speak to the value of surveillance cultures with routine testing for microbial resistance – including mupirocin resistance – and to the importance of antibiotic stewardship not only for oral antibiotics but for topicals as well, according to Laura E. Levin, MD, and Kimberly D. Morel, MD, of the departments of dermatology and pediatrics, Columbia University Irving Medical Center, New York, the lead and senior authors, respectively, of the paper recently published in Pediatric Dermatology.
Almost all of the 158 patients with at least one wound culture recorded in the database from the period of 2001-2018 had one or more positive culture results. Of 152 patients with positive cultures, 131 (86%) were positive for SA and 56 (37%) and 34 (22%) were positive for PA and GAS, respectively. Other bacteria isolated included Corynebacterium spp and Proteus spp. Nearly half (47%) of patients with SA-positive cultures had methicillin-resistant SA, and 68% had methicillin-susceptible SA. (Some patients grew both MSSA and MRSA at different points in time.)
Mupirocin-susceptibility testing was performed at only some of the 13 participating centers. Of 15 patients whose cultures had recorded SA mupirocin-susceptibility testing, 11 had cultures positive for mupirocin-susceptible SA and 6 (40%) had mupirocin-resistant SA isolates (2 patients grew both). Of these six patients, half had isolates that were also methicillin-resistant.
Mupirocin, a topical antibiotic, has been a cornerstone of decolonization regimens for MSSA and MRSA, but resistance has been demonstrated in other research as well and is not specific to EB, wrote Dr. Levin, Dr. Morel, and coauthors.
“Pediatric dermatologists often rely on topical antimicrobials in the treatment of patients’ open wounds to both prevent and treat infection, depending on the clinical scenario,” and surveillance cultures with routine testing for mupirocin resistance can help guide antibiotic choice and management strategies, Dr. Levin said in an interview.
More broadly, she added, “it’s helpful to know what bacteria are routinely colonizing wounds, not causing infection, versus those that are more likely to be associated with infection, chronic wounds, or the risk of developing skin cancer ... [to know] which wounds need to be treated more aggressively.”
A subset of patients with EB have been known to be at risk for squamous cell carcinoma, and research is implicating certain bacteria “as contributing to wound inflammation,” Dr. Morel said in an interview.
SCC was reported in 23 out of 717 patients in the database – but fewer than half of the patients with SCC had recorded wound cultures. The small numbers precluded the identification of microbes that may confer significant risk.
Correlating particular microbes with clinical features also will take more research. About half (57%) of the patients with recorded wound cultures had wounds with purulent exudate or other features of clinical infection. However, the presence or absence of clinical signs of infection was not temporally correlated with culture results in the database.
The 158 patients with recorded wound cultures had a mean age of 12.8 years and represented a range of EB subtypes.
PA was present in the wounds of patients as young as 1 month old, the authors noted. Investigators are “looking to further study PA and characterize clinical features ... to understand more about this microbe and its impact on patients with EB,” Dr. Morel said.
In the meantime, the analysis reaffirms the importance of antibiotic stewardship. Mupirocin is labeled to be used three times a day for a short period of time, but “tends to be prescribed and used less judiciously than intended,” Dr. Morel said. “It’s important [not to overuse it]. We have seen that patients’ culture results become sensitive to mupirocin again in the future when they avoid it for a period of time.”
The work was supported by the EB Research Partnership and EB Medical Research Foundation, as well as an NIH/NCATS grant. No investigator disclosures were listed.
SOURCE: Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14444.
FROM PEDIATRIC DERMATOLOGY
Disparities in child abuse evaluation arise from implicit bias
according to research discussed by Tiffani J. Johnson, MD, an assistant professor of emergency medicine at the University of California, Davis.
“These disparities in child abuse evaluation and reporting are bidirectional,” she said. “We also recognize that abuse is more likely to be unrecognized in White children.”
Dr. Johnson presented data on the health disparities in child abuse reporting in a session at the annual meeting of the American Academy of Pediatrics, held virtually this year. Health care disparities, as defined by the National Academy of Sciences, refers to differences in the quality of care between minority and nonminority populations that are not caused by clinical appropriateness, access, need, or patient preference, she explained. Instead, they result from discrimination, bias, stereotyping, and uncertainty.
Disparities lead to harm in all children
For example, a 2018 systematic review found that Black and other non-White children were significantly more likely than White children to be evaluated with a skeletal survey. In one of the studies included, at a large urban academic center, Black and Latinx children with accidental fractures were 8.75 times more likely to undergo a skeletal survey than White children and 4.3 times more likely to be reported to child protective services.
“And let me emphasize that these are children who were ultimately found to have accidental fractures,” Dr. Johnson said.
Meanwhile, in an analysis of known cases of head trauma, researchers found that abuse was missed in 37% of White children, compared with 19% of non-White children.
“These only represent the tip of the iceberg as a true number of cases of abuse may never really be detected because some cases are still unknown,” Dr. Johnson told attendees. And the harm of these disparities runs in both directions.
“Failing to diagnose abuse in White children clearly puts them at increased risk for return visits and return evaluations for repeated abuse by the perpetrators,” she said. But harm also can result from overreporting and investigation, including psychological trauma and a waste of limited resources. Overinvestigation also can erode family-physician relationships and perpetuate distrust of medical care in communities of color.
Yet at the same time, it’s clear that Black children, adolescents, and young adults are not protected from harm in society more generally, when at home, where they learn, or where they play, Dr. Johnson said, referencing the deaths of Breonna Taylor and Tamir Rice as examples.
“And now we’re seeing increased evidence that children are not protected in the health care center when we think about the many disparities that have been identified in the care and outcomes of children, including the disproportionality in terms of child abuse evaluation and referrals,” Dr. Johnson said.
Racism is a root cause of that harm to Black children, she said, as the systemic structure of opportunities unfairly disadvantages some individuals and communities while unfairly advantaging others, thereby “sapping the strength of the whole society through the waste of human resources.”
Tonya Chaffee, MD, MPH, a clinical professor of health sciences at the University of California, San Francisco, who attended the session, said she particularly appreciated “seeing data on which racial/ethnic populations have child abuse reports made and the disparities that exist that are similar to what we are noticing in our own institution.”
Role of individual-level implicit bias and racism
While institutional and structural racism play a substantial role in health care disparities, Dr. Johnson focused primarily on the impact of personal racism when it comes to child abuse evaluations, through overt discrimination, explicit bias, implicit bias, and stigmatization. The most challenging of these to identify and acknowledge is often implicit bias, a tendency to believe, even unconsciously, that some people or ideas are better than others, which results in unfair treatment.
For example, a 2016 study found that half of medical students and residents held at least one biological belief about differences between Black and White individuals that was actually false, such as Black people having more pain tolerance or stronger bones than White people, which then affected treatment recommendations.
“Implicit bias refers to our attitudes that lie below the surface, but they can still influence our behaviors,” Dr. Johnson explained. She encouraged providers to take the implicit bias test online to learn about their own unrecognized implicit biases. These biases have a hand in influencing decisions particularly in fast-paced environments where cognitive load is high – such as EDs, where many child abuse evaluations occur.
For example, in one study Dr. Johnson led, the researchers measured implicit bias in participants before and after an ED shift to assess how cognitive load affected bias. They found that participants who care for more than 10 patients, the average score for implicit bias increased.
Similarly, “when the ED was more overcrowded, there was also increased bias at the end of the shift, compared to the beginning of the shift,” Dr. Johnson said. She asked clinicians to take into consideration that at the start of the shift, they may feel well rested and freshly caffeinated, able to suppress or overcome the biases that they know they have.
“But our biases [are] more likely to come into play with every subsequent decision that we make throughout the day when we’re engaged in clinical encounters,” such as who does and does not receive a skeletal survey or get referred to child protective services, she said.
In another study where she hypothesized that resident physicians would have less bias on the child race implicit bias test than on the adult race one, Dr. Johnson reported that 85% of 91 residents working in an ED had an implicit pro-White/anti-Black bias in the test on adult race, but an even higher bias score – 91% – with child race.
Research has found that even children’s names can conjure implicit bias when it comes to stereotypically “White-sounding” names versus stereotypically “Black-sounding names.”
The implicit bias among clinicians extends beyond care of different children. Research has also identified association between higher implicit bias scores and less interpersonal treatment, less supportive communication, less patient-centered communication, poorer patient ratings of satisfaction, and greater patient-reported difficulty with following recommendations, Dr. Johnson said.
“I want you to think about that because I know that when we’re engaging with parents and making decisions about whether or not we’re going to do a skeletal survey or report someone for it, there is a lot of subjectivity that comes into play with how you’re interacting with families,” Dr. Johnson said. Those verbal and nonverbal cues may be triggering to parents, which then affects your interaction with them. Further, research shows that these biases may impact treatment decisions as well.
Personal-mediated racism also shows up in the use of stigmatizing language, Dr. Johnson said.
“When providers read stigmatizing language in the patient’s medical records, it was associated with them having more negative attitudes about that patient,” which then influenced their clinical decision-making, she said. “So when providers got primed with stigmatizing language, they subsequently had less aggressive pain management for those patients.”
Clinical implications for patient care
Dr. Johnson encouraged attendees to be careful about the language and tone they use in communicating with other health care providers and during documentation in medical records. Disparities in child abuse evaluation and reporting tend to be greater in EDs with more subjective conditions, whereas disparities are lower in departments with more established protocols.
She recommended several changes to practice that can reduce the impact of implicit bias. Universal screening for child abuse can increase how many injuries are found, but usually at the cost of increased resources and radiation. Another option is use of validated clinical decision support rules to identify who is at high or low risk for maltreatment, something Dr. Johnson is working on in her research.
But it’s also important for individual providers to confront their personal biases. Evidence-based strategies for reducing bias include perspective taking, focusing on common identities with patients, using counter-stereotypical imaging, seeking increased opportunity for cross-cultural contact, and mindfulness meditation.
“When you interact with people of different backgrounds, it helps to reduce the impact of stereotypes in society about those individuals,” Dr. Johnson told attendees. It’s also important to recognize how diversity in your clinical team can reduce bias.
“We need to work with our institutions to confront racial biases in child abuse reporting and develop quality improvement projects to ensure reporting is done objectively,” Dr. Chaffee said in an interview after attending the session. “This will require training and likely policy changes, including how reports are made to child welfare and/or the police moving forward.”
according to research discussed by Tiffani J. Johnson, MD, an assistant professor of emergency medicine at the University of California, Davis.
“These disparities in child abuse evaluation and reporting are bidirectional,” she said. “We also recognize that abuse is more likely to be unrecognized in White children.”
