7 tips for successful value-based care contracts

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Clear contracts with payers are critical as physicians enter into value-based care arrangements. During a recent webinar presented by the American Bar Association, legal experts provided guidance on how doctors can successfully draft pay-for-performance contracts and prevent disputes with payers.

1. Clearly define terms

Contract terms and definitions should be clearly outlined and understood by both parties before value-based agreements are signed, said Melissa J. Hulke, a director in the Berkeley Research Group, LLC health analytics practice.

Melissa Hulke
It may sound simple, but Ms. Hulke said she often sees contracts with ambiguous terms or contracts in which important clauses are omitted. For example, some contracts leave questions about what is included in a bundled payment. If unclear, one party may later argue that a particular service should be carved out, while the other party argues that the service should be included, Ms. Hulke said. Ensure that carve-out services or procedures are well defined within the contract, she stressed.

“Contract terms become central to resolving differences, so it’s important the contract is well defined, especially when moving away from fee for service,” she said. “These are more complex arrangements.”

Another area that needs thorough definition surrounds referral volume. Contracts can include the phrases, “predominately refer” or “primarily refer,” without defining the meaning of “predominately” or “primarily,” Ms. Hulke said.

“If that’s not defined in the contract, it’s hard to establish a benchmark to not only project the provider’s performance under the arrangement and how much revenue they can expect to receive, but it’s hard to know if you’re meeting that benchmark, as well,” she said. “I strongly encourage that if [a term states] “primarily, predominately, [or] mostly refer,” that you have a specific percentage benchmark included. That will help to avoid any disagreement later on.”
 

2. Review payment calculations

Ensure that payment formulas are examined and agreed upon.

Denise Hanna
Business teams on both sides of the deal should review the contract terms and understand the formulas well before contracts are completed, said Denise E. Hanna, a Washington health law attorney. Include examples of different scenarios within the contract regarding what will happen if quality metrics are reached or not, Ms. Hanna said.

“I think that should be baked into the contracts of today because they are so complex and there is so much money at stake,” she said. “Walk through that compensation exhibit, walk through the examples of what’s supposed to happen.

If not in agreement with calculations, talk to the payer’s financial personnel about how the numbers were reached and try to resolve any differences.
 

3. Monitor results

Actively monitor projected-to-actual financial performance under the contract. If performance is not being monitored and results are not being tested, it’s impossible to tell whether the contract is succeeding or failing, Ms. Hulke said.

It’s a good idea to monitor projected-to-actual financial performance monthly or at least quarterly, she advised.

“Tracking budget to actual performance and investigating successes and failures are important if the contracts are material to the provider’s business,” Ms. Hulke said.
 

4. Institute time frames for government methodologies

Be specific about when contracts are linked to Medicare reimbursement methodologies.

If commercial payers are tying payment rates to government programs, which often occurs, contracts should include whether the reimbursement is based on Medicare rates and methodologies as of a particular date and time, according to Ms. Hulke. For instance, the contract could specify that rates are tied to Medicare methodologies at the time the contract was executed. Alternatively, contracts could allow the physician payment rate to fluctuate depending on changes the government makes to Medicare rates and methodologies during the span of the contract.

“If this is not defined, when Medicare makes a change, the parties may have differing opinions on the appropriate rate of reimbursement that’s being paid,” she said.
 

5. Structure around state and federal laws

Conduct a regulatory analysis before inking any value based payment arrangement/transaction, and structure and document around potential legal constraints, Ms. Hanna said.

Know the laws in your state, she advised. Some states have requirements for provider incentive programs, while others may have rules for provider organizations or intermediaries that assume certain financial risk. When working with federal health care payers, review the Stark Law and Anti-Kickback regulations and ensure that if triggered by the arrangement, the venture falls within an exception of the statutes. Other legal considerations when drafting contracts include:

• HIPAA and state privacy laws.

• Antitrust laws.

• Telemedicine and telehealth laws.

• Medicare Advantage benefit guidelines for programs designed for specific Medicare Advantage populations.

• Scope of practice laws applicable to mid-level medical providers.

 

 

6. Design a dispute-resolution strategy

Include a thorough dispute-resolution strategy within the contract. The strategies help facilitate an orderly process for resolving disputes cost effectively, Ms. Hanna said. She suggested that policies start with an informal dispute-resolution process that sends unresolved matters to senior executives at each organization.

“This allows business leaders – and not the lawyers – to find a business solution to a thorny and potentially costly problem before each party gets entrenched in its own position and own sense of having been wronged,” she said in an interview. “The business solution may or may not rely on contract language but may be tailored to keep the relationship moving forward. However, if the informal process proves unsuccessful, then the process gets punted to the legal system – whether in a court proceeding or arbitration.”
 

7. Have an exit strategy

Include an exit strategy that ensures an end to the arrangement goes as smoothly and fairly as possible. The strategy will depend on the nature and structure of the payer-provider alignment and the value-based payment arrangement, Ms. Hanna said in an interview.

For example, in a true, corporate joint venture, the exit strategy may include buyout rights of the newly formed entity. In this case, it’s important to consider and negotiate the price of the buyout and what circumstances that will trigger the buyout. Termination rights should also be included in an exit strategy, Ms. Hanna said. One option is to allow termination “without case,” by either party.

“Clients often do not like this approach because the intention of the parties going in is to build a strong, long-term relationship where provider and payer benefit,” she said. “A ‘without cause’ termination rights gives the parties a safety valve if circumstances change or the relationship is just not successful.”

An alternative is to allow the relationship time to mature and grow before either party can exercise a without cause termination. A related approach is to develop triggering events that would give one or both parties the right to terminate the agreement, without the other party “having committed a bad act,” Ms. Hanna said in the interview.

“For instance, if the relationship does not meet certain financial or other benchmarks within an agreed-upon time frame, this may be a sufficient reason to terminate the relationship, abandon, or renegotiate the value-based purchasing payment formula or, perhaps, end an exclusive or other preferential relationship,” she said.
 

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Clear contracts with payers are critical as physicians enter into value-based care arrangements. During a recent webinar presented by the American Bar Association, legal experts provided guidance on how doctors can successfully draft pay-for-performance contracts and prevent disputes with payers.

1. Clearly define terms

Contract terms and definitions should be clearly outlined and understood by both parties before value-based agreements are signed, said Melissa J. Hulke, a director in the Berkeley Research Group, LLC health analytics practice.

Melissa Hulke
It may sound simple, but Ms. Hulke said she often sees contracts with ambiguous terms or contracts in which important clauses are omitted. For example, some contracts leave questions about what is included in a bundled payment. If unclear, one party may later argue that a particular service should be carved out, while the other party argues that the service should be included, Ms. Hulke said. Ensure that carve-out services or procedures are well defined within the contract, she stressed.

“Contract terms become central to resolving differences, so it’s important the contract is well defined, especially when moving away from fee for service,” she said. “These are more complex arrangements.”

Another area that needs thorough definition surrounds referral volume. Contracts can include the phrases, “predominately refer” or “primarily refer,” without defining the meaning of “predominately” or “primarily,” Ms. Hulke said.

“If that’s not defined in the contract, it’s hard to establish a benchmark to not only project the provider’s performance under the arrangement and how much revenue they can expect to receive, but it’s hard to know if you’re meeting that benchmark, as well,” she said. “I strongly encourage that if [a term states] “primarily, predominately, [or] mostly refer,” that you have a specific percentage benchmark included. That will help to avoid any disagreement later on.”
 

2. Review payment calculations

Ensure that payment formulas are examined and agreed upon.

Denise Hanna
Business teams on both sides of the deal should review the contract terms and understand the formulas well before contracts are completed, said Denise E. Hanna, a Washington health law attorney. Include examples of different scenarios within the contract regarding what will happen if quality metrics are reached or not, Ms. Hanna said.

“I think that should be baked into the contracts of today because they are so complex and there is so much money at stake,” she said. “Walk through that compensation exhibit, walk through the examples of what’s supposed to happen.

If not in agreement with calculations, talk to the payer’s financial personnel about how the numbers were reached and try to resolve any differences.
 

3. Monitor results

Actively monitor projected-to-actual financial performance under the contract. If performance is not being monitored and results are not being tested, it’s impossible to tell whether the contract is succeeding or failing, Ms. Hulke said.

It’s a good idea to monitor projected-to-actual financial performance monthly or at least quarterly, she advised.

“Tracking budget to actual performance and investigating successes and failures are important if the contracts are material to the provider’s business,” Ms. Hulke said.
 

4. Institute time frames for government methodologies

Be specific about when contracts are linked to Medicare reimbursement methodologies.

If commercial payers are tying payment rates to government programs, which often occurs, contracts should include whether the reimbursement is based on Medicare rates and methodologies as of a particular date and time, according to Ms. Hulke. For instance, the contract could specify that rates are tied to Medicare methodologies at the time the contract was executed. Alternatively, contracts could allow the physician payment rate to fluctuate depending on changes the government makes to Medicare rates and methodologies during the span of the contract.

“If this is not defined, when Medicare makes a change, the parties may have differing opinions on the appropriate rate of reimbursement that’s being paid,” she said.
 

5. Structure around state and federal laws

Conduct a regulatory analysis before inking any value based payment arrangement/transaction, and structure and document around potential legal constraints, Ms. Hanna said.

Know the laws in your state, she advised. Some states have requirements for provider incentive programs, while others may have rules for provider organizations or intermediaries that assume certain financial risk. When working with federal health care payers, review the Stark Law and Anti-Kickback regulations and ensure that if triggered by the arrangement, the venture falls within an exception of the statutes. Other legal considerations when drafting contracts include:

• HIPAA and state privacy laws.

• Antitrust laws.

• Telemedicine and telehealth laws.

• Medicare Advantage benefit guidelines for programs designed for specific Medicare Advantage populations.

• Scope of practice laws applicable to mid-level medical providers.

 

 

6. Design a dispute-resolution strategy

Include a thorough dispute-resolution strategy within the contract. The strategies help facilitate an orderly process for resolving disputes cost effectively, Ms. Hanna said. She suggested that policies start with an informal dispute-resolution process that sends unresolved matters to senior executives at each organization.

“This allows business leaders – and not the lawyers – to find a business solution to a thorny and potentially costly problem before each party gets entrenched in its own position and own sense of having been wronged,” she said in an interview. “The business solution may or may not rely on contract language but may be tailored to keep the relationship moving forward. However, if the informal process proves unsuccessful, then the process gets punted to the legal system – whether in a court proceeding or arbitration.”
 

7. Have an exit strategy

Include an exit strategy that ensures an end to the arrangement goes as smoothly and fairly as possible. The strategy will depend on the nature and structure of the payer-provider alignment and the value-based payment arrangement, Ms. Hanna said in an interview.

For example, in a true, corporate joint venture, the exit strategy may include buyout rights of the newly formed entity. In this case, it’s important to consider and negotiate the price of the buyout and what circumstances that will trigger the buyout. Termination rights should also be included in an exit strategy, Ms. Hanna said. One option is to allow termination “without case,” by either party.

“Clients often do not like this approach because the intention of the parties going in is to build a strong, long-term relationship where provider and payer benefit,” she said. “A ‘without cause’ termination rights gives the parties a safety valve if circumstances change or the relationship is just not successful.”

An alternative is to allow the relationship time to mature and grow before either party can exercise a without cause termination. A related approach is to develop triggering events that would give one or both parties the right to terminate the agreement, without the other party “having committed a bad act,” Ms. Hanna said in the interview.

“For instance, if the relationship does not meet certain financial or other benchmarks within an agreed-upon time frame, this may be a sufficient reason to terminate the relationship, abandon, or renegotiate the value-based purchasing payment formula or, perhaps, end an exclusive or other preferential relationship,” she said.
 

 

Clear contracts with payers are critical as physicians enter into value-based care arrangements. During a recent webinar presented by the American Bar Association, legal experts provided guidance on how doctors can successfully draft pay-for-performance contracts and prevent disputes with payers.

1. Clearly define terms

Contract terms and definitions should be clearly outlined and understood by both parties before value-based agreements are signed, said Melissa J. Hulke, a director in the Berkeley Research Group, LLC health analytics practice.

Melissa Hulke
It may sound simple, but Ms. Hulke said she often sees contracts with ambiguous terms or contracts in which important clauses are omitted. For example, some contracts leave questions about what is included in a bundled payment. If unclear, one party may later argue that a particular service should be carved out, while the other party argues that the service should be included, Ms. Hulke said. Ensure that carve-out services or procedures are well defined within the contract, she stressed.

“Contract terms become central to resolving differences, so it’s important the contract is well defined, especially when moving away from fee for service,” she said. “These are more complex arrangements.”

Another area that needs thorough definition surrounds referral volume. Contracts can include the phrases, “predominately refer” or “primarily refer,” without defining the meaning of “predominately” or “primarily,” Ms. Hulke said.

“If that’s not defined in the contract, it’s hard to establish a benchmark to not only project the provider’s performance under the arrangement and how much revenue they can expect to receive, but it’s hard to know if you’re meeting that benchmark, as well,” she said. “I strongly encourage that if [a term states] “primarily, predominately, [or] mostly refer,” that you have a specific percentage benchmark included. That will help to avoid any disagreement later on.”
 

2. Review payment calculations

Ensure that payment formulas are examined and agreed upon.

Denise Hanna
Business teams on both sides of the deal should review the contract terms and understand the formulas well before contracts are completed, said Denise E. Hanna, a Washington health law attorney. Include examples of different scenarios within the contract regarding what will happen if quality metrics are reached or not, Ms. Hanna said.

“I think that should be baked into the contracts of today because they are so complex and there is so much money at stake,” she said. “Walk through that compensation exhibit, walk through the examples of what’s supposed to happen.

If not in agreement with calculations, talk to the payer’s financial personnel about how the numbers were reached and try to resolve any differences.
 

3. Monitor results

Actively monitor projected-to-actual financial performance under the contract. If performance is not being monitored and results are not being tested, it’s impossible to tell whether the contract is succeeding or failing, Ms. Hulke said.

It’s a good idea to monitor projected-to-actual financial performance monthly or at least quarterly, she advised.

“Tracking budget to actual performance and investigating successes and failures are important if the contracts are material to the provider’s business,” Ms. Hulke said.
 

4. Institute time frames for government methodologies

Be specific about when contracts are linked to Medicare reimbursement methodologies.

If commercial payers are tying payment rates to government programs, which often occurs, contracts should include whether the reimbursement is based on Medicare rates and methodologies as of a particular date and time, according to Ms. Hulke. For instance, the contract could specify that rates are tied to Medicare methodologies at the time the contract was executed. Alternatively, contracts could allow the physician payment rate to fluctuate depending on changes the government makes to Medicare rates and methodologies during the span of the contract.

“If this is not defined, when Medicare makes a change, the parties may have differing opinions on the appropriate rate of reimbursement that’s being paid,” she said.
 

5. Structure around state and federal laws

Conduct a regulatory analysis before inking any value based payment arrangement/transaction, and structure and document around potential legal constraints, Ms. Hanna said.

Know the laws in your state, she advised. Some states have requirements for provider incentive programs, while others may have rules for provider organizations or intermediaries that assume certain financial risk. When working with federal health care payers, review the Stark Law and Anti-Kickback regulations and ensure that if triggered by the arrangement, the venture falls within an exception of the statutes. Other legal considerations when drafting contracts include:

• HIPAA and state privacy laws.

• Antitrust laws.

• Telemedicine and telehealth laws.

• Medicare Advantage benefit guidelines for programs designed for specific Medicare Advantage populations.

• Scope of practice laws applicable to mid-level medical providers.

 

 

6. Design a dispute-resolution strategy

Include a thorough dispute-resolution strategy within the contract. The strategies help facilitate an orderly process for resolving disputes cost effectively, Ms. Hanna said. She suggested that policies start with an informal dispute-resolution process that sends unresolved matters to senior executives at each organization.

