EASTON, PA. — Walk into a big-box retailer such as Walmart or Michaels and you’re likely to see MCS Industries’ picture frames, decorative mirrors, or kitschy wall décor.

Adjacent to a dairy farm a few miles west of downtown Easton, MCS is the nation’s largest maker of such household products. But MCS doesn’t actually make anything here anymore. It has moved its manufacturing operations to Mexico and China, with the last manufacturing jobs departing this city along the Delaware River in 2005. MCS now has about 175 U.S. employees and 600 people overseas.

“We were going to lose the business because we were no longer competitive,” CEO Richard Master explained. And one of the biggest impediments to keeping labor costs in line, he said, has been the increasing expense of health coverage in the United States.

Today, he’s at the vanguard of a small but growing group of business executives who are lining up to support a Medicare-for-all national health program. He argues not that health care is a human right but that covering everyone with a government plan and decoupling health care coverage from the workplace would benefit entrepreneurship.

In February, Master stood with Rep. Pramila Jayapal (D-Wash.) outside the Capitol after she introduced her Medicare-for-all bill. “This bill removes an albatross from the neck of American business, puts more money in consumer products and will boost our economy,” he said.

As health costs continue to grow, straining employer budgets and slowing wage growth, others in the business community are beginning to take the option more seriously.

While the influential U.S. Chamber of Commerce and other large business lobbying groups strongly oppose increased government involvement in health care, the resolve of many in the business community – especially among smaller firms – may be shifting.

“There is growing momentum among employers supporting single-payer,” said Dan Geiger, codirector of the Business Alliance for a Healthy California, which has sought to generate business support for a universal health care program in California. About 300 mostly small employers have signed on.

“Businesses are really angry about the system, and there is a lot of frustration with its rising costs and dysfunction,” he said.

Mr. Geiger acknowledged the effort still lacks support from any Fortune 500 company CEOs. He said large businesses are hesitant to get involved in this political debate and many don’t want to lose the ability to attract workers with generous health benefits. “There is also a lingering distrust of the government, and they think they can offer coverage better than the government,” he said.

In addition, some in the business community are hesitant to sign on to Medicare-for-all with many details missing, such as how much it would increase taxes, said Ellen Kelsay, chief strategy officer for the National Business Group on Health, a leading business group focused on health benefits.
 

Democrats propel the debate

For decades, a government-run health plan was considered too radical an idea for serious consideration. But Medicare-for-all has been garnering more political support in recent months, especially after a progressive wave helped Democrats take control of the House this year. Several 2020 Democratic presidential candidates, including Sens. Bernie Sanders and Elizabeth Warren, strongly back it.

The labor unions and consumer groups that have long endorsed a single-payer health system hope that the embrace of it by employers such as Mr. Master marks another turning point for the movement.

Supporters of the concept say the health system overall would see savings from a coordinated effort to bring down prices and the elimination of many administrative costs or insurance company profits.

“It’s critical for our success to engage employers, particularly because our current system is hurting employers almost as much as it is patients,” said Melinda St. Louis, campaign director of Medicare-for-all at Public Citizen, a consumer-rights group based in Washington.

Mr. Master, a former Washington lawyer, worked on Democratic Sen. George McGovern’s presidential campaign before returning to Pennsylvania in 1973 to take over his father’s company, which made rigid paper boxes. In 1980, he founded MCS, which pioneered the popular front-loading picture frame and steamless fog-free mirrors for bathrooms. The company has grown into a $250 million corporation.

Mr. Master frequently travels to Washington and around the country to talk with business leaders as he seeks to build political support for a single-payer health system.

In the past 4 years, he has produced several documentary videos on the topic. In 2018, he formed the Business Initiative for Health Policy, a nonprofit group of business leaders, economists, and health policy experts trying to explain the financial benefits of a single-payer system.

Dan Wolf, CEO of Cape Air, a Hyannis, Mass.–based regional airline that employs 800 people calls himself “a free-market guy.” But he also supports Medicare-for-all. He said Mr. Master helps turn the political argument over single-payer into a practical one.

“It’s about good business sense and about caring for his employees and their well-being,” he said, adding that employers should no longer be straddled with the cost and complexity of health care.

“It makes no more sense for an airline to understand health policy for the bulk of its workers than for a health facility to have to supply all the air transportation for its employees,” he said.

Employers also are an important voice in the debate because 156 million Americans get employer-paid health care, making it by far the single-largest form of coverage.

Mr. Master said his company has tried various methods to control costs with little success, including high deductibles, narrow networks of providers and wellness plans that emphasize preventive medicine.

Insurers who are supposed to negotiate lower rates from hospitals and doctors have failed, he added, and too many premium dollars go to covering administrative costs. Only by having the federal government set rates can the United States control costs of drugs, hospitals, and other health services, he said.

“Insurance companies are not watching the store and don’t have incentives to hold down costs in the current system,” he said.
 

Glad the boss is trying to make a difference

What’s left of MCS in Pennsylvania is a spacious corporate office building housing administrative staff, designers, and a giant distribution center piled high with carton boxes from floor to ceiling.

MCS pays an average of $1,260 per month for each employee’s health care, up from $716 in 2009, the company said. In recent years, the company has reduced out-of-pocket costs for employees by covering most of their deductibles.

Medicare-for-all would require several new taxes to raise money, but Mr. Master said such a plan would mean savings for his company and employees.

MCS employees largely support Mr. Master’s attempt to fix the health system even if they are not all on board with a Medicare-for-all approach, according to interviews with several workers in Easton.

“I think it’s a good idea,” said Faith Wildrick, a shipper at MCS who has worked for the company 26 years. “If the other countries are doing it and it is working for them, why can’t it work for us?”

Ms. Wildrick said that even with insurance her family struggles with health costs as her husband, Bill, a former MCS employee, deals with liver disease and needs many diagnostic tests and prescription medications. Their annual deductible has swung from $4,000 several years ago to $500 this year as the company has worked to lower employees’ out-of-pocket costs.

“I’m really glad someone is fighting for this and trying to make a difference,” said Ms. Wildrick.

Jessica Ehrhardt, the human resources manager at MCS, said the effort to reduce employees’ out-of-pocket health costs means the company must pay higher health costs. That results in less money for salary increases and other benefits, she added.

Asked about Medicare-for-all, Ms. Ehrhardt said, “It’s a drastic solution, but something needs to happen.”

For too long, Mr. Master said, the push for a single-payer health system has been about ideology.

“The movement has been about making health care a human right and that we have a right to universal health care,” he said. “What I am saying is this is prudent for our economy and am trying to make the business and economic case.”

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

EASTON, PA. — Walk into a big-box retailer such as Walmart or Michaels and you’re likely to see MCS Industries’ picture frames, decorative mirrors, or kitschy wall décor.

Adjacent to a dairy farm a few miles west of downtown Easton, MCS is the nation’s largest maker of such household products. But MCS doesn’t actually make anything here anymore. It has moved its manufacturing operations to Mexico and China, with the last manufacturing jobs departing this city along the Delaware River in 2005. MCS now has about 175 U.S. employees and 600 people overseas.

“We were going to lose the business because we were no longer competitive,” CEO Richard Master explained. And one of the biggest impediments to keeping labor costs in line, he said, has been the increasing expense of health coverage in the United States.

Today, he’s at the vanguard of a small but growing group of business executives who are lining up to support a Medicare-for-all national health program. He argues not that health care is a human right but that covering everyone with a government plan and decoupling health care coverage from the workplace would benefit entrepreneurship.

In February, Master stood with Rep. Pramila Jayapal (D-Wash.) outside the Capitol after she introduced her Medicare-for-all bill. “This bill removes an albatross from the neck of American business, puts more money in consumer products and will boost our economy,” he said.

As health costs continue to grow, straining employer budgets and slowing wage growth, others in the business community are beginning to take the option more seriously.

While the influential U.S. Chamber of Commerce and other large business lobbying groups strongly oppose increased government involvement in health care, the resolve of many in the business community – especially among smaller firms – may be shifting.

“There is growing momentum among employers supporting single-payer,” said Dan Geiger, codirector of the Business Alliance for a Healthy California, which has sought to generate business support for a universal health care program in California. About 300 mostly small employers have signed on.

“Businesses are really angry about the system, and there is a lot of frustration with its rising costs and dysfunction,” he said.

Mr. Geiger acknowledged the effort still lacks support from any Fortune 500 company CEOs. He said large businesses are hesitant to get involved in this political debate and many don’t want to lose the ability to attract workers with generous health benefits. “There is also a lingering distrust of the government, and they think they can offer coverage better than the government,” he said.

In addition, some in the business community are hesitant to sign on to Medicare-for-all with many details missing, such as how much it would increase taxes, said Ellen Kelsay, chief strategy officer for the National Business Group on Health, a leading business group focused on health benefits.
 

Democrats propel the debate

For decades, a government-run health plan was considered too radical an idea for serious consideration. But Medicare-for-all has been garnering more political support in recent months, especially after a progressive wave helped Democrats take control of the House this year. Several 2020 Democratic presidential candidates, including Sens. Bernie Sanders and Elizabeth Warren, strongly back it.

The labor unions and consumer groups that have long endorsed a single-payer health system hope that the embrace of it by employers such as Mr. Master marks another turning point for the movement.

Supporters of the concept say the health system overall would see savings from a coordinated effort to bring down prices and the elimination of many administrative costs or insurance company profits.

“It’s critical for our success to engage employers, particularly because our current system is hurting employers almost as much as it is patients,” said Melinda St. Louis, campaign director of Medicare-for-all at Public Citizen, a consumer-rights group based in Washington.

Mr. Master, a former Washington lawyer, worked on Democratic Sen. George McGovern’s presidential campaign before returning to Pennsylvania in 1973 to take over his father’s company, which made rigid paper boxes. In 1980, he founded MCS, which pioneered the popular front-loading picture frame and steamless fog-free mirrors for bathrooms. The company has grown into a $250 million corporation.

Mr. Master frequently travels to Washington and around the country to talk with business leaders as he seeks to build political support for a single-payer health system.

In the past 4 years, he has produced several documentary videos on the topic. In 2018, he formed the Business Initiative for Health Policy, a nonprofit group of business leaders, economists, and health policy experts trying to explain the financial benefits of a single-payer system.

Dan Wolf, CEO of Cape Air, a Hyannis, Mass.–based regional airline that employs 800 people calls himself “a free-market guy.” But he also supports Medicare-for-all. He said Mr. Master helps turn the political argument over single-payer into a practical one.

“It’s about good business sense and about caring for his employees and their well-being,” he said, adding that employers should no longer be straddled with the cost and complexity of health care.

“It makes no more sense for an airline to understand health policy for the bulk of its workers than for a health facility to have to supply all the air transportation for its employees,” he said.

Employers also are an important voice in the debate because 156 million Americans get employer-paid health care, making it by far the single-largest form of coverage.

Mr. Master said his company has tried various methods to control costs with little success, including high deductibles, narrow networks of providers and wellness plans that emphasize preventive medicine.

Insurers who are supposed to negotiate lower rates from hospitals and doctors have failed, he added, and too many premium dollars go to covering administrative costs. Only by having the federal government set rates can the United States control costs of drugs, hospitals, and other health services, he said.

“Insurance companies are not watching the store and don’t have incentives to hold down costs in the current system,” he said.
 

Glad the boss is trying to make a difference

What’s left of MCS in Pennsylvania is a spacious corporate office building housing administrative staff, designers, and a giant distribution center piled high with carton boxes from floor to ceiling.

MCS pays an average of $1,260 per month for each employee’s health care, up from $716 in 2009, the company said. In recent years, the company has reduced out-of-pocket costs for employees by covering most of their deductibles.

Medicare-for-all would require several new taxes to raise money, but Mr. Master said such a plan would mean savings for his company and employees.

MCS employees largely support Mr. Master’s attempt to fix the health system even if they are not all on board with a Medicare-for-all approach, according to interviews with several workers in Easton.

“I think it’s a good idea,” said Faith Wildrick, a shipper at MCS who has worked for the company 26 years. “If the other countries are doing it and it is working for them, why can’t it work for us?”

Ms. Wildrick said that even with insurance her family struggles with health costs as her husband, Bill, a former MCS employee, deals with liver disease and needs many diagnostic tests and prescription medications. Their annual deductible has swung from $4,000 several years ago to $500 this year as the company has worked to lower employees’ out-of-pocket costs.

“I’m really glad someone is fighting for this and trying to make a difference,” said Ms. Wildrick.

Jessica Ehrhardt, the human resources manager at MCS, said the effort to reduce employees’ out-of-pocket health costs means the company must pay higher health costs. That results in less money for salary increases and other benefits, she added.

Asked about Medicare-for-all, Ms. Ehrhardt said, “It’s a drastic solution, but something needs to happen.”

For too long, Mr. Master said, the push for a single-payer health system has been about ideology.

“The movement has been about making health care a human right and that we have a right to universal health care,” he said. “What I am saying is this is prudent for our economy and am trying to make the business and economic case.”

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

EASTON, PA. — Walk into a big-box retailer such as Walmart or Michaels and you’re likely to see MCS Industries’ picture frames, decorative mirrors, or kitschy wall décor.

Adjacent to a dairy farm a few miles west of downtown Easton, MCS is the nation’s largest maker of such household products. But MCS doesn’t actually make anything here anymore. It has moved its manufacturing operations to Mexico and China, with the last manufacturing jobs departing this city along the Delaware River in 2005. MCS now has about 175 U.S. employees and 600 people overseas.

“We were going to lose the business because we were no longer competitive,” CEO Richard Master explained. And one of the biggest impediments to keeping labor costs in line, he said, has been the increasing expense of health coverage in the United States.

Today, he’s at the vanguard of a small but growing group of business executives who are lining up to support a Medicare-for-all national health program. He argues not that health care is a human right but that covering everyone with a government plan and decoupling health care coverage from the workplace would benefit entrepreneurship.

In February, Master stood with Rep. Pramila Jayapal (D-Wash.) outside the Capitol after she introduced her Medicare-for-all bill. “This bill removes an albatross from the neck of American business, puts more money in consumer products and will boost our economy,” he said.

As health costs continue to grow, straining employer budgets and slowing wage growth, others in the business community are beginning to take the option more seriously.

While the influential U.S. Chamber of Commerce and other large business lobbying groups strongly oppose increased government involvement in health care, the resolve of many in the business community – especially among smaller firms – may be shifting.

“There is growing momentum among employers supporting single-payer,” said Dan Geiger, codirector of the Business Alliance for a Healthy California, which has sought to generate business support for a universal health care program in California. About 300 mostly small employers have signed on.

“Businesses are really angry about the system, and there is a lot of frustration with its rising costs and dysfunction,” he said.

Mr. Geiger acknowledged the effort still lacks support from any Fortune 500 company CEOs. He said large businesses are hesitant to get involved in this political debate and many don’t want to lose the ability to attract workers with generous health benefits. “There is also a lingering distrust of the government, and they think they can offer coverage better than the government,” he said.

In addition, some in the business community are hesitant to sign on to Medicare-for-all with many details missing, such as how much it would increase taxes, said Ellen Kelsay, chief strategy officer for the National Business Group on Health, a leading business group focused on health benefits.
 