Dr. Johnson presented data on the health disparities in child abuse reporting in a session at the annual meeting of the American Academy of Pediatrics, held virtually this year. Health care disparities, as defined by the National Academy of Sciences, refers to differences in the quality of care between minority and nonminority populations that are not caused by clinical appropriateness, access, need, or patient preference, she explained. Instead, they result from discrimination, bias, stereotyping, and uncertainty.
Disparities lead to harm in all children
For example, a 2018 systematic review found that Black and other non-White children were significantly more likely than White children to be evaluated with a skeletal survey. In one of the studies included, at a large urban academic center, Black and Latinx children with accidental fractures were 8.75 times more likely to undergo a skeletal survey than White children and 4.3 times more likely to be reported to child protective services.
“And let me emphasize that these are children who were ultimately found to have accidental fractures,” Dr. Johnson said.
Meanwhile, in an analysis of known cases of head trauma, researchers found that abuse was missed in 37% of White children, compared with 19% of non-White children.
“These only represent the tip of the iceberg as a true number of cases of abuse may never really be detected because some cases are still unknown,” Dr. Johnson told attendees. And the harm of these disparities runs in both directions.
“Failing to diagnose abuse in White children clearly puts them at increased risk for return visits and return evaluations for repeated abuse by the perpetrators,” she said. But harm also can result from overreporting and investigation, including psychological trauma and a waste of limited resources. Overinvestigation also can erode family-physician relationships and perpetuate distrust of medical care in communities of color.
Yet at the same time, it’s clear that Black children, adolescents, and young adults are not protected from harm in society more generally, when at home, where they learn, or where they play, Dr. Johnson said, referencing the deaths of Breonna Taylor and Tamir Rice as examples.
“And now we’re seeing increased evidence that children are not protected in the health care center when we think about the many disparities that have been identified in the care and outcomes of children, including the disproportionality in terms of child abuse evaluation and referrals,” Dr. Johnson said.
Racism is a root cause of that harm to Black children, she said, as the systemic structure of opportunities unfairly disadvantages some individuals and communities while unfairly advantaging others, thereby “sapping the strength of the whole society through the waste of human resources.”
Tonya Chaffee, MD, MPH, a clinical professor of health sciences at the University of California, San Francisco, who attended the session, said she particularly appreciated “seeing data on which racial/ethnic populations have child abuse reports made and the disparities that exist that are similar to what we are noticing in our own institution.”
Role of individual-level implicit bias and racism
While institutional and structural racism play a substantial role in health care disparities, Dr. Johnson focused primarily on the impact of personal racism when it comes to child abuse evaluations, through overt discrimination, explicit bias, implicit bias, and stigmatization. The most challenging of these to identify and acknowledge is often implicit bias, a tendency to believe, even unconsciously, that some people or ideas are better than others, which results in unfair treatment.
For example, a 2016 study found that half of medical students and residents held at least one biological belief about differences between Black and White individuals that was actually false, such as Black people having more pain tolerance or stronger bones than White people, which then affected treatment recommendations.
“Implicit bias refers to our attitudes that lie below the surface, but they can still influence our behaviors,” Dr. Johnson explained. She encouraged providers to take the implicit bias test online to learn about their own unrecognized implicit biases. These biases have a hand in influencing decisions particularly in fast-paced environments where cognitive load is high – such as EDs, where many child abuse evaluations occur.
For example, in one study Dr. Johnson led, the researchers measured implicit bias in participants before and after an ED shift to assess how cognitive load affected bias. They found that participants who care for more than 10 patients, the average score for implicit bias increased.
Similarly, “when the ED was more overcrowded, there was also increased bias at the end of the shift, compared to the beginning of the shift,” Dr. Johnson said. She asked clinicians to take into consideration that at the start of the shift, they may feel well rested and freshly caffeinated, able to suppress or overcome the biases that they know they have.
“But our biases [are] more likely to come into play with every subsequent decision that we make throughout the day when we’re engaged in clinical encounters,” such as who does and does not receive a skeletal survey or get referred to child protective services, she said.
In another study where she hypothesized that resident physicians would have less bias on the child race implicit bias test than on the adult race one, Dr. Johnson reported that 85% of 91 residents working in an ED had an implicit pro-White/anti-Black bias in the test on adult race, but an even higher bias score – 91% – with child race.
Research has found that even children’s names can conjure implicit bias when it comes to stereotypically “White-sounding” names versus stereotypically “Black-sounding names.”
The implicit bias among clinicians extends beyond care of different children. Research has also identified association between higher implicit bias scores and less interpersonal treatment, less supportive communication, less patient-centered communication, poorer patient ratings of satisfaction, and greater patient-reported difficulty with following recommendations, Dr. Johnson said.
“I want you to think about that because I know that when we’re engaging with parents and making decisions about whether or not we’re going to do a skeletal survey or report someone for it, there is a lot of subjectivity that comes into play with how you’re interacting with families,” Dr. Johnson said. Those verbal and nonverbal cues may be triggering to parents, which then affects your interaction with them. Further, research shows that these biases may impact treatment decisions as well.
Personal-mediated racism also shows up in the use of stigmatizing language, Dr. Johnson said.
“When providers read stigmatizing language in the patient’s medical records, it was associated with them having more negative attitudes about that patient,” which then influenced their clinical decision-making, she said. “So when providers got primed with stigmatizing language, they subsequently had less aggressive pain management for those patients.”
Clinical implications for patient care
Dr. Johnson encouraged attendees to be careful about the language and tone they use in communicating with other health care providers and during documentation in medical records. Disparities in child abuse evaluation and reporting tend to be greater in EDs with more subjective conditions, whereas disparities are lower in departments with more established protocols.
She recommended several changes to practice that can reduce the impact of implicit bias. Universal screening for child abuse can increase how many injuries are found, but usually at the cost of increased resources and radiation. Another option is use of validated clinical decision support rules to identify who is at high or low risk for maltreatment, something Dr. Johnson is working on in her research.
But it’s also important for individual providers to confront their personal biases. Evidence-based strategies for reducing bias include perspective taking, focusing on common identities with patients, using counter-stereotypical imaging, seeking increased opportunity for cross-cultural contact, and mindfulness meditation.
“When you interact with people of different backgrounds, it helps to reduce the impact of stereotypes in society about those individuals,” Dr. Johnson told attendees. It’s also important to recognize how diversity in your clinical team can reduce bias.
“We need to work with our institutions to confront racial biases in child abuse reporting and develop quality improvement projects to ensure reporting is done objectively,” Dr. Chaffee said in an interview after attending the session. “This will require training and likely policy changes, including how reports are made to child welfare and/or the police moving forward.”
according to research discussed by Tiffani J. Johnson, MD, an assistant professor of emergency medicine at the University of California, Davis.
“These disparities in child abuse evaluation and reporting are bidirectional,” she said. “We also recognize that abuse is more likely to be unrecognized in White children.”
Dr. Johnson presented data on the health disparities in child abuse reporting in a session at the annual meeting of the American Academy of Pediatrics, held virtually this year. Health care disparities, as defined by the National Academy of Sciences, refers to differences in the quality of care between minority and nonminority populations that are not caused by clinical appropriateness, access, need, or patient preference, she explained. Instead, they result from discrimination, bias, stereotyping, and uncertainty.
Disparities lead to harm in all children
For example, a 2018 systematic review found that Black and other non-White children were significantly more likely than White children to be evaluated with a skeletal survey. In one of the studies included, at a large urban academic center, Black and Latinx children with accidental fractures were 8.75 times more likely to undergo a skeletal survey than White children and 4.3 times more likely to be reported to child protective services.
“And let me emphasize that these are children who were ultimately found to have accidental fractures,” Dr. Johnson said.
Meanwhile, in an analysis of known cases of head trauma, researchers found that abuse was missed in 37% of White children, compared with 19% of non-White children.
“These only represent the tip of the iceberg as a true number of cases of abuse may never really be detected because some cases are still unknown,” Dr. Johnson told attendees. And the harm of these disparities runs in both directions.
“Failing to diagnose abuse in White children clearly puts them at increased risk for return visits and return evaluations for repeated abuse by the perpetrators,” she said. But harm also can result from overreporting and investigation, including psychological trauma and a waste of limited resources. Overinvestigation also can erode family-physician relationships and perpetuate distrust of medical care in communities of color.
Yet at the same time, it’s clear that Black children, adolescents, and young adults are not protected from harm in society more generally, when at home, where they learn, or where they play, Dr. Johnson said, referencing the deaths of Breonna Taylor and Tamir Rice as examples.
“And now we’re seeing increased evidence that children are not protected in the health care center when we think about the many disparities that have been identified in the care and outcomes of children, including the disproportionality in terms of child abuse evaluation and referrals,” Dr. Johnson said.
Racism is a root cause of that harm to Black children, she said, as the systemic structure of opportunities unfairly disadvantages some individuals and communities while unfairly advantaging others, thereby “sapping the strength of the whole society through the waste of human resources.”
Tonya Chaffee, MD, MPH, a clinical professor of health sciences at the University of California, San Francisco, who attended the session, said she particularly appreciated “seeing data on which racial/ethnic populations have child abuse reports made and the disparities that exist that are similar to what we are noticing in our own institution.”
Role of individual-level implicit bias and racism
While institutional and structural racism play a substantial role in health care disparities, Dr. Johnson focused primarily on the impact of personal racism when it comes to child abuse evaluations, through overt discrimination, explicit bias, implicit bias, and stigmatization. The most challenging of these to identify and acknowledge is often implicit bias, a tendency to believe, even unconsciously, that some people or ideas are better than others, which results in unfair treatment.
For example, a 2016 study found that half of medical students and residents held at least one biological belief about differences between Black and White individuals that was actually false, such as Black people having more pain tolerance or stronger bones than White people, which then affected treatment recommendations.
“Implicit bias refers to our attitudes that lie below the surface, but they can still influence our behaviors,” Dr. Johnson explained. She encouraged providers to take the implicit bias test online to learn about their own unrecognized implicit biases. These biases have a hand in influencing decisions particularly in fast-paced environments where cognitive load is high – such as EDs, where many child abuse evaluations occur.
For example, in one study Dr. Johnson led, the researchers measured implicit bias in participants before and after an ED shift to assess how cognitive load affected bias. They found that participants who care for more than 10 patients, the average score for implicit bias increased.
Similarly, “when the ED was more overcrowded, there was also increased bias at the end of the shift, compared to the beginning of the shift,” Dr. Johnson said. She asked clinicians to take into consideration that at the start of the shift, they may feel well rested and freshly caffeinated, able to suppress or overcome the biases that they know they have.