“This allows business leaders – and not the lawyers – to find a business solution to a thorny and potentially costly problem before each party gets entrenched in its own position and own sense of having been wronged,” she said in an interview. “The business solution may or may not rely on contract language but may be tailored to keep the relationship moving forward. However, if the informal process proves unsuccessful, then the process gets punted to the legal system – whether in a court proceeding or arbitration.”
 

7. Have an exit strategy

Include an exit strategy that ensures an end to the arrangement goes as smoothly and fairly as possible. The strategy will depend on the nature and structure of the payer-provider alignment and the value-based payment arrangement, Ms. Hanna said in an interview.

For example, in a true, corporate joint venture, the exit strategy may include buyout rights of the newly formed entity. In this case, it’s important to consider and negotiate the price of the buyout and what circumstances that will trigger the buyout. Termination rights should also be included in an exit strategy, Ms. Hanna said. One option is to allow termination “without case,” by either party.

“Clients often do not like this approach because the intention of the parties going in is to build a strong, long-term relationship where provider and payer benefit,” she said. “A ‘without cause’ termination rights gives the parties a safety valve if circumstances change or the relationship is just not successful.”

An alternative is to allow the relationship time to mature and grow before either party can exercise a without cause termination. A related approach is to develop triggering events that would give one or both parties the right to terminate the agreement, without the other party “having committed a bad act,” Ms. Hanna said in the interview.

“For instance, if the relationship does not meet certain financial or other benchmarks within an agreed-upon time frame, this may be a sufficient reason to terminate the relationship, abandon, or renegotiate the value-based purchasing payment formula or, perhaps, end an exclusive or other preferential relationship,” she said.
 

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‘Committed’ is culmination of journey examining involuntary care

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After 3 years of work, Anne Hanson and I are delighted that our book, “Committed: The Battle over Involuntary Psychiatric Care” was officially released Nov. 1! Our publisher, Johns Hopkins University Press, asked me to write a post for its blog to start the launch and with permission, Clinical Psychiatry News has let me begin the story of our research here as well.

So how did I find myself sitting in courtrooms and riding alongside a police officer? Let me tell you a little about the process of writing this book, because it was a quite the adventure for me. The title implies that this is another book by psychiatrists for psychiatrists, but for me, the days I spent working on this manuscript were days off from psychiatry. Those mornings I woke up a psychiatrist and felt like I walked into a phone booth (maybe it was just my shower) and emerged as a journalist.

Dr. Dinah Miller
Those days I spent doing research in a whole new way: I cajoled people into talking with me; made call after call that sometimes led to dead ends; trolled message boards; shadowed a variety of psychiatrists, judges, and a crisis intervention police officer; attended legislative hearings; and sat in on government work groups. I arranged video meetings with patients, doctors, lawyers, advocates, and adversaries by phone and Skype, including one with a psychiatrist in New Zealand – quite the challenge with the 18-hour time difference.

To read more, please visit the Johns Hopkins University blog here.
 
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After 3 years of work, Anne Hanson and I are delighted that our book, “Committed: The Battle over Involuntary Psychiatric Care” was officially released Nov. 1! Our publisher, Johns Hopkins University Press, asked me to write a post for its blog to start the launch and with permission, Clinical Psychiatry News has let me begin the story of our research here as well.

So how did I find myself sitting in courtrooms and riding alongside a police officer? Let me tell you a little about the process of writing this book, because it was a quite the adventure for me. The title implies that this is another book by psychiatrists for psychiatrists, but for me, the days I spent working on this manuscript were days off from psychiatry. Those mornings I woke up a psychiatrist and felt like I walked into a phone booth (maybe it was just my shower) and emerged as a journalist.

Dr. Dinah Miller
Those days I spent doing research in a whole new way: I cajoled people into talking with me; made call after call that sometimes led to dead ends; trolled message boards; shadowed a variety of psychiatrists, judges, and a crisis intervention police officer; attended legislative hearings; and sat in on government work groups. I arranged video meetings with patients, doctors, lawyers, advocates, and adversaries by phone and Skype, including one with a psychiatrist in New Zealand – quite the challenge with the 18-hour time difference.

To read more, please visit the Johns Hopkins University blog here.
 

After 3 years of work, Anne Hanson and I are delighted that our book, “Committed: The Battle over Involuntary Psychiatric Care” was officially released Nov. 1! Our publisher, Johns Hopkins University Press, asked me to write a post for its blog to start the launch and with permission, Clinical Psychiatry News has let me begin the story of our research here as well.

So how did I find myself sitting in courtrooms and riding alongside a police officer? Let me tell you a little about the process of writing this book, because it was a quite the adventure for me. The title implies that this is another book by psychiatrists for psychiatrists, but for me, the days I spent working on this manuscript were days off from psychiatry. Those mornings I woke up a psychiatrist and felt like I walked into a phone booth (maybe it was just my shower) and emerged as a journalist.

Dr. Dinah Miller
Those days I spent doing research in a whole new way: I cajoled people into talking with me; made call after call that sometimes led to dead ends; trolled message boards; shadowed a variety of psychiatrists, judges, and a crisis intervention police officer; attended legislative hearings; and sat in on government work groups. I arranged video meetings with patients, doctors, lawyers, advocates, and adversaries by phone and Skype, including one with a psychiatrist in New Zealand – quite the challenge with the 18-hour time difference.

To read more, please visit the Johns Hopkins University blog here.
 
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Two factors associated with vocal cord dysfunction in study

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– Female sex and the absence of wheezing were the only factors significantly associated with vocal cord dysfunction in patients with high pretest probability of disease, a retrospective analysis showed.

The findings differ from those of the Pittsburgh Vocal Cord Index, which identified symptoms of throat tightness, dysphonia, absence of wheezing, and the presence of odors as key features predictive of vocal cord dysfunction (VCD). “This proves the point that VCD is an elusive diagnosis,” lead study author Phalgoon Shah, MD, said, in an interview, at the annual meeting of the American College of Chest Physicians.

Doug Brunk/Frontline Medical News
Dr. Phalgoon Shah
Of 244 patients who Dr. Shah and his colleagues retrospectively evaluated, 136 (56%) were diagnosed with VCD; the remaining 108 (44%) were not. As many as 66% of females had a diagnosis of VCD, compared with 48% of males (P = .006) The percentage of patients with VCD who had an absence of wheezing was 49% (P = .037).

The researchers found that a history of depression or anxiety, throat tightness, dysphonia, odor symptom trigger, lack of response to bronchodilator or truncation, and flattening of the inspiratory volume curve did not predict VCD.

The patients were active duty military personnel and veterans who were referred to the pulmonary function lab at Tripler Army Medical Center, Honolulu, for suspected VCD between 2010 and 2014. The researchers identified patients by laryngoscopy procedure code and collected numerous variables, including demographic information, past medical history, pulmonary function test data, and clinical variables such as ED visits for dyspnea.

Dr. Shah of the division of pulmonary and critical care at Tripler said that direct laryngoscopic visualization is used to diagnose VCD in military personnel because the diagnosis is grounds for dismissal, but in other practice settings, the technique is not readily available, even though it is considered the gold standard. “You might still have a very high clinical suspicion of VCD in spite of a negative laryngoscopy, and you send these patients to speech therapy and they get better,” he said. “By logic, you can assume that these patients had VCD, you just didn’t catch it right in the lab. For the first time, we are saying that exercise laryngoscopy is not the gold standard.”

He emphasized that more research is required to develop a validated scoring system to predict a diagnosis of VCD and to distinguish it from asthma. He reported having no financial disclosures.
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– Female sex and the absence of wheezing were the only factors significantly associated with vocal cord dysfunction in patients with high pretest probability of disease, a retrospective analysis showed.

The findings differ from those of the Pittsburgh Vocal Cord Index, which identified symptoms of throat tightness, dysphonia, absence of wheezing, and the presence of odors as key features predictive of vocal cord dysfunction (VCD). “This proves the point that VCD is an elusive diagnosis,” lead study author Phalgoon Shah, MD, said, in an interview, at the annual meeting of the American College of Chest Physicians.

Doug Brunk/Frontline Medical News
Dr. Phalgoon Shah
Of 244 patients who Dr. Shah and his colleagues retrospectively evaluated, 136 (56%) were diagnosed with VCD; the remaining 108 (44%) were not. As many as 66% of females had a diagnosis of VCD, compared with 48% of males (P = .006) The percentage of patients with VCD who had an absence of wheezing was 49% (P = .037).

The researchers found that a history of depression or anxiety, throat tightness, dysphonia, odor symptom trigger, lack of response to bronchodilator or truncation, and flattening of the inspiratory volume curve did not predict VCD.

The patients were active duty military personnel and veterans who were referred to the pulmonary function lab at Tripler Army Medical Center, Honolulu, for suspected VCD between 2010 and 2014. The researchers identified patients by laryngoscopy procedure code and collected numerous variables, including demographic information, past medical history, pulmonary function test data, and clinical variables such as ED visits for dyspnea.

Dr. Shah of the division of pulmonary and critical care at Tripler said that direct laryngoscopic visualization is used to diagnose VCD in military personnel because the diagnosis is grounds for dismissal, but in other practice settings, the technique is not readily available, even though it is considered the gold standard. “You might still have a very high clinical suspicion of VCD in spite of a negative laryngoscopy, and you send these patients to speech therapy and they get better,” he said. “By logic, you can assume that these patients had VCD, you just didn’t catch it right in the lab. For the first time, we are saying that exercise laryngoscopy is not the gold standard.”

He emphasized that more research is required to develop a validated scoring system to predict a diagnosis of VCD and to distinguish it from asthma. He reported having no financial disclosures.

– Female sex and the absence of wheezing were the only factors significantly associated with vocal cord dysfunction in patients with high pretest probability of disease, a retrospective analysis showed.

The findings differ from those of the Pittsburgh Vocal Cord Index, which identified symptoms of throat tightness, dysphonia, absence of wheezing, and the presence of odors as key features predictive of vocal cord dysfunction (VCD). “This proves the point that VCD is an elusive diagnosis,” lead study author Phalgoon Shah, MD, said, in an interview, at the annual meeting of the American College of Chest Physicians.

Doug Brunk/Frontline Medical News
Dr. Phalgoon Shah
Of 244 patients who Dr. Shah and his colleagues retrospectively evaluated, 136 (56%) were diagnosed with VCD; the remaining 108 (44%) were not. As many as 66% of females had a diagnosis of VCD, compared with 48% of males (P = .006) The percentage of patients with VCD who had an absence of wheezing was 49% (P = .037).

The researchers found that a history of depression or anxiety, throat tightness, dysphonia, odor symptom trigger, lack of response to bronchodilator or truncation, and flattening of the inspiratory volume curve did not predict VCD.

The patients were active duty military personnel and veterans who were referred to the pulmonary function lab at Tripler Army Medical Center, Honolulu, for suspected VCD between 2010 and 2014. The researchers identified patients by laryngoscopy procedure code and collected numerous variables, including demographic information, past medical history, pulmonary function test data, and clinical variables such as ED visits for dyspnea.

Dr. Shah of the division of pulmonary and critical care at Tripler said that direct laryngoscopic visualization is used to diagnose VCD in military personnel because the diagnosis is grounds for dismissal, but in other practice settings, the technique is not readily available, even though it is considered the gold standard. “You might still have a very high clinical suspicion of VCD in spite of a negative laryngoscopy, and you send these patients to speech therapy and they get better,” he said. “By logic, you can assume that these patients had VCD, you just didn’t catch it right in the lab. For the first time, we are saying that exercise laryngoscopy is not the gold standard.”

He emphasized that more research is required to develop a validated scoring system to predict a diagnosis of VCD and to distinguish it from asthma. He reported having no financial disclosures.
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Key clinical point: Further research is required to develop a validated scoring system to predict a diagnosis of vocal cord dysfunction.

Major finding: The only variables significantly associated with VCD were female sex (P = .006) and the absence of wheezing (P = .037).

Data source: A retrospective analysis of 244 patients referred to a pulmonary function lab for suspected VCD.

Disclosures: Dr. Shah reported having no financial disclosures.

Prenatal triple ART arrests HIV transmission

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A triple-drug antiretroviral therapy given to HIV-infected pregnant women significantly reduced transmission of the disease to their newborns, but with greater risk of adverse outcomes for mothers and infants, a study showed.

The findings were based on data from three treatment regimens in approximately 3,500 women and infant sets. The three treatments were zidovudine plus intrapartum single-dose nevirapine with 6-14 days of tenofovir and emtricitabine post partum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based antiretroviral therapy [ART]); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All infants received nevirapine once daily, and infants of mothers coinfected with hepatitis B also received hepatitis B vaccination.

MattZ90/Thinkstock.com
The rate of disease transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8% in the zidovudine group). “However, both ART regimens were associated with higher rates of adverse events than zidovudine alone,” wrote Mary G. Fowler, MD, of Johns Hopkins University, Baltimore, and her colleagues (N Engl J Med. 2016;375:1726-37. doi: 10.1056/NEJMoa1511691).

The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial included patients at 14 sites in seven countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). The current study presented findings from women with a CD4 count of at least 350 cells per cubic millimeter who were randomized at 14 weeks’ gestation to one of the three treatment regimens.

Maternal adverse events (grade 2 or higher) were significantly more common in the zidovudine-based ART group than in the zidovudine-only group (21.1% vs. 17.3%), as was the rate of grade 2 or higher abnormal blood chemical values (5.8% vs. 1.3%).

In addition, rates of abnormal blood chemical values grade 2 or higher were significantly more common in women treated with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%).

Low birth weight (less than 2,500 g) was significantly more likely for infants of mothers in the zidovudine-based ART group, compared with the zidovudine-only group (23.0% vs. 12.0%) and in the tenofovir-based ART group, compared with the zidovudine-only group (16.9% vs. 8.9%). Preterm delivery and early infant death rates were significantly more likely in the tenofovir-based ART group than in the zidovudine-based ART group. Overall, the rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART, the investigators reported.

The findings were limited by several factors, and the safest and most effective regimens have yet to be determined, the researchers said. “Our findings emphasize the need for continued research to assess ART in pregnancy to ensure safer pregnancies for HIV-infected women and healthier outcomes for their uninfected infants,” they wrote.

A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers, disclosed any financial conflicts.
 

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A triple-drug antiretroviral therapy given to HIV-infected pregnant women significantly reduced transmission of the disease to their newborns, but with greater risk of adverse outcomes for mothers and infants, a study showed.

The findings were based on data from three treatment regimens in approximately 3,500 women and infant sets. The three treatments were zidovudine plus intrapartum single-dose nevirapine with 6-14 days of tenofovir and emtricitabine post partum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based antiretroviral therapy [ART]); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All infants received nevirapine once daily, and infants of mothers coinfected with hepatitis B also received hepatitis B vaccination.

MattZ90/Thinkstock.com
The rate of disease transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8% in the zidovudine group). “However, both ART regimens were associated with higher rates of adverse events than zidovudine alone,” wrote Mary G. Fowler, MD, of Johns Hopkins University, Baltimore, and her colleagues (N Engl J Med. 2016;375:1726-37. doi: 10.1056/NEJMoa1511691).

The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial included patients at 14 sites in seven countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). The current study presented findings from women with a CD4 count of at least 350 cells per cubic millimeter who were randomized at 14 weeks’ gestation to one of the three treatment regimens.

Maternal adverse events (grade 2 or higher) were significantly more common in the zidovudine-based ART group than in the zidovudine-only group (21.1% vs. 17.3%), as was the rate of grade 2 or higher abnormal blood chemical values (5.8% vs. 1.3%).

In addition, rates of abnormal blood chemical values grade 2 or higher were significantly more common in women treated with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%).

Low birth weight (less than 2,500 g) was significantly more likely for infants of mothers in the zidovudine-based ART group, compared with the zidovudine-only group (23.0% vs. 12.0%) and in the tenofovir-based ART group, compared with the zidovudine-only group (16.9% vs. 8.9%). Preterm delivery and early infant death rates were significantly more likely in the tenofovir-based ART group than in the zidovudine-based ART group. Overall, the rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART, the investigators reported.

