Christine Kilgore

WASHINGTON – Pediatric practices can combat the toxic stress created by intimate partner violence – and often prevent child maltreatment – by providing “multiple layers of opportunity” for disclosure and access to resources, Dr. Kimberly Randell said at the annual meeting of the American Academy of Pediatrics.

Each year, approximately 15.5 million children – disproportionately younger children – are exposed to intimate partner violence (IPV) (J Fam Psychol. 2006;20[1]:137-42). Their mothers, IPV victims, will seek care for their children when they don’t seek care for themselves, and they will address IPV for their children, she said.

“These are women who are coming in for the 2-, 4-, 6-month visits, but haven’t seen their ob for the postpartum visit ,and they may not see their primary care physician for several more years,” said Dr. Randell, who coordinates the IPV program at Children’s Mercy Hospital in Kansas City, Mo. “They’ll address IPV in the context of how it affects their kids.”

Between 1 in 3 women and 1 in 4 men will experience intimate partner violence (IPV) at some point in their lifetime, according to The National Intimate Partner and Sexual Violence Survey 2010 Summary Report by the Centers for Disease Control and Prevention. Families experiencing IPV “look no different from families who aren’t,” making it worthwhile to universally screen for the problem as part of anticipatory guidance. There is no hard evidence favoring written or verbal assessment – “it all depends on what works best for your practice,” Dr. Randell said.

However, she implored pediatricians to line up advocacy resources, educate staff, and develop processes for intervention. “We know that if you just hand someone a pamphlet or a help line number and say ‘call when you’re ready,’ the odds are they’re not going to call,” Dr. Randell said.

Instead, tell the mother you would like to connect her with a community partner who specializes in IVP and can help her figure out a plan for her and her child’s safety. Ideally, a nurse or staff member in the pediatric office who is educated about IVP could be the initial link – someone “to whom you can make a warm hand-off.”

In this case, she explained, the pediatrician can “say something like, ‘I’d like you to talk with Jennifer. She knows a lot about situations like these and can offer some resources. We can even make the call from the office today.’ ”

Phone calls made from the office, when agreed to, are “very safe calls,” Dr. Randell emphasized.

Ideally, pediatric offices can partner with a local IPV agency for education and referrals. Other possibilities are the social work department at a local children’s hospital or the National Domestic Violence hot line (1-800-799-7233, 1-800-787-3224 TTY). Dr. Randell advised using the term “help line” instead of “hotline” because, in her experience, families associate a “hotline” with children “being taken away.”

Physicians worry about damaging trust by asking about IPV, but numerous studies show most mothers agree that pediatric health care providers should ask.

Introducing questions about IPV with a “framing statement” can minimize any perception of judgment. An example: “Because violence at home is common and affects children’s health and safety, I now ask all families in my practice about exposure to violence.”

The framing statement can then be followed with an indirect question such as “Do you feel safe at home and in your relationship?” or a more direct question, such as:

• “Has your child ever seen a violent or frightening event at home or in your neighborhood?”

• “Have you ever been hurt or threatened by your partner?”

• “Do you ever feel afraid of or controlled by or isolated by your partner?”

IPV is an adverse childhood experience that not only creates toxic stress, but puts children at significantly higher risk – up to 15 times the risk – for all forms of childhood maltreatment. Men also experience IPV, but women are most frequently the nonoffenders, she noted.

Pediatricians should know their states’ child abuse and IVP reporting laws, and inform the nonoffending parent of any limits on confidentiality. “If your state has mandatory reporting for exposure to IVP, you need to let the parent know,” she said. “They need to be able to take this into consideration when they’re deciding if it’s safe or the right time to disclose.”

Dr. Randell advised physicians to try to involve the parent when reporting IPV, either per mandatory reporting laws or per results of a child safety assessment. Explain that you’d like them to make the report with you,” she said. “This can be an important step in maintaining a trusting relationship and empowering her.”

Care must be taken in documenting IPV disclosure because the abusive parent often has access to the child’s chart and/or receives insurance statements. Dr. Randell offered several tips:

Use limited, coded documentation in the chart.

• Do not use IPV-related billing codes or mention the terms “domestic violence” or “IPV.”

• Do not use the word shelter or include notes about safety plans.

• Do not screen in the presence of verbal children, or children aged 3 years and older.

Children may inadvertently tell the abuser that mom has been talking to someone, she explained. “And it’s also probably bad for kids to hear mom denying [IPV] because it reinforces that this is a behavior that we keep secret and don’t talk about.”

Posters, pamphlets, and other environmental cues are an important layer for helping families who are experiencing IPV, largely because these items provide women with the opportunity to access resources without having to disclose IPV.

In focus groups at Children’s Mercy, mothers who had experienced or were experiencing IPV said they wanted information “not only on what IPV looks like … but about how it impacts kids, about resources, and about safety planning,” Dr. Randell said. “And they wanted things that are hopeful ... They don’t want to be labeled [as victims].”

There are several validated screening instruments for IPV (such as the Partner Violence Screen and the Woman Abuse Screening Tool), but the tools have significantly variable sensitivities and specificities and have not been studied in pediatric settings. General psychosocial screening tools used in pediatrics, such as the Pediatric Symptom Checklist and the Strengths and Difficulties Questionnaire, may provide clues of possible trauma, including IPV, she noted.

Among the resources recommended by Dr. Randell:

• The Harvard Center for the Developing Child (www.developingchild.harvard.edu).

• Futures Without Violence (www.futureswithoutviolence.org).

• AAP’s policy statement on IPV: pediatrics.aappublications.org/content/125/5/1094).

WASHINGTON – Pediatric practices can combat the toxic stress created by intimate partner violence – and often prevent child maltreatment – by providing “multiple layers of opportunity” for disclosure and access to resources, Dr. Kimberly Randell said at the annual meeting of the American Academy of Pediatrics.

Each year, approximately 15.5 million children – disproportionately younger children – are exposed to intimate partner violence (IPV) (J Fam Psychol. 2006;20[1]:137-42). Their mothers, IPV victims, will seek care for their children when they don’t seek care for themselves, and they will address IPV for their children, she said.

“These are women who are coming in for the 2-, 4-, 6-month visits, but haven’t seen their ob for the postpartum visit ,and they may not see their primary care physician for several more years,” said Dr. Randell, who coordinates the IPV program at Children’s Mercy Hospital in Kansas City, Mo. “They’ll address IPV in the context of how it affects their kids.”

Between 1 in 3 women and 1 in 4 men will experience intimate partner violence (IPV) at some point in their lifetime, according to The National Intimate Partner and Sexual Violence Survey 2010 Summary Report by the Centers for Disease Control and Prevention. Families experiencing IPV “look no different from families who aren’t,” making it worthwhile to universally screen for the problem as part of anticipatory guidance. There is no hard evidence favoring written or verbal assessment – “it all depends on what works best for your practice,” Dr. Randell said.

However, she implored pediatricians to line up advocacy resources, educate staff, and develop processes for intervention. “We know that if you just hand someone a pamphlet or a help line number and say ‘call when you’re ready,’ the odds are they’re not going to call,” Dr. Randell said.

Instead, tell the mother you would like to connect her with a community partner who specializes in IVP and can help her figure out a plan for her and her child’s safety. Ideally, a nurse or staff member in the pediatric office who is educated about IVP could be the initial link – someone “to whom you can make a warm hand-off.”

In this case, she explained, the pediatrician can “say something like, ‘I’d like you to talk with Jennifer. She knows a lot about situations like these and can offer some resources. We can even make the call from the office today.’ ”

Phone calls made from the office, when agreed to, are “very safe calls,” Dr. Randell emphasized.

Ideally, pediatric offices can partner with a local IPV agency for education and referrals. Other possibilities are the social work department at a local children’s hospital or the National Domestic Violence hot line (1-800-799-7233, 1-800-787-3224 TTY). Dr. Randell advised using the term “help line” instead of “hotline” because, in her experience, families associate a “hotline” with children “being taken away.”

Physicians worry about damaging trust by asking about IPV, but numerous studies show most mothers agree that pediatric health care providers should ask.

Introducing questions about IPV with a “framing statement” can minimize any perception of judgment. An example: “Because violence at home is common and affects children’s health and safety, I now ask all families in my practice about exposure to violence.”

The framing statement can then be followed with an indirect question such as “Do you feel safe at home and in your relationship?” or a more direct question, such as:

• “Has your child ever seen a violent or frightening event at home or in your neighborhood?”

• “Have you ever been hurt or threatened by your partner?”

• “Do you ever feel afraid of or controlled by or isolated by your partner?”

IPV is an adverse childhood experience that not only creates toxic stress, but puts children at significantly higher risk – up to 15 times the risk – for all forms of childhood maltreatment. Men also experience IPV, but women are most frequently the nonoffenders, she noted.

Pediatricians should know their states’ child abuse and IVP reporting laws, and inform the nonoffending parent of any limits on confidentiality. “If your state has mandatory reporting for exposure to IVP, you need to let the parent know,” she said. “They need to be able to take this into consideration when they’re deciding if it’s safe or the right time to disclose.”

Dr. Randell advised physicians to try to involve the parent when reporting IPV, either per mandatory reporting laws or per results of a child safety assessment. Explain that you’d like them to make the report with you,” she said. “This can be an important step in maintaining a trusting relationship and empowering her.”

Care must be taken in documenting IPV disclosure because the abusive parent often has access to the child’s chart and/or receives insurance statements. Dr. Randell offered several tips:

Use limited, coded documentation in the chart.

• Do not use IPV-related billing codes or mention the terms “domestic violence” or “IPV.”

• Do not use the word shelter or include notes about safety plans.

• Do not screen in the presence of verbal children, or children aged 3 years and older.

Children may inadvertently tell the abuser that mom has been talking to someone, she explained. “And it’s also probably bad for kids to hear mom denying [IPV] because it reinforces that this is a behavior that we keep secret and don’t talk about.”

Posters, pamphlets, and other environmental cues are an important layer for helping families who are experiencing IPV, largely because these items provide women with the opportunity to access resources without having to disclose IPV.

In focus groups at Children’s Mercy, mothers who had experienced or were experiencing IPV said they wanted information “not only on what IPV looks like … but about how it impacts kids, about resources, and about safety planning,” Dr. Randell said. “And they wanted things that are hopeful ... They don’t want to be labeled [as victims].”

There are several validated screening instruments for IPV (such as the Partner Violence Screen and the Woman Abuse Screening Tool), but the tools have significantly variable sensitivities and specificities and have not been studied in pediatric settings. General psychosocial screening tools used in pediatrics, such as the Pediatric Symptom Checklist and the Strengths and Difficulties Questionnaire, may provide clues of possible trauma, including IPV, she noted.

Among the resources recommended by Dr. Randell:

• The Harvard Center for the Developing Child (www.developingchild.harvard.edu).

• Futures Without Violence (www.futureswithoutviolence.org).

• AAP’s policy statement on IPV: pediatrics.aappublications.org/content/125/5/1094).

WASHINGTON – Pediatric practices can combat the toxic stress created by intimate partner violence – and often prevent child maltreatment – by providing “multiple layers of opportunity” for disclosure and access to resources, Dr. Kimberly Randell said at the annual meeting of the American Academy of Pediatrics.

Each year, approximately 15.5 million children – disproportionately younger children – are exposed to intimate partner violence (IPV) (J Fam Psychol. 2006;20[1]:137-42). Their mothers, IPV victims, will seek care for their children when they don’t seek care for themselves, and they will address IPV for their children, she said.

“These are women who are coming in for the 2-, 4-, 6-month visits, but haven’t seen their ob for the postpartum visit ,and they may not see their primary care physician for several more years,” said Dr. Randell, who coordinates the IPV program at Children’s Mercy Hospital in Kansas City, Mo. “They’ll address IPV in the context of how it affects their kids.”

Between 1 in 3 women and 1 in 4 men will experience intimate partner violence (IPV) at some point in their lifetime, according to The National Intimate Partner and Sexual Violence Survey 2010 Summary Report by the Centers for Disease Control and Prevention. Families experiencing IPV “look no different from families who aren’t,” making it worthwhile to universally screen for the problem as part of anticipatory guidance. There is no hard evidence favoring written or verbal assessment – “it all depends on what works best for your practice,” Dr. Randell said.

However, she implored pediatricians to line up advocacy resources, educate staff, and develop processes for intervention. “We know that if you just hand someone a pamphlet or a help line number and say ‘call when you’re ready,’ the odds are they’re not going to call,” Dr. Randell said.

Instead, tell the mother you would like to connect her with a community partner who specializes in IVP and can help her figure out a plan for her and her child’s safety. Ideally, a nurse or staff member in the pediatric office who is educated about IVP could be the initial link – someone “to whom you can make a warm hand-off.”

In this case, she explained, the pediatrician can “say something like, ‘I’d like you to talk with Jennifer. She knows a lot about situations like these and can offer some resources. We can even make the call from the office today.’ ”

Phone calls made from the office, when agreed to, are “very safe calls,” Dr. Randell emphasized.

Ideally, pediatric offices can partner with a local IPV agency for education and referrals. Other possibilities are the social work department at a local children’s hospital or the National Domestic Violence hot line (1-800-799-7233, 1-800-787-3224 TTY). Dr. Randell advised using the term “help line” instead of “hotline” because, in her experience, families associate a “hotline” with children “being taken away.”

Physicians worry about damaging trust by asking about IPV, but numerous studies show most mothers agree that pediatric health care providers should ask.

Introducing questions about IPV with a “framing statement” can minimize any perception of judgment. An example: “Because violence at home is common and affects children’s health and safety, I now ask all families in my practice about exposure to violence.”

The framing statement can then be followed with an indirect question such as “Do you feel safe at home and in your relationship?” or a more direct question, such as:

• “Has your child ever seen a violent or frightening event at home or in your neighborhood?”

• “Have you ever been hurt or threatened by your partner?”

• “Do you ever feel afraid of or controlled by or isolated by your partner?”

IPV is an adverse childhood experience that not only creates toxic stress, but puts children at significantly higher risk – up to 15 times the risk – for all forms of childhood maltreatment. Men also experience IPV, but women are most frequently the nonoffenders, she noted.

Pediatricians should know their states’ child abuse and IVP reporting laws, and inform the nonoffending parent of any limits on confidentiality. “If your state has mandatory reporting for exposure to IVP, you need to let the parent know,” she said. “They need to be able to take this into consideration when they’re deciding if it’s safe or the right time to disclose.”

Dr. Randell advised physicians to try to involve the parent when reporting IPV, either per mandatory reporting laws or per results of a child safety assessment. Explain that you’d like them to make the report with you,” she said. “This can be an important step in maintaining a trusting relationship and empowering her.”

Care must be taken in documenting IPV disclosure because the abusive parent often has access to the child’s chart and/or receives insurance statements. Dr. Randell offered several tips:

Use limited, coded documentation in the chart.

• Do not use IPV-related billing codes or mention the terms “domestic violence” or “IPV.”

• Do not use the word shelter or include notes about safety plans.

• Do not screen in the presence of verbal children, or children aged 3 years and older.

Children may inadvertently tell the abuser that mom has been talking to someone, she explained. “And it’s also probably bad for kids to hear mom denying [IPV] because it reinforces that this is a behavior that we keep secret and don’t talk about.”

Posters, pamphlets, and other environmental cues are an important layer for helping families who are experiencing IPV, largely because these items provide women with the opportunity to access resources without having to disclose IPV.

In focus groups at Children’s Mercy, mothers who had experienced or were experiencing IPV said they wanted information “not only on what IPV looks like … but about how it impacts kids, about resources, and about safety planning,” Dr. Randell said. “And they wanted things that are hopeful ... They don’t want to be labeled [as victims].”

There are several validated screening instruments for IPV (such as the Partner Violence Screen and the Woman Abuse Screening Tool), but the tools have significantly variable sensitivities and specificities and have not been studied in pediatric settings. General psychosocial screening tools used in pediatrics, such as the Pediatric Symptom Checklist and the Strengths and Difficulties Questionnaire, may provide clues of possible trauma, including IPV, she noted.

Among the resources recommended by Dr. Randell:

• The Harvard Center for the Developing Child (www.developingchild.harvard.edu).

• Futures Without Violence (www.futureswithoutviolence.org).

• AAP’s policy statement on IPV: pediatrics.aappublications.org/content/125/5/1094).

WASHINGTON – The legal definition of what constitutes “reasonable” corporal punishment is contracting, making it more critical than ever to inquire about discipline, provide alternatives to corporal punishment, and address religious objections with culturally sensitive responses.

In delivering this message, Victor I. Vieth, J.D., founder and senior director of the Gundersen National Child Protection Training Center in La Crosse, Wisc., stressed that spanking and other forms of corporal punishment are still widely practiced, and that the many parents who employ this form of discipline are open to considering alternatives that they can learn and believe in.

“The vast majority of parents are doing the best they know how. … They don’t know the alternatives,” Mr. Vieth said.

