Unresolved fatigue lingers for most PsA patients

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– Fatigue is an important symptom in patients with psoriatic arthritis but often goes unaddressed when treatment only involves disease modifying drugs.

A survey of more than 1,000 patients with psoriatic arthritis (PsA) in Denmark found that more than half had moderate or severe levels of fatigue, and a principal component analysis of the sources of fatigue found three factors responsible for the majority of reported patient fatigue: chronic inflammation, chronic pain, and chronification of the PsA, Tanja S. Jørgensen, PhD, said at the European Congress of Rheumatology.

Mitchel L. Zoler/Frontline Medical News
“These findings are highly suggestive that central sensitization is an important, extra-articular manifestation of psoriatic arthritis and should be a focus of patient management,” said Dr. Jørgensen, a clinical epidemiologist at the Parker Institute in Copenhagen.

“Pain is the most important symptom in patients with psoriatic arthritis, but fatigue is second-most important. It has a huge impact on patient quality of life,” she said.

“Just treating inflammation doesn’t do it all. We need to do more, think differently, think outside the box” of relying primarily on disease-modifying antirheumatic drugs, especially biological drugs, to resolve symptoms in PsA patients. “We should not think that biologicals do it all.”

The upshot is that PsA patients may have their inflammatory markers under control with treatment but still report that they don’t feel well, have pain, are tired, and have no energy.

But Dr. Jørgensen admitted that she couldn’t say with any certainty what additional interventions might help resolve pain and fatigue in PsA patients.

“I tell them to walk and be active; I think that may help. But we don’t really know what to do,” she said in an interview.

Her study included 1,062 PsA patients enrolled during December 2013-December 2014 in the Danish DANBIO registry of patients with inflammatory arthritides who received treatment with a biological drug. These participants also agreed to both complete a painDETECT Questionnaire and to rate their fatigue on a visual analog scale.

Dr. Jørgensen and her associates designated a visual analog scale score of at least 57 out of 100 as representing moderate or severe fatigue and found that 542 (51%) of the patients had fatigue self-ratings that fell in this range. Patients with this higher fatigue level also had significantly worse PsA with significantly higher numbers of swollen and tender joints, higher painDETECT scores, and higher scores on their Health Assessment Questionnaire and their 28-joint Disease Activity Score using C-reactive protein.

When the researchers ran a principal component analysis on these data, they identified three primary factors contributing to fatigue. Chronic inflammation contributed 31% of the fatigue effect, chronification contributed 17%, and chronic pain contributed 15%, Dr. Jørgensen reported.

Dr. Jørgensen has received research support from AbbVie, Biogen, Novartis, Pfizer, Roche, and UCB.

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– Fatigue is an important symptom in patients with psoriatic arthritis but often goes unaddressed when treatment only involves disease modifying drugs.

A survey of more than 1,000 patients with psoriatic arthritis (PsA) in Denmark found that more than half had moderate or severe levels of fatigue, and a principal component analysis of the sources of fatigue found three factors responsible for the majority of reported patient fatigue: chronic inflammation, chronic pain, and chronification of the PsA, Tanja S. Jørgensen, PhD, said at the European Congress of Rheumatology.

Mitchel L. Zoler/Frontline Medical News
“These findings are highly suggestive that central sensitization is an important, extra-articular manifestation of psoriatic arthritis and should be a focus of patient management,” said Dr. Jørgensen, a clinical epidemiologist at the Parker Institute in Copenhagen.

“Pain is the most important symptom in patients with psoriatic arthritis, but fatigue is second-most important. It has a huge impact on patient quality of life,” she said.

“Just treating inflammation doesn’t do it all. We need to do more, think differently, think outside the box” of relying primarily on disease-modifying antirheumatic drugs, especially biological drugs, to resolve symptoms in PsA patients. “We should not think that biologicals do it all.”

The upshot is that PsA patients may have their inflammatory markers under control with treatment but still report that they don’t feel well, have pain, are tired, and have no energy.

But Dr. Jørgensen admitted that she couldn’t say with any certainty what additional interventions might help resolve pain and fatigue in PsA patients.

“I tell them to walk and be active; I think that may help. But we don’t really know what to do,” she said in an interview.

Her study included 1,062 PsA patients enrolled during December 2013-December 2014 in the Danish DANBIO registry of patients with inflammatory arthritides who received treatment with a biological drug. These participants also agreed to both complete a painDETECT Questionnaire and to rate their fatigue on a visual analog scale.

Dr. Jørgensen and her associates designated a visual analog scale score of at least 57 out of 100 as representing moderate or severe fatigue and found that 542 (51%) of the patients had fatigue self-ratings that fell in this range. Patients with this higher fatigue level also had significantly worse PsA with significantly higher numbers of swollen and tender joints, higher painDETECT scores, and higher scores on their Health Assessment Questionnaire and their 28-joint Disease Activity Score using C-reactive protein.

When the researchers ran a principal component analysis on these data, they identified three primary factors contributing to fatigue. Chronic inflammation contributed 31% of the fatigue effect, chronification contributed 17%, and chronic pain contributed 15%, Dr. Jørgensen reported.

Dr. Jørgensen has received research support from AbbVie, Biogen, Novartis, Pfizer, Roche, and UCB.

 

– Fatigue is an important symptom in patients with psoriatic arthritis but often goes unaddressed when treatment only involves disease modifying drugs.

A survey of more than 1,000 patients with psoriatic arthritis (PsA) in Denmark found that more than half had moderate or severe levels of fatigue, and a principal component analysis of the sources of fatigue found three factors responsible for the majority of reported patient fatigue: chronic inflammation, chronic pain, and chronification of the PsA, Tanja S. Jørgensen, PhD, said at the European Congress of Rheumatology.

Mitchel L. Zoler/Frontline Medical News
“These findings are highly suggestive that central sensitization is an important, extra-articular manifestation of psoriatic arthritis and should be a focus of patient management,” said Dr. Jørgensen, a clinical epidemiologist at the Parker Institute in Copenhagen.

“Pain is the most important symptom in patients with psoriatic arthritis, but fatigue is second-most important. It has a huge impact on patient quality of life,” she said.

“Just treating inflammation doesn’t do it all. We need to do more, think differently, think outside the box” of relying primarily on disease-modifying antirheumatic drugs, especially biological drugs, to resolve symptoms in PsA patients. “We should not think that biologicals do it all.”

The upshot is that PsA patients may have their inflammatory markers under control with treatment but still report that they don’t feel well, have pain, are tired, and have no energy.

But Dr. Jørgensen admitted that she couldn’t say with any certainty what additional interventions might help resolve pain and fatigue in PsA patients.

“I tell them to walk and be active; I think that may help. But we don’t really know what to do,” she said in an interview.

Her study included 1,062 PsA patients enrolled during December 2013-December 2014 in the Danish DANBIO registry of patients with inflammatory arthritides who received treatment with a biological drug. These participants also agreed to both complete a painDETECT Questionnaire and to rate their fatigue on a visual analog scale.

Dr. Jørgensen and her associates designated a visual analog scale score of at least 57 out of 100 as representing moderate or severe fatigue and found that 542 (51%) of the patients had fatigue self-ratings that fell in this range. Patients with this higher fatigue level also had significantly worse PsA with significantly higher numbers of swollen and tender joints, higher painDETECT scores, and higher scores on their Health Assessment Questionnaire and their 28-joint Disease Activity Score using C-reactive protein.

When the researchers ran a principal component analysis on these data, they identified three primary factors contributing to fatigue. Chronic inflammation contributed 31% of the fatigue effect, chronification contributed 17%, and chronic pain contributed 15%, Dr. Jørgensen reported.

Dr. Jørgensen has received research support from AbbVie, Biogen, Novartis, Pfizer, Roche, and UCB.

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Key clinical point: A majority of psoriatic arthritis patients reported having moderate or severe fatigue despite receiving effective anti-inflammatory treatment.

Major finding: Visual analog scoring showed 51% of patients rated their fatigue as 57 or higher on a 0-100 scale.

Data source: A review of 1,062 Danish psoriatic arthritis patients treated with a biological drug and enrolled in the DANBIO registry

Disclosures: Dr. Jørgensen has received research support from AbbVie, Biogen, Novartis, Pfizer, Roche, and UCB.

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Clinically integrated networks: 5 roadblocks and how to overcome them

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CHICAGO – With growing pressure to deliver higher-quality care at reduced costs, more physicians and practices are looking to join a clinically integrated network. But establishing and successfully operating such a network is sometimes easier said than done.

A clinically integrated network is defined as a collection of health providers, such as physicians, hospitals, and post-acute specialists that join together to improve care and reduce costs. Such networks generally share record systems, track data, and rely on evidence-based guidelines to provide high-quality care across participating providers.

If a group meets Federal Trade Commission compliance requirements to be considered a clinically integrated network, the government will provide a safe harbor from antitrust scrutiny. The four components that networks must meet to be considered clinically integrated include: physician leadership and commitment, development and implementation of clinical practice guidelines to improve performance, development of infrastructure and technology, and financial incentives for achieving goals.

An accountable care organization (ACO) that participates in the Medicare Shared Savings Program is deemed “clinically integrated.” The clinical integration network (CIN) is the actual legal entity/network that the physicians join. Unlike physician hospital organizations (PHOs), clinically integrated networks can jointly negotiate contractual fees as long as the primary purpose of the negotiation is to achieve care improvement, according to a summary by the Medical Group Management Association.

Clinically integrated networks can also support ACOs or patient centered medical homes as part of the clinically integrated network by serving as a mechanism for sharing infrastructure and development costs.

“For doctors, participating in a clinically integrated network is an opportunity to work as part of a group, without giving up their independence,” George Mayzell, MD, chief clinical officer for Vizient Southeast, said during a recent American Bar Association meeting. Participation in such a network also may potentially support some of the alternative payment models under the Medicare Access and CHIP Reauthorization Act (MACRA), he said.

From financial challenges to lack of collaboration to data woes, physicians can face unexpected barriers as their clinically integrated network gets off the ground. Below, experts discuss the top five roadblocks to clinically integrated networks and how doctors and hospitals can overcome them.
 

1. Contribution reluctance

Although there is no hard-and-fast level, investments of time, energy, and financial resources by all participating providers are necessary to create and maintain a clinically integrated network, according to the Federal Trade Commission. However, physicians can sometimes be wary of contributing substantially to a new network, said April E. Schweitzer, a Chicago-based health law attorney who specializes in clinical integration networks and accountable care organizations.

Some doctors feel comfortable contributing only nominal amounts or believe that the system should bear the burden of costs, Ms. Schweitzer said at an American Bar Association meeting.

April Schweitzer
“There’s no bright line dollar amount that the government agencies say is enough,” Ms. Schweitzer said at the meeting. “So [networks] really need to demonstrate participation and physician buy-in.”

Consider different contribution options that will satisfy new members. One option is charging initiation fees, which typically run between $250 and $500, Ms. Schweitzer said. Another option is charging annual dues, which can be a similar amount, depending on specialty. If hesitation among members continues, come up with an alternative plan, Ms. Schweitzer said.

“If opposition is strong, you might do away with those [options],” she said. “[Instead], you may say, ‘We’re going to take a portion of the bonus pool before going into any bonus distribution methodology to reimburse what we would’ve used those dues or initiation fees to cover to pay back the [network] and operating costs.”

2. Savings expectations

Network members often have high hopes when it comes to the savings and reimbursement bonuses they expect to see once the network launches. The reality can be disappointing, said Dr. Mayzell.

“Creating savings takes time and a high level of patience/commitment,” Dr. Mayzell said in an interview. “Even when the savings are realized early on, financial awards are often low, and if they’re spread out between all of the primary care physicians and the specialists, they are not very motivating. This must be taken into account.”

It helps to set reasonable expectations early on about reimbursement, Ms. Schweitzer said. The same goes for managing payer contract expectations.

“You want to manage expectations at the outset,” she said during the meeting. “And you really do want to be honest about what the payers in your market are looking for and are expecting.”

3. Balancing leadership

Sophisticated clinically integrated networks require significant infrastructure and IT costs, thus most are funded by a hospital or health system, Ms. Schweitzer said. As a result, the hospital or health system is likely to be the sole corporate member of the legal entity serving as the network. But because success within the network requires physicians to potentially change their practice patterns, it is important to have true physician leadership on the governing board of the clinically integrated network.

 

 

Class voting is one way to balance the need for a physician-led network with appropriate governance of a clinically integrated network, Ms. Schweitzer said in an interview. Class voting allows “physicians to comprise a majority of the governing board of a clinically integrated network [while allowing the corporate member] to retain decision-making power because the physician class gets one vote and the hospital or health system class gets one vote.”

In addition, she advised giving the hospital or health system certain reserved powers to protect the health system’s tax-exempt status. This includes:

  • Ensuring that the CIN serves community and charitable purposes.
  • Protecting and promoting the community benefits served by the corporate member and ensuring that the assets and income of the corporate member and the CIN are used to serve community objectives.
  • Protecting the assets and income of the corporate member and the CIN by ensuring that the CIN complies with all applicable laws and regulatory requirements.

4. EHR interoperability

For a successful network, quality data must be aggregated from all providers. This can prove challenging when independent physicians each have separate electronic health record systems, Dr. Mayzell said.

“You can try to aggregate this data manually, but that is extremely challenging,” he said in an interview. “To aggregate [EHR] level data, you generally need to use additional software and organizations that connect electronically with each of their systems. This is often very expensive and cumbersome, with each system requiring a different interface and often each version of each system requiring a different interface.”

In the beginning stages of the network, survey all participating providers about the most widely used EHR systems to narrow interfacing to a manageable number, Ms. Schweitzer advised.

“This is what a lot of our clients are doing during the steering committee phase,” she said. “That’s when you’re bringing the health system and the doctors together to make decisions about how this entity will run.”

Additionally, consider alternative methods for data downloads, such as flat fees, payer downloads, or manual entries. Incorporate a long-term strategy about how many record systems the network will be using in future years, added Dr. Mayzell.

5. Resistance to data download

When it comes to data, many physicians feel that patient data are “their” data, and they are uneasy about giving access to that data when participating in a clinically integrated network, Ms. Schweitzer said. Patient privacy is also a top concern.

While these are valid concerns, networks need as much data as possible in their data warehouse to show payers that their participating physicians are providing quality care, while reducing cost, she said.

A full data download is beneficial for the network because overinclusion allows for more accurate assessment and better extrapolation in quality improvement, she said. This means each participating physician submits all their patient data, regardless of payer. Remind members that from an IT perspective, data from one doctor are merely grains of sand in a beach of data. Explain to uneasy members that the data are scrubbed of all patient identifiers and that it is the aggregate data that are most valuable to the network.

“If you’re going through one of these processes, I would encourage you to push the lawyers hard because there are answers to these questions about data privacy and you should understand that 99% of the time, the data that are going to be seen, are going to be scrubbed,” she said. “I urge you to ask tough questions if you’re in the room and discussing that particular issue.”