The findings were limited by several factors, and the safest and most effective regimens have yet to be determined, the researchers said. “Our findings emphasize the need for continued research to assess ART in pregnancy to ensure safer pregnancies for HIV-infected women and healthier outcomes for their uninfected infants,” they wrote.

A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers, disclosed any financial conflicts.
 

A triple-drug antiretroviral therapy given to HIV-infected pregnant women significantly reduced transmission of the disease to their newborns, but with greater risk of adverse outcomes for mothers and infants, a study showed.

The findings were based on data from three treatment regimens in approximately 3,500 women and infant sets. The three treatments were zidovudine plus intrapartum single-dose nevirapine with 6-14 days of tenofovir and emtricitabine post partum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based antiretroviral therapy [ART]); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All infants received nevirapine once daily, and infants of mothers coinfected with hepatitis B also received hepatitis B vaccination.

MattZ90/Thinkstock.com
The rate of disease transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8% in the zidovudine group). “However, both ART regimens were associated with higher rates of adverse events than zidovudine alone,” wrote Mary G. Fowler, MD, of Johns Hopkins University, Baltimore, and her colleagues (N Engl J Med. 2016;375:1726-37. doi: 10.1056/NEJMoa1511691).

The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial included patients at 14 sites in seven countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). The current study presented findings from women with a CD4 count of at least 350 cells per cubic millimeter who were randomized at 14 weeks’ gestation to one of the three treatment regimens.

Maternal adverse events (grade 2 or higher) were significantly more common in the zidovudine-based ART group than in the zidovudine-only group (21.1% vs. 17.3%), as was the rate of grade 2 or higher abnormal blood chemical values (5.8% vs. 1.3%).

In addition, rates of abnormal blood chemical values grade 2 or higher were significantly more common in women treated with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%).

Low birth weight (less than 2,500 g) was significantly more likely for infants of mothers in the zidovudine-based ART group, compared with the zidovudine-only group (23.0% vs. 12.0%) and in the tenofovir-based ART group, compared with the zidovudine-only group (16.9% vs. 8.9%). Preterm delivery and early infant death rates were significantly more likely in the tenofovir-based ART group than in the zidovudine-based ART group. Overall, the rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART, the investigators reported.

The findings were limited by several factors, and the safest and most effective regimens have yet to be determined, the researchers said. “Our findings emphasize the need for continued research to assess ART in pregnancy to ensure safer pregnancies for HIV-infected women and healthier outcomes for their uninfected infants,” they wrote.

A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers, disclosed any financial conflicts.
 

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Key clinical point: Prenatal ART significantly lowered rates of early HIV transmission from HIV-infected pregnant women to their newborns, compared with zidovudine alone.

Major finding: The transmission rate for HIV was significantly lower in patients who underwent ART, compared with zidovudine alone (0.5% vs. 1.8%).

Data source: A randomized trial including 3,529 HIV-positive pregnant women at at least 14 weeks’ gestation.

Disclosures: A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers disclosed any financial conflicts.
 

Nivolumab + ipilimumab induced fulminant, fatal myocarditis

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Two patients taking the immune checkpoint inhibitors nivolumab and ipilimumab for metastatic melanoma developed fulminant, fatal myocarditis, investigators reported in the New England Journal of Medicine.

Even though this adverse effect is rare, “clinicians should be vigilant for immune-mediated myocarditis, particularly because of its early onset, nonspecific symptomatology, and fulminant progression,” said Douglas B. Johnson, MD, of Vanderbilt University Medical Center, Nashville, and his associates.

The first case involved a 65-year-old woman with no cardiac risk factors who was admitted to the hospital with chest pain, dyspnea, and fatigue 12 days after she received her first dose of the combination therapy. She was found to have myocarditis and myositis with rhabdomylysis. Despite treatment with high-dose glucocorticoids, she developed intraventricular conduction delay within 24 hours, followed by complete heart block. She died from multisystem organ failure and refractory ventricular tachycardia.

The second case involved a 63-year-old man with no cardiac risk factors who was admitted with fatigue and myalgias 15 days after he received his first dose of the combination therapy. He showed profound ST-segment depression, an intraventricular conduction delay, myocarditis, and myositis. He also was treated with high-dose glucocorticoids but developed complete heart block and died from cardiac arrest.

Both patients had “strikingly elevated troponin levels and refractory conduction-system abnormalities with preserved cardiac function,” the investigators noted. Postmortem assessments showed intense lymphocytic infiltrates only in striated cardiac and skeletal muscle and in metastases; adjacent smooth muscle and other tissues were unaffected. Pathology results “were reminiscent of those observed in patients with acute allograft rejection after cardiac transplantation,” Dr. Johnson and his associates said (N Engl J Med. 2016 Nov 3. doi: 10.1056/NEJMoa1609214).

To assess the frequency of myocarditis and myositis in patients receiving immune checkpoint inhibitors for many different cancers, the investigators searched Bristol-Myers Squibb safety databases. They found 18 drug-related cases of severe myocarditis among 20,594 patients, for a frequency of 0.09%. Patients who received combined nivolumab and ipilimumab had more frequent and more severe myocarditis than those who took either agent alone.

“There are no known data regarding what monitoring strategy may be of value; in our practice, we are performing baseline ECG and weekly testing of troponin levels during weeks 1-3 for patients receiving combination immunotherapy,” the researchers noted.

This work was supported by the Bready Family Foundation, the National Cancer Institute, Vanderbilt-Ingram Cancer Center Ambassadors, the Breast Cancer Specialized Program of Research Excellence, the National Comprehensive Cancer Network, the National Institutes of Health, the Howard Hughes Medical Institute, and Gilead Life Sciences. Dr. Johnson reported receiving personal fees from Genoptix and Bristol-Myers Squibb, and his associates reported ties to numerous industry sources.

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Two patients taking the immune checkpoint inhibitors nivolumab and ipilimumab for metastatic melanoma developed fulminant, fatal myocarditis, investigators reported in the New England Journal of Medicine.

Even though this adverse effect is rare, “clinicians should be vigilant for immune-mediated myocarditis, particularly because of its early onset, nonspecific symptomatology, and fulminant progression,” said Douglas B. Johnson, MD, of Vanderbilt University Medical Center, Nashville, and his associates.

The first case involved a 65-year-old woman with no cardiac risk factors who was admitted to the hospital with chest pain, dyspnea, and fatigue 12 days after she received her first dose of the combination therapy. She was found to have myocarditis and myositis with rhabdomylysis. Despite treatment with high-dose glucocorticoids, she developed intraventricular conduction delay within 24 hours, followed by complete heart block. She died from multisystem organ failure and refractory ventricular tachycardia.

The second case involved a 63-year-old man with no cardiac risk factors who was admitted with fatigue and myalgias 15 days after he received his first dose of the combination therapy. He showed profound ST-segment depression, an intraventricular conduction delay, myocarditis, and myositis. He also was treated with high-dose glucocorticoids but developed complete heart block and died from cardiac arrest.

Both patients had “strikingly elevated troponin levels and refractory conduction-system abnormalities with preserved cardiac function,” the investigators noted. Postmortem assessments showed intense lymphocytic infiltrates only in striated cardiac and skeletal muscle and in metastases; adjacent smooth muscle and other tissues were unaffected. Pathology results “were reminiscent of those observed in patients with acute allograft rejection after cardiac transplantation,” Dr. Johnson and his associates said (N Engl J Med. 2016 Nov 3. doi: 10.1056/NEJMoa1609214).

To assess the frequency of myocarditis and myositis in patients receiving immune checkpoint inhibitors for many different cancers, the investigators searched Bristol-Myers Squibb safety databases. They found 18 drug-related cases of severe myocarditis among 20,594 patients, for a frequency of 0.09%. Patients who received combined nivolumab and ipilimumab had more frequent and more severe myocarditis than those who took either agent alone.

“There are no known data regarding what monitoring strategy may be of value; in our practice, we are performing baseline ECG and weekly testing of troponin levels during weeks 1-3 for patients receiving combination immunotherapy,” the researchers noted.

This work was supported by the Bready Family Foundation, the National Cancer Institute, Vanderbilt-Ingram Cancer Center Ambassadors, the Breast Cancer Specialized Program of Research Excellence, the National Comprehensive Cancer Network, the National Institutes of Health, the Howard Hughes Medical Institute, and Gilead Life Sciences. Dr. Johnson reported receiving personal fees from Genoptix and Bristol-Myers Squibb, and his associates reported ties to numerous industry sources.

 

Two patients taking the immune checkpoint inhibitors nivolumab and ipilimumab for metastatic melanoma developed fulminant, fatal myocarditis, investigators reported in the New England Journal of Medicine.

Even though this adverse effect is rare, “clinicians should be vigilant for immune-mediated myocarditis, particularly because of its early onset, nonspecific symptomatology, and fulminant progression,” said Douglas B. Johnson, MD, of Vanderbilt University Medical Center, Nashville, and his associates.

The first case involved a 65-year-old woman with no cardiac risk factors who was admitted to the hospital with chest pain, dyspnea, and fatigue 12 days after she received her first dose of the combination therapy. She was found to have myocarditis and myositis with rhabdomylysis. Despite treatment with high-dose glucocorticoids, she developed intraventricular conduction delay within 24 hours, followed by complete heart block. She died from multisystem organ failure and refractory ventricular tachycardia.

The second case involved a 63-year-old man with no cardiac risk factors who was admitted with fatigue and myalgias 15 days after he received his first dose of the combination therapy. He showed profound ST-segment depression, an intraventricular conduction delay, myocarditis, and myositis. He also was treated with high-dose glucocorticoids but developed complete heart block and died from cardiac arrest.

Both patients had “strikingly elevated troponin levels and refractory conduction-system abnormalities with preserved cardiac function,” the investigators noted. Postmortem assessments showed intense lymphocytic infiltrates only in striated cardiac and skeletal muscle and in metastases; adjacent smooth muscle and other tissues were unaffected. Pathology results “were reminiscent of those observed in patients with acute allograft rejection after cardiac transplantation,” Dr. Johnson and his associates said (N Engl J Med. 2016 Nov 3. doi: 10.1056/NEJMoa1609214).

To assess the frequency of myocarditis and myositis in patients receiving immune checkpoint inhibitors for many different cancers, the investigators searched Bristol-Myers Squibb safety databases. They found 18 drug-related cases of severe myocarditis among 20,594 patients, for a frequency of 0.09%. Patients who received combined nivolumab and ipilimumab had more frequent and more severe myocarditis than those who took either agent alone.

“There are no known data regarding what monitoring strategy may be of value; in our practice, we are performing baseline ECG and weekly testing of troponin levels during weeks 1-3 for patients receiving combination immunotherapy,” the researchers noted.

This work was supported by the Bready Family Foundation, the National Cancer Institute, Vanderbilt-Ingram Cancer Center Ambassadors, the Breast Cancer Specialized Program of Research Excellence, the National Comprehensive Cancer Network, the National Institutes of Health, the Howard Hughes Medical Institute, and Gilead Life Sciences. Dr. Johnson reported receiving personal fees from Genoptix and Bristol-Myers Squibb, and his associates reported ties to numerous industry sources.

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FROM THE NEW ENGLAND JOURNAL OF MEDICINE

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Key clinical point: Two patients taking the immune checkpoint inhibitors nivolumab and ipilimumab for metastatic melanoma developed fulminant, fatal myocarditis.

Major finding: A search of Bristol-Myers Squibb safety databases found 18 drug-related cases of severe myocarditis among 20,594 patients, for a frequency of 0.09%.

Data source: Two case reports of a rare adverse effect of treatment with immune checkpoint inhibitors.

Disclosures: This work was supported by the Bready Family Foundation, the National Cancer Institute, Vanderbilt-Ingram Cancer Center Ambassadors, the Breast Cancer Specialized Program of Research Excellence, the National Comprehensive Cancer Network, the National Institutes of Health, the Howard Hughes Medical Institute, and Gilead Life Sciences. Dr. Johnson reported receiving personal fees from Genoptix and Bristol-Myers Squibb, and his associates reported ties to numerous industry sources.

Discussing screen time with parents

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The American Academy of Pediatrics released a new set of recommendations for the appropriate amount of screen time for children and adolescents in October 2016.

Among other changes, the AAP now recommends no screen time (except for video chatting) for infants and children up to 18 months old. For 18- to 24-month-olds, the AAP discourages screen time, recommending that parents introduce only selected “high-quality” programming and cowatch with their children. Likewise, for children up to 5 years old, the AAP urges parents to limit all screen time to 1 hour/day, half of its previous recommendation, and again recommends that parents cowatch with their children and use only reliable providers of quality content, such as the Public Broadcasting Service (PBS). For older children, the AAP does not set specific time limits, but recommends that parents collaborate with the children on a media plan that limits screen time so that it does not interfere with other important activities, including homework, social time, exercise, and sleep.

Dr. Susan D. Swick
Despite the clarity of these recommendations, there is a large variance between AAP recommendations and what limits parents have actually placed on screen time for their children. Data suggest that children from 2 to 11 years old are spending an average of 4.5 hours/day on screens (TV, computer, tablets, or smart phones, not counting homework). By adolescence, that number balloons to over 7 hours of daily screen time. Up to three-quarters of surveyed adolescents describe themselves as “constantly connected” to the Internet (Pew Internet and American Life Project, 2015). The reasons are many: Screens, from TV’s to laptops and smartphones, are omnipresent and limiting access can feel simply impossible. Indeed, many parents may have difficulty limiting their own use. Children may (accurately) complain that their peers get easy access to phones and apps, and that limiting their access puts them at a social disadvantage. Many exhausted parents default to a screen as a babysitter or reward. Parents also recognize the power of technology to help cultivate independence (when they give a cellphone to their older child), to have a research library at their fingertips, or to build supportive social networks. Most families are eager for help in setting reasonable limits on screen time for their children. What can pediatricians recommend so that screen time fits into the family’s life in a manageable way that might promote healthy development and family cohesion?

Dr. Michael S. Jellinek
The data about the potential risks to children and adolescents of unchecked time spent passively engaged in screen-based entertainment are growing, but it is important to note that these are challenging questions to answer, given the difficulty of separating causal links from simple associations. The youngest children should be learning about themselves and the world through joint engagement in activities with their parents. Passive engagement with a screen might impede the development of self-regulation of emotion and attention. Indeed, there is some evidence that the prevalence of attention-deficit/hyperactivity disorder in young children increases with increased time spent on screens, although this may reflect a predilection for screen-based activities among children with ADHD or their difficulty switching focus when engaged in engrossing activities. There is more robust evidence for a link between time spent in passive consumption of TV or Internet-based activities and obesity: Having a TV in the bedroom, spending more than 1.5 hours daily in media consumption, and snacking while watching TV all have been independently associated with the risk of obesity in childhood. Sleep also appears to be very sensitive to a child’s time spent engaged with media. Having a mobile device in the bedroom or simply being a heavy user of social media both predict inadequate sleep in children and teenagers. Exposure to back-lit screens directly suppresses melatonin release and can contribute to the drop in melatonin that is part of the hormonal trigger for the start of puberty. Combined with the added risk of obesity, excessive daily screen use can significantly increase the risk of early puberty. Finally, time spent on the Internet also appears to be habit forming for vulnerable youth: Up to 8.5% of children 8-18 years old meet criteria for Internet gaming disorder (Psychological Science. 2009;20[5]:594-602).

BunnyHollywood/iStockphoto.com
What children are watching appears to also be critical to the degree of developmental risk. While young children may learn some fundamentals of reading or mathematics from the best educational video games, their efficacy is not as good as time spent with parents reading together or working jointly on a math problem. Exposure to violent content on TV or video games can potentially be traumatizing for children, causing sleep disruptions and anxiety symptoms. And it can take away from the time children would otherwise spend in unstructured play, meeting new friends in the neighborhood, or trying new physical skills outside. When children have inadequate time spent in self-directed activities, they are less likely to develop their creative potential and discover their genuine interests and abilities.