“But our biases [are] more likely to come into play with every subsequent decision that we make throughout the day when we’re engaged in clinical encounters,” such as who does and does not receive a skeletal survey or get referred to child protective services, she said.
In another study where she hypothesized that resident physicians would have less bias on the child race implicit bias test than on the adult race one, Dr. Johnson reported that 85% of 91 residents working in an ED had an implicit pro-White/anti-Black bias in the test on adult race, but an even higher bias score – 91% – with child race.
Research has found that even children’s names can conjure implicit bias when it comes to stereotypically “White-sounding” names versus stereotypically “Black-sounding names.”
The implicit bias among clinicians extends beyond care of different children. Research has also identified association between higher implicit bias scores and less interpersonal treatment, less supportive communication, less patient-centered communication, poorer patient ratings of satisfaction, and greater patient-reported difficulty with following recommendations, Dr. Johnson said.
“I want you to think about that because I know that when we’re engaging with parents and making decisions about whether or not we’re going to do a skeletal survey or report someone for it, there is a lot of subjectivity that comes into play with how you’re interacting with families,” Dr. Johnson said. Those verbal and nonverbal cues may be triggering to parents, which then affects your interaction with them. Further, research shows that these biases may impact treatment decisions as well.
Personal-mediated racism also shows up in the use of stigmatizing language, Dr. Johnson said.
“When providers read stigmatizing language in the patient’s medical records, it was associated with them having more negative attitudes about that patient,” which then influenced their clinical decision-making, she said. “So when providers got primed with stigmatizing language, they subsequently had less aggressive pain management for those patients.”
Clinical implications for patient care
Dr. Johnson encouraged attendees to be careful about the language and tone they use in communicating with other health care providers and during documentation in medical records. Disparities in child abuse evaluation and reporting tend to be greater in EDs with more subjective conditions, whereas disparities are lower in departments with more established protocols.
She recommended several changes to practice that can reduce the impact of implicit bias. Universal screening for child abuse can increase how many injuries are found, but usually at the cost of increased resources and radiation. Another option is use of validated clinical decision support rules to identify who is at high or low risk for maltreatment, something Dr. Johnson is working on in her research.
But it’s also important for individual providers to confront their personal biases. Evidence-based strategies for reducing bias include perspective taking, focusing on common identities with patients, using counter-stereotypical imaging, seeking increased opportunity for cross-cultural contact, and mindfulness meditation.
“When you interact with people of different backgrounds, it helps to reduce the impact of stereotypes in society about those individuals,” Dr. Johnson told attendees. It’s also important to recognize how diversity in your clinical team can reduce bias.
“We need to work with our institutions to confront racial biases in child abuse reporting and develop quality improvement projects to ensure reporting is done objectively,” Dr. Chaffee said in an interview after attending the session. “This will require training and likely policy changes, including how reports are made to child welfare and/or the police moving forward.”
FROM AAP 2020
Building a New Framework for Equity: Pediatric Hospital Medicine Must Lead the Way
Pediatric Hospital Medicine (PHM) only recently became a recognized pediatric subspecialty with the first certification exam taking place in 2019. As a new field composed largely of women, it has a unique opportunity to set the example of how to operationalize gender equity in leadership by tracking metrics, creating intentional processes for hiring and promotion, and implementing policies in a transparent way.
In this issue of the Journal of Hospital Medicine, Allan et al1 report that women, who comprise 70% of the field, appear proportionally represented in associate/assistant but not senior leadership roles when compared to the PHM field at large. Eighty-one percent of associate division directors but only 55% of division directors were women, and 82% of assistant fellowship directors but only 66% of fellowship directors were women. These downward trends in the proportion of women in leadership roles as the roles become more senior is not an unfamiliar pattern. This echoes academic pediatric positions more broadly: women’s representation slides from 63% of active physicians to approximately 57% active faculty and then to 26% as department chairs.2 The same story holds true for deans’ offices in US medical schools, where 34% of associate deans are women and yet only 18% of deans are women. The number of women deans has only increased by about one each year, on average, since 2009.3 C-suite leadership roles in healthcare mimic this same downward trajectory.4 Burden et al found that while there was equal gender representation of hospitalists and general internists who worked in university hospitals, women led only a minority of (adult) hospital medicine (16%) or general internal medicine (35%) sections or divisions at university hospitals.5 Women with intersectionality, such as Black women and other women of color, are even more grossly underrepresented in leadership roles.
How can we change this pattern to ensure that leadership in PHM, and in medicine in general, represents diverse voices and reflects the community it serves? Allan et al have established an important baseline for tracking gender equity in PHM. Institutions, organizations, and societies must now prioritize, value and promote a culture of diversity, inclusivity, sponsorship, and allyship. For example, institutions can create and enforce policies in which compensation and promotion are tied to a leader’s achievement of transparent gender equity and diversity targets to ensure accountability. Institutions should commit dedicated and substantive funding to diversity, equity, and inclusion efforts and provide a regular diversity report that tracks gender distribution, hiring and attrition, and representation in leadership. Institutions should implement “best search practices” for all leadership positions. Additionally, all faculty should receive regular and ongoing professional development planning to enhance academic productivity and professional satisfaction and improve retention.
Women in medicine disproportionately experience many issues, including harassment, bias, and childcare and household responsibilities, that adversely affect their career trajectory. PHM is in a unique position to trailblaze a new framework for ensuring gender equity in its field. Let’s not lose this opportunity to set a new course that other specialties can follow.
1. Allan JM, Kim JL, Ralston SL, et al. Gender distribution in pediatric hospital medicine leadership. J Hosp Med. 2021;16:31-33. https://doi.org/10.12788/jhm.3555
2. Spector ND, Asante PA, Marcelin JR, et al. Women in pediatrics: progress, barriers, and opportunities for equity, diversity, and inclusion. Pediatrics. 2019;144 (5):e20192149. https://doi.org/10.1542/peds.2019-2149
3. Lautenberger DM, Dandar VM. The State of Women in Academic Medicine 2018-2019. Association of American Medical Colleges; 2020.
4. Berlin G, Darino L, Groh R, Kumar P. Women in Healthcare: Moving From the Front Lines to the Top Rung. McKinsey & Company; August 15, 2020.
5. Burden M, Frank MG, Keniston A, et al. Gender disparities for academic hospitalists. J Hosp Med. 2015;10(8):481-485. https://doi.org/10.1002/jhm.2340
Pediatric Hospital Medicine (PHM) only recently became a recognized pediatric subspecialty with the first certification exam taking place in 2019. As a new field composed largely of women, it has a unique opportunity to set the example of how to operationalize gender equity in leadership by tracking metrics, creating intentional processes for hiring and promotion, and implementing policies in a transparent way.
In this issue of the Journal of Hospital Medicine, Allan et al1 report that women, who comprise 70% of the field, appear proportionally represented in associate/assistant but not senior leadership roles when compared to the PHM field at large. Eighty-one percent of associate division directors but only 55% of division directors were women, and 82% of assistant fellowship directors but only 66% of fellowship directors were women. These downward trends in the proportion of women in leadership roles as the roles become more senior is not an unfamiliar pattern. This echoes academic pediatric positions more broadly: women’s representation slides from 63% of active physicians to approximately 57% active faculty and then to 26% as department chairs.2 The same story holds true for deans’ offices in US medical schools, where 34% of associate deans are women and yet only 18% of deans are women. The number of women deans has only increased by about one each year, on average, since 2009.3 C-suite leadership roles in healthcare mimic this same downward trajectory.4 Burden et al found that while there was equal gender representation of hospitalists and general internists who worked in university hospitals, women led only a minority of (adult) hospital medicine (16%) or general internal medicine (35%) sections or divisions at university hospitals.5 Women with intersectionality, such as Black women and other women of color, are even more grossly underrepresented in leadership roles.
How can we change this pattern to ensure that leadership in PHM, and in medicine in general, represents diverse voices and reflects the community it serves? Allan et al have established an important baseline for tracking gender equity in PHM. Institutions, organizations, and societies must now prioritize, value and promote a culture of diversity, inclusivity, sponsorship, and allyship. For example, institutions can create and enforce policies in which compensation and promotion are tied to a leader’s achievement of transparent gender equity and diversity targets to ensure accountability. Institutions should commit dedicated and substantive funding to diversity, equity, and inclusion efforts and provide a regular diversity report that tracks gender distribution, hiring and attrition, and representation in leadership. Institutions should implement “best search practices” for all leadership positions. Additionally, all faculty should receive regular and ongoing professional development planning to enhance academic productivity and professional satisfaction and improve retention.
Women in medicine disproportionately experience many issues, including harassment, bias, and childcare and household responsibilities, that adversely affect their career trajectory. PHM is in a unique position to trailblaze a new framework for ensuring gender equity in its field. Let’s not lose this opportunity to set a new course that other specialties can follow.
Pediatric Hospital Medicine (PHM) only recently became a recognized pediatric subspecialty with the first certification exam taking place in 2019. As a new field composed largely of women, it has a unique opportunity to set the example of how to operationalize gender equity in leadership by tracking metrics, creating intentional processes for hiring and promotion, and implementing policies in a transparent way.
In this issue of the Journal of Hospital Medicine, Allan et al1 report that women, who comprise 70% of the field, appear proportionally represented in associate/assistant but not senior leadership roles when compared to the PHM field at large. Eighty-one percent of associate division directors but only 55% of division directors were women, and 82% of assistant fellowship directors but only 66% of fellowship directors were women. These downward trends in the proportion of women in leadership roles as the roles become more senior is not an unfamiliar pattern. This echoes academic pediatric positions more broadly: women’s representation slides from 63% of active physicians to approximately 57% active faculty and then to 26% as department chairs.2 The same story holds true for deans’ offices in US medical schools, where 34% of associate deans are women and yet only 18% of deans are women. The number of women deans has only increased by about one each year, on average, since 2009.3 C-suite leadership roles in healthcare mimic this same downward trajectory.4 Burden et al found that while there was equal gender representation of hospitalists and general internists who worked in university hospitals, women led only a minority of (adult) hospital medicine (16%) or general internal medicine (35%) sections or divisions at university hospitals.5 Women with intersectionality, such as Black women and other women of color, are even more grossly underrepresented in leadership roles.
How can we change this pattern to ensure that leadership in PHM, and in medicine in general, represents diverse voices and reflects the community it serves? Allan et al have established an important baseline for tracking gender equity in PHM. Institutions, organizations, and societies must now prioritize, value and promote a culture of diversity, inclusivity, sponsorship, and allyship. For example, institutions can create and enforce policies in which compensation and promotion are tied to a leader’s achievement of transparent gender equity and diversity targets to ensure accountability. Institutions should commit dedicated and substantive funding to diversity, equity, and inclusion efforts and provide a regular diversity report that tracks gender distribution, hiring and attrition, and representation in leadership. Institutions should implement “best search practices” for all leadership positions. Additionally, all faculty should receive regular and ongoing professional development planning to enhance academic productivity and professional satisfaction and improve retention.