Democrats propel the debate

For decades, a government-run health plan was considered too radical an idea for serious consideration. But Medicare-for-all has been garnering more political support in recent months, especially after a progressive wave helped Democrats take control of the House this year. Several 2020 Democratic presidential candidates, including Sens. Bernie Sanders and Elizabeth Warren, strongly back it.

The labor unions and consumer groups that have long endorsed a single-payer health system hope that the embrace of it by employers such as Mr. Master marks another turning point for the movement.

Supporters of the concept say the health system overall would see savings from a coordinated effort to bring down prices and the elimination of many administrative costs or insurance company profits.

“It’s critical for our success to engage employers, particularly because our current system is hurting employers almost as much as it is patients,” said Melinda St. Louis, campaign director of Medicare-for-all at Public Citizen, a consumer-rights group based in Washington.

Mr. Master, a former Washington lawyer, worked on Democratic Sen. George McGovern’s presidential campaign before returning to Pennsylvania in 1973 to take over his father’s company, which made rigid paper boxes. In 1980, he founded MCS, which pioneered the popular front-loading picture frame and steamless fog-free mirrors for bathrooms. The company has grown into a $250 million corporation.

Mr. Master frequently travels to Washington and around the country to talk with business leaders as he seeks to build political support for a single-payer health system.

In the past 4 years, he has produced several documentary videos on the topic. In 2018, he formed the Business Initiative for Health Policy, a nonprofit group of business leaders, economists, and health policy experts trying to explain the financial benefits of a single-payer system.

Dan Wolf, CEO of Cape Air, a Hyannis, Mass.–based regional airline that employs 800 people calls himself “a free-market guy.” But he also supports Medicare-for-all. He said Mr. Master helps turn the political argument over single-payer into a practical one.

“It’s about good business sense and about caring for his employees and their well-being,” he said, adding that employers should no longer be straddled with the cost and complexity of health care.

“It makes no more sense for an airline to understand health policy for the bulk of its workers than for a health facility to have to supply all the air transportation for its employees,” he said.

Employers also are an important voice in the debate because 156 million Americans get employer-paid health care, making it by far the single-largest form of coverage.

Mr. Master said his company has tried various methods to control costs with little success, including high deductibles, narrow networks of providers and wellness plans that emphasize preventive medicine.

Insurers who are supposed to negotiate lower rates from hospitals and doctors have failed, he added, and too many premium dollars go to covering administrative costs. Only by having the federal government set rates can the United States control costs of drugs, hospitals, and other health services, he said.

“Insurance companies are not watching the store and don’t have incentives to hold down costs in the current system,” he said.
 

Glad the boss is trying to make a difference

What’s left of MCS in Pennsylvania is a spacious corporate office building housing administrative staff, designers, and a giant distribution center piled high with carton boxes from floor to ceiling.

MCS pays an average of $1,260 per month for each employee’s health care, up from $716 in 2009, the company said. In recent years, the company has reduced out-of-pocket costs for employees by covering most of their deductibles.

Medicare-for-all would require several new taxes to raise money, but Mr. Master said such a plan would mean savings for his company and employees.

MCS employees largely support Mr. Master’s attempt to fix the health system even if they are not all on board with a Medicare-for-all approach, according to interviews with several workers in Easton.

“I think it’s a good idea,” said Faith Wildrick, a shipper at MCS who has worked for the company 26 years. “If the other countries are doing it and it is working for them, why can’t it work for us?”

Ms. Wildrick said that even with insurance her family struggles with health costs as her husband, Bill, a former MCS employee, deals with liver disease and needs many diagnostic tests and prescription medications. Their annual deductible has swung from $4,000 several years ago to $500 this year as the company has worked to lower employees’ out-of-pocket costs.

“I’m really glad someone is fighting for this and trying to make a difference,” said Ms. Wildrick.

Jessica Ehrhardt, the human resources manager at MCS, said the effort to reduce employees’ out-of-pocket health costs means the company must pay higher health costs. That results in less money for salary increases and other benefits, she added.

Asked about Medicare-for-all, Ms. Ehrhardt said, “It’s a drastic solution, but something needs to happen.”

For too long, Mr. Master said, the push for a single-payer health system has been about ideology.

“The movement has been about making health care a human right and that we have a right to universal health care,” he said. “What I am saying is this is prudent for our economy and am trying to make the business and economic case.”

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

TORONTO – A Swedish national primary care–centered self-management program for patients with knee or hip osteoarthritis (OA) resulted in clinically meaningful improvements through 1 year of follow-up in an observational registry study of 47,035 participants, Therese S. Jönsson reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

“The BOA [Better management of patients with Osteoarthritis] program is feasible and demonstrates positive results in a large clinical context. Our results indicate that offering this intervention as the first-line treatment for patients with hip and knee osteoarthritis may reduce the burden of disease,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.

Indeed, the results of the Swedish BOA program for nonsurgical treatment of OA played an influential role in the new draft of OARSI guidelines for management of knee osteoarthritis. The program could serve as a template for implementation of a similar approach in other health care settings. The BOA program has been rolled out to more than 700 Swedish primary care practice sites, according to Ms. Jönsson, a PhD student at Lund (Sweden) University.

The program was created to meet a defined national goal that, as early as possible in the course of the disease, every Swedish patient with knee or hip OA should receive education about their disease and the importance of exercise as a means of improving their quality of life. The impetus for BOA was a widespread concern that, in Sweden and elsewhere, far too many OA patients were being referred for joint surgery without ever having tried the evidence-based core nonsurgical treatments.
 

The BOA intervention

Following patient referral by a primary care physician, the Swedish BOA program starts off with individual assessment and biomechanical testing by a physical therapist. This is followed by two small-group education sessions of about 90 minutes led by a physical therapist or occupational therapist. Session one includes information about the pathology of OA, risk factors, symptoms, and the available treatments. Session two focuses on coping skills, self-management strategies to reduce pain and symptoms, the central role of exercise as a core treatment in OA, and ways to incorporate physical activity into daily living.

Then comes a decision point. Having listened to a motivational message extolling the benefits of exercise as a means of empowering self-management of their chronic disease, participants next have three choices: They can attend supervised group exercise classes twice weekly for 6 weeks to kick-start a more physically active lifestyle, they can start an individually adapted home exercise program, or they can decline exercise.

Giving patients a choice in this matter is a strategy rooted in the psychological concept of motivational stages of change, which recognizes that some patients with a chronic illness whose course is modifiable through lifestyle change are initially in a precontemplation stage of change. And pushing them hard at that point is counterproductive. The home exercise option, which permits patients to take a low-and-slow approach to exercise, is based upon the BOA program developers’ stated philosophy that 5 minutes of exercise daily, performed as part of everyday life, has a bigger impact upon function than does a 30-minute exercise program that’s abandoned after a few weeks. The goal of the BOA program is for patients to eventually build up to at least 150 minutes of moderate-intensity exercise per week.
 

The results

Roughly 15% of patients enrolled in the registry declined the exercise option. Ms. Jönsson’s analysis focused on those who opted to participate in an exercise program, 40% of whom selected the home exercise option. This analysis included 30,682 patients with knee OA and 16,363 with hip OA. They returned to the physical therapist for a face-to-face reassessment after 3 months, and they completed a mailed outcome-oriented questionnaire at 12 months.

The BOA intervention was more effective in reducing pain in the knee OA group than in those with hip OA. A statistically significant reduction in self-assessed pain scores on a 0-10 scale was seen in both the knee and hip OA groups at 3 and 12 months; however, only the knee OA patients achieved a clinically important decrease in pain, defined as at least a 15% drop in pain scores. Their pain scores improved from 5.24 at baseline to 4.07 at 3 months and 4.23 at 12 months. In the hip OA patients, pain scores went from 5.39 at baseline to 4.56 at 3 months and 4.7 at 12 months.

However, at 3 and 12 months, significantly fewer patients in both the hip and knee OA groups reported experiencing pain more than once per week, compared with baseline. They also took fewer pain-killing medications, reported less avoidance behavior involving fear of movement, were less willing to undergo joint surgery, and scored significantly higher on the five-level EQ-5D quality-of-life measure than at baseline. Moreover, fewer patients were on sick leave at the 12-month follow-up than at baseline, an outcome that wasn’t assessed at 3 months.

Adherence to the group exercise classes was “quite low,” according to Ms. Jönsson, and poor adherence was reflected in smaller reductions in pain scores. Only 30% of patients who elected the supervised group exercise option attended 10 of the 12 sessions, she noted.

Ms. Jönsson reported having no financial conflicts regarding her study. The BOA program is funded by the Swedish government.

bjancin@mdedge.com

SOURCE: Jönsson TS et al. Osteoarthritis Cartilage. 2019 Apr;27(suppl 1):S497, Abstract 717.

TORONTO – A Swedish national primary care–centered self-management program for patients with knee or hip osteoarthritis (OA) resulted in clinically meaningful improvements through 1 year of follow-up in an observational registry study of 47,035 participants, Therese S. Jönsson reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

“The BOA [Better management of patients with Osteoarthritis] program is feasible and demonstrates positive results in a large clinical context. Our results indicate that offering this intervention as the first-line treatment for patients with hip and knee osteoarthritis may reduce the burden of disease,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.

Indeed, the results of the Swedish BOA program for nonsurgical treatment of OA played an influential role in the new draft of OARSI guidelines for management of knee osteoarthritis. The program could serve as a template for implementation of a similar approach in other health care settings. The BOA program has been rolled out to more than 700 Swedish primary care practice sites, according to Ms. Jönsson, a PhD student at Lund (Sweden) University.

The program was created to meet a defined national goal that, as early as possible in the course of the disease, every Swedish patient with knee or hip OA should receive education about their disease and the importance of exercise as a means of improving their quality of life. The impetus for BOA was a widespread concern that, in Sweden and elsewhere, far too many OA patients were being referred for joint surgery without ever having tried the evidence-based core nonsurgical treatments.
 

The BOA intervention

Following patient referral by a primary care physician, the Swedish BOA program starts off with individual assessment and biomechanical testing by a physical therapist. This is followed by two small-group education sessions of about 90 minutes led by a physical therapist or occupational therapist. Session one includes information about the pathology of OA, risk factors, symptoms, and the available treatments. Session two focuses on coping skills, self-management strategies to reduce pain and symptoms, the central role of exercise as a core treatment in OA, and ways to incorporate physical activity into daily living.

Then comes a decision point. Having listened to a motivational message extolling the benefits of exercise as a means of empowering self-management of their chronic disease, participants next have three choices: They can attend supervised group exercise classes twice weekly for 6 weeks to kick-start a more physically active lifestyle, they can start an individually adapted home exercise program, or they can decline exercise.

Giving patients a choice in this matter is a strategy rooted in the psychological concept of motivational stages of change, which recognizes that some patients with a chronic illness whose course is modifiable through lifestyle change are initially in a precontemplation stage of change. And pushing them hard at that point is counterproductive. The home exercise option, which permits patients to take a low-and-slow approach to exercise, is based upon the BOA program developers’ stated philosophy that 5 minutes of exercise daily, performed as part of everyday life, has a bigger impact upon function than does a 30-minute exercise program that’s abandoned after a few weeks. The goal of the BOA program is for patients to eventually build up to at least 150 minutes of moderate-intensity exercise per week.
 

The results

Roughly 15% of patients enrolled in the registry declined the exercise option. Ms. Jönsson’s analysis focused on those who opted to participate in an exercise program, 40% of whom selected the home exercise option. This analysis included 30,682 patients with knee OA and 16,363 with hip OA. They returned to the physical therapist for a face-to-face reassessment after 3 months, and they completed a mailed outcome-oriented questionnaire at 12 months.

The BOA intervention was more effective in reducing pain in the knee OA group than in those with hip OA. A statistically significant reduction in self-assessed pain scores on a 0-10 scale was seen in both the knee and hip OA groups at 3 and 12 months; however, only the knee OA patients achieved a clinically important decrease in pain, defined as at least a 15% drop in pain scores. Their pain scores improved from 5.24 at baseline to 4.07 at 3 months and 4.23 at 12 months. In the hip OA patients, pain scores went from 5.39 at baseline to 4.56 at 3 months and 4.7 at 12 months.

However, at 3 and 12 months, significantly fewer patients in both the hip and knee OA groups reported experiencing pain more than once per week, compared with baseline. They also took fewer pain-killing medications, reported less avoidance behavior involving fear of movement, were less willing to undergo joint surgery, and scored significantly higher on the five-level EQ-5D quality-of-life measure than at baseline. Moreover, fewer patients were on sick leave at the 12-month follow-up than at baseline, an outcome that wasn’t assessed at 3 months.

Adherence to the group exercise classes was “quite low,” according to Ms. Jönsson, and poor adherence was reflected in smaller reductions in pain scores. Only 30% of patients who elected the supervised group exercise option attended 10 of the 12 sessions, she noted.

Ms. Jönsson reported having no financial conflicts regarding her study. The BOA program is funded by the Swedish government.

bjancin@mdedge.com

SOURCE: Jönsson TS et al. Osteoarthritis Cartilage. 2019 Apr;27(suppl 1):S497, Abstract 717.

TORONTO – A Swedish national primary care–centered self-management program for patients with knee or hip osteoarthritis (OA) resulted in clinically meaningful improvements through 1 year of follow-up in an observational registry study of 47,035 participants, Therese S. Jönsson reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

“The BOA [Better management of patients with Osteoarthritis] program is feasible and demonstrates positive results in a large clinical context. Our results indicate that offering this intervention as the first-line treatment for patients with hip and knee osteoarthritis may reduce the burden of disease,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.

Indeed, the results of the Swedish BOA program for nonsurgical treatment of OA played an influential role in the new draft of OARSI guidelines for management of knee osteoarthritis. The program could serve as a template for implementation of a similar approach in other health care settings. The BOA program has been rolled out to more than 700 Swedish primary care practice sites, according to Ms. Jönsson, a PhD student at Lund (Sweden) University.

The program was created to meet a defined national goal that, as early as possible in the course of the disease, every Swedish patient with knee or hip OA should receive education about their disease and the importance of exercise as a means of improving their quality of life. The impetus for BOA was a widespread concern that, in Sweden and elsewhere, far too many OA patients were being referred for joint surgery without ever having tried the evidence-based core nonsurgical treatments.
 

The BOA intervention

Following patient referral by a primary care physician, the Swedish BOA program starts off with individual assessment and biomechanical testing by a physical therapist. This is followed by two small-group education sessions of about 90 minutes led by a physical therapist or occupational therapist. Session one includes information about the pathology of OA, risk factors, symptoms, and the available treatments. Session two focuses on coping skills, self-management strategies to reduce pain and symptoms, the central role of exercise as a core treatment in OA, and ways to incorporate physical activity into daily living.

Then comes a decision point. Having listened to a motivational message extolling the benefits of exercise as a means of empowering self-management of their chronic disease, participants next have three choices: They can attend supervised group exercise classes twice weekly for 6 weeks to kick-start a more physically active lifestyle, they can start an individually adapted home exercise program, or they can decline exercise.