There also is evidence that teenagers who spend substantial time engaged passively in social media (seeing what others are doing or saying via Facebook or Instagram) report higher levels of depression and anxiety, whereas those who use social media as a platform to stay connected (via two-way communication) report lower levels of these symptoms. While many young people use social sites as a forum to find peer support, share concerns, or develop their own “voice,” some young people might be vulnerable to exploitation, cyberbullying, or even online solicitation. The key here may be for parents, who have a sense of their child’s strengths and vulnerabilities, to be aware of where their children are spending their virtual time and to check in about the kinds of connections they have there. Of course, screen time can be equally seductive for parents. And when a parent is spending time reading texts or checking for Facebook updates, they are missing opportunities to be engaged with their children, helping them with homework or simply noticing that they seem stressed, or catching an opportunity to talk with them.

The pediatrician has the opportunity to educate parents about the potential risks that unchecked screen time can pose to their children’s healthy development. But it is critical that you approach these conversations with specificity and compassion. Customize the conversation to the age and personality of the child and family. A computer in the bedroom may make sense for an academically oriented 9th grader in a demanding school who is generally well-balanced in activities and friendships. A bedroom computer may be a poor choice for an isolated 9th grader almost addicted to video games with few friends or activities.

Simply reciting recommendations may heighten a parent’s feelings of isolation and shame, and not lead to meaningful change. Instead, start by asking about the details: Where are the screens in the home? Bedrooms? Who has a computer, tablet, or smartphone? How are these screens used in the context of the child’s overall psychosocial functioning? Depending on the circumstance, a smaller change, such as “no phones while doing homework,” can make a big difference. Simple, clear rules can be easier to explain and enforce, and protect parents from the perils of daily negotiations of screen terms with their children or teenagers. Perhaps they can have a “phone zone” where phones get parked and charged once kids get home from school. Perhaps there are limits on TV or video games on school nights (for the student performing below potential, rather than the driven student who would benefit from down time). Perhaps for preteens, computer-based homework can be done only on the desktop computer that is kept in a family study, rather than a laptop in a bedroom where kids are more likely to become distracted and surf the net. Pediatricians can help families think through the right approach to screen time that may range from restriction to shared use exploring shared interests to jointly watching a favorite TV show or sporting event.

You can help parents consider how they will talk about all this, acknowledging what is fun and rewarding about TV shows, social media, and the Internet alongside the problems of excessive use. Ask parents if it is hard for them to put down their own phones or tablets. They can acknowledge this explicitly with their children when establishing new media use rules. It is powerful for children, especially teenagers, to hear their parents acknowledge that “phones, tablets, and computers are powerful tools, but we all need to improve our skills at being in control of our use of them.” You might suggest that parents try this exercise: list all of the activities they wish they had time for in every day, and how much time they would spend in them. Then they should guess how much time they spend in screen-based entertainment. If they wish to protect time for screen-based entertainment, they can actively choose to do so. If you are able to help parents better understand the risks of excessive screen time and facilitate desired and appropriate use of media, you will have added to the quality of the family’s life.

The AAP has resources to help pediatricians partner with parents to create a Family Media Use Plan (www.healthychildren.org/MediaUsePlan).
 

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

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The American Academy of Pediatrics released a new set of recommendations for the appropriate amount of screen time for children and adolescents in October 2016.

Among other changes, the AAP now recommends no screen time (except for video chatting) for infants and children up to 18 months old. For 18- to 24-month-olds, the AAP discourages screen time, recommending that parents introduce only selected “high-quality” programming and cowatch with their children. Likewise, for children up to 5 years old, the AAP urges parents to limit all screen time to 1 hour/day, half of its previous recommendation, and again recommends that parents cowatch with their children and use only reliable providers of quality content, such as the Public Broadcasting Service (PBS). For older children, the AAP does not set specific time limits, but recommends that parents collaborate with the children on a media plan that limits screen time so that it does not interfere with other important activities, including homework, social time, exercise, and sleep.

Dr. Susan D. Swick
Despite the clarity of these recommendations, there is a large variance between AAP recommendations and what limits parents have actually placed on screen time for their children. Data suggest that children from 2 to 11 years old are spending an average of 4.5 hours/day on screens (TV, computer, tablets, or smart phones, not counting homework). By adolescence, that number balloons to over 7 hours of daily screen time. Up to three-quarters of surveyed adolescents describe themselves as “constantly connected” to the Internet (Pew Internet and American Life Project, 2015). The reasons are many: Screens, from TV’s to laptops and smartphones, are omnipresent and limiting access can feel simply impossible. Indeed, many parents may have difficulty limiting their own use. Children may (accurately) complain that their peers get easy access to phones and apps, and that limiting their access puts them at a social disadvantage. Many exhausted parents default to a screen as a babysitter or reward. Parents also recognize the power of technology to help cultivate independence (when they give a cellphone to their older child), to have a research library at their fingertips, or to build supportive social networks. Most families are eager for help in setting reasonable limits on screen time for their children. What can pediatricians recommend so that screen time fits into the family’s life in a manageable way that might promote healthy development and family cohesion?

Dr. Michael S. Jellinek
The data about the potential risks to children and adolescents of unchecked time spent passively engaged in screen-based entertainment are growing, but it is important to note that these are challenging questions to answer, given the difficulty of separating causal links from simple associations. The youngest children should be learning about themselves and the world through joint engagement in activities with their parents. Passive engagement with a screen might impede the development of self-regulation of emotion and attention. Indeed, there is some evidence that the prevalence of attention-deficit/hyperactivity disorder in young children increases with increased time spent on screens, although this may reflect a predilection for screen-based activities among children with ADHD or their difficulty switching focus when engaged in engrossing activities. There is more robust evidence for a link between time spent in passive consumption of TV or Internet-based activities and obesity: Having a TV in the bedroom, spending more than 1.5 hours daily in media consumption, and snacking while watching TV all have been independently associated with the risk of obesity in childhood. Sleep also appears to be very sensitive to a child’s time spent engaged with media. Having a mobile device in the bedroom or simply being a heavy user of social media both predict inadequate sleep in children and teenagers. Exposure to back-lit screens directly suppresses melatonin release and can contribute to the drop in melatonin that is part of the hormonal trigger for the start of puberty. Combined with the added risk of obesity, excessive daily screen use can significantly increase the risk of early puberty. Finally, time spent on the Internet also appears to be habit forming for vulnerable youth: Up to 8.5% of children 8-18 years old meet criteria for Internet gaming disorder (Psychological Science. 2009;20[5]:594-602).

BunnyHollywood/iStockphoto.com
What children are watching appears to also be critical to the degree of developmental risk. While young children may learn some fundamentals of reading or mathematics from the best educational video games, their efficacy is not as good as time spent with parents reading together or working jointly on a math problem. Exposure to violent content on TV or video games can potentially be traumatizing for children, causing sleep disruptions and anxiety symptoms. And it can take away from the time children would otherwise spend in unstructured play, meeting new friends in the neighborhood, or trying new physical skills outside. When children have inadequate time spent in self-directed activities, they are less likely to develop their creative potential and discover their genuine interests and abilities.

There also is evidence that teenagers who spend substantial time engaged passively in social media (seeing what others are doing or saying via Facebook or Instagram) report higher levels of depression and anxiety, whereas those who use social media as a platform to stay connected (via two-way communication) report lower levels of these symptoms. While many young people use social sites as a forum to find peer support, share concerns, or develop their own “voice,” some young people might be vulnerable to exploitation, cyberbullying, or even online solicitation. The key here may be for parents, who have a sense of their child’s strengths and vulnerabilities, to be aware of where their children are spending their virtual time and to check in about the kinds of connections they have there. Of course, screen time can be equally seductive for parents. And when a parent is spending time reading texts or checking for Facebook updates, they are missing opportunities to be engaged with their children, helping them with homework or simply noticing that they seem stressed, or catching an opportunity to talk with them.

The pediatrician has the opportunity to educate parents about the potential risks that unchecked screen time can pose to their children’s healthy development. But it is critical that you approach these conversations with specificity and compassion. Customize the conversation to the age and personality of the child and family. A computer in the bedroom may make sense for an academically oriented 9th grader in a demanding school who is generally well-balanced in activities and friendships. A bedroom computer may be a poor choice for an isolated 9th grader almost addicted to video games with few friends or activities.

Simply reciting recommendations may heighten a parent’s feelings of isolation and shame, and not lead to meaningful change. Instead, start by asking about the details: Where are the screens in the home? Bedrooms? Who has a computer, tablet, or smartphone? How are these screens used in the context of the child’s overall psychosocial functioning? Depending on the circumstance, a smaller change, such as “no phones while doing homework,” can make a big difference. Simple, clear rules can be easier to explain and enforce, and protect parents from the perils of daily negotiations of screen terms with their children or teenagers. Perhaps they can have a “phone zone” where phones get parked and charged once kids get home from school. Perhaps there are limits on TV or video games on school nights (for the student performing below potential, rather than the driven student who would benefit from down time). Perhaps for preteens, computer-based homework can be done only on the desktop computer that is kept in a family study, rather than a laptop in a bedroom where kids are more likely to become distracted and surf the net. Pediatricians can help families think through the right approach to screen time that may range from restriction to shared use exploring shared interests to jointly watching a favorite TV show or sporting event.

You can help parents consider how they will talk about all this, acknowledging what is fun and rewarding about TV shows, social media, and the Internet alongside the problems of excessive use. Ask parents if it is hard for them to put down their own phones or tablets. They can acknowledge this explicitly with their children when establishing new media use rules. It is powerful for children, especially teenagers, to hear their parents acknowledge that “phones, tablets, and computers are powerful tools, but we all need to improve our skills at being in control of our use of them.” You might suggest that parents try this exercise: list all of the activities they wish they had time for in every day, and how much time they would spend in them. Then they should guess how much time they spend in screen-based entertainment. If they wish to protect time for screen-based entertainment, they can actively choose to do so. If you are able to help parents better understand the risks of excessive screen time and facilitate desired and appropriate use of media, you will have added to the quality of the family’s life.

The AAP has resources to help pediatricians partner with parents to create a Family Media Use Plan (www.healthychildren.org/MediaUsePlan).
 

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

 

The American Academy of Pediatrics released a new set of recommendations for the appropriate amount of screen time for children and adolescents in October 2016.

Among other changes, the AAP now recommends no screen time (except for video chatting) for infants and children up to 18 months old. For 18- to 24-month-olds, the AAP discourages screen time, recommending that parents introduce only selected “high-quality” programming and cowatch with their children. Likewise, for children up to 5 years old, the AAP urges parents to limit all screen time to 1 hour/day, half of its previous recommendation, and again recommends that parents cowatch with their children and use only reliable providers of quality content, such as the Public Broadcasting Service (PBS). For older children, the AAP does not set specific time limits, but recommends that parents collaborate with the children on a media plan that limits screen time so that it does not interfere with other important activities, including homework, social time, exercise, and sleep.

Dr. Susan D. Swick
Despite the clarity of these recommendations, there is a large variance between AAP recommendations and what limits parents have actually placed on screen time for their children. Data suggest that children from 2 to 11 years old are spending an average of 4.5 hours/day on screens (TV, computer, tablets, or smart phones, not counting homework). By adolescence, that number balloons to over 7 hours of daily screen time. Up to three-quarters of surveyed adolescents describe themselves as “constantly connected” to the Internet (Pew Internet and American Life Project, 2015). The reasons are many: Screens, from TV’s to laptops and smartphones, are omnipresent and limiting access can feel simply impossible. Indeed, many parents may have difficulty limiting their own use. Children may (accurately) complain that their peers get easy access to phones and apps, and that limiting their access puts them at a social disadvantage. Many exhausted parents default to a screen as a babysitter or reward. Parents also recognize the power of technology to help cultivate independence (when they give a cellphone to their older child), to have a research library at their fingertips, or to build supportive social networks. Most families are eager for help in setting reasonable limits on screen time for their children. What can pediatricians recommend so that screen time fits into the family’s life in a manageable way that might promote healthy development and family cohesion?

Dr. Michael S. Jellinek
The data about the potential risks to children and adolescents of unchecked time spent passively engaged in screen-based entertainment are growing, but it is important to note that these are challenging questions to answer, given the difficulty of separating causal links from simple associations. The youngest children should be learning about themselves and the world through joint engagement in activities with their parents. Passive engagement with a screen might impede the development of self-regulation of emotion and attention. Indeed, there is some evidence that the prevalence of attention-deficit/hyperactivity disorder in young children increases with increased time spent on screens, although this may reflect a predilection for screen-based activities among children with ADHD or their difficulty switching focus when engaged in engrossing activities. There is more robust evidence for a link between time spent in passive consumption of TV or Internet-based activities and obesity: Having a TV in the bedroom, spending more than 1.5 hours daily in media consumption, and snacking while watching TV all have been independently associated with the risk of obesity in childhood. Sleep also appears to be very sensitive to a child’s time spent engaged with media. Having a mobile device in the bedroom or simply being a heavy user of social media both predict inadequate sleep in children and teenagers. Exposure to back-lit screens directly suppresses melatonin release and can contribute to the drop in melatonin that is part of the hormonal trigger for the start of puberty. Combined with the added risk of obesity, excessive daily screen use can significantly increase the risk of early puberty. Finally, time spent on the Internet also appears to be habit forming for vulnerable youth: Up to 8.5% of children 8-18 years old meet criteria for Internet gaming disorder (Psychological Science. 2009;20[5]:594-602).

BunnyHollywood/iStockphoto.com
What children are watching appears to also be critical to the degree of developmental risk. While young children may learn some fundamentals of reading or mathematics from the best educational video games, their efficacy is not as good as time spent with parents reading together or working jointly on a math problem. Exposure to violent content on TV or video games can potentially be traumatizing for children, causing sleep disruptions and anxiety symptoms. And it can take away from the time children would otherwise spend in unstructured play, meeting new friends in the neighborhood, or trying new physical skills outside. When children have inadequate time spent in self-directed activities, they are less likely to develop their creative potential and discover their genuine interests and abilities.

There also is evidence that teenagers who spend substantial time engaged passively in social media (seeing what others are doing or saying via Facebook or Instagram) report higher levels of depression and anxiety, whereas those who use social media as a platform to stay connected (via two-way communication) report lower levels of these symptoms. While many young people use social sites as a forum to find peer support, share concerns, or develop their own “voice,” some young people might be vulnerable to exploitation, cyberbullying, or even online solicitation. The key here may be for parents, who have a sense of their child’s strengths and vulnerabilities, to be aware of where their children are spending their virtual time and to check in about the kinds of connections they have there. Of course, screen time can be equally seductive for parents. And when a parent is spending time reading texts or checking for Facebook updates, they are missing opportunities to be engaged with their children, helping them with homework or simply noticing that they seem stressed, or catching an opportunity to talk with them.

The pediatrician has the opportunity to educate parents about the potential risks that unchecked screen time can pose to their children’s healthy development. But it is critical that you approach these conversations with specificity and compassion. Customize the conversation to the age and personality of the child and family. A computer in the bedroom may make sense for an academically oriented 9th grader in a demanding school who is generally well-balanced in activities and friendships. A bedroom computer may be a poor choice for an isolated 9th grader almost addicted to video games with few friends or activities.