Women in medicine disproportionately experience many issues, including harassment, bias, and childcare and household responsibilities, that adversely affect their career trajectory. PHM is in a unique position to trailblaze a new framework for ensuring gender equity in its field. Let’s not lose this opportunity to set a new course that other specialties can follow.
1. Allan JM, Kim JL, Ralston SL, et al. Gender distribution in pediatric hospital medicine leadership. J Hosp Med. 2021;16:31-33. https://doi.org/10.12788/jhm.3555
2. Spector ND, Asante PA, Marcelin JR, et al. Women in pediatrics: progress, barriers, and opportunities for equity, diversity, and inclusion. Pediatrics. 2019;144 (5):e20192149. https://doi.org/10.1542/peds.2019-2149
3. Lautenberger DM, Dandar VM. The State of Women in Academic Medicine 2018-2019. Association of American Medical Colleges; 2020.
4. Berlin G, Darino L, Groh R, Kumar P. Women in Healthcare: Moving From the Front Lines to the Top Rung. McKinsey & Company; August 15, 2020.
5. Burden M, Frank MG, Keniston A, et al. Gender disparities for academic hospitalists. J Hosp Med. 2015;10(8):481-485. https://doi.org/10.1002/jhm.2340
1. Allan JM, Kim JL, Ralston SL, et al. Gender distribution in pediatric hospital medicine leadership. J Hosp Med. 2021;16:31-33. https://doi.org/10.12788/jhm.3555
2. Spector ND, Asante PA, Marcelin JR, et al. Women in pediatrics: progress, barriers, and opportunities for equity, diversity, and inclusion. Pediatrics. 2019;144 (5):e20192149. https://doi.org/10.1542/peds.2019-2149
3. Lautenberger DM, Dandar VM. The State of Women in Academic Medicine 2018-2019. Association of American Medical Colleges; 2020.
4. Berlin G, Darino L, Groh R, Kumar P. Women in Healthcare: Moving From the Front Lines to the Top Rung. McKinsey & Company; August 15, 2020.
5. Burden M, Frank MG, Keniston A, et al. Gender disparities for academic hospitalists. J Hosp Med. 2015;10(8):481-485. https://doi.org/10.1002/jhm.2340
© 2021 Society of Hospital Medicine
Email: [email protected]; Telephone: 215-991-8240; Twitter: @ELAMProgram; @NancyDSpector.
Deimplementation: Discontinuing Low-Value, Potentially Harmful Hospital Care
Nearly 30% of healthcare spending may relate to overuse of unnecessary medical interventions.1 Deimplementation of such practices can reduce negative outcomes and unnecessary costs.2 Nonetheless, changing practice is difficult. Why is it so hard to stop doing things that don’t work? A variety of factors influences deimplementation, and research aiming to identify and understand these factors can promote the delivery of more appropriate care.2
In this issue, Wolk et al describe barriers and facilitators in deimplementing non-guideline adherent use of continuous pulse oximetry (CPO) in pediatric patients with bronchiolitis not requiring supplemental oxygen.3 Unnecessary CPO use for these patients is associated with increased hospitalization rates, length of stay, alarm fatigue, and costs, without evidence of improved clinical outcomes. Despite these data, many hospitals participating in the multicenter Eliminating Monitor Overuse study struggled to decrease CPO usage. The authors conducted semistructured interviews with a broad range of stakeholders from 12 hospitals, representing a variety of institutions with low and high CPO utilization rates.
Specific barriers to deimplementation included institutional factors, eg, unclear or missing guidelines, a culture of high utilization, and challenges educating medical staff. Perceived parental discomfort with stopping CPO was also observed. Four key facilitators were noted: strong institutional leadership, evidence-based guidelines, electronic health record order sets or reminders, and clear institutional policy. These results are similar to other deimplementation studies.
A commonality to deimplementation studies is the difficulty of changing practice. Much like implementation, deimplementation requires multipronged approaches that are sensitive to contextual factors. Interventions must account for local conditions, such as resource availability, practice norms, current workflows and processes of care, relationships among clinicians, and leadership, to create feasible and sustainable change.
Deimplementation may be even more challenging than implementation of new practices, however, because of loss aversion—the tendency to prefer avoiding losses to acquiring equivalent gains. “Taking away” something that clinicians are used to, even when proven to not be helpful, can feel uncomfortable, hindering adoption. Rather than simply discontinuing a practice, replacing it with a better option may help to overcome behavioral inertia and motivate change.
Underscoring the importance of local influences, clinicians often respond more to their close colleagues’ practices than to knowledge of national guidelines. Leveraging existing peer networks can facilitate collaboration, learning, and behavior change.4 Nudge strategies, in which local contexts are primed to promote desired behaviors, are also increasingly used.4 Priming has been effective in deimplementation efforts in medication prescribing and diagnostic testing.4
Including patients’ and families’ perspectives in deimplementation research is critical to practice change. Because diagnostic and treatment plans occur in the context of collaborative decision-making with patients, caregivers, and families, these groups are critical to engage in deimplementation efforts.
Hospitalists’ efforts at the front line of improvement require us to become more proficient in not only adopting evidence-based practices, but also in discontinuing ineffective ones. Identifying what we should stop doing is only the first step. Deimplementation is critical to this effort. Wolk et al provide insights into factors that influence deimplementation success. However, more work is needed, particularly regarding adapting approaches to local contexts, minimizing perceived loss, leveraging local conditions to shape behavior, and partnering with patients and families to achieve higher-value care.
1. Brownlee S, Chalkidou K, Doust J, at al. Evidence for overuse of medical services around the world. Lancet. 2017;390(10090):156-168. https://doi.org/10.1016/S0140-6736(16)32585-5
2. Norton WE, Chambers DA. Unpacking the complexities of de-implementing inappropriate health interventions. Implement Sci. 2020;15(1):2. https://doi.org/10.1186/s13012-019-0960-9
3. Wolk CB, Schondelmeyer AC, Barg FK, et al. Barriers and facilitators to guideline-adherent pulse oximetry use in bronchiolitis. J Hosp Med. 2021;16:23-30. https://doi.org/10.12788/jhm.3535
4 Yoong SL, Hall A, Stacey F, et al. Nudge strategies to improve healthcare providers’ implementation of evidence-based guidelines, policies and practices: a systematic review of trials included within Cochrane systematic reviews. Implement Sci. 2020;15(1):50. https://doi.org/10.1186/s13012-020-01011-0
Nearly 30% of healthcare spending may relate to overuse of unnecessary medical interventions.1 Deimplementation of such practices can reduce negative outcomes and unnecessary costs.2 Nonetheless, changing practice is difficult. Why is it so hard to stop doing things that don’t work? A variety of factors influences deimplementation, and research aiming to identify and understand these factors can promote the delivery of more appropriate care.2
In this issue, Wolk et al describe barriers and facilitators in deimplementing non-guideline adherent use of continuous pulse oximetry (CPO) in pediatric patients with bronchiolitis not requiring supplemental oxygen.3 Unnecessary CPO use for these patients is associated with increased hospitalization rates, length of stay, alarm fatigue, and costs, without evidence of improved clinical outcomes. Despite these data, many hospitals participating in the multicenter Eliminating Monitor Overuse study struggled to decrease CPO usage. The authors conducted semistructured interviews with a broad range of stakeholders from 12 hospitals, representing a variety of institutions with low and high CPO utilization rates.
Specific barriers to deimplementation included institutional factors, eg, unclear or missing guidelines, a culture of high utilization, and challenges educating medical staff. Perceived parental discomfort with stopping CPO was also observed. Four key facilitators were noted: strong institutional leadership, evidence-based guidelines, electronic health record order sets or reminders, and clear institutional policy. These results are similar to other deimplementation studies.
A commonality to deimplementation studies is the difficulty of changing practice. Much like implementation, deimplementation requires multipronged approaches that are sensitive to contextual factors. Interventions must account for local conditions, such as resource availability, practice norms, current workflows and processes of care, relationships among clinicians, and leadership, to create feasible and sustainable change.
Deimplementation may be even more challenging than implementation of new practices, however, because of loss aversion—the tendency to prefer avoiding losses to acquiring equivalent gains. “Taking away” something that clinicians are used to, even when proven to not be helpful, can feel uncomfortable, hindering adoption. Rather than simply discontinuing a practice, replacing it with a better option may help to overcome behavioral inertia and motivate change.
Underscoring the importance of local influences, clinicians often respond more to their close colleagues’ practices than to knowledge of national guidelines. Leveraging existing peer networks can facilitate collaboration, learning, and behavior change.4 Nudge strategies, in which local contexts are primed to promote desired behaviors, are also increasingly used.4 Priming has been effective in deimplementation efforts in medication prescribing and diagnostic testing.4
Including patients’ and families’ perspectives in deimplementation research is critical to practice change. Because diagnostic and treatment plans occur in the context of collaborative decision-making with patients, caregivers, and families, these groups are critical to engage in deimplementation efforts.
Hospitalists’ efforts at the front line of improvement require us to become more proficient in not only adopting evidence-based practices, but also in discontinuing ineffective ones. Identifying what we should stop doing is only the first step. Deimplementation is critical to this effort. Wolk et al provide insights into factors that influence deimplementation success. However, more work is needed, particularly regarding adapting approaches to local contexts, minimizing perceived loss, leveraging local conditions to shape behavior, and partnering with patients and families to achieve higher-value care.
Nearly 30% of healthcare spending may relate to overuse of unnecessary medical interventions.1 Deimplementation of such practices can reduce negative outcomes and unnecessary costs.2 Nonetheless, changing practice is difficult. Why is it so hard to stop doing things that don’t work? A variety of factors influences deimplementation, and research aiming to identify and understand these factors can promote the delivery of more appropriate care.2
In this issue, Wolk et al describe barriers and facilitators in deimplementing non-guideline adherent use of continuous pulse oximetry (CPO) in pediatric patients with bronchiolitis not requiring supplemental oxygen.3 Unnecessary CPO use for these patients is associated with increased hospitalization rates, length of stay, alarm fatigue, and costs, without evidence of improved clinical outcomes. Despite these data, many hospitals participating in the multicenter Eliminating Monitor Overuse study struggled to decrease CPO usage. The authors conducted semistructured interviews with a broad range of stakeholders from 12 hospitals, representing a variety of institutions with low and high CPO utilization rates.