©tzahiV/Thinkstock

“Reasonable” corporal punishment is lawful in all 50 states, but the definition of reasonable is narrowing. Courts now will consider the child’s size, frowning upon such punishment for children under the age of 2 years. They will consider where on the body the child is hit, generally viewing anything but the buttocks as unreasonable, and they’ll look at whether objects have been used.

Courts even appear willing today to consider the “nature of the child’s misbehavior,” which “opens the door to even mild corporal punishment cases sometimes being considered unlawful,” such as a parent hitting a child on the buttocks once or twice after milk is spilled, said Mr. Vieth, whose training center oversees a Center for Effective Discipline.

“Think about this as a mandatory reporter,” he said at the annual meeting of the American Academy of Pediatrics. “The vast majority of corporal punishment cases we see probably are running afoul of criminal or civil codes today.”

Shifts in case law are likely being driven by research showing that corporal punishment is a risk factor for both short-term and long-term physical and mental injury, he said. It has long been known that even mild forms of physical abuse – what’s been called “ordinary” physical punishment – can cause negative behavioral and psychological outcomes such as alcohol abuse, depression, behavioral problems, and low achievement.

More recent research has expanded the toll, linking acts such as pushing, grabbing, shoving, slapping, and hitting not only with higher risks of mental disorders and family dysfunction, but with higher risks of cardiovascular disease, arthritis, and obesity.

Ask parents about what form of discipline they’re using, and educate parents who indicate using corporal punishment about the medical risks and mental health risks in the short and long term. It’s important to then give parents “practical, concrete” tools that model alternative methods. Vanderbilt University’s Play Nicely free online parenting program is one that Mr. Vieth often recommends.

The parental response of “my parents hit me and I turned out just fine” is not uncommon, and it can be handled in various ways, he said.

You could segue into a discussion of risks by saying, for example, “Well, let’s explore that. I’ve known you for a long time, and I think you did turn out well. And that’s consistent with the research because the research doesn’t show that if you receive corporal punishment, you’re going to grow up to have negative outcomes. The research says that it’s a risk factor, and the more you hit and the longer you hit, the greater the risk will be.”

You also could compare corporal punishment research to research on smoking, Mr. Vieth said, by saying, “It’s not that different from smoking. One cigarette in the back of the school house won’t kill you, but two packs a day will dramatically increase the risk.”

Religion is a top reason – if not the No. 1 reason – for the use of corporal punishment, and it’s important to understand its influence on discipline and to develop culturally sensitive responses to parents who object for religious reasons to alternative approaches, Mr. Vieth said.

He recommended the following strategies when a parent cites religious grounds for physical discipline:

• Be aware of your own biases. Do not automatically label parents as neglectful or abusive.

• Refrain from pastoral work. “Assure the parent that you’re not trying to take away her religious beliefs, that you’re discussing religion because she’s speaking about discipline that must fit within her belief system.”

• Ask if the belief system “authorizes” or “requires” corporal punishment. If it is authorized, there’s a clear basis for working together.

• Try to distinguish between parents who need education and those who should be prosecuted. Some parents may accept and use corporal punishment, but may be amenable to discussion and education.

• Emphasize the patient’s strengths. Parental warmth, for instance, does not negate the risks of corporal punishment, but it can be a good foundation.

• Acknowledge the benefits of religion, such as its promotion of well-being and healthy behavior.

• Recognize the value of discipline and emphasize that you’re advocating for “effective” discipline with the fewest risk factors.

• “Play in the parent’s ball field.” If the parent believes she is God’s representative to the child, consider asking questions such as “What is your child learning about God when you hit her? What did you learn about God from being physically disciplined?” Parents often will pause and reflect.

Mr. Vieth told the story of Carol, a deeply religious single mother who was raised in a home with corporal discipline and who believed that God’s word in her Protestant faith told her that she must sometimes hit her 3-year-old son with an object. She confessed to a coworker that she was paddling her son on the buttocks, but did not like doing so and was scared of hurting him.

Carol’s coworker called Child Protective Services. The subsequent multidisciplinary team investigation chose not to file criminal charges, but to file a civil child protection petition. Carol pledged to improve her parenting, but was unwilling to forgo the practice altogether. Over time, it became apparent to the team working with Carol that she was heavily influenced by James Dobson, Ph.D., the founder of an organization called Focus on the Family. Unlike other more extreme advocates of corporal punishment, Dr. Dobson caps the number of spanks at two, with one for lesser infractions, and says spanking must never leave a bruise or injury (“From Sticks to Flowers: Guidelines for Child Protection Professionals Working with Parents Using Scripture to Justify Corporal Punishment,” [St. Paul, Minn.: William Mitchell Law Review, 2014, p. 923]), Mr. Vieth noted.

“For Carol, his views trumped all medical and health research,” Mr. Vieth said. “We had to figure out a way to play in her court.” Working with a social worker, he found passages in Dobson’s writing that conveyed the message that not every child needs corporal punishment.

“Once I started quoting Dobson, it changed the dynamic” and the team was able to work with her on embracing and learning alternative approaches. The petition was dropped, and Carol now is an advocate in her church for discipline methods other than corporal punishment.

Mr. Vieth reported having no relevant financial disclosures.

WASHINGTON – The legal definition of what constitutes “reasonable” corporal punishment is contracting, making it more critical than ever to inquire about discipline, provide alternatives to corporal punishment, and address religious objections with culturally sensitive responses.

In delivering this message, Victor I. Vieth, J.D., founder and senior director of the Gundersen National Child Protection Training Center in La Crosse, Wisc., stressed that spanking and other forms of corporal punishment are still widely practiced, and that the many parents who employ this form of discipline are open to considering alternatives that they can learn and believe in.

“The vast majority of parents are doing the best they know how. … They don’t know the alternatives,” Mr. Vieth said.

©tzahiV/Thinkstock

“Reasonable” corporal punishment is lawful in all 50 states, but the definition of reasonable is narrowing. Courts now will consider the child’s size, frowning upon such punishment for children under the age of 2 years. They will consider where on the body the child is hit, generally viewing anything but the buttocks as unreasonable, and they’ll look at whether objects have been used.

Courts even appear willing today to consider the “nature of the child’s misbehavior,” which “opens the door to even mild corporal punishment cases sometimes being considered unlawful,” such as a parent hitting a child on the buttocks once or twice after milk is spilled, said Mr. Vieth, whose training center oversees a Center for Effective Discipline.

“Think about this as a mandatory reporter,” he said at the annual meeting of the American Academy of Pediatrics. “The vast majority of corporal punishment cases we see probably are running afoul of criminal or civil codes today.”

Shifts in case law are likely being driven by research showing that corporal punishment is a risk factor for both short-term and long-term physical and mental injury, he said. It has long been known that even mild forms of physical abuse – what’s been called “ordinary” physical punishment – can cause negative behavioral and psychological outcomes such as alcohol abuse, depression, behavioral problems, and low achievement.

More recent research has expanded the toll, linking acts such as pushing, grabbing, shoving, slapping, and hitting not only with higher risks of mental disorders and family dysfunction, but with higher risks of cardiovascular disease, arthritis, and obesity.

Ask parents about what form of discipline they’re using, and educate parents who indicate using corporal punishment about the medical risks and mental health risks in the short and long term. It’s important to then give parents “practical, concrete” tools that model alternative methods. Vanderbilt University’s Play Nicely free online parenting program is one that Mr. Vieth often recommends.

The parental response of “my parents hit me and I turned out just fine” is not uncommon, and it can be handled in various ways, he said.

You could segue into a discussion of risks by saying, for example, “Well, let’s explore that. I’ve known you for a long time, and I think you did turn out well. And that’s consistent with the research because the research doesn’t show that if you receive corporal punishment, you’re going to grow up to have negative outcomes. The research says that it’s a risk factor, and the more you hit and the longer you hit, the greater the risk will be.”

You also could compare corporal punishment research to research on smoking, Mr. Vieth said, by saying, “It’s not that different from smoking. One cigarette in the back of the school house won’t kill you, but two packs a day will dramatically increase the risk.”

Religion is a top reason – if not the No. 1 reason – for the use of corporal punishment, and it’s important to understand its influence on discipline and to develop culturally sensitive responses to parents who object for religious reasons to alternative approaches, Mr. Vieth said.

He recommended the following strategies when a parent cites religious grounds for physical discipline:

• Be aware of your own biases. Do not automatically label parents as neglectful or abusive.

• Refrain from pastoral work. “Assure the parent that you’re not trying to take away her religious beliefs, that you’re discussing religion because she’s speaking about discipline that must fit within her belief system.”

• Ask if the belief system “authorizes” or “requires” corporal punishment. If it is authorized, there’s a clear basis for working together.

• Try to distinguish between parents who need education and those who should be prosecuted. Some parents may accept and use corporal punishment, but may be amenable to discussion and education.

• Emphasize the patient’s strengths. Parental warmth, for instance, does not negate the risks of corporal punishment, but it can be a good foundation.

• Acknowledge the benefits of religion, such as its promotion of well-being and healthy behavior.

• Recognize the value of discipline and emphasize that you’re advocating for “effective” discipline with the fewest risk factors.

• “Play in the parent’s ball field.” If the parent believes she is God’s representative to the child, consider asking questions such as “What is your child learning about God when you hit her? What did you learn about God from being physically disciplined?” Parents often will pause and reflect.

Mr. Vieth told the story of Carol, a deeply religious single mother who was raised in a home with corporal discipline and who believed that God’s word in her Protestant faith told her that she must sometimes hit her 3-year-old son with an object. She confessed to a coworker that she was paddling her son on the buttocks, but did not like doing so and was scared of hurting him.

Carol’s coworker called Child Protective Services. The subsequent multidisciplinary team investigation chose not to file criminal charges, but to file a civil child protection petition. Carol pledged to improve her parenting, but was unwilling to forgo the practice altogether. Over time, it became apparent to the team working with Carol that she was heavily influenced by James Dobson, Ph.D., the founder of an organization called Focus on the Family. Unlike other more extreme advocates of corporal punishment, Dr. Dobson caps the number of spanks at two, with one for lesser infractions, and says spanking must never leave a bruise or injury (“From Sticks to Flowers: Guidelines for Child Protection Professionals Working with Parents Using Scripture to Justify Corporal Punishment,” [St. Paul, Minn.: William Mitchell Law Review, 2014, p. 923]), Mr. Vieth noted.

“For Carol, his views trumped all medical and health research,” Mr. Vieth said. “We had to figure out a way to play in her court.” Working with a social worker, he found passages in Dobson’s writing that conveyed the message that not every child needs corporal punishment.

“Once I started quoting Dobson, it changed the dynamic” and the team was able to work with her on embracing and learning alternative approaches. The petition was dropped, and Carol now is an advocate in her church for discipline methods other than corporal punishment.

Mr. Vieth reported having no relevant financial disclosures.

WASHINGTON – The legal definition of what constitutes “reasonable” corporal punishment is contracting, making it more critical than ever to inquire about discipline, provide alternatives to corporal punishment, and address religious objections with culturally sensitive responses.

In delivering this message, Victor I. Vieth, J.D., founder and senior director of the Gundersen National Child Protection Training Center in La Crosse, Wisc., stressed that spanking and other forms of corporal punishment are still widely practiced, and that the many parents who employ this form of discipline are open to considering alternatives that they can learn and believe in.

“The vast majority of parents are doing the best they know how. … They don’t know the alternatives,” Mr. Vieth said.

©tzahiV/Thinkstock

“Reasonable” corporal punishment is lawful in all 50 states, but the definition of reasonable is narrowing. Courts now will consider the child’s size, frowning upon such punishment for children under the age of 2 years. They will consider where on the body the child is hit, generally viewing anything but the buttocks as unreasonable, and they’ll look at whether objects have been used.

Courts even appear willing today to consider the “nature of the child’s misbehavior,” which “opens the door to even mild corporal punishment cases sometimes being considered unlawful,” such as a parent hitting a child on the buttocks once or twice after milk is spilled, said Mr. Vieth, whose training center oversees a Center for Effective Discipline.

“Think about this as a mandatory reporter,” he said at the annual meeting of the American Academy of Pediatrics. “The vast majority of corporal punishment cases we see probably are running afoul of criminal or civil codes today.”

Shifts in case law are likely being driven by research showing that corporal punishment is a risk factor for both short-term and long-term physical and mental injury, he said. It has long been known that even mild forms of physical abuse – what’s been called “ordinary” physical punishment – can cause negative behavioral and psychological outcomes such as alcohol abuse, depression, behavioral problems, and low achievement.

More recent research has expanded the toll, linking acts such as pushing, grabbing, shoving, slapping, and hitting not only with higher risks of mental disorders and family dysfunction, but with higher risks of cardiovascular disease, arthritis, and obesity.

Ask parents about what form of discipline they’re using, and educate parents who indicate using corporal punishment about the medical risks and mental health risks in the short and long term. It’s important to then give parents “practical, concrete” tools that model alternative methods. Vanderbilt University’s Play Nicely free online parenting program is one that Mr. Vieth often recommends.

The parental response of “my parents hit me and I turned out just fine” is not uncommon, and it can be handled in various ways, he said.

You could segue into a discussion of risks by saying, for example, “Well, let’s explore that. I’ve known you for a long time, and I think you did turn out well. And that’s consistent with the research because the research doesn’t show that if you receive corporal punishment, you’re going to grow up to have negative outcomes. The research says that it’s a risk factor, and the more you hit and the longer you hit, the greater the risk will be.”

You also could compare corporal punishment research to research on smoking, Mr. Vieth said, by saying, “It’s not that different from smoking. One cigarette in the back of the school house won’t kill you, but two packs a day will dramatically increase the risk.”

Religion is a top reason – if not the No. 1 reason – for the use of corporal punishment, and it’s important to understand its influence on discipline and to develop culturally sensitive responses to parents who object for religious reasons to alternative approaches, Mr. Vieth said.

He recommended the following strategies when a parent cites religious grounds for physical discipline:

• Be aware of your own biases. Do not automatically label parents as neglectful or abusive.

• Refrain from pastoral work. “Assure the parent that you’re not trying to take away her religious beliefs, that you’re discussing religion because she’s speaking about discipline that must fit within her belief system.”

• Ask if the belief system “authorizes” or “requires” corporal punishment. If it is authorized, there’s a clear basis for working together.

• Try to distinguish between parents who need education and those who should be prosecuted. Some parents may accept and use corporal punishment, but may be amenable to discussion and education.

• Emphasize the patient’s strengths. Parental warmth, for instance, does not negate the risks of corporal punishment, but it can be a good foundation.

• Acknowledge the benefits of religion, such as its promotion of well-being and healthy behavior.

• Recognize the value of discipline and emphasize that you’re advocating for “effective” discipline with the fewest risk factors.

• “Play in the parent’s ball field.” If the parent believes she is God’s representative to the child, consider asking questions such as “What is your child learning about God when you hit her? What did you learn about God from being physically disciplined?” Parents often will pause and reflect.

Mr. Vieth told the story of Carol, a deeply religious single mother who was raised in a home with corporal discipline and who believed that God’s word in her Protestant faith told her that she must sometimes hit her 3-year-old son with an object. She confessed to a coworker that she was paddling her son on the buttocks, but did not like doing so and was scared of hurting him.

Carol’s coworker called Child Protective Services. The subsequent multidisciplinary team investigation chose not to file criminal charges, but to file a civil child protection petition. Carol pledged to improve her parenting, but was unwilling to forgo the practice altogether. Over time, it became apparent to the team working with Carol that she was heavily influenced by James Dobson, Ph.D., the founder of an organization called Focus on the Family. Unlike other more extreme advocates of corporal punishment, Dr. Dobson caps the number of spanks at two, with one for lesser infractions, and says spanking must never leave a bruise or injury (“From Sticks to Flowers: Guidelines for Child Protection Professionals Working with Parents Using Scripture to Justify Corporal Punishment,” [St. Paul, Minn.: William Mitchell Law Review, 2014, p. 923]), Mr. Vieth noted.

“For Carol, his views trumped all medical and health research,” Mr. Vieth said. “We had to figure out a way to play in her court.” Working with a social worker, he found passages in Dobson’s writing that conveyed the message that not every child needs corporal punishment.

“Once I started quoting Dobson, it changed the dynamic” and the team was able to work with her on embracing and learning alternative approaches. The petition was dropped, and Carol now is an advocate in her church for discipline methods other than corporal punishment.

Mr. Vieth reported having no relevant financial disclosures.

WASHINGTON – Recommendations for universal lipid screening between 9 and 11 years and again between ages 17 and 21 – and selective screening of children with risk factors starting at age 2 years – may best be heeded by measuring nonfasting total cholesterol and high-density lipoprotein, pediatric cardiologist Dr. Sarah de Ferranti told a packed room at the annual meeting of the American Academy of Pediatrics.

The difference of the two values is the non-HDL cholesterol level (total cholesterol minus HDL) and represents the atherogenic portion of the lipid profile. It is a “valid” initial result, she assured pediatricians.