Simply reciting recommendations may heighten a parent’s feelings of isolation and shame, and not lead to meaningful change. Instead, start by asking about the details: Where are the screens in the home? Bedrooms? Who has a computer, tablet, or smartphone? How are these screens used in the context of the child’s overall psychosocial functioning? Depending on the circumstance, a smaller change, such as “no phones while doing homework,” can make a big difference. Simple, clear rules can be easier to explain and enforce, and protect parents from the perils of daily negotiations of screen terms with their children or teenagers. Perhaps they can have a “phone zone” where phones get parked and charged once kids get home from school. Perhaps there are limits on TV or video games on school nights (for the student performing below potential, rather than the driven student who would benefit from down time). Perhaps for preteens, computer-based homework can be done only on the desktop computer that is kept in a family study, rather than a laptop in a bedroom where kids are more likely to become distracted and surf the net. Pediatricians can help families think through the right approach to screen time that may range from restriction to shared use exploring shared interests to jointly watching a favorite TV show or sporting event.

You can help parents consider how they will talk about all this, acknowledging what is fun and rewarding about TV shows, social media, and the Internet alongside the problems of excessive use. Ask parents if it is hard for them to put down their own phones or tablets. They can acknowledge this explicitly with their children when establishing new media use rules. It is powerful for children, especially teenagers, to hear their parents acknowledge that “phones, tablets, and computers are powerful tools, but we all need to improve our skills at being in control of our use of them.” You might suggest that parents try this exercise: list all of the activities they wish they had time for in every day, and how much time they would spend in them. Then they should guess how much time they spend in screen-based entertainment. If they wish to protect time for screen-based entertainment, they can actively choose to do so. If you are able to help parents better understand the risks of excessive screen time and facilitate desired and appropriate use of media, you will have added to the quality of the family’s life.

The AAP has resources to help pediatricians partner with parents to create a Family Media Use Plan (www.healthychildren.org/MediaUsePlan).
 

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

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Cosmetic Corner: Dermatologists Weigh in on OTC Rosacea Treatments

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To improve patient care and outcomes, leading dermatologists offered their recommendations on OTC rosacea treatments. Consideration must be given to:

 

  • Eucerin Redness Relief
    Beiersdorf Inc
    Recommended by Gary Goldenberg, MD, New York, New York
     
  • Rosaliac CC Cream
    La Roche-Posay Laboratoire Dermatologique
    “This product provides hydration and an even tint to correct and reduce the erythema of rosacea. It is made with both titanium dioxide and organic UV filters to give broad-spectrum coverage with SPF 30.”—Cherise Mizrahi-Levi, DO, New York, New York
     
  • Vanicream
    Pharmaceutical Specialties, Inc.
    “I like Vanicream products since they are mild and hypoallergenic.”—Gary Goldenberg, MD, New York, New York
     

Cutis invites readers to send us their recommendations. Cleansing devices, skin-lightening agents, and self-tanners will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

 

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

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To improve patient care and outcomes, leading dermatologists offered their recommendations on OTC rosacea treatments. Consideration must be given to:

 

  • Eucerin Redness Relief
    Beiersdorf Inc
    Recommended by Gary Goldenberg, MD, New York, New York
     
  • Rosaliac CC Cream
    La Roche-Posay Laboratoire Dermatologique
    “This product provides hydration and an even tint to correct and reduce the erythema of rosacea. It is made with both titanium dioxide and organic UV filters to give broad-spectrum coverage with SPF 30.”—Cherise Mizrahi-Levi, DO, New York, New York
     
  • Vanicream
    Pharmaceutical Specialties, Inc.
    “I like Vanicream products since they are mild and hypoallergenic.”—Gary Goldenberg, MD, New York, New York
     

Cutis invites readers to send us their recommendations. Cleansing devices, skin-lightening agents, and self-tanners will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

 

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on OTC rosacea treatments. Consideration must be given to:

 

  • Eucerin Redness Relief
    Beiersdorf Inc
    Recommended by Gary Goldenberg, MD, New York, New York
     
  • Rosaliac CC Cream
    La Roche-Posay Laboratoire Dermatologique
    “This product provides hydration and an even tint to correct and reduce the erythema of rosacea. It is made with both titanium dioxide and organic UV filters to give broad-spectrum coverage with SPF 30.”—Cherise Mizrahi-Levi, DO, New York, New York
     
  • Vanicream
    Pharmaceutical Specialties, Inc.
    “I like Vanicream products since they are mild and hypoallergenic.”—Gary Goldenberg, MD, New York, New York
     

Cutis invites readers to send us their recommendations. Cleansing devices, skin-lightening agents, and self-tanners will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

 

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

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Discharging Nodule on the Jaw

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Discharging Nodule on the Jaw

The Diagnosis: Dental Sinus Secondary to Osteonecrosis of the Jaw

Cone beam computed tomography revealed an area of lucency measuring 40×20 mm in the body of the right mandible (Figure). The patient subsequently underwent curettage of the wound with sequestrectomy of the involved area.

Cone beam computed tomography revealed an area of lucency measuring 40×20 mm in the body of the right mandible.

Osteonecrosis of the jaw is a form of avascular necrosis. It is an uncommon but potentially serious side effect of bisphosphonate use.1 Bisphosphonates commonly are used as first-line therapy for osteoporosis, with proven efficacy to reduce fracture risk by exerting an antiresorptive effect on bones.2 Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is defined by the American Association of Oral and Maxillofacial Surgeons as the presence of exposed necrotic bone in the maxillofacial region that has persisted for more than 8 weeks, with current or prior treatment with a bisphosphonate and absence of prior radiation therapy to the jaw.3 Bisphosphonate-related osteonecrosis of the jaw can be associated with infections, pathologic fractures, extraoral fistulae, or osteolysis extending to the inferior border.

Our patient had a dental sinus that resulted from the underlying BRONJ. The jawbones, unlike the long bones, are in a special environment in that both acute and chronic infections occur often within the bone, and surgical procedures as well as masticatory trauma expose the bone to a bacteria-laden environment.4 Infection around the root apex of a tooth results in a dental abscess and a sinus tract can develop from the abscess, draining either intraorally or extraorally.5 Facial sinus tracts can be either odontogenic or nonodontogenic, and sometimes the lesions of dental origin may be confused with dermatological lesions.

Bisphosphonates inhibit osteoclasts, which are responsible for bone resorption. Antiangiogenetic effects also have been reported in bisphosphonates, resulting in devitalized bone.6 The potent and prolonged inhibition of bone remodeling likely plays an important role in BRONJ. The more frequently occurring microdamage inflicted on the lower jawbone with mastication also may represent a contributory factor.7

Bisphosphonate-related osteonecrosis of the jaw more often is associated with the use of high-dose intravenous (IV) bisphosphonate in cancer-related hypercalcemia and less so with oral bisphosphonates, which are generally used to treat osteoporosis.3 In a Swedish study conducted from 2003 to 2010, 55 cases of BRONJ were documented in a population of 1.2 million individuals. The prevalence of BRONJ in patients on oral bisphosphonates and IV bisphosphonates was estimated to be 0.024% and 2.8%, respectively.8

Bisphosphonates are widely used worldwide as the main treatment of osteoporosis. The association between osteonecrosis of the jaw and oral bisphosphonates is contentious among the osteoporosis population, as most studies focus on IV bisphosphonate use in cancer patients.9 Bisphosphonate-related osteonecrosis of the jaw adversely affects the patient's quality of life, producing notable morbidity in afflicted patients. Thus, a complete dental assessment and treatment is recommended before the initiation of bisphosphonate treatment. The risk for developing BRONJ associated with oral bisphosphonates increases when the duration of therapy exceeds 3 years.3 It has been reported that antifracture efficacy would persist for 1 to 2 years following discontinuation of alendronate or risedronate that had been taken for 3 to 5 years, but patients with low bone mineral density at the femoral neck (T-score below -2.5) after 3 to 5 years of treatment of bisphosphonates are at the highest risk for vertebral fractures and therefore appear to benefit most from continuation of therapy.10 For dental procedures, the American Association of Oral and Maxillofacial Surgeons suggests that if systemic conditions persist, the clinician might consider discontinuation of oral bisphosphonates for a 3-month period before and after elective invasive dental surgery to lower the risk for BRONJ.3 When possible, invasive dentoalveolar procedures such as extractions should be avoided; conservative endodontic treatment is preferable.

Bisphosphonate-related osteonecrosis of the jaw is a devastating condition that is difficult to treat and manage, thus the focus should be on prevention through dental clearance prior to starting bisphosphonates. It also is crucial to have a high index of suspicion for BRONJ in patients presenting with orofacial lesions so that they can be treated expediently.

References
  1. Edwards BJ, Gounder M, McKoy JM, et al. Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. Lancet Oncol. 2008;9:1166-1172.
  2. McClung M, Harris ST, Miller PD, et al. Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med. 2013;126:13-20.
  3. Ruggiero SL, Dodson TB, Assael LA, et al; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws--2009 update. J Oral Maxillofac Surg. 2009;67(5 suppl):2-12.
  4. Mawardi H, Treister N, Richardson P, et al. Sinus tracts--an early sign of bisphosphonate-associated osteonecrosis of the jaws? J Oral Maxillofac Surg. 2009;67:593-601.
  5. Sammut S, Malden N, Lopes V. Facial cutaneous sinuses of dental origin--a diagnostic challenge. Br Dent J. 2013;215:555-558.
  6. Wood J, Bonjean K, Ruetz S, et al. Novel antiangiogenic effects of the bisphosphonate compound zoledronic acid. J Pharmacol Exp Ther. 2002;302:1055-1061.
  7. Hoefert S, Schmitz I, Tannapfel A, et al. Importance of microcracks in etiology of bisphosphonate-related osteonecrosis of the jaw: a possible pathogenetic model of symptomatic and non-symptomatic osteonecrosis of the jaw based on scanning electron microscopy findings. Clin Oral Investig. 2010;14:271-284.
  8. Hallmer F, Bjørnland T, Nicklasson A, et al. Osteonecrosis of the jaw in patients treated with oral and intravenous bisphosphonates: experience in Sweden. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014;118:202-208.
  9. Lin TC, Yang CY, Kao Yang YH, et al. Incidence and risk of osteonecrosis of the jaw among the Taiwan osteoporosis population [published online February 11, 2014]. Osteoporos Int. 2014;25:1503-1511.
  10. Watts NB, Diab DL. Long-term use of bisphosphonates in osteoporosis. J Clin Endocrinol Metab. 2010;95:1555-1565.
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The authors report no conflict of interest.

Correspondence: Xiuhui Debra Han, MBBS, National Skin Centre, 1 Mandalay Rd, Singapore 308205 ([email protected]).

 

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The authors report no conflict of interest.

Correspondence: Xiuhui Debra Han, MBBS, National Skin Centre, 1 Mandalay Rd, Singapore 308205 ([email protected]).

 

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From the Department of Dermatology, National Skin Centre, Singapore.

The authors report no conflict of interest.

Correspondence: Xiuhui Debra Han, MBBS, National Skin Centre, 1 Mandalay Rd, Singapore 308205 ([email protected]).

 

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The Diagnosis: Dental Sinus Secondary to Osteonecrosis of the Jaw

Cone beam computed tomography revealed an area of lucency measuring 40×20 mm in the body of the right mandible (Figure). The patient subsequently underwent curettage of the wound with sequestrectomy of the involved area.

Cone beam computed tomography revealed an area of lucency measuring 40×20 mm in the body of the right mandible.

Osteonecrosis of the jaw is a form of avascular necrosis. It is an uncommon but potentially serious side effect of bisphosphonate use.1 Bisphosphonates commonly are used as first-line therapy for osteoporosis, with proven efficacy to reduce fracture risk by exerting an antiresorptive effect on bones.2 Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is defined by the American Association of Oral and Maxillofacial Surgeons as the presence of exposed necrotic bone in the maxillofacial region that has persisted for more than 8 weeks, with current or prior treatment with a bisphosphonate and absence of prior radiation therapy to the jaw.3 Bisphosphonate-related osteonecrosis of the jaw can be associated with infections, pathologic fractures, extraoral fistulae, or osteolysis extending to the inferior border.

Our patient had a dental sinus that resulted from the underlying BRONJ. The jawbones, unlike the long bones, are in a special environment in that both acute and chronic infections occur often within the bone, and surgical procedures as well as masticatory trauma expose the bone to a bacteria-laden environment.4 Infection around the root apex of a tooth results in a dental abscess and a sinus tract can develop from the abscess, draining either intraorally or extraorally.5 Facial sinus tracts can be either odontogenic or nonodontogenic, and sometimes the lesions of dental origin may be confused with dermatological lesions.

Bisphosphonates inhibit osteoclasts, which are responsible for bone resorption. Antiangiogenetic effects also have been reported in bisphosphonates, resulting in devitalized bone.6 The potent and prolonged inhibition of bone remodeling likely plays an important role in BRONJ. The more frequently occurring microdamage inflicted on the lower jawbone with mastication also may represent a contributory factor.7

Bisphosphonate-related osteonecrosis of the jaw more often is associated with the use of high-dose intravenous (IV) bisphosphonate in cancer-related hypercalcemia and less so with oral bisphosphonates, which are generally used to treat osteoporosis.3 In a Swedish study conducted from 2003 to 2010, 55 cases of BRONJ were documented in a population of 1.2 million individuals. The prevalence of BRONJ in patients on oral bisphosphonates and IV bisphosphonates was estimated to be 0.024% and 2.8%, respectively.8

Bisphosphonates are widely used worldwide as the main treatment of osteoporosis. The association between osteonecrosis of the jaw and oral bisphosphonates is contentious among the osteoporosis population, as most studies focus on IV bisphosphonate use in cancer patients.9 Bisphosphonate-related osteonecrosis of the jaw adversely affects the patient's quality of life, producing notable morbidity in afflicted patients. Thus, a complete dental assessment and treatment is recommended before the initiation of bisphosphonate treatment. The risk for developing BRONJ associated with oral bisphosphonates increases when the duration of therapy exceeds 3 years.3 It has been reported that antifracture efficacy would persist for 1 to 2 years following discontinuation of alendronate or risedronate that had been taken for 3 to 5 years, but patients with low bone mineral density at the femoral neck (T-score below -2.5) after 3 to 5 years of treatment of bisphosphonates are at the highest risk for vertebral fractures and therefore appear to benefit most from continuation of therapy.10 For dental procedures, the American Association of Oral and Maxillofacial Surgeons suggests that if systemic conditions persist, the clinician might consider discontinuation of oral bisphosphonates for a 3-month period before and after elective invasive dental surgery to lower the risk for BRONJ.3 When possible, invasive dentoalveolar procedures such as extractions should be avoided; conservative endodontic treatment is preferable.

Bisphosphonate-related osteonecrosis of the jaw is a devastating condition that is difficult to treat and manage, thus the focus should be on prevention through dental clearance prior to starting bisphosphonates. It also is crucial to have a high index of suspicion for BRONJ in patients presenting with orofacial lesions so that they can be treated expediently.

The Diagnosis: Dental Sinus Secondary to Osteonecrosis of the Jaw

Cone beam computed tomography revealed an area of lucency measuring 40×20 mm in the body of the right mandible (Figure). The patient subsequently underwent curettage of the wound with sequestrectomy of the involved area.

Cone beam computed tomography revealed an area of lucency measuring 40×20 mm in the body of the right mandible.

Osteonecrosis of the jaw is a form of avascular necrosis. It is an uncommon but potentially serious side effect of bisphosphonate use.1 Bisphosphonates commonly are used as first-line therapy for osteoporosis, with proven efficacy to reduce fracture risk by exerting an antiresorptive effect on bones.2 Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is defined by the American Association of Oral and Maxillofacial Surgeons as the presence of exposed necrotic bone in the maxillofacial region that has persisted for more than 8 weeks, with current or prior treatment with a bisphosphonate and absence of prior radiation therapy to the jaw.3 Bisphosphonate-related osteonecrosis of the jaw can be associated with infections, pathologic fractures, extraoral fistulae, or osteolysis extending to the inferior border.

Our patient had a dental sinus that resulted from the underlying BRONJ. The jawbones, unlike the long bones, are in a special environment in that both acute and chronic infections occur often within the bone, and surgical procedures as well as masticatory trauma expose the bone to a bacteria-laden environment.4 Infection around the root apex of a tooth results in a dental abscess and a sinus tract can develop from the abscess, draining either intraorally or extraorally.5 Facial sinus tracts can be either odontogenic or nonodontogenic, and sometimes the lesions of dental origin may be confused with dermatological lesions.