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CHICAGO – With growing pressure to deliver higher-quality care at reduced costs, more physicians and practices are looking to join a clinically integrated network. But establishing and successfully operating such a network is sometimes easier said than done.

A clinically integrated network is defined as a collection of health providers, such as physicians, hospitals, and post-acute specialists that join together to improve care and reduce costs. Such networks generally share record systems, track data, and rely on evidence-based guidelines to provide high-quality care across participating providers.

If a group meets Federal Trade Commission compliance requirements to be considered a clinically integrated network, the government will provide a safe harbor from antitrust scrutiny. The four components that networks must meet to be considered clinically integrated include: physician leadership and commitment, development and implementation of clinical practice guidelines to improve performance, development of infrastructure and technology, and financial incentives for achieving goals.

An accountable care organization (ACO) that participates in the Medicare Shared Savings Program is deemed “clinically integrated.” The clinical integration network (CIN) is the actual legal entity/network that the physicians join. Unlike physician hospital organizations (PHOs), clinically integrated networks can jointly negotiate contractual fees as long as the primary purpose of the negotiation is to achieve care improvement, according to a summary by the Medical Group Management Association.

Clinically integrated networks can also support ACOs or patient centered medical homes as part of the clinically integrated network by serving as a mechanism for sharing infrastructure and development costs.

“For doctors, participating in a clinically integrated network is an opportunity to work as part of a group, without giving up their independence,” George Mayzell, MD, chief clinical officer for Vizient Southeast, said during a recent American Bar Association meeting. Participation in such a network also may potentially support some of the alternative payment models under the Medicare Access and CHIP Reauthorization Act (MACRA), he said.

From financial challenges to lack of collaboration to data woes, physicians can face unexpected barriers as their clinically integrated network gets off the ground. Below, experts discuss the top five roadblocks to clinically integrated networks and how doctors and hospitals can overcome them.
 

1. Contribution reluctance

Although there is no hard-and-fast level, investments of time, energy, and financial resources by all participating providers are necessary to create and maintain a clinically integrated network, according to the Federal Trade Commission. However, physicians can sometimes be wary of contributing substantially to a new network, said April E. Schweitzer, a Chicago-based health law attorney who specializes in clinical integration networks and accountable care organizations.

Some doctors feel comfortable contributing only nominal amounts or believe that the system should bear the burden of costs, Ms. Schweitzer said at an American Bar Association meeting.

April Schweitzer
“There’s no bright line dollar amount that the government agencies say is enough,” Ms. Schweitzer said at the meeting. “So [networks] really need to demonstrate participation and physician buy-in.”

Consider different contribution options that will satisfy new members. One option is charging initiation fees, which typically run between $250 and $500, Ms. Schweitzer said. Another option is charging annual dues, which can be a similar amount, depending on specialty. If hesitation among members continues, come up with an alternative plan, Ms. Schweitzer said.

“If opposition is strong, you might do away with those [options],” she said. “[Instead], you may say, ‘We’re going to take a portion of the bonus pool before going into any bonus distribution methodology to reimburse what we would’ve used those dues or initiation fees to cover to pay back the [network] and operating costs.”

2. Savings expectations

Network members often have high hopes when it comes to the savings and reimbursement bonuses they expect to see once the network launches. The reality can be disappointing, said Dr. Mayzell.

“Creating savings takes time and a high level of patience/commitment,” Dr. Mayzell said in an interview. “Even when the savings are realized early on, financial awards are often low, and if they’re spread out between all of the primary care physicians and the specialists, they are not very motivating. This must be taken into account.”

It helps to set reasonable expectations early on about reimbursement, Ms. Schweitzer said. The same goes for managing payer contract expectations.

“You want to manage expectations at the outset,” she said during the meeting. “And you really do want to be honest about what the payers in your market are looking for and are expecting.”

3. Balancing leadership

Sophisticated clinically integrated networks require significant infrastructure and IT costs, thus most are funded by a hospital or health system, Ms. Schweitzer said. As a result, the hospital or health system is likely to be the sole corporate member of the legal entity serving as the network. But because success within the network requires physicians to potentially change their practice patterns, it is important to have true physician leadership on the governing board of the clinically integrated network.

 

 

Class voting is one way to balance the need for a physician-led network with appropriate governance of a clinically integrated network, Ms. Schweitzer said in an interview. Class voting allows “physicians to comprise a majority of the governing board of a clinically integrated network [while allowing the corporate member] to retain decision-making power because the physician class gets one vote and the hospital or health system class gets one vote.”

In addition, she advised giving the hospital or health system certain reserved powers to protect the health system’s tax-exempt status. This includes:

  • Ensuring that the CIN serves community and charitable purposes.
  • Protecting and promoting the community benefits served by the corporate member and ensuring that the assets and income of the corporate member and the CIN are used to serve community objectives.
  • Protecting the assets and income of the corporate member and the CIN by ensuring that the CIN complies with all applicable laws and regulatory requirements.

4. EHR interoperability

For a successful network, quality data must be aggregated from all providers. This can prove challenging when independent physicians each have separate electronic health record systems, Dr. Mayzell said.

“You can try to aggregate this data manually, but that is extremely challenging,” he said in an interview. “To aggregate [EHR] level data, you generally need to use additional software and organizations that connect electronically with each of their systems. This is often very expensive and cumbersome, with each system requiring a different interface and often each version of each system requiring a different interface.”

In the beginning stages of the network, survey all participating providers about the most widely used EHR systems to narrow interfacing to a manageable number, Ms. Schweitzer advised.

“This is what a lot of our clients are doing during the steering committee phase,” she said. “That’s when you’re bringing the health system and the doctors together to make decisions about how this entity will run.”

Additionally, consider alternative methods for data downloads, such as flat fees, payer downloads, or manual entries. Incorporate a long-term strategy about how many record systems the network will be using in future years, added Dr. Mayzell.

5. Resistance to data download

When it comes to data, many physicians feel that patient data are “their” data, and they are uneasy about giving access to that data when participating in a clinically integrated network, Ms. Schweitzer said. Patient privacy is also a top concern.

While these are valid concerns, networks need as much data as possible in their data warehouse to show payers that their participating physicians are providing quality care, while reducing cost, she said.

A full data download is beneficial for the network because overinclusion allows for more accurate assessment and better extrapolation in quality improvement, she said. This means each participating physician submits all their patient data, regardless of payer. Remind members that from an IT perspective, data from one doctor are merely grains of sand in a beach of data. Explain to uneasy members that the data are scrubbed of all patient identifiers and that it is the aggregate data that are most valuable to the network.

“If you’re going through one of these processes, I would encourage you to push the lawyers hard because there are answers to these questions about data privacy and you should understand that 99% of the time, the data that are going to be seen, are going to be scrubbed,” she said. “I urge you to ask tough questions if you’re in the room and discussing that particular issue.”

 

CHICAGO – With growing pressure to deliver higher-quality care at reduced costs, more physicians and practices are looking to join a clinically integrated network. But establishing and successfully operating such a network is sometimes easier said than done.

A clinically integrated network is defined as a collection of health providers, such as physicians, hospitals, and post-acute specialists that join together to improve care and reduce costs. Such networks generally share record systems, track data, and rely on evidence-based guidelines to provide high-quality care across participating providers.

If a group meets Federal Trade Commission compliance requirements to be considered a clinically integrated network, the government will provide a safe harbor from antitrust scrutiny. The four components that networks must meet to be considered clinically integrated include: physician leadership and commitment, development and implementation of clinical practice guidelines to improve performance, development of infrastructure and technology, and financial incentives for achieving goals.

An accountable care organization (ACO) that participates in the Medicare Shared Savings Program is deemed “clinically integrated.” The clinical integration network (CIN) is the actual legal entity/network that the physicians join. Unlike physician hospital organizations (PHOs), clinically integrated networks can jointly negotiate contractual fees as long as the primary purpose of the negotiation is to achieve care improvement, according to a summary by the Medical Group Management Association.

Clinically integrated networks can also support ACOs or patient centered medical homes as part of the clinically integrated network by serving as a mechanism for sharing infrastructure and development costs.

“For doctors, participating in a clinically integrated network is an opportunity to work as part of a group, without giving up their independence,” George Mayzell, MD, chief clinical officer for Vizient Southeast, said during a recent American Bar Association meeting. Participation in such a network also may potentially support some of the alternative payment models under the Medicare Access and CHIP Reauthorization Act (MACRA), he said.

From financial challenges to lack of collaboration to data woes, physicians can face unexpected barriers as their clinically integrated network gets off the ground. Below, experts discuss the top five roadblocks to clinically integrated networks and how doctors and hospitals can overcome them.
 

1. Contribution reluctance

Although there is no hard-and-fast level, investments of time, energy, and financial resources by all participating providers are necessary to create and maintain a clinically integrated network, according to the Federal Trade Commission. However, physicians can sometimes be wary of contributing substantially to a new network, said April E. Schweitzer, a Chicago-based health law attorney who specializes in clinical integration networks and accountable care organizations.

Some doctors feel comfortable contributing only nominal amounts or believe that the system should bear the burden of costs, Ms. Schweitzer said at an American Bar Association meeting.

April Schweitzer
“There’s no bright line dollar amount that the government agencies say is enough,” Ms. Schweitzer said at the meeting. “So [networks] really need to demonstrate participation and physician buy-in.”

Consider different contribution options that will satisfy new members. One option is charging initiation fees, which typically run between $250 and $500, Ms. Schweitzer said. Another option is charging annual dues, which can be a similar amount, depending on specialty. If hesitation among members continues, come up with an alternative plan, Ms. Schweitzer said.

“If opposition is strong, you might do away with those [options],” she said. “[Instead], you may say, ‘We’re going to take a portion of the bonus pool before going into any bonus distribution methodology to reimburse what we would’ve used those dues or initiation fees to cover to pay back the [network] and operating costs.”

2. Savings expectations

Network members often have high hopes when it comes to the savings and reimbursement bonuses they expect to see once the network launches. The reality can be disappointing, said Dr. Mayzell.

“Creating savings takes time and a high level of patience/commitment,” Dr. Mayzell said in an interview. “Even when the savings are realized early on, financial awards are often low, and if they’re spread out between all of the primary care physicians and the specialists, they are not very motivating. This must be taken into account.”

It helps to set reasonable expectations early on about reimbursement, Ms. Schweitzer said. The same goes for managing payer contract expectations.

“You want to manage expectations at the outset,” she said during the meeting. “And you really do want to be honest about what the payers in your market are looking for and are expecting.”

3. Balancing leadership

Sophisticated clinically integrated networks require significant infrastructure and IT costs, thus most are funded by a hospital or health system, Ms. Schweitzer said. As a result, the hospital or health system is likely to be the sole corporate member of the legal entity serving as the network. But because success within the network requires physicians to potentially change their practice patterns, it is important to have true physician leadership on the governing board of the clinically integrated network.

 

 

Class voting is one way to balance the need for a physician-led network with appropriate governance of a clinically integrated network, Ms. Schweitzer said in an interview. Class voting allows “physicians to comprise a majority of the governing board of a clinically integrated network [while allowing the corporate member] to retain decision-making power because the physician class gets one vote and the hospital or health system class gets one vote.”

In addition, she advised giving the hospital or health system certain reserved powers to protect the health system’s tax-exempt status. This includes:

  • Ensuring that the CIN serves community and charitable purposes.
  • Protecting and promoting the community benefits served by the corporate member and ensuring that the assets and income of the corporate member and the CIN are used to serve community objectives.
  • Protecting the assets and income of the corporate member and the CIN by ensuring that the CIN complies with all applicable laws and regulatory requirements.

4. EHR interoperability

For a successful network, quality data must be aggregated from all providers. This can prove challenging when independent physicians each have separate electronic health record systems, Dr. Mayzell said.

“You can try to aggregate this data manually, but that is extremely challenging,” he said in an interview. “To aggregate [EHR] level data, you generally need to use additional software and organizations that connect electronically with each of their systems. This is often very expensive and cumbersome, with each system requiring a different interface and often each version of each system requiring a different interface.”

In the beginning stages of the network, survey all participating providers about the most widely used EHR systems to narrow interfacing to a manageable number, Ms. Schweitzer advised.

“This is what a lot of our clients are doing during the steering committee phase,” she said. “That’s when you’re bringing the health system and the doctors together to make decisions about how this entity will run.”

Additionally, consider alternative methods for data downloads, such as flat fees, payer downloads, or manual entries. Incorporate a long-term strategy about how many record systems the network will be using in future years, added Dr. Mayzell.

5. Resistance to data download

When it comes to data, many physicians feel that patient data are “their” data, and they are uneasy about giving access to that data when participating in a clinically integrated network, Ms. Schweitzer said. Patient privacy is also a top concern.

While these are valid concerns, networks need as much data as possible in their data warehouse to show payers that their participating physicians are providing quality care, while reducing cost, she said.

A full data download is beneficial for the network because overinclusion allows for more accurate assessment and better extrapolation in quality improvement, she said. This means each participating physician submits all their patient data, regardless of payer. Remind members that from an IT perspective, data from one doctor are merely grains of sand in a beach of data. Explain to uneasy members that the data are scrubbed of all patient identifiers and that it is the aggregate data that are most valuable to the network.

“If you’re going through one of these processes, I would encourage you to push the lawyers hard because there are answers to these questions about data privacy and you should understand that 99% of the time, the data that are going to be seen, are going to be scrubbed,” she said. “I urge you to ask tough questions if you’re in the room and discussing that particular issue.”

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Blood markers can detect early pancreatic cancer

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A blood test has been found to be effective for detecting early pancreatic cancer in those at high risk, with the potential to find the deadly cancer at a time when it is more likely to be treatable with surgery, according to phase 2b findings recently published in Science Translational Medicine.

In a 337-person study, researchers found that a blood panel for the protein thrombospondin-2 (THBS2) and cancer antigen 19-9 (CA19-9), measured with a standard ELISA test, together detected pancreatic ductal adenocarcinoma (PDAC) with a specificity of 98% and a sensitivity of 87%. The test was effective at distinguishing patients with PDAC from controls and those with benign pancreatic disease across all stages of the cancer, wrote Kenneth Zaret, PhD, at the University of Pennsylvania, Philadelphia.

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There is a profound need for better early detection of PDAC, which is often only discovered in its advanced stages when it is essentially untreatable, leading to an overall 5-year survival rate of just 7%.

CA19-9 is already a known marker for PDAC, but it is a deeply flawed one because it is also elevated in people with nonmalignant pancreatic conditions and can produce false negatives in people without certain antibodies.

But, together, researchers found, THBS2 and CA19-9 make a good pairing for early detection. In the paper, researchers described cases of patients who had no CA19-9 signal at all, likely because they were Lewis-antigen negative, but who had high THBS2 levels. There were also several cases in which THBS2 levels overlapped with the upper end of the normal range but with elevated CA19-9 levels.