©Ugreen/thinkstockphotos.com

Non-HDL values of 145 mg/dL and over should then be further explored through a complete fasting lipid profile, said Dr. de Ferranti, who directs the preventive cardiology program at Boston Children’s Hospital.

While the nonfasting, non-HDL approach has been deemed acceptable for universal screening, national guidelines endorsed by the AAP recommend that selective testing of high-risk children be done with a fasting profile. “But I think people find that onerous,” Dr. de Ferranti said. “Doing a nonfasting test initially [in any pediatric case] is quite reasonable. It’s more convenient, and it may help us to better implement the guidelines and not lose families.”

In 2011, the National Heart, Lung, and Blood Institute (NHLBI) called on physicians not only to selectively screen children with risk factors for cardiovascular disease, but to screen their healthy 9- to 11- and 17- to 21-year-old patients, and to provide lifestyle therapy for patients who have high LDL cholesterol readings on follow-up testing, and then statin treatment for those who don’t respond.

Surveys have shown that fewer than half of pediatricians do routine screening, however, and that many are frustrated with the limitations of lifestyle interventions and at least somewhat uncomfortable with the concept of statin treatment.

The AAP’s own recommendations for lipid screening, issued in 2008, were confined to selective screening of children with risk factors such as obesity, diabetes, or hypertension, or a family history of heart attack, stroke, and high cholesterol. But in 2011, the academy endorsed the NHLBI’s Integrated Guidelines for Cardiovascular Risk Reduction in Childhood and Adolescence, embracing its additional call for screening healthy children during two windows of time.

Both guidelines – the AAP’s and the NHLBI’s – recommend statin treatment for patients whose LDL remains at 190 mg/dL or above after 6 months of lifestyle therapy, and for patients whose LDL is 160 mg/dL or above after lifestyle therapy when additional risk factors are present.

Dr. de Ferranti acknowledged gaps in research on the benefits of early treatment and said that, personally, she is “not sure that [universal screening] will definitely be the right approach for the future.”

She implored pediatricians, however, to remember when making practice decisions that universal screening “has attempted to address the fact that getting a family history [of cardiovascular disease] isn’t always helpful or reliable” for identifying children at high risk of cardiovascular disease, even those with familial hypercholesterolemia.

Familiar hypercholesterolemia is a disorder of LDL cholesterol processing estimated to affect 1 in 250 individuals. It’s usually “asymptomatic until individuals present in their young adulthood with a much higher risk of heart disease … or until they come to the ER as young adults,” said de Ferranti, assistant professor of medicine at Harvard Medical School, Boston.

Studies have shown that individuals aged 20-39 years who have the disorder are almost 90 times as likely to die from coronary heart disease as is the general population in that age group, she noted.

Available data on the impact of treating familiar hypercholesterolemia in childhood is “relatively scant” but “convincing,” she said. One randomized controlled study of statin treatment in children with the disorder used vascular thickness as a proxy for cardiovascular events. Children who took pravastatin for 2 years had a lower mean carotid intima media thickness, and lower LDL levels, compared with children assigned to placebo (JAMA 2004 Jul 21;292[3]:331-7).

Further follow-up of these children has suggested delayed atherosclerotic disease and prevention of cardiac events in the statin group, Dr. de Ferranti noted. And separate observational research shows a significant reduction in cardiovascular disease events in affected adults taking statins.

Not all pediatricians are convinced that screening is justified. A 2013 electronic survey of pediatric providers in Minnesota showed that while 77% supported the concept of lipid screening, 33% performed no screening, 50% screened selectively, and only 16% performed universal screening. (J. Pediatr. 2014 Mar;164[3]:572-6).

In a recent national survey of randomly selected, practicing AAP members, at least two-thirds indicated that they screen based on family history, high-risk conditions, and obesity. Fewer than half said they perform universal age-based screening.

Obtaining labs appears to be a major barrier, Dr. de Ferranti pointed out. Nearly half of the pediatricians who responded to the survey, which was presented at the 2015 annual meeting of the Pediatric Academic Societies, reported problems with patients not returning for a fasting test, she said.

Dr. de Ferranti and her colleagues at Boston Children’s Hospital recently led a quality improvement project to implement lipid screening in their center’s urban primary care practice. Provider adherence to recommended screening, which resembled the NHLBI recommendations, was high. Almost a quarter of the approximately 1,200 patients who received test orders, however, did not complete the ordered screening test, even though it entailed nonfasting non-HDL testing.

And patients screened based on their age alone (the universal screening component) had a low rate of abnormal findings: Only 2.7% were found to have non-HDL of 145 mg/dL or greater, which was surprising to Dr. de Ferranti given the high rate of obesity (45%) in the practice’s population.

“Age-only screening, at least from our data so far, is not very productive,” she said. Only one patient had a clinical picture consistent with familial hyperlipidemia, and this patient was identified based on risk factors and not age alone.

On the other hand, mild abnormalities (non-HDL of 120-145 mg/dL) – the kind that often prompt Dr. de Ferranti to advise lifestyle modification, including a low saturated fat intake of 12-15 g/day with no trans fat, high fiber, and high intake of fresh fruits and vegetables – were common across the board.

Asked about the safety of statins in children, Dr. de Ferranti said there appears to be a 1%-2% rate of side effects in the pediatric population. “My patients have done well,” she said. “Remember, initiation of statins (involves) a discussion – it’s not an emergency. We usually don’t decide in one visit.”

Low-dose statin therapy is an option starting at age 10 years, but Dr. de Ferranti said she sometimes will start “very high risk” patients earlier, between 8 and 10 years of age.

Many of the AAP survey participants believed that statins were appropriate for patients with confirmed high LDL unresponsive to lifestyle change; about 62% agreed with statin use for young children in such situations and almost 90% for older children. Significantly fewer started statin therapy themselves (about 8% for young children and 21% for older children). About half said they refer these patients to lipid specialists, but almost a third reported limited local access.

These low rates of statin treatment or referral for those with severe LDL elevations are concerning and “suggest a missed opportunity for cardiovascular risk reduction in these high-risk children,” Dr. de Ferranti said.

Pediatricians should soon receive more guidance on lipid screening from the U.S. Preventive Services Task Force. In 2007, the task force was unable to determine the balance between potential harms and benefits for routinely screening children and adolescents for dyslipidemia, and issued an “indeterminate” recommendation. It is now reviewing the evidence and is expected to release new guidelines in the near future, she said.

Dr. de Ferranti disclosed that she has current research funding from the Patient Centered Research Institute, the New England Congenital Cardiology Research Foundation, and the Pediatric Heart Network. She also receives royalties from UptoDate, an online clinical decision support resource.

WASHINGTON – Recommendations for universal lipid screening between 9 and 11 years and again between ages 17 and 21 – and selective screening of children with risk factors starting at age 2 years – may best be heeded by measuring nonfasting total cholesterol and high-density lipoprotein, pediatric cardiologist Dr. Sarah de Ferranti told a packed room at the annual meeting of the American Academy of Pediatrics.

The difference of the two values is the non-HDL cholesterol level (total cholesterol minus HDL) and represents the atherogenic portion of the lipid profile. It is a “valid” initial result, she assured pediatricians.

©Ugreen/thinkstockphotos.com

Non-HDL values of 145 mg/dL and over should then be further explored through a complete fasting lipid profile, said Dr. de Ferranti, who directs the preventive cardiology program at Boston Children’s Hospital.

While the nonfasting, non-HDL approach has been deemed acceptable for universal screening, national guidelines endorsed by the AAP recommend that selective testing of high-risk children be done with a fasting profile. “But I think people find that onerous,” Dr. de Ferranti said. “Doing a nonfasting test initially [in any pediatric case] is quite reasonable. It’s more convenient, and it may help us to better implement the guidelines and not lose families.”

In 2011, the National Heart, Lung, and Blood Institute (NHLBI) called on physicians not only to selectively screen children with risk factors for cardiovascular disease, but to screen their healthy 9- to 11- and 17- to 21-year-old patients, and to provide lifestyle therapy for patients who have high LDL cholesterol readings on follow-up testing, and then statin treatment for those who don’t respond.

Surveys have shown that fewer than half of pediatricians do routine screening, however, and that many are frustrated with the limitations of lifestyle interventions and at least somewhat uncomfortable with the concept of statin treatment.

The AAP’s own recommendations for lipid screening, issued in 2008, were confined to selective screening of children with risk factors such as obesity, diabetes, or hypertension, or a family history of heart attack, stroke, and high cholesterol. But in 2011, the academy endorsed the NHLBI’s Integrated Guidelines for Cardiovascular Risk Reduction in Childhood and Adolescence, embracing its additional call for screening healthy children during two windows of time.

Both guidelines – the AAP’s and the NHLBI’s – recommend statin treatment for patients whose LDL remains at 190 mg/dL or above after 6 months of lifestyle therapy, and for patients whose LDL is 160 mg/dL or above after lifestyle therapy when additional risk factors are present.

Dr. de Ferranti acknowledged gaps in research on the benefits of early treatment and said that, personally, she is “not sure that [universal screening] will definitely be the right approach for the future.”

She implored pediatricians, however, to remember when making practice decisions that universal screening “has attempted to address the fact that getting a family history [of cardiovascular disease] isn’t always helpful or reliable” for identifying children at high risk of cardiovascular disease, even those with familial hypercholesterolemia.

Familiar hypercholesterolemia is a disorder of LDL cholesterol processing estimated to affect 1 in 250 individuals. It’s usually “asymptomatic until individuals present in their young adulthood with a much higher risk of heart disease … or until they come to the ER as young adults,” said de Ferranti, assistant professor of medicine at Harvard Medical School, Boston.

Studies have shown that individuals aged 20-39 years who have the disorder are almost 90 times as likely to die from coronary heart disease as is the general population in that age group, she noted.

Available data on the impact of treating familiar hypercholesterolemia in childhood is “relatively scant” but “convincing,” she said. One randomized controlled study of statin treatment in children with the disorder used vascular thickness as a proxy for cardiovascular events. Children who took pravastatin for 2 years had a lower mean carotid intima media thickness, and lower LDL levels, compared with children assigned to placebo (JAMA 2004 Jul 21;292[3]:331-7).

Further follow-up of these children has suggested delayed atherosclerotic disease and prevention of cardiac events in the statin group, Dr. de Ferranti noted. And separate observational research shows a significant reduction in cardiovascular disease events in affected adults taking statins.

Not all pediatricians are convinced that screening is justified. A 2013 electronic survey of pediatric providers in Minnesota showed that while 77% supported the concept of lipid screening, 33% performed no screening, 50% screened selectively, and only 16% performed universal screening. (J. Pediatr. 2014 Mar;164[3]:572-6).

In a recent national survey of randomly selected, practicing AAP members, at least two-thirds indicated that they screen based on family history, high-risk conditions, and obesity. Fewer than half said they perform universal age-based screening.

Obtaining labs appears to be a major barrier, Dr. de Ferranti pointed out. Nearly half of the pediatricians who responded to the survey, which was presented at the 2015 annual meeting of the Pediatric Academic Societies, reported problems with patients not returning for a fasting test, she said.

Dr. de Ferranti and her colleagues at Boston Children’s Hospital recently led a quality improvement project to implement lipid screening in their center’s urban primary care practice. Provider adherence to recommended screening, which resembled the NHLBI recommendations, was high. Almost a quarter of the approximately 1,200 patients who received test orders, however, did not complete the ordered screening test, even though it entailed nonfasting non-HDL testing.

And patients screened based on their age alone (the universal screening component) had a low rate of abnormal findings: Only 2.7% were found to have non-HDL of 145 mg/dL or greater, which was surprising to Dr. de Ferranti given the high rate of obesity (45%) in the practice’s population.

“Age-only screening, at least from our data so far, is not very productive,” she said. Only one patient had a clinical picture consistent with familial hyperlipidemia, and this patient was identified based on risk factors and not age alone.

On the other hand, mild abnormalities (non-HDL of 120-145 mg/dL) – the kind that often prompt Dr. de Ferranti to advise lifestyle modification, including a low saturated fat intake of 12-15 g/day with no trans fat, high fiber, and high intake of fresh fruits and vegetables – were common across the board.

Asked about the safety of statins in children, Dr. de Ferranti said there appears to be a 1%-2% rate of side effects in the pediatric population. “My patients have done well,” she said. “Remember, initiation of statins (involves) a discussion – it’s not an emergency. We usually don’t decide in one visit.”

Low-dose statin therapy is an option starting at age 10 years, but Dr. de Ferranti said she sometimes will start “very high risk” patients earlier, between 8 and 10 years of age.

Many of the AAP survey participants believed that statins were appropriate for patients with confirmed high LDL unresponsive to lifestyle change; about 62% agreed with statin use for young children in such situations and almost 90% for older children. Significantly fewer started statin therapy themselves (about 8% for young children and 21% for older children). About half said they refer these patients to lipid specialists, but almost a third reported limited local access.

These low rates of statin treatment or referral for those with severe LDL elevations are concerning and “suggest a missed opportunity for cardiovascular risk reduction in these high-risk children,” Dr. de Ferranti said.

Pediatricians should soon receive more guidance on lipid screening from the U.S. Preventive Services Task Force. In 2007, the task force was unable to determine the balance between potential harms and benefits for routinely screening children and adolescents for dyslipidemia, and issued an “indeterminate” recommendation. It is now reviewing the evidence and is expected to release new guidelines in the near future, she said.

Dr. de Ferranti disclosed that she has current research funding from the Patient Centered Research Institute, the New England Congenital Cardiology Research Foundation, and the Pediatric Heart Network. She also receives royalties from UptoDate, an online clinical decision support resource.

WASHINGTON – Recommendations for universal lipid screening between 9 and 11 years and again between ages 17 and 21 – and selective screening of children with risk factors starting at age 2 years – may best be heeded by measuring nonfasting total cholesterol and high-density lipoprotein, pediatric cardiologist Dr. Sarah de Ferranti told a packed room at the annual meeting of the American Academy of Pediatrics.

The difference of the two values is the non-HDL cholesterol level (total cholesterol minus HDL) and represents the atherogenic portion of the lipid profile. It is a “valid” initial result, she assured pediatricians.

©Ugreen/thinkstockphotos.com

Non-HDL values of 145 mg/dL and over should then be further explored through a complete fasting lipid profile, said Dr. de Ferranti, who directs the preventive cardiology program at Boston Children’s Hospital.

While the nonfasting, non-HDL approach has been deemed acceptable for universal screening, national guidelines endorsed by the AAP recommend that selective testing of high-risk children be done with a fasting profile. “But I think people find that onerous,” Dr. de Ferranti said. “Doing a nonfasting test initially [in any pediatric case] is quite reasonable. It’s more convenient, and it may help us to better implement the guidelines and not lose families.”

In 2011, the National Heart, Lung, and Blood Institute (NHLBI) called on physicians not only to selectively screen children with risk factors for cardiovascular disease, but to screen their healthy 9- to 11- and 17- to 21-year-old patients, and to provide lifestyle therapy for patients who have high LDL cholesterol readings on follow-up testing, and then statin treatment for those who don’t respond.

Surveys have shown that fewer than half of pediatricians do routine screening, however, and that many are frustrated with the limitations of lifestyle interventions and at least somewhat uncomfortable with the concept of statin treatment.

The AAP’s own recommendations for lipid screening, issued in 2008, were confined to selective screening of children with risk factors such as obesity, diabetes, or hypertension, or a family history of heart attack, stroke, and high cholesterol. But in 2011, the academy endorsed the NHLBI’s Integrated Guidelines for Cardiovascular Risk Reduction in Childhood and Adolescence, embracing its additional call for screening healthy children during two windows of time.

Both guidelines – the AAP’s and the NHLBI’s – recommend statin treatment for patients whose LDL remains at 190 mg/dL or above after 6 months of lifestyle therapy, and for patients whose LDL is 160 mg/dL or above after lifestyle therapy when additional risk factors are present.

Dr. de Ferranti acknowledged gaps in research on the benefits of early treatment and said that, personally, she is “not sure that [universal screening] will definitely be the right approach for the future.”

She implored pediatricians, however, to remember when making practice decisions that universal screening “has attempted to address the fact that getting a family history [of cardiovascular disease] isn’t always helpful or reliable” for identifying children at high risk of cardiovascular disease, even those with familial hypercholesterolemia.

Familiar hypercholesterolemia is a disorder of LDL cholesterol processing estimated to affect 1 in 250 individuals. It’s usually “asymptomatic until individuals present in their young adulthood with a much higher risk of heart disease … or until they come to the ER as young adults,” said de Ferranti, assistant professor of medicine at Harvard Medical School, Boston.

Studies have shown that individuals aged 20-39 years who have the disorder are almost 90 times as likely to die from coronary heart disease as is the general population in that age group, she noted.

Available data on the impact of treating familiar hypercholesterolemia in childhood is “relatively scant” but “convincing,” she said. One randomized controlled study of statin treatment in children with the disorder used vascular thickness as a proxy for cardiovascular events. Children who took pravastatin for 2 years had a lower mean carotid intima media thickness, and lower LDL levels, compared with children assigned to placebo (JAMA 2004 Jul 21;292[3]:331-7).