Giving patients a choice in this matter is a strategy rooted in the psychological concept of motivational stages of change, which recognizes that some patients with a chronic illness whose course is modifiable through lifestyle change are initially in a precontemplation stage of change. And pushing them hard at that point is counterproductive. The home exercise option, which permits patients to take a low-and-slow approach to exercise, is based upon the BOA program developers’ stated philosophy that 5 minutes of exercise daily, performed as part of everyday life, has a bigger impact upon function than does a 30-minute exercise program that’s abandoned after a few weeks. The goal of the BOA program is for patients to eventually build up to at least 150 minutes of moderate-intensity exercise per week.
 

The results

Roughly 15% of patients enrolled in the registry declined the exercise option. Ms. Jönsson’s analysis focused on those who opted to participate in an exercise program, 40% of whom selected the home exercise option. This analysis included 30,682 patients with knee OA and 16,363 with hip OA. They returned to the physical therapist for a face-to-face reassessment after 3 months, and they completed a mailed outcome-oriented questionnaire at 12 months.

The BOA intervention was more effective in reducing pain in the knee OA group than in those with hip OA. A statistically significant reduction in self-assessed pain scores on a 0-10 scale was seen in both the knee and hip OA groups at 3 and 12 months; however, only the knee OA patients achieved a clinically important decrease in pain, defined as at least a 15% drop in pain scores. Their pain scores improved from 5.24 at baseline to 4.07 at 3 months and 4.23 at 12 months. In the hip OA patients, pain scores went from 5.39 at baseline to 4.56 at 3 months and 4.7 at 12 months.

However, at 3 and 12 months, significantly fewer patients in both the hip and knee OA groups reported experiencing pain more than once per week, compared with baseline. They also took fewer pain-killing medications, reported less avoidance behavior involving fear of movement, were less willing to undergo joint surgery, and scored significantly higher on the five-level EQ-5D quality-of-life measure than at baseline. Moreover, fewer patients were on sick leave at the 12-month follow-up than at baseline, an outcome that wasn’t assessed at 3 months.

Adherence to the group exercise classes was “quite low,” according to Ms. Jönsson, and poor adherence was reflected in smaller reductions in pain scores. Only 30% of patients who elected the supervised group exercise option attended 10 of the 12 sessions, she noted.

Ms. Jönsson reported having no financial conflicts regarding her study. The BOA program is funded by the Swedish government.

bjancin@mdedge.com

SOURCE: Jönsson TS et al. Osteoarthritis Cartilage. 2019 Apr;27(suppl 1):S497, Abstract 717.

TORONTO – Osteoarthritis research doesn’t get nearly the respect it deserves in the medical literature, Elizabeth M. Badley, PhD, asserted at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

“Osteoarthritis is by far the most common type of arthritis. There are easily 10 times more people who have osteoarthritis than any other joint disease, but when you look at the literature, the situation is kind of reversed. Osteoarthritis is brushed off by society to a degree,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.

Dr. Bradley and colleagues performed a search of MEDLINE for 2007-2016, which turned up a total of 1,625 publications in 2016 on osteoarthritis, excluding those with an orthopedic surgery focus, compared with 10,904 results regarding the broader topic of joint diseases and 28,932 on musculoskeletal diseases.

The bottom line: “Progress is slow, and at this rate osteoarthritis will not be receiving the attention it deserves in our lifetime,” said Dr. Badley, of the department of epidemiology at the University of Toronto and a senior scientist at the Krembil Research Institute, also in Toronto.

The number of publications per year devoted to OA rose by a robust 88% during 2007-2016, while the number on OA not focused on orthopedic procedures grew by 65%. Both of these increases were greater than those for publications on musculoskeletal diseases and joint diseases overall, which were 41% and 51%, respectively. But the absolute number of OA publications was dwarfed by the numbers of those in the other search categories. For example, the number of publications on OA without an orthopedic surgery thrust was 985 in 2007, compared with 7,204 on joint diseases overall.

Among the striking findings of the investigators’ study of the medical literature was the disconnect between the amount of attention devoted to some of the joint-specific manifestations of OA and the actual prevalence of these conditions in the population. For example, the prevalence of hand OA in people living with OA was 52% according to the 2009 Survey on Living with Chronic Diseases in Canada, conducted by Statistics Canada, yet only 6.5% of the publications on OA in 2016 were devoted to hand/thumb OA. Similarly, the prevalence of spine OA was 52% among Canadians with OA, but only 4.3% of OA publications in 2016 focused on that topic. And while the number of publications devoted to elbow OA soared by a seemingly impressive 233% during the study period, the actual numbers were 3 publications in 2007 and 10 in 2016.

“Also, the average number of affected joints in people with osteoarthritis is four. Yet very, very few papers are about multijoint osteoarthritis. And when they do talk about multijoint osteoarthritis, they’re still only talking about hand/hip/knee. So we’re missing the bigger picture of osteoarthritis as a multijoint disease. We’re missing the spine, largely, as a part of osteoarthritis, and we’re missing the peripheral joints,” she said.

Dr. Badley reported having no financial conflicts regarding her study, conducted free of commercial support.

bjancin@mdedge.com

SOURCE: Badley EM et al. Osteoarthritis Cartilage. 2019 Apr;27(Suppl 1):S278, Abstract 393.

TORONTO – Osteoarthritis research doesn’t get nearly the respect it deserves in the medical literature, Elizabeth M. Badley, PhD, asserted at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

“Osteoarthritis is by far the most common type of arthritis. There are easily 10 times more people who have osteoarthritis than any other joint disease, but when you look at the literature, the situation is kind of reversed. Osteoarthritis is brushed off by society to a degree,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.

Dr. Bradley and colleagues performed a search of MEDLINE for 2007-2016, which turned up a total of 1,625 publications in 2016 on osteoarthritis, excluding those with an orthopedic surgery focus, compared with 10,904 results regarding the broader topic of joint diseases and 28,932 on musculoskeletal diseases.

The bottom line: “Progress is slow, and at this rate osteoarthritis will not be receiving the attention it deserves in our lifetime,” said Dr. Badley, of the department of epidemiology at the University of Toronto and a senior scientist at the Krembil Research Institute, also in Toronto.

The number of publications per year devoted to OA rose by a robust 88% during 2007-2016, while the number on OA not focused on orthopedic procedures grew by 65%. Both of these increases were greater than those for publications on musculoskeletal diseases and joint diseases overall, which were 41% and 51%, respectively. But the absolute number of OA publications was dwarfed by the numbers of those in the other search categories. For example, the number of publications on OA without an orthopedic surgery thrust was 985 in 2007, compared with 7,204 on joint diseases overall.

Among the striking findings of the investigators’ study of the medical literature was the disconnect between the amount of attention devoted to some of the joint-specific manifestations of OA and the actual prevalence of these conditions in the population. For example, the prevalence of hand OA in people living with OA was 52% according to the 2009 Survey on Living with Chronic Diseases in Canada, conducted by Statistics Canada, yet only 6.5% of the publications on OA in 2016 were devoted to hand/thumb OA. Similarly, the prevalence of spine OA was 52% among Canadians with OA, but only 4.3% of OA publications in 2016 focused on that topic. And while the number of publications devoted to elbow OA soared by a seemingly impressive 233% during the study period, the actual numbers were 3 publications in 2007 and 10 in 2016.

“Also, the average number of affected joints in people with osteoarthritis is four. Yet very, very few papers are about multijoint osteoarthritis. And when they do talk about multijoint osteoarthritis, they’re still only talking about hand/hip/knee. So we’re missing the bigger picture of osteoarthritis as a multijoint disease. We’re missing the spine, largely, as a part of osteoarthritis, and we’re missing the peripheral joints,” she said.

Dr. Badley reported having no financial conflicts regarding her study, conducted free of commercial support.

bjancin@mdedge.com

SOURCE: Badley EM et al. Osteoarthritis Cartilage. 2019 Apr;27(Suppl 1):S278, Abstract 393.

TORONTO – Osteoarthritis research doesn’t get nearly the respect it deserves in the medical literature, Elizabeth M. Badley, PhD, asserted at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

“Osteoarthritis is by far the most common type of arthritis. There are easily 10 times more people who have osteoarthritis than any other joint disease, but when you look at the literature, the situation is kind of reversed. Osteoarthritis is brushed off by society to a degree,” she said at the meeting, sponsored by the Osteoarthritis Research Society International.

Dr. Bradley and colleagues performed a search of MEDLINE for 2007-2016, which turned up a total of 1,625 publications in 2016 on osteoarthritis, excluding those with an orthopedic surgery focus, compared with 10,904 results regarding the broader topic of joint diseases and 28,932 on musculoskeletal diseases.

The bottom line: “Progress is slow, and at this rate osteoarthritis will not be receiving the attention it deserves in our lifetime,” said Dr. Badley, of the department of epidemiology at the University of Toronto and a senior scientist at the Krembil Research Institute, also in Toronto.

The number of publications per year devoted to OA rose by a robust 88% during 2007-2016, while the number on OA not focused on orthopedic procedures grew by 65%. Both of these increases were greater than those for publications on musculoskeletal diseases and joint diseases overall, which were 41% and 51%, respectively. But the absolute number of OA publications was dwarfed by the numbers of those in the other search categories. For example, the number of publications on OA without an orthopedic surgery thrust was 985 in 2007, compared with 7,204 on joint diseases overall.

Among the striking findings of the investigators’ study of the medical literature was the disconnect between the amount of attention devoted to some of the joint-specific manifestations of OA and the actual prevalence of these conditions in the population. For example, the prevalence of hand OA in people living with OA was 52% according to the 2009 Survey on Living with Chronic Diseases in Canada, conducted by Statistics Canada, yet only 6.5% of the publications on OA in 2016 were devoted to hand/thumb OA. Similarly, the prevalence of spine OA was 52% among Canadians with OA, but only 4.3% of OA publications in 2016 focused on that topic. And while the number of publications devoted to elbow OA soared by a seemingly impressive 233% during the study period, the actual numbers were 3 publications in 2007 and 10 in 2016.

“Also, the average number of affected joints in people with osteoarthritis is four. Yet very, very few papers are about multijoint osteoarthritis. And when they do talk about multijoint osteoarthritis, they’re still only talking about hand/hip/knee. So we’re missing the bigger picture of osteoarthritis as a multijoint disease. We’re missing the spine, largely, as a part of osteoarthritis, and we’re missing the peripheral joints,” she said.

Dr. Badley reported having no financial conflicts regarding her study, conducted free of commercial support.

bjancin@mdedge.com

SOURCE: Badley EM et al. Osteoarthritis Cartilage. 2019 Apr;27(Suppl 1):S278, Abstract 393.

The American Medical Association has announced the final eight recipients of the Reimagining Residency initiative, who will receive a total of $14.4 million to support residency innovation projects led by medical schools, residency programs, and health systems.

“After establishing a framework for creating the medical schools of the future, the AMA is now supporting innovation projects that will better align residency training with the evolving needs of patients and communities, as well as the workforce needs of the current and future health care system,” AMA CEO and Executive Vice President James L. Madara, MD, stated in a press release.

The projects include curricular innovations to address workforce shortages and address social determinants of health. Other projects will be developed within the framework of innovations and concepts developed and implemented in medical schools over the past 6 years by the AMA’s consortium. These projects include implementing competency-based programs and incorporating Health Systems Science into residency training.

The projects were chosen through a competitive grant process by an advisory panel made up of leading experts in medical education, and selection was based on how well each program met the goals of the initiative: improving the transition from medical school to residency, ensuring readiness for practice through modifications of residency curricula, and optimizing the learning environment to support well-being.

Each of the following projects will receive $1.8 million over 5 years:

• California Oregon Medical Partnership to Address Disparities in Rural Education and Health – Oregon Health & Science University, Portland, and the University of California, Davis
• Fully Integrated Readiness for Service Training: Enhancing the Continuum from Medical School to Residency to Practice – University of North Carolina at Chapel Hill
• NYU Transition to Residency Advantage – New York University
• Promotion in Place: Enhancing Trainee Well-Being and Patient Care Through Time-Variable Graduate Medical Education – Partners HealthCare System, Massachusetts General Hospital, and Brigham and Women’s Hospital, Boston
• Reimagining Residency: Ensuring Readiness for Practice Through Growing Interprofessional Partnerships to Advance Care and Education – Maine Medical Center, Portland
• Residency Training to Effectively Address Social Determinants of Health: Applying a Curricular Framework Across Four Primary Care Specialties – Montefiore Health System, New York
• The Graduate Medical Training “Laboratory”: An Innovative Program to Generate, Implement, and Evaluate Interventions to Improve Resident Burnout and Clinical Skill – Johns Hopkins University, Baltimore; Stanford (Calif.) University; and the University of Alabama at Birmingham
• The GOL2D Project (Goals of Life and Learning Delineated): Collaboration Across Academic Health Systems to Better Align GME with Learner, Patient, and Societal Needs – Vanderbilt University, Nashville, Tenn., and the University of Mississippi, Jackson

An additional three programs will receive a smaller $50,000 planning grant to expedite further exploration and development.

“As the health care landscape and technology rapidly evolve, the AMA will continue working with its community of innovation to drive the future of medicine by supporting significant redesign in physician training. Our goal is to ensure physicians are prepared to adapt, grow, and thrive at every stage of their training and career. Better prepared physicians will deliver more effective and equitable health care,” said Dr. Madara.

lfranki@mdedge.com

The American Medical Association has announced the final eight recipients of the Reimagining Residency initiative, who will receive a total of $14.4 million to support residency innovation projects led by medical schools, residency programs, and health systems.

“After establishing a framework for creating the medical schools of the future, the AMA is now supporting innovation projects that will better align residency training with the evolving needs of patients and communities, as well as the workforce needs of the current and future health care system,” AMA CEO and Executive Vice President James L. Madara, MD, stated in a press release.

The projects include curricular innovations to address workforce shortages and address social determinants of health. Other projects will be developed within the framework of innovations and concepts developed and implemented in medical schools over the past 6 years by the AMA’s consortium. These projects include implementing competency-based programs and incorporating Health Systems Science into residency training.

The projects were chosen through a competitive grant process by an advisory panel made up of leading experts in medical education, and selection was based on how well each program met the goals of the initiative: improving the transition from medical school to residency, ensuring readiness for practice through modifications of residency curricula, and optimizing the learning environment to support well-being.

Each of the following projects will receive $1.8 million over 5 years:

• California Oregon Medical Partnership to Address Disparities in Rural Education and Health – Oregon Health & Science University, Portland, and the University of California, Davis
• Fully Integrated Readiness for Service Training: Enhancing the Continuum from Medical School to Residency to Practice – University of North Carolina at Chapel Hill
• NYU Transition to Residency Advantage – New York University
• Promotion in Place: Enhancing Trainee Well-Being and Patient Care Through Time-Variable Graduate Medical Education – Partners HealthCare System, Massachusetts General Hospital, and Brigham and Women’s Hospital, Boston
• Reimagining Residency: Ensuring Readiness for Practice Through Growing Interprofessional Partnerships to Advance Care and Education – Maine Medical Center, Portland
• Residency Training to Effectively Address Social Determinants of Health: Applying a Curricular Framework Across Four Primary Care Specialties – Montefiore Health System, New York
• The Graduate Medical Training “Laboratory”: An Innovative Program to Generate, Implement, and Evaluate Interventions to Improve Resident Burnout and Clinical Skill – Johns Hopkins University, Baltimore; Stanford (Calif.) University; and the University of Alabama at Birmingham
• The GOL2D Project (Goals of Life and Learning Delineated): Collaboration Across Academic Health Systems to Better Align GME with Learner, Patient, and Societal Needs – Vanderbilt University, Nashville, Tenn., and the University of Mississippi, Jackson

An additional three programs will receive a smaller $50,000 planning grant to expedite further exploration and development.