“Thus, the two markers appeared to be complementary in their ability to detect PDAC,” Dr. Zaret wrote.

Researchers were able to test for markers by reprogramming advanced PDAC cells to induce a pluripotent stem cell–like state.

Because of the low prevalence of PDAC in the general population, researchers are not recommending the panel as a general screening test.

“We suggest that the THBS2/CA19-9 marker panel could serve as a low-cost, nonintervention screening tool in asymptomatic individuals who have a high risk of developing PDAC,” Dr. Zaret wrote, “and also in patients who are newly diagnosed with diabetes mellitus that developed as a result of pancreatic injury – but not in the general population.”

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A blood test has been found to be effective for detecting early pancreatic cancer in those at high risk, with the potential to find the deadly cancer at a time when it is more likely to be treatable with surgery, according to phase 2b findings recently published in Science Translational Medicine.

In a 337-person study, researchers found that a blood panel for the protein thrombospondin-2 (THBS2) and cancer antigen 19-9 (CA19-9), measured with a standard ELISA test, together detected pancreatic ductal adenocarcinoma (PDAC) with a specificity of 98% and a sensitivity of 87%. The test was effective at distinguishing patients with PDAC from controls and those with benign pancreatic disease across all stages of the cancer, wrote Kenneth Zaret, PhD, at the University of Pennsylvania, Philadelphia.

©Martynasfoto/Thinkstock
There is a profound need for better early detection of PDAC, which is often only discovered in its advanced stages when it is essentially untreatable, leading to an overall 5-year survival rate of just 7%.

CA19-9 is already a known marker for PDAC, but it is a deeply flawed one because it is also elevated in people with nonmalignant pancreatic conditions and can produce false negatives in people without certain antibodies.

But, together, researchers found, THBS2 and CA19-9 make a good pairing for early detection. In the paper, researchers described cases of patients who had no CA19-9 signal at all, likely because they were Lewis-antigen negative, but who had high THBS2 levels. There were also several cases in which THBS2 levels overlapped with the upper end of the normal range but with elevated CA19-9 levels.

“Thus, the two markers appeared to be complementary in their ability to detect PDAC,” Dr. Zaret wrote.

Researchers were able to test for markers by reprogramming advanced PDAC cells to induce a pluripotent stem cell–like state.

Because of the low prevalence of PDAC in the general population, researchers are not recommending the panel as a general screening test.

“We suggest that the THBS2/CA19-9 marker panel could serve as a low-cost, nonintervention screening tool in asymptomatic individuals who have a high risk of developing PDAC,” Dr. Zaret wrote, “and also in patients who are newly diagnosed with diabetes mellitus that developed as a result of pancreatic injury – but not in the general population.”

 

A blood test has been found to be effective for detecting early pancreatic cancer in those at high risk, with the potential to find the deadly cancer at a time when it is more likely to be treatable with surgery, according to phase 2b findings recently published in Science Translational Medicine.

In a 337-person study, researchers found that a blood panel for the protein thrombospondin-2 (THBS2) and cancer antigen 19-9 (CA19-9), measured with a standard ELISA test, together detected pancreatic ductal adenocarcinoma (PDAC) with a specificity of 98% and a sensitivity of 87%. The test was effective at distinguishing patients with PDAC from controls and those with benign pancreatic disease across all stages of the cancer, wrote Kenneth Zaret, PhD, at the University of Pennsylvania, Philadelphia.

©Martynasfoto/Thinkstock
There is a profound need for better early detection of PDAC, which is often only discovered in its advanced stages when it is essentially untreatable, leading to an overall 5-year survival rate of just 7%.

CA19-9 is already a known marker for PDAC, but it is a deeply flawed one because it is also elevated in people with nonmalignant pancreatic conditions and can produce false negatives in people without certain antibodies.

But, together, researchers found, THBS2 and CA19-9 make a good pairing for early detection. In the paper, researchers described cases of patients who had no CA19-9 signal at all, likely because they were Lewis-antigen negative, but who had high THBS2 levels. There were also several cases in which THBS2 levels overlapped with the upper end of the normal range but with elevated CA19-9 levels.

“Thus, the two markers appeared to be complementary in their ability to detect PDAC,” Dr. Zaret wrote.

Researchers were able to test for markers by reprogramming advanced PDAC cells to induce a pluripotent stem cell–like state.

Because of the low prevalence of PDAC in the general population, researchers are not recommending the panel as a general screening test.

“We suggest that the THBS2/CA19-9 marker panel could serve as a low-cost, nonintervention screening tool in asymptomatic individuals who have a high risk of developing PDAC,” Dr. Zaret wrote, “and also in patients who are newly diagnosed with diabetes mellitus that developed as a result of pancreatic injury – but not in the general population.”

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Key clinical point: A blood panel was able to detect pancreatic ductal adenocarcinoma in high-risk people across all stages of their cancer.

Major finding: Using a panel of the protein thrombospondin-2 and cancer antigen 19-9, the specificity was 98% and the sensitivity was 87%.

Data source: A phase 2b study of 337 people, including those at high-risk for PDAC, those with benign pancreatic disease, and control subjects.

Disclosures: Dr. Zaret reported consulting work with BetaLogics/J&J and RaNA Therapeutics.

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Antiviral shows early promise for treatment of Zika infection

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– An antiviral drug that is a key player in the recent revolution in the treatment of hepatitis C infection also blocks Zika virus replication both in vitro and in a mouse model, Alysson R. Muotri, PhD, said at the annual meeting of the Teratology Society.

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This preclinical success warrants further pursuit of the antiviral drug sofosbuvir (Sovaldi). While the development of a Zika vaccine is a research priority, there is also an urgent need to come up with effective treatment for Zika-infected individuals, especially pregnant women for whom prevention of infection is no longer an option, observed Dr. Muotri of the University of California, San Diego.

Sofosbuvir is a promising candidate. Not only has it demonstrated efficacy in preclinical work by Dr. Muotri and other groups of investigators, but it is also already a Food and Drug Administration–approved antiviral agent with a relatively reassuring Category B rating for use in pregnancy, meaning no evidence of teratogenicity in animal studies.

Investigators at the Scripps Clinic in La Jolla, Calif., have shown that the replication machinery in the Zika virus genome is closely similar to that of another flavivirus: hepatitis C. Both viruses express an NS2B-NS3 protease essential for generation of functional viral proteins.

“That observation led us to look for drugs that would interact with that replication pocket,” Dr. Muotri said.

The researchers first established in vitro that sofosbuvir can bind to the Zika virus NS2B-NS3 protease interface in an area known as the RNA-directed RNA polymerase domain, both in Zika virus–infected human neural progenitor cells and in cerebral organoids. Next, they demonstrated that sofosbuvir inhibited Zika virus replication in mice in dose-dependent fashion (Antiviral Res. 2017 Jul;143:218-29
).

Most recently – and most importantly – the researchers showed that sofosbuvir blocked vertical transmission of Zika virus infection in the mouse model. “It’s neuroprotective for the fetus. There was no PCR [polymerase chain reaction] evidence of Zika virus in the fetal head. Those animals are born normal as far as we can tell,” he said.

The researchers are also engaged in preclinical evaluation of other antiviral agents as potential treatments for Zika infection. Some show even more potent anti-Zika activity than did sofosbuvir. But they have the disadvantage of being nonapproved investigational drugs and hence are far earlier in the developmental pipeline.

Dr. Muotri, whose research is supported by the National Institutes of Health, reported having no relevant financial disclosures.

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– An antiviral drug that is a key player in the recent revolution in the treatment of hepatitis C infection also blocks Zika virus replication both in vitro and in a mouse model, Alysson R. Muotri, PhD, said at the annual meeting of the Teratology Society.

Rattikankeawpun/Thinkstock
This preclinical success warrants further pursuit of the antiviral drug sofosbuvir (Sovaldi). While the development of a Zika vaccine is a research priority, there is also an urgent need to come up with effective treatment for Zika-infected individuals, especially pregnant women for whom prevention of infection is no longer an option, observed Dr. Muotri of the University of California, San Diego.

Sofosbuvir is a promising candidate. Not only has it demonstrated efficacy in preclinical work by Dr. Muotri and other groups of investigators, but it is also already a Food and Drug Administration–approved antiviral agent with a relatively reassuring Category B rating for use in pregnancy, meaning no evidence of teratogenicity in animal studies.

Investigators at the Scripps Clinic in La Jolla, Calif., have shown that the replication machinery in the Zika virus genome is closely similar to that of another flavivirus: hepatitis C. Both viruses express an NS2B-NS3 protease essential for generation of functional viral proteins.

“That observation led us to look for drugs that would interact with that replication pocket,” Dr. Muotri said.

The researchers first established in vitro that sofosbuvir can bind to the Zika virus NS2B-NS3 protease interface in an area known as the RNA-directed RNA polymerase domain, both in Zika virus–infected human neural progenitor cells and in cerebral organoids. Next, they demonstrated that sofosbuvir inhibited Zika virus replication in mice in dose-dependent fashion (Antiviral Res. 2017 Jul;143:218-29
).

Most recently – and most importantly – the researchers showed that sofosbuvir blocked vertical transmission of Zika virus infection in the mouse model. “It’s neuroprotective for the fetus. There was no PCR [polymerase chain reaction] evidence of Zika virus in the fetal head. Those animals are born normal as far as we can tell,” he said.

The researchers are also engaged in preclinical evaluation of other antiviral agents as potential treatments for Zika infection. Some show even more potent anti-Zika activity than did sofosbuvir. But they have the disadvantage of being nonapproved investigational drugs and hence are far earlier in the developmental pipeline.

Dr. Muotri, whose research is supported by the National Institutes of Health, reported having no relevant financial disclosures.

 

– An antiviral drug that is a key player in the recent revolution in the treatment of hepatitis C infection also blocks Zika virus replication both in vitro and in a mouse model, Alysson R. Muotri, PhD, said at the annual meeting of the Teratology Society.

Rattikankeawpun/Thinkstock
This preclinical success warrants further pursuit of the antiviral drug sofosbuvir (Sovaldi). While the development of a Zika vaccine is a research priority, there is also an urgent need to come up with effective treatment for Zika-infected individuals, especially pregnant women for whom prevention of infection is no longer an option, observed Dr. Muotri of the University of California, San Diego.

Sofosbuvir is a promising candidate. Not only has it demonstrated efficacy in preclinical work by Dr. Muotri and other groups of investigators, but it is also already a Food and Drug Administration–approved antiviral agent with a relatively reassuring Category B rating for use in pregnancy, meaning no evidence of teratogenicity in animal studies.

Investigators at the Scripps Clinic in La Jolla, Calif., have shown that the replication machinery in the Zika virus genome is closely similar to that of another flavivirus: hepatitis C. Both viruses express an NS2B-NS3 protease essential for generation of functional viral proteins.

“That observation led us to look for drugs that would interact with that replication pocket,” Dr. Muotri said.

The researchers first established in vitro that sofosbuvir can bind to the Zika virus NS2B-NS3 protease interface in an area known as the RNA-directed RNA polymerase domain, both in Zika virus–infected human neural progenitor cells and in cerebral organoids. Next, they demonstrated that sofosbuvir inhibited Zika virus replication in mice in dose-dependent fashion (Antiviral Res. 2017 Jul;143:218-29
).

Most recently – and most importantly – the researchers showed that sofosbuvir blocked vertical transmission of Zika virus infection in the mouse model. “It’s neuroprotective for the fetus. There was no PCR [polymerase chain reaction] evidence of Zika virus in the fetal head. Those animals are born normal as far as we can tell,” he said.

The researchers are also engaged in preclinical evaluation of other antiviral agents as potential treatments for Zika infection. Some show even more potent anti-Zika activity than did sofosbuvir. But they have the disadvantage of being nonapproved investigational drugs and hence are far earlier in the developmental pipeline.

Dr. Muotri, whose research is supported by the National Institutes of Health, reported having no relevant financial disclosures.

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EXPERT ANALYSIS FROM TERATOLOGY SOCIETY 2017

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Firing

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Last month’s column on good hiring practices, which stressed the importance of replacing marginal employees with excellent ones, triggered an interesting round of discussion. “Isn’t it true,” asked one contributor, “that most physicians tolerate marginal employees because it’s less painful than firing them?”

Indeed it is. Firing someone is never easy, and it is particularly tough on physicians. Sometimes, however, it is unavoidable if you want to preserve the efficiency and morale of your other employees, as well as your own.

Before you do it, however, be sure that you have legitimate grounds, and assemble as much documentation as you can. Record all terminatable transgressions in the employee’s permanent record, and document all verbal and written warnings. This is essential. You must be prepared to prove that your reasons for termination were legal.

Former employees will sometimes charge that any of a number of their civil rights was violated. For example, federal law prohibits you from firing anyone because of race, gender, national origin, disability, religion, or age (if the employee is over 40). You cannot fire a woman because she is pregnant or recently gave birth. Other illegal reasons include assertion of antidiscrimination rights, refusal to take a lie detector test, and report of OSHA violations.

You also can’t terminate someone for refusing to commit an illegal act, such as filing false insurance claims, or for exercising a legal right, such as voting or participating in a political demonstration. You cannot fire an alcohol abuser unless he or she is caught drinking at work, but many forms of illegal drug use are legitimate cause for termination. Other laws may apply, depending on where you live. When in doubt, contact your state labor department or fair employment office.

If a fired employee alleges that he or she was fired for any of these illegal reasons and you do not have convincing documentation to counter the charge, you may find yourself defending your actions in court. If you anticipate such problems, you can ask the employee to sign a waver of future litigation in exchange for a concession from you – such as extra severance pay or a promise not to contest an unemployment application. Also, consider adding employment practices liability insurance (EPLI) to your umbrella policy, since lawsuits are always a possibility despite all efforts to prevent them.

Once you have all your legal ducks in a row, don’t procrastinate. Get it over with first thing on Monday morning. If you wait until Friday afternoon (as many do), you will worry about the dreaded task all week long, and the fired employee will stew about it all weekend.

Explain the performance you have expected, the steps you have taken to help correct the problems you have seen, and the fact that the problems persist. Try to limit the conversation to a minute or two, have the final paycheck ready, and make it clear that the decision has already been made, so begging and pleading will not change anything.

I’ve been asked to share exactly what I say, so, for what it’s worth: “I have called you in to discuss a difficult issue. You know that we have not been happy with your performance. We are still not happy with it, despite all the discussions we have had, and we feel that you can do better elsewhere. So, today, we will part company, and I wish you the best of luck in your future endeavors. Here is your severance check. I hope there are no hard feelings.”

There will, of course, be hard feelings, but that cannot be helped. The point is to be quick, firm, and decisive. Get it over with and allow everyone to move on.

Be sure to get all your office keys back – or change the locks if you cannot. Back up all important computer files, and change all your passwords. Most employees know more of them than you would ever suspect.