Specific barriers to deimplementation included institutional factors, eg, unclear or missing guidelines, a culture of high utilization, and challenges educating medical staff. Perceived parental discomfort with stopping CPO was also observed. Four key facilitators were noted: strong institutional leadership, evidence-based guidelines, electronic health record order sets or reminders, and clear institutional policy. These results are similar to other deimplementation studies.
A commonality to deimplementation studies is the difficulty of changing practice. Much like implementation, deimplementation requires multipronged approaches that are sensitive to contextual factors. Interventions must account for local conditions, such as resource availability, practice norms, current workflows and processes of care, relationships among clinicians, and leadership, to create feasible and sustainable change.
Deimplementation may be even more challenging than implementation of new practices, however, because of loss aversion—the tendency to prefer avoiding losses to acquiring equivalent gains. “Taking away” something that clinicians are used to, even when proven to not be helpful, can feel uncomfortable, hindering adoption. Rather than simply discontinuing a practice, replacing it with a better option may help to overcome behavioral inertia and motivate change.
Underscoring the importance of local influences, clinicians often respond more to their close colleagues’ practices than to knowledge of national guidelines. Leveraging existing peer networks can facilitate collaboration, learning, and behavior change.4 Nudge strategies, in which local contexts are primed to promote desired behaviors, are also increasingly used.4 Priming has been effective in deimplementation efforts in medication prescribing and diagnostic testing.4
Including patients’ and families’ perspectives in deimplementation research is critical to practice change. Because diagnostic and treatment plans occur in the context of collaborative decision-making with patients, caregivers, and families, these groups are critical to engage in deimplementation efforts.
Hospitalists’ efforts at the front line of improvement require us to become more proficient in not only adopting evidence-based practices, but also in discontinuing ineffective ones. Identifying what we should stop doing is only the first step. Deimplementation is critical to this effort. Wolk et al provide insights into factors that influence deimplementation success. However, more work is needed, particularly regarding adapting approaches to local contexts, minimizing perceived loss, leveraging local conditions to shape behavior, and partnering with patients and families to achieve higher-value care.
1. Brownlee S, Chalkidou K, Doust J, at al. Evidence for overuse of medical services around the world. Lancet. 2017;390(10090):156-168. https://doi.org/10.1016/S0140-6736(16)32585-5
2. Norton WE, Chambers DA. Unpacking the complexities of de-implementing inappropriate health interventions. Implement Sci. 2020;15(1):2. https://doi.org/10.1186/s13012-019-0960-9
3. Wolk CB, Schondelmeyer AC, Barg FK, et al. Barriers and facilitators to guideline-adherent pulse oximetry use in bronchiolitis. J Hosp Med. 2021;16:23-30. https://doi.org/10.12788/jhm.3535
4 Yoong SL, Hall A, Stacey F, et al. Nudge strategies to improve healthcare providers’ implementation of evidence-based guidelines, policies and practices: a systematic review of trials included within Cochrane systematic reviews. Implement Sci. 2020;15(1):50. https://doi.org/10.1186/s13012-020-01011-0
1. Brownlee S, Chalkidou K, Doust J, at al. Evidence for overuse of medical services around the world. Lancet. 2017;390(10090):156-168. https://doi.org/10.1016/S0140-6736(16)32585-5
2. Norton WE, Chambers DA. Unpacking the complexities of de-implementing inappropriate health interventions. Implement Sci. 2020;15(1):2. https://doi.org/10.1186/s13012-019-0960-9
3. Wolk CB, Schondelmeyer AC, Barg FK, et al. Barriers and facilitators to guideline-adherent pulse oximetry use in bronchiolitis. J Hosp Med. 2021;16:23-30. https://doi.org/10.12788/jhm.3535
4 Yoong SL, Hall A, Stacey F, et al. Nudge strategies to improve healthcare providers’ implementation of evidence-based guidelines, policies and practices: a systematic review of trials included within Cochrane systematic reviews. Implement Sci. 2020;15(1):50. https://doi.org/10.1186/s13012-020-01011-0
© 2021 Society of Hospital Medicine
Email: [email protected];Telephone: 415-476-1742; Twitter: @shradhakulk.
Care Transitions: A Complex Problem That Requires a Complexity Mindset
In recent years, there has been increased scrutiny of transitions of care in medicine, particularly at hospital discharge. Much focus has been on preventing readmissions, motivated at least in part by the Affordable Care Act’s Hospital Readmissions Reduction Program, which financially penalizes hospitals for higher-than-expected readmission rates.1 However, the problem of transition from hospital to home is not just a readmissions issue—it is a quality and patient safety issue.2 Therefore, measuring readmissions alone is inadequate. More effective systems for transition from hospital to home are needed in order to deliver high-quality care that actually restores patient well-being after hospitalization.
In this month’s issue of Journal of Hospital Medicine, Schnipper and Samal, et al report the results of a stepped-wedge randomized trial examining the effect of a multifaceted intervention on postdischarge patient-centered outcomes when compared with usual care.3 At 30 days after discharge, adverse events were reduced from 23 per 100 patients in the usual care group to 18 per 100 patients in the intervention group, with an incidence rate ratio of 0.55 (95% CI, 0.35-0.84) after adjustment for study month and baseline characteristics. Interestingly, there was no statistically significant difference in nonelective readmissions, and penetrance was notably poor: The majority of components of the intervention were received by fewer than half of intended patients, and 13% failed to receive any component at all.
With such incomplete implementation, what explains the reduction in adverse events? To best answer this, it is helpful to recognize the transition from hospital to home as a complex problem rather than a complicated one.4 The difference is key. Complicated problems follow a predictable set of rules that can be thought of and planned for, and when the plan is methodically followed, complicated problems can be solved. Complex problems, on the other hand, have a more unpredictable interplay between multiple nonindependent and sometimes unknown factors. Complex problems cannot be solved by merely following a well-designed plan; rather, they require tremendous preparation, adaptability, and active management as the problem plays itself out.
Fortunately, Schnipper and Samal, et al properly identified the problem of transition from hospital to home as complex and approached it from a complexity mindset. In their design of a multifaceted intervention, they aimed high and cast a wide net. Understanding that different practices have different cultures and resources, they standardized the function of the intervention components rather than the exact form. As the trial progressed, they allowed for modification of the intervention, incorporating input from multiple stakeholders and feedback from early failures. Thus, by recognizing and embracing the complexity of the problem, the authors set themselves and their patients up for success. The most likely explanation for the observed effect of the intervention on this complex problem is therefore quite simple: The study design allowed for the components most likely to work to be most readily implemented on a patient-by-patient and practice-by-practice basis.
While the trial aims to imitate the “real world,” it does not leave clear-cut answers for real healthcare professionals. Without knowing if any individual component of the intervention was effective on its own, it may be difficult for institutions to justify the cost of implementation. And while there should be adequate incentive to action for any intervention that improves how patients function or feel, without a reduction in readmissions, the financial downside may in some instances be prohibitive.
Despite these limitations, the path forward is clear. Institutions looking to implement a similar program now should approach the problem with a complexity mindset, even if their downstream interventions may differ. Researchers looking to design similar trials should focus on narrowing the scope of the intervention while maintaining a complexity mindset, which might help lead to more widespread implementation of evidence-based interventions in the future. In teaching us more about the approach to finding a solution than the solution itself, the present study marks an important next step in hospital to home transitions of care and transitions-of-care research.
1. McIlvennan CK, Eapen ZJ, Allen LA. Hospital readmissions reduction program. Circulation. 2015;131(20):1796-1803. https://doi.org/10.1161/circulationaha.114.010270
2. Forster AJ, Clark HD, Menard A, et al. Adverse events among medical patients after discharge from hospital. CMAJ. 2004;170(3):345-349.
3. Schnipper JL, Samal L, Nolido N, et al. The effects of a multifaceted intervention to improve care transitions within an accountable care organization: results of a stepped-wedge cluster-randomized trial. J Hosp Med. 2020:16:15-22. https://doi.org/10.12788/jhm.3513
4. Kinni T. “The critical difference between complex and complicated: featured excerpt from It’s Not Complicated: The Art and Science of Complexity for Business.” MIT Sloan Management Review. June 21, 2017. Accessed August 12, 2020. https://sloanreview.mit.edu/article/the-critical-difference-between-comp...
In recent years, there has been increased scrutiny of transitions of care in medicine, particularly at hospital discharge. Much focus has been on preventing readmissions, motivated at least in part by the Affordable Care Act’s Hospital Readmissions Reduction Program, which financially penalizes hospitals for higher-than-expected readmission rates.1 However, the problem of transition from hospital to home is not just a readmissions issue—it is a quality and patient safety issue.2 Therefore, measuring readmissions alone is inadequate. More effective systems for transition from hospital to home are needed in order to deliver high-quality care that actually restores patient well-being after hospitalization.
In this month’s issue of Journal of Hospital Medicine, Schnipper and Samal, et al report the results of a stepped-wedge randomized trial examining the effect of a multifaceted intervention on postdischarge patient-centered outcomes when compared with usual care.3 At 30 days after discharge, adverse events were reduced from 23 per 100 patients in the usual care group to 18 per 100 patients in the intervention group, with an incidence rate ratio of 0.55 (95% CI, 0.35-0.84) after adjustment for study month and baseline characteristics. Interestingly, there was no statistically significant difference in nonelective readmissions, and penetrance was notably poor: The majority of components of the intervention were received by fewer than half of intended patients, and 13% failed to receive any component at all.
With such incomplete implementation, what explains the reduction in adverse events? To best answer this, it is helpful to recognize the transition from hospital to home as a complex problem rather than a complicated one.4 The difference is key. Complicated problems follow a predictable set of rules that can be thought of and planned for, and when the plan is methodically followed, complicated problems can be solved. Complex problems, on the other hand, have a more unpredictable interplay between multiple nonindependent and sometimes unknown factors. Complex problems cannot be solved by merely following a well-designed plan; rather, they require tremendous preparation, adaptability, and active management as the problem plays itself out.
Fortunately, Schnipper and Samal, et al properly identified the problem of transition from hospital to home as complex and approached it from a complexity mindset. In their design of a multifaceted intervention, they aimed high and cast a wide net. Understanding that different practices have different cultures and resources, they standardized the function of the intervention components rather than the exact form. As the trial progressed, they allowed for modification of the intervention, incorporating input from multiple stakeholders and feedback from early failures. Thus, by recognizing and embracing the complexity of the problem, the authors set themselves and their patients up for success. The most likely explanation for the observed effect of the intervention on this complex problem is therefore quite simple: The study design allowed for the components most likely to work to be most readily implemented on a patient-by-patient and practice-by-practice basis.
