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Getting unstuck: Helping patients with behavior change
Kyle is a 14-year-old cisgender male who just moved to your town. At his first well-check, his single father brings him in reluctantly, stating, “We’ve never liked doctors.” Kyle has a history of asthma and obesity that have been relatively unchanged over time. He is an average student, an avid gamer, and seems somewhat shy. Privately he admits to occasional cannabis use. His father has no concerns, lamenting, “He’s always been pretty healthy for a fat kid.” Next patient?
Of course there is a lot to work with here. You might be concerned with Kyle’s asthma; his weight, sedentary nature, and body image; the criticism from his father and concerns about self-esteem; the possibility of anxiety in relation to his shyness; and the health effects of his cannabis use. In the end, recommendations for behavior change seem likely. These might take the form of tips on exercise, nutrition, substance use, study habits, parenting, social activities, or mental health support; the literature on behavior change would suggest that any success will be predicated on trust. How can we learn from someone we do not trust?1
To build trust is no easy task, and yet is perhaps the foundation on which the entire clinical relationship rests. Guidance from decades of evidence supporting the use of motivational interviewing2 suggests that the process of building rapport can be neatly summed up in an acronym as PACE. This represents Partnership, Acceptance, Compassion, and Evocation. Almost too clichéd to repeat, the most powerful change agent is the person making the change. In the setting of pediatric health care, we sometimes lean on caregivers to initiate or promote change because they are an intimate part of the patient’s microsystem, and thus moving one gear (the parents) inevitably shifts something in connected gears (the children).
So Partnership is centered on the patient, but inclusive of any important person in the patient’s sphere. In a family-based approach, this might show up as leveraging Kyle’s father’s motivation for behavior change by having the father start an exercise routine. This role models behavior change, shifts the home environment around the behavior, and builds empathy in the parent for the inherent challenges of change processes.
Acceptance can be distilled into knowing that the patient and family are doing the best they can. This does not preclude the possibility of change, but it seats this possibility in an attitude of assumed adequacy. There is nothing wrong with the patient, nothing to be fixed, just the possibility for change.
Similarly, Compassion takes a nonjudgmental viewpoint. With the stance of “this could happen to anybody,” the patient can feel responsible without feeling blamed. Noting the patient’s suffering without blame allows the clinician to be motivated not just to empathize, but to help.
And from this basis of compassionate partnership, the work of Evocation begins. What is happening in the patient’s life and relationships? What are their own goals and values? Where are the discrepancies between what the patient wants and what the patient does? For teenagers, this often brings into conflict developmentally appropriate wishes for autonomy – wanting to drive or get a car or stay out later or have more privacy – with developmentally typical challenges regarding responsibility.3 For example:
Clinician: “You want to use the car, and your parents want you to pay for the gas, but you’re out of money from buying weed. I see how you’re stuck.”
Teen: “Yeah, they really need to give me more allowance. It’s not like we’re living in the 1990s anymore!”
Clinician: “So you could ask for more allowance to get more money for gas. Any other ideas?”
Teen: “I could give up smoking pot and just be miserable all the time.”
Clinician: “Yeah, that sounds too difficult right now; if anything it sounds like you’d like to smoke more pot if you had more money.”
Teen: “Nah, I’m not that hooked on it. ... I could probably smoke a bit less each week and save some gas money.”
The PACE acronym also serves as a reminder of the patience required to grow connection where none has previously existed – pace yourself. Here are some skills-based tips to foster the spirit of motivational interviewing to help balance patience with the time frame of a pediatric check-in. The OARS skills represent the fundamental building blocks of motivational interviewing in practice. Taking the case of Kyle as an example, an Open-Ended Question makes space for the child or parent to express their views with less interviewer bias. Reflections expand this space by underscoring and, in the case of complex Reflections, adding some nuance to what the patient has to say.
Clinician: “How do you feel about your body?”
Teen: “Well, I’m fat. Nobody really wants to be fat. It sucks. But what can I do?”
Clinician: “You feel fat and kind of hopeless.”
Teen: “Yeah, I know you’re going to tell me to go on a diet and start exercising. Doesn’t work. My dad says I was born fat; I guess I’m going to stay that way.”
Clinician: “Sounds like you and your dad can get down on you for your weight. That must feel terrible.”
Teen: “Ah, it’s not that bad. I’m kind of used to it. Fat kid at home, fat kid at school.”
Affirmations are statements focusing on positive actions or attributes of the patient. They tend to build rapport by demonstrating that the clinician sees the strengths of the patient, not just the problems.
Clinician: “I’m pretty impressed that you’re able to show up here and talk about this. It can’t be easy when it sounds like your family and friends have put you down so much that you’re even putting yourself down about your body.”
Teen: “I didn’t really want to come, but then I thought, maybe this new doctor will have some new ideas. I actually want to do something about it, I just don’t know if anything will help. Plus my dad said if I showed up, we could go to McDonald’s afterward.”
Summaries are multipurpose. They demonstrate that you have been listening closely, which builds rapport. They provide a chance to put information together so that both clinician and patient can reflect on the sum of the data and notice what may be missing. And they provide a pause to consider where to go next.
Clinician: “So if I’m getting it right, you’ve been worried about your weight for a long time now. Your dad and your friends give you a hard time about it, which makes you feel down and hopeless, but somehow you stay brave and keep trying to figure it out. You feel ready to do something, you just don’t know what, and you were hoping maybe coming here could give you a place to work on your health. Does that sound about right?”
Teen: “I think that’s pretty much it. Plus the McDonald’s.”
Clinician: “Right, that’s important too – we have to consider your motivation! I wonder if we could talk about this more at our next visit – would that be alright?”
Offices with additional resources might be able to offer some of those as well, if timing seems appropriate; for example, referral to a wellness coach or social worker or nutritionist could be helpful int his case. With the spirit of PACE and the skills of OARS, you can be well on your way to fostering behavior changes that could last a lifetime! Check out the resources from the American Academy of Pediatrics with video and narrative demonstrations of motivational interviewing in pediatrics.
Dr. Rosenfeld is assistant professor in the departments of psychiatry and pediatrics at the University of Vermont Medical Center and the university’s Robert Larner College of Medicine, Burlington. He reported no relevant disclosures. Email him at [email protected].
References
1. Miller WR, Rollnick S. “Engagement and disengagement,” in “Motivational interviewing: Helping people change,” 3rd ed. (New York: Guilford, 2013).
2. Miller WR, Rollnick S. “The spirit of motivational interviewing,” in “Motivational interviewing: Helping people change,” 3rd ed. (New York: Guilford, 2013).
3. Naar S, Suarez M. “Adolescence and emerging adulthood: A brief review of development,” in “Motivational interviewing with adolescents and young adults” (New York: Guilford, 2011).
Kyle is a 14-year-old cisgender male who just moved to your town. At his first well-check, his single father brings him in reluctantly, stating, “We’ve never liked doctors.” Kyle has a history of asthma and obesity that have been relatively unchanged over time. He is an average student, an avid gamer, and seems somewhat shy. Privately he admits to occasional cannabis use. His father has no concerns, lamenting, “He’s always been pretty healthy for a fat kid.” Next patient?
Of course there is a lot to work with here. You might be concerned with Kyle’s asthma; his weight, sedentary nature, and body image; the criticism from his father and concerns about self-esteem; the possibility of anxiety in relation to his shyness; and the health effects of his cannabis use. In the end, recommendations for behavior change seem likely. These might take the form of tips on exercise, nutrition, substance use, study habits, parenting, social activities, or mental health support; the literature on behavior change would suggest that any success will be predicated on trust. How can we learn from someone we do not trust?1
To build trust is no easy task, and yet is perhaps the foundation on which the entire clinical relationship rests. Guidance from decades of evidence supporting the use of motivational interviewing2 suggests that the process of building rapport can be neatly summed up in an acronym as PACE. This represents Partnership, Acceptance, Compassion, and Evocation. Almost too clichéd to repeat, the most powerful change agent is the person making the change. In the setting of pediatric health care, we sometimes lean on caregivers to initiate or promote change because they are an intimate part of the patient’s microsystem, and thus moving one gear (the parents) inevitably shifts something in connected gears (the children).
So Partnership is centered on the patient, but inclusive of any important person in the patient’s sphere. In a family-based approach, this might show up as leveraging Kyle’s father’s motivation for behavior change by having the father start an exercise routine. This role models behavior change, shifts the home environment around the behavior, and builds empathy in the parent for the inherent challenges of change processes.
Acceptance can be distilled into knowing that the patient and family are doing the best they can. This does not preclude the possibility of change, but it seats this possibility in an attitude of assumed adequacy. There is nothing wrong with the patient, nothing to be fixed, just the possibility for change.
Similarly, Compassion takes a nonjudgmental viewpoint. With the stance of “this could happen to anybody,” the patient can feel responsible without feeling blamed. Noting the patient’s suffering without blame allows the clinician to be motivated not just to empathize, but to help.
And from this basis of compassionate partnership, the work of Evocation begins. What is happening in the patient’s life and relationships? What are their own goals and values? Where are the discrepancies between what the patient wants and what the patient does? For teenagers, this often brings into conflict developmentally appropriate wishes for autonomy – wanting to drive or get a car or stay out later or have more privacy – with developmentally typical challenges regarding responsibility.3 For example:
Clinician: “You want to use the car, and your parents want you to pay for the gas, but you’re out of money from buying weed. I see how you’re stuck.”
Teen: “Yeah, they really need to give me more allowance. It’s not like we’re living in the 1990s anymore!”
Clinician: “So you could ask for more allowance to get more money for gas. Any other ideas?”
Teen: “I could give up smoking pot and just be miserable all the time.”
Clinician: “Yeah, that sounds too difficult right now; if anything it sounds like you’d like to smoke more pot if you had more money.”
Teen: “Nah, I’m not that hooked on it. ... I could probably smoke a bit less each week and save some gas money.”
The PACE acronym also serves as a reminder of the patience required to grow connection where none has previously existed – pace yourself. Here are some skills-based tips to foster the spirit of motivational interviewing to help balance patience with the time frame of a pediatric check-in. The OARS skills represent the fundamental building blocks of motivational interviewing in practice. Taking the case of Kyle as an example, an Open-Ended Question makes space for the child or parent to express their views with less interviewer bias. Reflections expand this space by underscoring and, in the case of complex Reflections, adding some nuance to what the patient has to say.
Clinician: “How do you feel about your body?”
Teen: “Well, I’m fat. Nobody really wants to be fat. It sucks. But what can I do?”
Clinician: “You feel fat and kind of hopeless.”
Teen: “Yeah, I know you’re going to tell me to go on a diet and start exercising. Doesn’t work. My dad says I was born fat; I guess I’m going to stay that way.”
Clinician: “Sounds like you and your dad can get down on you for your weight. That must feel terrible.”
Teen: “Ah, it’s not that bad. I’m kind of used to it. Fat kid at home, fat kid at school.”
Affirmations are statements focusing on positive actions or attributes of the patient. They tend to build rapport by demonstrating that the clinician sees the strengths of the patient, not just the problems.
Clinician: “I’m pretty impressed that you’re able to show up here and talk about this. It can’t be easy when it sounds like your family and friends have put you down so much that you’re even putting yourself down about your body.”