Further follow-up of these children has suggested delayed atherosclerotic disease and prevention of cardiac events in the statin group, Dr. de Ferranti noted. And separate observational research shows a significant reduction in cardiovascular disease events in affected adults taking statins.

Not all pediatricians are convinced that screening is justified. A 2013 electronic survey of pediatric providers in Minnesota showed that while 77% supported the concept of lipid screening, 33% performed no screening, 50% screened selectively, and only 16% performed universal screening. (J. Pediatr. 2014 Mar;164[3]:572-6).

In a recent national survey of randomly selected, practicing AAP members, at least two-thirds indicated that they screen based on family history, high-risk conditions, and obesity. Fewer than half said they perform universal age-based screening.

Obtaining labs appears to be a major barrier, Dr. de Ferranti pointed out. Nearly half of the pediatricians who responded to the survey, which was presented at the 2015 annual meeting of the Pediatric Academic Societies, reported problems with patients not returning for a fasting test, she said.

Dr. de Ferranti and her colleagues at Boston Children’s Hospital recently led a quality improvement project to implement lipid screening in their center’s urban primary care practice. Provider adherence to recommended screening, which resembled the NHLBI recommendations, was high. Almost a quarter of the approximately 1,200 patients who received test orders, however, did not complete the ordered screening test, even though it entailed nonfasting non-HDL testing.

And patients screened based on their age alone (the universal screening component) had a low rate of abnormal findings: Only 2.7% were found to have non-HDL of 145 mg/dL or greater, which was surprising to Dr. de Ferranti given the high rate of obesity (45%) in the practice’s population.

“Age-only screening, at least from our data so far, is not very productive,” she said. Only one patient had a clinical picture consistent with familial hyperlipidemia, and this patient was identified based on risk factors and not age alone.

On the other hand, mild abnormalities (non-HDL of 120-145 mg/dL) – the kind that often prompt Dr. de Ferranti to advise lifestyle modification, including a low saturated fat intake of 12-15 g/day with no trans fat, high fiber, and high intake of fresh fruits and vegetables – were common across the board.

Asked about the safety of statins in children, Dr. de Ferranti said there appears to be a 1%-2% rate of side effects in the pediatric population. “My patients have done well,” she said. “Remember, initiation of statins (involves) a discussion – it’s not an emergency. We usually don’t decide in one visit.”

Low-dose statin therapy is an option starting at age 10 years, but Dr. de Ferranti said she sometimes will start “very high risk” patients earlier, between 8 and 10 years of age.

Many of the AAP survey participants believed that statins were appropriate for patients with confirmed high LDL unresponsive to lifestyle change; about 62% agreed with statin use for young children in such situations and almost 90% for older children. Significantly fewer started statin therapy themselves (about 8% for young children and 21% for older children). About half said they refer these patients to lipid specialists, but almost a third reported limited local access.

These low rates of statin treatment or referral for those with severe LDL elevations are concerning and “suggest a missed opportunity for cardiovascular risk reduction in these high-risk children,” Dr. de Ferranti said.

Pediatricians should soon receive more guidance on lipid screening from the U.S. Preventive Services Task Force. In 2007, the task force was unable to determine the balance between potential harms and benefits for routinely screening children and adolescents for dyslipidemia, and issued an “indeterminate” recommendation. It is now reviewing the evidence and is expected to release new guidelines in the near future, she said.

Dr. de Ferranti disclosed that she has current research funding from the Patient Centered Research Institute, the New England Congenital Cardiology Research Foundation, and the Pediatric Heart Network. She also receives royalties from UptoDate, an online clinical decision support resource.

Protecting oneself when parents refuse vaccinations for their children entails documenting all discussions – including a conversation about how parents should respond to illness or fever – as well as creating a system in the office to identify incompletely immunized patients for proper triage and care should the need arise, Dr. James P. Scibilia said at the annual meeting of the American Academy of Pediatrics.

Pediatricians should also document that parents have received a vaccine information sheet at each relevant visit and ensure that parents sign appropriate and unaltered “informed refusal” forms, preferably the AAP’s Refusal to Vaccinate form, each time vaccination is refused, said Dr. Scibilia, who is not an attorney but serves on the AAP Committee on Medical Liability and Risk Management.

©dina2001/thinkstockphotos.com

“If patients bring their own form, make sure you read it properly. I received one that had an AAP logo and looked like our form but had a different set of information,” he said.

Physicians may be at legal risk if parents claim in the wake of a bad outcome that they weren’t informed of the risk of nonvaccination; courts have favored the plaintiffs in at least a couple of reported cases thus far, he explained.

Documentation of repeated vaccine discussions – with chart notes indicating that “you’ve reemphasized the risks of not getting a vaccine,” for instance – is important. “Have some little phrase to integrate into your records so you can show that each time the patient came in, you readdressed the issue with them,” said Dr. Scibilia, of Heritage Valley Health System, Beaver, Pa.

“Then make sure you tell your parents that their [unvaccinated] child may require more aggressive evaluation when ill,” he said. “And make sure you have some kind of triage in your phone protocol system.”

Not properly triaging or caring for an unimmunized or underimmunized child may be legally risky, he explained. “If you have a 10-month-old child who hasn’t had their pneumococcal vaccine and develops a 104° fever, you’re going to treat that child differently than one who had the vaccine,” he said. “You need to have some way to identify kids who aren’t immunized and triage them properly.”

Less clear is a situation in which a child infected with a vaccine-preventable illness is seen in the office and infects another child while there. “There is no case law in the U.S. on this. It may happen at some point, but there is nothing right now that suggests you’re at special legal risk [in such a case],” said Dr. Scibilia.

Just as vaccine refusal has been a growing problem, so have requests for altered vaccine schedules. In a recent survey of pediatricians and family physicians, 93% of physicians reported that some parents had requested altered vaccine schedules within the prior month. A significant number of physicians agreed to spread out vaccines, either always or often (37%) or sometimes (37%).

In a minority of cases, physicians decided to dismiss families from their practice: 2% said they “always or often” dismissed patients, and 4% said they “sometimes” did (Pediatrics. 2015 Apr;135:666-77).

“As a group, it seems like pediatricians are following the AAP’s guidance in that we’re trying to convince parents [that vaccination is in their child’s best interest], but it seems that we’re willing to alter schedules in order to get kids vaccinated,” he said.

Whether to agree to alternative scheduling requests is a “philosophical question” for the individual physician to answer, with the understanding that “when you alter the established vaccine schedule, you’re putting yourself at some risk if a patient develops a vaccine-preventable illness during the time frame when you’ve altered the schedule,” he said.

If a physician-patient relationship must be severed, the termination should be done properly and formally in order to avoid possible claims of abandonment. This means providing written notification and documenting that the patient received the notification in a timely fashion, usually with a return receipt. The notification must include an offer to provide emergency care for a specified period of time, Dr. Scibilia said.

Protecting oneself when parents refuse vaccinations for their children entails documenting all discussions – including a conversation about how parents should respond to illness or fever – as well as creating a system in the office to identify incompletely immunized patients for proper triage and care should the need arise, Dr. James P. Scibilia said at the annual meeting of the American Academy of Pediatrics.

Pediatricians should also document that parents have received a vaccine information sheet at each relevant visit and ensure that parents sign appropriate and unaltered “informed refusal” forms, preferably the AAP’s Refusal to Vaccinate form, each time vaccination is refused, said Dr. Scibilia, who is not an attorney but serves on the AAP Committee on Medical Liability and Risk Management.

©dina2001/thinkstockphotos.com

“If patients bring their own form, make sure you read it properly. I received one that had an AAP logo and looked like our form but had a different set of information,” he said.

Physicians may be at legal risk if parents claim in the wake of a bad outcome that they weren’t informed of the risk of nonvaccination; courts have favored the plaintiffs in at least a couple of reported cases thus far, he explained.

Documentation of repeated vaccine discussions – with chart notes indicating that “you’ve reemphasized the risks of not getting a vaccine,” for instance – is important. “Have some little phrase to integrate into your records so you can show that each time the patient came in, you readdressed the issue with them,” said Dr. Scibilia, of Heritage Valley Health System, Beaver, Pa.

“Then make sure you tell your parents that their [unvaccinated] child may require more aggressive evaluation when ill,” he said. “And make sure you have some kind of triage in your phone protocol system.”

Not properly triaging or caring for an unimmunized or underimmunized child may be legally risky, he explained. “If you have a 10-month-old child who hasn’t had their pneumococcal vaccine and develops a 104° fever, you’re going to treat that child differently than one who had the vaccine,” he said. “You need to have some way to identify kids who aren’t immunized and triage them properly.”

Less clear is a situation in which a child infected with a vaccine-preventable illness is seen in the office and infects another child while there. “There is no case law in the U.S. on this. It may happen at some point, but there is nothing right now that suggests you’re at special legal risk [in such a case],” said Dr. Scibilia.

Just as vaccine refusal has been a growing problem, so have requests for altered vaccine schedules. In a recent survey of pediatricians and family physicians, 93% of physicians reported that some parents had requested altered vaccine schedules within the prior month. A significant number of physicians agreed to spread out vaccines, either always or often (37%) or sometimes (37%).

In a minority of cases, physicians decided to dismiss families from their practice: 2% said they “always or often” dismissed patients, and 4% said they “sometimes” did (Pediatrics. 2015 Apr;135:666-77).

“As a group, it seems like pediatricians are following the AAP’s guidance in that we’re trying to convince parents [that vaccination is in their child’s best interest], but it seems that we’re willing to alter schedules in order to get kids vaccinated,” he said.

Whether to agree to alternative scheduling requests is a “philosophical question” for the individual physician to answer, with the understanding that “when you alter the established vaccine schedule, you’re putting yourself at some risk if a patient develops a vaccine-preventable illness during the time frame when you’ve altered the schedule,” he said.

If a physician-patient relationship must be severed, the termination should be done properly and formally in order to avoid possible claims of abandonment. This means providing written notification and documenting that the patient received the notification in a timely fashion, usually with a return receipt. The notification must include an offer to provide emergency care for a specified period of time, Dr. Scibilia said.

Protecting oneself when parents refuse vaccinations for their children entails documenting all discussions – including a conversation about how parents should respond to illness or fever – as well as creating a system in the office to identify incompletely immunized patients for proper triage and care should the need arise, Dr. James P. Scibilia said at the annual meeting of the American Academy of Pediatrics.

Pediatricians should also document that parents have received a vaccine information sheet at each relevant visit and ensure that parents sign appropriate and unaltered “informed refusal” forms, preferably the AAP’s Refusal to Vaccinate form, each time vaccination is refused, said Dr. Scibilia, who is not an attorney but serves on the AAP Committee on Medical Liability and Risk Management.

©dina2001/thinkstockphotos.com

“If patients bring their own form, make sure you read it properly. I received one that had an AAP logo and looked like our form but had a different set of information,” he said.

Physicians may be at legal risk if parents claim in the wake of a bad outcome that they weren’t informed of the risk of nonvaccination; courts have favored the plaintiffs in at least a couple of reported cases thus far, he explained.

Documentation of repeated vaccine discussions – with chart notes indicating that “you’ve reemphasized the risks of not getting a vaccine,” for instance – is important. “Have some little phrase to integrate into your records so you can show that each time the patient came in, you readdressed the issue with them,” said Dr. Scibilia, of Heritage Valley Health System, Beaver, Pa.

“Then make sure you tell your parents that their [unvaccinated] child may require more aggressive evaluation when ill,” he said. “And make sure you have some kind of triage in your phone protocol system.”

Not properly triaging or caring for an unimmunized or underimmunized child may be legally risky, he explained. “If you have a 10-month-old child who hasn’t had their pneumococcal vaccine and develops a 104° fever, you’re going to treat that child differently than one who had the vaccine,” he said. “You need to have some way to identify kids who aren’t immunized and triage them properly.”

Less clear is a situation in which a child infected with a vaccine-preventable illness is seen in the office and infects another child while there. “There is no case law in the U.S. on this. It may happen at some point, but there is nothing right now that suggests you’re at special legal risk [in such a case],” said Dr. Scibilia.

Just as vaccine refusal has been a growing problem, so have requests for altered vaccine schedules. In a recent survey of pediatricians and family physicians, 93% of physicians reported that some parents had requested altered vaccine schedules within the prior month. A significant number of physicians agreed to spread out vaccines, either always or often (37%) or sometimes (37%).

In a minority of cases, physicians decided to dismiss families from their practice: 2% said they “always or often” dismissed patients, and 4% said they “sometimes” did (Pediatrics. 2015 Apr;135:666-77).

“As a group, it seems like pediatricians are following the AAP’s guidance in that we’re trying to convince parents [that vaccination is in their child’s best interest], but it seems that we’re willing to alter schedules in order to get kids vaccinated,” he said.

Whether to agree to alternative scheduling requests is a “philosophical question” for the individual physician to answer, with the understanding that “when you alter the established vaccine schedule, you’re putting yourself at some risk if a patient develops a vaccine-preventable illness during the time frame when you’ve altered the schedule,” he said.

If a physician-patient relationship must be severed, the termination should be done properly and formally in order to avoid possible claims of abandonment. This means providing written notification and documenting that the patient received the notification in a timely fashion, usually with a return receipt. The notification must include an offer to provide emergency care for a specified period of time, Dr. Scibilia said.

The Fairfax Family Practice Comprehensive Concussion Center is an example of what dedicated physicians can accomplish when they undertake to improve upon an accepted medical approach to a health problem because it falls far short of effective. The concussion center’s hall wall is adorned with a broad and colorful sign autographed by scores of patients – many of them student-athletes – who have been cleared to return to their sports and activities and to lives free of restrictions and struggle following concussion.

Dr. Garry W.K. Ho, the double-credentialed family practice and sports medicine physician who directs the 2-year-old concussion center in Fairfax, Va., takes pride in the skills his team has acquired to facilitate these recoveries.

He and his colleagues within the practice’s sports medicine division established the center, teaming up with several certified athletic trainers, to meet what they saw as a growing, urgent need: to help concussed patients who were taking longer than the oft-mentioned 7-10 days or 2 weeks to heal.

Christine Kilgore/Frontline Medical Media

“While many of the people we’d been treating in the clinic with typical 15- to 30-minute appointments and relatively simple follow-up were able to get better, there was clearly a subset of the population that was more complicated and needed a more dedicated, multidimensional approach,” Dr. Ho said.

Findings from a growing number of studies have shown that concussions can involve a vast array of deficits – problems with the vestibular and vision systems, for example – and that a more comprehensive initial evaluation and a multipronged approach to management could shorten recovery time for any individual with the brain injury, he said.

“We’d started to realize how much patients can benefit from new and creative approaches,” said Dr. Ho. “We were also appreciating that no one person can own this disorder. You can’t say that only the neurologist can treat a concussion, or only the family physician or sports medicine physician.

‘Silent epidemic’

A small but growing number of concussion-care programs and clinics are being established across the country. Most often, the programs are incorporated into hospitals and sports medicine clinics. But some, like the program Dr. Ho leads, are embedded within larger primary care practices with a sports medicine component.

And, in other traditional family practices, some physicians are deepening their knowledge of concussions and building the networks necessary for managing prolonged impairment.

“If we have a good understanding of brain injury, we can often facilitate recovery and help [our patients] get back on track seamlessly,” said Dr. Rebecca Jaffe, a family physician in Wilmington, Del. “And when recovery is protracted, when issues don’t resolve in 2-3 weeks, there’s often more to the situation than is initially apparent, and it’s often better that we have a team of individuals who can help us.”

According to the Institute of Medicine (IOM), there are not enough data for an accurate estimate of the incidence of sports-related concussions in youth (Institute of Medicine and National Research Council. 2014. Sports-related concussions in youth: Improving the science, changing the culture. Washington, D.C.: The National Academies Press.)

But among high school athletes, an increase in concussions has been documented in several emergency department studies and other longitudinal studies published over the past 7-8 years. Most recently, the first national study to look at trends among high school athletes showed the numbers of concussions reported by certified athletic trainers increasing from 0.23/1,000 athlete-exposures in the 2005-2006 academic year to 0.51/1,000 in the 2011-2012 academic year (Am. J. Sports Med. 2014;42:1710-5).

Experts attribute such increases largely to improved awareness and new state laws. The Centers for Disease Control and Prevention’s launched its “Heads Up” educational program in 2004, for instance. And as of last year, every state and the District of Columbia had enacted at least one law to protect young athletes with concussions.

State concussion laws vary, but most require that parents, athletes, and coaches be educated about concussions, and that athletes with suspected concussions be evaluated and cleared by a health care professional with knowledge in concussions before returning to play.

It is likely, some experts say, that the upward curve is leveling off with improved awareness and diagnosis. But with such improvements there lurks a void of data on concussions in youth outside the realm of high school sports. And, according to the 2014 IOM report, the acute and long-term health threat from concussions is “not fully appreciated or acted upon” in many settings. “Kids are getting removed from play more frequently, but then it’s not really clear what anyone should do after that,” said Dr. Shireen Atabaki, an emergency medicine specialist at Children’s National Medical Center in Washington, who is leading several national initiatives to improve concussion care.