Finally, call the staff together and explain what you have done. They should hear the real story from you, not some distorted version via the rumor mill. You don’t have to explain your reasoning or divulge every detail, but do explain how the termination will affect everyone else. Responsibilities will need to be shifted until a replacement can be hired, and all employees should understand that.

If you are asked in the future to give a reference or write a letter of recommendation for the terminated employee, be sure that everything you say is truthful and well documented.

Dr. Joseph S. Eastern
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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Last month’s column on good hiring practices, which stressed the importance of replacing marginal employees with excellent ones, triggered an interesting round of discussion. “Isn’t it true,” asked one contributor, “that most physicians tolerate marginal employees because it’s less painful than firing them?”

Indeed it is. Firing someone is never easy, and it is particularly tough on physicians. Sometimes, however, it is unavoidable if you want to preserve the efficiency and morale of your other employees, as well as your own.

Before you do it, however, be sure that you have legitimate grounds, and assemble as much documentation as you can. Record all terminatable transgressions in the employee’s permanent record, and document all verbal and written warnings. This is essential. You must be prepared to prove that your reasons for termination were legal.

Former employees will sometimes charge that any of a number of their civil rights was violated. For example, federal law prohibits you from firing anyone because of race, gender, national origin, disability, religion, or age (if the employee is over 40). You cannot fire a woman because she is pregnant or recently gave birth. Other illegal reasons include assertion of antidiscrimination rights, refusal to take a lie detector test, and report of OSHA violations.

You also can’t terminate someone for refusing to commit an illegal act, such as filing false insurance claims, or for exercising a legal right, such as voting or participating in a political demonstration. You cannot fire an alcohol abuser unless he or she is caught drinking at work, but many forms of illegal drug use are legitimate cause for termination. Other laws may apply, depending on where you live. When in doubt, contact your state labor department or fair employment office.

If a fired employee alleges that he or she was fired for any of these illegal reasons and you do not have convincing documentation to counter the charge, you may find yourself defending your actions in court. If you anticipate such problems, you can ask the employee to sign a waver of future litigation in exchange for a concession from you – such as extra severance pay or a promise not to contest an unemployment application. Also, consider adding employment practices liability insurance (EPLI) to your umbrella policy, since lawsuits are always a possibility despite all efforts to prevent them.

Once you have all your legal ducks in a row, don’t procrastinate. Get it over with first thing on Monday morning. If you wait until Friday afternoon (as many do), you will worry about the dreaded task all week long, and the fired employee will stew about it all weekend.

Explain the performance you have expected, the steps you have taken to help correct the problems you have seen, and the fact that the problems persist. Try to limit the conversation to a minute or two, have the final paycheck ready, and make it clear that the decision has already been made, so begging and pleading will not change anything.

I’ve been asked to share exactly what I say, so, for what it’s worth: “I have called you in to discuss a difficult issue. You know that we have not been happy with your performance. We are still not happy with it, despite all the discussions we have had, and we feel that you can do better elsewhere. So, today, we will part company, and I wish you the best of luck in your future endeavors. Here is your severance check. I hope there are no hard feelings.”

There will, of course, be hard feelings, but that cannot be helped. The point is to be quick, firm, and decisive. Get it over with and allow everyone to move on.

Be sure to get all your office keys back – or change the locks if you cannot. Back up all important computer files, and change all your passwords. Most employees know more of them than you would ever suspect.

Finally, call the staff together and explain what you have done. They should hear the real story from you, not some distorted version via the rumor mill. You don’t have to explain your reasoning or divulge every detail, but do explain how the termination will affect everyone else. Responsibilities will need to be shifted until a replacement can be hired, and all employees should understand that.

If you are asked in the future to give a reference or write a letter of recommendation for the terminated employee, be sure that everything you say is truthful and well documented.

Dr. Joseph S. Eastern
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

 

Last month’s column on good hiring practices, which stressed the importance of replacing marginal employees with excellent ones, triggered an interesting round of discussion. “Isn’t it true,” asked one contributor, “that most physicians tolerate marginal employees because it’s less painful than firing them?”

Indeed it is. Firing someone is never easy, and it is particularly tough on physicians. Sometimes, however, it is unavoidable if you want to preserve the efficiency and morale of your other employees, as well as your own.

Before you do it, however, be sure that you have legitimate grounds, and assemble as much documentation as you can. Record all terminatable transgressions in the employee’s permanent record, and document all verbal and written warnings. This is essential. You must be prepared to prove that your reasons for termination were legal.

Former employees will sometimes charge that any of a number of their civil rights was violated. For example, federal law prohibits you from firing anyone because of race, gender, national origin, disability, religion, or age (if the employee is over 40). You cannot fire a woman because she is pregnant or recently gave birth. Other illegal reasons include assertion of antidiscrimination rights, refusal to take a lie detector test, and report of OSHA violations.

You also can’t terminate someone for refusing to commit an illegal act, such as filing false insurance claims, or for exercising a legal right, such as voting or participating in a political demonstration. You cannot fire an alcohol abuser unless he or she is caught drinking at work, but many forms of illegal drug use are legitimate cause for termination. Other laws may apply, depending on where you live. When in doubt, contact your state labor department or fair employment office.

If a fired employee alleges that he or she was fired for any of these illegal reasons and you do not have convincing documentation to counter the charge, you may find yourself defending your actions in court. If you anticipate such problems, you can ask the employee to sign a waver of future litigation in exchange for a concession from you – such as extra severance pay or a promise not to contest an unemployment application. Also, consider adding employment practices liability insurance (EPLI) to your umbrella policy, since lawsuits are always a possibility despite all efforts to prevent them.

Once you have all your legal ducks in a row, don’t procrastinate. Get it over with first thing on Monday morning. If you wait until Friday afternoon (as many do), you will worry about the dreaded task all week long, and the fired employee will stew about it all weekend.

Explain the performance you have expected, the steps you have taken to help correct the problems you have seen, and the fact that the problems persist. Try to limit the conversation to a minute or two, have the final paycheck ready, and make it clear that the decision has already been made, so begging and pleading will not change anything.

I’ve been asked to share exactly what I say, so, for what it’s worth: “I have called you in to discuss a difficult issue. You know that we have not been happy with your performance. We are still not happy with it, despite all the discussions we have had, and we feel that you can do better elsewhere. So, today, we will part company, and I wish you the best of luck in your future endeavors. Here is your severance check. I hope there are no hard feelings.”

There will, of course, be hard feelings, but that cannot be helped. The point is to be quick, firm, and decisive. Get it over with and allow everyone to move on.

Be sure to get all your office keys back – or change the locks if you cannot. Back up all important computer files, and change all your passwords. Most employees know more of them than you would ever suspect.

Finally, call the staff together and explain what you have done. They should hear the real story from you, not some distorted version via the rumor mill. You don’t have to explain your reasoning or divulge every detail, but do explain how the termination will affect everyone else. Responsibilities will need to be shifted until a replacement can be hired, and all employees should understand that.

If you are asked in the future to give a reference or write a letter of recommendation for the terminated employee, be sure that everything you say is truthful and well documented.

Dr. Joseph S. Eastern
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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Appeals court strikes down Wisconsin medical malpractice cap

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Wed, 04/03/2019 - 10:26

 

An appeals court has struck down Wisconsin’s medical malpractice cap for noneconomic damages, ruling that the $750,000 limit is unconstitutional.

In a July opinion, a panel of the First District Court of Appeals wrote that the medical liability cap denies equal protection for the most severely injured patients who are awarded damages exceeding the limit. The decision reinstates a $16.5 million noneconomic damages verdict awarded to a Wisconsin women who lost her limbs after a delayed sepsis diagnosis, according to court documents.

The Wisconsin Medical Society expressed its disappointment at the decision, warning that the ruling could destabilize Wisconsin’s medical liability environment and endanger patients’ access to high-quality, affordable care.

“This decision endangers the long-term solvency of the Injured Patients and Families Compensation Fund and its ability to adequately compensate patients and incentivizes attorneys to file questionable cases in hopes of astronomical jury awards seen in other states without caps,” Noel Deep, MD, president of the Wisconsin Medical Society, said in a statement. “We look forward to further opportunities to explain the importance of the cap to the stability of Wisconsin’s medical liability environment and its benefits for all Wisconsin patients as this case progresses.”

The Wisconsin Association for Justice, an association for the plaintiffs’ bar, praised the cap’s elimination.

“The Court of Appeals, in a concise and well-reasoned opinion, took a brave step toward ensuring that injured patients in Wisconsin can achieve justice by utilizing their constitutional right to a civil jury trial,” Association President Benjamin S. Wagner said in a statement. “The data the court relied upon speaks for itself. The imposition of damage caps against a person like Ascaris Mayo has no rational relationship to controlling medical costs, nor does the verdict impose a financial hardship on the Injured Patients and Families Compensation Fund. To the contrary, the court’s decision ensures that the fund meets its dual statutory obligations to provide excess insurance to medical professionals and provide compensation to injured patients and families.”

The ruling results from a medical malpractice lawsuit filed by patient Ascaris Mayo and her family against Infinity Health Care in Milwaukee, an emergency physician, a physician assistant, ProAssurance Wisconsin Insurance, and the Wisconsin Injured Patients and Families Compensation Fund. The suit claimed that, during a visit to the emergency department at Columbia St. Mary’s Hospital in Milwaukee for abdominal pain and a high fever, health providers failed to diagnosis and treat Ms. Mayo for sepsis. The sepsis led to organ failure, dry gangrene, and, eventually, amputation of her extremities, according to court documents.

A jury awarded Ms. Mayo and her husband $9 million in economic damages and $16.5 million in noneconomic damages. After the verdict, representatives for the Wisconsin Injured Patients and Families Compensation Fund moved to reduce the noneconomic damages award to $750,000 per the state’s cap. The Mayos challenged the reduction, arguing that the cap violated their constitutional rights. A circuit court concluded that the cap was not facially unconstitutional and that it was unconstitutional as applied to the Mayos because it violated the Mayos’ rights to equal protection and due process. Both the Mayos and representatives for the compensation fund appealed.

In their decision, the appeals panel shot down the reasoning used by Wisconsin’s Legislature to enact the noneconomic damages cap, raising doubts that the limit reduces defensive medicine by physicians and prevents a doctor shortage in the state.

“The record before us does not support a finding that the legislative objectives articulated in [the statute] are promoted in any way because the amount of the noneconomic damages cap is $750,000,” the judges wrote. “Data demonstrate that many states with no caps on noneconomic damages actually have higher physician retention rates than Wisconsin. [In addition,] the record before us shows that the ability to accurately measure the financial impact of ‘defensive medicine’ practices has not improved. ... Indeed, data suggest that the existence of noneconomic damages caps may actually increase the risk to patient safety.”

The case is expected to be appealed to the Wisconsin Supreme Court.

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An appeals court has struck down Wisconsin’s medical malpractice cap for noneconomic damages, ruling that the $750,000 limit is unconstitutional.

In a July opinion, a panel of the First District Court of Appeals wrote that the medical liability cap denies equal protection for the most severely injured patients who are awarded damages exceeding the limit. The decision reinstates a $16.5 million noneconomic damages verdict awarded to a Wisconsin women who lost her limbs after a delayed sepsis diagnosis, according to court documents.

The Wisconsin Medical Society expressed its disappointment at the decision, warning that the ruling could destabilize Wisconsin’s medical liability environment and endanger patients’ access to high-quality, affordable care.

“This decision endangers the long-term solvency of the Injured Patients and Families Compensation Fund and its ability to adequately compensate patients and incentivizes attorneys to file questionable cases in hopes of astronomical jury awards seen in other states without caps,” Noel Deep, MD, president of the Wisconsin Medical Society, said in a statement. “We look forward to further opportunities to explain the importance of the cap to the stability of Wisconsin’s medical liability environment and its benefits for all Wisconsin patients as this case progresses.”

The Wisconsin Association for Justice, an association for the plaintiffs’ bar, praised the cap’s elimination.

“The Court of Appeals, in a concise and well-reasoned opinion, took a brave step toward ensuring that injured patients in Wisconsin can achieve justice by utilizing their constitutional right to a civil jury trial,” Association President Benjamin S. Wagner said in a statement. “The data the court relied upon speaks for itself. The imposition of damage caps against a person like Ascaris Mayo has no rational relationship to controlling medical costs, nor does the verdict impose a financial hardship on the Injured Patients and Families Compensation Fund. To the contrary, the court’s decision ensures that the fund meets its dual statutory obligations to provide excess insurance to medical professionals and provide compensation to injured patients and families.”

The ruling results from a medical malpractice lawsuit filed by patient Ascaris Mayo and her family against Infinity Health Care in Milwaukee, an emergency physician, a physician assistant, ProAssurance Wisconsin Insurance, and the Wisconsin Injured Patients and Families Compensation Fund. The suit claimed that, during a visit to the emergency department at Columbia St. Mary’s Hospital in Milwaukee for abdominal pain and a high fever, health providers failed to diagnosis and treat Ms. Mayo for sepsis. The sepsis led to organ failure, dry gangrene, and, eventually, amputation of her extremities, according to court documents.

A jury awarded Ms. Mayo and her husband $9 million in economic damages and $16.5 million in noneconomic damages. After the verdict, representatives for the Wisconsin Injured Patients and Families Compensation Fund moved to reduce the noneconomic damages award to $750,000 per the state’s cap. The Mayos challenged the reduction, arguing that the cap violated their constitutional rights. A circuit court concluded that the cap was not facially unconstitutional and that it was unconstitutional as applied to the Mayos because it violated the Mayos’ rights to equal protection and due process. Both the Mayos and representatives for the compensation fund appealed.

In their decision, the appeals panel shot down the reasoning used by Wisconsin’s Legislature to enact the noneconomic damages cap, raising doubts that the limit reduces defensive medicine by physicians and prevents a doctor shortage in the state.

“The record before us does not support a finding that the legislative objectives articulated in [the statute] are promoted in any way because the amount of the noneconomic damages cap is $750,000,” the judges wrote. “Data demonstrate that many states with no caps on noneconomic damages actually have higher physician retention rates than Wisconsin. [In addition,] the record before us shows that the ability to accurately measure the financial impact of ‘defensive medicine’ practices has not improved. ... Indeed, data suggest that the existence of noneconomic damages caps may actually increase the risk to patient safety.”

The case is expected to be appealed to the Wisconsin Supreme Court.

 

An appeals court has struck down Wisconsin’s medical malpractice cap for noneconomic damages, ruling that the $750,000 limit is unconstitutional.

In a July opinion, a panel of the First District Court of Appeals wrote that the medical liability cap denies equal protection for the most severely injured patients who are awarded damages exceeding the limit. The decision reinstates a $16.5 million noneconomic damages verdict awarded to a Wisconsin women who lost her limbs after a delayed sepsis diagnosis, according to court documents.

The Wisconsin Medical Society expressed its disappointment at the decision, warning that the ruling could destabilize Wisconsin’s medical liability environment and endanger patients’ access to high-quality, affordable care.