Teen: “I didn’t really want to come, but then I thought, maybe this new doctor will have some new ideas. I actually want to do something about it, I just don’t know if anything will help. Plus my dad said if I showed up, we could go to McDonald’s afterward.”
Summaries are multipurpose. They demonstrate that you have been listening closely, which builds rapport. They provide a chance to put information together so that both clinician and patient can reflect on the sum of the data and notice what may be missing. And they provide a pause to consider where to go next.
Clinician: “So if I’m getting it right, you’ve been worried about your weight for a long time now. Your dad and your friends give you a hard time about it, which makes you feel down and hopeless, but somehow you stay brave and keep trying to figure it out. You feel ready to do something, you just don’t know what, and you were hoping maybe coming here could give you a place to work on your health. Does that sound about right?”
Teen: “I think that’s pretty much it. Plus the McDonald’s.”
Clinician: “Right, that’s important too – we have to consider your motivation! I wonder if we could talk about this more at our next visit – would that be alright?”
Offices with additional resources might be able to offer some of those as well, if timing seems appropriate; for example, referral to a wellness coach or social worker or nutritionist could be helpful int his case. With the spirit of PACE and the skills of OARS, you can be well on your way to fostering behavior changes that could last a lifetime! Check out the resources from the American Academy of Pediatrics with video and narrative demonstrations of motivational interviewing in pediatrics.
Dr. Rosenfeld is assistant professor in the departments of psychiatry and pediatrics at the University of Vermont Medical Center and the university’s Robert Larner College of Medicine, Burlington. He reported no relevant disclosures. Email him at [email protected].
References
1. Miller WR, Rollnick S. “Engagement and disengagement,” in “Motivational interviewing: Helping people change,” 3rd ed. (New York: Guilford, 2013).
2. Miller WR, Rollnick S. “The spirit of motivational interviewing,” in “Motivational interviewing: Helping people change,” 3rd ed. (New York: Guilford, 2013).
3. Naar S, Suarez M. “Adolescence and emerging adulthood: A brief review of development,” in “Motivational interviewing with adolescents and young adults” (New York: Guilford, 2011).
Kyle is a 14-year-old cisgender male who just moved to your town. At his first well-check, his single father brings him in reluctantly, stating, “We’ve never liked doctors.” Kyle has a history of asthma and obesity that have been relatively unchanged over time. He is an average student, an avid gamer, and seems somewhat shy. Privately he admits to occasional cannabis use. His father has no concerns, lamenting, “He’s always been pretty healthy for a fat kid.” Next patient?
Of course there is a lot to work with here. You might be concerned with Kyle’s asthma; his weight, sedentary nature, and body image; the criticism from his father and concerns about self-esteem; the possibility of anxiety in relation to his shyness; and the health effects of his cannabis use. In the end, recommendations for behavior change seem likely. These might take the form of tips on exercise, nutrition, substance use, study habits, parenting, social activities, or mental health support; the literature on behavior change would suggest that any success will be predicated on trust. How can we learn from someone we do not trust?1
To build trust is no easy task, and yet is perhaps the foundation on which the entire clinical relationship rests. Guidance from decades of evidence supporting the use of motivational interviewing2 suggests that the process of building rapport can be neatly summed up in an acronym as PACE. This represents Partnership, Acceptance, Compassion, and Evocation. Almost too clichéd to repeat, the most powerful change agent is the person making the change. In the setting of pediatric health care, we sometimes lean on caregivers to initiate or promote change because they are an intimate part of the patient’s microsystem, and thus moving one gear (the parents) inevitably shifts something in connected gears (the children).
So Partnership is centered on the patient, but inclusive of any important person in the patient’s sphere. In a family-based approach, this might show up as leveraging Kyle’s father’s motivation for behavior change by having the father start an exercise routine. This role models behavior change, shifts the home environment around the behavior, and builds empathy in the parent for the inherent challenges of change processes.
Acceptance can be distilled into knowing that the patient and family are doing the best they can. This does not preclude the possibility of change, but it seats this possibility in an attitude of assumed adequacy. There is nothing wrong with the patient, nothing to be fixed, just the possibility for change.
Similarly, Compassion takes a nonjudgmental viewpoint. With the stance of “this could happen to anybody,” the patient can feel responsible without feeling blamed. Noting the patient’s suffering without blame allows the clinician to be motivated not just to empathize, but to help.
And from this basis of compassionate partnership, the work of Evocation begins. What is happening in the patient’s life and relationships? What are their own goals and values? Where are the discrepancies between what the patient wants and what the patient does? For teenagers, this often brings into conflict developmentally appropriate wishes for autonomy – wanting to drive or get a car or stay out later or have more privacy – with developmentally typical challenges regarding responsibility.3 For example:
Clinician: “You want to use the car, and your parents want you to pay for the gas, but you’re out of money from buying weed. I see how you’re stuck.”
Teen: “Yeah, they really need to give me more allowance. It’s not like we’re living in the 1990s anymore!”
Clinician: “So you could ask for more allowance to get more money for gas. Any other ideas?”
Teen: “I could give up smoking pot and just be miserable all the time.”
Clinician: “Yeah, that sounds too difficult right now; if anything it sounds like you’d like to smoke more pot if you had more money.”
Teen: “Nah, I’m not that hooked on it. ... I could probably smoke a bit less each week and save some gas money.”
The PACE acronym also serves as a reminder of the patience required to grow connection where none has previously existed – pace yourself. Here are some skills-based tips to foster the spirit of motivational interviewing to help balance patience with the time frame of a pediatric check-in. The OARS skills represent the fundamental building blocks of motivational interviewing in practice. Taking the case of Kyle as an example, an Open-Ended Question makes space for the child or parent to express their views with less interviewer bias. Reflections expand this space by underscoring and, in the case of complex Reflections, adding some nuance to what the patient has to say.
Clinician: “How do you feel about your body?”
Teen: “Well, I’m fat. Nobody really wants to be fat. It sucks. But what can I do?”
Clinician: “You feel fat and kind of hopeless.”
Teen: “Yeah, I know you’re going to tell me to go on a diet and start exercising. Doesn’t work. My dad says I was born fat; I guess I’m going to stay that way.”
Clinician: “Sounds like you and your dad can get down on you for your weight. That must feel terrible.”
Teen: “Ah, it’s not that bad. I’m kind of used to it. Fat kid at home, fat kid at school.”
Affirmations are statements focusing on positive actions or attributes of the patient. They tend to build rapport by demonstrating that the clinician sees the strengths of the patient, not just the problems.
Clinician: “I’m pretty impressed that you’re able to show up here and talk about this. It can’t be easy when it sounds like your family and friends have put you down so much that you’re even putting yourself down about your body.”
Teen: “I didn’t really want to come, but then I thought, maybe this new doctor will have some new ideas. I actually want to do something about it, I just don’t know if anything will help. Plus my dad said if I showed up, we could go to McDonald’s afterward.”
Summaries are multipurpose. They demonstrate that you have been listening closely, which builds rapport. They provide a chance to put information together so that both clinician and patient can reflect on the sum of the data and notice what may be missing. And they provide a pause to consider where to go next.
Clinician: “So if I’m getting it right, you’ve been worried about your weight for a long time now. Your dad and your friends give you a hard time about it, which makes you feel down and hopeless, but somehow you stay brave and keep trying to figure it out. You feel ready to do something, you just don’t know what, and you were hoping maybe coming here could give you a place to work on your health. Does that sound about right?”
Teen: “I think that’s pretty much it. Plus the McDonald’s.”
Clinician: “Right, that’s important too – we have to consider your motivation! I wonder if we could talk about this more at our next visit – would that be alright?”
Offices with additional resources might be able to offer some of those as well, if timing seems appropriate; for example, referral to a wellness coach or social worker or nutritionist could be helpful int his case. With the spirit of PACE and the skills of OARS, you can be well on your way to fostering behavior changes that could last a lifetime! Check out the resources from the American Academy of Pediatrics with video and narrative demonstrations of motivational interviewing in pediatrics.
Dr. Rosenfeld is assistant professor in the departments of psychiatry and pediatrics at the University of Vermont Medical Center and the university’s Robert Larner College of Medicine, Burlington. He reported no relevant disclosures. Email him at [email protected].
References
1. Miller WR, Rollnick S. “Engagement and disengagement,” in “Motivational interviewing: Helping people change,” 3rd ed. (New York: Guilford, 2013).
2. Miller WR, Rollnick S. “The spirit of motivational interviewing,” in “Motivational interviewing: Helping people change,” 3rd ed. (New York: Guilford, 2013).
3. Naar S, Suarez M. “Adolescence and emerging adulthood: A brief review of development,” in “Motivational interviewing with adolescents and young adults” (New York: Guilford, 2011).
Racism: Developmental perspective can inform tough conversations
Can we help our pediatric patients with the complicated problems of racism, especially if we are privileged (and even white) professionals? We may not have experienced discrimination, but we can still advise and address it. Racist discrimination, fear, trauma, or distress may produce or exacerbate conditions we are treating.
Three levels of racism impact children’s health and health care: “structural or institutional” policies that influence social determinants of health; “personally mediated” differential treatment based on assumptions about one’s abilities, motives, or intents; and the resulting “internalization” of stereotypes into one’s identity, undermining confidence, self-esteem, and mental health. We can help advocate about structural racism and ensure equity within our offices, but how best to counsel the families and children themselves?
Racism includes actions of “assigning value based on the social interpretation of how a person looks” (Ethn Dis. 2008;18[4]:496-504). “Social interpretations” develop from an early age. Newborns detect differences in appearance and may startle or cry seeing a parent’s drastic haircut or new hat. Parents generally know to use soothing words and tone, bring the difference into view gradually, smile and comfort the child, and explain the change; these are good skills for later, too. Infants notice skin color, which, unlike clothes, is a stable feature by which to recognize parents. Social interpretation of these differences is cued from the parents’ feelings and reactions. Adults naturally transmit biases from their own past unless they work to dampen them. If the parent was taught to regard “other” as negative or is generally fearful, the child mirrors this. Working to reduce racism thus requires parents (and professionals) to examine their prejudices to be able to convey positive or neutral reactions to people who are different. Parents need to show curiosity, positive affect, and comfort about people who are different, and do well to seek contact and friendships with people from other groups and include their children in these relationships. We can encourage this outreach plus ensure diversity and respectful interactions in our offices.
Children from age 3 years value fairness and are upset seeing others treated unfairly – easily understanding “not fair” or “mean.” If the person being hurt is like them in race, ethnicity, religion, gender, or sexual preference, they also fear for themselves, family, and friends. Balance is needed in discussing racism to avoid increasing fear or overpromising as risks are real and solutions difficult. Children look to adults for understanding and evidence of action to feel safer, rather than helpless. We should state that leaders are working on “making the rules more fair,” ensuring that people “won’t be allowed do it again,” and “teaching that everyone deserves respect.” Even better, parents and children can generate ideas about child actions, giving them some power as an antidote to anxiety. Age-related possibilities might include drawing a picture of people getting along, talking at show-and-tell, writing a note to officials, making a protest sign, posting thoughts on Facebook, or protesting.