Bisphosphonates inhibit osteoclasts, which are responsible for bone resorption. Antiangiogenetic effects also have been reported in bisphosphonates, resulting in devitalized bone.6 The potent and prolonged inhibition of bone remodeling likely plays an important role in BRONJ. The more frequently occurring microdamage inflicted on the lower jawbone with mastication also may represent a contributory factor.7

Bisphosphonate-related osteonecrosis of the jaw more often is associated with the use of high-dose intravenous (IV) bisphosphonate in cancer-related hypercalcemia and less so with oral bisphosphonates, which are generally used to treat osteoporosis.3 In a Swedish study conducted from 2003 to 2010, 55 cases of BRONJ were documented in a population of 1.2 million individuals. The prevalence of BRONJ in patients on oral bisphosphonates and IV bisphosphonates was estimated to be 0.024% and 2.8%, respectively.8

Bisphosphonates are widely used worldwide as the main treatment of osteoporosis. The association between osteonecrosis of the jaw and oral bisphosphonates is contentious among the osteoporosis population, as most studies focus on IV bisphosphonate use in cancer patients.9 Bisphosphonate-related osteonecrosis of the jaw adversely affects the patient's quality of life, producing notable morbidity in afflicted patients. Thus, a complete dental assessment and treatment is recommended before the initiation of bisphosphonate treatment. The risk for developing BRONJ associated with oral bisphosphonates increases when the duration of therapy exceeds 3 years.3 It has been reported that antifracture efficacy would persist for 1 to 2 years following discontinuation of alendronate or risedronate that had been taken for 3 to 5 years, but patients with low bone mineral density at the femoral neck (T-score below -2.5) after 3 to 5 years of treatment of bisphosphonates are at the highest risk for vertebral fractures and therefore appear to benefit most from continuation of therapy.10 For dental procedures, the American Association of Oral and Maxillofacial Surgeons suggests that if systemic conditions persist, the clinician might consider discontinuation of oral bisphosphonates for a 3-month period before and after elective invasive dental surgery to lower the risk for BRONJ.3 When possible, invasive dentoalveolar procedures such as extractions should be avoided; conservative endodontic treatment is preferable.

Bisphosphonate-related osteonecrosis of the jaw is a devastating condition that is difficult to treat and manage, thus the focus should be on prevention through dental clearance prior to starting bisphosphonates. It also is crucial to have a high index of suspicion for BRONJ in patients presenting with orofacial lesions so that they can be treated expediently.

References
  1. Edwards BJ, Gounder M, McKoy JM, et al. Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. Lancet Oncol. 2008;9:1166-1172.
  2. McClung M, Harris ST, Miller PD, et al. Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med. 2013;126:13-20.
  3. Ruggiero SL, Dodson TB, Assael LA, et al; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws--2009 update. J Oral Maxillofac Surg. 2009;67(5 suppl):2-12.
  4. Mawardi H, Treister N, Richardson P, et al. Sinus tracts--an early sign of bisphosphonate-associated osteonecrosis of the jaws? J Oral Maxillofac Surg. 2009;67:593-601.
  5. Sammut S, Malden N, Lopes V. Facial cutaneous sinuses of dental origin--a diagnostic challenge. Br Dent J. 2013;215:555-558.
  6. Wood J, Bonjean K, Ruetz S, et al. Novel antiangiogenic effects of the bisphosphonate compound zoledronic acid. J Pharmacol Exp Ther. 2002;302:1055-1061.
  7. Hoefert S, Schmitz I, Tannapfel A, et al. Importance of microcracks in etiology of bisphosphonate-related osteonecrosis of the jaw: a possible pathogenetic model of symptomatic and non-symptomatic osteonecrosis of the jaw based on scanning electron microscopy findings. Clin Oral Investig. 2010;14:271-284.
  8. Hallmer F, Bjørnland T, Nicklasson A, et al. Osteonecrosis of the jaw in patients treated with oral and intravenous bisphosphonates: experience in Sweden. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014;118:202-208.
  9. Lin TC, Yang CY, Kao Yang YH, et al. Incidence and risk of osteonecrosis of the jaw among the Taiwan osteoporosis population [published online February 11, 2014]. Osteoporos Int. 2014;25:1503-1511.
  10. Watts NB, Diab DL. Long-term use of bisphosphonates in osteoporosis. J Clin Endocrinol Metab. 2010;95:1555-1565.
References
  1. Edwards BJ, Gounder M, McKoy JM, et al. Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. Lancet Oncol. 2008;9:1166-1172.
  2. McClung M, Harris ST, Miller PD, et al. Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med. 2013;126:13-20.
  3. Ruggiero SL, Dodson TB, Assael LA, et al; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws--2009 update. J Oral Maxillofac Surg. 2009;67(5 suppl):2-12.
  4. Mawardi H, Treister N, Richardson P, et al. Sinus tracts--an early sign of bisphosphonate-associated osteonecrosis of the jaws? J Oral Maxillofac Surg. 2009;67:593-601.
  5. Sammut S, Malden N, Lopes V. Facial cutaneous sinuses of dental origin--a diagnostic challenge. Br Dent J. 2013;215:555-558.
  6. Wood J, Bonjean K, Ruetz S, et al. Novel antiangiogenic effects of the bisphosphonate compound zoledronic acid. J Pharmacol Exp Ther. 2002;302:1055-1061.
  7. Hoefert S, Schmitz I, Tannapfel A, et al. Importance of microcracks in etiology of bisphosphonate-related osteonecrosis of the jaw: a possible pathogenetic model of symptomatic and non-symptomatic osteonecrosis of the jaw based on scanning electron microscopy findings. Clin Oral Investig. 2010;14:271-284.
  8. Hallmer F, Bjørnland T, Nicklasson A, et al. Osteonecrosis of the jaw in patients treated with oral and intravenous bisphosphonates: experience in Sweden. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014;118:202-208.
  9. Lin TC, Yang CY, Kao Yang YH, et al. Incidence and risk of osteonecrosis of the jaw among the Taiwan osteoporosis population [published online February 11, 2014]. Osteoporos Int. 2014;25:1503-1511.
  10. Watts NB, Diab DL. Long-term use of bisphosphonates in osteoporosis. J Clin Endocrinol Metab. 2010;95:1555-1565.
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Discharging Nodule on the Jaw
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An 83-year-old woman presented with a painless, discharging, swollen nodule on the right side of the jaw of 6 months' duration. She had a history of osteoporosis diagnosed 3 years prior for which she was taking alendronate and cholecalciferol. Bone mineral density test scores were -3.93 (spine) and -2.81 (hip)(reference range, -2 and above). She also had hypertension that was treated with amlodipine. On examination there was fetor oris and a discharging sinus with purulent discharge at the jaw. The lower jaw was edentulous. A 5-mm area of red beefy granulation tissue was attached to underlying bone. An exposed sequestrum was seen intraorally with a 3-cm opening at the mandible. There also was submandibular lymphadenopathy.  

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Contact Allergy to Poliglecaprone 25 Sutures

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To the Editor:

A 42-year-old woman who had a tattoo on the right wrist surgically removed 2 days prior developed severe erythema and swelling at the incision site (Figure 1). Exposure at the incision site was limited to bacitracin, poliglecaprone 25 suture, and plain cotton gauze. Patch testing of bacitracin was performed, which was ++ (moderately positive reaction) at the 96-hour reading, indicating that part of the reaction was due to the topical antibiotic. Testing of the suture was performed by tying the suture to the skin of the forearm and removing it at 48 hours. There was a ++ reaction to the suture prior to removal at 48 hours, which increased to +++ (severely positive reaction) after suture removal at 96 hours (Figure 2). Therefore, it appears that allergy to the suture also was partially responsible for the postsurgical reaction.

Figure 1. Tattoo prior to surgical removal (A). Erythema and swelling developed at the surgical site 2 days after removal (B).

Figure 2. Contact allergy reading at 96 hours.

Poliglecaprone 25 suture is a monofilament synthetic absorbable material that is a copolymer of glycolide and ε-caprolactone. One case report of oral contact allergy to this suture material resulted in failure of an oral graft; however, no testing was performed to verify the contact allergy.1 Caprolactam ([CH2]5C[O]NH) is a related chemical that can be synthesized by treating caprolactone ([CH2]5CO2) with ammonia at elevated temperatures.2 Contact allergy has been reported to polyamide 6 suture, which is obtained by polymerizing ε-caprolactam. This report stated that contact allergy to ε-caprolactam also has been reported occupationally during manufacture and from its use in fishing nets, socks, gloves, and stockings.3

The package insert for the poliglecaprone 25 suture states that the material is “nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.”4 We present a case of contact allergy to poliglecaprone 25 suture that was confirmed by allergy testing.

References
  1. Mawardi H. Oral contact allergy to suture material results in connective tissue graft failure: a case report. J Periodontol Online. 2014;4:155-160.
  2. Buntara T, Noel S, Phua PH, et al. Caprolactam from renewable resources: catalytic conversion of 5-hydroxymethylfurfural into caprolactone. Angew Chem Int Ed Engl. 2011;50:7083-7087.
  3. Hausen BM. Allergic contact dermatitis from colored surgical suture material: contact allergy to epsilon-caprolactam and acid blue 158. Am J Contact Dermat. 2003;14:174-175.
  4. Monocryl [package insert]. Somerville, NJ: Ethicon, Inc; 1996.
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Drs. Scheman, Sheehan, and Derick are from Northwestern University Medical Center, Chicago, Illinois. Ms. Rakowski is in private practice, Northbrook, Illinois. Dr. Campbell is in private practice, West Dundee, Illinois.

The authors report no conflict of interest.

Correspondence: Andrew Scheman, MD, 1535 Lake Cook Rd, Ste 401, Northbrook, IL 60062 ([email protected]).

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Drs. Scheman, Sheehan, and Derick are from Northwestern University Medical Center, Chicago, Illinois. Ms. Rakowski is in private practice, Northbrook, Illinois. Dr. Campbell is in private practice, West Dundee, Illinois.

The authors report no conflict of interest.

Correspondence: Andrew Scheman, MD, 1535 Lake Cook Rd, Ste 401, Northbrook, IL 60062 ([email protected]).

Author and Disclosure Information

Drs. Scheman, Sheehan, and Derick are from Northwestern University Medical Center, Chicago, Illinois. Ms. Rakowski is in private practice, Northbrook, Illinois. Dr. Campbell is in private practice, West Dundee, Illinois.

The authors report no conflict of interest.

Correspondence: Andrew Scheman, MD, 1535 Lake Cook Rd, Ste 401, Northbrook, IL 60062 ([email protected]).

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To the Editor:

A 42-year-old woman who had a tattoo on the right wrist surgically removed 2 days prior developed severe erythema and swelling at the incision site (Figure 1). Exposure at the incision site was limited to bacitracin, poliglecaprone 25 suture, and plain cotton gauze. Patch testing of bacitracin was performed, which was ++ (moderately positive reaction) at the 96-hour reading, indicating that part of the reaction was due to the topical antibiotic. Testing of the suture was performed by tying the suture to the skin of the forearm and removing it at 48 hours. There was a ++ reaction to the suture prior to removal at 48 hours, which increased to +++ (severely positive reaction) after suture removal at 96 hours (Figure 2). Therefore, it appears that allergy to the suture also was partially responsible for the postsurgical reaction.

Figure 1. Tattoo prior to surgical removal (A). Erythema and swelling developed at the surgical site 2 days after removal (B).

Figure 2. Contact allergy reading at 96 hours.

Poliglecaprone 25 suture is a monofilament synthetic absorbable material that is a copolymer of glycolide and ε-caprolactone. One case report of oral contact allergy to this suture material resulted in failure of an oral graft; however, no testing was performed to verify the contact allergy.1 Caprolactam ([CH2]5C[O]NH) is a related chemical that can be synthesized by treating caprolactone ([CH2]5CO2) with ammonia at elevated temperatures.2 Contact allergy has been reported to polyamide 6 suture, which is obtained by polymerizing ε-caprolactam. This report stated that contact allergy to ε-caprolactam also has been reported occupationally during manufacture and from its use in fishing nets, socks, gloves, and stockings.3

The package insert for the poliglecaprone 25 suture states that the material is “nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.”4 We present a case of contact allergy to poliglecaprone 25 suture that was confirmed by allergy testing.

To the Editor:

A 42-year-old woman who had a tattoo on the right wrist surgically removed 2 days prior developed severe erythema and swelling at the incision site (Figure 1). Exposure at the incision site was limited to bacitracin, poliglecaprone 25 suture, and plain cotton gauze. Patch testing of bacitracin was performed, which was ++ (moderately positive reaction) at the 96-hour reading, indicating that part of the reaction was due to the topical antibiotic. Testing of the suture was performed by tying the suture to the skin of the forearm and removing it at 48 hours. There was a ++ reaction to the suture prior to removal at 48 hours, which increased to +++ (severely positive reaction) after suture removal at 96 hours (Figure 2). Therefore, it appears that allergy to the suture also was partially responsible for the postsurgical reaction.

Figure 1. Tattoo prior to surgical removal (A). Erythema and swelling developed at the surgical site 2 days after removal (B).

Figure 2. Contact allergy reading at 96 hours.

Poliglecaprone 25 suture is a monofilament synthetic absorbable material that is a copolymer of glycolide and ε-caprolactone. One case report of oral contact allergy to this suture material resulted in failure of an oral graft; however, no testing was performed to verify the contact allergy.1 Caprolactam ([CH2]5C[O]NH) is a related chemical that can be synthesized by treating caprolactone ([CH2]5CO2) with ammonia at elevated temperatures.2 Contact allergy has been reported to polyamide 6 suture, which is obtained by polymerizing ε-caprolactam. This report stated that contact allergy to ε-caprolactam also has been reported occupationally during manufacture and from its use in fishing nets, socks, gloves, and stockings.3

The package insert for the poliglecaprone 25 suture states that the material is “nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.”4 We present a case of contact allergy to poliglecaprone 25 suture that was confirmed by allergy testing.

References
  1. Mawardi H. Oral contact allergy to suture material results in connective tissue graft failure: a case report. J Periodontol Online. 2014;4:155-160.
  2. Buntara T, Noel S, Phua PH, et al. Caprolactam from renewable resources: catalytic conversion of 5-hydroxymethylfurfural into caprolactone. Angew Chem Int Ed Engl. 2011;50:7083-7087.
  3. Hausen BM. Allergic contact dermatitis from colored surgical suture material: contact allergy to epsilon-caprolactam and acid blue 158. Am J Contact Dermat. 2003;14:174-175.
  4. Monocryl [package insert]. Somerville, NJ: Ethicon, Inc; 1996.
References
  1. Mawardi H. Oral contact allergy to suture material results in connective tissue graft failure: a case report. J Periodontol Online. 2014;4:155-160.
  2. Buntara T, Noel S, Phua PH, et al. Caprolactam from renewable resources: catalytic conversion of 5-hydroxymethylfurfural into caprolactone. Angew Chem Int Ed Engl. 2011;50:7083-7087.
  3. Hausen BM. Allergic contact dermatitis from colored surgical suture material: contact allergy to epsilon-caprolactam and acid blue 158. Am J Contact Dermat. 2003;14:174-175.
  4. Monocryl [package insert]. Somerville, NJ: Ethicon, Inc; 1996.
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  • Physicians should be aware that rare contact reactions can occur with certain types of sutures.
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The culture change of assessing parents for ACEs

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Several years ago, pediatricians R.J. Gillespie, MD, MHPE, and Teri Pettersen, MD, piloted the use of a questionnaire about adverse childhood experiences (ACEs) and resilience at the 4-month well-child visit.