“As the health care landscape and technology rapidly evolve, the AMA will continue working with its community of innovation to drive the future of medicine by supporting significant redesign in physician training. Our goal is to ensure physicians are prepared to adapt, grow, and thrive at every stage of their training and career. Better prepared physicians will deliver more effective and equitable health care,” said Dr. Madara.

lfranki@mdedge.com

The American Medical Association has announced the final eight recipients of the Reimagining Residency initiative, who will receive a total of $14.4 million to support residency innovation projects led by medical schools, residency programs, and health systems.

“After establishing a framework for creating the medical schools of the future, the AMA is now supporting innovation projects that will better align residency training with the evolving needs of patients and communities, as well as the workforce needs of the current and future health care system,” AMA CEO and Executive Vice President James L. Madara, MD, stated in a press release.

The projects include curricular innovations to address workforce shortages and address social determinants of health. Other projects will be developed within the framework of innovations and concepts developed and implemented in medical schools over the past 6 years by the AMA’s consortium. These projects include implementing competency-based programs and incorporating Health Systems Science into residency training.

The projects were chosen through a competitive grant process by an advisory panel made up of leading experts in medical education, and selection was based on how well each program met the goals of the initiative: improving the transition from medical school to residency, ensuring readiness for practice through modifications of residency curricula, and optimizing the learning environment to support well-being.

Each of the following projects will receive $1.8 million over 5 years:

• California Oregon Medical Partnership to Address Disparities in Rural Education and Health – Oregon Health & Science University, Portland, and the University of California, Davis
• Fully Integrated Readiness for Service Training: Enhancing the Continuum from Medical School to Residency to Practice – University of North Carolina at Chapel Hill
• NYU Transition to Residency Advantage – New York University
• Promotion in Place: Enhancing Trainee Well-Being and Patient Care Through Time-Variable Graduate Medical Education – Partners HealthCare System, Massachusetts General Hospital, and Brigham and Women’s Hospital, Boston
• Reimagining Residency: Ensuring Readiness for Practice Through Growing Interprofessional Partnerships to Advance Care and Education – Maine Medical Center, Portland
• Residency Training to Effectively Address Social Determinants of Health: Applying a Curricular Framework Across Four Primary Care Specialties – Montefiore Health System, New York
• The Graduate Medical Training “Laboratory”: An Innovative Program to Generate, Implement, and Evaluate Interventions to Improve Resident Burnout and Clinical Skill – Johns Hopkins University, Baltimore; Stanford (Calif.) University; and the University of Alabama at Birmingham
• The GOL2D Project (Goals of Life and Learning Delineated): Collaboration Across Academic Health Systems to Better Align GME with Learner, Patient, and Societal Needs – Vanderbilt University, Nashville, Tenn., and the University of Mississippi, Jackson

An additional three programs will receive a smaller $50,000 planning grant to expedite further exploration and development.

“As the health care landscape and technology rapidly evolve, the AMA will continue working with its community of innovation to drive the future of medicine by supporting significant redesign in physician training. Our goal is to ensure physicians are prepared to adapt, grow, and thrive at every stage of their training and career. Better prepared physicians will deliver more effective and equitable health care,” said Dr. Madara.

lfranki@mdedge.com

Introduction

Burnout in physicians has received significant attention within the past several years, particularly among trainees and early-career physicians. The subspecialties of gastroenterology and hepatology are not immune to burnout, with multiple studies indicating that early career gastroenterologists may be disproportionately affected, compared with their more-established counterparts.^1-4 Although the drivers of depersonalization, emotional exhaustion, and a reduced sense of personal accomplishment among trainees and early-career gastroenterologists are not fully understood, maximizing career fit during the transition from fellowship into the first posttraining position has been promoted as a potential method to decrease burnout in this population.^4,5

While most trainees enter gastroenterology fellowships with a set of predefined career goals, mentorship during fellowship can provide critical guidance along with exposure to new areas and career tracks that were not previously considered. In a survey of gastroenterology and transplant hepatology fellows, 94% of participants with a mentor reported that the mentor significantly influenced their career decision.⁶ Effective mentoring also has been identified as one possible method to decrease burnout among trainees.^7,8

Formal mentoring in gastroenterology fellowship programs might decrease burnout through effectively identifying risk factors such as work hour violations or a lack of social support. Additionally, when fellows are being prepared for transition to their first positions as attending gastroenterologists, there is a critical opportunity to improve career fit and decrease burnout rates among early-career gastroenterologists. Making the correct choice of subsequent career path after fellowship might be a source of stress, but this should allow early-career gastroenterologists to maximize the time spent doing those activities they feel are the most rewarding. A formal mentoring system and an accessible career mentor can be invaluable in allowing the mentee to identify and select that position.
 

Career fit

The concept of career fit has been described as the ability of individuals to focus their effort on the aspect or aspects of their work that they find most meaningful.⁵ Multiple specialties have recognized the importance of career fit and the need to choose appropriately when selecting a position and career path upon completing fellowship. In one evaluation of faculty members from the department of medicine at a large academic medical center, those individuals who spent less than 20% of their time working on the activity that they found most meaningful were significantly more likely to demonstrate burnout.⁵

In a relatively short time period, gastroenterology fellows are required to gather multiple new skill sets, including functioning as a consultant, performing endoscopic procedures, and potentially gaining formal training in clinical, basic, or translational research methods. During this same period, an intense phase of self-assessment should begin, with one critical aim of training being to identify those factors most likely to lead to a long, satisfying career. The growth that occurs during fellowship may allow for the identification of a career track that is likely to be the most rewarding, such as a career as a clinical investigator, clinician educator, or in clinical practice. Importantly, the trainee must decide which career track will most likely lead to self-fulfillment, even if the chosen path does not align with a mentor or advisor. Additionally, self-assessment also may aid in the identification of a niche that an individual finds most intellectually stimulating, which may lead to an area of research or clinical expertise.

While the demonstrated relationship between career fit and burnout is only an association without demonstrated causation, this does merit further consideration. For the first time in most trainees’ careers, the position after fellowship represents an opportunity to choose a job as opposed to going through a “match” process. Therefore, the trainee must strongly consider the factors that will ultimately lead to career satisfaction. If a large disconnect is present between self-identified career goals and the actual tasks required within daily workflow, this may lead to burnout relatively early in a career. Perhaps more importantly, if an individual did not perform adequate self-reflection when choosing a career path or did not receive effective guidance from career mentors, this also might lead to decreased career satisfaction, poor career fit, and an increased risk for burnout as an early-career gastroenterologist.
 

The mentor’s role

Although a structured career mentoring program is in place within many gastroenterology training programs, other fellowships encourage the mentee to select from a pool of potential mentors. In many cases, trainees and early career gastroenterologists will benefit from building a mentorship team, including career mentor or mentors, research mentors, and other advisors.⁹

While the mentor-mentee relationship can be an extremely rewarding experience for both parties, the effective mentor must meet a high standard. Several qualities have been identified that will maximize the benefit of the mentor-mentee relationship for the trainee, including the mentor taking a selfless approach to the relationship, working to assist the mentee in choosing a career path that will be the most rewarding, and then aiding the mentee in making helpful connections to promote growth along that chosen path.⁹ A good mentors should inspire a mentees, but also should be willing to provide honest and at times critical feedback to ensure that mentees maximizes their potential and ultimately assume the appropriate career trajectory. Unbiased mentorship, as well as continued reevaluations of strengths, weaknesses, and career goals by the mentor and mentee, will ultimately offer an opportunity to ensure the best combination of career fit,⁵ work-life balance,¹⁰ and satisfaction with career choice.¹¹
 

The mentor-mentee relationship after training is complete

Once a trainee has completed gastroenterology fellowship, another stressful transition to the role of an attending physician commences. It is critical that early-career gastroenterologists not only have confidence in the guidance that their mentor has provided to ensure appropriate career fit in their new role but also maintain these critical mentor-mentee relationships during this transition. A good mentor does not disappear because one phase of training is complete. The need for effective mentoring at the junior faculty level also is well recognized,¹² and early-career gastroenterologists should continue to rely on established mentoring relationships when new decision points are encountered.

Depending on the career track of an early-career gastroenterologist, formal mentoring also may be offered in the new role as a junior faculty member.¹² Additionally, external mentoring can exist within foundations or other subspecialty groups. One example of extramural mentoring is the Career Connection Program offered through the Crohn’s & Colitis Foundation’s Rising Educators Academics and Clinicians Helping IBD (REACH-IBD) platform. In this program, early-career gastroenterologists are selected and paired with national opinion leaders for one-on-one mentoring relationships. Such a program offers further opportunities for career growth, establishing connections within a smaller subspecialty of gastroenterology, and maximizing career fit.
 

Conclusion

In an era where the toll of burnout and other influences on early-career gastroenterologists are increasingly being recognized, the importance of career fit during the transition into the role of an attending should not be underestimated. In conjunction with appropriate self-reflection, unbiased and critical mentorship during fellowship can promote significant growth among trainees and allow for the ultimate selection of a career track or career path that will promote happiness, work-life balance, and long-term success as defined by the mentee.

Edward L. Barnes, MD, MPH, is with the Multidisciplinary Center for Inflammatory Bowel Diseases and the Center for Gastrointestinal Biology and Disease in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. Dr. Barnes reports no relevant disclosures.

References

1. Keswani RN et al. Am J Gastroenterol. 2011;106(10):1734-40.

2. Burke C et al. Am J Gastroenterol. 2017;112:S593-4.

3. DeCross AJ. AGA Perspectives. 2017.

4. Barnes EL et al. Dig Dis Sci. 2019;64(2):302-6.

5. Shanafelt TD et al. Arch Intern Med. 2009;169(10):990-5.

6. Ordway SM et al. Hepatol Commun. 2017;1(4):347-53.

7. Janko MR, Smeds MR. J Vasc Surg. 2019;69(4):1233-42.

8. Eckleberry-Hunt J et al. Acad Med. 2009;84(2):269-77.

9. Lieberman D. Gastroenterology. 2016;151(1):17-9.

10. Shanafelt TD et al. Mayo Clin Proc. 2015;90(12):1600-13.

11. Shanafelt TD et al. Ann Surg. 2009;250(3):463-71.

12. Shaheen NJ, Sandler RS. Gastroenterology. 2018;155(5):1293-7.

Introduction

Burnout in physicians has received significant attention within the past several years, particularly among trainees and early-career physicians. The subspecialties of gastroenterology and hepatology are not immune to burnout, with multiple studies indicating that early career gastroenterologists may be disproportionately affected, compared with their more-established counterparts.^1-4 Although the drivers of depersonalization, emotional exhaustion, and a reduced sense of personal accomplishment among trainees and early-career gastroenterologists are not fully understood, maximizing career fit during the transition from fellowship into the first posttraining position has been promoted as a potential method to decrease burnout in this population.^4,5

While most trainees enter gastroenterology fellowships with a set of predefined career goals, mentorship during fellowship can provide critical guidance along with exposure to new areas and career tracks that were not previously considered. In a survey of gastroenterology and transplant hepatology fellows, 94% of participants with a mentor reported that the mentor significantly influenced their career decision.⁶ Effective mentoring also has been identified as one possible method to decrease burnout among trainees.^7,8

Formal mentoring in gastroenterology fellowship programs might decrease burnout through effectively identifying risk factors such as work hour violations or a lack of social support. Additionally, when fellows are being prepared for transition to their first positions as attending gastroenterologists, there is a critical opportunity to improve career fit and decrease burnout rates among early-career gastroenterologists. Making the correct choice of subsequent career path after fellowship might be a source of stress, but this should allow early-career gastroenterologists to maximize the time spent doing those activities they feel are the most rewarding. A formal mentoring system and an accessible career mentor can be invaluable in allowing the mentee to identify and select that position.
 

Career fit

The concept of career fit has been described as the ability of individuals to focus their effort on the aspect or aspects of their work that they find most meaningful.⁵ Multiple specialties have recognized the importance of career fit and the need to choose appropriately when selecting a position and career path upon completing fellowship. In one evaluation of faculty members from the department of medicine at a large academic medical center, those individuals who spent less than 20% of their time working on the activity that they found most meaningful were significantly more likely to demonstrate burnout.⁵

In a relatively short time period, gastroenterology fellows are required to gather multiple new skill sets, including functioning as a consultant, performing endoscopic procedures, and potentially gaining formal training in clinical, basic, or translational research methods. During this same period, an intense phase of self-assessment should begin, with one critical aim of training being to identify those factors most likely to lead to a long, satisfying career. The growth that occurs during fellowship may allow for the identification of a career track that is likely to be the most rewarding, such as a career as a clinical investigator, clinician educator, or in clinical practice. Importantly, the trainee must decide which career track will most likely lead to self-fulfillment, even if the chosen path does not align with a mentor or advisor. Additionally, self-assessment also may aid in the identification of a niche that an individual finds most intellectually stimulating, which may lead to an area of research or clinical expertise.

While the demonstrated relationship between career fit and burnout is only an association without demonstrated causation, this does merit further consideration. For the first time in most trainees’ careers, the position after fellowship represents an opportunity to choose a job as opposed to going through a “match” process. Therefore, the trainee must strongly consider the factors that will ultimately lead to career satisfaction. If a large disconnect is present between self-identified career goals and the actual tasks required within daily workflow, this may lead to burnout relatively early in a career. Perhaps more importantly, if an individual did not perform adequate self-reflection when choosing a career path or did not receive effective guidance from career mentors, this also might lead to decreased career satisfaction, poor career fit, and an increased risk for burnout as an early-career gastroenterologist.
 

The mentor’s role

Although a structured career mentoring program is in place within many gastroenterology training programs, other fellowships encourage the mentee to select from a pool of potential mentors. In many cases, trainees and early career gastroenterologists will benefit from building a mentorship team, including career mentor or mentors, research mentors, and other advisors.⁹

While the mentor-mentee relationship can be an extremely rewarding experience for both parties, the effective mentor must meet a high standard. Several qualities have been identified that will maximize the benefit of the mentor-mentee relationship for the trainee, including the mentor taking a selfless approach to the relationship, working to assist the mentee in choosing a career path that will be the most rewarding, and then aiding the mentee in making helpful connections to promote growth along that chosen path.⁹ A good mentors should inspire a mentees, but also should be willing to provide honest and at times critical feedback to ensure that mentees maximizes their potential and ultimately assume the appropriate career trajectory. Unbiased mentorship, as well as continued reevaluations of strengths, weaknesses, and career goals by the mentor and mentee, will ultimately offer an opportunity to ensure the best combination of career fit,⁵ work-life balance,¹⁰ and satisfaction with career choice.¹¹
 

The mentor-mentee relationship after training is complete

Once a trainee has completed gastroenterology fellowship, another stressful transition to the role of an attending physician commences. It is critical that early-career gastroenterologists not only have confidence in the guidance that their mentor has provided to ensure appropriate career fit in their new role but also maintain these critical mentor-mentee relationships during this transition. A good mentor does not disappear because one phase of training is complete. The need for effective mentoring at the junior faculty level also is well recognized,¹² and early-career gastroenterologists should continue to rely on established mentoring relationships when new decision points are encountered.