With age, the culture increasingly influences a child’s attitudes. Children see lots of teasing and bullying based on differences from being overweight or wearing glasses, to skin color. It is helpful to interpret for children that bullies are insecure, or sometimes have been hurt, and they put other people down to feel better than someone else. Thinking about racist acts this way may reduce the desire for revenge and a cycle of aggression. Effective anti-bullying programs help children recognize bullying, see it as an emergency that requires their action, tell adults, and take action. This action could be surrounding the bully, standing tall, making eye contact, having a dismissive retort, or asking questions that require the bully to think, such as “What do you want to happen by doing this?” We can coach our patients and their parents on these principles as well as advising schools.
Children need to be told that those being put down or held down – especially those like them – have strengths; have made discoveries; have produced writings, art, and music; have shown military bravery, moral leadership, and resistance to discrimination, but it is not the time to show strength when confronted by a gun or police. We can use and arm parents with examples to discuss strengths and accomplishments to help buffer the child from internalization of racist stereotypes. Children need positive role models who look like them; parents can seek out diverse professionals in their children’s lives, such as dentists, doctors, teachers, clergy, mentors, or coaches. We, and parents, can ensure that dolls and books are available, and that the children’s shows, movies, and video games are watched together and include diverse people doing good or brave things. These exposures also are key to all children becoming anti-racist.
Parents can be advised to initiate discussion of racism because children, detecting adult discomfort, may avoid the topic. We can encourage families to give their point of view; otherwise children simply absorb those of peers or the press. Parents should tell their children, “I want you to be able to talk about it if someone is mean or treats you unfairly because of [the color of your skin, your religion, your sex, your disability, etc.]. You might feel helpless, or angry, which is natural. We need to talk about this so you can feel strong. Then we can plan on what we are going to do.” The “sandwich” method of “ask-give information-ask what they think” can encourage discussion and correct misperceptions.
Racist policies have succeeded partly by adult “bullies” dehumanizing the “other.” Most children can consider someone else’s point of view by 4½ years old, shaped with adult help. Parents can begin by telling babies, “That hurts, doesn’t it?” asking toddlers and older, “How would you feel if ... [someone called you a name just because of having red hair]?” or “How do you think she feels when ... [someone pushes her out of line because she wears certain clothes]?” in cases of grabbing, not sharing, hitting, bullying, etc. Older children and teens can analyze more abstract situations when asked, “What if you were the one who ... [got expelled for mumbling about the teacher]?” or “What if that were your sister?” or “How would the world be if everyone ... [got a chance to go to college]?” We can encourage parents to propose these mental exercises to build the child’s perspective-taking while conveying their opinions.
Experiences, including through media, may increase or decrease fear; the child needs to have a supportive person moderating the exposure, providing a positive interpretation, and protecting the child from overwhelm, if needed.
Experiences are insufficient for developing anti-racist attitudes; listening and talking are needed. The first step is to ask children about what they notice, think, and feel about situations reflecting racism, especially as they lack words for these complicated observations. There are television, Internet, and newspaper examples of both racism and anti-racism that can be fruitfully discussed. We can recommend watching or reading together, and asking questions such as, “Why do you think they are shouting [protesting]?” “How do you think the [victim, police] felt?” or “What do you think should be done about this?”
It is important to acknowledge the child’s confusion, fear, anxiety, sadness, or anger as normal and appropriate, not dismissing, too quickly reassuring, or changing the subject, even though it’s uncomfortable.
Physicians and nurse practitioners can make a difference by being aware of our privilege and biases, being open, modeling discussion, screening for impact, offering strategies, advocating with schools, and providing resources such as therapy or legal counsel, as for other social determinants of health.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (https://www.site.chadis.com/). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Can we help our pediatric patients with the complicated problems of racism, especially if we are privileged (and even white) professionals? We may not have experienced discrimination, but we can still advise and address it. Racist discrimination, fear, trauma, or distress may produce or exacerbate conditions we are treating.
Three levels of racism impact children’s health and health care: “structural or institutional” policies that influence social determinants of health; “personally mediated” differential treatment based on assumptions about one’s abilities, motives, or intents; and the resulting “internalization” of stereotypes into one’s identity, undermining confidence, self-esteem, and mental health. We can help advocate about structural racism and ensure equity within our offices, but how best to counsel the families and children themselves?
Racism includes actions of “assigning value based on the social interpretation of how a person looks” (Ethn Dis. 2008;18[4]:496-504). “Social interpretations” develop from an early age. Newborns detect differences in appearance and may startle or cry seeing a parent’s drastic haircut or new hat. Parents generally know to use soothing words and tone, bring the difference into view gradually, smile and comfort the child, and explain the change; these are good skills for later, too. Infants notice skin color, which, unlike clothes, is a stable feature by which to recognize parents. Social interpretation of these differences is cued from the parents’ feelings and reactions. Adults naturally transmit biases from their own past unless they work to dampen them. If the parent was taught to regard “other” as negative or is generally fearful, the child mirrors this. Working to reduce racism thus requires parents (and professionals) to examine their prejudices to be able to convey positive or neutral reactions to people who are different. Parents need to show curiosity, positive affect, and comfort about people who are different, and do well to seek contact and friendships with people from other groups and include their children in these relationships. We can encourage this outreach plus ensure diversity and respectful interactions in our offices.
Children from age 3 years value fairness and are upset seeing others treated unfairly – easily understanding “not fair” or “mean.” If the person being hurt is like them in race, ethnicity, religion, gender, or sexual preference, they also fear for themselves, family, and friends. Balance is needed in discussing racism to avoid increasing fear or overpromising as risks are real and solutions difficult. Children look to adults for understanding and evidence of action to feel safer, rather than helpless. We should state that leaders are working on “making the rules more fair,” ensuring that people “won’t be allowed do it again,” and “teaching that everyone deserves respect.” Even better, parents and children can generate ideas about child actions, giving them some power as an antidote to anxiety. Age-related possibilities might include drawing a picture of people getting along, talking at show-and-tell, writing a note to officials, making a protest sign, posting thoughts on Facebook, or protesting.
With age, the culture increasingly influences a child’s attitudes. Children see lots of teasing and bullying based on differences from being overweight or wearing glasses, to skin color. It is helpful to interpret for children that bullies are insecure, or sometimes have been hurt, and they put other people down to feel better than someone else. Thinking about racist acts this way may reduce the desire for revenge and a cycle of aggression. Effective anti-bullying programs help children recognize bullying, see it as an emergency that requires their action, tell adults, and take action. This action could be surrounding the bully, standing tall, making eye contact, having a dismissive retort, or asking questions that require the bully to think, such as “What do you want to happen by doing this?” We can coach our patients and their parents on these principles as well as advising schools.
Children need to be told that those being put down or held down – especially those like them – have strengths; have made discoveries; have produced writings, art, and music; have shown military bravery, moral leadership, and resistance to discrimination, but it is not the time to show strength when confronted by a gun or police. We can use and arm parents with examples to discuss strengths and accomplishments to help buffer the child from internalization of racist stereotypes. Children need positive role models who look like them; parents can seek out diverse professionals in their children’s lives, such as dentists, doctors, teachers, clergy, mentors, or coaches. We, and parents, can ensure that dolls and books are available, and that the children’s shows, movies, and video games are watched together and include diverse people doing good or brave things. These exposures also are key to all children becoming anti-racist.
Parents can be advised to initiate discussion of racism because children, detecting adult discomfort, may avoid the topic. We can encourage families to give their point of view; otherwise children simply absorb those of peers or the press. Parents should tell their children, “I want you to be able to talk about it if someone is mean or treats you unfairly because of [the color of your skin, your religion, your sex, your disability, etc.]. You might feel helpless, or angry, which is natural. We need to talk about this so you can feel strong. Then we can plan on what we are going to do.” The “sandwich” method of “ask-give information-ask what they think” can encourage discussion and correct misperceptions.
Racist policies have succeeded partly by adult “bullies” dehumanizing the “other.” Most children can consider someone else’s point of view by 4½ years old, shaped with adult help. Parents can begin by telling babies, “That hurts, doesn’t it?” asking toddlers and older, “How would you feel if ... [someone called you a name just because of having red hair]?” or “How do you think she feels when ... [someone pushes her out of line because she wears certain clothes]?” in cases of grabbing, not sharing, hitting, bullying, etc. Older children and teens can analyze more abstract situations when asked, “What if you were the one who ... [got expelled for mumbling about the teacher]?” or “What if that were your sister?” or “How would the world be if everyone ... [got a chance to go to college]?” We can encourage parents to propose these mental exercises to build the child’s perspective-taking while conveying their opinions.
Experiences, including through media, may increase or decrease fear; the child needs to have a supportive person moderating the exposure, providing a positive interpretation, and protecting the child from overwhelm, if needed.
Experiences are insufficient for developing anti-racist attitudes; listening and talking are needed. The first step is to ask children about what they notice, think, and feel about situations reflecting racism, especially as they lack words for these complicated observations. There are television, Internet, and newspaper examples of both racism and anti-racism that can be fruitfully discussed. We can recommend watching or reading together, and asking questions such as, “Why do you think they are shouting [protesting]?” “How do you think the [victim, police] felt?” or “What do you think should be done about this?”
It is important to acknowledge the child’s confusion, fear, anxiety, sadness, or anger as normal and appropriate, not dismissing, too quickly reassuring, or changing the subject, even though it’s uncomfortable.
Physicians and nurse practitioners can make a difference by being aware of our privilege and biases, being open, modeling discussion, screening for impact, offering strategies, advocating with schools, and providing resources such as therapy or legal counsel, as for other social determinants of health.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (https://www.site.chadis.com/). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Can we help our pediatric patients with the complicated problems of racism, especially if we are privileged (and even white) professionals? We may not have experienced discrimination, but we can still advise and address it. Racist discrimination, fear, trauma, or distress may produce or exacerbate conditions we are treating.
Three levels of racism impact children’s health and health care: “structural or institutional” policies that influence social determinants of health; “personally mediated” differential treatment based on assumptions about one’s abilities, motives, or intents; and the resulting “internalization” of stereotypes into one’s identity, undermining confidence, self-esteem, and mental health. We can help advocate about structural racism and ensure equity within our offices, but how best to counsel the families and children themselves?
Racism includes actions of “assigning value based on the social interpretation of how a person looks” (Ethn Dis. 2008;18[4]:496-504). “Social interpretations” develop from an early age. Newborns detect differences in appearance and may startle or cry seeing a parent’s drastic haircut or new hat. Parents generally know to use soothing words and tone, bring the difference into view gradually, smile and comfort the child, and explain the change; these are good skills for later, too. Infants notice skin color, which, unlike clothes, is a stable feature by which to recognize parents. Social interpretation of these differences is cued from the parents’ feelings and reactions. Adults naturally transmit biases from their own past unless they work to dampen them. If the parent was taught to regard “other” as negative or is generally fearful, the child mirrors this. Working to reduce racism thus requires parents (and professionals) to examine their prejudices to be able to convey positive or neutral reactions to people who are different. Parents need to show curiosity, positive affect, and comfort about people who are different, and do well to seek contact and friendships with people from other groups and include their children in these relationships. We can encourage this outreach plus ensure diversity and respectful interactions in our offices.