While the trial aims to imitate the “real world,” it does not leave clear-cut answers for real healthcare professionals. Without knowing if any individual component of the intervention was effective on its own, it may be difficult for institutions to justify the cost of implementation. And while there should be adequate incentive to action for any intervention that improves how patients function or feel, without a reduction in readmissions, the financial downside may in some instances be prohibitive.
Despite these limitations, the path forward is clear. Institutions looking to implement a similar program now should approach the problem with a complexity mindset, even if their downstream interventions may differ. Researchers looking to design similar trials should focus on narrowing the scope of the intervention while maintaining a complexity mindset, which might help lead to more widespread implementation of evidence-based interventions in the future. In teaching us more about the approach to finding a solution than the solution itself, the present study marks an important next step in hospital to home transitions of care and transitions-of-care research.
In recent years, there has been increased scrutiny of transitions of care in medicine, particularly at hospital discharge. Much focus has been on preventing readmissions, motivated at least in part by the Affordable Care Act’s Hospital Readmissions Reduction Program, which financially penalizes hospitals for higher-than-expected readmission rates.1 However, the problem of transition from hospital to home is not just a readmissions issue—it is a quality and patient safety issue.2 Therefore, measuring readmissions alone is inadequate. More effective systems for transition from hospital to home are needed in order to deliver high-quality care that actually restores patient well-being after hospitalization.
In this month’s issue of Journal of Hospital Medicine, Schnipper and Samal, et al report the results of a stepped-wedge randomized trial examining the effect of a multifaceted intervention on postdischarge patient-centered outcomes when compared with usual care.3 At 30 days after discharge, adverse events were reduced from 23 per 100 patients in the usual care group to 18 per 100 patients in the intervention group, with an incidence rate ratio of 0.55 (95% CI, 0.35-0.84) after adjustment for study month and baseline characteristics. Interestingly, there was no statistically significant difference in nonelective readmissions, and penetrance was notably poor: The majority of components of the intervention were received by fewer than half of intended patients, and 13% failed to receive any component at all.
With such incomplete implementation, what explains the reduction in adverse events? To best answer this, it is helpful to recognize the transition from hospital to home as a complex problem rather than a complicated one.4 The difference is key. Complicated problems follow a predictable set of rules that can be thought of and planned for, and when the plan is methodically followed, complicated problems can be solved. Complex problems, on the other hand, have a more unpredictable interplay between multiple nonindependent and sometimes unknown factors. Complex problems cannot be solved by merely following a well-designed plan; rather, they require tremendous preparation, adaptability, and active management as the problem plays itself out.
Fortunately, Schnipper and Samal, et al properly identified the problem of transition from hospital to home as complex and approached it from a complexity mindset. In their design of a multifaceted intervention, they aimed high and cast a wide net. Understanding that different practices have different cultures and resources, they standardized the function of the intervention components rather than the exact form. As the trial progressed, they allowed for modification of the intervention, incorporating input from multiple stakeholders and feedback from early failures. Thus, by recognizing and embracing the complexity of the problem, the authors set themselves and their patients up for success. The most likely explanation for the observed effect of the intervention on this complex problem is therefore quite simple: The study design allowed for the components most likely to work to be most readily implemented on a patient-by-patient and practice-by-practice basis.
While the trial aims to imitate the “real world,” it does not leave clear-cut answers for real healthcare professionals. Without knowing if any individual component of the intervention was effective on its own, it may be difficult for institutions to justify the cost of implementation. And while there should be adequate incentive to action for any intervention that improves how patients function or feel, without a reduction in readmissions, the financial downside may in some instances be prohibitive.
Despite these limitations, the path forward is clear. Institutions looking to implement a similar program now should approach the problem with a complexity mindset, even if their downstream interventions may differ. Researchers looking to design similar trials should focus on narrowing the scope of the intervention while maintaining a complexity mindset, which might help lead to more widespread implementation of evidence-based interventions in the future. In teaching us more about the approach to finding a solution than the solution itself, the present study marks an important next step in hospital to home transitions of care and transitions-of-care research.
1. McIlvennan CK, Eapen ZJ, Allen LA. Hospital readmissions reduction program. Circulation. 2015;131(20):1796-1803. https://doi.org/10.1161/circulationaha.114.010270
2. Forster AJ, Clark HD, Menard A, et al. Adverse events among medical patients after discharge from hospital. CMAJ. 2004;170(3):345-349.
3. Schnipper JL, Samal L, Nolido N, et al. The effects of a multifaceted intervention to improve care transitions within an accountable care organization: results of a stepped-wedge cluster-randomized trial. J Hosp Med. 2020:16:15-22. https://doi.org/10.12788/jhm.3513
4. Kinni T. “The critical difference between complex and complicated: featured excerpt from It’s Not Complicated: The Art and Science of Complexity for Business.” MIT Sloan Management Review. June 21, 2017. Accessed August 12, 2020. https://sloanreview.mit.edu/article/the-critical-difference-between-comp...
1. McIlvennan CK, Eapen ZJ, Allen LA. Hospital readmissions reduction program. Circulation. 2015;131(20):1796-1803. https://doi.org/10.1161/circulationaha.114.010270
2. Forster AJ, Clark HD, Menard A, et al. Adverse events among medical patients after discharge from hospital. CMAJ. 2004;170(3):345-349.
3. Schnipper JL, Samal L, Nolido N, et al. The effects of a multifaceted intervention to improve care transitions within an accountable care organization: results of a stepped-wedge cluster-randomized trial. J Hosp Med. 2020:16:15-22. https://doi.org/10.12788/jhm.3513
4. Kinni T. “The critical difference between complex and complicated: featured excerpt from It’s Not Complicated: The Art and Science of Complexity for Business.” MIT Sloan Management Review. June 21, 2017. Accessed August 12, 2020. https://sloanreview.mit.edu/article/the-critical-difference-between-comp...
© 2021 Society of Hospital Medicine
Email: [email protected]; Telephone: 212-746-4071.
Light-based technologies emerging as promising acne treatments
such as Fernanda H. Sakamoto, MD, PhD.
“I love treating acne, because it can have a huge impact on our patients’ lives,” Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “Acne is the most common disease in dermatology, affecting about 80% of our patients. Eleven percent of these patients have difficult-to-treat acne, and it is also the No. 1 cause of depression and suicide among teenagers and young adults. And, even though there’s no strong evidence that optical treatments work better than conventional acne treatments, people still spend a lot on those treatments: more than 220 million in 2019.”
Early results from a pilot study suggest that use of a novel laser system known as Accure in patients with mild to moderate acne resulted in an 80% reduction in acne lesions at 12 weeks. The laser prototype, which uses a 1,726 nm wavelength and is being developed by researchers at the Wellman Center for Photomedicine, features a built-in thermal camera in the handpiece that allows the user to monitor the skin’s temperature during treatment.
In initial pilot studies of the device, Dr. Sakamoto and colleagues observed consistent damage of the sebaceous glands, with no damage to the epidermis, surrounding dermis, or other follicular structures. “But because the contrast of absorption of lipids and water is not very high, we needed to create a laser with features that we have never seen before,” she said. “One of them is a robust cooling system. The second prototype features a built-in thermal camera within the handpiece that allows us to see the temperature while we’re treating the patient. It also has built-in software that would shut down the laser if the temperature is too high. “This is the first laser with some safety features that will give the user direct feedback while treating the patient,” she said, noting that its “unique cooling system and real-time monitoring ... makes it different from any of the lasers we see on the market right now.”
Dr. Sakamoto and colleagues (Emil Tanghetti, MD, in San Diego, Roy Geronemus, MD, in New York, and Joel L. Cohen, MD, in Colorado) are conducting a clinical trial of the device, to evaluate whether Accure can selectively target sebaceous glands. As of Oct. 23, 2020, the study enrolled more than 50 patients, who are followed at 4, 8, 12, and 24 weeks post treatment, she said.
To date, 16 patients have completed the study, and the researchers have observed an average lesion reduction of 80% at 12 weeks post treatment, after four treatment sessions. This amounted to more than 12,000 trigger pulls of the device, with no unexpected adverse events. Average visual analogue scale pain scores immediately after treatment have been 1.09 out of 10.
Histologic assessment of skin samples collected from the study participants have revealed selective damage of the sebaceous glands with a normal epidermis and surrounding dermis. “Because this laser is near infrared, it is not absorbed by melanin, making it possible for a safe treatment in darker skin tones,” Dr. Sakamoto said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.
“We have shown that it is possible to create a selective laser for acne treatment at 1,726 nm. We have proven it mathematically as well as with histological samples,” she said. “Now we are moving on to a larger clinical trial for the FDA clearance.”
Another strategy being developed for acne treatment is to make nonselective lasers selective by adding gold microparticles into the hair follicle and sebaceous glands, to allow the lasers to be absorbed. In a study that used a free electron laser, Dr. Sakamoto and colleagues demonstrated that these microparticles can stay within the sebaceous glands for selective damage of the sebaceous glands. In a subsequent pilot clinical trial they showed that the addition of the gold microparticles followed by a diode laser treatment made it possible to reduce both inflammatory and noninflammatory lesions.
More recently, an open-label European study of acne treatment with light absorbing gold microparticles and optical pulses demonstrated that the treatment led to an 80%-90% reduction of inflammatory lesions at 12 weeks, with a reduction of Investigator’s Global Assessment scale from 2 to 4.
The Food and Drug Administration cleared the treatment, Sebacia Microparticles, for the treatment of mild to moderate acne in September of 2018, but according to Dr. Sakamoto, “the company has struggled, as they were only commercializing the device in California and Washington, DC.”
Photodynamic therapy (PDT) is also being studied as an acne treatment. “PDT uses a photosensitizer that needs to be activated by a light source,” she noted. “The combination of red light and aminolevulinic acid (ALA) or methyl ester ALA has been shown to damage the sebaceous glands”.
In a recent randomized controlled trial that compared PDT to adapalene gel plus oral doxycycline, PDT showed superiority. “Because PDT induces apoptosis of the sebaceous glands, it causes a lot of pain and side effects after treatment,” Dr. Sakamoto said. “However, it can clear 80%-90% of acne in 80%-90% of patients. But because of the side effects, PDT should be limited to those patients who cannot take conventional treatments.”
Dr. Sakamoto reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.
such as Fernanda H. Sakamoto, MD, PhD.
“I love treating acne, because it can have a huge impact on our patients’ lives,” Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “Acne is the most common disease in dermatology, affecting about 80% of our patients. Eleven percent of these patients have difficult-to-treat acne, and it is also the No. 1 cause of depression and suicide among teenagers and young adults. And, even though there’s no strong evidence that optical treatments work better than conventional acne treatments, people still spend a lot on those treatments: more than 220 million in 2019.”