Depending on the career track of an early-career gastroenterologist, formal mentoring also may be offered in the new role as a junior faculty member.¹² Additionally, external mentoring can exist within foundations or other subspecialty groups. One example of extramural mentoring is the Career Connection Program offered through the Crohn’s & Colitis Foundation’s Rising Educators Academics and Clinicians Helping IBD (REACH-IBD) platform. In this program, early-career gastroenterologists are selected and paired with national opinion leaders for one-on-one mentoring relationships. Such a program offers further opportunities for career growth, establishing connections within a smaller subspecialty of gastroenterology, and maximizing career fit.
 

Conclusion

In an era where the toll of burnout and other influences on early-career gastroenterologists are increasingly being recognized, the importance of career fit during the transition into the role of an attending should not be underestimated. In conjunction with appropriate self-reflection, unbiased and critical mentorship during fellowship can promote significant growth among trainees and allow for the ultimate selection of a career track or career path that will promote happiness, work-life balance, and long-term success as defined by the mentee.

Edward L. Barnes, MD, MPH, is with the Multidisciplinary Center for Inflammatory Bowel Diseases and the Center for Gastrointestinal Biology and Disease in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. Dr. Barnes reports no relevant disclosures.

References

1. Keswani RN et al. Am J Gastroenterol. 2011;106(10):1734-40.

2. Burke C et al. Am J Gastroenterol. 2017;112:S593-4.

3. DeCross AJ. AGA Perspectives. 2017.

4. Barnes EL et al. Dig Dis Sci. 2019;64(2):302-6.

5. Shanafelt TD et al. Arch Intern Med. 2009;169(10):990-5.

6. Ordway SM et al. Hepatol Commun. 2017;1(4):347-53.

7. Janko MR, Smeds MR. J Vasc Surg. 2019;69(4):1233-42.

8. Eckleberry-Hunt J et al. Acad Med. 2009;84(2):269-77.

9. Lieberman D. Gastroenterology. 2016;151(1):17-9.

10. Shanafelt TD et al. Mayo Clin Proc. 2015;90(12):1600-13.

11. Shanafelt TD et al. Ann Surg. 2009;250(3):463-71.

12. Shaheen NJ, Sandler RS. Gastroenterology. 2018;155(5):1293-7.

Introduction

Burnout in physicians has received significant attention within the past several years, particularly among trainees and early-career physicians. The subspecialties of gastroenterology and hepatology are not immune to burnout, with multiple studies indicating that early career gastroenterologists may be disproportionately affected, compared with their more-established counterparts.^1-4 Although the drivers of depersonalization, emotional exhaustion, and a reduced sense of personal accomplishment among trainees and early-career gastroenterologists are not fully understood, maximizing career fit during the transition from fellowship into the first posttraining position has been promoted as a potential method to decrease burnout in this population.^4,5

While most trainees enter gastroenterology fellowships with a set of predefined career goals, mentorship during fellowship can provide critical guidance along with exposure to new areas and career tracks that were not previously considered. In a survey of gastroenterology and transplant hepatology fellows, 94% of participants with a mentor reported that the mentor significantly influenced their career decision.⁶ Effective mentoring also has been identified as one possible method to decrease burnout among trainees.^7,8

Formal mentoring in gastroenterology fellowship programs might decrease burnout through effectively identifying risk factors such as work hour violations or a lack of social support. Additionally, when fellows are being prepared for transition to their first positions as attending gastroenterologists, there is a critical opportunity to improve career fit and decrease burnout rates among early-career gastroenterologists. Making the correct choice of subsequent career path after fellowship might be a source of stress, but this should allow early-career gastroenterologists to maximize the time spent doing those activities they feel are the most rewarding. A formal mentoring system and an accessible career mentor can be invaluable in allowing the mentee to identify and select that position.
 

Career fit

The concept of career fit has been described as the ability of individuals to focus their effort on the aspect or aspects of their work that they find most meaningful.⁵ Multiple specialties have recognized the importance of career fit and the need to choose appropriately when selecting a position and career path upon completing fellowship. In one evaluation of faculty members from the department of medicine at a large academic medical center, those individuals who spent less than 20% of their time working on the activity that they found most meaningful were significantly more likely to demonstrate burnout.⁵

In a relatively short time period, gastroenterology fellows are required to gather multiple new skill sets, including functioning as a consultant, performing endoscopic procedures, and potentially gaining formal training in clinical, basic, or translational research methods. During this same period, an intense phase of self-assessment should begin, with one critical aim of training being to identify those factors most likely to lead to a long, satisfying career. The growth that occurs during fellowship may allow for the identification of a career track that is likely to be the most rewarding, such as a career as a clinical investigator, clinician educator, or in clinical practice. Importantly, the trainee must decide which career track will most likely lead to self-fulfillment, even if the chosen path does not align with a mentor or advisor. Additionally, self-assessment also may aid in the identification of a niche that an individual finds most intellectually stimulating, which may lead to an area of research or clinical expertise.

While the demonstrated relationship between career fit and burnout is only an association without demonstrated causation, this does merit further consideration. For the first time in most trainees’ careers, the position after fellowship represents an opportunity to choose a job as opposed to going through a “match” process. Therefore, the trainee must strongly consider the factors that will ultimately lead to career satisfaction. If a large disconnect is present between self-identified career goals and the actual tasks required within daily workflow, this may lead to burnout relatively early in a career. Perhaps more importantly, if an individual did not perform adequate self-reflection when choosing a career path or did not receive effective guidance from career mentors, this also might lead to decreased career satisfaction, poor career fit, and an increased risk for burnout as an early-career gastroenterologist.
 

The mentor’s role

Although a structured career mentoring program is in place within many gastroenterology training programs, other fellowships encourage the mentee to select from a pool of potential mentors. In many cases, trainees and early career gastroenterologists will benefit from building a mentorship team, including career mentor or mentors, research mentors, and other advisors.⁹

While the mentor-mentee relationship can be an extremely rewarding experience for both parties, the effective mentor must meet a high standard. Several qualities have been identified that will maximize the benefit of the mentor-mentee relationship for the trainee, including the mentor taking a selfless approach to the relationship, working to assist the mentee in choosing a career path that will be the most rewarding, and then aiding the mentee in making helpful connections to promote growth along that chosen path.⁹ A good mentors should inspire a mentees, but also should be willing to provide honest and at times critical feedback to ensure that mentees maximizes their potential and ultimately assume the appropriate career trajectory. Unbiased mentorship, as well as continued reevaluations of strengths, weaknesses, and career goals by the mentor and mentee, will ultimately offer an opportunity to ensure the best combination of career fit,⁵ work-life balance,¹⁰ and satisfaction with career choice.¹¹
 

The mentor-mentee relationship after training is complete

Once a trainee has completed gastroenterology fellowship, another stressful transition to the role of an attending physician commences. It is critical that early-career gastroenterologists not only have confidence in the guidance that their mentor has provided to ensure appropriate career fit in their new role but also maintain these critical mentor-mentee relationships during this transition. A good mentor does not disappear because one phase of training is complete. The need for effective mentoring at the junior faculty level also is well recognized,¹² and early-career gastroenterologists should continue to rely on established mentoring relationships when new decision points are encountered.

Depending on the career track of an early-career gastroenterologist, formal mentoring also may be offered in the new role as a junior faculty member.¹² Additionally, external mentoring can exist within foundations or other subspecialty groups. One example of extramural mentoring is the Career Connection Program offered through the Crohn’s & Colitis Foundation’s Rising Educators Academics and Clinicians Helping IBD (REACH-IBD) platform. In this program, early-career gastroenterologists are selected and paired with national opinion leaders for one-on-one mentoring relationships. Such a program offers further opportunities for career growth, establishing connections within a smaller subspecialty of gastroenterology, and maximizing career fit.
 

Conclusion

In an era where the toll of burnout and other influences on early-career gastroenterologists are increasingly being recognized, the importance of career fit during the transition into the role of an attending should not be underestimated. In conjunction with appropriate self-reflection, unbiased and critical mentorship during fellowship can promote significant growth among trainees and allow for the ultimate selection of a career track or career path that will promote happiness, work-life balance, and long-term success as defined by the mentee.

Edward L. Barnes, MD, MPH, is with the Multidisciplinary Center for Inflammatory Bowel Diseases and the Center for Gastrointestinal Biology and Disease in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. Dr. Barnes reports no relevant disclosures.

References

1. Keswani RN et al. Am J Gastroenterol. 2011;106(10):1734-40.

2. Burke C et al. Am J Gastroenterol. 2017;112:S593-4.

3. DeCross AJ. AGA Perspectives. 2017.

4. Barnes EL et al. Dig Dis Sci. 2019;64(2):302-6.

5. Shanafelt TD et al. Arch Intern Med. 2009;169(10):990-5.

6. Ordway SM et al. Hepatol Commun. 2017;1(4):347-53.

7. Janko MR, Smeds MR. J Vasc Surg. 2019;69(4):1233-42.

8. Eckleberry-Hunt J et al. Acad Med. 2009;84(2):269-77.

9. Lieberman D. Gastroenterology. 2016;151(1):17-9.

10. Shanafelt TD et al. Mayo Clin Proc. 2015;90(12):1600-13.

11. Shanafelt TD et al. Ann Surg. 2009;250(3):463-71.

12. Shaheen NJ, Sandler RS. Gastroenterology. 2018;155(5):1293-7.

Fewer opioid retail prescriptions are being filled, according to a new report issued by the American Medical Association Opioid Task Force.

AndreyPopov/Getty Images

Opioid prescribing declined by 33% over a 5-year period based on the total number of opioid retail prescriptions filled. Total prescriptions declined from 251.8 million in 2013 to 168.8 million in 2018, according to the report.

The numbers come as the most recent data from the Centers for Disease Control and Prevention show a leveling of deaths involving prescription opioids. The CDC data were most recently updated in January 2019 and cover the period 1999-2017.

A closer look shows that deaths involving prescription opioids, but not other synthetic narcotics, peaked in 2011 and have generally declined since then. Deaths involving other synthetic narcotics, however, have been rising, offsetting the reduction and keeping the total number of deaths involving opioids relatively stable between 2016 and 2017.

Other data released by the AMA Opioid Task Force show that physicians are increasing their use of state-level prescription drug monitoring programs (PDMPs).

In 2017, there were 1.5 million physicians registered to use state PDMPs. That number rose to 1.97 million in 2019. And the physicians are using PDMPs. In 2018, physicians made 460 million PDMP queries, up 56% from 2017 and up 651% from 2014.

More education about opioid prescribing is being sought, with 700,000 physicians completing CME training and accessing other training related to opioid prescribing, pain management, screening for substance use disorders, and other related topics.

While the report does show positive trends, the task force is calling for more action, including more access to naloxone and better access to mental health treatment.

The report notes that more than 66,000 physicians and other health professionals have a federal waiver to prescribe buprenorphine, up more than 28,000 since 2016.

A number of policy recommendations are made in the report, including removing inappropriate administrative burdens or barriers that delay access to medications used in medication-assisted treatment (MAT); removing barriers to comprehensive pain care and rehabilitation programs, and reforming the civil and criminal justice system to help ensure access to high-quality, evidence-based care for opioid use disorder.

“We are at a crossroads in our nation’s efforts to end the opioid epidemic,” AMA Opioid Task Force Chair Patrice A. Harris, MD, stated in the report. “It is time to end delays and barriers to medication-assisted treatment – evidence based care proven to save lives; time for payers, [pharmacy benefit managers] and pharmacy chains to reevaluate and revise policies that restrict opioid therapy to patients based on arbitrary thresholds; and time to commit to helping all patients access evidence-based care for pain and substance use disorders.”

Dr. Harris continued: “Physicians must continue to demonstrate leadership, but unless these actions occur, the progress we are making will not stop patients from dying.”

gtwachtman@mdedge.com

Fewer opioid retail prescriptions are being filled, according to a new report issued by the American Medical Association Opioid Task Force.

AndreyPopov/Getty Images

Opioid prescribing declined by 33% over a 5-year period based on the total number of opioid retail prescriptions filled. Total prescriptions declined from 251.8 million in 2013 to 168.8 million in 2018, according to the report.

The numbers come as the most recent data from the Centers for Disease Control and Prevention show a leveling of deaths involving prescription opioids. The CDC data were most recently updated in January 2019 and cover the period 1999-2017.

A closer look shows that deaths involving prescription opioids, but not other synthetic narcotics, peaked in 2011 and have generally declined since then. Deaths involving other synthetic narcotics, however, have been rising, offsetting the reduction and keeping the total number of deaths involving opioids relatively stable between 2016 and 2017.

Other data released by the AMA Opioid Task Force show that physicians are increasing their use of state-level prescription drug monitoring programs (PDMPs).

In 2017, there were 1.5 million physicians registered to use state PDMPs. That number rose to 1.97 million in 2019. And the physicians are using PDMPs. In 2018, physicians made 460 million PDMP queries, up 56% from 2017 and up 651% from 2014.

More education about opioid prescribing is being sought, with 700,000 physicians completing CME training and accessing other training related to opioid prescribing, pain management, screening for substance use disorders, and other related topics.

While the report does show positive trends, the task force is calling for more action, including more access to naloxone and better access to mental health treatment.

The report notes that more than 66,000 physicians and other health professionals have a federal waiver to prescribe buprenorphine, up more than 28,000 since 2016.

A number of policy recommendations are made in the report, including removing inappropriate administrative burdens or barriers that delay access to medications used in medication-assisted treatment (MAT); removing barriers to comprehensive pain care and rehabilitation programs, and reforming the civil and criminal justice system to help ensure access to high-quality, evidence-based care for opioid use disorder.

“We are at a crossroads in our nation’s efforts to end the opioid epidemic,” AMA Opioid Task Force Chair Patrice A. Harris, MD, stated in the report. “It is time to end delays and barriers to medication-assisted treatment – evidence based care proven to save lives; time for payers, [pharmacy benefit managers] and pharmacy chains to reevaluate and revise policies that restrict opioid therapy to patients based on arbitrary thresholds; and time to commit to helping all patients access evidence-based care for pain and substance use disorders.”

Dr. Harris continued: “Physicians must continue to demonstrate leadership, but unless these actions occur, the progress we are making will not stop patients from dying.”

gtwachtman@mdedge.com

Fewer opioid retail prescriptions are being filled, according to a new report issued by the American Medical Association Opioid Task Force.

AndreyPopov/Getty Images

Opioid prescribing declined by 33% over a 5-year period based on the total number of opioid retail prescriptions filled. Total prescriptions declined from 251.8 million in 2013 to 168.8 million in 2018, according to the report.