Children from age 3 years value fairness and are upset seeing others treated unfairly – easily understanding “not fair” or “mean.” If the person being hurt is like them in race, ethnicity, religion, gender, or sexual preference, they also fear for themselves, family, and friends. Balance is needed in discussing racism to avoid increasing fear or overpromising as risks are real and solutions difficult. Children look to adults for understanding and evidence of action to feel safer, rather than helpless. We should state that leaders are working on “making the rules more fair,” ensuring that people “won’t be allowed do it again,” and “teaching that everyone deserves respect.” Even better, parents and children can generate ideas about child actions, giving them some power as an antidote to anxiety. Age-related possibilities might include drawing a picture of people getting along, talking at show-and-tell, writing a note to officials, making a protest sign, posting thoughts on Facebook, or protesting.
With age, the culture increasingly influences a child’s attitudes. Children see lots of teasing and bullying based on differences from being overweight or wearing glasses, to skin color. It is helpful to interpret for children that bullies are insecure, or sometimes have been hurt, and they put other people down to feel better than someone else. Thinking about racist acts this way may reduce the desire for revenge and a cycle of aggression. Effective anti-bullying programs help children recognize bullying, see it as an emergency that requires their action, tell adults, and take action. This action could be surrounding the bully, standing tall, making eye contact, having a dismissive retort, or asking questions that require the bully to think, such as “What do you want to happen by doing this?” We can coach our patients and their parents on these principles as well as advising schools.
Children need to be told that those being put down or held down – especially those like them – have strengths; have made discoveries; have produced writings, art, and music; have shown military bravery, moral leadership, and resistance to discrimination, but it is not the time to show strength when confronted by a gun or police. We can use and arm parents with examples to discuss strengths and accomplishments to help buffer the child from internalization of racist stereotypes. Children need positive role models who look like them; parents can seek out diverse professionals in their children’s lives, such as dentists, doctors, teachers, clergy, mentors, or coaches. We, and parents, can ensure that dolls and books are available, and that the children’s shows, movies, and video games are watched together and include diverse people doing good or brave things. These exposures also are key to all children becoming anti-racist.
Parents can be advised to initiate discussion of racism because children, detecting adult discomfort, may avoid the topic. We can encourage families to give their point of view; otherwise children simply absorb those of peers or the press. Parents should tell their children, “I want you to be able to talk about it if someone is mean or treats you unfairly because of [the color of your skin, your religion, your sex, your disability, etc.]. You might feel helpless, or angry, which is natural. We need to talk about this so you can feel strong. Then we can plan on what we are going to do.” The “sandwich” method of “ask-give information-ask what they think” can encourage discussion and correct misperceptions.
Racist policies have succeeded partly by adult “bullies” dehumanizing the “other.” Most children can consider someone else’s point of view by 4½ years old, shaped with adult help. Parents can begin by telling babies, “That hurts, doesn’t it?” asking toddlers and older, “How would you feel if ... [someone called you a name just because of having red hair]?” or “How do you think she feels when ... [someone pushes her out of line because she wears certain clothes]?” in cases of grabbing, not sharing, hitting, bullying, etc. Older children and teens can analyze more abstract situations when asked, “What if you were the one who ... [got expelled for mumbling about the teacher]?” or “What if that were your sister?” or “How would the world be if everyone ... [got a chance to go to college]?” We can encourage parents to propose these mental exercises to build the child’s perspective-taking while conveying their opinions.
Experiences, including through media, may increase or decrease fear; the child needs to have a supportive person moderating the exposure, providing a positive interpretation, and protecting the child from overwhelm, if needed.
Experiences are insufficient for developing anti-racist attitudes; listening and talking are needed. The first step is to ask children about what they notice, think, and feel about situations reflecting racism, especially as they lack words for these complicated observations. There are television, Internet, and newspaper examples of both racism and anti-racism that can be fruitfully discussed. We can recommend watching or reading together, and asking questions such as, “Why do you think they are shouting [protesting]?” “How do you think the [victim, police] felt?” or “What do you think should be done about this?”
It is important to acknowledge the child’s confusion, fear, anxiety, sadness, or anger as normal and appropriate, not dismissing, too quickly reassuring, or changing the subject, even though it’s uncomfortable.
Physicians and nurse practitioners can make a difference by being aware of our privilege and biases, being open, modeling discussion, screening for impact, offering strategies, advocating with schools, and providing resources such as therapy or legal counsel, as for other social determinants of health.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (https://www.site.chadis.com/). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Preventive services coalition recommends routine anxiety screening for women
according to a new recommendation from the Women’s Preventive Services Initiative.
The lifetime prevalence of anxiety disorders in women in the United States is 40%, approximately twice that of men, and anxiety can be a manifestation of underlying issues including posttraumatic stress, sexual harassment, and assault, wrote Kimberly D. Gregory, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues on behalf of the Women’s Preventive Services Initiative (WPSI), a national coalition of women’s health professional organizations and patient representatives.
“The WPSI based its rationale for anxiety screening on several considerations,” the researchers noted. “Anxiety disorders are the most prevalent mental health disorders in women, and the problems created by untreated anxiety can impair function in all areas of a woman’s life.”
“Effective screening may lead to earlier or timelier treatment (including behavioral and medical interventions) and result in improved clinical outcomes, such as symptoms, function, and quality of life. Screening may also lead to the detection of associated conditions, such as depression and posttraumatic stress disorder, which may also require treatment,” they wrote.
To support the recommendation, the researchers evaluated data from 33 studies and 2 systematic reviews for a total of 171 studies. Most studies included screening instruments that involved clinician- or patient-administered questionnaires designed for use in clinical practice. Although none of the studies evaluated the overall effectiveness versus harm of screening for anxiety, the strength of evidence for the effectiveness of anxiety treatment ranged from moderate to high, and the evidence of harms ranged from low for cognitive-behavioral therapy to moderate for anxiety medications.
“Overall, the WPSI determined that the balance of benefits and harms would likely be favorable on the basis of the high prevalence of anxiety in women; its substantial effect on health, function, and quality of life; and evidence on the accuracy of screening instruments in primary care settings and the effectiveness and harms of treatment,” the researchers wrote.
Although anxiety screening is not currently routine in clinical practice in the United States, such screening could be done quickly and efficiently as part of an intake visit in a primary care or obstetric setting, using a brief screening tool similar to those used for depression, the researchers wrote. The goal of anxiety screening, as with depression screening, is to identify those who need further evaluation to diagnose or rule out an anxiety disorder.
“A revised version [of the draft recommendation] was adopted by the Health Resources and Services Administration in December 2019; it will be incorporated into the summary of covered benefits for preventive services without cost sharing as required by the Patient Protection and Affordable Care Act immediately or no later than 1 January 2021, depending on individual coverage,” the researchers noted.
“Covered benefits apply to most group health plans and issuers of group and individual health insurance coverage, as well as to persons who qualify for Medicaid on the basis of Medicaid expansion under the Affordable Care Act,” they wrote.
“Because anxiety disorders can be successfully treated, early detection through the use of a brief questionnaire could prevent years of symptoms and impairment in the lives of women at every stage of life,” they concluded.
Aaron Sutton, LCSW, a behavioral health consultant at Abington (Pa.) Hospital–Jefferson Health, expressed support for the guidelines in an interview.
“With almost half of all women experiencing an anxiety disorder sometime in their life, effective recognition and treatment of anxiety disorders is needed,” he said.
Mr. Sutton described treatment as being “fairly benign” with the initial approach being cognitive-behavioral therapy, a form of psychological talk therapy, and first-line pharmacologic therapies being SSRIs and serotonin norepinephrine reuptake inhibitors.
Mr. Sutton also explained how he expects effective screening and treatment will benefit women with anxiety and the health care system.
“Women will see improvement in areas such as personal relationships, work, school, and social settings. The health care system will see benefits as costs related to anxiety disorders, be it direct or indirect, are in the billions of dollars,” he said.
Although screening for anxiety will increase the workload of primary care physicians, anxiety screening should be included and could perhaps be administered in conjunction with the routine depression screening already recommended as part of primary care visits, Mr. Sutton noted.
“Anxiety disorders can be successfully treated, and early detection can prevent years of symptoms and impairment,” he emphasized.
“Anxiety often occurs among adolescents and adult women and often becomes a chronic problem with impairments,” said Cynthia Pfeffer, MD, professor of psychiatry at Weill Cornell Medicine, New York, in an interview. “Screening for anxiety could identify and enable planning to decrease and prevent this impairing prevalent condition and its associated problems. For example, anxiety can impair adolescents’ academic and social functioning and if this is lasting also impair their success in work and future planning for families. There are successful treatments for anxiety and identification of individuals at an early time may prevent impairments in daily functioning.”
Dr. Pfeffer noted that steps to overcome barriers to prevention and treatment for anxiety include “educating health care professionals about the problems caused from anxiety, learning means to identify and diagnose anxiety, and developing proficiency in offering methods to prevent and intervene for women with symptoms of anxiety.”
The take-home message for clinicians is that anxiety is prevalent among females of all ages and often begins early and becomes chronic.
“There are excellent treatments including psychotherapy and medication that can decrease and prevent anxiety,” she emphasized. “Training practicing clinicians including MDs as well as other professionals in the health care system about anxiety will enhance the wellbeing of women.”
More research is needed to evaluate methods used during health care visits for anxiety screening and treatment in order to determine valid means of preventing the impairments associated with anxiety, Dr. Pfeffer said.
Mr. Sutton noted that no trials “have evaluated overall effectiveness or potential harms including labeling, misdiagnosis, and overdiagnosis.” Other areas in need of research include the changes in incidence and prevalence of anxiety over time, as well as specific risk factors including marriage, divorce, pregnancy, and childbirth, he added.
The research for the recommendation was supported by the Health Resources and Services Administration. The researchers had no financial conflicts to disclose. Mr. Sutton had no financial conflicts to disclose. Dr. Pfeffer has written extensively on depression and anxiety in children, adolescents, and adults. She had no financial conflicts to disclose.
SOURCE: Gregory KD et al. Ann Intern Med. 2020 June 9. doi: 10.7326/M20-0580.
according to a new recommendation from the Women’s Preventive Services Initiative.
The lifetime prevalence of anxiety disorders in women in the United States is 40%, approximately twice that of men, and anxiety can be a manifestation of underlying issues including posttraumatic stress, sexual harassment, and assault, wrote Kimberly D. Gregory, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues on behalf of the Women’s Preventive Services Initiative (WPSI), a national coalition of women’s health professional organizations and patient representatives.
“The WPSI based its rationale for anxiety screening on several considerations,” the researchers noted. “Anxiety disorders are the most prevalent mental health disorders in women, and the problems created by untreated anxiety can impair function in all areas of a woman’s life.”
“Effective screening may lead to earlier or timelier treatment (including behavioral and medical interventions) and result in improved clinical outcomes, such as symptoms, function, and quality of life. Screening may also lead to the detection of associated conditions, such as depression and posttraumatic stress disorder, which may also require treatment,” they wrote.