Early results from a pilot study suggest that use of a novel laser system known as Accure in patients with mild to moderate acne resulted in an 80% reduction in acne lesions at 12 weeks. The laser prototype, which uses a 1,726 nm wavelength and is being developed by researchers at the Wellman Center for Photomedicine, features a built-in thermal camera in the handpiece that allows the user to monitor the skin’s temperature during treatment.
In initial pilot studies of the device, Dr. Sakamoto and colleagues observed consistent damage of the sebaceous glands, with no damage to the epidermis, surrounding dermis, or other follicular structures. “But because the contrast of absorption of lipids and water is not very high, we needed to create a laser with features that we have never seen before,” she said. “One of them is a robust cooling system. The second prototype features a built-in thermal camera within the handpiece that allows us to see the temperature while we’re treating the patient. It also has built-in software that would shut down the laser if the temperature is too high. “This is the first laser with some safety features that will give the user direct feedback while treating the patient,” she said, noting that its “unique cooling system and real-time monitoring ... makes it different from any of the lasers we see on the market right now.”
Dr. Sakamoto and colleagues (Emil Tanghetti, MD, in San Diego, Roy Geronemus, MD, in New York, and Joel L. Cohen, MD, in Colorado) are conducting a clinical trial of the device, to evaluate whether Accure can selectively target sebaceous glands. As of Oct. 23, 2020, the study enrolled more than 50 patients, who are followed at 4, 8, 12, and 24 weeks post treatment, she said.
To date, 16 patients have completed the study, and the researchers have observed an average lesion reduction of 80% at 12 weeks post treatment, after four treatment sessions. This amounted to more than 12,000 trigger pulls of the device, with no unexpected adverse events. Average visual analogue scale pain scores immediately after treatment have been 1.09 out of 10.
Histologic assessment of skin samples collected from the study participants have revealed selective damage of the sebaceous glands with a normal epidermis and surrounding dermis. “Because this laser is near infrared, it is not absorbed by melanin, making it possible for a safe treatment in darker skin tones,” Dr. Sakamoto said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.
“We have shown that it is possible to create a selective laser for acne treatment at 1,726 nm. We have proven it mathematically as well as with histological samples,” she said. “Now we are moving on to a larger clinical trial for the FDA clearance.”
Another strategy being developed for acne treatment is to make nonselective lasers selective by adding gold microparticles into the hair follicle and sebaceous glands, to allow the lasers to be absorbed. In a study that used a free electron laser, Dr. Sakamoto and colleagues demonstrated that these microparticles can stay within the sebaceous glands for selective damage of the sebaceous glands. In a subsequent pilot clinical trial they showed that the addition of the gold microparticles followed by a diode laser treatment made it possible to reduce both inflammatory and noninflammatory lesions.
More recently, an open-label European study of acne treatment with light absorbing gold microparticles and optical pulses demonstrated that the treatment led to an 80%-90% reduction of inflammatory lesions at 12 weeks, with a reduction of Investigator’s Global Assessment scale from 2 to 4.
The Food and Drug Administration cleared the treatment, Sebacia Microparticles, for the treatment of mild to moderate acne in September of 2018, but according to Dr. Sakamoto, “the company has struggled, as they were only commercializing the device in California and Washington, DC.”
Photodynamic therapy (PDT) is also being studied as an acne treatment. “PDT uses a photosensitizer that needs to be activated by a light source,” she noted. “The combination of red light and aminolevulinic acid (ALA) or methyl ester ALA has been shown to damage the sebaceous glands”.
In a recent randomized controlled trial that compared PDT to adapalene gel plus oral doxycycline, PDT showed superiority. “Because PDT induces apoptosis of the sebaceous glands, it causes a lot of pain and side effects after treatment,” Dr. Sakamoto said. “However, it can clear 80%-90% of acne in 80%-90% of patients. But because of the side effects, PDT should be limited to those patients who cannot take conventional treatments.”
Dr. Sakamoto reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.
such as Fernanda H. Sakamoto, MD, PhD.
“I love treating acne, because it can have a huge impact on our patients’ lives,” Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “Acne is the most common disease in dermatology, affecting about 80% of our patients. Eleven percent of these patients have difficult-to-treat acne, and it is also the No. 1 cause of depression and suicide among teenagers and young adults. And, even though there’s no strong evidence that optical treatments work better than conventional acne treatments, people still spend a lot on those treatments: more than 220 million in 2019.”
Early results from a pilot study suggest that use of a novel laser system known as Accure in patients with mild to moderate acne resulted in an 80% reduction in acne lesions at 12 weeks. The laser prototype, which uses a 1,726 nm wavelength and is being developed by researchers at the Wellman Center for Photomedicine, features a built-in thermal camera in the handpiece that allows the user to monitor the skin’s temperature during treatment.
In initial pilot studies of the device, Dr. Sakamoto and colleagues observed consistent damage of the sebaceous glands, with no damage to the epidermis, surrounding dermis, or other follicular structures. “But because the contrast of absorption of lipids and water is not very high, we needed to create a laser with features that we have never seen before,” she said. “One of them is a robust cooling system. The second prototype features a built-in thermal camera within the handpiece that allows us to see the temperature while we’re treating the patient. It also has built-in software that would shut down the laser if the temperature is too high. “This is the first laser with some safety features that will give the user direct feedback while treating the patient,” she said, noting that its “unique cooling system and real-time monitoring ... makes it different from any of the lasers we see on the market right now.”
Dr. Sakamoto and colleagues (Emil Tanghetti, MD, in San Diego, Roy Geronemus, MD, in New York, and Joel L. Cohen, MD, in Colorado) are conducting a clinical trial of the device, to evaluate whether Accure can selectively target sebaceous glands. As of Oct. 23, 2020, the study enrolled more than 50 patients, who are followed at 4, 8, 12, and 24 weeks post treatment, she said.
To date, 16 patients have completed the study, and the researchers have observed an average lesion reduction of 80% at 12 weeks post treatment, after four treatment sessions. This amounted to more than 12,000 trigger pulls of the device, with no unexpected adverse events. Average visual analogue scale pain scores immediately after treatment have been 1.09 out of 10.
Histologic assessment of skin samples collected from the study participants have revealed selective damage of the sebaceous glands with a normal epidermis and surrounding dermis. “Because this laser is near infrared, it is not absorbed by melanin, making it possible for a safe treatment in darker skin tones,” Dr. Sakamoto said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.
“We have shown that it is possible to create a selective laser for acne treatment at 1,726 nm. We have proven it mathematically as well as with histological samples,” she said. “Now we are moving on to a larger clinical trial for the FDA clearance.”
Another strategy being developed for acne treatment is to make nonselective lasers selective by adding gold microparticles into the hair follicle and sebaceous glands, to allow the lasers to be absorbed. In a study that used a free electron laser, Dr. Sakamoto and colleagues demonstrated that these microparticles can stay within the sebaceous glands for selective damage of the sebaceous glands. In a subsequent pilot clinical trial they showed that the addition of the gold microparticles followed by a diode laser treatment made it possible to reduce both inflammatory and noninflammatory lesions.
More recently, an open-label European study of acne treatment with light absorbing gold microparticles and optical pulses demonstrated that the treatment led to an 80%-90% reduction of inflammatory lesions at 12 weeks, with a reduction of Investigator’s Global Assessment scale from 2 to 4.
The Food and Drug Administration cleared the treatment, Sebacia Microparticles, for the treatment of mild to moderate acne in September of 2018, but according to Dr. Sakamoto, “the company has struggled, as they were only commercializing the device in California and Washington, DC.”
Photodynamic therapy (PDT) is also being studied as an acne treatment. “PDT uses a photosensitizer that needs to be activated by a light source,” she noted. “The combination of red light and aminolevulinic acid (ALA) or methyl ester ALA has been shown to damage the sebaceous glands”.
In a recent randomized controlled trial that compared PDT to adapalene gel plus oral doxycycline, PDT showed superiority. “Because PDT induces apoptosis of the sebaceous glands, it causes a lot of pain and side effects after treatment,” Dr. Sakamoto said. “However, it can clear 80%-90% of acne in 80%-90% of patients. But because of the side effects, PDT should be limited to those patients who cannot take conventional treatments.”
Dr. Sakamoto reported having received research funding and/or consulting fees from numerous device and pharmaceutical companies.
EXPERT ANALYSIS FROM A LASER & AESTHETIC SKIN THERAPY COURSE
Caring for Noncritically Ill Coronavirus Patients
The early days of the coronavirus disease 2019 (COVID-19) pandemic were fraught with uncertainty as hospitalists struggled to develop standards of care for noncritically ill patients. Although data were available from intensive care units (ICUs) in Asia and Europe, it was unclear whether these findings applied to the acute but noncritically ill patients who would ultimately make up most coronavirus admissions. Which therapeutics could benefit these patients? Who needs continuous cardiopulmonary monitoring? And perhaps most importantly, which patients are at risk for clinical deterioration?
In this issue, Nemer et al begin to answer these questions using a retrospective analysis of 350 noncritically ill COVID-19 patients admitted to non-ICU care at Cleveland Clinic hospitals in Ohio and Florida between March 13 and May 1, 2020.1 The primary outcome was a composite of three endpoints: increased respiratory support (high-flow nasal cannula, noninvasive positive pressure ventilation, or intubation), ICU transfer, or death. The primary outcome occurred in 18% of all patients and the risk was greatest among patients with high admission levels of C-reactive protein (CRP). This analysis found that while clinically significant arrhythmias occurred in 14% of patients, 90% of those were in patients with either known cardiac disease or an elevated admission troponin T level and in only one case (<1%) necessitated transition to a higher level of care. Overall mortality for COVID-19 patients initially admitted to non-ICU settings was 3%.
While several tests have been proposed as clinically relevant to coronavirus disease, those recommendations are based on studies performed on critically ill patients outside of the US and have focused on survival, not clinical deterioration.2,3 In their cohort of noncritically ill patients in the US, Nemer et al found that not only is CRP associated with clinical worsening, but that increasing levels of CRP are associated with increasing risk of deterioration. Perhaps even more interesting was the finding that no patient with a normal CRP suffered the composite outcome, including death. The authors did not report levels of other laboratory tests that have been associated with severe coronavirus disease, such as platelets, fibrin degradation products, or prolonged prothrombin time/activated partial thromboplastin time. As many clinicians will note, CRP’s lack of specificity may be its Achilles heel, potentially lowering its prognostic value. Still, given its wide availability, low cost, and rapid turnaround, CRP could serve as a screening tool to risk stratify admitted coronavirus patients, while also providing reassurance when it is normal.