Too often, concussed children and teens receive little besides unnecessary CT scans in emergency departments and concussions go undiagnosed. And when concussions are diagnosed, discharge instructions are poor and “kids are sent out into a no-man’s land” where recovery is often poorly managed, she said.

When Dr. Ho and his colleagues opened their concussion center in March 2013, they began seeing patients who remained symptomatic after concussions that had occurred 6-12 months ago, and longer. “It was almost like a silent epidemic,” he said. “We had one young woman who’d been injured in her senior year of high school and was still symptomatic after 2 years.”

To build the program at Fairfax Family Practice, Dr. Ho and his colleagues, Dr. Thomas Howard and Dr. Marc Childress (who, like Dr. Ho, are board certified in sports medicine as well as family medicine), capitalized on what they saw as a valuable synergy with high school athletic trainers.

Dr. Ho had worked closely with athletic trainers as a volunteer medical adviser to the Fairfax County Public School System’s athletic training program, which provides care to student-athletes in 25 high schools. He drew on his relationships to recruit three athletic trainers who were at transition points in their careers and who had both experience and “passion” in the treatment of concussions.

One of them, Jon Almquist, VATL, ATC, had led the development of return-to-learn protocols and other management practices for the high schools. He had also partnered with investigators at MedStar Health Research Institute in Baltimore on research that documented a 4.2-fold increase in concussions among the school system’s high school athletes between 1997 and 2008 (Am. J. Sports Med. 2011;39:958-63).

More surprising than this increase, however, were some data collected after the study period ended. When Mr. Almquist looked at recovery times for the concussions reported between 2011 and 2013, he found that about 25% of concussions took 30 days or longer to recover – a portion greater than he’d seen anywhere in the literature.

According to the 2014 IOM report, youth athletes typically recover from a concussion within 2 weeks of the injury, but in 10-20% of cases the symptoms persist for a number of weeks, months, or even years.

“Families would come to us for advice,” Mr. Almquist recalled. Other than referring them to the University of Pittsburgh Medical Center’s (UPMC) Sports Medicine Concussion Program, there were few local providers whom they believed offered comprehensive care and had experience with prolonged impairment.

Mr. Almquist and his fellow athletic trainers, and Dr. Ho and his physician colleagues, all had been following developments at UPMC’s Sports Medicine Concussion Program since it was established in 2000. The program had evolved to assess and manage diverse facets of concussions, including vision, vestibular, exertion, and medication components—not all of which are fully addressed in clinical practice guidelines and position statements. By 2010, the program was drawing 10,000 patients a year.

Care at UPMC is guided by a clinical neuropsychologist who assesses head injuries and then refers patients on as needed to other members of the team – like a neurovestibular expert for vestibular assessment and therapy, a neuro-optometrist for vision therapy, a physical therapist for exertion training, or a sports medicine physician for medication.

In planning their own concussion center, Dr. Ho and his team visited various programs in the country but homed in on UPMC. They decided to mimic several aspects of UPMC’s approach by providing comprehensive and individualized care, and by having the certified athletic trainers serve as the “quarterbacks.”

“The athletic trainer in our center does all the symptom inventories and history taking, a concussion-focused physical exam, vestibular-ocular-motor screening, and neurocognitive tests if appropriate,” said Dr. Ho.

Dr. Ho or one of his sports medicine physician colleagues then discusses results with the athletic trainer and completes the patient visit – with the trainer – by asking any necessary follow-up questions, probing further with additional evaluation, and writing medication prescriptions when appropriate.

Throughout the course of care – visits occur weekly to monthly and often last 30-90 minutes – the athletic trainer and physician work together on clinical issues such as sleep and mental health and on subtyping headaches (cognitive fatigue, cervicogenic, or migrainelike) and “determining where the headaches lie relative to other areas of dysfunction,” said Dr. Ho.

Much of the individualized counseling, monitoring, and coordination that’s required to address sleep hygiene, rest, nutrition, and graded return to physical and cognitive activity can be led by the athletic trainer, he said.

For the first year or so, patients were referred out for such special services as vision or vestibular therapy. But there were problems with this approach: One frequent issue was poor insurance coverage for these therapies. Another was the stress involved in getting to additional appointments on Fairfax’s congested roads. “Traffic and busy environments aren’t always tolerable for a concussed patient,” Dr. Ho said.

Dr. Ho searched the Internet, worked the phone, read the neuro-optometry and vestibular therapy literature, and attended conferences to learn what kinds of therapeutic exercises they could integrate into office visits and take-home care plans. Dr. Ho said he was “surprised at how willing some of [their] colleagues were to give us some basic skills” to help patients who “don’t all need the Cadillac version” of therapy.

About the same time they integrated basic vision and vestibular therapy, they also revamped their billing strategy, moving away from the use of prolonged service billing codes, which Dr. Ho said were frequently denied on the first submission, to using separate codes for the encounter, therapeutic exercise (which encompasses vision therapy and vestibular therapy), and various physical tests.

Concussion care networks

Fairfax Family Practice is not the only practice to center its concussion program on physician-athletic trainer partnerships. Carolina Family Practice and Sports Medicine, a 12-provider practice with three offices in and around Raleigh, N.C., took a similar approach when it established its concussion clinic in 2008.

“Concussion is the ultimate example of an injury that benefits from a team approach,” said Dr. Josh Bloom, medical director of the Carolina Sports Concussion Clinic that is embedded into the practice. “And it’s the one injury – the only injury in sports medicine – where the standard of care calls for the injury to be 100% resolved prior to being cleared to return to play.”

Dr. Jaffe, the family physician in Delaware, said she is fortunate to have a neuro-optometrist practicing in the medical building where her three-physician family practice resides, and a concussion care team in the nearby Nemours/Alfred I. Dupont Hospital for Children, also in Wilmington.

Someday, she and others hope, physicians who see patients soon after injury will have tools to better predict clinical trajectories and identify who could benefit from earlier referral to a “more sophisticated team.”

For now, Dr. Jaffe said, she seeks assistance when headache and initial symptoms persist after 2-3 weeks or when their symptoms “seem out of proportion to the incident.”

Dr. Scott Ross of Novant Health Bull Run Family Medicine based in Manassas, Va., said that family physicians are well suited to guide management and should learn to evaluate each patient’s concussion-related impairments as thoroughly as possible.

About 3 years ago, he and a partner established an official “Sports Medicine and Concussion Management” service line in their practice. “We don’t have a concussion center all under one roof, but we have the knowledge, skills, and resources that we need,” he said.

This article was updated April 13, 2015.

The Fairfax Family Practice Comprehensive Concussion Center is an example of what dedicated physicians can accomplish when they undertake to improve upon an accepted medical approach to a health problem because it falls far short of effective. The concussion center’s hall wall is adorned with a broad and colorful sign autographed by scores of patients – many of them student-athletes – who have been cleared to return to their sports and activities and to lives free of restrictions and struggle following concussion.

Dr. Garry W.K. Ho, the double-credentialed family practice and sports medicine physician who directs the 2-year-old concussion center in Fairfax, Va., takes pride in the skills his team has acquired to facilitate these recoveries.

He and his colleagues within the practice’s sports medicine division established the center, teaming up with several certified athletic trainers, to meet what they saw as a growing, urgent need: to help concussed patients who were taking longer than the oft-mentioned 7-10 days or 2 weeks to heal.

Christine Kilgore/Frontline Medical Media

“While many of the people we’d been treating in the clinic with typical 15- to 30-minute appointments and relatively simple follow-up were able to get better, there was clearly a subset of the population that was more complicated and needed a more dedicated, multidimensional approach,” Dr. Ho said.

Findings from a growing number of studies have shown that concussions can involve a vast array of deficits – problems with the vestibular and vision systems, for example – and that a more comprehensive initial evaluation and a multipronged approach to management could shorten recovery time for any individual with the brain injury, he said.

“We’d started to realize how much patients can benefit from new and creative approaches,” said Dr. Ho. “We were also appreciating that no one person can own this disorder. You can’t say that only the neurologist can treat a concussion, or only the family physician or sports medicine physician.

‘Silent epidemic’

A small but growing number of concussion-care programs and clinics are being established across the country. Most often, the programs are incorporated into hospitals and sports medicine clinics. But some, like the program Dr. Ho leads, are embedded within larger primary care practices with a sports medicine component.

And, in other traditional family practices, some physicians are deepening their knowledge of concussions and building the networks necessary for managing prolonged impairment.

“If we have a good understanding of brain injury, we can often facilitate recovery and help [our patients] get back on track seamlessly,” said Dr. Rebecca Jaffe, a family physician in Wilmington, Del. “And when recovery is protracted, when issues don’t resolve in 2-3 weeks, there’s often more to the situation than is initially apparent, and it’s often better that we have a team of individuals who can help us.”

According to the Institute of Medicine (IOM), there are not enough data for an accurate estimate of the incidence of sports-related concussions in youth (Institute of Medicine and National Research Council. 2014. Sports-related concussions in youth: Improving the science, changing the culture. Washington, D.C.: The National Academies Press.)

But among high school athletes, an increase in concussions has been documented in several emergency department studies and other longitudinal studies published over the past 7-8 years. Most recently, the first national study to look at trends among high school athletes showed the numbers of concussions reported by certified athletic trainers increasing from 0.23/1,000 athlete-exposures in the 2005-2006 academic year to 0.51/1,000 in the 2011-2012 academic year (Am. J. Sports Med. 2014;42:1710-5).

Experts attribute such increases largely to improved awareness and new state laws. The Centers for Disease Control and Prevention’s launched its “Heads Up” educational program in 2004, for instance. And as of last year, every state and the District of Columbia had enacted at least one law to protect young athletes with concussions.

State concussion laws vary, but most require that parents, athletes, and coaches be educated about concussions, and that athletes with suspected concussions be evaluated and cleared by a health care professional with knowledge in concussions before returning to play.

It is likely, some experts say, that the upward curve is leveling off with improved awareness and diagnosis. But with such improvements there lurks a void of data on concussions in youth outside the realm of high school sports. And, according to the 2014 IOM report, the acute and long-term health threat from concussions is “not fully appreciated or acted upon” in many settings. “Kids are getting removed from play more frequently, but then it’s not really clear what anyone should do after that,” said Dr. Shireen Atabaki, an emergency medicine specialist at Children’s National Medical Center in Washington, who is leading several national initiatives to improve concussion care.

Too often, concussed children and teens receive little besides unnecessary CT scans in emergency departments and concussions go undiagnosed. And when concussions are diagnosed, discharge instructions are poor and “kids are sent out into a no-man’s land” where recovery is often poorly managed, she said.

When Dr. Ho and his colleagues opened their concussion center in March 2013, they began seeing patients who remained symptomatic after concussions that had occurred 6-12 months ago, and longer. “It was almost like a silent epidemic,” he said. “We had one young woman who’d been injured in her senior year of high school and was still symptomatic after 2 years.”

To build the program at Fairfax Family Practice, Dr. Ho and his colleagues, Dr. Thomas Howard and Dr. Marc Childress (who, like Dr. Ho, are board certified in sports medicine as well as family medicine), capitalized on what they saw as a valuable synergy with high school athletic trainers.

Dr. Ho had worked closely with athletic trainers as a volunteer medical adviser to the Fairfax County Public School System’s athletic training program, which provides care to student-athletes in 25 high schools. He drew on his relationships to recruit three athletic trainers who were at transition points in their careers and who had both experience and “passion” in the treatment of concussions.

One of them, Jon Almquist, VATL, ATC, had led the development of return-to-learn protocols and other management practices for the high schools. He had also partnered with investigators at MedStar Health Research Institute in Baltimore on research that documented a 4.2-fold increase in concussions among the school system’s high school athletes between 1997 and 2008 (Am. J. Sports Med. 2011;39:958-63).

More surprising than this increase, however, were some data collected after the study period ended. When Mr. Almquist looked at recovery times for the concussions reported between 2011 and 2013, he found that about 25% of concussions took 30 days or longer to recover – a portion greater than he’d seen anywhere in the literature.

According to the 2014 IOM report, youth athletes typically recover from a concussion within 2 weeks of the injury, but in 10-20% of cases the symptoms persist for a number of weeks, months, or even years.

“Families would come to us for advice,” Mr. Almquist recalled. Other than referring them to the University of Pittsburgh Medical Center’s (UPMC) Sports Medicine Concussion Program, there were few local providers whom they believed offered comprehensive care and had experience with prolonged impairment.

Mr. Almquist and his fellow athletic trainers, and Dr. Ho and his physician colleagues, all had been following developments at UPMC’s Sports Medicine Concussion Program since it was established in 2000. The program had evolved to assess and manage diverse facets of concussions, including vision, vestibular, exertion, and medication components—not all of which are fully addressed in clinical practice guidelines and position statements. By 2010, the program was drawing 10,000 patients a year.

Care at UPMC is guided by a clinical neuropsychologist who assesses head injuries and then refers patients on as needed to other members of the team – like a neurovestibular expert for vestibular assessment and therapy, a neuro-optometrist for vision therapy, a physical therapist for exertion training, or a sports medicine physician for medication.

In planning their own concussion center, Dr. Ho and his team visited various programs in the country but homed in on UPMC. They decided to mimic several aspects of UPMC’s approach by providing comprehensive and individualized care, and by having the certified athletic trainers serve as the “quarterbacks.”

“The athletic trainer in our center does all the symptom inventories and history taking, a concussion-focused physical exam, vestibular-ocular-motor screening, and neurocognitive tests if appropriate,” said Dr. Ho.

Dr. Ho or one of his sports medicine physician colleagues then discusses results with the athletic trainer and completes the patient visit – with the trainer – by asking any necessary follow-up questions, probing further with additional evaluation, and writing medication prescriptions when appropriate.

Throughout the course of care – visits occur weekly to monthly and often last 30-90 minutes – the athletic trainer and physician work together on clinical issues such as sleep and mental health and on subtyping headaches (cognitive fatigue, cervicogenic, or migrainelike) and “determining where the headaches lie relative to other areas of dysfunction,” said Dr. Ho.

Much of the individualized counseling, monitoring, and coordination that’s required to address sleep hygiene, rest, nutrition, and graded return to physical and cognitive activity can be led by the athletic trainer, he said.

For the first year or so, patients were referred out for such special services as vision or vestibular therapy. But there were problems with this approach: One frequent issue was poor insurance coverage for these therapies. Another was the stress involved in getting to additional appointments on Fairfax’s congested roads. “Traffic and busy environments aren’t always tolerable for a concussed patient,” Dr. Ho said.

Dr. Ho searched the Internet, worked the phone, read the neuro-optometry and vestibular therapy literature, and attended conferences to learn what kinds of therapeutic exercises they could integrate into office visits and take-home care plans. Dr. Ho said he was “surprised at how willing some of [their] colleagues were to give us some basic skills” to help patients who “don’t all need the Cadillac version” of therapy.

About the same time they integrated basic vision and vestibular therapy, they also revamped their billing strategy, moving away from the use of prolonged service billing codes, which Dr. Ho said were frequently denied on the first submission, to using separate codes for the encounter, therapeutic exercise (which encompasses vision therapy and vestibular therapy), and various physical tests.

Concussion care networks

Fairfax Family Practice is not the only practice to center its concussion program on physician-athletic trainer partnerships. Carolina Family Practice and Sports Medicine, a 12-provider practice with three offices in and around Raleigh, N.C., took a similar approach when it established its concussion clinic in 2008.

“Concussion is the ultimate example of an injury that benefits from a team approach,” said Dr. Josh Bloom, medical director of the Carolina Sports Concussion Clinic that is embedded into the practice. “And it’s the one injury – the only injury in sports medicine – where the standard of care calls for the injury to be 100% resolved prior to being cleared to return to play.”

Dr. Jaffe, the family physician in Delaware, said she is fortunate to have a neuro-optometrist practicing in the medical building where her three-physician family practice resides, and a concussion care team in the nearby Nemours/Alfred I. Dupont Hospital for Children, also in Wilmington.

Someday, she and others hope, physicians who see patients soon after injury will have tools to better predict clinical trajectories and identify who could benefit from earlier referral to a “more sophisticated team.”

For now, Dr. Jaffe said, she seeks assistance when headache and initial symptoms persist after 2-3 weeks or when their symptoms “seem out of proportion to the incident.”

Dr. Scott Ross of Novant Health Bull Run Family Medicine based in Manassas, Va., said that family physicians are well suited to guide management and should learn to evaluate each patient’s concussion-related impairments as thoroughly as possible.

About 3 years ago, he and a partner established an official “Sports Medicine and Concussion Management” service line in their practice. “We don’t have a concussion center all under one roof, but we have the knowledge, skills, and resources that we need,” he said.

This article was updated April 13, 2015.