“This decision endangers the long-term solvency of the Injured Patients and Families Compensation Fund and its ability to adequately compensate patients and incentivizes attorneys to file questionable cases in hopes of astronomical jury awards seen in other states without caps,” Noel Deep, MD, president of the Wisconsin Medical Society, said in a statement. “We look forward to further opportunities to explain the importance of the cap to the stability of Wisconsin’s medical liability environment and its benefits for all Wisconsin patients as this case progresses.”

The Wisconsin Association for Justice, an association for the plaintiffs’ bar, praised the cap’s elimination.

“The Court of Appeals, in a concise and well-reasoned opinion, took a brave step toward ensuring that injured patients in Wisconsin can achieve justice by utilizing their constitutional right to a civil jury trial,” Association President Benjamin S. Wagner said in a statement. “The data the court relied upon speaks for itself. The imposition of damage caps against a person like Ascaris Mayo has no rational relationship to controlling medical costs, nor does the verdict impose a financial hardship on the Injured Patients and Families Compensation Fund. To the contrary, the court’s decision ensures that the fund meets its dual statutory obligations to provide excess insurance to medical professionals and provide compensation to injured patients and families.”

The ruling results from a medical malpractice lawsuit filed by patient Ascaris Mayo and her family against Infinity Health Care in Milwaukee, an emergency physician, a physician assistant, ProAssurance Wisconsin Insurance, and the Wisconsin Injured Patients and Families Compensation Fund. The suit claimed that, during a visit to the emergency department at Columbia St. Mary’s Hospital in Milwaukee for abdominal pain and a high fever, health providers failed to diagnosis and treat Ms. Mayo for sepsis. The sepsis led to organ failure, dry gangrene, and, eventually, amputation of her extremities, according to court documents.

A jury awarded Ms. Mayo and her husband $9 million in economic damages and $16.5 million in noneconomic damages. After the verdict, representatives for the Wisconsin Injured Patients and Families Compensation Fund moved to reduce the noneconomic damages award to $750,000 per the state’s cap. The Mayos challenged the reduction, arguing that the cap violated their constitutional rights. A circuit court concluded that the cap was not facially unconstitutional and that it was unconstitutional as applied to the Mayos because it violated the Mayos’ rights to equal protection and due process. Both the Mayos and representatives for the compensation fund appealed.

In their decision, the appeals panel shot down the reasoning used by Wisconsin’s Legislature to enact the noneconomic damages cap, raising doubts that the limit reduces defensive medicine by physicians and prevents a doctor shortage in the state.

“The record before us does not support a finding that the legislative objectives articulated in [the statute] are promoted in any way because the amount of the noneconomic damages cap is $750,000,” the judges wrote. “Data demonstrate that many states with no caps on noneconomic damages actually have higher physician retention rates than Wisconsin. [In addition,] the record before us shows that the ability to accurately measure the financial impact of ‘defensive medicine’ practices has not improved. ... Indeed, data suggest that the existence of noneconomic damages caps may actually increase the risk to patient safety.”

The case is expected to be appealed to the Wisconsin Supreme Court.

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Erosive hand OA evades dual IL-1 blocker’s effects

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– Treatment with the dual interleukin (IL) 1 blocker ABT-981 did not improve pain scores or erosive joint damage in patients with hand osteoarthritis (OA) in a phase 2a trial reported at the European Congress of Rheumatology.

The disappointing findings suggest that IL-1 may not be an effective target in erosive hand OA, said Margreet Kloppenburg, MD, of Leiden (the Netherlands) University Medical Center, even though the investigators obtained adequate pharmacodynamic results that suggested it was effectively blocking both IL-1 alpha and IL-1 beta.

Sara Freeman/Frontline Medical News
Dr. Margreet Kloppenburg
“ABT-981 200 mg was not significantly different from placebo on primary, secondary, or exploratory endpoints,” she said. The treatment was associated with injection site reactions and neutropenia, she added, although it was otherwise well tolerated.

The phase 2a, multicenter, randomized, double-blind, placebo-controlled study she reported followed on from a phase 1 trial showing that ABT-981 could dose-dependently reduce neutrophil counts and markers of joint inflammation in patients with knee OA. So it was perhaps natural to see if it could potentially have an effect in patients with erosive hand OA.

The aim of the phase 2a trial was to evaluate the safety and efficacy of ABT-981 in the treatment of 131 patients with erosive hand OA. After screening and a 45-day washout period, patients with confirmed erosive hand OA were randomized to receive ABT-981 200 mg injected every 2 weeks or matching placebo.

The primary endpoint was the change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) pain from baseline to 16 weeks, but no significant difference was observed. The mean change in AUSCAN pain was –9.2 for the 64 ABT-981-treated patients and –10.7 for placebo-treated patients (P = .039).

“There were similar results with AUSCAN function and tender and swollen joint counts,” Dr. Kloppenburg said.

There were also no differences seen in radiographic or MRI endpoints, such as the number of erosive joints, Kellgren and Lawrence scores, joint-space narrowing, or the presence of osteophytes.

Nevertheless, there was evidence that ABT-981 was decreasing inflammatory markers, such as high-sensitivity C-reactive protein and neutrophils. IL-1 alpha and IL-1 beta were difficult to measure, but data suggested that IL-1 was being blocked.
 

Disappointing results with cytokine targeting

Hand OA affects around 11% of the OA population and erosive hand OA is a very painful phenotype that affects multiple joints, Xavier Chevalier, MD, of Henri-Mondor Hospital, Paris XII University (France), said during a separate session at the congress.

While there is a rationale for using anti-inflammatory drugs for erosive hand OA, so far there just have not been many, if any, real successes. “The effect sizes are small,” Dr. Chevalier said. “There are not a lot of drugs when compared to hip and knee OA,” he observed.

Sara Freeman/Frontline Medical News
Dr. Xavier Chevalier
From nonsteroidal anti-inflammatory drugs to corticosteroids and disease modifying anti-rheumatic drugs such as hydroxychloroquine and methotrexate, none has been shown to have any real benefit in addressing erosive hand OA, Dr. Chevalier observed. Even biologic agents targeting IL-2, tumor necrosis factor (TNF), and now IL-1 have not lived up to their promise.

His general conclusion was that targeting cytokines in hand OA had been “disappointing” with “small effect in subgroup of clinically inflamed IP [interphalangeal] joints.”

Dr. Chevalier questioned: “Is hand OA a real OA?” There are features of the disease that imply it could be more of a ligamentous or enthesitis disease, or perhaps a subchondral bone disorder.

Is erosive hand OA even an inflammatory disease? he asked. Are TNF and IL-1 the right targets? Perhaps not, given the research presented by Dr. Kloppenburg and others, he suggested. Further research needs to look for surrogate markers and try to quantify the structural evolution of the disease, he proposed.

It is important to talk about negative studies and to not make excuses for why they might be negative, Tonia Vincent, PhD, observed during the discussion that followed Dr. Chevalier’s presentation.

“If you do proper, randomized, controlled studies in decent numbers and you don’t see effect sizes, and the only times when you see things are when they are open-label, they are not randomized, you’re looking at small numbers, it just goes to show easy it is to over interpret the results of those small studies,” said Dr. Vincent, professor of musculoskeletal biology at the Kennedy Institute of Rheumatology in Oxford, England.

“My conclusion, from my own in vivo studies and from what you’ve [Dr. Chevalier] just said, is that these are the wrong targets. Just because we are rheumatologists does not mean to say everything is about cytokines,” she said.

AbbVie funded the study. Dr. Kloppenburg acknowledged receiving research support from Pfizer and consultancy fees from AbbVie, GlaxoSmithKline, Merck, and Levicept. Dr. Chevalier disclosed working as an advisor to IBSA [Institut Biochimique SA], Sanofi, and Flexion Therapeutics; as an advisory board member for Laboratoires Genevrier and Labpharma; and receiving travel and accommodation support to attend the meeting from Nordic Pharma. Dr. Vincent did not report her disclosures.

 

 

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– Treatment with the dual interleukin (IL) 1 blocker ABT-981 did not improve pain scores or erosive joint damage in patients with hand osteoarthritis (OA) in a phase 2a trial reported at the European Congress of Rheumatology.

The disappointing findings suggest that IL-1 may not be an effective target in erosive hand OA, said Margreet Kloppenburg, MD, of Leiden (the Netherlands) University Medical Center, even though the investigators obtained adequate pharmacodynamic results that suggested it was effectively blocking both IL-1 alpha and IL-1 beta.

Sara Freeman/Frontline Medical News
Dr. Margreet Kloppenburg
“ABT-981 200 mg was not significantly different from placebo on primary, secondary, or exploratory endpoints,” she said. The treatment was associated with injection site reactions and neutropenia, she added, although it was otherwise well tolerated.

The phase 2a, multicenter, randomized, double-blind, placebo-controlled study she reported followed on from a phase 1 trial showing that ABT-981 could dose-dependently reduce neutrophil counts and markers of joint inflammation in patients with knee OA. So it was perhaps natural to see if it could potentially have an effect in patients with erosive hand OA.

The aim of the phase 2a trial was to evaluate the safety and efficacy of ABT-981 in the treatment of 131 patients with erosive hand OA. After screening and a 45-day washout period, patients with confirmed erosive hand OA were randomized to receive ABT-981 200 mg injected every 2 weeks or matching placebo.

The primary endpoint was the change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) pain from baseline to 16 weeks, but no significant difference was observed. The mean change in AUSCAN pain was –9.2 for the 64 ABT-981-treated patients and –10.7 for placebo-treated patients (P = .039).

“There were similar results with AUSCAN function and tender and swollen joint counts,” Dr. Kloppenburg said.

There were also no differences seen in radiographic or MRI endpoints, such as the number of erosive joints, Kellgren and Lawrence scores, joint-space narrowing, or the presence of osteophytes.

Nevertheless, there was evidence that ABT-981 was decreasing inflammatory markers, such as high-sensitivity C-reactive protein and neutrophils. IL-1 alpha and IL-1 beta were difficult to measure, but data suggested that IL-1 was being blocked.
 

Disappointing results with cytokine targeting

Hand OA affects around 11% of the OA population and erosive hand OA is a very painful phenotype that affects multiple joints, Xavier Chevalier, MD, of Henri-Mondor Hospital, Paris XII University (France), said during a separate session at the congress.

While there is a rationale for using anti-inflammatory drugs for erosive hand OA, so far there just have not been many, if any, real successes. “The effect sizes are small,” Dr. Chevalier said. “There are not a lot of drugs when compared to hip and knee OA,” he observed.

Sara Freeman/Frontline Medical News
Dr. Xavier Chevalier
From nonsteroidal anti-inflammatory drugs to corticosteroids and disease modifying anti-rheumatic drugs such as hydroxychloroquine and methotrexate, none has been shown to have any real benefit in addressing erosive hand OA, Dr. Chevalier observed. Even biologic agents targeting IL-2, tumor necrosis factor (TNF), and now IL-1 have not lived up to their promise.

His general conclusion was that targeting cytokines in hand OA had been “disappointing” with “small effect in subgroup of clinically inflamed IP [interphalangeal] joints.”

Dr. Chevalier questioned: “Is hand OA a real OA?” There are features of the disease that imply it could be more of a ligamentous or enthesitis disease, or perhaps a subchondral bone disorder.

Is erosive hand OA even an inflammatory disease? he asked. Are TNF and IL-1 the right targets? Perhaps not, given the research presented by Dr. Kloppenburg and others, he suggested. Further research needs to look for surrogate markers and try to quantify the structural evolution of the disease, he proposed.

It is important to talk about negative studies and to not make excuses for why they might be negative, Tonia Vincent, PhD, observed during the discussion that followed Dr. Chevalier’s presentation.

“If you do proper, randomized, controlled studies in decent numbers and you don’t see effect sizes, and the only times when you see things are when they are open-label, they are not randomized, you’re looking at small numbers, it just goes to show easy it is to over interpret the results of those small studies,” said Dr. Vincent, professor of musculoskeletal biology at the Kennedy Institute of Rheumatology in Oxford, England.

“My conclusion, from my own in vivo studies and from what you’ve [Dr. Chevalier] just said, is that these are the wrong targets. Just because we are rheumatologists does not mean to say everything is about cytokines,” she said.

AbbVie funded the study. Dr. Kloppenburg acknowledged receiving research support from Pfizer and consultancy fees from AbbVie, GlaxoSmithKline, Merck, and Levicept. Dr. Chevalier disclosed working as an advisor to IBSA [Institut Biochimique SA], Sanofi, and Flexion Therapeutics; as an advisory board member for Laboratoires Genevrier and Labpharma; and receiving travel and accommodation support to attend the meeting from Nordic Pharma. Dr. Vincent did not report her disclosures.

 

 

 

– Treatment with the dual interleukin (IL) 1 blocker ABT-981 did not improve pain scores or erosive joint damage in patients with hand osteoarthritis (OA) in a phase 2a trial reported at the European Congress of Rheumatology.

The disappointing findings suggest that IL-1 may not be an effective target in erosive hand OA, said Margreet Kloppenburg, MD, of Leiden (the Netherlands) University Medical Center, even though the investigators obtained adequate pharmacodynamic results that suggested it was effectively blocking both IL-1 alpha and IL-1 beta.

Sara Freeman/Frontline Medical News
Dr. Margreet Kloppenburg
“ABT-981 200 mg was not significantly different from placebo on primary, secondary, or exploratory endpoints,” she said. The treatment was associated with injection site reactions and neutropenia, she added, although it was otherwise well tolerated.

The phase 2a, multicenter, randomized, double-blind, placebo-controlled study she reported followed on from a phase 1 trial showing that ABT-981 could dose-dependently reduce neutrophil counts and markers of joint inflammation in patients with knee OA. So it was perhaps natural to see if it could potentially have an effect in patients with erosive hand OA.

The aim of the phase 2a trial was to evaluate the safety and efficacy of ABT-981 in the treatment of 131 patients with erosive hand OA. After screening and a 45-day washout period, patients with confirmed erosive hand OA were randomized to receive ABT-981 200 mg injected every 2 weeks or matching placebo.

The primary endpoint was the change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) pain from baseline to 16 weeks, but no significant difference was observed. The mean change in AUSCAN pain was –9.2 for the 64 ABT-981-treated patients and –10.7 for placebo-treated patients (P = .039).

“There were similar results with AUSCAN function and tender and swollen joint counts,” Dr. Kloppenburg said.

There were also no differences seen in radiographic or MRI endpoints, such as the number of erosive joints, Kellgren and Lawrence scores, joint-space narrowing, or the presence of osteophytes.

Nevertheless, there was evidence that ABT-981 was decreasing inflammatory markers, such as high-sensitivity C-reactive protein and neutrophils. IL-1 alpha and IL-1 beta were difficult to measure, but data suggested that IL-1 was being blocked.
 