The results of this study could also impact use of hospital resources. The findings regarding the low risk of arrhythmias provide support for limiting the use of continuous cardiac monitoring in noncritically ill patients without previous histories of cardiac disease or elevated admission troponin levels. Patients with normal admission CRP levels could potentially be monitored safely with intermittent pulse oximetry. Continuous pulse oximetry and cardiac monitoring are already overused in many hospitals, and in the case of coronavirus the implications are even more significant given the importance of minimizing unnecessary healthcare worker exposures.
The vast majority (79% to 90%) of patients hospitalized for coronavirus will be cared for in non–ICU settings,4,5 yet most research has thus far focused on ICU patients. Nemer et al provide much-needed information on how to care for the noncritically ill coronavirus patients whom hospitalists are most likely to treat. As a resurgence of infections is expected this winter, this work has the potential to help physicians identify not only those who have the highest probability of deteriorating, but also those who may not. In a world of limited resources, knowing which patient is unlikely to deteriorate may be just as important as recognizing which one is.
1. Nemer D, Wilner BR, Burkle A, et al. Clinical characteristics and outcomes of non-ICU hospitalization for COVID-19 in a nonepicenter, centrally monitored healthcare system. J Hosp Med. 2021;16:7-14. https://doi.org/10.12788/jhm.3510
2. Lippi G, Pleban M, Henry B. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020;506:145-148. https://doi.org/10.1016/j.cca.2020.03.022
3. Klok FA, Kruip MJHA, van der Meer NJM, et al. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020;191:145-147. https://doi.org/10.1016/j.thromres.2020.04.013
4. Giannakeas V, Bhatia D, Warkentin M, et al. Estimating the maximum capacity of COVID-19 cases manageable per day given a health care system’s constrained resources. Ann Intern Med. April 16, 2020. https://doi.org/10.7326/M20-1169
5. Tsai T, Jacobson B, Jha A. American hospital capacity and projected need for COVID-19 patient care. Health Affairs blog. March 17, 2020. Accessed October 12, 2020. https://www.healthaffairs.org/do/10.1377/hblog20200317.457910/full/
The early days of the coronavirus disease 2019 (COVID-19) pandemic were fraught with uncertainty as hospitalists struggled to develop standards of care for noncritically ill patients. Although data were available from intensive care units (ICUs) in Asia and Europe, it was unclear whether these findings applied to the acute but noncritically ill patients who would ultimately make up most coronavirus admissions. Which therapeutics could benefit these patients? Who needs continuous cardiopulmonary monitoring? And perhaps most importantly, which patients are at risk for clinical deterioration?
In this issue, Nemer et al begin to answer these questions using a retrospective analysis of 350 noncritically ill COVID-19 patients admitted to non-ICU care at Cleveland Clinic hospitals in Ohio and Florida between March 13 and May 1, 2020.1 The primary outcome was a composite of three endpoints: increased respiratory support (high-flow nasal cannula, noninvasive positive pressure ventilation, or intubation), ICU transfer, or death. The primary outcome occurred in 18% of all patients and the risk was greatest among patients with high admission levels of C-reactive protein (CRP). This analysis found that while clinically significant arrhythmias occurred in 14% of patients, 90% of those were in patients with either known cardiac disease or an elevated admission troponin T level and in only one case (<1%) necessitated transition to a higher level of care. Overall mortality for COVID-19 patients initially admitted to non-ICU settings was 3%.
While several tests have been proposed as clinically relevant to coronavirus disease, those recommendations are based on studies performed on critically ill patients outside of the US and have focused on survival, not clinical deterioration.2,3 In their cohort of noncritically ill patients in the US, Nemer et al found that not only is CRP associated with clinical worsening, but that increasing levels of CRP are associated with increasing risk of deterioration. Perhaps even more interesting was the finding that no patient with a normal CRP suffered the composite outcome, including death. The authors did not report levels of other laboratory tests that have been associated with severe coronavirus disease, such as platelets, fibrin degradation products, or prolonged prothrombin time/activated partial thromboplastin time. As many clinicians will note, CRP’s lack of specificity may be its Achilles heel, potentially lowering its prognostic value. Still, given its wide availability, low cost, and rapid turnaround, CRP could serve as a screening tool to risk stratify admitted coronavirus patients, while also providing reassurance when it is normal.
The results of this study could also impact use of hospital resources. The findings regarding the low risk of arrhythmias provide support for limiting the use of continuous cardiac monitoring in noncritically ill patients without previous histories of cardiac disease or elevated admission troponin levels. Patients with normal admission CRP levels could potentially be monitored safely with intermittent pulse oximetry. Continuous pulse oximetry and cardiac monitoring are already overused in many hospitals, and in the case of coronavirus the implications are even more significant given the importance of minimizing unnecessary healthcare worker exposures.
The vast majority (79% to 90%) of patients hospitalized for coronavirus will be cared for in non–ICU settings,4,5 yet most research has thus far focused on ICU patients. Nemer et al provide much-needed information on how to care for the noncritically ill coronavirus patients whom hospitalists are most likely to treat. As a resurgence of infections is expected this winter, this work has the potential to help physicians identify not only those who have the highest probability of deteriorating, but also those who may not. In a world of limited resources, knowing which patient is unlikely to deteriorate may be just as important as recognizing which one is.
The early days of the coronavirus disease 2019 (COVID-19) pandemic were fraught with uncertainty as hospitalists struggled to develop standards of care for noncritically ill patients. Although data were available from intensive care units (ICUs) in Asia and Europe, it was unclear whether these findings applied to the acute but noncritically ill patients who would ultimately make up most coronavirus admissions. Which therapeutics could benefit these patients? Who needs continuous cardiopulmonary monitoring? And perhaps most importantly, which patients are at risk for clinical deterioration?
In this issue, Nemer et al begin to answer these questions using a retrospective analysis of 350 noncritically ill COVID-19 patients admitted to non-ICU care at Cleveland Clinic hospitals in Ohio and Florida between March 13 and May 1, 2020.1 The primary outcome was a composite of three endpoints: increased respiratory support (high-flow nasal cannula, noninvasive positive pressure ventilation, or intubation), ICU transfer, or death. The primary outcome occurred in 18% of all patients and the risk was greatest among patients with high admission levels of C-reactive protein (CRP). This analysis found that while clinically significant arrhythmias occurred in 14% of patients, 90% of those were in patients with either known cardiac disease or an elevated admission troponin T level and in only one case (<1%) necessitated transition to a higher level of care. Overall mortality for COVID-19 patients initially admitted to non-ICU settings was 3%.
While several tests have been proposed as clinically relevant to coronavirus disease, those recommendations are based on studies performed on critically ill patients outside of the US and have focused on survival, not clinical deterioration.2,3 In their cohort of noncritically ill patients in the US, Nemer et al found that not only is CRP associated with clinical worsening, but that increasing levels of CRP are associated with increasing risk of deterioration. Perhaps even more interesting was the finding that no patient with a normal CRP suffered the composite outcome, including death. The authors did not report levels of other laboratory tests that have been associated with severe coronavirus disease, such as platelets, fibrin degradation products, or prolonged prothrombin time/activated partial thromboplastin time. As many clinicians will note, CRP’s lack of specificity may be its Achilles heel, potentially lowering its prognostic value. Still, given its wide availability, low cost, and rapid turnaround, CRP could serve as a screening tool to risk stratify admitted coronavirus patients, while also providing reassurance when it is normal.
The results of this study could also impact use of hospital resources. The findings regarding the low risk of arrhythmias provide support for limiting the use of continuous cardiac monitoring in noncritically ill patients without previous histories of cardiac disease or elevated admission troponin levels. Patients with normal admission CRP levels could potentially be monitored safely with intermittent pulse oximetry. Continuous pulse oximetry and cardiac monitoring are already overused in many hospitals, and in the case of coronavirus the implications are even more significant given the importance of minimizing unnecessary healthcare worker exposures.
The vast majority (79% to 90%) of patients hospitalized for coronavirus will be cared for in non–ICU settings,4,5 yet most research has thus far focused on ICU patients. Nemer et al provide much-needed information on how to care for the noncritically ill coronavirus patients whom hospitalists are most likely to treat. As a resurgence of infections is expected this winter, this work has the potential to help physicians identify not only those who have the highest probability of deteriorating, but also those who may not. In a world of limited resources, knowing which patient is unlikely to deteriorate may be just as important as recognizing which one is.
1. Nemer D, Wilner BR, Burkle A, et al. Clinical characteristics and outcomes of non-ICU hospitalization for COVID-19 in a nonepicenter, centrally monitored healthcare system. J Hosp Med. 2021;16:7-14. https://doi.org/10.12788/jhm.3510
2. Lippi G, Pleban M, Henry B. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020;506:145-148. https://doi.org/10.1016/j.cca.2020.03.022
3. Klok FA, Kruip MJHA, van der Meer NJM, et al. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020;191:145-147. https://doi.org/10.1016/j.thromres.2020.04.013
4. Giannakeas V, Bhatia D, Warkentin M, et al. Estimating the maximum capacity of COVID-19 cases manageable per day given a health care system’s constrained resources. Ann Intern Med. April 16, 2020. https://doi.org/10.7326/M20-1169
5. Tsai T, Jacobson B, Jha A. American hospital capacity and projected need for COVID-19 patient care. Health Affairs blog. March 17, 2020. Accessed October 12, 2020. https://www.healthaffairs.org/do/10.1377/hblog20200317.457910/full/
1. Nemer D, Wilner BR, Burkle A, et al. Clinical characteristics and outcomes of non-ICU hospitalization for COVID-19 in a nonepicenter, centrally monitored healthcare system. J Hosp Med. 2021;16:7-14. https://doi.org/10.12788/jhm.3510
2. Lippi G, Pleban M, Henry B. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020;506:145-148. https://doi.org/10.1016/j.cca.2020.03.022
3. Klok FA, Kruip MJHA, van der Meer NJM, et al. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020;191:145-147. https://doi.org/10.1016/j.thromres.2020.04.013
4. Giannakeas V, Bhatia D, Warkentin M, et al. Estimating the maximum capacity of COVID-19 cases manageable per day given a health care system’s constrained resources. Ann Intern Med. April 16, 2020. https://doi.org/10.7326/M20-1169
5. Tsai T, Jacobson B, Jha A. American hospital capacity and projected need for COVID-19 patient care. Health Affairs blog. March 17, 2020. Accessed October 12, 2020. https://www.healthaffairs.org/do/10.1377/hblog20200317.457910/full/
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