They and six other pediatricians at The Children’s Clinic in Portland, Ore., explained in a cover letter why they were posing the questions of parents, and they ended the survey by asking them about their interest in potential resources.

[[{"fid":"172157","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"R.J. Gillespie, MD, MHPE","field_file_image_credit[und][0][value]":"Courtesy The Children's Clinic","field_file_image_caption[und][0][value]":"Dr. R.J. Gillespie "},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]Today, all 28 of the pediatricians at the clinic screen for ACEs and resilience, and Dr. Pettersen, now retired from the practice, travels through the state conducting training for the Oregon Pediatric Society about the impact of ACEs in parents and their children, and how to go about identifying and addressing them.

“So many of our visits are about behavioral problems or emotional disturbances, and so often at the root of these issues is some sort of trauma the child is experiencing,” Dr. Gillespie said in an interview. “What we’re seeing in many of these cases really are coping strategies for that child to deal with the toxic stress in his or her life.”

By assessing parents’ exposure to ACEs, briefly talking with them about how ACEs might impact their parenting, and tailoring their counseling and anticipatory guidance, the pediatricians hope to prevent ACEs and consequent toxic stress from developing in children.

Dr. Teri Pettersen
“We know there’s an intergenerational transmission of ACEs and traumas. If we can identify parents who are most at risk and agree to support them in a nonjudgmental way when they feel most challenged, then we can help create a healthier cycle of parenting,” Dr. Pettersen said in an interview.

The driving science

The term ACEs entered the medical lexicon after 1998, when a landmark study called the Adverse Childhood Experiences Study showed that traumatic experiences in childhood – abuse, neglect, and other severe dysfunctions in a household – not only are common among American adults but are associated with numerous poor health outcomes.

In the study and subsequent analyses, Dr. Vincent Felitti of Kaiser Permanente in San Diego and Dr. Robert Anda of the Centers for Disease Control and Prevention surveyed more than 17,000 patients about 10 types of ACEs and their current health status and behaviors. About two-thirds reported having at least one ACE, and one in eight reported four or more (Am J Prev Med. 1998;14[4]:245-58, www.cdc.gov/violenceprevention/acestudy/about.html).

Adults with four or more ACEs were not only significantly more likely to report health risk behaviors (smoking, substance abuse) and poor mental health outcomes (depression, suicide attempt); they were also significantly more likely to have poor physical health outcomes, with 2.2 times the risk of ischemic heart disease, 1.9 times the risk of cancer, and 3.9 times the risk of chronic bronchitis or emphysema, for instance. There was a strong dose-response relationship between ACEs and poor outcomes.

The Felitti study spawned dozens of analyses and additional research – in children as well as adults – on the associations between early-life adversity and the incidence of poor behavioral, mental, and physical outcomes, as well as on potential mechanisms.

Some research suggested a direct link between ACEs and negative outcomes, independent of whether individuals adopt risky behavior. Other studies suggested what experts in child development and mental health have long argued – that the more ACEs a parent has, the more ACEs their child will have.

And a growing body of biomedical literature linked the extreme, frequent, or prolonged activation of the body’s stress response in childhood – what has come to be known as “toxic stress” – with disruptions of the developing nervous, cardiovascular, immune, and metabolic systems.

Ryan Twomey
Dr. Nadine Burke Harris
“We now understand the basic mechanism, which is the dysregulation of the fight-or-flight response,” said Nadine Burke Harris, MD, MPH, a pediatrician in San Francisco who started screening for ACEs in her urban clinic almost a decade ago and founded the Center for Youth Wellness in 2011 to raise awareness and advance research on ACEs and toxic stress.

While precise connections and mechanisms need to be clarified, “we now know that the repeated activation of the stress response leads to [negative] changes in the neuroendocrine immune pathways,” said Dr. Burke Harris, who coauthored a recent review of toxic stress in children and adolescents (Adv Pediatr. 2016;63[1]:403-28).

In January 2012, the American Academy of Pediatrics published a policy statement titled “Early Childhood Adversity, Toxic Stress, and the Role of the Pediatrician: Translating Developmental Science into Lifelong Health,” in which it urged pediatricians to consider actively screening for precipitants of toxic stress that are common in their communities (Pediatrics. 2011 Dec. doi: 10.1542/peds.2011-2662). But it stopped short of recommending particular tools or methods.

Dr. Gillespie and Dr. Pettersen did not want to wait for tools to be validated and approaches to be proven. “We’re building the plane as we fly,” Dr. Pettersen said.
 

 

The clinic’s roll-out

Dr. Pettersen learned about the ACE study and related research about 8 years ago while on a sabbatical to learn more about mental health issues. It “changed everything” about the way she viewed children and families and adversity. “I knew (we) didn’t have the infrastructure at the clinic, or the clinic’s support, to really start assessing children for what was happening to them,” she said, so she began thinking about ACE prevention and a focus on parenting.

Dr. Gillespie, in the meantime, was active in various quality improvement efforts at the state and national level, and had also become increasingly bothered by visits in which he saw children affected by maternal depression, abnormal attachment, and other problems. “I was seeing the consequences of ACEs, but I didn’t know specifically what was going on or how to talk about it,” he said.

The two pediatricians agreed to ask parents about ACEs at the 4-month well visit – a time when the families “knew us a little bit” and when “we could still influence parenting styles.”

In March 2013, they and their colleagues in the pilot group began giving parents a questionnaire that included the 10 ACE questions from Felitti’s study, questions about resilience from the Children’s Resilience Initiative, and a list of potential resources so they could understand parents’ needs.

They created a confidential field in their electronic medical record for documentation that appears during a visit, but does not print into notes and therefore will not be inadvertently released.

As they moved through the pilot phase, the pediatricians used various approaches to follow up on the assessment face-to-face. Eventually, they chose three particular questions as nonthreatening and helpful for conversation: Are there any experiences that still bother you? Of those experiences that don’t bother you, how did you get to the point where they don’t bother you? And how do these experiences affect your parenting now?

“It’s a motivational interviewing sort of style,” said Dr. Gillespie. “Parents can start identifying for themselves the solutions for the problems they’ve experienced, and they can start thinking about how their parenting might be impacted by things that have happened [or are still happening] to them.”

As the project rolled out, the physicians tweaked their process. They added four more ACE questions to address issues – community violence, extreme bullying, racism and prejudice, and foster care exposure – that they thought might lead to toxic stress in their population, for instance. And rather than ask on the written questionnaire for a “yes” or “no” to each of the ACE questions, they began asking the parent how many of the ACE questions applied to them. Moving away from the yes-no format to asking for a total count has led to more disclosures, Dr. Gillespie said.

To “keep the conversation going” in subsequent well-child visits, they developed a few questions to ask high-risk parents, like “How do you and your partner resolve conflict?” and “How did your parents resolve conflict in your household when you were a child?” And they provided training to all of the clinic’s staff on trauma-informed care and the need for support and compassion in their interactions with family members.

In the 3-plus years since incorporating ACEs assessments, the clinic’s pediatricians have made soft referrals to mental health professionals in only several cases – in each case, by suggesting that the parent contact their primary care physician. What most parents have wanted, says Dr. Gillespie, is recommendations for parenting classes and support groups. The clinic’s care manager assists the pediatricians in maintaining and providing links and handouts for various resources.

For Dr. Gillespie, the impact of the culture shift has been dramatic. “I’ve had 8-10 moms spontaneously reveal domestic violence to me in a subsequent visit, and say that they need a little help, because they’ve gotten the message that this is a safe place to talk about their experiences,” he said. “That had never happened to me in the previous 12 years of so of my career.”

Dr. Pettersen’s relationships with parents became “more intimate and more honest.” There was more trust. “If we can talk with parents [about ACEs] and not judge them for it,” she said, “then nothing is off the table.”
 

The ‘Two-Gen’ approach

Courtesy Children's Mercy Hospitals
Dr. Denise Dowd
The clinic’s approach has not been without controversy. “Dr. Gillespie was one of the very first people to screen parents for their ACEs. There’s been push-back, where some have said that you shouldn’t [ask parents about ACEs] if you don’t have anything to give people,” said Denise Dowd, MD, MPH, a pediatrician at Children’s Mercy Hospitals & Clinics in Kansas City, Mo., who chairs the AAP’s Resilience Project and has helped lead a partnership with her state’s largest early Head Start program to treat toxic stress in families.
 

 

“But I’d push back and say, parents know they have toxic stress but they don’t name it,” she said. “What we can do as trusted providers who want to advocate for families is to bear witness to their history by asking about it. Once they realize it’s not what’s wrong with [them], it’s what’s happened to [them], a shift occurs. That’s extremely validating for parents.”

That validation is part of a two-generation approach that she and Dr. Burke Harris see as part of a movement to break cycles of ACEs and toxic stress. At the California Pacific Medical Center’s Bayview Child Health Center in San Francisco, Dr. Burke Harris uses three ACE questionnaires – two of them ask parents (of children or teens) to report how many adverse experience types, or categories, apply to them and/or their child or teen, and one surveys adolescents themselves.

With the resources and clinical support of the Center for Youth Wellness, whose major funders include Google, Dr. Burke Harris can initiate a “warm hand-off” of patients with a high ACE score to a care coordinator or therapist. (The Center for Youth Wellness is beginning research to validate its ACE screening tools.) And in the meantime, the medical care she provides is trauma-informed.

“If a patient comes in for ADHD [attention-deficit/hyperactivity disorder] and has an ACE score of 6, my differential diagnosis and assessment will be different than if I see a patient sent by the school who has an ACE score of 0,” she said.

At the Portland Clinic, even though ACEs screening is now tied with the 4-month visit, pediatricians are much more attentive across the board to possible ACEs and toxic stress, and feel better able to converse with families, Dr. Gillespie said. One of his partners recently saw a 12-year-old boy who was failing in school and not making friends. Trauma-informed history-taking revealed at least several ACEs, and conversation turned to “all the resilience pieces… the connections he was missing and what he needed to cope,” he said.

References

 Resilience Project: This AAP project houses a “trauma toolkit” for primary care, case studies, and a variety of other tools.

 Center for Youth Wellness: The ACEs screening tools used by Dr. Burke Harris may be accessed at this website, along with a user guide containing sample scripts, and two white papers on ACEs and toxic stress.

 Resilience: The Biology of Stress and the Science of Hope: This documentary film, released in September 2016, is about ACEs and “a new movement” to treat and prevent toxic stress; it features the work of Dr. Burke Harris and others.

 Academy on Violence & Abuse: Various papers on ACEs screening and case finding in practice may be accessed here.

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Several years ago, pediatricians R.J. Gillespie, MD, MHPE, and Teri Pettersen, MD, piloted the use of a questionnaire about adverse childhood experiences (ACEs) and resilience at the 4-month well-child visit.

They and six other pediatricians at The Children’s Clinic in Portland, Ore., explained in a cover letter why they were posing the questions of parents, and they ended the survey by asking them about their interest in potential resources.

[[{"fid":"172157","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"R.J. Gillespie, MD, MHPE","field_file_image_credit[und][0][value]":"Courtesy The Children's Clinic","field_file_image_caption[und][0][value]":"Dr. R.J. Gillespie "},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]Today, all 28 of the pediatricians at the clinic screen for ACEs and resilience, and Dr. Pettersen, now retired from the practice, travels through the state conducting training for the Oregon Pediatric Society about the impact of ACEs in parents and their children, and how to go about identifying and addressing them.

“So many of our visits are about behavioral problems or emotional disturbances, and so often at the root of these issues is some sort of trauma the child is experiencing,” Dr. Gillespie said in an interview. “What we’re seeing in many of these cases really are coping strategies for that child to deal with the toxic stress in his or her life.”

By assessing parents’ exposure to ACEs, briefly talking with them about how ACEs might impact their parenting, and tailoring their counseling and anticipatory guidance, the pediatricians hope to prevent ACEs and consequent toxic stress from developing in children.

Dr. Teri Pettersen
“We know there’s an intergenerational transmission of ACEs and traumas. If we can identify parents who are most at risk and agree to support them in a nonjudgmental way when they feel most challenged, then we can help create a healthier cycle of parenting,” Dr. Pettersen said in an interview.

The driving science

The term ACEs entered the medical lexicon after 1998, when a landmark study called the Adverse Childhood Experiences Study showed that traumatic experiences in childhood – abuse, neglect, and other severe dysfunctions in a household – not only are common among American adults but are associated with numerous poor health outcomes.

In the study and subsequent analyses, Dr. Vincent Felitti of Kaiser Permanente in San Diego and Dr. Robert Anda of the Centers for Disease Control and Prevention surveyed more than 17,000 patients about 10 types of ACEs and their current health status and behaviors. About two-thirds reported having at least one ACE, and one in eight reported four or more (Am J Prev Med. 1998;14[4]:245-58, www.cdc.gov/violenceprevention/acestudy/about.html).

Adults with four or more ACEs were not only significantly more likely to report health risk behaviors (smoking, substance abuse) and poor mental health outcomes (depression, suicide attempt); they were also significantly more likely to have poor physical health outcomes, with 2.2 times the risk of ischemic heart disease, 1.9 times the risk of cancer, and 3.9 times the risk of chronic bronchitis or emphysema, for instance. There was a strong dose-response relationship between ACEs and poor outcomes.

The Felitti study spawned dozens of analyses and additional research – in children as well as adults – on the associations between early-life adversity and the incidence of poor behavioral, mental, and physical outcomes, as well as on potential mechanisms.

Some research suggested a direct link between ACEs and negative outcomes, independent of whether individuals adopt risky behavior. Other studies suggested what experts in child development and mental health have long argued – that the more ACEs a parent has, the more ACEs their child will have.

And a growing body of biomedical literature linked the extreme, frequent, or prolonged activation of the body’s stress response in childhood – what has come to be known as “toxic stress” – with disruptions of the developing nervous, cardiovascular, immune, and metabolic systems.

Ryan Twomey
Dr. Nadine Burke Harris
“We now understand the basic mechanism, which is the dysregulation of the fight-or-flight response,” said Nadine Burke Harris, MD, MPH, a pediatrician in San Francisco who started screening for ACEs in her urban clinic almost a decade ago and founded the Center for Youth Wellness in 2011 to raise awareness and advance research on ACEs and toxic stress.

While precise connections and mechanisms need to be clarified, “we now know that the repeated activation of the stress response leads to [negative] changes in the neuroendocrine immune pathways,” said Dr. Burke Harris, who coauthored a recent review of toxic stress in children and adolescents (Adv Pediatr. 2016;63[1]:403-28).

In January 2012, the American Academy of Pediatrics published a policy statement titled “Early Childhood Adversity, Toxic Stress, and the Role of the Pediatrician: Translating Developmental Science into Lifelong Health,” in which it urged pediatricians to consider actively screening for precipitants of toxic stress that are common in their communities (Pediatrics. 2011 Dec. doi: 10.1542/peds.2011-2662). But it stopped short of recommending particular tools or methods.

Dr. Gillespie and Dr. Pettersen did not want to wait for tools to be validated and approaches to be proven. “We’re building the plane as we fly,” Dr. Pettersen said.
 

 

The clinic’s roll-out

Dr. Pettersen learned about the ACE study and related research about 8 years ago while on a sabbatical to learn more about mental health issues. It “changed everything” about the way she viewed children and families and adversity. “I knew (we) didn’t have the infrastructure at the clinic, or the clinic’s support, to really start assessing children for what was happening to them,” she said, so she began thinking about ACE prevention and a focus on parenting.

Dr. Gillespie, in the meantime, was active in various quality improvement efforts at the state and national level, and had also become increasingly bothered by visits in which he saw children affected by maternal depression, abnormal attachment, and other problems. “I was seeing the consequences of ACEs, but I didn’t know specifically what was going on or how to talk about it,” he said.

The two pediatricians agreed to ask parents about ACEs at the 4-month well visit – a time when the families “knew us a little bit” and when “we could still influence parenting styles.”