The Fairfax Family Practice Comprehensive Concussion Center is an example of what dedicated physicians can accomplish when they undertake to improve upon an accepted medical approach to a health problem because it falls far short of effective. The concussion center’s hall wall is adorned with a broad and colorful sign autographed by scores of patients – many of them student-athletes – who have been cleared to return to their sports and activities and to lives free of restrictions and struggle following concussion.

Dr. Garry W.K. Ho, the double-credentialed family practice and sports medicine physician who directs the 2-year-old concussion center in Fairfax, Va., takes pride in the skills his team has acquired to facilitate these recoveries.

He and his colleagues within the practice’s sports medicine division established the center, teaming up with several certified athletic trainers, to meet what they saw as a growing, urgent need: to help concussed patients who were taking longer than the oft-mentioned 7-10 days or 2 weeks to heal.

Christine Kilgore/Frontline Medical Media

“While many of the people we’d been treating in the clinic with typical 15- to 30-minute appointments and relatively simple follow-up were able to get better, there was clearly a subset of the population that was more complicated and needed a more dedicated, multidimensional approach,” Dr. Ho said.

Findings from a growing number of studies have shown that concussions can involve a vast array of deficits – problems with the vestibular and vision systems, for example – and that a more comprehensive initial evaluation and a multipronged approach to management could shorten recovery time for any individual with the brain injury, he said.

“We’d started to realize how much patients can benefit from new and creative approaches,” said Dr. Ho. “We were also appreciating that no one person can own this disorder. You can’t say that only the neurologist can treat a concussion, or only the family physician or sports medicine physician.

‘Silent epidemic’

A small but growing number of concussion-care programs and clinics are being established across the country. Most often, the programs are incorporated into hospitals and sports medicine clinics. But some, like the program Dr. Ho leads, are embedded within larger primary care practices with a sports medicine component.

And, in other traditional family practices, some physicians are deepening their knowledge of concussions and building the networks necessary for managing prolonged impairment.

“If we have a good understanding of brain injury, we can often facilitate recovery and help [our patients] get back on track seamlessly,” said Dr. Rebecca Jaffe, a family physician in Wilmington, Del. “And when recovery is protracted, when issues don’t resolve in 2-3 weeks, there’s often more to the situation than is initially apparent, and it’s often better that we have a team of individuals who can help us.”

According to the Institute of Medicine (IOM), there are not enough data for an accurate estimate of the incidence of sports-related concussions in youth (Institute of Medicine and National Research Council. 2014. Sports-related concussions in youth: Improving the science, changing the culture. Washington, D.C.: The National Academies Press.)

But among high school athletes, an increase in concussions has been documented in several emergency department studies and other longitudinal studies published over the past 7-8 years. Most recently, the first national study to look at trends among high school athletes showed the numbers of concussions reported by certified athletic trainers increasing from 0.23/1,000 athlete-exposures in the 2005-2006 academic year to 0.51/1,000 in the 2011-2012 academic year (Am. J. Sports Med. 2014;42:1710-5).

Experts attribute such increases largely to improved awareness and new state laws. The Centers for Disease Control and Prevention’s launched its “Heads Up” educational program in 2004, for instance. And as of last year, every state and the District of Columbia had enacted at least one law to protect young athletes with concussions.

State concussion laws vary, but most require that parents, athletes, and coaches be educated about concussions, and that athletes with suspected concussions be evaluated and cleared by a health care professional with knowledge in concussions before returning to play.

It is likely, some experts say, that the upward curve is leveling off with improved awareness and diagnosis. But with such improvements there lurks a void of data on concussions in youth outside the realm of high school sports. And, according to the 2014 IOM report, the acute and long-term health threat from concussions is “not fully appreciated or acted upon” in many settings. “Kids are getting removed from play more frequently, but then it’s not really clear what anyone should do after that,” said Dr. Shireen Atabaki, an emergency medicine specialist at Children’s National Medical Center in Washington, who is leading several national initiatives to improve concussion care.

Too often, concussed children and teens receive little besides unnecessary CT scans in emergency departments and concussions go undiagnosed. And when concussions are diagnosed, discharge instructions are poor and “kids are sent out into a no-man’s land” where recovery is often poorly managed, she said.

When Dr. Ho and his colleagues opened their concussion center in March 2013, they began seeing patients who remained symptomatic after concussions that had occurred 6-12 months ago, and longer. “It was almost like a silent epidemic,” he said. “We had one young woman who’d been injured in her senior year of high school and was still symptomatic after 2 years.”

To build the program at Fairfax Family Practice, Dr. Ho and his colleagues, Dr. Thomas Howard and Dr. Marc Childress (who, like Dr. Ho, are board certified in sports medicine as well as family medicine), capitalized on what they saw as a valuable synergy with high school athletic trainers.

Dr. Ho had worked closely with athletic trainers as a volunteer medical adviser to the Fairfax County Public School System’s athletic training program, which provides care to student-athletes in 25 high schools. He drew on his relationships to recruit three athletic trainers who were at transition points in their careers and who had both experience and “passion” in the treatment of concussions.

One of them, Jon Almquist, VATL, ATC, had led the development of return-to-learn protocols and other management practices for the high schools. He had also partnered with investigators at MedStar Health Research Institute in Baltimore on research that documented a 4.2-fold increase in concussions among the school system’s high school athletes between 1997 and 2008 (Am. J. Sports Med. 2011;39:958-63).

More surprising than this increase, however, were some data collected after the study period ended. When Mr. Almquist looked at recovery times for the concussions reported between 2011 and 2013, he found that about 25% of concussions took 30 days or longer to recover – a portion greater than he’d seen anywhere in the literature.

According to the 2014 IOM report, youth athletes typically recover from a concussion within 2 weeks of the injury, but in 10-20% of cases the symptoms persist for a number of weeks, months, or even years.

“Families would come to us for advice,” Mr. Almquist recalled. Other than referring them to the University of Pittsburgh Medical Center’s (UPMC) Sports Medicine Concussion Program, there were few local providers whom they believed offered comprehensive care and had experience with prolonged impairment.

Mr. Almquist and his fellow athletic trainers, and Dr. Ho and his physician colleagues, all had been following developments at UPMC’s Sports Medicine Concussion Program since it was established in 2000. The program had evolved to assess and manage diverse facets of concussions, including vision, vestibular, exertion, and medication components—not all of which are fully addressed in clinical practice guidelines and position statements. By 2010, the program was drawing 10,000 patients a year.

Care at UPMC is guided by a clinical neuropsychologist who assesses head injuries and then refers patients on as needed to other members of the team – like a neurovestibular expert for vestibular assessment and therapy, a neuro-optometrist for vision therapy, a physical therapist for exertion training, or a sports medicine physician for medication.

In planning their own concussion center, Dr. Ho and his team visited various programs in the country but homed in on UPMC. They decided to mimic several aspects of UPMC’s approach by providing comprehensive and individualized care, and by having the certified athletic trainers serve as the “quarterbacks.”

“The athletic trainer in our center does all the symptom inventories and history taking, a concussion-focused physical exam, vestibular-ocular-motor screening, and neurocognitive tests if appropriate,” said Dr. Ho.

Dr. Ho or one of his sports medicine physician colleagues then discusses results with the athletic trainer and completes the patient visit – with the trainer – by asking any necessary follow-up questions, probing further with additional evaluation, and writing medication prescriptions when appropriate.

Throughout the course of care – visits occur weekly to monthly and often last 30-90 minutes – the athletic trainer and physician work together on clinical issues such as sleep and mental health and on subtyping headaches (cognitive fatigue, cervicogenic, or migrainelike) and “determining where the headaches lie relative to other areas of dysfunction,” said Dr. Ho.

Much of the individualized counseling, monitoring, and coordination that’s required to address sleep hygiene, rest, nutrition, and graded return to physical and cognitive activity can be led by the athletic trainer, he said.

For the first year or so, patients were referred out for such special services as vision or vestibular therapy. But there were problems with this approach: One frequent issue was poor insurance coverage for these therapies. Another was the stress involved in getting to additional appointments on Fairfax’s congested roads. “Traffic and busy environments aren’t always tolerable for a concussed patient,” Dr. Ho said.

Dr. Ho searched the Internet, worked the phone, read the neuro-optometry and vestibular therapy literature, and attended conferences to learn what kinds of therapeutic exercises they could integrate into office visits and take-home care plans. Dr. Ho said he was “surprised at how willing some of [their] colleagues were to give us some basic skills” to help patients who “don’t all need the Cadillac version” of therapy.

About the same time they integrated basic vision and vestibular therapy, they also revamped their billing strategy, moving away from the use of prolonged service billing codes, which Dr. Ho said were frequently denied on the first submission, to using separate codes for the encounter, therapeutic exercise (which encompasses vision therapy and vestibular therapy), and various physical tests.

Concussion care networks

Fairfax Family Practice is not the only practice to center its concussion program on physician-athletic trainer partnerships. Carolina Family Practice and Sports Medicine, a 12-provider practice with three offices in and around Raleigh, N.C., took a similar approach when it established its concussion clinic in 2008.

“Concussion is the ultimate example of an injury that benefits from a team approach,” said Dr. Josh Bloom, medical director of the Carolina Sports Concussion Clinic that is embedded into the practice. “And it’s the one injury – the only injury in sports medicine – where the standard of care calls for the injury to be 100% resolved prior to being cleared to return to play.”

Dr. Jaffe, the family physician in Delaware, said she is fortunate to have a neuro-optometrist practicing in the medical building where her three-physician family practice resides, and a concussion care team in the nearby Nemours/Alfred I. Dupont Hospital for Children, also in Wilmington.

Someday, she and others hope, physicians who see patients soon after injury will have tools to better predict clinical trajectories and identify who could benefit from earlier referral to a “more sophisticated team.”

For now, Dr. Jaffe said, she seeks assistance when headache and initial symptoms persist after 2-3 weeks or when their symptoms “seem out of proportion to the incident.”

Dr. Scott Ross of Novant Health Bull Run Family Medicine based in Manassas, Va., said that family physicians are well suited to guide management and should learn to evaluate each patient’s concussion-related impairments as thoroughly as possible.

About 3 years ago, he and a partner established an official “Sports Medicine and Concussion Management” service line in their practice. “We don’t have a concussion center all under one roof, but we have the knowledge, skills, and resources that we need,” he said.

This article was updated April 13, 2015.

WASHINGTON – Women are not seeking care for even moderate to severe urinary incontinence because they have a fear of treatment and lack knowledge of the etiology of the condition and available treatment options, according to a qualitative focus group study at Kaiser Permanente Orange County (Calif.).

Embarrassment is another barrier. So are physicians themselves, said Dr. Jennifer K. Lee, a urogynecologist at Kaiser in Anaheim, Calif., who reported the findings at the annual meeting of the American Urogynecologic Society.

"Providers were mentioned (in the focus groups) to be barriers," Dr. Lee said. "Patients were either dismissed, or they were given misinformation."

By 2050, an estimated 50 million Americans will have urinary incontinence. Previous research has shown, however, that less than 50% of women with moderate incontinence seek care.

The focus group study involved 19 women – 11 who had not sought care but were found after recruitment to have moderate to severe incontinence by the Sandvik severity index, and 8 who had previous treatment or had been evaluated for urinary incontinence.

A moderator led discussions among small groups of these women, all of whom were fluent in English and most of whom (90%) had a college education or higher. The participants were of varying ethnicities, including Caucasian, Hispanic, and Asian.

A fear of medical or surgical treatment, including medication side effects and recovery time for surgery, was one of the themes to emerge. Women also said they felt embarrassed and were therefore not likely to raise the issue, particularly with time constraints in their medical visits.

There was a prevailing idea that urinary incontinence is a normal part of aging or childbearing, or that it is hereditary, and that other health issues take priority. Physicians, moreover, did not ask about the issue, and in cases in which it was mentioned, physicians were dismissive or gave misinformation, the study showed.

Dr. Lee said the barriers are significant, and that "there’s a lot of work to be done" to facilitate communication and change practices.

Leaders at Kaiser Permanente Orange County, Anaheim, Calif., plan to give physicians question prompts to incorporate into routine and primary care visits, she noted during a press conference at the meeting. "We also want to work on educational tools for the public," she said.

"There are urinary incontinence questions [for] the Medicare wellness visit, but these are for women over 65," she said. "There certainly are plenty of women under 65 who have incontinence."

Food and Drug Administration warnings about complications associated with transvaginal placement of surgical mesh did not come up in the focus group discussions, but Dr. Lee said that in her practice she has seen this controversy feed patients’ fear of incontinence and its treatment.

Study participants were recruited through e-mail research announcements and flyers, as well as more actively through the offices of urogynecology providers.

Dr. Lee said she had no disclosures to report. Her coauthors and research colleagues at the University of California, Irvine, reported numerous disclosures ranging from speakers’ bureau participation and consulting fees at Hospira and Cadence Pharmaceuticals to consultant positions with Medtronic and Boston Scientific.

WASHINGTON – Women are not seeking care for even moderate to severe urinary incontinence because they have a fear of treatment and lack knowledge of the etiology of the condition and available treatment options, according to a qualitative focus group study at Kaiser Permanente Orange County (Calif.).

Embarrassment is another barrier. So are physicians themselves, said Dr. Jennifer K. Lee, a urogynecologist at Kaiser in Anaheim, Calif., who reported the findings at the annual meeting of the American Urogynecologic Society.

"Providers were mentioned (in the focus groups) to be barriers," Dr. Lee said. "Patients were either dismissed, or they were given misinformation."

By 2050, an estimated 50 million Americans will have urinary incontinence. Previous research has shown, however, that less than 50% of women with moderate incontinence seek care.

The focus group study involved 19 women – 11 who had not sought care but were found after recruitment to have moderate to severe incontinence by the Sandvik severity index, and 8 who had previous treatment or had been evaluated for urinary incontinence.

A moderator led discussions among small groups of these women, all of whom were fluent in English and most of whom (90%) had a college education or higher. The participants were of varying ethnicities, including Caucasian, Hispanic, and Asian.

A fear of medical or surgical treatment, including medication side effects and recovery time for surgery, was one of the themes to emerge. Women also said they felt embarrassed and were therefore not likely to raise the issue, particularly with time constraints in their medical visits.

There was a prevailing idea that urinary incontinence is a normal part of aging or childbearing, or that it is hereditary, and that other health issues take priority. Physicians, moreover, did not ask about the issue, and in cases in which it was mentioned, physicians were dismissive or gave misinformation, the study showed.

Dr. Lee said the barriers are significant, and that "there’s a lot of work to be done" to facilitate communication and change practices.

Leaders at Kaiser Permanente Orange County, Anaheim, Calif., plan to give physicians question prompts to incorporate into routine and primary care visits, she noted during a press conference at the meeting. "We also want to work on educational tools for the public," she said.

"There are urinary incontinence questions [for] the Medicare wellness visit, but these are for women over 65," she said. "There certainly are plenty of women under 65 who have incontinence."

Food and Drug Administration warnings about complications associated with transvaginal placement of surgical mesh did not come up in the focus group discussions, but Dr. Lee said that in her practice she has seen this controversy feed patients’ fear of incontinence and its treatment.

Study participants were recruited through e-mail research announcements and flyers, as well as more actively through the offices of urogynecology providers.

Dr. Lee said she had no disclosures to report. Her coauthors and research colleagues at the University of California, Irvine, reported numerous disclosures ranging from speakers’ bureau participation and consulting fees at Hospira and Cadence Pharmaceuticals to consultant positions with Medtronic and Boston Scientific.

WASHINGTON – Women are not seeking care for even moderate to severe urinary incontinence because they have a fear of treatment and lack knowledge of the etiology of the condition and available treatment options, according to a qualitative focus group study at Kaiser Permanente Orange County (Calif.).

Embarrassment is another barrier. So are physicians themselves, said Dr. Jennifer K. Lee, a urogynecologist at Kaiser in Anaheim, Calif., who reported the findings at the annual meeting of the American Urogynecologic Society.

"Providers were mentioned (in the focus groups) to be barriers," Dr. Lee said. "Patients were either dismissed, or they were given misinformation."

By 2050, an estimated 50 million Americans will have urinary incontinence. Previous research has shown, however, that less than 50% of women with moderate incontinence seek care.

The focus group study involved 19 women – 11 who had not sought care but were found after recruitment to have moderate to severe incontinence by the Sandvik severity index, and 8 who had previous treatment or had been evaluated for urinary incontinence.

A moderator led discussions among small groups of these women, all of whom were fluent in English and most of whom (90%) had a college education or higher. The participants were of varying ethnicities, including Caucasian, Hispanic, and Asian.

A fear of medical or surgical treatment, including medication side effects and recovery time for surgery, was one of the themes to emerge. Women also said they felt embarrassed and were therefore not likely to raise the issue, particularly with time constraints in their medical visits.

There was a prevailing idea that urinary incontinence is a normal part of aging or childbearing, or that it is hereditary, and that other health issues take priority. Physicians, moreover, did not ask about the issue, and in cases in which it was mentioned, physicians were dismissive or gave misinformation, the study showed.