To support the recommendation, the researchers evaluated data from 33 studies and 2 systematic reviews for a total of 171 studies. Most studies included screening instruments that involved clinician- or patient-administered questionnaires designed for use in clinical practice. Although none of the studies evaluated the overall effectiveness versus harm of screening for anxiety, the strength of evidence for the effectiveness of anxiety treatment ranged from moderate to high, and the evidence of harms ranged from low for cognitive-behavioral therapy to moderate for anxiety medications.
“Overall, the WPSI determined that the balance of benefits and harms would likely be favorable on the basis of the high prevalence of anxiety in women; its substantial effect on health, function, and quality of life; and evidence on the accuracy of screening instruments in primary care settings and the effectiveness and harms of treatment,” the researchers wrote.
Although anxiety screening is not currently routine in clinical practice in the United States, such screening could be done quickly and efficiently as part of an intake visit in a primary care or obstetric setting, using a brief screening tool similar to those used for depression, the researchers wrote. The goal of anxiety screening, as with depression screening, is to identify those who need further evaluation to diagnose or rule out an anxiety disorder.
“A revised version [of the draft recommendation] was adopted by the Health Resources and Services Administration in December 2019; it will be incorporated into the summary of covered benefits for preventive services without cost sharing as required by the Patient Protection and Affordable Care Act immediately or no later than 1 January 2021, depending on individual coverage,” the researchers noted.
“Covered benefits apply to most group health plans and issuers of group and individual health insurance coverage, as well as to persons who qualify for Medicaid on the basis of Medicaid expansion under the Affordable Care Act,” they wrote.
“Because anxiety disorders can be successfully treated, early detection through the use of a brief questionnaire could prevent years of symptoms and impairment in the lives of women at every stage of life,” they concluded.
Aaron Sutton, LCSW, a behavioral health consultant at Abington (Pa.) Hospital–Jefferson Health, expressed support for the guidelines in an interview.
“With almost half of all women experiencing an anxiety disorder sometime in their life, effective recognition and treatment of anxiety disorders is needed,” he said.
Mr. Sutton described treatment as being “fairly benign” with the initial approach being cognitive-behavioral therapy, a form of psychological talk therapy, and first-line pharmacologic therapies being SSRIs and serotonin norepinephrine reuptake inhibitors.
Mr. Sutton also explained how he expects effective screening and treatment will benefit women with anxiety and the health care system.
“Women will see improvement in areas such as personal relationships, work, school, and social settings. The health care system will see benefits as costs related to anxiety disorders, be it direct or indirect, are in the billions of dollars,” he said.
Although screening for anxiety will increase the workload of primary care physicians, anxiety screening should be included and could perhaps be administered in conjunction with the routine depression screening already recommended as part of primary care visits, Mr. Sutton noted.
“Anxiety disorders can be successfully treated, and early detection can prevent years of symptoms and impairment,” he emphasized.
“Anxiety often occurs among adolescents and adult women and often becomes a chronic problem with impairments,” said Cynthia Pfeffer, MD, professor of psychiatry at Weill Cornell Medicine, New York, in an interview. “Screening for anxiety could identify and enable planning to decrease and prevent this impairing prevalent condition and its associated problems. For example, anxiety can impair adolescents’ academic and social functioning and if this is lasting also impair their success in work and future planning for families. There are successful treatments for anxiety and identification of individuals at an early time may prevent impairments in daily functioning.”
Dr. Pfeffer noted that steps to overcome barriers to prevention and treatment for anxiety include “educating health care professionals about the problems caused from anxiety, learning means to identify and diagnose anxiety, and developing proficiency in offering methods to prevent and intervene for women with symptoms of anxiety.”
The take-home message for clinicians is that anxiety is prevalent among females of all ages and often begins early and becomes chronic.
“There are excellent treatments including psychotherapy and medication that can decrease and prevent anxiety,” she emphasized. “Training practicing clinicians including MDs as well as other professionals in the health care system about anxiety will enhance the wellbeing of women.”
More research is needed to evaluate methods used during health care visits for anxiety screening and treatment in order to determine valid means of preventing the impairments associated with anxiety, Dr. Pfeffer said.
Mr. Sutton noted that no trials “have evaluated overall effectiveness or potential harms including labeling, misdiagnosis, and overdiagnosis.” Other areas in need of research include the changes in incidence and prevalence of anxiety over time, as well as specific risk factors including marriage, divorce, pregnancy, and childbirth, he added.
The research for the recommendation was supported by the Health Resources and Services Administration. The researchers had no financial conflicts to disclose. Mr. Sutton had no financial conflicts to disclose. Dr. Pfeffer has written extensively on depression and anxiety in children, adolescents, and adults. She had no financial conflicts to disclose.
SOURCE: Gregory KD et al. Ann Intern Med. 2020 June 9. doi: 10.7326/M20-0580.
according to a new recommendation from the Women’s Preventive Services Initiative.
The lifetime prevalence of anxiety disorders in women in the United States is 40%, approximately twice that of men, and anxiety can be a manifestation of underlying issues including posttraumatic stress, sexual harassment, and assault, wrote Kimberly D. Gregory, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues on behalf of the Women’s Preventive Services Initiative (WPSI), a national coalition of women’s health professional organizations and patient representatives.
“The WPSI based its rationale for anxiety screening on several considerations,” the researchers noted. “Anxiety disorders are the most prevalent mental health disorders in women, and the problems created by untreated anxiety can impair function in all areas of a woman’s life.”
“Effective screening may lead to earlier or timelier treatment (including behavioral and medical interventions) and result in improved clinical outcomes, such as symptoms, function, and quality of life. Screening may also lead to the detection of associated conditions, such as depression and posttraumatic stress disorder, which may also require treatment,” they wrote.
To support the recommendation, the researchers evaluated data from 33 studies and 2 systematic reviews for a total of 171 studies. Most studies included screening instruments that involved clinician- or patient-administered questionnaires designed for use in clinical practice. Although none of the studies evaluated the overall effectiveness versus harm of screening for anxiety, the strength of evidence for the effectiveness of anxiety treatment ranged from moderate to high, and the evidence of harms ranged from low for cognitive-behavioral therapy to moderate for anxiety medications.
“Overall, the WPSI determined that the balance of benefits and harms would likely be favorable on the basis of the high prevalence of anxiety in women; its substantial effect on health, function, and quality of life; and evidence on the accuracy of screening instruments in primary care settings and the effectiveness and harms of treatment,” the researchers wrote.
Although anxiety screening is not currently routine in clinical practice in the United States, such screening could be done quickly and efficiently as part of an intake visit in a primary care or obstetric setting, using a brief screening tool similar to those used for depression, the researchers wrote. The goal of anxiety screening, as with depression screening, is to identify those who need further evaluation to diagnose or rule out an anxiety disorder.
“A revised version [of the draft recommendation] was adopted by the Health Resources and Services Administration in December 2019; it will be incorporated into the summary of covered benefits for preventive services without cost sharing as required by the Patient Protection and Affordable Care Act immediately or no later than 1 January 2021, depending on individual coverage,” the researchers noted.
“Covered benefits apply to most group health plans and issuers of group and individual health insurance coverage, as well as to persons who qualify for Medicaid on the basis of Medicaid expansion under the Affordable Care Act,” they wrote.
“Because anxiety disorders can be successfully treated, early detection through the use of a brief questionnaire could prevent years of symptoms and impairment in the lives of women at every stage of life,” they concluded.
Aaron Sutton, LCSW, a behavioral health consultant at Abington (Pa.) Hospital–Jefferson Health, expressed support for the guidelines in an interview.
“With almost half of all women experiencing an anxiety disorder sometime in their life, effective recognition and treatment of anxiety disorders is needed,” he said.
Mr. Sutton described treatment as being “fairly benign” with the initial approach being cognitive-behavioral therapy, a form of psychological talk therapy, and first-line pharmacologic therapies being SSRIs and serotonin norepinephrine reuptake inhibitors.
Mr. Sutton also explained how he expects effective screening and treatment will benefit women with anxiety and the health care system.
“Women will see improvement in areas such as personal relationships, work, school, and social settings. The health care system will see benefits as costs related to anxiety disorders, be it direct or indirect, are in the billions of dollars,” he said.
Although screening for anxiety will increase the workload of primary care physicians, anxiety screening should be included and could perhaps be administered in conjunction with the routine depression screening already recommended as part of primary care visits, Mr. Sutton noted.
“Anxiety disorders can be successfully treated, and early detection can prevent years of symptoms and impairment,” he emphasized.
“Anxiety often occurs among adolescents and adult women and often becomes a chronic problem with impairments,” said Cynthia Pfeffer, MD, professor of psychiatry at Weill Cornell Medicine, New York, in an interview. “Screening for anxiety could identify and enable planning to decrease and prevent this impairing prevalent condition and its associated problems. For example, anxiety can impair adolescents’ academic and social functioning and if this is lasting also impair their success in work and future planning for families. There are successful treatments for anxiety and identification of individuals at an early time may prevent impairments in daily functioning.”
Dr. Pfeffer noted that steps to overcome barriers to prevention and treatment for anxiety include “educating health care professionals about the problems caused from anxiety, learning means to identify and diagnose anxiety, and developing proficiency in offering methods to prevent and intervene for women with symptoms of anxiety.”
The take-home message for clinicians is that anxiety is prevalent among females of all ages and often begins early and becomes chronic.
“There are excellent treatments including psychotherapy and medication that can decrease and prevent anxiety,” she emphasized. “Training practicing clinicians including MDs as well as other professionals in the health care system about anxiety will enhance the wellbeing of women.”
More research is needed to evaluate methods used during health care visits for anxiety screening and treatment in order to determine valid means of preventing the impairments associated with anxiety, Dr. Pfeffer said.
Mr. Sutton noted that no trials “have evaluated overall effectiveness or potential harms including labeling, misdiagnosis, and overdiagnosis.” Other areas in need of research include the changes in incidence and prevalence of anxiety over time, as well as specific risk factors including marriage, divorce, pregnancy, and childbirth, he added.
The research for the recommendation was supported by the Health Resources and Services Administration. The researchers had no financial conflicts to disclose. Mr. Sutton had no financial conflicts to disclose. Dr. Pfeffer has written extensively on depression and anxiety in children, adolescents, and adults. She had no financial conflicts to disclose.
SOURCE: Gregory KD et al. Ann Intern Med. 2020 June 9. doi: 10.7326/M20-0580.
FROM ANNALS OF INTERNAL MEDICINE
Consider the stresses experienced by LGBTQ people of color
Given that Pride month is coinciding with so much upheaval in our community around racism and oppression, it is important to discuss the overlap in the experiences of both LGBTQ and people of color (POC).
The year 2020 will go down in history books. We will always remember the issues faced during this critical year. At least I hope so, because as we have seen, history repeats itself. How do these issues that we are currently facing relate to LGBTQ youth? The histories are linked. One cannot look at the history of LGBTQ rights without looking at other civil rights movements, particularly those for black people. The timing of these social movements often intertwined, both being inspired by and inspiring each other. For example, Bayard Rustin worked with Dr. Martin Luther King Jr. as an organizer for the March on Washington for Jobs and Freedom in addition to being a public advocate for gay rights later on in his life. Similarly, the Stonewall Uprising that is known by many to be one of the first acts of the gay liberation movement, prominently featured Marsha P. Johnson (a black, transgender, self-identified drag queen) and Sylvia Rivera (a Latina American transgender rights activist). As we reflect on these histories, it is important to think about the effect of minority stress and intersectionality and how this impacts LGBTQ-POC and their health disparities.