In March 2013, they and their colleagues in the pilot group began giving parents a questionnaire that included the 10 ACE questions from Felitti’s study, questions about resilience from the Children’s Resilience Initiative, and a list of potential resources so they could understand parents’ needs.

They created a confidential field in their electronic medical record for documentation that appears during a visit, but does not print into notes and therefore will not be inadvertently released.

As they moved through the pilot phase, the pediatricians used various approaches to follow up on the assessment face-to-face. Eventually, they chose three particular questions as nonthreatening and helpful for conversation: Are there any experiences that still bother you? Of those experiences that don’t bother you, how did you get to the point where they don’t bother you? And how do these experiences affect your parenting now?

“It’s a motivational interviewing sort of style,” said Dr. Gillespie. “Parents can start identifying for themselves the solutions for the problems they’ve experienced, and they can start thinking about how their parenting might be impacted by things that have happened [or are still happening] to them.”

As the project rolled out, the physicians tweaked their process. They added four more ACE questions to address issues – community violence, extreme bullying, racism and prejudice, and foster care exposure – that they thought might lead to toxic stress in their population, for instance. And rather than ask on the written questionnaire for a “yes” or “no” to each of the ACE questions, they began asking the parent how many of the ACE questions applied to them. Moving away from the yes-no format to asking for a total count has led to more disclosures, Dr. Gillespie said.

To “keep the conversation going” in subsequent well-child visits, they developed a few questions to ask high-risk parents, like “How do you and your partner resolve conflict?” and “How did your parents resolve conflict in your household when you were a child?” And they provided training to all of the clinic’s staff on trauma-informed care and the need for support and compassion in their interactions with family members.

In the 3-plus years since incorporating ACEs assessments, the clinic’s pediatricians have made soft referrals to mental health professionals in only several cases – in each case, by suggesting that the parent contact their primary care physician. What most parents have wanted, says Dr. Gillespie, is recommendations for parenting classes and support groups. The clinic’s care manager assists the pediatricians in maintaining and providing links and handouts for various resources.

For Dr. Gillespie, the impact of the culture shift has been dramatic. “I’ve had 8-10 moms spontaneously reveal domestic violence to me in a subsequent visit, and say that they need a little help, because they’ve gotten the message that this is a safe place to talk about their experiences,” he said. “That had never happened to me in the previous 12 years of so of my career.”

Dr. Pettersen’s relationships with parents became “more intimate and more honest.” There was more trust. “If we can talk with parents [about ACEs] and not judge them for it,” she said, “then nothing is off the table.”
 

The ‘Two-Gen’ approach

Courtesy Children's Mercy Hospitals
Dr. Denise Dowd
The clinic’s approach has not been without controversy. “Dr. Gillespie was one of the very first people to screen parents for their ACEs. There’s been push-back, where some have said that you shouldn’t [ask parents about ACEs] if you don’t have anything to give people,” said Denise Dowd, MD, MPH, a pediatrician at Children’s Mercy Hospitals & Clinics in Kansas City, Mo., who chairs the AAP’s Resilience Project and has helped lead a partnership with her state’s largest early Head Start program to treat toxic stress in families.
 

 

“But I’d push back and say, parents know they have toxic stress but they don’t name it,” she said. “What we can do as trusted providers who want to advocate for families is to bear witness to their history by asking about it. Once they realize it’s not what’s wrong with [them], it’s what’s happened to [them], a shift occurs. That’s extremely validating for parents.”

That validation is part of a two-generation approach that she and Dr. Burke Harris see as part of a movement to break cycles of ACEs and toxic stress. At the California Pacific Medical Center’s Bayview Child Health Center in San Francisco, Dr. Burke Harris uses three ACE questionnaires – two of them ask parents (of children or teens) to report how many adverse experience types, or categories, apply to them and/or their child or teen, and one surveys adolescents themselves.

With the resources and clinical support of the Center for Youth Wellness, whose major funders include Google, Dr. Burke Harris can initiate a “warm hand-off” of patients with a high ACE score to a care coordinator or therapist. (The Center for Youth Wellness is beginning research to validate its ACE screening tools.) And in the meantime, the medical care she provides is trauma-informed.

“If a patient comes in for ADHD [attention-deficit/hyperactivity disorder] and has an ACE score of 6, my differential diagnosis and assessment will be different than if I see a patient sent by the school who has an ACE score of 0,” she said.

At the Portland Clinic, even though ACEs screening is now tied with the 4-month visit, pediatricians are much more attentive across the board to possible ACEs and toxic stress, and feel better able to converse with families, Dr. Gillespie said. One of his partners recently saw a 12-year-old boy who was failing in school and not making friends. Trauma-informed history-taking revealed at least several ACEs, and conversation turned to “all the resilience pieces… the connections he was missing and what he needed to cope,” he said.

References

 Resilience Project: This AAP project houses a “trauma toolkit” for primary care, case studies, and a variety of other tools.

 Center for Youth Wellness: The ACEs screening tools used by Dr. Burke Harris may be accessed at this website, along with a user guide containing sample scripts, and two white papers on ACEs and toxic stress.

 Resilience: The Biology of Stress and the Science of Hope: This documentary film, released in September 2016, is about ACEs and “a new movement” to treat and prevent toxic stress; it features the work of Dr. Burke Harris and others.

 Academy on Violence & Abuse: Various papers on ACEs screening and case finding in practice may be accessed here.

 

Several years ago, pediatricians R.J. Gillespie, MD, MHPE, and Teri Pettersen, MD, piloted the use of a questionnaire about adverse childhood experiences (ACEs) and resilience at the 4-month well-child visit.

They and six other pediatricians at The Children’s Clinic in Portland, Ore., explained in a cover letter why they were posing the questions of parents, and they ended the survey by asking them about their interest in potential resources.

[[{"fid":"172157","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"R.J. Gillespie, MD, MHPE","field_file_image_credit[und][0][value]":"Courtesy The Children's Clinic","field_file_image_caption[und][0][value]":"Dr. R.J. Gillespie "},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]Today, all 28 of the pediatricians at the clinic screen for ACEs and resilience, and Dr. Pettersen, now retired from the practice, travels through the state conducting training for the Oregon Pediatric Society about the impact of ACEs in parents and their children, and how to go about identifying and addressing them.

“So many of our visits are about behavioral problems or emotional disturbances, and so often at the root of these issues is some sort of trauma the child is experiencing,” Dr. Gillespie said in an interview. “What we’re seeing in many of these cases really are coping strategies for that child to deal with the toxic stress in his or her life.”

By assessing parents’ exposure to ACEs, briefly talking with them about how ACEs might impact their parenting, and tailoring their counseling and anticipatory guidance, the pediatricians hope to prevent ACEs and consequent toxic stress from developing in children.

Dr. Teri Pettersen
“We know there’s an intergenerational transmission of ACEs and traumas. If we can identify parents who are most at risk and agree to support them in a nonjudgmental way when they feel most challenged, then we can help create a healthier cycle of parenting,” Dr. Pettersen said in an interview.

The driving science

The term ACEs entered the medical lexicon after 1998, when a landmark study called the Adverse Childhood Experiences Study showed that traumatic experiences in childhood – abuse, neglect, and other severe dysfunctions in a household – not only are common among American adults but are associated with numerous poor health outcomes.

In the study and subsequent analyses, Dr. Vincent Felitti of Kaiser Permanente in San Diego and Dr. Robert Anda of the Centers for Disease Control and Prevention surveyed more than 17,000 patients about 10 types of ACEs and their current health status and behaviors. About two-thirds reported having at least one ACE, and one in eight reported four or more (Am J Prev Med. 1998;14[4]:245-58, www.cdc.gov/violenceprevention/acestudy/about.html).

Adults with four or more ACEs were not only significantly more likely to report health risk behaviors (smoking, substance abuse) and poor mental health outcomes (depression, suicide attempt); they were also significantly more likely to have poor physical health outcomes, with 2.2 times the risk of ischemic heart disease, 1.9 times the risk of cancer, and 3.9 times the risk of chronic bronchitis or emphysema, for instance. There was a strong dose-response relationship between ACEs and poor outcomes.

The Felitti study spawned dozens of analyses and additional research – in children as well as adults – on the associations between early-life adversity and the incidence of poor behavioral, mental, and physical outcomes, as well as on potential mechanisms.

Some research suggested a direct link between ACEs and negative outcomes, independent of whether individuals adopt risky behavior. Other studies suggested what experts in child development and mental health have long argued – that the more ACEs a parent has, the more ACEs their child will have.

And a growing body of biomedical literature linked the extreme, frequent, or prolonged activation of the body’s stress response in childhood – what has come to be known as “toxic stress” – with disruptions of the developing nervous, cardiovascular, immune, and metabolic systems.

Ryan Twomey
Dr. Nadine Burke Harris
“We now understand the basic mechanism, which is the dysregulation of the fight-or-flight response,” said Nadine Burke Harris, MD, MPH, a pediatrician in San Francisco who started screening for ACEs in her urban clinic almost a decade ago and founded the Center for Youth Wellness in 2011 to raise awareness and advance research on ACEs and toxic stress.

While precise connections and mechanisms need to be clarified, “we now know that the repeated activation of the stress response leads to [negative] changes in the neuroendocrine immune pathways,” said Dr. Burke Harris, who coauthored a recent review of toxic stress in children and adolescents (Adv Pediatr. 2016;63[1]:403-28).

In January 2012, the American Academy of Pediatrics published a policy statement titled “Early Childhood Adversity, Toxic Stress, and the Role of the Pediatrician: Translating Developmental Science into Lifelong Health,” in which it urged pediatricians to consider actively screening for precipitants of toxic stress that are common in their communities (Pediatrics. 2011 Dec. doi: 10.1542/peds.2011-2662). But it stopped short of recommending particular tools or methods.

Dr. Gillespie and Dr. Pettersen did not want to wait for tools to be validated and approaches to be proven. “We’re building the plane as we fly,” Dr. Pettersen said.
 

 

The clinic’s roll-out

Dr. Pettersen learned about the ACE study and related research about 8 years ago while on a sabbatical to learn more about mental health issues. It “changed everything” about the way she viewed children and families and adversity. “I knew (we) didn’t have the infrastructure at the clinic, or the clinic’s support, to really start assessing children for what was happening to them,” she said, so she began thinking about ACE prevention and a focus on parenting.

Dr. Gillespie, in the meantime, was active in various quality improvement efforts at the state and national level, and had also become increasingly bothered by visits in which he saw children affected by maternal depression, abnormal attachment, and other problems. “I was seeing the consequences of ACEs, but I didn’t know specifically what was going on or how to talk about it,” he said.

The two pediatricians agreed to ask parents about ACEs at the 4-month well visit – a time when the families “knew us a little bit” and when “we could still influence parenting styles.”

In March 2013, they and their colleagues in the pilot group began giving parents a questionnaire that included the 10 ACE questions from Felitti’s study, questions about resilience from the Children’s Resilience Initiative, and a list of potential resources so they could understand parents’ needs.

They created a confidential field in their electronic medical record for documentation that appears during a visit, but does not print into notes and therefore will not be inadvertently released.

As they moved through the pilot phase, the pediatricians used various approaches to follow up on the assessment face-to-face. Eventually, they chose three particular questions as nonthreatening and helpful for conversation: Are there any experiences that still bother you? Of those experiences that don’t bother you, how did you get to the point where they don’t bother you? And how do these experiences affect your parenting now?

“It’s a motivational interviewing sort of style,” said Dr. Gillespie. “Parents can start identifying for themselves the solutions for the problems they’ve experienced, and they can start thinking about how their parenting might be impacted by things that have happened [or are still happening] to them.”

As the project rolled out, the physicians tweaked their process. They added four more ACE questions to address issues – community violence, extreme bullying, racism and prejudice, and foster care exposure – that they thought might lead to toxic stress in their population, for instance. And rather than ask on the written questionnaire for a “yes” or “no” to each of the ACE questions, they began asking the parent how many of the ACE questions applied to them. Moving away from the yes-no format to asking for a total count has led to more disclosures, Dr. Gillespie said.

To “keep the conversation going” in subsequent well-child visits, they developed a few questions to ask high-risk parents, like “How do you and your partner resolve conflict?” and “How did your parents resolve conflict in your household when you were a child?” And they provided training to all of the clinic’s staff on trauma-informed care and the need for support and compassion in their interactions with family members.

In the 3-plus years since incorporating ACEs assessments, the clinic’s pediatricians have made soft referrals to mental health professionals in only several cases – in each case, by suggesting that the parent contact their primary care physician. What most parents have wanted, says Dr. Gillespie, is recommendations for parenting classes and support groups. The clinic’s care manager assists the pediatricians in maintaining and providing links and handouts for various resources.

For Dr. Gillespie, the impact of the culture shift has been dramatic. “I’ve had 8-10 moms spontaneously reveal domestic violence to me in a subsequent visit, and say that they need a little help, because they’ve gotten the message that this is a safe place to talk about their experiences,” he said. “That had never happened to me in the previous 12 years of so of my career.”

Dr. Pettersen’s relationships with parents became “more intimate and more honest.” There was more trust. “If we can talk with parents [about ACEs] and not judge them for it,” she said, “then nothing is off the table.”
 

The ‘Two-Gen’ approach

Courtesy Children's Mercy Hospitals
Dr. Denise Dowd
The clinic’s approach has not been without controversy. “Dr. Gillespie was one of the very first people to screen parents for their ACEs. There’s been push-back, where some have said that you shouldn’t [ask parents about ACEs] if you don’t have anything to give people,” said Denise Dowd, MD, MPH, a pediatrician at Children’s Mercy Hospitals & Clinics in Kansas City, Mo., who chairs the AAP’s Resilience Project and has helped lead a partnership with her state’s largest early Head Start program to treat toxic stress in families.
 

 

“But I’d push back and say, parents know they have toxic stress but they don’t name it,” she said. “What we can do as trusted providers who want to advocate for families is to bear witness to their history by asking about it. Once they realize it’s not what’s wrong with [them], it’s what’s happened to [them], a shift occurs. That’s extremely validating for parents.”

That validation is part of a two-generation approach that she and Dr. Burke Harris see as part of a movement to break cycles of ACEs and toxic stress. At the California Pacific Medical Center’s Bayview Child Health Center in San Francisco, Dr. Burke Harris uses three ACE questionnaires – two of them ask parents (of children or teens) to report how many adverse experience types, or categories, apply to them and/or their child or teen, and one surveys adolescents themselves.

With the resources and clinical support of the Center for Youth Wellness, whose major funders include Google, Dr. Burke Harris can initiate a “warm hand-off” of patients with a high ACE score to a care coordinator or therapist. (The Center for Youth Wellness is beginning research to validate its ACE screening tools.) And in the meantime, the medical care she provides is trauma-informed.

“If a patient comes in for ADHD [attention-deficit/hyperactivity disorder] and has an ACE score of 6, my differential diagnosis and assessment will be different than if I see a patient sent by the school who has an ACE score of 0,” she said.

At the Portland Clinic, even though ACEs screening is now tied with the 4-month visit, pediatricians are much more attentive across the board to possible ACEs and toxic stress, and feel better able to converse with families, Dr. Gillespie said. One of his partners recently saw a 12-year-old boy who was failing in school and not making friends. Trauma-informed history-taking revealed at least several ACEs, and conversation turned to “all the resilience pieces… the connections he was missing and what he needed to cope,” he said.

References

 Resilience Project: This AAP project houses a “trauma toolkit” for primary care, case studies, and a variety of other tools.

 Center for Youth Wellness: The ACEs screening tools used by Dr. Burke Harris may be accessed at this website, along with a user guide containing sample scripts, and two white papers on ACEs and toxic stress.

 Resilience: The Biology of Stress and the Science of Hope: This documentary film, released in September 2016, is about ACEs and “a new movement” to treat and prevent toxic stress; it features the work of Dr. Burke Harris and others.

 Academy on Violence & Abuse: Various papers on ACEs screening and case finding in practice may be accessed here.

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