Dr. Lee said the barriers are significant, and that "there’s a lot of work to be done" to facilitate communication and change practices.

Leaders at Kaiser Permanente Orange County, Anaheim, Calif., plan to give physicians question prompts to incorporate into routine and primary care visits, she noted during a press conference at the meeting. "We also want to work on educational tools for the public," she said.

"There are urinary incontinence questions [for] the Medicare wellness visit, but these are for women over 65," she said. "There certainly are plenty of women under 65 who have incontinence."

Food and Drug Administration warnings about complications associated with transvaginal placement of surgical mesh did not come up in the focus group discussions, but Dr. Lee said that in her practice she has seen this controversy feed patients’ fear of incontinence and its treatment.

Study participants were recruited through e-mail research announcements and flyers, as well as more actively through the offices of urogynecology providers.

Dr. Lee said she had no disclosures to report. Her coauthors and research colleagues at the University of California, Irvine, reported numerous disclosures ranging from speakers’ bureau participation and consulting fees at Hospira and Cadence Pharmaceuticals to consultant positions with Medtronic and Boston Scientific.

WASHINGTON – The use of mediolateral episiotomy in women undergoing operative vaginal delivery – a common practice in the Netherlands – was associated with a large reduction in the risk of obstetrical anal sphincter injuries, according to an analysis of 10 years of data from the Netherlands Perinatal Registry.

For physicians and other obstetrical providers in the small European country, the findings reinforce current practice of favoring mediolateral episiotomies in operative vaginal deliveries as protection against obstetrical anal sphincter injuries (OASIS) – a risk factor for fecal incontinence, the investigators said.

"In the Netherlands, a mediolateral episiotomy is common practice. ... Our opinion is that the mediolateral episiotomies are causing less morbidity than an anal sphincter rupture would cause," Dr. Jeroen van Bavel reported during a press conference at the scientific meetings of the American Urogynecologic Society (AUGS) and the International Urogynecological Association.

But for physicians here in the United States, the risks are weighed differently. "It’s not that we don’t know that a mediolateral episiotomy decreases the risk of sphincter injury," Dr. Haywood Brown, professor and chair of obstetrics and gynecology at Duke University, Durham, N.C., said in a telephone interview after the conference.

"The problem is, mediolateral incisions are so uncomfortable," said Dr. Brown, who also is chair of the American College of Obstetricians and Gynecologists, District IV.

"They heal poorly, they heal with defects, ... and as a result the patient has more pain related to the mediolateral [episiotomy] than they would have with a third- or fourth-degree tear," he said. "Doing the mediolateral is really not the answer."

The Netherlands Perinatal Registry contains information on 96% of the 1.5 million deliveries that occurred during 2000-2009. Dr. van Bavel, of Amphia Hospital in Breda, the Netherlands, and his coinvestigators focused their analysis on the 170,974 women who had operative vaginal deliveries, comparing the rates of OASIS in women who had mediolateral episiotomies with those who did not.

Among primiparous women who had vacuum deliveries, OASIS occurred in 2.5% of those who had mediolateral episiotomies, compared with 14% who did not. Among multiparous women who had vacuum deliveries, OASIS rates were 2.1% with mediolateral episiotomy versus 7.5% without.

The differences were more striking with forceps deliveries. Anal sphincter injuries occurred in 3.4% versus 26.7% in primiparous women with and without mediolateral episiotomies, respectively. Among multiparous women, the risk of OASIS was 2.6% versus 14.2%.

For primiparous women, the number of mediolateral episiotomies needed to prevent one OASIS was 8 for vacuum delivery and 4 for forceps delivery, according to the analysis. For multiparous women, 18 mediolateral episiotomies were needed to prevent one OASIS for vacuum delivery, and 8 for forceps delivery.

ACOG’s Practice Bulletin No. 71 on episiotomy, which was written in 2006 (Obstet. Gynecol. 2006;107:957-62) and reaffirmed in 2013, states that median episiotomy is associated with higher rates of injury to the anal sphincter and rectum than mediolateral episiotomy (level A evidence), and that mediolateral episiotomy may be preferable in selected cases (level B evidence).

Overall, "restricted use of episiotomy is preferable to routine use of episiotomy," the guidelines say (level A evidence). Postpartum recovery, the guidelines note, is an area of obstetrics that lacks systematic study and analysis.

Dr. Brown said he stands firmly with his belief that mediolateral episiotomy as a routine prophylactic procedure in operative vaginal deliveries cannot be justified. "Having lived through an era of mediolaterals and seeing how long they take to heal, and the discomfort that patients have, I can’t justify it," he said.

"We’ve moved away from episiotomies [in the United States], period," he said. "We’ve moved away from them primarily because of the data showing that midline episiotomies increase the risk of sphincter injury. And the mediolateral episiotomies are just too painful."

The risk of OASIS can be minimized through good delivery technique, he noted.

"The trend here is toward more vacuum deliveries, which have [been shown to be less risky] than forceps deliveries, although its depends on the type of forceps used and the skill of the [obstetrician]," Dr. Brown said. "The challenge we face is that we don’t have enough forceps and vacuum deliveries to easily keep skill levels up."

Dr. Charles W. Nager, president of AUGS and director the urogynecological and reconstructive pelvic surgery division at the University of California, San Diego, said that rates of both episiotomy and operative vaginal delivery have been declining in the United States, and that simultaneously, "there’s been a parallel drop in OASIS."

There also is more training ongoing in U.S. hospitals on repairing third- and fourth-degree obstetric lacerations, he said in an interview at the meeting.

The Netherlands analysis excluded women with preterm delivery, stillbirth, multiple gestation, transverse position, and breech delivery, as well as women whose deliveries involved both forceps and vacuum and women who had a midline episiotomy.

Factors controlled for in the study included parity, fetal position, birth weight, augmentation with oxytocin, and duration of the second stage of labor.

Dr. van Bavel and all but one of his coinvestigators reported no disclosures.

WASHINGTON – The use of mediolateral episiotomy in women undergoing operative vaginal delivery – a common practice in the Netherlands – was associated with a large reduction in the risk of obstetrical anal sphincter injuries, according to an analysis of 10 years of data from the Netherlands Perinatal Registry.

For physicians and other obstetrical providers in the small European country, the findings reinforce current practice of favoring mediolateral episiotomies in operative vaginal deliveries as protection against obstetrical anal sphincter injuries (OASIS) – a risk factor for fecal incontinence, the investigators said.

"In the Netherlands, a mediolateral episiotomy is common practice. ... Our opinion is that the mediolateral episiotomies are causing less morbidity than an anal sphincter rupture would cause," Dr. Jeroen van Bavel reported during a press conference at the scientific meetings of the American Urogynecologic Society (AUGS) and the International Urogynecological Association.

But for physicians here in the United States, the risks are weighed differently. "It’s not that we don’t know that a mediolateral episiotomy decreases the risk of sphincter injury," Dr. Haywood Brown, professor and chair of obstetrics and gynecology at Duke University, Durham, N.C., said in a telephone interview after the conference.

"The problem is, mediolateral incisions are so uncomfortable," said Dr. Brown, who also is chair of the American College of Obstetricians and Gynecologists, District IV.

"They heal poorly, they heal with defects, ... and as a result the patient has more pain related to the mediolateral [episiotomy] than they would have with a third- or fourth-degree tear," he said. "Doing the mediolateral is really not the answer."

The Netherlands Perinatal Registry contains information on 96% of the 1.5 million deliveries that occurred during 2000-2009. Dr. van Bavel, of Amphia Hospital in Breda, the Netherlands, and his coinvestigators focused their analysis on the 170,974 women who had operative vaginal deliveries, comparing the rates of OASIS in women who had mediolateral episiotomies with those who did not.

Among primiparous women who had vacuum deliveries, OASIS occurred in 2.5% of those who had mediolateral episiotomies, compared with 14% who did not. Among multiparous women who had vacuum deliveries, OASIS rates were 2.1% with mediolateral episiotomy versus 7.5% without.

The differences were more striking with forceps deliveries. Anal sphincter injuries occurred in 3.4% versus 26.7% in primiparous women with and without mediolateral episiotomies, respectively. Among multiparous women, the risk of OASIS was 2.6% versus 14.2%.

For primiparous women, the number of mediolateral episiotomies needed to prevent one OASIS was 8 for vacuum delivery and 4 for forceps delivery, according to the analysis. For multiparous women, 18 mediolateral episiotomies were needed to prevent one OASIS for vacuum delivery, and 8 for forceps delivery.

ACOG’s Practice Bulletin No. 71 on episiotomy, which was written in 2006 (Obstet. Gynecol. 2006;107:957-62) and reaffirmed in 2013, states that median episiotomy is associated with higher rates of injury to the anal sphincter and rectum than mediolateral episiotomy (level A evidence), and that mediolateral episiotomy may be preferable in selected cases (level B evidence).

Overall, "restricted use of episiotomy is preferable to routine use of episiotomy," the guidelines say (level A evidence). Postpartum recovery, the guidelines note, is an area of obstetrics that lacks systematic study and analysis.

Dr. Brown said he stands firmly with his belief that mediolateral episiotomy as a routine prophylactic procedure in operative vaginal deliveries cannot be justified. "Having lived through an era of mediolaterals and seeing how long they take to heal, and the discomfort that patients have, I can’t justify it," he said.

"We’ve moved away from episiotomies [in the United States], period," he said. "We’ve moved away from them primarily because of the data showing that midline episiotomies increase the risk of sphincter injury. And the mediolateral episiotomies are just too painful."

The risk of OASIS can be minimized through good delivery technique, he noted.

"The trend here is toward more vacuum deliveries, which have [been shown to be less risky] than forceps deliveries, although its depends on the type of forceps used and the skill of the [obstetrician]," Dr. Brown said. "The challenge we face is that we don’t have enough forceps and vacuum deliveries to easily keep skill levels up."

Dr. Charles W. Nager, president of AUGS and director the urogynecological and reconstructive pelvic surgery division at the University of California, San Diego, said that rates of both episiotomy and operative vaginal delivery have been declining in the United States, and that simultaneously, "there’s been a parallel drop in OASIS."

There also is more training ongoing in U.S. hospitals on repairing third- and fourth-degree obstetric lacerations, he said in an interview at the meeting.

The Netherlands analysis excluded women with preterm delivery, stillbirth, multiple gestation, transverse position, and breech delivery, as well as women whose deliveries involved both forceps and vacuum and women who had a midline episiotomy.

Factors controlled for in the study included parity, fetal position, birth weight, augmentation with oxytocin, and duration of the second stage of labor.

Dr. van Bavel and all but one of his coinvestigators reported no disclosures.

WASHINGTON – The use of mediolateral episiotomy in women undergoing operative vaginal delivery – a common practice in the Netherlands – was associated with a large reduction in the risk of obstetrical anal sphincter injuries, according to an analysis of 10 years of data from the Netherlands Perinatal Registry.

For physicians and other obstetrical providers in the small European country, the findings reinforce current practice of favoring mediolateral episiotomies in operative vaginal deliveries as protection against obstetrical anal sphincter injuries (OASIS) – a risk factor for fecal incontinence, the investigators said.

"In the Netherlands, a mediolateral episiotomy is common practice. ... Our opinion is that the mediolateral episiotomies are causing less morbidity than an anal sphincter rupture would cause," Dr. Jeroen van Bavel reported during a press conference at the scientific meetings of the American Urogynecologic Society (AUGS) and the International Urogynecological Association.

But for physicians here in the United States, the risks are weighed differently. "It’s not that we don’t know that a mediolateral episiotomy decreases the risk of sphincter injury," Dr. Haywood Brown, professor and chair of obstetrics and gynecology at Duke University, Durham, N.C., said in a telephone interview after the conference.

"The problem is, mediolateral incisions are so uncomfortable," said Dr. Brown, who also is chair of the American College of Obstetricians and Gynecologists, District IV.

"They heal poorly, they heal with defects, ... and as a result the patient has more pain related to the mediolateral [episiotomy] than they would have with a third- or fourth-degree tear," he said. "Doing the mediolateral is really not the answer."

The Netherlands Perinatal Registry contains information on 96% of the 1.5 million deliveries that occurred during 2000-2009. Dr. van Bavel, of Amphia Hospital in Breda, the Netherlands, and his coinvestigators focused their analysis on the 170,974 women who had operative vaginal deliveries, comparing the rates of OASIS in women who had mediolateral episiotomies with those who did not.

Among primiparous women who had vacuum deliveries, OASIS occurred in 2.5% of those who had mediolateral episiotomies, compared with 14% who did not. Among multiparous women who had vacuum deliveries, OASIS rates were 2.1% with mediolateral episiotomy versus 7.5% without.

The differences were more striking with forceps deliveries. Anal sphincter injuries occurred in 3.4% versus 26.7% in primiparous women with and without mediolateral episiotomies, respectively. Among multiparous women, the risk of OASIS was 2.6% versus 14.2%.

For primiparous women, the number of mediolateral episiotomies needed to prevent one OASIS was 8 for vacuum delivery and 4 for forceps delivery, according to the analysis. For multiparous women, 18 mediolateral episiotomies were needed to prevent one OASIS for vacuum delivery, and 8 for forceps delivery.

ACOG’s Practice Bulletin No. 71 on episiotomy, which was written in 2006 (Obstet. Gynecol. 2006;107:957-62) and reaffirmed in 2013, states that median episiotomy is associated with higher rates of injury to the anal sphincter and rectum than mediolateral episiotomy (level A evidence), and that mediolateral episiotomy may be preferable in selected cases (level B evidence).

Overall, "restricted use of episiotomy is preferable to routine use of episiotomy," the guidelines say (level A evidence). Postpartum recovery, the guidelines note, is an area of obstetrics that lacks systematic study and analysis.

Dr. Brown said he stands firmly with his belief that mediolateral episiotomy as a routine prophylactic procedure in operative vaginal deliveries cannot be justified. "Having lived through an era of mediolaterals and seeing how long they take to heal, and the discomfort that patients have, I can’t justify it," he said.

"We’ve moved away from episiotomies [in the United States], period," he said. "We’ve moved away from them primarily because of the data showing that midline episiotomies increase the risk of sphincter injury. And the mediolateral episiotomies are just too painful."

The risk of OASIS can be minimized through good delivery technique, he noted.

"The trend here is toward more vacuum deliveries, which have [been shown to be less risky] than forceps deliveries, although its depends on the type of forceps used and the skill of the [obstetrician]," Dr. Brown said. "The challenge we face is that we don’t have enough forceps and vacuum deliveries to easily keep skill levels up."

Dr. Charles W. Nager, president of AUGS and director the urogynecological and reconstructive pelvic surgery division at the University of California, San Diego, said that rates of both episiotomy and operative vaginal delivery have been declining in the United States, and that simultaneously, "there’s been a parallel drop in OASIS."

There also is more training ongoing in U.S. hospitals on repairing third- and fourth-degree obstetric lacerations, he said in an interview at the meeting.

The Netherlands analysis excluded women with preterm delivery, stillbirth, multiple gestation, transverse position, and breech delivery, as well as women whose deliveries involved both forceps and vacuum and women who had a midline episiotomy.

Factors controlled for in the study included parity, fetal position, birth weight, augmentation with oxytocin, and duration of the second stage of labor.

Dr. van Bavel and all but one of his coinvestigators reported no disclosures.

WASHINGTON – Use of a vaginal bowel control device currently under review by the Food and Drug Administration resulted in a significant reduction of fecal incontinence episodes and significant improvement in quality of life, with only mild and transient adverse events, a pivotal study has shown.

The device – the Vaginal Bowel Control (VBC) System made by Pelvalon (Sunnyvale, Calif.) – consists of a silicone base and a posteriorly directed balloon. The patient controls the inflation pump, inflating the balloon to deflect the rectovaginal septum and interrupt stool passage, and deflating it to allow bowel movements.

Courtesy Pelvalon Inc.

"It provides [the patient with] dynamic control of the rectum," said Holly E. Richter, Ph.D., M.D., who served as the national principal investigator of the study. "It’s a new paradigm for treating patients with fecal incontinence."

At the 1-month primary endpoint, 79% of the 61 patients in the study’s intent-to-treat cohort – and 86% of patients in the per-protocol cohort – had experienced treatment success, which was defined as a 50% or greater reduction in fecal incontinence episodes, Dr. Richter reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.

Mean weekly fecal incontinence episodes were reduced from 5.9 per week at baseline to 1.1 at 1 month.

After the 1-month treatment period, women were given the option of continuing with an additional 2-month study period. The rate of treatment success held steady among the 44 women who continued, with 86% seeing a 50% or greater reduction in fecal incontinence at 3 months, said Dr. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham.

Total continence was achieved in approximately 40% of women in the 1-month and 3-month per-protocol cohorts, she noted.

Scores on the Fecal Incontinence Quality of Life survey and the Modified Manchester Health Questionnaire improved significantly across all subscales. At 1 month, 86% reported their fecal incontinence to be "very much better" (57%) or "much better" (29%). Almost all – 96% – reported their insert to be comfortable, and half said they could not feel it.