Disappointing results with cytokine targeting

Hand OA affects around 11% of the OA population and erosive hand OA is a very painful phenotype that affects multiple joints, Xavier Chevalier, MD, of Henri-Mondor Hospital, Paris XII University (France), said during a separate session at the congress.

While there is a rationale for using anti-inflammatory drugs for erosive hand OA, so far there just have not been many, if any, real successes. “The effect sizes are small,” Dr. Chevalier said. “There are not a lot of drugs when compared to hip and knee OA,” he observed.

Sara Freeman/Frontline Medical News
Dr. Xavier Chevalier
From nonsteroidal anti-inflammatory drugs to corticosteroids and disease modifying anti-rheumatic drugs such as hydroxychloroquine and methotrexate, none has been shown to have any real benefit in addressing erosive hand OA, Dr. Chevalier observed. Even biologic agents targeting IL-2, tumor necrosis factor (TNF), and now IL-1 have not lived up to their promise.

His general conclusion was that targeting cytokines in hand OA had been “disappointing” with “small effect in subgroup of clinically inflamed IP [interphalangeal] joints.”

Dr. Chevalier questioned: “Is hand OA a real OA?” There are features of the disease that imply it could be more of a ligamentous or enthesitis disease, or perhaps a subchondral bone disorder.

Is erosive hand OA even an inflammatory disease? he asked. Are TNF and IL-1 the right targets? Perhaps not, given the research presented by Dr. Kloppenburg and others, he suggested. Further research needs to look for surrogate markers and try to quantify the structural evolution of the disease, he proposed.

It is important to talk about negative studies and to not make excuses for why they might be negative, Tonia Vincent, PhD, observed during the discussion that followed Dr. Chevalier’s presentation.

“If you do proper, randomized, controlled studies in decent numbers and you don’t see effect sizes, and the only times when you see things are when they are open-label, they are not randomized, you’re looking at small numbers, it just goes to show easy it is to over interpret the results of those small studies,” said Dr. Vincent, professor of musculoskeletal biology at the Kennedy Institute of Rheumatology in Oxford, England.

“My conclusion, from my own in vivo studies and from what you’ve [Dr. Chevalier] just said, is that these are the wrong targets. Just because we are rheumatologists does not mean to say everything is about cytokines,” she said.

AbbVie funded the study. Dr. Kloppenburg acknowledged receiving research support from Pfizer and consultancy fees from AbbVie, GlaxoSmithKline, Merck, and Levicept. Dr. Chevalier disclosed working as an advisor to IBSA [Institut Biochimique SA], Sanofi, and Flexion Therapeutics; as an advisory board member for Laboratoires Genevrier and Labpharma; and receiving travel and accommodation support to attend the meeting from Nordic Pharma. Dr. Vincent did not report her disclosures.

 

 

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Key clinical point: Erosive hand osteoarthritis (OA) pain was not alleviated by treatment with a dual interleukin (IL)-1 blocker ABT-981.

Major finding: The mean change in AUSCAN pain from baseline to week 16 was –9.2 and –10.7 comparing ABT-981 and placebo-treated patients (P = .039).

Data source: A phase 2a, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of ABT-981 in the treatment of 131 patients with erosive hand OA.

Disclosures: AbbVie funded the study. The study presenter acknowledged receiving research support from Pfizer and consultancy fees from AbbVie, GlaxoSmithKline, Merck, and Levicept. The other speaker disclosed working as an adviser to IBSA [Institut Biochimique SA], Sanofi, and Flexion Therapeutics; as an advisory board member for Laboratoires Genevrier and Labpharma; and receiving travel and accommodation support to attend the meeting from Nordic Pharma.
 

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Office visit conversations are clues to teens’ predepressive symptoms

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SAN FRANCISCO – Teens may express feelings that indicate an increased risk for depression and give you an opportunity for early intervention and prevention if you know what to look for, suggest the findings of a qualitative study on teens’ sub-threshold symptoms of depression.

“Probing with sensitive questioning and understanding can help providers assess teens’ risks for depression,” said study coauthor Huma Khan, MD, of the University of Illinois Children’s Hospital in Chicago. “Furthermore, close follow-up with teens who mention certain topics, such as losing interest in activities or the loss of a loved one, also may help providers redirect the trajectory of depressive symptoms.”

Dr. Huma Khan
Despite a lifetime prevalence of depression in adolescents of about 11% and a 12-month prevalence of 7.5%, about 8 in 10 teens do not receive adequate mental health treatment, explained Dr. Khan at the Pediatric Academic Societies meeting. Further, primary care providers often lack the time and training to recognize and follow up on early signs of depression in their teen patients.

To better understand ways in which teens may manifest sub-threshold depressive symptoms and possible coping mechanisms, Dr. Khan’s team conducted a qualitative analysis of 37 hour-long interviews with a subsample of teens enrolled in a larger study for adolescents at risk for depression. The teens, recruited from urban and suburban pediatric clinics, were aged 13-18 years and included 12 from Boston and 25 from Chicago. Ten were Hispanic, 15 were African American, and 12 were white.

The participants qualified for the study based on assessments using the Center for Epidemiological Studies Depression (CESD) scale and two questions about anhedonia and/or a depressed or irritable mood for at least 2 weeks. Teens with a current diagnosis of major depressive disorder or currently receiving therapy for depression were excluded.

AlexRaths/Thinkstock
The adolescents underwent face-to-face interviews using the Kiddie–Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). These taped interviews then were transcribed for the content analysis.

Starting without a priori assumptions regarding potential findings, the researchers each independently used codes to identify key concepts in the transcripts and then categorized the codes. During regular meetings, they compared findings and continued until patterns in the content emerged.

The findings revealed that teens often express sadness in ways that don’t necessarily immediately call to mind a risk for depression.

“Our participants rarely described themselves as ‘depressed’ and instead used less specific terms such as ‘stressed’ or ‘down,’ ” Dr. Khan said. “Adolescents spoke of topics including unhappiness with school or family relationships that could be attributed to normal teenage angst by some. However, with further probing, adolescents revealed – in their own words – how profoundly impacted they were by their symptoms in various aspects of their lives.”

The research identified themes in three areas: external negative sources of stress, expressions of sadness, and coping practices. The three main sources of external stress identified included school pressure, family discord, and death of a close friend or family member.

The school pressures included difficulty understanding the material, completing work, passing classes, and achieving set goals. Problems with family ranged from tension and fighting to verbal and emotional abuse as well as stress from specific changes, such as divorce or frequent moves.

The researchers identified four main categories of sadness expression:

• Feeling stressed, sad, or down, often involving crying and interfering with their lives.

• Anger and irritability, often directed at others: One teen said, “Little things annoy me that used not to annoy me.”

• New feelings of apathy: One teen said, “I can still do the stuff I want to do, I just don’t feel like it. I used to love, love singing. Now, I sing, but I don’t really... it’s not all that.”

• Problems sleeping, including difficulty falling or staying asleep or sleeping too much.

“In contrast to the depression screening scales that only indicated sub-threshold depression, adolescents – with further questioning – spoke of significant symptoms of unhappiness, loss of interest in activities, and anger/irritability,” Dr. Khan said. “Some teens had little insight into their feelings.”

For example, statements made by the teens included, “They don’t understand why I’m upset. Sometimes I don’t either,” and “I just got really sad. I don’t know. You cry, but you don’t really know why you’re crying. You’re just crying.”

The adolescents told the researchers that spending time with friends was a major way of dealing with their feelings. In addition, two-thirds of the participants had a health issue that led them to visit their primary care provider or the emergency department. These conditions included asthma, allergies, thyroid issues, attention-deficit/hyperactivity disorder, migraines and headaches, arthritis, ulcers, abdominal pain, colonoscopy, fainting, acne, needing birth control pills, and panic attacks.

The researchers concluded that you need to tune into the feelings teens have through conversations about seemingly innocuous topics, whether it’s an annual check-up or an appointment for a specific concern. The statements and feelings expressed by the teens cut across ethnicities, indicating a possible “universality of symptoms for teens with predepression,” the researchers noted.

“The take-away message of our study is that adolescent providers can play an important role in the prevention of major depressive episodes by heavily relying on individual interviews with patients,” Dr. Khan said. “These conversations are powerful tools in uncovering psychological disturbances that may progress to debilitating depressive episodes if gone unnoticed.”

The research was funded by the National Institutes of Mental Health. Dr. Khan had no relevant financial disclosures.

 

 

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SAN FRANCISCO – Teens may express feelings that indicate an increased risk for depression and give you an opportunity for early intervention and prevention if you know what to look for, suggest the findings of a qualitative study on teens’ sub-threshold symptoms of depression.

“Probing with sensitive questioning and understanding can help providers assess teens’ risks for depression,” said study coauthor Huma Khan, MD, of the University of Illinois Children’s Hospital in Chicago. “Furthermore, close follow-up with teens who mention certain topics, such as losing interest in activities or the loss of a loved one, also may help providers redirect the trajectory of depressive symptoms.”

Dr. Huma Khan
Despite a lifetime prevalence of depression in adolescents of about 11% and a 12-month prevalence of 7.5%, about 8 in 10 teens do not receive adequate mental health treatment, explained Dr. Khan at the Pediatric Academic Societies meeting. Further, primary care providers often lack the time and training to recognize and follow up on early signs of depression in their teen patients.

To better understand ways in which teens may manifest sub-threshold depressive symptoms and possible coping mechanisms, Dr. Khan’s team conducted a qualitative analysis of 37 hour-long interviews with a subsample of teens enrolled in a larger study for adolescents at risk for depression. The teens, recruited from urban and suburban pediatric clinics, were aged 13-18 years and included 12 from Boston and 25 from Chicago. Ten were Hispanic, 15 were African American, and 12 were white.

The participants qualified for the study based on assessments using the Center for Epidemiological Studies Depression (CESD) scale and two questions about anhedonia and/or a depressed or irritable mood for at least 2 weeks. Teens with a current diagnosis of major depressive disorder or currently receiving therapy for depression were excluded.

AlexRaths/Thinkstock
The adolescents underwent face-to-face interviews using the Kiddie–Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). These taped interviews then were transcribed for the content analysis.

Starting without a priori assumptions regarding potential findings, the researchers each independently used codes to identify key concepts in the transcripts and then categorized the codes. During regular meetings, they compared findings and continued until patterns in the content emerged.

The findings revealed that teens often express sadness in ways that don’t necessarily immediately call to mind a risk for depression.

“Our participants rarely described themselves as ‘depressed’ and instead used less specific terms such as ‘stressed’ or ‘down,’ ” Dr. Khan said. “Adolescents spoke of topics including unhappiness with school or family relationships that could be attributed to normal teenage angst by some. However, with further probing, adolescents revealed – in their own words – how profoundly impacted they were by their symptoms in various aspects of their lives.”

The research identified themes in three areas: external negative sources of stress, expressions of sadness, and coping practices. The three main sources of external stress identified included school pressure, family discord, and death of a close friend or family member.

The school pressures included difficulty understanding the material, completing work, passing classes, and achieving set goals. Problems with family ranged from tension and fighting to verbal and emotional abuse as well as stress from specific changes, such as divorce or frequent moves.

The researchers identified four main categories of sadness expression:

• Feeling stressed, sad, or down, often involving crying and interfering with their lives.

• Anger and irritability, often directed at others: One teen said, “Little things annoy me that used not to annoy me.”

• New feelings of apathy: One teen said, “I can still do the stuff I want to do, I just don’t feel like it. I used to love, love singing. Now, I sing, but I don’t really... it’s not all that.”

• Problems sleeping, including difficulty falling or staying asleep or sleeping too much.

“In contrast to the depression screening scales that only indicated sub-threshold depression, adolescents – with further questioning – spoke of significant symptoms of unhappiness, loss of interest in activities, and anger/irritability,” Dr. Khan said. “Some teens had little insight into their feelings.”

For example, statements made by the teens included, “They don’t understand why I’m upset. Sometimes I don’t either,” and “I just got really sad. I don’t know. You cry, but you don’t really know why you’re crying. You’re just crying.”

The adolescents told the researchers that spending time with friends was a major way of dealing with their feelings. In addition, two-thirds of the participants had a health issue that led them to visit their primary care provider or the emergency department. These conditions included asthma, allergies, thyroid issues, attention-deficit/hyperactivity disorder, migraines and headaches, arthritis, ulcers, abdominal pain, colonoscopy, fainting, acne, needing birth control pills, and panic attacks.

The researchers concluded that you need to tune into the feelings teens have through conversations about seemingly innocuous topics, whether it’s an annual check-up or an appointment for a specific concern. The statements and feelings expressed by the teens cut across ethnicities, indicating a possible “universality of symptoms for teens with predepression,” the researchers noted.

“The take-away message of our study is that adolescent providers can play an important role in the prevention of major depressive episodes by heavily relying on individual interviews with patients,” Dr. Khan said. “These conversations are powerful tools in uncovering psychological disturbances that may progress to debilitating depressive episodes if gone unnoticed.”

The research was funded by the National Institutes of Mental Health. Dr. Khan had no relevant financial disclosures.

 

 

 

SAN FRANCISCO – Teens may express feelings that indicate an increased risk for depression and give you an opportunity for early intervention and prevention if you know what to look for, suggest the findings of a qualitative study on teens’ sub-threshold symptoms of depression.

“Probing with sensitive questioning and understanding can help providers assess teens’ risks for depression,” said study coauthor Huma Khan, MD, of the University of Illinois Children’s Hospital in Chicago. “Furthermore, close follow-up with teens who mention certain topics, such as losing interest in activities or the loss of a loved one, also may help providers redirect the trajectory of depressive symptoms.”

Dr. Huma Khan
Despite a lifetime prevalence of depression in adolescents of about 11% and a 12-month prevalence of 7.5%, about 8 in 10 teens do not receive adequate mental health treatment, explained Dr. Khan at the Pediatric Academic Societies meeting. Further, primary care providers often lack the time and training to recognize and follow up on early signs of depression in their teen patients.

To better understand ways in which teens may manifest sub-threshold depressive symptoms and possible coping mechanisms, Dr. Khan’s team conducted a qualitative analysis of 37 hour-long interviews with a subsample of teens enrolled in a larger study for adolescents at risk for depression. The teens, recruited from urban and suburban pediatric clinics, were aged 13-18 years and included 12 from Boston and 25 from Chicago. Ten were Hispanic, 15 were African American, and 12 were white.

The participants qualified for the study based on assessments using the Center for Epidemiological Studies Depression (CESD) scale and two questions about anhedonia and/or a depressed or irritable mood for at least 2 weeks. Teens with a current diagnosis of major depressive disorder or currently receiving therapy for depression were excluded.

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The adolescents underwent face-to-face interviews using the Kiddie–Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). These taped interviews then were transcribed for the content analysis.

Starting without a priori assumptions regarding potential findings, the researchers each independently used codes to identify key concepts in the transcripts and then categorized the codes. During regular meetings, they compared findings and continued until patterns in the content emerged.