Minority stress shows that . One example of such stressors is microaggressions – brief interactions that one might not realize are discriminatory or hurtful, but to the person on the receiving end of such comments, they are harmful and they add up. A suspicious look from a store owner as one browses the aisles of a local convenience store, a comment about how one “doesn’t’ seem gay” or “doesn’t sound black” all are examples of microaggressions.
Overt discrimination, expectation of rejection, and hate crimes also contribute to minority stress. LGBTQ individuals often also have to hide their identity whereas POC might not be able to hide their identity. Experiencing constant bombardment of discrimination from the outside world can lead one to internalize these thoughts of homophobia, transphobia, or racism.
Minority stress becomes even more complicated when you apply the theoretical framework of intersectionality – overlapping identities that compound one’s minority stress. Lesbian, gay, bisexual, transgender, and queer people of color (LGBTQ-POC) are a classic example of intersecting identities. They may experience racism from the LGBT community or homophobia/transphobia from their own racial or ethnic community in addition to the discrimination they already face from the majority population for both identities. Some LGBTQ people of color may feel the need to choose between these two identities, forcing them to compartmentalize one aspect of their identity from the other. Imagine how stressful that must be! In addition, LGBTQ-POC are less likely to come out to family members.
Most of us are aware that health disparities exist, both for the LGBTQ community as well as for racial and ethnic minorities; couple these together and the effect can be additive, placing LGBTQ-POC at higher risk for adverse health outcomes. In the late 1990s, racial and ethnic minority men having sex with men made up 48% of all HIV infection cases, a number that is clearly disproportionate to their representation in our overall society. Given both LGBTQ and POC have issues accessing care, one can only imagine that this would make it hard to get diagnosed or treated regularly for these issues.
Transgender POC also are particularly vulnerable to health disparities. The 2015 U.S. Transgender Survey looked at the experiences of over 28,000 transgender people in the United States, but the survey also broke down the experiences for transgender people of color. Black transgender individuals were more likely than their black cisgender counterparts to experience unemployment (20% vs. 10%) and poverty (38% vs. 24%). They were more likely to experience homelessness compared with the overall transgender sample (42% vs. 30%) and more likely to have been sexually assaulted in their lives (53% vs. 47%). Understandably, 67% of black transgender respondents said they would feel somewhat or very uncomfortable asking the police for help.
The findings were similar for Latinx transgender respondents: 21% were unemployed compared with the overall rate of unemployment for Latinx in the United States at 7%, and 43% were living in poverty compared with 18% of their cisgender peers.
Perhaps the most striking result among American Indian and Alaska Native respondents was that 57% had experienced homelessness – nearly twice the rate of the survey sample overall (30%). For the transgender Asian and Native Hawaiian/Pacific Islander respondents, 32% were living in poverty and 39% had experienced serious psychological distress in the month before completing the survey.
So please, check in on your patients, friends, and family that identify as both LGBTQ and POC. Imagine how scary this must be for LGBTQ youth of color. They can be targeted for both their race and their sexuality and/or gender identity.
Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures. Email her at [email protected].
Given that Pride month is coinciding with so much upheaval in our community around racism and oppression, it is important to discuss the overlap in the experiences of both LGBTQ and people of color (POC).
The year 2020 will go down in history books. We will always remember the issues faced during this critical year. At least I hope so, because as we have seen, history repeats itself. How do these issues that we are currently facing relate to LGBTQ youth? The histories are linked. One cannot look at the history of LGBTQ rights without looking at other civil rights movements, particularly those for black people. The timing of these social movements often intertwined, both being inspired by and inspiring each other. For example, Bayard Rustin worked with Dr. Martin Luther King Jr. as an organizer for the March on Washington for Jobs and Freedom in addition to being a public advocate for gay rights later on in his life. Similarly, the Stonewall Uprising that is known by many to be one of the first acts of the gay liberation movement, prominently featured Marsha P. Johnson (a black, transgender, self-identified drag queen) and Sylvia Rivera (a Latina American transgender rights activist). As we reflect on these histories, it is important to think about the effect of minority stress and intersectionality and how this impacts LGBTQ-POC and their health disparities.
Minority stress shows that . One example of such stressors is microaggressions – brief interactions that one might not realize are discriminatory or hurtful, but to the person on the receiving end of such comments, they are harmful and they add up. A suspicious look from a store owner as one browses the aisles of a local convenience store, a comment about how one “doesn’t’ seem gay” or “doesn’t sound black” all are examples of microaggressions.
Overt discrimination, expectation of rejection, and hate crimes also contribute to minority stress. LGBTQ individuals often also have to hide their identity whereas POC might not be able to hide their identity. Experiencing constant bombardment of discrimination from the outside world can lead one to internalize these thoughts of homophobia, transphobia, or racism.
Minority stress becomes even more complicated when you apply the theoretical framework of intersectionality – overlapping identities that compound one’s minority stress. Lesbian, gay, bisexual, transgender, and queer people of color (LGBTQ-POC) are a classic example of intersecting identities. They may experience racism from the LGBT community or homophobia/transphobia from their own racial or ethnic community in addition to the discrimination they already face from the majority population for both identities. Some LGBTQ people of color may feel the need to choose between these two identities, forcing them to compartmentalize one aspect of their identity from the other. Imagine how stressful that must be! In addition, LGBTQ-POC are less likely to come out to family members.
Most of us are aware that health disparities exist, both for the LGBTQ community as well as for racial and ethnic minorities; couple these together and the effect can be additive, placing LGBTQ-POC at higher risk for adverse health outcomes. In the late 1990s, racial and ethnic minority men having sex with men made up 48% of all HIV infection cases, a number that is clearly disproportionate to their representation in our overall society. Given both LGBTQ and POC have issues accessing care, one can only imagine that this would make it hard to get diagnosed or treated regularly for these issues.
Transgender POC also are particularly vulnerable to health disparities. The 2015 U.S. Transgender Survey looked at the experiences of over 28,000 transgender people in the United States, but the survey also broke down the experiences for transgender people of color. Black transgender individuals were more likely than their black cisgender counterparts to experience unemployment (20% vs. 10%) and poverty (38% vs. 24%). They were more likely to experience homelessness compared with the overall transgender sample (42% vs. 30%) and more likely to have been sexually assaulted in their lives (53% vs. 47%). Understandably, 67% of black transgender respondents said they would feel somewhat or very uncomfortable asking the police for help.
The findings were similar for Latinx transgender respondents: 21% were unemployed compared with the overall rate of unemployment for Latinx in the United States at 7%, and 43% were living in poverty compared with 18% of their cisgender peers.
Perhaps the most striking result among American Indian and Alaska Native respondents was that 57% had experienced homelessness – nearly twice the rate of the survey sample overall (30%). For the transgender Asian and Native Hawaiian/Pacific Islander respondents, 32% were living in poverty and 39% had experienced serious psychological distress in the month before completing the survey.
So please, check in on your patients, friends, and family that identify as both LGBTQ and POC. Imagine how scary this must be for LGBTQ youth of color. They can be targeted for both their race and their sexuality and/or gender identity.
Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures. Email her at [email protected].
Given that Pride month is coinciding with so much upheaval in our community around racism and oppression, it is important to discuss the overlap in the experiences of both LGBTQ and people of color (POC).
The year 2020 will go down in history books. We will always remember the issues faced during this critical year. At least I hope so, because as we have seen, history repeats itself. How do these issues that we are currently facing relate to LGBTQ youth? The histories are linked. One cannot look at the history of LGBTQ rights without looking at other civil rights movements, particularly those for black people. The timing of these social movements often intertwined, both being inspired by and inspiring each other. For example, Bayard Rustin worked with Dr. Martin Luther King Jr. as an organizer for the March on Washington for Jobs and Freedom in addition to being a public advocate for gay rights later on in his life. Similarly, the Stonewall Uprising that is known by many to be one of the first acts of the gay liberation movement, prominently featured Marsha P. Johnson (a black, transgender, self-identified drag queen) and Sylvia Rivera (a Latina American transgender rights activist). As we reflect on these histories, it is important to think about the effect of minority stress and intersectionality and how this impacts LGBTQ-POC and their health disparities.
Minority stress shows that . One example of such stressors is microaggressions – brief interactions that one might not realize are discriminatory or hurtful, but to the person on the receiving end of such comments, they are harmful and they add up. A suspicious look from a store owner as one browses the aisles of a local convenience store, a comment about how one “doesn’t’ seem gay” or “doesn’t sound black” all are examples of microaggressions.
Overt discrimination, expectation of rejection, and hate crimes also contribute to minority stress. LGBTQ individuals often also have to hide their identity whereas POC might not be able to hide their identity. Experiencing constant bombardment of discrimination from the outside world can lead one to internalize these thoughts of homophobia, transphobia, or racism.
Minority stress becomes even more complicated when you apply the theoretical framework of intersectionality – overlapping identities that compound one’s minority stress. Lesbian, gay, bisexual, transgender, and queer people of color (LGBTQ-POC) are a classic example of intersecting identities. They may experience racism from the LGBT community or homophobia/transphobia from their own racial or ethnic community in addition to the discrimination they already face from the majority population for both identities. Some LGBTQ people of color may feel the need to choose between these two identities, forcing them to compartmentalize one aspect of their identity from the other. Imagine how stressful that must be! In addition, LGBTQ-POC are less likely to come out to family members.
Most of us are aware that health disparities exist, both for the LGBTQ community as well as for racial and ethnic minorities; couple these together and the effect can be additive, placing LGBTQ-POC at higher risk for adverse health outcomes. In the late 1990s, racial and ethnic minority men having sex with men made up 48% of all HIV infection cases, a number that is clearly disproportionate to their representation in our overall society. Given both LGBTQ and POC have issues accessing care, one can only imagine that this would make it hard to get diagnosed or treated regularly for these issues.
Transgender POC also are particularly vulnerable to health disparities. The 2015 U.S. Transgender Survey looked at the experiences of over 28,000 transgender people in the United States, but the survey also broke down the experiences for transgender people of color. Black transgender individuals were more likely than their black cisgender counterparts to experience unemployment (20% vs. 10%) and poverty (38% vs. 24%). They were more likely to experience homelessness compared with the overall transgender sample (42% vs. 30%) and more likely to have been sexually assaulted in their lives (53% vs. 47%). Understandably, 67% of black transgender respondents said they would feel somewhat or very uncomfortable asking the police for help.
The findings were similar for Latinx transgender respondents: 21% were unemployed compared with the overall rate of unemployment for Latinx in the United States at 7%, and 43% were living in poverty compared with 18% of their cisgender peers.
Perhaps the most striking result among American Indian and Alaska Native respondents was that 57% had experienced homelessness – nearly twice the rate of the survey sample overall (30%). For the transgender Asian and Native Hawaiian/Pacific Islander respondents, 32% were living in poverty and 39% had experienced serious psychological distress in the month before completing the survey.