The numbers come as the most recent data from the Centers for Disease Control and Prevention show a leveling of deaths involving prescription opioids. The CDC data were most recently updated in January 2019 and cover the period 1999-2017.

A closer look shows that deaths involving prescription opioids, but not other synthetic narcotics, peaked in 2011 and have generally declined since then. Deaths involving other synthetic narcotics, however, have been rising, offsetting the reduction and keeping the total number of deaths involving opioids relatively stable between 2016 and 2017.

Other data released by the AMA Opioid Task Force show that physicians are increasing their use of state-level prescription drug monitoring programs (PDMPs).

In 2017, there were 1.5 million physicians registered to use state PDMPs. That number rose to 1.97 million in 2019. And the physicians are using PDMPs. In 2018, physicians made 460 million PDMP queries, up 56% from 2017 and up 651% from 2014.

More education about opioid prescribing is being sought, with 700,000 physicians completing CME training and accessing other training related to opioid prescribing, pain management, screening for substance use disorders, and other related topics.

While the report does show positive trends, the task force is calling for more action, including more access to naloxone and better access to mental health treatment.

The report notes that more than 66,000 physicians and other health professionals have a federal waiver to prescribe buprenorphine, up more than 28,000 since 2016.

A number of policy recommendations are made in the report, including removing inappropriate administrative burdens or barriers that delay access to medications used in medication-assisted treatment (MAT); removing barriers to comprehensive pain care and rehabilitation programs, and reforming the civil and criminal justice system to help ensure access to high-quality, evidence-based care for opioid use disorder.

“We are at a crossroads in our nation’s efforts to end the opioid epidemic,” AMA Opioid Task Force Chair Patrice A. Harris, MD, stated in the report. “It is time to end delays and barriers to medication-assisted treatment – evidence based care proven to save lives; time for payers, [pharmacy benefit managers] and pharmacy chains to reevaluate and revise policies that restrict opioid therapy to patients based on arbitrary thresholds; and time to commit to helping all patients access evidence-based care for pain and substance use disorders.”

Dr. Harris continued: “Physicians must continue to demonstrate leadership, but unless these actions occur, the progress we are making will not stop patients from dying.”

gtwachtman@mdedge.com

When it comes to anaphylaxis episodes leading to pediatric intensive care–unit stays, peanuts are the most common culprit. Now the results of a recent clinical trial may lead to approval of the first oral medication to ameliorate reactions in children with severe peanut allergies.

copyright mates/Fotolia.com

After 6 months of treatment and 6 months of maintenance therapy, two-thirds of the 372 children who received this treatment could ingest the equivalent of two peanuts without allergic symptoms. Just 4% of the 124 children given a placebo powder were able to consume that amount of peanut without reacting. The treatment was not effective for the small number of adults in the study.

This trial of the drug, called AR101 and developed by Aimmune Therapeutics, was published in Nov. 2018 in the New England Journal of Medicine. The company has submitted a biologics license application to the U.S. Food and Drug Administration, and because the drug has been designated a breakthrough therapy, it will go through an accelerated approval process. It could be on the market by the end of 2019.
 

Reference

1. Rabin RC. New Peanut Allergy Drug Shows ‘Lifesaving’ Potential. New York Times. Nov. 18, 2018. https://www.nytimes.com/2018/11/18/well/live/new-peanut-allergy-drug-shows-lifesaving-potential.html. Accessed Nov. 26, 2018.

When it comes to anaphylaxis episodes leading to pediatric intensive care–unit stays, peanuts are the most common culprit. Now the results of a recent clinical trial may lead to approval of the first oral medication to ameliorate reactions in children with severe peanut allergies.

copyright mates/Fotolia.com

After 6 months of treatment and 6 months of maintenance therapy, two-thirds of the 372 children who received this treatment could ingest the equivalent of two peanuts without allergic symptoms. Just 4% of the 124 children given a placebo powder were able to consume that amount of peanut without reacting. The treatment was not effective for the small number of adults in the study.

This trial of the drug, called AR101 and developed by Aimmune Therapeutics, was published in Nov. 2018 in the New England Journal of Medicine. The company has submitted a biologics license application to the U.S. Food and Drug Administration, and because the drug has been designated a breakthrough therapy, it will go through an accelerated approval process. It could be on the market by the end of 2019.
 

Reference

1. Rabin RC. New Peanut Allergy Drug Shows ‘Lifesaving’ Potential. New York Times. Nov. 18, 2018. https://www.nytimes.com/2018/11/18/well/live/new-peanut-allergy-drug-shows-lifesaving-potential.html. Accessed Nov. 26, 2018.

When it comes to anaphylaxis episodes leading to pediatric intensive care–unit stays, peanuts are the most common culprit. Now the results of a recent clinical trial may lead to approval of the first oral medication to ameliorate reactions in children with severe peanut allergies.

copyright mates/Fotolia.com

After 6 months of treatment and 6 months of maintenance therapy, two-thirds of the 372 children who received this treatment could ingest the equivalent of two peanuts without allergic symptoms. Just 4% of the 124 children given a placebo powder were able to consume that amount of peanut without reacting. The treatment was not effective for the small number of adults in the study.

This trial of the drug, called AR101 and developed by Aimmune Therapeutics, was published in Nov. 2018 in the New England Journal of Medicine. The company has submitted a biologics license application to the U.S. Food and Drug Administration, and because the drug has been designated a breakthrough therapy, it will go through an accelerated approval process. It could be on the market by the end of 2019.
 

Reference

1. Rabin RC. New Peanut Allergy Drug Shows ‘Lifesaving’ Potential. New York Times. Nov. 18, 2018. https://www.nytimes.com/2018/11/18/well/live/new-peanut-allergy-drug-shows-lifesaving-potential.html. Accessed Nov. 26, 2018.

CHICAGO – A fixed-duration venetoclax-obinutuzumab regimen is safe and provides a superior outcome versus standard chlorambucil-obinutuzumab in elderly patients with untreated chronic lymphocytic leukemia (CLL) and comorbidities, results of a randomized phase 3 trial showed.

At 24 months, progression-free survival was 88.2% for the venetoclax-obinutuzumab regimen, versus 64.1% for chlorambucil-obinutuzumab (hazard ratio, 0.35; 95% confidence interval, 0.23-0.53; P less than .0001) in CLL-14, an open-label, multinational trial presented at the annual meeting of the American Society of Clinical Oncology.

The regimen, given for just 12 28-day cycles, also achieved the highest rate of minimal residual disease (MRD)-negative responses ever seen in a randomized prospective CLL study, according to investigator Kirsten Fischer, MD, of the University of Cologne in Germany.

“We really think that these unprecedented MRD negativity levels will eventually translate into an improved overall survival,” Dr. Fischer said during an oral abstract presentation.

Matthew Steven Davids, MD, of Dana-Farber Cancer Institute/Harvard Medical School, Boston, said venetoclax plus obinutuzumab offers the potential for 1-year, time-limited therapy, which limits concerns over long-term adherence and has the potential for cost savings, should the therapy prove to be highly durable with further follow-up.

“A limitation of the study is that the comparator arm – chlorambucil plus obinutuzumab – is directly applicable to only a relatively small subset of our older and frailer CLL patients,” Dr. Davids said during a podium discussion of the results.

“But nonetheless, venetoclax plus obinutuzumab is a promising, time-limited regimen, and CLL14 is an immediately practice-changing study for frontline CLL treatment,” he added.

The regimen stands in contrast to ibrutinib, which offers durable responses but requires continuous dosing, and FCR (fludarabine, cyclophosphamide, and rituximab), a time-limited therapy with curative potential that is restricted to younger patients with IGHV-mutated CLL, according to Dr. Davids.

In CLL-14, 432 patients were randomized 1:1 to receive venetoclax-obinutuzumab for six cycles followed by venetoclax for six cycles, or chlorambucil-obinutuzumab for six cycles followed by chlorambucil for six cycles. The median age was 72 years in the venetoclax-obinutuzumab arm and 71 years in the chlorambucil-obinutuzumab arm.

The overall response rate was 85% for venetoclax-obinutuzumab and 71% for chlorambucil-obinutuzumab (P = .0007), Dr. Fischer reported at the meeting.

The improvement in progression-free survival seen in the overall study population was also seen in patients with TP53 deletions or mutations, and in those with unmutated IGHV, Dr. Fischer reported.

Rates of MRD negativity in peripheral blood were 76% versus 35% for the venetoclax- and chlorambucil-containing combinations, respectively (P less than .001), and similarly, MRD negativity in bone marrow was 57% versus 17% (P less than .001), she said.

There were no significant differences in the rates of grade 3 or 4 neutropenia, which occurred in 52.8% of the venetoclax–obinutuzumab treated patients and 48.1% of the chlorambucil-obinutuzumab treated patients, or in grade 3 or 4 infections, which occurred in 17.5% and 15.0%, respectively, according to a report, published simultaneously in the New England Journal of Medicine (2019;380:2225-36).

Likewise, all-cause mortality was not significantly different between the arms, at 9.3% and 7.9%, respectively.

F. Hoffmann-La Roche and AbbVie supported the study. Dr. Fischer reported travel, accommodations, or expenses from Roche in her abstract disclosure.

SOURCE: Fischer K et al. ASCO 2019, Abstract 7502.

CHICAGO – A fixed-duration venetoclax-obinutuzumab regimen is safe and provides a superior outcome versus standard chlorambucil-obinutuzumab in elderly patients with untreated chronic lymphocytic leukemia (CLL) and comorbidities, results of a randomized phase 3 trial showed.

At 24 months, progression-free survival was 88.2% for the venetoclax-obinutuzumab regimen, versus 64.1% for chlorambucil-obinutuzumab (hazard ratio, 0.35; 95% confidence interval, 0.23-0.53; P less than .0001) in CLL-14, an open-label, multinational trial presented at the annual meeting of the American Society of Clinical Oncology.

The regimen, given for just 12 28-day cycles, also achieved the highest rate of minimal residual disease (MRD)-negative responses ever seen in a randomized prospective CLL study, according to investigator Kirsten Fischer, MD, of the University of Cologne in Germany.

“We really think that these unprecedented MRD negativity levels will eventually translate into an improved overall survival,” Dr. Fischer said during an oral abstract presentation.

Matthew Steven Davids, MD, of Dana-Farber Cancer Institute/Harvard Medical School, Boston, said venetoclax plus obinutuzumab offers the potential for 1-year, time-limited therapy, which limits concerns over long-term adherence and has the potential for cost savings, should the therapy prove to be highly durable with further follow-up.

“A limitation of the study is that the comparator arm – chlorambucil plus obinutuzumab – is directly applicable to only a relatively small subset of our older and frailer CLL patients,” Dr. Davids said during a podium discussion of the results.

“But nonetheless, venetoclax plus obinutuzumab is a promising, time-limited regimen, and CLL14 is an immediately practice-changing study for frontline CLL treatment,” he added.

The regimen stands in contrast to ibrutinib, which offers durable responses but requires continuous dosing, and FCR (fludarabine, cyclophosphamide, and rituximab), a time-limited therapy with curative potential that is restricted to younger patients with IGHV-mutated CLL, according to Dr. Davids.

In CLL-14, 432 patients were randomized 1:1 to receive venetoclax-obinutuzumab for six cycles followed by venetoclax for six cycles, or chlorambucil-obinutuzumab for six cycles followed by chlorambucil for six cycles. The median age was 72 years in the venetoclax-obinutuzumab arm and 71 years in the chlorambucil-obinutuzumab arm.

The overall response rate was 85% for venetoclax-obinutuzumab and 71% for chlorambucil-obinutuzumab (P = .0007), Dr. Fischer reported at the meeting.

The improvement in progression-free survival seen in the overall study population was also seen in patients with TP53 deletions or mutations, and in those with unmutated IGHV, Dr. Fischer reported.

Rates of MRD negativity in peripheral blood were 76% versus 35% for the venetoclax- and chlorambucil-containing combinations, respectively (P less than .001), and similarly, MRD negativity in bone marrow was 57% versus 17% (P less than .001), she said.

There were no significant differences in the rates of grade 3 or 4 neutropenia, which occurred in 52.8% of the venetoclax–obinutuzumab treated patients and 48.1% of the chlorambucil-obinutuzumab treated patients, or in grade 3 or 4 infections, which occurred in 17.5% and 15.0%, respectively, according to a report, published simultaneously in the New England Journal of Medicine (2019;380:2225-36).

Likewise, all-cause mortality was not significantly different between the arms, at 9.3% and 7.9%, respectively.

F. Hoffmann-La Roche and AbbVie supported the study. Dr. Fischer reported travel, accommodations, or expenses from Roche in her abstract disclosure.

SOURCE: Fischer K et al. ASCO 2019, Abstract 7502.

CHICAGO – A fixed-duration venetoclax-obinutuzumab regimen is safe and provides a superior outcome versus standard chlorambucil-obinutuzumab in elderly patients with untreated chronic lymphocytic leukemia (CLL) and comorbidities, results of a randomized phase 3 trial showed.

At 24 months, progression-free survival was 88.2% for the venetoclax-obinutuzumab regimen, versus 64.1% for chlorambucil-obinutuzumab (hazard ratio, 0.35; 95% confidence interval, 0.23-0.53; P less than .0001) in CLL-14, an open-label, multinational trial presented at the annual meeting of the American Society of Clinical Oncology.

The regimen, given for just 12 28-day cycles, also achieved the highest rate of minimal residual disease (MRD)-negative responses ever seen in a randomized prospective CLL study, according to investigator Kirsten Fischer, MD, of the University of Cologne in Germany.

“We really think that these unprecedented MRD negativity levels will eventually translate into an improved overall survival,” Dr. Fischer said during an oral abstract presentation.

Matthew Steven Davids, MD, of Dana-Farber Cancer Institute/Harvard Medical School, Boston, said venetoclax plus obinutuzumab offers the potential for 1-year, time-limited therapy, which limits concerns over long-term adherence and has the potential for cost savings, should the therapy prove to be highly durable with further follow-up.

“A limitation of the study is that the comparator arm – chlorambucil plus obinutuzumab – is directly applicable to only a relatively small subset of our older and frailer CLL patients,” Dr. Davids said during a podium discussion of the results.

“But nonetheless, venetoclax plus obinutuzumab is a promising, time-limited regimen, and CLL14 is an immediately practice-changing study for frontline CLL treatment,” he added.

The regimen stands in contrast to ibrutinib, which offers durable responses but requires continuous dosing, and FCR (fludarabine, cyclophosphamide, and rituximab), a time-limited therapy with curative potential that is restricted to younger patients with IGHV-mutated CLL, according to Dr. Davids.

In CLL-14, 432 patients were randomized 1:1 to receive venetoclax-obinutuzumab for six cycles followed by venetoclax for six cycles, or chlorambucil-obinutuzumab for six cycles followed by chlorambucil for six cycles. The median age was 72 years in the venetoclax-obinutuzumab arm and 71 years in the chlorambucil-obinutuzumab arm.

The overall response rate was 85% for venetoclax-obinutuzumab and 71% for chlorambucil-obinutuzumab (P = .0007), Dr. Fischer reported at the meeting.

The improvement in progression-free survival seen in the overall study population was also seen in patients with TP53 deletions or mutations, and in those with unmutated IGHV, Dr. Fischer reported.