The findings revealed that teens often express sadness in ways that don’t necessarily immediately call to mind a risk for depression.

“Our participants rarely described themselves as ‘depressed’ and instead used less specific terms such as ‘stressed’ or ‘down,’ ” Dr. Khan said. “Adolescents spoke of topics including unhappiness with school or family relationships that could be attributed to normal teenage angst by some. However, with further probing, adolescents revealed – in their own words – how profoundly impacted they were by their symptoms in various aspects of their lives.”

The research identified themes in three areas: external negative sources of stress, expressions of sadness, and coping practices. The three main sources of external stress identified included school pressure, family discord, and death of a close friend or family member.

The school pressures included difficulty understanding the material, completing work, passing classes, and achieving set goals. Problems with family ranged from tension and fighting to verbal and emotional abuse as well as stress from specific changes, such as divorce or frequent moves.

The researchers identified four main categories of sadness expression:

• Feeling stressed, sad, or down, often involving crying and interfering with their lives.

• Anger and irritability, often directed at others: One teen said, “Little things annoy me that used not to annoy me.”

• New feelings of apathy: One teen said, “I can still do the stuff I want to do, I just don’t feel like it. I used to love, love singing. Now, I sing, but I don’t really... it’s not all that.”

• Problems sleeping, including difficulty falling or staying asleep or sleeping too much.

“In contrast to the depression screening scales that only indicated sub-threshold depression, adolescents – with further questioning – spoke of significant symptoms of unhappiness, loss of interest in activities, and anger/irritability,” Dr. Khan said. “Some teens had little insight into their feelings.”

For example, statements made by the teens included, “They don’t understand why I’m upset. Sometimes I don’t either,” and “I just got really sad. I don’t know. You cry, but you don’t really know why you’re crying. You’re just crying.”

The adolescents told the researchers that spending time with friends was a major way of dealing with their feelings. In addition, two-thirds of the participants had a health issue that led them to visit their primary care provider or the emergency department. These conditions included asthma, allergies, thyroid issues, attention-deficit/hyperactivity disorder, migraines and headaches, arthritis, ulcers, abdominal pain, colonoscopy, fainting, acne, needing birth control pills, and panic attacks.

The researchers concluded that you need to tune into the feelings teens have through conversations about seemingly innocuous topics, whether it’s an annual check-up or an appointment for a specific concern. The statements and feelings expressed by the teens cut across ethnicities, indicating a possible “universality of symptoms for teens with predepression,” the researchers noted.

“The take-away message of our study is that adolescent providers can play an important role in the prevention of major depressive episodes by heavily relying on individual interviews with patients,” Dr. Khan said. “These conversations are powerful tools in uncovering psychological disturbances that may progress to debilitating depressive episodes if gone unnoticed.”

The research was funded by the National Institutes of Mental Health. Dr. Khan had no relevant financial disclosures.

 

 

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Key clinical point: Dialogue with teens at each visit may reveal predepressive symptoms indicating an opportunity for depression prevention.

Major finding: The research identified themes in three areas: external negative sources of stress, expressions of sadness, and coping practices. The three main sources of external stress identified included school pressure, family discord, and death of a close friend or family member.

Data source: The findings are based on a qualitative analysis of 37 K-SADS interviews with teens aged 13-18 years from Chicago and Boston community pediatric clinics.

Disclosures: The research was funded by the National Institutes of Mental Health. Dr. Khan had no relevant financial disclosures.

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Expert: Engage patients, clinicians as partners in research

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– Not all researchers are clinicians, but what if all clinicians were researchers? Clinical studies would yield more relevant data, resulting in better patient care, according to an expert.

“The clinical research enterprise is broken,” Andrew A. Nierenberg, MD, said during a keynote plenary session dedicated to serving diverse populations, at a meeting of the American Society of Clinical Psychopharmacology, formerly known as the New Clinical Drug Evaluation Unit meeting. “It’s a problem, because it really does not have an impact on the actual care we give, and it doesn’t answer the types of questions that patients care about.”

One persistent problem, Dr. Nierenberg said, is that often those who enroll in trials have unclear motives for doing so, but those motives usually are tied to incentives such as cash. “Who goes into these trials and why is absolutely critical to the signal,” he said.

Dr. Andrew Nierenberg


Questionable intent is compounded by inadequate or nonexistent explanations to study participants about the researchers’ reasons for the trial, and no clear justification for why the participants should adhere to the protocols. This leads to medications often not being taken as directed, and poor attendance at follow-up points and psychosocial visits. The result overall, he said, is that clinical research amounts to symptomatic volunteers who are strangers to the investigator “doing weird things in places where they have never been before and [not really understanding] why they are doing them.” In practical terms, this means that the amount of evidence-based medicine practiced across the specialties is low – only about 15%, said Dr. Nierenberg, who cited a study that pinned blame for the “fragmented ‘nonsystem’ of [clinical research] on a lack of common goals, vision, and collaboration” (JAMA. 2009;301[8]:831-41).

The best solution would be integrating the clinical and the research enterprises into a single system – where patients and clinicians alike are engaged in the research process, he said.

“Transform clinicians into partners and collaborators. Engage them up front to help recruit, not just for your study but for all studies,” said Dr. Nierenberg, the incumbent holder of the Thomas P. Hackett, MD Endowed Chair in Psychiatry at Massachusetts General Hospital in Boston. “If someone comes in [seeking treatment], they can opt out of doing research, but the assumption is that they will collaborate and that we will expect them to collaborate.”

In his own work, Dr. Nierenberg helps run the MoodNetwork, a growing, nationwide database of patient-reported outcomes for those with mood disorders that he said is dedicated to filling knowledge gaps around those illnesses not easily gleaned from clinical response data alone. “Patients know what it is like to live with their illness more than we do,” said Dr. Nierenberg, also director of the Dauten Family Center for Bipolar Treatment Innovation in Boston.

The data from the MoodNetwork also feed into a nationwide network of databases run by the Patient-Centered Outcomes Research Institute network, originally created as part of the Affordable Care Act, and which, at least for now, Dr. Nierenberg said, appears safe from repeal. The network recently received $28 million to help create the necessary infrastructure for connecting research and clinical databases – including the electronic health records – from a variety of health institutions nationwide. “Most of you have your EHRs embedded into those networks even if you don’t know it,” Dr. Nierenberg said.

PCORInet’s resulting uber-database currently has patient-reported data on more than 122 million people. All of the data are queryable and available for use for virtually any study a clinical researcher or clinician would like to conduct into any aspect of any clinical specialty.

In his clinical practice, Dr. Nierenberg said, he is able to solicit patients in MoodNetwork studies by appealing to them as partners and collaborators from the moment they present in the clinic. He and his colleagues ensure that patients understand the importance of their participation not just to them as sufferers of an illness, but to the care of millions of others. Key to working together as partners is to use plain language when explaining treatment and research goals. It also is important to survey patients and listen to them when they share their experience of trials and treatment.

“We tend to suffer from the curse of knowledge,” Dr. Nierenberg said, referring to the amount of technical jargon that often separates study participants from researchers. “We are so embedded in our world; we can’t imagine not understanding it. It’s a failure to communicate, and it happens over and over again.”

Dr. Nierenberg’s talk generated buzz days after he gave it. During the meeting’s final regulatory plenary session, ASCP President Mark H. Rapaport, MD, chair of psychiatry and behavioral sciences at Emory University in Atlanta, invited Dr. Nierenberg to help clarify for Food and Drug Administration officials and attendees alike the extent to which point-of-care research could avoid numerous pitfalls, including expectation bias and an outsized placebo effect – two drawbacks that researchers typically avoid by purposefully not interacting with patients.

The way around those confounders, Dr. Nierenberg said, is to begin communicating with patients as soon as they enter the clinic. Randomize those who are seeking care from those who are willing to participate in research for a time-limited duration, and emphasize that there is continuity before and after the research with the same clinician providing the clinical care. “Be very explicit in saying to them that: ‘The study might affect your care and the care of others in the future, but that it is just as important to the study if you don’t respond as if you do [respond].’ ”

To avoid rater bias, he suggested blinding raters as to which clinicians gathered the data on which patients.

Incentivizing clinicians to change their work flows to accommodate becoming researchers requires seeing them as equals. As the current system of research is now, Dr. Nierenberg said, “clinicians get pushed aside.” Instead, he suggested, meet clinicians’ desires for access to the data to help care for their patients, or CMEs, and webinars – all resources and tools he said were possible to achieve with dashboards built into the information networks.

Dr. Nierenberg talked about the importance of teaching patients how to be collaborators, such as by having them respond to practice questions, asking whether they understand what is being asked of them, and presenting them with videos about what to expect.

Conversely, the patient can teach the researcher how to be a better collaborator. During the regulatory plenary session, Dr. Rapaport called upon David Sheehan, MD, a distinguished university health professor emeritus at University of South Florida in Tampa, now in private practice. His Sheehan Suicidality Tracking Scale was validated in a study that described the scale as having “excellent accuracy for suicidal ideation” (J Clin Psychiatry. 2015 Dec;76[12]:1676-82).
Dr. David Sheehan


Throughout his career, Dr. Sheehan said, he has asked his patients to arrive early to their appointments to answer questions on scales of his own creation. He then reviews them with the patient in each visit and asks for their feedback. “Honestly, they gave me the best advice ...” Dr. Sheehan said. “It’s the way they phrase the questions that I would never would have thought up. They would say to me, ‘We would understand [the questions] if you put them this way, but if you don’t change the wording, a whole cohort of your patients will give you the wrong kind of answer.’ With decades of input like that, I realized it was the best way to go.”

Dr. Nierenberg described an alchemy of sorts that occurs when the power differential between the holder of the learned knowledge (the researcher) and the holder of experiential knowledge (the patient) is bridged. “What happens to your attitude when you’re working with a ‘collaborator’ compared to when you are working with a ‘patient’? You feel it, but you’re unaware of the bias. But if you think of them as your partners, and tell them that they are, you find they shift. They own it. It’s an authentic engagement over time.”

Ultimately, better research will lead to better patient care, he said.

Dr. Nierenberg had no relevant disclosures.

 

 

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– Not all researchers are clinicians, but what if all clinicians were researchers? Clinical studies would yield more relevant data, resulting in better patient care, according to an expert.

“The clinical research enterprise is broken,” Andrew A. Nierenberg, MD, said during a keynote plenary session dedicated to serving diverse populations, at a meeting of the American Society of Clinical Psychopharmacology, formerly known as the New Clinical Drug Evaluation Unit meeting. “It’s a problem, because it really does not have an impact on the actual care we give, and it doesn’t answer the types of questions that patients care about.”

One persistent problem, Dr. Nierenberg said, is that often those who enroll in trials have unclear motives for doing so, but those motives usually are tied to incentives such as cash. “Who goes into these trials and why is absolutely critical to the signal,” he said.

Dr. Andrew Nierenberg


Questionable intent is compounded by inadequate or nonexistent explanations to study participants about the researchers’ reasons for the trial, and no clear justification for why the participants should adhere to the protocols. This leads to medications often not being taken as directed, and poor attendance at follow-up points and psychosocial visits. The result overall, he said, is that clinical research amounts to symptomatic volunteers who are strangers to the investigator “doing weird things in places where they have never been before and [not really understanding] why they are doing them.” In practical terms, this means that the amount of evidence-based medicine practiced across the specialties is low – only about 15%, said Dr. Nierenberg, who cited a study that pinned blame for the “fragmented ‘nonsystem’ of [clinical research] on a lack of common goals, vision, and collaboration” (JAMA. 2009;301[8]:831-41).

The best solution would be integrating the clinical and the research enterprises into a single system – where patients and clinicians alike are engaged in the research process, he said.

“Transform clinicians into partners and collaborators. Engage them up front to help recruit, not just for your study but for all studies,” said Dr. Nierenberg, the incumbent holder of the Thomas P. Hackett, MD Endowed Chair in Psychiatry at Massachusetts General Hospital in Boston. “If someone comes in [seeking treatment], they can opt out of doing research, but the assumption is that they will collaborate and that we will expect them to collaborate.”

In his own work, Dr. Nierenberg helps run the MoodNetwork, a growing, nationwide database of patient-reported outcomes for those with mood disorders that he said is dedicated to filling knowledge gaps around those illnesses not easily gleaned from clinical response data alone. “Patients know what it is like to live with their illness more than we do,” said Dr. Nierenberg, also director of the Dauten Family Center for Bipolar Treatment Innovation in Boston.

The data from the MoodNetwork also feed into a nationwide network of databases run by the Patient-Centered Outcomes Research Institute network, originally created as part of the Affordable Care Act, and which, at least for now, Dr. Nierenberg said, appears safe from repeal. The network recently received $28 million to help create the necessary infrastructure for connecting research and clinical databases – including the electronic health records – from a variety of health institutions nationwide. “Most of you have your EHRs embedded into those networks even if you don’t know it,” Dr. Nierenberg said.

PCORInet’s resulting uber-database currently has patient-reported data on more than 122 million people. All of the data are queryable and available for use for virtually any study a clinical researcher or clinician would like to conduct into any aspect of any clinical specialty.

In his clinical practice, Dr. Nierenberg said, he is able to solicit patients in MoodNetwork studies by appealing to them as partners and collaborators from the moment they present in the clinic. He and his colleagues ensure that patients understand the importance of their participation not just to them as sufferers of an illness, but to the care of millions of others. Key to working together as partners is to use plain language when explaining treatment and research goals. It also is important to survey patients and listen to them when they share their experience of trials and treatment.

“We tend to suffer from the curse of knowledge,” Dr. Nierenberg said, referring to the amount of technical jargon that often separates study participants from researchers. “We are so embedded in our world; we can’t imagine not understanding it. It’s a failure to communicate, and it happens over and over again.”

Dr. Nierenberg’s talk generated buzz days after he gave it. During the meeting’s final regulatory plenary session, ASCP President Mark H. Rapaport, MD, chair of psychiatry and behavioral sciences at Emory University in Atlanta, invited Dr. Nierenberg to help clarify for Food and Drug Administration officials and attendees alike the extent to which point-of-care research could avoid numerous pitfalls, including expectation bias and an outsized placebo effect – two drawbacks that researchers typically avoid by purposefully not interacting with patients.

The way around those confounders, Dr. Nierenberg said, is to begin communicating with patients as soon as they enter the clinic. Randomize those who are seeking care from those who are willing to participate in research for a time-limited duration, and emphasize that there is continuity before and after the research with the same clinician providing the clinical care. “Be very explicit in saying to them that: ‘The study might affect your care and the care of others in the future, but that it is just as important to the study if you don’t respond as if you do [respond].’ ”

To avoid rater bias, he suggested blinding raters as to which clinicians gathered the data on which patients.