So please, check in on your patients, friends, and family that identify as both LGBTQ and POC. Imagine how scary this must be for LGBTQ youth of color. They can be targeted for both their race and their sexuality and/or gender identity.
Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures. Email her at [email protected].
Survey: 26% of parents hesitant about influenza vaccine
according to a nationally representative survey.
Influenza vaccination hesitancy may be driven by concerns about vaccine effectiveness, researchers wrote in Pediatrics. These findings “underscore the importance of better communicating to providers and parents the effectiveness of influenza vaccines in reducing severity and morbidity from influenza, even in years when the vaccine has relatively low effectiveness,” noted Allison Kempe, MD, MPH, professor of pediatrics and director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science at the University of Colorado at Denver, Aurora, and colleagues.
The World Health Organization considers vaccine hesitancy a leading threat to global health, but national data about vaccine hesitancy in the United States are limited. To assess hesitancy about routine childhood and influenza vaccinations and related factors, Dr. Kempe and colleagues surveyed more than 2,000 parents in February 2019.
The investigators used an online panel to survey a nationally representative sample of families with children aged between 6 months and 18 years. Parents completed a modified version of the Vaccine Hesitancy Scale, which measures confidence in and concerns about vaccines. Parents with an average score greater than 3 on the scale were considered hesitant.
Factors associated with vaccine hesitancy
Of 4,445 parents sampled, 2,176 completed the survey and 2,052 were eligible respondents. For routine childhood vaccines, the average score on the modified Vaccine Hesitancy Scale was 2 and the percentage of hesitant parents was 6%. For influenza vaccine, the average score was 2 and the percentage of hesitant parents was 26%.
Among hesitant parents, 68% had deferred or refused routine childhood vaccination, compared with 9% of nonhesitant parents (risk ratio, 8.0). For the influenza vaccine, 70% of hesitant parents had deferred or refused influenza vaccination for their child versus 10% of nonhesitant parents (RR, 7.0). Parents were more likely to strongly agree that routine childhood vaccines are effective, compared with the influenza vaccine (70% vs. 26%). “Hesitancy about influenza vaccination is largely driven by concerns about low vaccine effectiveness,” Dr. Kempe and associates wrote.
Although concern about serious side effects was the factor most associated with hesitancy, the percentage of parents who were strongly (12%) or somewhat (27%) concerned about serious side effects was the same for routine childhood vaccines and influenza vaccines. Other factors associated with hesitancy for both routine childhood vaccines and influenza vaccines included lower educational level and household income less than 400% of the federal poverty level.
The survey data may be subject to reporting bias based on social desirability, the authors noted. In addition, the exclusion of infants younger than 6 months may have resulted in an underestimate of hesitancy.
“Although influenza vaccine could be included as a ‘routine’ vaccine, in that it is recommended yearly, we hypothesized that parents view it differently from other childhood vaccines because each year it needs to be given again, its content and effectiveness vary, and it addresses a disease that is often perceived as minor, compared with other childhood diseases,” Dr. Kempe and colleagues wrote. Interventions to counter hesitancy have “a surprising lack of evidence,” and “more work needs to be done to develop methods that are practical and effective for convincing vaccine-hesitant parents to vaccinate.”
Logical next step
“From the pragmatic standpoint of improving immunization rates and disease control, determining the correct evidence-based messaging to counter these perceptions is the next logical step,” Annabelle de St. Maurice, MD, MPH, an assistant professor of pediatrics in the division of infectious diseases at University of California, Los Angeles, and Kathryn Edwards, MD, a professor of pediatrics and director of the vaccine research program at Vanderbilt University, Nashville, wrote in an accompanying editorial.
“Communications should be focused on the burden of influenza in children, rebranding influenza vaccine as a ‘routine’ childhood immunization, reassurance on influenza vaccine safety, and discussion of the efficacy of influenza vaccine in preventing severe disease,” they wrote. “Even in the years when there is a poor match, the vaccine is impactful.”
The research was supported by the National Institutes of Health. Two study authors disclosed financial ties to Sanofi Pasteur, with one also disclosing financial ties to Merck, for work related to vaccinations. The remaining investigators had no relevant financial disclosures. Dr. de St. Maurice indicated that she had no relevant financial disclosures. Dr. Edwards disclosed grants from the Centers for Disease Control and Prevention and the NIH; consulting for Merck, Bionet, and IBM; and serving on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer.
SOURCE: Kempe A et al. Pediatrics. 2020 Jun 15. doi: 10.1542/peds.2019-3852.
according to a nationally representative survey.
Influenza vaccination hesitancy may be driven by concerns about vaccine effectiveness, researchers wrote in Pediatrics. These findings “underscore the importance of better communicating to providers and parents the effectiveness of influenza vaccines in reducing severity and morbidity from influenza, even in years when the vaccine has relatively low effectiveness,” noted Allison Kempe, MD, MPH, professor of pediatrics and director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science at the University of Colorado at Denver, Aurora, and colleagues.
The World Health Organization considers vaccine hesitancy a leading threat to global health, but national data about vaccine hesitancy in the United States are limited. To assess hesitancy about routine childhood and influenza vaccinations and related factors, Dr. Kempe and colleagues surveyed more than 2,000 parents in February 2019.
The investigators used an online panel to survey a nationally representative sample of families with children aged between 6 months and 18 years. Parents completed a modified version of the Vaccine Hesitancy Scale, which measures confidence in and concerns about vaccines. Parents with an average score greater than 3 on the scale were considered hesitant.
Factors associated with vaccine hesitancy
Of 4,445 parents sampled, 2,176 completed the survey and 2,052 were eligible respondents. For routine childhood vaccines, the average score on the modified Vaccine Hesitancy Scale was 2 and the percentage of hesitant parents was 6%. For influenza vaccine, the average score was 2 and the percentage of hesitant parents was 26%.
Among hesitant parents, 68% had deferred or refused routine childhood vaccination, compared with 9% of nonhesitant parents (risk ratio, 8.0). For the influenza vaccine, 70% of hesitant parents had deferred or refused influenza vaccination for their child versus 10% of nonhesitant parents (RR, 7.0). Parents were more likely to strongly agree that routine childhood vaccines are effective, compared with the influenza vaccine (70% vs. 26%). “Hesitancy about influenza vaccination is largely driven by concerns about low vaccine effectiveness,” Dr. Kempe and associates wrote.
Although concern about serious side effects was the factor most associated with hesitancy, the percentage of parents who were strongly (12%) or somewhat (27%) concerned about serious side effects was the same for routine childhood vaccines and influenza vaccines. Other factors associated with hesitancy for both routine childhood vaccines and influenza vaccines included lower educational level and household income less than 400% of the federal poverty level.
The survey data may be subject to reporting bias based on social desirability, the authors noted. In addition, the exclusion of infants younger than 6 months may have resulted in an underestimate of hesitancy.
“Although influenza vaccine could be included as a ‘routine’ vaccine, in that it is recommended yearly, we hypothesized that parents view it differently from other childhood vaccines because each year it needs to be given again, its content and effectiveness vary, and it addresses a disease that is often perceived as minor, compared with other childhood diseases,” Dr. Kempe and colleagues wrote. Interventions to counter hesitancy have “a surprising lack of evidence,” and “more work needs to be done to develop methods that are practical and effective for convincing vaccine-hesitant parents to vaccinate.”
Logical next step
“From the pragmatic standpoint of improving immunization rates and disease control, determining the correct evidence-based messaging to counter these perceptions is the next logical step,” Annabelle de St. Maurice, MD, MPH, an assistant professor of pediatrics in the division of infectious diseases at University of California, Los Angeles, and Kathryn Edwards, MD, a professor of pediatrics and director of the vaccine research program at Vanderbilt University, Nashville, wrote in an accompanying editorial.
“Communications should be focused on the burden of influenza in children, rebranding influenza vaccine as a ‘routine’ childhood immunization, reassurance on influenza vaccine safety, and discussion of the efficacy of influenza vaccine in preventing severe disease,” they wrote. “Even in the years when there is a poor match, the vaccine is impactful.”
The research was supported by the National Institutes of Health. Two study authors disclosed financial ties to Sanofi Pasteur, with one also disclosing financial ties to Merck, for work related to vaccinations. The remaining investigators had no relevant financial disclosures. Dr. de St. Maurice indicated that she had no relevant financial disclosures. Dr. Edwards disclosed grants from the Centers for Disease Control and Prevention and the NIH; consulting for Merck, Bionet, and IBM; and serving on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer.
SOURCE: Kempe A et al. Pediatrics. 2020 Jun 15. doi: 10.1542/peds.2019-3852.
according to a nationally representative survey.
Influenza vaccination hesitancy may be driven by concerns about vaccine effectiveness, researchers wrote in Pediatrics. These findings “underscore the importance of better communicating to providers and parents the effectiveness of influenza vaccines in reducing severity and morbidity from influenza, even in years when the vaccine has relatively low effectiveness,” noted Allison Kempe, MD, MPH, professor of pediatrics and director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science at the University of Colorado at Denver, Aurora, and colleagues.
The World Health Organization considers vaccine hesitancy a leading threat to global health, but national data about vaccine hesitancy in the United States are limited. To assess hesitancy about routine childhood and influenza vaccinations and related factors, Dr. Kempe and colleagues surveyed more than 2,000 parents in February 2019.
The investigators used an online panel to survey a nationally representative sample of families with children aged between 6 months and 18 years. Parents completed a modified version of the Vaccine Hesitancy Scale, which measures confidence in and concerns about vaccines. Parents with an average score greater than 3 on the scale were considered hesitant.
Factors associated with vaccine hesitancy
Of 4,445 parents sampled, 2,176 completed the survey and 2,052 were eligible respondents. For routine childhood vaccines, the average score on the modified Vaccine Hesitancy Scale was 2 and the percentage of hesitant parents was 6%. For influenza vaccine, the average score was 2 and the percentage of hesitant parents was 26%.
Among hesitant parents, 68% had deferred or refused routine childhood vaccination, compared with 9% of nonhesitant parents (risk ratio, 8.0). For the influenza vaccine, 70% of hesitant parents had deferred or refused influenza vaccination for their child versus 10% of nonhesitant parents (RR, 7.0). Parents were more likely to strongly agree that routine childhood vaccines are effective, compared with the influenza vaccine (70% vs. 26%). “Hesitancy about influenza vaccination is largely driven by concerns about low vaccine effectiveness,” Dr. Kempe and associates wrote.
Although concern about serious side effects was the factor most associated with hesitancy, the percentage of parents who were strongly (12%) or somewhat (27%) concerned about serious side effects was the same for routine childhood vaccines and influenza vaccines. Other factors associated with hesitancy for both routine childhood vaccines and influenza vaccines included lower educational level and household income less than 400% of the federal poverty level.
The survey data may be subject to reporting bias based on social desirability, the authors noted. In addition, the exclusion of infants younger than 6 months may have resulted in an underestimate of hesitancy.