To qualify for the six-center study, women had to have a history of fecal incontinence of at least 6 months, with 4 or more incontinence episodes recorded during a 2-week baseline bowel diary.

Study participants had a mean age of 61 years and a mean of 5.9 weekly fecal incontinence episodes (or 12 in their diaries).Thirty percent were obese. Nearly 50% had prior hysterectomy, 8% had prior pelvic prolapse surgery, and 15% had prior urinary incontinence surgery.

There were no device-related serious adverse events. The most common complaint was cramping or discomfort, which most often occurred during the fitting period. There were approximately a half-dozen reported changes in urinary incontinence or overactive bladder symptoms.

Courtesy Pelvalon Inc.

"We believe that the Vaginal Bowel Control System can be tried early in the algorithm of treatment for fecal incontinence," Dr. Richter said.

It won’t be a good option for everyone, however. After being fitted with the device (it is made with three base sizes and two balloon sizes), women in the study were instructed to try it for a week before entering the 1-month treatment period. Approximately 40 women who were screened and fitted did not continue. This rate of discomfort or nonacceptance is similar to that associated with pessaries, Dr. Richter noted.

The initial fitting procedure for the new bowel control device "requires a little more provider and patient training, beyond [what is needed] for use of a traditional vaginal pessary," she said.

"Patients in the study could put the device in and take it out as they wished. Most patients used it all day long, and some took it out at night," she said. Patients were instructed to "take it out once or twice a week to wash it."

Dr. Richter is a paid consultant for Pelvalon. Her coinvestigators reported consulting for Pelvalon and other companies.

WASHINGTON – Use of a vaginal bowel control device currently under review by the Food and Drug Administration resulted in a significant reduction of fecal incontinence episodes and significant improvement in quality of life, with only mild and transient adverse events, a pivotal study has shown.

The device – the Vaginal Bowel Control (VBC) System made by Pelvalon (Sunnyvale, Calif.) – consists of a silicone base and a posteriorly directed balloon. The patient controls the inflation pump, inflating the balloon to deflect the rectovaginal septum and interrupt stool passage, and deflating it to allow bowel movements.

Courtesy Pelvalon Inc.

"It provides [the patient with] dynamic control of the rectum," said Holly E. Richter, Ph.D., M.D., who served as the national principal investigator of the study. "It’s a new paradigm for treating patients with fecal incontinence."

At the 1-month primary endpoint, 79% of the 61 patients in the study’s intent-to-treat cohort – and 86% of patients in the per-protocol cohort – had experienced treatment success, which was defined as a 50% or greater reduction in fecal incontinence episodes, Dr. Richter reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.

Mean weekly fecal incontinence episodes were reduced from 5.9 per week at baseline to 1.1 at 1 month.

After the 1-month treatment period, women were given the option of continuing with an additional 2-month study period. The rate of treatment success held steady among the 44 women who continued, with 86% seeing a 50% or greater reduction in fecal incontinence at 3 months, said Dr. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham.

Total continence was achieved in approximately 40% of women in the 1-month and 3-month per-protocol cohorts, she noted.

Scores on the Fecal Incontinence Quality of Life survey and the Modified Manchester Health Questionnaire improved significantly across all subscales. At 1 month, 86% reported their fecal incontinence to be "very much better" (57%) or "much better" (29%). Almost all – 96% – reported their insert to be comfortable, and half said they could not feel it.

To qualify for the six-center study, women had to have a history of fecal incontinence of at least 6 months, with 4 or more incontinence episodes recorded during a 2-week baseline bowel diary.

Study participants had a mean age of 61 years and a mean of 5.9 weekly fecal incontinence episodes (or 12 in their diaries).Thirty percent were obese. Nearly 50% had prior hysterectomy, 8% had prior pelvic prolapse surgery, and 15% had prior urinary incontinence surgery.

There were no device-related serious adverse events. The most common complaint was cramping or discomfort, which most often occurred during the fitting period. There were approximately a half-dozen reported changes in urinary incontinence or overactive bladder symptoms.

Courtesy Pelvalon Inc.

"We believe that the Vaginal Bowel Control System can be tried early in the algorithm of treatment for fecal incontinence," Dr. Richter said.

It won’t be a good option for everyone, however. After being fitted with the device (it is made with three base sizes and two balloon sizes), women in the study were instructed to try it for a week before entering the 1-month treatment period. Approximately 40 women who were screened and fitted did not continue. This rate of discomfort or nonacceptance is similar to that associated with pessaries, Dr. Richter noted.

The initial fitting procedure for the new bowel control device "requires a little more provider and patient training, beyond [what is needed] for use of a traditional vaginal pessary," she said.

"Patients in the study could put the device in and take it out as they wished. Most patients used it all day long, and some took it out at night," she said. Patients were instructed to "take it out once or twice a week to wash it."

Dr. Richter is a paid consultant for Pelvalon. Her coinvestigators reported consulting for Pelvalon and other companies.

WASHINGTON – Use of a vaginal bowel control device currently under review by the Food and Drug Administration resulted in a significant reduction of fecal incontinence episodes and significant improvement in quality of life, with only mild and transient adverse events, a pivotal study has shown.

The device – the Vaginal Bowel Control (VBC) System made by Pelvalon (Sunnyvale, Calif.) – consists of a silicone base and a posteriorly directed balloon. The patient controls the inflation pump, inflating the balloon to deflect the rectovaginal septum and interrupt stool passage, and deflating it to allow bowel movements.

Courtesy Pelvalon Inc.

"It provides [the patient with] dynamic control of the rectum," said Holly E. Richter, Ph.D., M.D., who served as the national principal investigator of the study. "It’s a new paradigm for treating patients with fecal incontinence."

At the 1-month primary endpoint, 79% of the 61 patients in the study’s intent-to-treat cohort – and 86% of patients in the per-protocol cohort – had experienced treatment success, which was defined as a 50% or greater reduction in fecal incontinence episodes, Dr. Richter reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.

Mean weekly fecal incontinence episodes were reduced from 5.9 per week at baseline to 1.1 at 1 month.

After the 1-month treatment period, women were given the option of continuing with an additional 2-month study period. The rate of treatment success held steady among the 44 women who continued, with 86% seeing a 50% or greater reduction in fecal incontinence at 3 months, said Dr. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham.

Total continence was achieved in approximately 40% of women in the 1-month and 3-month per-protocol cohorts, she noted.

Scores on the Fecal Incontinence Quality of Life survey and the Modified Manchester Health Questionnaire improved significantly across all subscales. At 1 month, 86% reported their fecal incontinence to be "very much better" (57%) or "much better" (29%). Almost all – 96% – reported their insert to be comfortable, and half said they could not feel it.

To qualify for the six-center study, women had to have a history of fecal incontinence of at least 6 months, with 4 or more incontinence episodes recorded during a 2-week baseline bowel diary.

Study participants had a mean age of 61 years and a mean of 5.9 weekly fecal incontinence episodes (or 12 in their diaries).Thirty percent were obese. Nearly 50% had prior hysterectomy, 8% had prior pelvic prolapse surgery, and 15% had prior urinary incontinence surgery.

There were no device-related serious adverse events. The most common complaint was cramping or discomfort, which most often occurred during the fitting period. There were approximately a half-dozen reported changes in urinary incontinence or overactive bladder symptoms.

Courtesy Pelvalon Inc.

"We believe that the Vaginal Bowel Control System can be tried early in the algorithm of treatment for fecal incontinence," Dr. Richter said.

It won’t be a good option for everyone, however. After being fitted with the device (it is made with three base sizes and two balloon sizes), women in the study were instructed to try it for a week before entering the 1-month treatment period. Approximately 40 women who were screened and fitted did not continue. This rate of discomfort or nonacceptance is similar to that associated with pessaries, Dr. Richter noted.

The initial fitting procedure for the new bowel control device "requires a little more provider and patient training, beyond [what is needed] for use of a traditional vaginal pessary," she said.

"Patients in the study could put the device in and take it out as they wished. Most patients used it all day long, and some took it out at night," she said. Patients were instructed to "take it out once or twice a week to wash it."

Dr. Richter is a paid consultant for Pelvalon. Her coinvestigators reported consulting for Pelvalon and other companies.

WASHINGTON – Repeat treatment with onabotulinumtoxin A provided sustained improvements in the symptoms of overactive bladder and was well tolerated in women who were followed for a median 2.4 years beyond their participation in one of the two large clinical trials that established the agent’s effectiveness and safety for this indication.

"This treatment remains a safe and effective therapeutic option" for patients with overactive bladder, said Dr. Tomasz Rechberger of the Medical University of Lublin (Poland). It’s "an attractive alternative [in the longer term] for patients who were inadequately treated with anticholinergics."

Women who completed either of the placebo-controlled, multicenter phase III studies were given the option of entering a 3-year open-label extension study in which they could receive additional treatments upon request and as needed to maintain symptom control. The intradetrusor injections of 100 U of onabotulinumtoxin A (Botox) needed to be at least 12 weeks apart.

At the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, Dr. Rechberger reported on an interim analysis of this extension study, which was scheduled to end in August 2014.

As of June 2014, the overall discontinuation rate among the 749 patients who entered the extension study was 38%, but only 4.5% discontinued because of adverse effects or a lack of efficacy. "It was extremely low – much lower than [we expected]," said Dr. Rechberger.

The women had a mean age of 60 and had experienced symptoms of overactive bladder (OAB) for more than 6 years. At the start of the extension study, they had a mean of 5.6 episodes per day of urinary incontinence, 11.6 micturitions per day, and 8.4 urgency episodes per day.

In the original studies, the results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6-1.9 times fewer per day than did patients treated with placebo, and they needed to urinate on average 1.0-1.7 times fewer per day, according to the Food and Drug Administration. In 2013, the FDA approved the use of Botox to treat adults with OAB who cannot use or do not adequately respond to anticholinergics.

Consistent reductions in symptoms were seen after the one to five treatments evaluated as part of the interim analysis of the extension study. Investigators checked all endpoints against the baseline 12 weeks after each treatment. The number of urinary incontinence episodes per day, for instance, was reduced by 3.3 after the first treatment cycle, 3.7 after two treatments, 3.9 after the third treatment, and 3.2 after the fourth and fifth treatment cycles.

Approximately 63%-72% of patients achieved a reduction of incontinence episodes of at least 50% across the treatment cycles.

Additionally, women saw mean reductions in micturition ranging from 2.4 to 3 over the five treatment cycles, and mean reductions in urgency episodes ranging from 3.6 to 4.2. A consistent increase in the volume voided per micturition also was seen.

Urinary tract infection was the most common side effect in each repeat treatment, as was the case in the original studies, but declined slightly with each treatment cycle, from approximately 30% after the first treatment to approximately 20% after the fifth. There were no new safety signals, Dr. Rechberger reported.

Each treatment consisted of 20 cystoscopic injections of 0.5 mL each. The median time between treatments ranged from 24 to 33 weeks – significantly longer than the required 12-week minimum.

Dr. Rechberger is an advisory committee member for Allergan (maker of Botox) and consults for Astellas and Johnson & Johnson. The study was funded by Allergan.

WASHINGTON – Repeat treatment with onabotulinumtoxin A provided sustained improvements in the symptoms of overactive bladder and was well tolerated in women who were followed for a median 2.4 years beyond their participation in one of the two large clinical trials that established the agent’s effectiveness and safety for this indication.

"This treatment remains a safe and effective therapeutic option" for patients with overactive bladder, said Dr. Tomasz Rechberger of the Medical University of Lublin (Poland). It’s "an attractive alternative [in the longer term] for patients who were inadequately treated with anticholinergics."

Women who completed either of the placebo-controlled, multicenter phase III studies were given the option of entering a 3-year open-label extension study in which they could receive additional treatments upon request and as needed to maintain symptom control. The intradetrusor injections of 100 U of onabotulinumtoxin A (Botox) needed to be at least 12 weeks apart.

At the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, Dr. Rechberger reported on an interim analysis of this extension study, which was scheduled to end in August 2014.

As of June 2014, the overall discontinuation rate among the 749 patients who entered the extension study was 38%, but only 4.5% discontinued because of adverse effects or a lack of efficacy. "It was extremely low – much lower than [we expected]," said Dr. Rechberger.

The women had a mean age of 60 and had experienced symptoms of overactive bladder (OAB) for more than 6 years. At the start of the extension study, they had a mean of 5.6 episodes per day of urinary incontinence, 11.6 micturitions per day, and 8.4 urgency episodes per day.

In the original studies, the results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6-1.9 times fewer per day than did patients treated with placebo, and they needed to urinate on average 1.0-1.7 times fewer per day, according to the Food and Drug Administration. In 2013, the FDA approved the use of Botox to treat adults with OAB who cannot use or do not adequately respond to anticholinergics.

Consistent reductions in symptoms were seen after the one to five treatments evaluated as part of the interim analysis of the extension study. Investigators checked all endpoints against the baseline 12 weeks after each treatment. The number of urinary incontinence episodes per day, for instance, was reduced by 3.3 after the first treatment cycle, 3.7 after two treatments, 3.9 after the third treatment, and 3.2 after the fourth and fifth treatment cycles.

Approximately 63%-72% of patients achieved a reduction of incontinence episodes of at least 50% across the treatment cycles.

Additionally, women saw mean reductions in micturition ranging from 2.4 to 3 over the five treatment cycles, and mean reductions in urgency episodes ranging from 3.6 to 4.2. A consistent increase in the volume voided per micturition also was seen.

Urinary tract infection was the most common side effect in each repeat treatment, as was the case in the original studies, but declined slightly with each treatment cycle, from approximately 30% after the first treatment to approximately 20% after the fifth. There were no new safety signals, Dr. Rechberger reported.

Each treatment consisted of 20 cystoscopic injections of 0.5 mL each. The median time between treatments ranged from 24 to 33 weeks – significantly longer than the required 12-week minimum.

Dr. Rechberger is an advisory committee member for Allergan (maker of Botox) and consults for Astellas and Johnson & Johnson. The study was funded by Allergan.

WASHINGTON – Repeat treatment with onabotulinumtoxin A provided sustained improvements in the symptoms of overactive bladder and was well tolerated in women who were followed for a median 2.4 years beyond their participation in one of the two large clinical trials that established the agent’s effectiveness and safety for this indication.

"This treatment remains a safe and effective therapeutic option" for patients with overactive bladder, said Dr. Tomasz Rechberger of the Medical University of Lublin (Poland). It’s "an attractive alternative [in the longer term] for patients who were inadequately treated with anticholinergics."

Women who completed either of the placebo-controlled, multicenter phase III studies were given the option of entering a 3-year open-label extension study in which they could receive additional treatments upon request and as needed to maintain symptom control. The intradetrusor injections of 100 U of onabotulinumtoxin A (Botox) needed to be at least 12 weeks apart.

At the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, Dr. Rechberger reported on an interim analysis of this extension study, which was scheduled to end in August 2014.

As of June 2014, the overall discontinuation rate among the 749 patients who entered the extension study was 38%, but only 4.5% discontinued because of adverse effects or a lack of efficacy. "It was extremely low – much lower than [we expected]," said Dr. Rechberger.

The women had a mean age of 60 and had experienced symptoms of overactive bladder (OAB) for more than 6 years. At the start of the extension study, they had a mean of 5.6 episodes per day of urinary incontinence, 11.6 micturitions per day, and 8.4 urgency episodes per day.

In the original studies, the results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6-1.9 times fewer per day than did patients treated with placebo, and they needed to urinate on average 1.0-1.7 times fewer per day, according to the Food and Drug Administration. In 2013, the FDA approved the use of Botox to treat adults with OAB who cannot use or do not adequately respond to anticholinergics.

Consistent reductions in symptoms were seen after the one to five treatments evaluated as part of the interim analysis of the extension study. Investigators checked all endpoints against the baseline 12 weeks after each treatment. The number of urinary incontinence episodes per day, for instance, was reduced by 3.3 after the first treatment cycle, 3.7 after two treatments, 3.9 after the third treatment, and 3.2 after the fourth and fifth treatment cycles.

Approximately 63%-72% of patients achieved a reduction of incontinence episodes of at least 50% across the treatment cycles.

Additionally, women saw mean reductions in micturition ranging from 2.4 to 3 over the five treatment cycles, and mean reductions in urgency episodes ranging from 3.6 to 4.2. A consistent increase in the volume voided per micturition also was seen.

Urinary tract infection was the most common side effect in each repeat treatment, as was the case in the original studies, but declined slightly with each treatment cycle, from approximately 30% after the first treatment to approximately 20% after the fifth. There were no new safety signals, Dr. Rechberger reported.

Each treatment consisted of 20 cystoscopic injections of 0.5 mL each. The median time between treatments ranged from 24 to 33 weeks – significantly longer than the required 12-week minimum.

Dr. Rechberger is an advisory committee member for Allergan (maker of Botox) and consults for Astellas and Johnson & Johnson. The study was funded by Allergan.