Incentivizing clinicians to change their work flows to accommodate becoming researchers requires seeing them as equals. As the current system of research is now, Dr. Nierenberg said, “clinicians get pushed aside.” Instead, he suggested, meet clinicians’ desires for access to the data to help care for their patients, or CMEs, and webinars – all resources and tools he said were possible to achieve with dashboards built into the information networks.

Dr. Nierenberg talked about the importance of teaching patients how to be collaborators, such as by having them respond to practice questions, asking whether they understand what is being asked of them, and presenting them with videos about what to expect.

Conversely, the patient can teach the researcher how to be a better collaborator. During the regulatory plenary session, Dr. Rapaport called upon David Sheehan, MD, a distinguished university health professor emeritus at University of South Florida in Tampa, now in private practice. His Sheehan Suicidality Tracking Scale was validated in a study that described the scale as having “excellent accuracy for suicidal ideation” (J Clin Psychiatry. 2015 Dec;76[12]:1676-82).
Dr. David Sheehan


Throughout his career, Dr. Sheehan said, he has asked his patients to arrive early to their appointments to answer questions on scales of his own creation. He then reviews them with the patient in each visit and asks for their feedback. “Honestly, they gave me the best advice ...” Dr. Sheehan said. “It’s the way they phrase the questions that I would never would have thought up. They would say to me, ‘We would understand [the questions] if you put them this way, but if you don’t change the wording, a whole cohort of your patients will give you the wrong kind of answer.’ With decades of input like that, I realized it was the best way to go.”

Dr. Nierenberg described an alchemy of sorts that occurs when the power differential between the holder of the learned knowledge (the researcher) and the holder of experiential knowledge (the patient) is bridged. “What happens to your attitude when you’re working with a ‘collaborator’ compared to when you are working with a ‘patient’? You feel it, but you’re unaware of the bias. But if you think of them as your partners, and tell them that they are, you find they shift. They own it. It’s an authentic engagement over time.”

Ultimately, better research will lead to better patient care, he said.

Dr. Nierenberg had no relevant disclosures.

 

 

 

– Not all researchers are clinicians, but what if all clinicians were researchers? Clinical studies would yield more relevant data, resulting in better patient care, according to an expert.

“The clinical research enterprise is broken,” Andrew A. Nierenberg, MD, said during a keynote plenary session dedicated to serving diverse populations, at a meeting of the American Society of Clinical Psychopharmacology, formerly known as the New Clinical Drug Evaluation Unit meeting. “It’s a problem, because it really does not have an impact on the actual care we give, and it doesn’t answer the types of questions that patients care about.”

One persistent problem, Dr. Nierenberg said, is that often those who enroll in trials have unclear motives for doing so, but those motives usually are tied to incentives such as cash. “Who goes into these trials and why is absolutely critical to the signal,” he said.

Dr. Andrew Nierenberg


Questionable intent is compounded by inadequate or nonexistent explanations to study participants about the researchers’ reasons for the trial, and no clear justification for why the participants should adhere to the protocols. This leads to medications often not being taken as directed, and poor attendance at follow-up points and psychosocial visits. The result overall, he said, is that clinical research amounts to symptomatic volunteers who are strangers to the investigator “doing weird things in places where they have never been before and [not really understanding] why they are doing them.” In practical terms, this means that the amount of evidence-based medicine practiced across the specialties is low – only about 15%, said Dr. Nierenberg, who cited a study that pinned blame for the “fragmented ‘nonsystem’ of [clinical research] on a lack of common goals, vision, and collaboration” (JAMA. 2009;301[8]:831-41).

The best solution would be integrating the clinical and the research enterprises into a single system – where patients and clinicians alike are engaged in the research process, he said.

“Transform clinicians into partners and collaborators. Engage them up front to help recruit, not just for your study but for all studies,” said Dr. Nierenberg, the incumbent holder of the Thomas P. Hackett, MD Endowed Chair in Psychiatry at Massachusetts General Hospital in Boston. “If someone comes in [seeking treatment], they can opt out of doing research, but the assumption is that they will collaborate and that we will expect them to collaborate.”

In his own work, Dr. Nierenberg helps run the MoodNetwork, a growing, nationwide database of patient-reported outcomes for those with mood disorders that he said is dedicated to filling knowledge gaps around those illnesses not easily gleaned from clinical response data alone. “Patients know what it is like to live with their illness more than we do,” said Dr. Nierenberg, also director of the Dauten Family Center for Bipolar Treatment Innovation in Boston.

The data from the MoodNetwork also feed into a nationwide network of databases run by the Patient-Centered Outcomes Research Institute network, originally created as part of the Affordable Care Act, and which, at least for now, Dr. Nierenberg said, appears safe from repeal. The network recently received $28 million to help create the necessary infrastructure for connecting research and clinical databases – including the electronic health records – from a variety of health institutions nationwide. “Most of you have your EHRs embedded into those networks even if you don’t know it,” Dr. Nierenberg said.

PCORInet’s resulting uber-database currently has patient-reported data on more than 122 million people. All of the data are queryable and available for use for virtually any study a clinical researcher or clinician would like to conduct into any aspect of any clinical specialty.

In his clinical practice, Dr. Nierenberg said, he is able to solicit patients in MoodNetwork studies by appealing to them as partners and collaborators from the moment they present in the clinic. He and his colleagues ensure that patients understand the importance of their participation not just to them as sufferers of an illness, but to the care of millions of others. Key to working together as partners is to use plain language when explaining treatment and research goals. It also is important to survey patients and listen to them when they share their experience of trials and treatment.

“We tend to suffer from the curse of knowledge,” Dr. Nierenberg said, referring to the amount of technical jargon that often separates study participants from researchers. “We are so embedded in our world; we can’t imagine not understanding it. It’s a failure to communicate, and it happens over and over again.”

Dr. Nierenberg’s talk generated buzz days after he gave it. During the meeting’s final regulatory plenary session, ASCP President Mark H. Rapaport, MD, chair of psychiatry and behavioral sciences at Emory University in Atlanta, invited Dr. Nierenberg to help clarify for Food and Drug Administration officials and attendees alike the extent to which point-of-care research could avoid numerous pitfalls, including expectation bias and an outsized placebo effect – two drawbacks that researchers typically avoid by purposefully not interacting with patients.

The way around those confounders, Dr. Nierenberg said, is to begin communicating with patients as soon as they enter the clinic. Randomize those who are seeking care from those who are willing to participate in research for a time-limited duration, and emphasize that there is continuity before and after the research with the same clinician providing the clinical care. “Be very explicit in saying to them that: ‘The study might affect your care and the care of others in the future, but that it is just as important to the study if you don’t respond as if you do [respond].’ ”

To avoid rater bias, he suggested blinding raters as to which clinicians gathered the data on which patients.

Incentivizing clinicians to change their work flows to accommodate becoming researchers requires seeing them as equals. As the current system of research is now, Dr. Nierenberg said, “clinicians get pushed aside.” Instead, he suggested, meet clinicians’ desires for access to the data to help care for their patients, or CMEs, and webinars – all resources and tools he said were possible to achieve with dashboards built into the information networks.

Dr. Nierenberg talked about the importance of teaching patients how to be collaborators, such as by having them respond to practice questions, asking whether they understand what is being asked of them, and presenting them with videos about what to expect.

Conversely, the patient can teach the researcher how to be a better collaborator. During the regulatory plenary session, Dr. Rapaport called upon David Sheehan, MD, a distinguished university health professor emeritus at University of South Florida in Tampa, now in private practice. His Sheehan Suicidality Tracking Scale was validated in a study that described the scale as having “excellent accuracy for suicidal ideation” (J Clin Psychiatry. 2015 Dec;76[12]:1676-82).
Dr. David Sheehan


Throughout his career, Dr. Sheehan said, he has asked his patients to arrive early to their appointments to answer questions on scales of his own creation. He then reviews them with the patient in each visit and asks for their feedback. “Honestly, they gave me the best advice ...” Dr. Sheehan said. “It’s the way they phrase the questions that I would never would have thought up. They would say to me, ‘We would understand [the questions] if you put them this way, but if you don’t change the wording, a whole cohort of your patients will give you the wrong kind of answer.’ With decades of input like that, I realized it was the best way to go.”

Dr. Nierenberg described an alchemy of sorts that occurs when the power differential between the holder of the learned knowledge (the researcher) and the holder of experiential knowledge (the patient) is bridged. “What happens to your attitude when you’re working with a ‘collaborator’ compared to when you are working with a ‘patient’? You feel it, but you’re unaware of the bias. But if you think of them as your partners, and tell them that they are, you find they shift. They own it. It’s an authentic engagement over time.”

Ultimately, better research will lead to better patient care, he said.

Dr. Nierenberg had no relevant disclosures.

 

 

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Preventing Zika in pregnancy: What you need to know

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– Prevention of Zika virus infection in pregnancy is critical, given the lack of an effective treatment or vaccine, but it’s easier said than done.

“The particular mosquito that transmits Zika is really difficult because it tends to be indoors and live under the coffee table in your living room rather than outside. It bites in the day, as well as night, so it’s hard to prevent. Trying to consistently have repellent on [and] wear long-sleeved shirts and long pants, even when you’re indoors, in places that are typically quite warm – it’s challenging,” Margaret Honein, PhD, said at the annual meeting of the Teratology Society.

©DamrongpanThongwat/thinkstockphotos.com
It’s also important to try to eliminate breeding sites. “The Aedes aegypti mosquito can breed in a bottle cap full of liquid. It doesn’t take a large reservoir of standing water,” added Dr. Honein, chief of the birth defects branch at the Centers for Disease Control and Prevention in Atlanta.

The CDC’s top Zika prevention advice is that pregnant women should not travel to any area where Zika is a risk. If they absolutely have to go, they should talk to their health care provider first, strictly follow measures to prevent mosquito bites during the trip, take steps to prevent sexual transmission – namely, use a condom – and talk with their health care provider once again upon their return.

It is now clear that Zika can be transmitted sexually. For this reason, even a pregnant woman who doesn’t visit an area with Zika risk, but whose partner has been to such a place, must also practice safe sex using a condom, even if the partner is asymptomatic.

In response to an audience question from a Washington, D.C.–area ob.gyn. who noted that there isn’t a Zika problem in his region, Dr. Honein said that her personal view is that pregnant women living in the vicinity of the nation’s capitol should also follow the CDC recommendations for travelers to, or residents of, areas where Zika is found.

“You have mosquito vectors that can transmit Zika in Washington, D.C., and a lot of other parts of the country,” she said. “There are travelers coming back from areas with risk for Zika all the time. If they get bit by a mosquito, which then bites another person and transmits the infection, there’s a problem. So, for pregnant women in areas that have a mosquito vector that can transmit the virus, I think it’s very wise advice to consistently use mosquito repellent and take the other protective measures. People should be doing everything they can to protect against Zika infection in pregnancy.”

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– Prevention of Zika virus infection in pregnancy is critical, given the lack of an effective treatment or vaccine, but it’s easier said than done.

“The particular mosquito that transmits Zika is really difficult because it tends to be indoors and live under the coffee table in your living room rather than outside. It bites in the day, as well as night, so it’s hard to prevent. Trying to consistently have repellent on [and] wear long-sleeved shirts and long pants, even when you’re indoors, in places that are typically quite warm – it’s challenging,” Margaret Honein, PhD, said at the annual meeting of the Teratology Society.

©DamrongpanThongwat/thinkstockphotos.com
It’s also important to try to eliminate breeding sites. “The Aedes aegypti mosquito can breed in a bottle cap full of liquid. It doesn’t take a large reservoir of standing water,” added Dr. Honein, chief of the birth defects branch at the Centers for Disease Control and Prevention in Atlanta.

The CDC’s top Zika prevention advice is that pregnant women should not travel to any area where Zika is a risk. If they absolutely have to go, they should talk to their health care provider first, strictly follow measures to prevent mosquito bites during the trip, take steps to prevent sexual transmission – namely, use a condom – and talk with their health care provider once again upon their return.

It is now clear that Zika can be transmitted sexually. For this reason, even a pregnant woman who doesn’t visit an area with Zika risk, but whose partner has been to such a place, must also practice safe sex using a condom, even if the partner is asymptomatic.

In response to an audience question from a Washington, D.C.–area ob.gyn. who noted that there isn’t a Zika problem in his region, Dr. Honein said that her personal view is that pregnant women living in the vicinity of the nation’s capitol should also follow the CDC recommendations for travelers to, or residents of, areas where Zika is found.

“You have mosquito vectors that can transmit Zika in Washington, D.C., and a lot of other parts of the country,” she said. “There are travelers coming back from areas with risk for Zika all the time. If they get bit by a mosquito, which then bites another person and transmits the infection, there’s a problem. So, for pregnant women in areas that have a mosquito vector that can transmit the virus, I think it’s very wise advice to consistently use mosquito repellent and take the other protective measures. People should be doing everything they can to protect against Zika infection in pregnancy.”

 

– Prevention of Zika virus infection in pregnancy is critical, given the lack of an effective treatment or vaccine, but it’s easier said than done.

“The particular mosquito that transmits Zika is really difficult because it tends to be indoors and live under the coffee table in your living room rather than outside. It bites in the day, as well as night, so it’s hard to prevent. Trying to consistently have repellent on [and] wear long-sleeved shirts and long pants, even when you’re indoors, in places that are typically quite warm – it’s challenging,” Margaret Honein, PhD, said at the annual meeting of the Teratology Society.

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It’s also important to try to eliminate breeding sites. “The Aedes aegypti mosquito can breed in a bottle cap full of liquid. It doesn’t take a large reservoir of standing water,” added Dr. Honein, chief of the birth defects branch at the Centers for Disease Control and Prevention in Atlanta.

The CDC’s top Zika prevention advice is that pregnant women should not travel to any area where Zika is a risk. If they absolutely have to go, they should talk to their health care provider first, strictly follow measures to prevent mosquito bites during the trip, take steps to prevent sexual transmission – namely, use a condom – and talk with their health care provider once again upon their return.

It is now clear that Zika can be transmitted sexually. For this reason, even a pregnant woman who doesn’t visit an area with Zika risk, but whose partner has been to such a place, must also practice safe sex using a condom, even if the partner is asymptomatic.

In response to an audience question from a Washington, D.C.–area ob.gyn. who noted that there isn’t a Zika problem in his region, Dr. Honein said that her personal view is that pregnant women living in the vicinity of the nation’s capitol should also follow the CDC recommendations for travelers to, or residents of, areas where Zika is found.

“You have mosquito vectors that can transmit Zika in Washington, D.C., and a lot of other parts of the country,” she said. “There are travelers coming back from areas with risk for Zika all the time. If they get bit by a mosquito, which then bites another person and transmits the infection, there’s a problem. So, for pregnant women in areas that have a mosquito vector that can transmit the virus, I think it’s very wise advice to consistently use mosquito repellent and take the other protective measures. People should be doing everything they can to protect against Zika infection in pregnancy.”

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EXPERT ANALYSIS FROM TERATOLOGY SOCIETY 2017

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