Rates of MRD negativity in peripheral blood were 76% versus 35% for the venetoclax- and chlorambucil-containing combinations, respectively (P less than .001), and similarly, MRD negativity in bone marrow was 57% versus 17% (P less than .001), she said.

There were no significant differences in the rates of grade 3 or 4 neutropenia, which occurred in 52.8% of the venetoclax–obinutuzumab treated patients and 48.1% of the chlorambucil-obinutuzumab treated patients, or in grade 3 or 4 infections, which occurred in 17.5% and 15.0%, respectively, according to a report, published simultaneously in the New England Journal of Medicine (2019;380:2225-36).

Likewise, all-cause mortality was not significantly different between the arms, at 9.3% and 7.9%, respectively.

F. Hoffmann-La Roche and AbbVie supported the study. Dr. Fischer reported travel, accommodations, or expenses from Roche in her abstract disclosure.

SOURCE: Fischer K et al. ASCO 2019, Abstract 7502.

Particular features of the vaginal microbiome were significantly associated with an increased risk of preterm birth in an analysis of approximately 12,000 samples, according to a study published in Nature Medicine.

CDC/Janice Carr

Preterm births, defined as less than 37 weeks’ gestation, remain the second most common cause of neonatal death worldwide, but few strategies exist to prevent and predict preterm birth (PTB) wrote Jennifer M. Fettweis, MD, of Virginia Commonwealth University, Richmond, and her colleagues. In the United States, women of African ancestry are at significantly greater risk for PTB.

A highly diverse vaginal microbiome is thought to be associated with an increased risk of inflammation, infection, and PTB, “however, many asymptomatic healthy women have diverse vaginal microbiota,” the researchers said.

To identify vaginal microbiota distinct to women who experienced PTB, the researchers analyzed data from the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI), part of the National Institutes of Health–sponsored Integrative Human Microbiome Project. The MOMS-PI study included 12,039 samples of vaginal flora from 597 pregnancies; the analysis included 45 singleton pregnancies that met the criteria for spontaneous PTB (23-36 weeks, 6 days of gestation) and 90 case-matched full-term singleton pregnancies (greater than or equal to 39 weeks). Approximately 78% of the women were of African descent in both groups, and their average age was 26 years in both groups.

Overall, the diversity of the vaginal microbiome was greater among women who experienced PTB, compared with term birth (TB). Women who experienced PTB had less Lactobacillus crispatus, but more bacterial vaginosis–associated bacterium-1 (BVAB1), Prevotella cluster 2, and Sneathia amnii, compared with TB women.

Of note, vaginal cytokine data showed that proinflammatory cytokines, which may be associated with the induction of labor, may be prompted by inflammation in the vaginal microbiome, Dr. Fettweis and her associates said. “We observed that vaginal IP-10/CXCL10 levels were inversely correlated with BVAB1 in PTB, inversely correlated with L. crispatus in TB, and positively correlated with L. iners in TB, suggesting complex host-microbiome interactions in pregnancy,” they said.

“Further studies are needed to determine whether the signatures of PTB reported in the present study replicate in other cohorts of women of African ancestry, to examine whether the observed differences in vaginal microbiome composition between women of different ancestries has a direct causal link to the ethnic and racial disparities in PTB rates, and to establish whether population-specific microbial markers can be ultimately integrated into a generalizable spectrum of vaginal microbiome states linked to the risk for PTB,” Dr. Fettweis and her associates said.

In a companion study also published in Nature Medicine, Myrna G. Serrano, MD, also of Virginia Commonwealth University, and her colleagues as part of the MOMS-PI initially determined that vaginal microbiome profiles varied between 613 pregnant and 1,969 nonpregnant women in that “pregnant women had significantly higher prevalence of the four most common Lactobacillus vagitypes (L. crispatus, L. iners, L. gasseri, and L. jensenii) and a commensurately lower prevalence of vagitypes dominated by other taxa.” The primary driver of the differences was L. iners.

They then compared vaginal microbiome data from 300 pregnant and 300 nonpregnant case-matched women of African, Hispanic, or European ancestry, as well as 90 pregnant women (49 of African ancestry and 41 of European) ancestry.

In the subset of 300 pregnant and 300 nonpregnant women, the vaginal microbiome of the pregnant women overall became more dominated by Lactobacillus early in pregnancy. Further stratification by race showed that pregnant women of African and Hispanic ancestry had significantly higher levels of four types of Lactobacillus than their nonpregnant counterparts, but no significant difference was seen between pregnant and nonpregnant women of European ancestry.

“It appears that changes occurring during pregnancy may render the reproductive tracts of women of all racial backgrounds more hospitable to taxa of Lactobacillus and less favorable for Gardnerella vaginalis and other taxa associated with BV [bacterial vaginosis] and dysbiosis,” the researchers said.

“Interestingly, BVAB1, which has been associated with dysbiotic vaginal conditions and risk of PTB, and which is present as a major vagitype largely in women of African ancestry, is not noticeably decreased in prevalence in pregnancy,” Dr. Serrano and her associates said. “Thus, BVAB1, for reasons yet to be determined, is apparently resistant to factors sculpting the microbiome in pregnant women, possibly explaining in part the enhanced risk for PTB experienced by women of African ancestry.”

In a look at the 49 pregnant women of African ancestry and 41 of European ancestry, those of African ancestry had “significantly lower representation of the L. crispatus, L. gasseri and L. jensenii vagitypes, and higher representation of L. iners and BVAB1 vagitypes. Variability in women of African ancestry was driven by BVAB1 and L. iners, whereas variability in women of non-African ancestry was driven by L. crispatus and L. iners. Again, pregnancy had no significant effect on prevalence of the BVAB1 vagitype. Prevalence of Lactobacillus-dominated profiles in women of African ancestry was lower in the first than in later trimesters, whereas women of European ancestry had a higher prevalence of Lactobacillus vagitypes throughout pregnancy.”

The presence of vaginal microbiome profiles associated with adverse pregnancy outcomes highlights the need for further studies that take advantage of this information, Dr. Serrano and her associates said. “That the vaginal microbiomes known to confer higher risk of poor health and adverse outcomes of pregnancy are more highly associated with women of African and Hispanic ancestry, but that pregnancy tends to drive these microbiomes toward more favorable microbiota, suggests that an external intervention that favors this trend might be beneficial for these populations,” they concluded. “What remains is to verify the most favorable microbiome and the most effective strategy for intervention.”

Dr. Fettweis had no financial conflicts to disclose; two coauthors are full-time employees at Pacific Biosciences. Dr. Serrano and her coauthors had no relevant financial disclosures. Dr. Serrano’s study received grants from the National Institutes of Health and other sources, as well as support from the Common Fund, the National Center for Complementary and Integrative Health, the Office of Research on Women’s Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases.

SOURCES: Fettweis J et al. Nature Medicine 2019 May 29. doi: 10.1038/s41591-019-0450-2; Serrano M et al. Nature Medicine. 2019 May 29. doi: 10.1038/s41591-019-0465-8.

Particular features of the vaginal microbiome were significantly associated with an increased risk of preterm birth in an analysis of approximately 12,000 samples, according to a study published in Nature Medicine.

CDC/Janice Carr

Preterm births, defined as less than 37 weeks’ gestation, remain the second most common cause of neonatal death worldwide, but few strategies exist to prevent and predict preterm birth (PTB) wrote Jennifer M. Fettweis, MD, of Virginia Commonwealth University, Richmond, and her colleagues. In the United States, women of African ancestry are at significantly greater risk for PTB.

A highly diverse vaginal microbiome is thought to be associated with an increased risk of inflammation, infection, and PTB, “however, many asymptomatic healthy women have diverse vaginal microbiota,” the researchers said.

To identify vaginal microbiota distinct to women who experienced PTB, the researchers analyzed data from the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI), part of the National Institutes of Health–sponsored Integrative Human Microbiome Project. The MOMS-PI study included 12,039 samples of vaginal flora from 597 pregnancies; the analysis included 45 singleton pregnancies that met the criteria for spontaneous PTB (23-36 weeks, 6 days of gestation) and 90 case-matched full-term singleton pregnancies (greater than or equal to 39 weeks). Approximately 78% of the women were of African descent in both groups, and their average age was 26 years in both groups.

Overall, the diversity of the vaginal microbiome was greater among women who experienced PTB, compared with term birth (TB). Women who experienced PTB had less Lactobacillus crispatus, but more bacterial vaginosis–associated bacterium-1 (BVAB1), Prevotella cluster 2, and Sneathia amnii, compared with TB women.

Of note, vaginal cytokine data showed that proinflammatory cytokines, which may be associated with the induction of labor, may be prompted by inflammation in the vaginal microbiome, Dr. Fettweis and her associates said. “We observed that vaginal IP-10/CXCL10 levels were inversely correlated with BVAB1 in PTB, inversely correlated with L. crispatus in TB, and positively correlated with L. iners in TB, suggesting complex host-microbiome interactions in pregnancy,” they said.

“Further studies are needed to determine whether the signatures of PTB reported in the present study replicate in other cohorts of women of African ancestry, to examine whether the observed differences in vaginal microbiome composition between women of different ancestries has a direct causal link to the ethnic and racial disparities in PTB rates, and to establish whether population-specific microbial markers can be ultimately integrated into a generalizable spectrum of vaginal microbiome states linked to the risk for PTB,” Dr. Fettweis and her associates said.

In a companion study also published in Nature Medicine, Myrna G. Serrano, MD, also of Virginia Commonwealth University, and her colleagues as part of the MOMS-PI initially determined that vaginal microbiome profiles varied between 613 pregnant and 1,969 nonpregnant women in that “pregnant women had significantly higher prevalence of the four most common Lactobacillus vagitypes (L. crispatus, L. iners, L. gasseri, and L. jensenii) and a commensurately lower prevalence of vagitypes dominated by other taxa.” The primary driver of the differences was L. iners.

They then compared vaginal microbiome data from 300 pregnant and 300 nonpregnant case-matched women of African, Hispanic, or European ancestry, as well as 90 pregnant women (49 of African ancestry and 41 of European) ancestry.

In the subset of 300 pregnant and 300 nonpregnant women, the vaginal microbiome of the pregnant women overall became more dominated by Lactobacillus early in pregnancy. Further stratification by race showed that pregnant women of African and Hispanic ancestry had significantly higher levels of four types of Lactobacillus than their nonpregnant counterparts, but no significant difference was seen between pregnant and nonpregnant women of European ancestry.

“It appears that changes occurring during pregnancy may render the reproductive tracts of women of all racial backgrounds more hospitable to taxa of Lactobacillus and less favorable for Gardnerella vaginalis and other taxa associated with BV [bacterial vaginosis] and dysbiosis,” the researchers said.

“Interestingly, BVAB1, which has been associated with dysbiotic vaginal conditions and risk of PTB, and which is present as a major vagitype largely in women of African ancestry, is not noticeably decreased in prevalence in pregnancy,” Dr. Serrano and her associates said. “Thus, BVAB1, for reasons yet to be determined, is apparently resistant to factors sculpting the microbiome in pregnant women, possibly explaining in part the enhanced risk for PTB experienced by women of African ancestry.”

In a look at the 49 pregnant women of African ancestry and 41 of European ancestry, those of African ancestry had “significantly lower representation of the L. crispatus, L. gasseri and L. jensenii vagitypes, and higher representation of L. iners and BVAB1 vagitypes. Variability in women of African ancestry was driven by BVAB1 and L. iners, whereas variability in women of non-African ancestry was driven by L. crispatus and L. iners. Again, pregnancy had no significant effect on prevalence of the BVAB1 vagitype. Prevalence of Lactobacillus-dominated profiles in women of African ancestry was lower in the first than in later trimesters, whereas women of European ancestry had a higher prevalence of Lactobacillus vagitypes throughout pregnancy.”

The presence of vaginal microbiome profiles associated with adverse pregnancy outcomes highlights the need for further studies that take advantage of this information, Dr. Serrano and her associates said. “That the vaginal microbiomes known to confer higher risk of poor health and adverse outcomes of pregnancy are more highly associated with women of African and Hispanic ancestry, but that pregnancy tends to drive these microbiomes toward more favorable microbiota, suggests that an external intervention that favors this trend might be beneficial for these populations,” they concluded. “What remains is to verify the most favorable microbiome and the most effective strategy for intervention.”

Dr. Fettweis had no financial conflicts to disclose; two coauthors are full-time employees at Pacific Biosciences. Dr. Serrano and her coauthors had no relevant financial disclosures. Dr. Serrano’s study received grants from the National Institutes of Health and other sources, as well as support from the Common Fund, the National Center for Complementary and Integrative Health, the Office of Research on Women’s Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases.

SOURCES: Fettweis J et al. Nature Medicine 2019 May 29. doi: 10.1038/s41591-019-0450-2; Serrano M et al. Nature Medicine. 2019 May 29. doi: 10.1038/s41591-019-0465-8.

Particular features of the vaginal microbiome were significantly associated with an increased risk of preterm birth in an analysis of approximately 12,000 samples, according to a study published in Nature Medicine.

CDC/Janice Carr

Preterm births, defined as less than 37 weeks’ gestation, remain the second most common cause of neonatal death worldwide, but few strategies exist to prevent and predict preterm birth (PTB) wrote Jennifer M. Fettweis, MD, of Virginia Commonwealth University, Richmond, and her colleagues. In the United States, women of African ancestry are at significantly greater risk for PTB.

A highly diverse vaginal microbiome is thought to be associated with an increased risk of inflammation, infection, and PTB, “however, many asymptomatic healthy women have diverse vaginal microbiota,” the researchers said.

To identify vaginal microbiota distinct to women who experienced PTB, the researchers analyzed data from the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI), part of the National Institutes of Health–sponsored Integrative Human Microbiome Project. The MOMS-PI study included 12,039 samples of vaginal flora from 597 pregnancies; the analysis included 45 singleton pregnancies that met the criteria for spontaneous PTB (23-36 weeks, 6 days of gestation) and 90 case-matched full-term singleton pregnancies (greater than or equal to 39 weeks). Approximately 78% of the women were of African descent in both groups, and their average age was 26 years in both groups.

Overall, the diversity of the vaginal microbiome was greater among women who experienced PTB, compared with term birth (TB). Women who experienced PTB had less Lactobacillus crispatus, but more bacterial vaginosis–associated bacterium-1 (BVAB1), Prevotella cluster 2, and Sneathia amnii, compared with TB women.

Of note, vaginal cytokine data showed that proinflammatory cytokines, which may be associated with the induction of labor, may be prompted by inflammation in the vaginal microbiome, Dr. Fettweis and her associates said. “We observed that vaginal IP-10/CXCL10 levels were inversely correlated with BVAB1 in PTB, inversely correlated with L. crispatus in TB, and positively correlated with L. iners in TB, suggesting complex host-microbiome interactions in pregnancy,” they said.

“Further studies are needed to determine whether the signatures of PTB reported in the present study replicate in other cohorts of women of African ancestry, to examine whether the observed differences in vaginal microbiome composition between women of different ancestries has a direct causal link to the ethnic and racial disparities in PTB rates, and to establish whether population-specific microbial markers can be ultimately integrated into a generalizable spectrum of vaginal microbiome states linked to the risk for PTB,” Dr. Fettweis and her associates said.

In a companion study also published in Nature Medicine, Myrna G. Serrano, MD, also of Virginia Commonwealth University, and her colleagues as part of the MOMS-PI initially determined that vaginal microbiome profiles varied between 613 pregnant and 1,969 nonpregnant women in that “pregnant women had significantly higher prevalence of the four most common Lactobacillus vagitypes (L. crispatus, L. iners, L. gasseri, and L. jensenii) and a commensurately lower prevalence of vagitypes dominated by other taxa.” The primary driver of the differences was L. iners.

They then compared vaginal microbiome data from 300 pregnant and 300 nonpregnant case-matched women of African, Hispanic, or European ancestry, as well as 90 pregnant women (49 of African ancestry and 41 of European) ancestry.

In the subset of 300 pregnant and 300 nonpregnant women, the vaginal microbiome of the pregnant women overall became more dominated by Lactobacillus early in pregnancy. Further stratification by race showed that pregnant women of African and Hispanic ancestry had significantly higher levels of four types of Lactobacillus than their nonpregnant counterparts, but no significant difference was seen between pregnant and nonpregnant women of European ancestry.

“It appears that changes occurring during pregnancy may render the reproductive tracts of women of all racial backgrounds more hospitable to taxa of Lactobacillus and less favorable for Gardnerella vaginalis and other taxa associated with BV [bacterial vaginosis] and dysbiosis,” the researchers said.

“Interestingly, BVAB1, which has been associated with dysbiotic vaginal conditions and risk of PTB, and which is present as a major vagitype largely in women of African ancestry, is not noticeably decreased in prevalence in pregnancy,” Dr. Serrano and her associates said. “Thus, BVAB1, for reasons yet to be determined, is apparently resistant to factors sculpting the microbiome in pregnant women, possibly explaining in part the enhanced risk for PTB experienced by women of African ancestry.”

In a look at the 49 pregnant women of African ancestry and 41 of European ancestry, those of African ancestry had “significantly lower representation of the L. crispatus, L. gasseri and L. jensenii vagitypes, and higher representation of L. iners and BVAB1 vagitypes. Variability in women of African ancestry was driven by BVAB1 and L. iners, whereas variability in women of non-African ancestry was driven by L. crispatus and L. iners. Again, pregnancy had no significant effect on prevalence of the BVAB1 vagitype. Prevalence of Lactobacillus-dominated profiles in women of African ancestry was lower in the first than in later trimesters, whereas women of European ancestry had a higher prevalence of Lactobacillus vagitypes throughout pregnancy.”

The presence of vaginal microbiome profiles associated with adverse pregnancy outcomes highlights the need for further studies that take advantage of this information, Dr. Serrano and her associates said. “That the vaginal microbiomes known to confer higher risk of poor health and adverse outcomes of pregnancy are more highly associated with women of African and Hispanic ancestry, but that pregnancy tends to drive these microbiomes toward more favorable microbiota, suggests that an external intervention that favors this trend might be beneficial for these populations,” they concluded. “What remains is to verify the most favorable microbiome and the most effective strategy for intervention.”

Dr. Fettweis had no financial conflicts to disclose; two coauthors are full-time employees at Pacific Biosciences. Dr. Serrano and her coauthors had no relevant financial disclosures. Dr. Serrano’s study received grants from the National Institutes of Health and other sources, as well as support from the Common Fund, the National Center for Complementary and Integrative Health, the Office of Research on Women’s Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases.

SOURCES: Fettweis J et al. Nature Medicine 2019 May 29. doi: 10.1038/s41591-019-0450-2; Serrano M et al. Nature Medicine. 2019 May 29. doi: 10.1038/s41591-019-0465-8.

The past 20 years has seen an explosion of approaches to improve the recognition of children who deteriorate in the hospital. Early Warning Scores, Rapid Response Teams, Situational Awareness, and Parent-Triggered Activation systems are a few of the safety initiatives implemented worldwide. Many have an inherent face validity; for example, it would appear to be intuitive that highlighting the changes in physiology via a Pediatric Early Warning Score (PEWS) would enable staff to recognize a change in disease process and intervene accordingly. However, although mortality trends have been shown to diminish over time,¹ the evidence base supporting their impact has often been quite heterogeneous.^2,3 In particular, a recent international randomized control trial of a PEWS approach was found not to improve overall mortality.⁴

A major challenge with the evaluation of these patient safety systems is the reliance on mortality as an outcome measure. This is relatively rare, even in large tertiary institutions with complex patients and finding other proxy measures of quality of care are important. Hussain et al. have created a relatively easy to measure metric, an emergency transfer (ET). The benefit of the ET is its simplicity and transferability, which is described as follows:

“Emergency Transfer (ET) is defined as any patient transferred to the ICU where the patient received intubation, inotropes, or three or more fluid boluses in the first hour after arrival or before transfer.”⁵

All these components are easily extractable from written or electronic records and are representative of meaningful deterioration. Pressure on bed states, challenges with staff skill mix, and increasing parental expectation may all impact on decisions to transfer patients. The ET metric is relatively immune to these biases as its tight time definition separates it from the previous Bonafide et al.⁶ measure (similar interventions but within a 12-hour window) as being centered on an abrupt critical change, rather than a potential drift toward deterioration. This makes the measure useful not only to an individual institution to measure the impact of an intervention but also internationally, as a comparison between institutions will not be influenced by health system differences.

The ET metric is important as Hussain et al. have demonstrated that it is associated with a worse outcome for the child both as a concrete outcome (increased mortality when it does occur) and as an experience (a longer stay in hospital). “You can’t improve what you can’t measure” is an old improvement maxim, and only by broadening our use of alternative metrics of care will we be able to understand which interventions will make a difference to patients. Certainly, evidence suggests that cultures, hierarchies, and leadership may well be as important as other more concrete or tangible tools,⁷ but these have seldom been evaluated as part of studies on improving the response to deterioration. The pediatric early warning system utilization and mortality avoidance (PUMA) study, a research program funded by the National Institute for Health Research (United Kingdom), is exploring these tools and will likely report later in 2019.⁸

Two immediate practical implications of this work emerge, which should be of relevance to clinical leaders in children’s hospitals. The first is that it is highly likely that there will be some events you cannot anticipate. A bronchiolitic infant is always likely to suddenly plug off, and invasive group A streptococcus is a mastery of mimicry and deceit. The authors noted that even with a mature, long-standing Rapid Response System process, ETs were still associated with adverse outcomes. Therefore, it may well be that the ET metric measured over time delineates a locally defined acceptable level of unplanned intensive care admission. If your hospital is significantly above this, they must seriously look at how they can improve their performance. It should be noted here that there were only 45 ETs identified in 4.5 years in Cincinnati and 50% of these were from specialist units within the hospital. It is possible that perhaps the ETs will in the future become as rare as mortality is today, and as hospitals improve, new frames of reference will be needed.

These new references are likely to come from high-performing child health institutions such as those in Philadelphia and Cincinnati, and this leads to a second important principle that hospitals should acknowledge. One of the reasons for patient safety success is the relentless pursuit of excellence. The very act of consistently, and transparently, auditing and analyzing performance is vital to change outcomes. We should digest, evaluate, adopt, and improve the research that groups such as these are undertaking as, although sometimes imperfect, they should also inspire us to ensure that children in our own institutions are as safe as they possibly can be.

Disclosure

Dr. Roland reports that he is currently the cochief investigator of a National Institute for Health Research (NIHR) grant investigating pediatric early warning systems (the PUMA study)

The past 20 years has seen an explosion of approaches to improve the recognition of children who deteriorate in the hospital. Early Warning Scores, Rapid Response Teams, Situational Awareness, and Parent-Triggered Activation systems are a few of the safety initiatives implemented worldwide. Many have an inherent face validity; for example, it would appear to be intuitive that highlighting the changes in physiology via a Pediatric Early Warning Score (PEWS) would enable staff to recognize a change in disease process and intervene accordingly. However, although mortality trends have been shown to diminish over time,¹ the evidence base supporting their impact has often been quite heterogeneous.^2,3 In particular, a recent international randomized control trial of a PEWS approach was found not to improve overall mortality.⁴

A major challenge with the evaluation of these patient safety systems is the reliance on mortality as an outcome measure. This is relatively rare, even in large tertiary institutions with complex patients and finding other proxy measures of quality of care are important. Hussain et al. have created a relatively easy to measure metric, an emergency transfer (ET). The benefit of the ET is its simplicity and transferability, which is described as follows:

“Emergency Transfer (ET) is defined as any patient transferred to the ICU where the patient received intubation, inotropes, or three or more fluid boluses in the first hour after arrival or before transfer.”⁵

All these components are easily extractable from written or electronic records and are representative of meaningful deterioration. Pressure on bed states, challenges with staff skill mix, and increasing parental expectation may all impact on decisions to transfer patients. The ET metric is relatively immune to these biases as its tight time definition separates it from the previous Bonafide et al.⁶ measure (similar interventions but within a 12-hour window) as being centered on an abrupt critical change, rather than a potential drift toward deterioration. This makes the measure useful not only to an individual institution to measure the impact of an intervention but also internationally, as a comparison between institutions will not be influenced by health system differences.

The ET metric is important as Hussain et al. have demonstrated that it is associated with a worse outcome for the child both as a concrete outcome (increased mortality when it does occur) and as an experience (a longer stay in hospital). “You can’t improve what you can’t measure” is an old improvement maxim, and only by broadening our use of alternative metrics of care will we be able to understand which interventions will make a difference to patients. Certainly, evidence suggests that cultures, hierarchies, and leadership may well be as important as other more concrete or tangible tools,⁷ but these have seldom been evaluated as part of studies on improving the response to deterioration. The pediatric early warning system utilization and mortality avoidance (PUMA) study, a research program funded by the National Institute for Health Research (United Kingdom), is exploring these tools and will likely report later in 2019.⁸

Two immediate practical implications of this work emerge, which should be of relevance to clinical leaders in children’s hospitals. The first is that it is highly likely that there will be some events you cannot anticipate. A bronchiolitic infant is always likely to suddenly plug off, and invasive group A streptococcus is a mastery of mimicry and deceit. The authors noted that even with a mature, long-standing Rapid Response System process, ETs were still associated with adverse outcomes. Therefore, it may well be that the ET metric measured over time delineates a locally defined acceptable level of unplanned intensive care admission. If your hospital is significantly above this, they must seriously look at how they can improve their performance. It should be noted here that there were only 45 ETs identified in 4.5 years in Cincinnati and 50% of these were from specialist units within the hospital. It is possible that perhaps the ETs will in the future become as rare as mortality is today, and as hospitals improve, new frames of reference will be needed.

These new references are likely to come from high-performing child health institutions such as those in Philadelphia and Cincinnati, and this leads to a second important principle that hospitals should acknowledge. One of the reasons for patient safety success is the relentless pursuit of excellence. The very act of consistently, and transparently, auditing and analyzing performance is vital to change outcomes. We should digest, evaluate, adopt, and improve the research that groups such as these are undertaking as, although sometimes imperfect, they should also inspire us to ensure that children in our own institutions are as safe as they possibly can be.

Disclosure

Dr. Roland reports that he is currently the cochief investigator of a National Institute for Health Research (NIHR) grant investigating pediatric early warning systems (the PUMA study)

The past 20 years has seen an explosion of approaches to improve the recognition of children who deteriorate in the hospital. Early Warning Scores, Rapid Response Teams, Situational Awareness, and Parent-Triggered Activation systems are a few of the safety initiatives implemented worldwide. Many have an inherent face validity; for example, it would appear to be intuitive that highlighting the changes in physiology via a Pediatric Early Warning Score (PEWS) would enable staff to recognize a change in disease process and intervene accordingly. However, although mortality trends have been shown to diminish over time,¹ the evidence base supporting their impact has often been quite heterogeneous.^2,3 In particular, a recent international randomized control trial of a PEWS approach was found not to improve overall mortality.⁴

A major challenge with the evaluation of these patient safety systems is the reliance on mortality as an outcome measure. This is relatively rare, even in large tertiary institutions with complex patients and finding other proxy measures of quality of care are important. Hussain et al. have created a relatively easy to measure metric, an emergency transfer (ET). The benefit of the ET is its simplicity and transferability, which is described as follows:

“Emergency Transfer (ET) is defined as any patient transferred to the ICU where the patient received intubation, inotropes, or three or more fluid boluses in the first hour after arrival or before transfer.”⁵

All these components are easily extractable from written or electronic records and are representative of meaningful deterioration. Pressure on bed states, challenges with staff skill mix, and increasing parental expectation may all impact on decisions to transfer patients. The ET metric is relatively immune to these biases as its tight time definition separates it from the previous Bonafide et al.⁶ measure (similar interventions but within a 12-hour window) as being centered on an abrupt critical change, rather than a potential drift toward deterioration. This makes the measure useful not only to an individual institution to measure the impact of an intervention but also internationally, as a comparison between institutions will not be influenced by health system differences.

The ET metric is important as Hussain et al. have demonstrated that it is associated with a worse outcome for the child both as a concrete outcome (increased mortality when it does occur) and as an experience (a longer stay in hospital). “You can’t improve what you can’t measure” is an old improvement maxim, and only by broadening our use of alternative metrics of care will we be able to understand which interventions will make a difference to patients. Certainly, evidence suggests that cultures, hierarchies, and leadership may well be as important as other more concrete or tangible tools,⁷ but these have seldom been evaluated as part of studies on improving the response to deterioration. The pediatric early warning system utilization and mortality avoidance (PUMA) study, a research program funded by the National Institute for Health Research (United Kingdom), is exploring these tools and will likely report later in 2019.⁸

Two immediate practical implications of this work emerge, which should be of relevance to clinical leaders in children’s hospitals. The first is that it is highly likely that there will be some events you cannot anticipate. A bronchiolitic infant is always likely to suddenly plug off, and invasive group A streptococcus is a mastery of mimicry and deceit. The authors noted that even with a mature, long-standing Rapid Response System process, ETs were still associated with adverse outcomes. Therefore, it may well be that the ET metric measured over time delineates a locally defined acceptable level of unplanned intensive care admission. If your hospital is significantly above this, they must seriously look at how they can improve their performance. It should be noted here that there were only 45 ETs identified in 4.5 years in Cincinnati and 50% of these were from specialist units within the hospital. It is possible that perhaps the ETs will in the future become as rare as mortality is today, and as hospitals improve, new frames of reference will be needed.

These new references are likely to come from high-performing child health institutions such as those in Philadelphia and Cincinnati, and this leads to a second important principle that hospitals should acknowledge. One of the reasons for patient safety success is the relentless pursuit of excellence. The very act of consistently, and transparently, auditing and analyzing performance is vital to change outcomes. We should digest, evaluate, adopt, and improve the research that groups such as these are undertaking as, although sometimes imperfect, they should also inspire us to ensure that children in our own institutions are as safe as they possibly can be.

Disclosure

Dr. Roland reports that he is currently the cochief investigator of a National Institute for Health Research (NIHR) grant investigating pediatric early warning systems (the PUMA study)