“Although influenza vaccine could be included as a ‘routine’ vaccine, in that it is recommended yearly, we hypothesized that parents view it differently from other childhood vaccines because each year it needs to be given again, its content and effectiveness vary, and it addresses a disease that is often perceived as minor, compared with other childhood diseases,” Dr. Kempe and colleagues wrote. Interventions to counter hesitancy have “a surprising lack of evidence,” and “more work needs to be done to develop methods that are practical and effective for convincing vaccine-hesitant parents to vaccinate.”
Logical next step
“From the pragmatic standpoint of improving immunization rates and disease control, determining the correct evidence-based messaging to counter these perceptions is the next logical step,” Annabelle de St. Maurice, MD, MPH, an assistant professor of pediatrics in the division of infectious diseases at University of California, Los Angeles, and Kathryn Edwards, MD, a professor of pediatrics and director of the vaccine research program at Vanderbilt University, Nashville, wrote in an accompanying editorial.
“Communications should be focused on the burden of influenza in children, rebranding influenza vaccine as a ‘routine’ childhood immunization, reassurance on influenza vaccine safety, and discussion of the efficacy of influenza vaccine in preventing severe disease,” they wrote. “Even in the years when there is a poor match, the vaccine is impactful.”
The research was supported by the National Institutes of Health. Two study authors disclosed financial ties to Sanofi Pasteur, with one also disclosing financial ties to Merck, for work related to vaccinations. The remaining investigators had no relevant financial disclosures. Dr. de St. Maurice indicated that she had no relevant financial disclosures. Dr. Edwards disclosed grants from the Centers for Disease Control and Prevention and the NIH; consulting for Merck, Bionet, and IBM; and serving on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer.
SOURCE: Kempe A et al. Pediatrics. 2020 Jun 15. doi: 10.1542/peds.2019-3852.
FROM PEDIATRICS
Study spotlights the skin microbiome’s evolving nature
, while the skin microbiome of the mothers of the children whose microbiome was analyzed remained relatively constant over the same time period.
The findings come from what is believed to be the longest longitudinal study specific to the skin microbiome of infants and mothers.
“Even at 10 years, the skin microbiome does not look like an adult skin microbiome, based on composition of the ecosystem,” lead author Kimberly A. Capone, PhD, said in an interview during the virtual annual meeting of the American Academy of Dermatology. “The diversity of the microbiome in children’s skin is distinct to that of an adult’s skin. We all have the same bacteria present, but in children it is distributed differently because the bacteria set themselves up based on the nutrients and topography that they find on the skin. Since infant skin is unique to infants, so too is their microbiome when we compare it to adults. It’s been fascinating to observe these children grow and mature, and follow the skin microbiome along this same period.”
During five time points over a period of 10 years, Dr. Capone and her colleagues at the Skillman, N.J.–based Johnson & Johnson Consumer Experience Center, a research and development site, used 16s rRNA gene sequencing to evaluate the skin microbiome on the forearms and foreheads of 30 mothers and their 31 children. The study participants had Fitzpatrick skin types I-IV and the mean age of mothers was 37 years. “We used 16s rRNA gene sequencing for microbiome analysis at the beginning, as that was what was available 10 years ago,” said Dr. Capone, head of the microbiome platform for Johnson & Johnson Consumer Health. “Since then, we continue to use 16s for continuity, but also collected additional swabs for deeper analysis later.”
She and her colleagues often draw samples from the forearm in baby skin clinical studies, “as the arm is a good site to collect relevant data on the body overall,” she explained. “We chose the forearm and forehead specifically here so we can make same body site comparisons to adult sample data which we took from the mothers on the same areas of their body.” Time point 1 was 3 months to 1 year, time point 2 was 2-3 years, time point 3 was 5-6 years, time point 4 was 7-8 years, and time point 5 was 9-10 years.
The researchers found that the skin of infants during the first few weeks of life was similar at age 3 and 4 years. “From that second time point on, we see significant increases in richness and diversity, richness being presence or absence of various bacterial species, and diversity being the relative abundance of those species,” Dr. Capone said. “What you’re basically seeing is that there are new organisms, i.e., richness, coming into the microbiome. We start to detect new ones. Over time, the ecosystem is expanding. It’s evolving because it’s not yet set up.” The evolving skin microbiome on children was dominated by Streptococcus and Staphylococcus. In addition, children had higher levels of Streptococcus, Moraxella, Granulicatella, Gemella and Veillonella, compared with their adult mothers. Adult skin was colonized predominantly by Propionibacterium/Cutibacterium and Staphylococcus.
“The skin microbiome also increased in diversity over time on the forearm, but not face, of the mothers,” Dr. Capone said. “Previous studies have shown how stable the adult skin microbiome is, so it’s intriguing to see the changes that we saw on the mothers in this study.”
The increase in skin microbiome diversity observed in the children is likely due to a variety of factors, she continued, including inherent growth and development, dietary changes, as well as exposure to various environments and other people. “The fact remains that diversity is increasing over time, as the ecosystem evolves,” she said. “Eventually, the skin microbiome will become ‘adultlike’ in puberty, when lipid production increases. This drives increases in Cutibacterium acnes, particularly on the face.”
She acknowledged certain limitations of the study, including its relatively small size and the fact that some of the original subjects did not return for microbiome analysis at later time points. “We need larger cohort studies, additional deeper sequence data, metabolomics and transcriptomics to better understand the function of the skin microbiome over these various ages,” she said.
The study was sponsored by Johnson & Johnson Consumer. Dr. Capone and her two coauthors are employees of the company.
, while the skin microbiome of the mothers of the children whose microbiome was analyzed remained relatively constant over the same time period.
The findings come from what is believed to be the longest longitudinal study specific to the skin microbiome of infants and mothers.
“Even at 10 years, the skin microbiome does not look like an adult skin microbiome, based on composition of the ecosystem,” lead author Kimberly A. Capone, PhD, said in an interview during the virtual annual meeting of the American Academy of Dermatology. “The diversity of the microbiome in children’s skin is distinct to that of an adult’s skin. We all have the same bacteria present, but in children it is distributed differently because the bacteria set themselves up based on the nutrients and topography that they find on the skin. Since infant skin is unique to infants, so too is their microbiome when we compare it to adults. It’s been fascinating to observe these children grow and mature, and follow the skin microbiome along this same period.”
During five time points over a period of 10 years, Dr. Capone and her colleagues at the Skillman, N.J.–based Johnson & Johnson Consumer Experience Center, a research and development site, used 16s rRNA gene sequencing to evaluate the skin microbiome on the forearms and foreheads of 30 mothers and their 31 children. The study participants had Fitzpatrick skin types I-IV and the mean age of mothers was 37 years. “We used 16s rRNA gene sequencing for microbiome analysis at the beginning, as that was what was available 10 years ago,” said Dr. Capone, head of the microbiome platform for Johnson & Johnson Consumer Health. “Since then, we continue to use 16s for continuity, but also collected additional swabs for deeper analysis later.”
She and her colleagues often draw samples from the forearm in baby skin clinical studies, “as the arm is a good site to collect relevant data on the body overall,” she explained. “We chose the forearm and forehead specifically here so we can make same body site comparisons to adult sample data which we took from the mothers on the same areas of their body.” Time point 1 was 3 months to 1 year, time point 2 was 2-3 years, time point 3 was 5-6 years, time point 4 was 7-8 years, and time point 5 was 9-10 years.
The researchers found that the skin of infants during the first few weeks of life was similar at age 3 and 4 years. “From that second time point on, we see significant increases in richness and diversity, richness being presence or absence of various bacterial species, and diversity being the relative abundance of those species,” Dr. Capone said. “What you’re basically seeing is that there are new organisms, i.e., richness, coming into the microbiome. We start to detect new ones. Over time, the ecosystem is expanding. It’s evolving because it’s not yet set up.” The evolving skin microbiome on children was dominated by Streptococcus and Staphylococcus. In addition, children had higher levels of Streptococcus, Moraxella, Granulicatella, Gemella and Veillonella, compared with their adult mothers. Adult skin was colonized predominantly by Propionibacterium/Cutibacterium and Staphylococcus.
“The skin microbiome also increased in diversity over time on the forearm, but not face, of the mothers,” Dr. Capone said. “Previous studies have shown how stable the adult skin microbiome is, so it’s intriguing to see the changes that we saw on the mothers in this study.”
The increase in skin microbiome diversity observed in the children is likely due to a variety of factors, she continued, including inherent growth and development, dietary changes, as well as exposure to various environments and other people. “The fact remains that diversity is increasing over time, as the ecosystem evolves,” she said. “Eventually, the skin microbiome will become ‘adultlike’ in puberty, when lipid production increases. This drives increases in Cutibacterium acnes, particularly on the face.”
She acknowledged certain limitations of the study, including its relatively small size and the fact that some of the original subjects did not return for microbiome analysis at later time points. “We need larger cohort studies, additional deeper sequence data, metabolomics and transcriptomics to better understand the function of the skin microbiome over these various ages,” she said.
The study was sponsored by Johnson & Johnson Consumer. Dr. Capone and her two coauthors are employees of the company.
, while the skin microbiome of the mothers of the children whose microbiome was analyzed remained relatively constant over the same time period.
The findings come from what is believed to be the longest longitudinal study specific to the skin microbiome of infants and mothers.
“Even at 10 years, the skin microbiome does not look like an adult skin microbiome, based on composition of the ecosystem,” lead author Kimberly A. Capone, PhD, said in an interview during the virtual annual meeting of the American Academy of Dermatology. “The diversity of the microbiome in children’s skin is distinct to that of an adult’s skin. We all have the same bacteria present, but in children it is distributed differently because the bacteria set themselves up based on the nutrients and topography that they find on the skin. Since infant skin is unique to infants, so too is their microbiome when we compare it to adults. It’s been fascinating to observe these children grow and mature, and follow the skin microbiome along this same period.”
During five time points over a period of 10 years, Dr. Capone and her colleagues at the Skillman, N.J.–based Johnson & Johnson Consumer Experience Center, a research and development site, used 16s rRNA gene sequencing to evaluate the skin microbiome on the forearms and foreheads of 30 mothers and their 31 children. The study participants had Fitzpatrick skin types I-IV and the mean age of mothers was 37 years. “We used 16s rRNA gene sequencing for microbiome analysis at the beginning, as that was what was available 10 years ago,” said Dr. Capone, head of the microbiome platform for Johnson & Johnson Consumer Health. “Since then, we continue to use 16s for continuity, but also collected additional swabs for deeper analysis later.”
She and her colleagues often draw samples from the forearm in baby skin clinical studies, “as the arm is a good site to collect relevant data on the body overall,” she explained. “We chose the forearm and forehead specifically here so we can make same body site comparisons to adult sample data which we took from the mothers on the same areas of their body.” Time point 1 was 3 months to 1 year, time point 2 was 2-3 years, time point 3 was 5-6 years, time point 4 was 7-8 years, and time point 5 was 9-10 years.
The researchers found that the skin of infants during the first few weeks of life was similar at age 3 and 4 years. “From that second time point on, we see significant increases in richness and diversity, richness being presence or absence of various bacterial species, and diversity being the relative abundance of those species,” Dr. Capone said. “What you’re basically seeing is that there are new organisms, i.e., richness, coming into the microbiome. We start to detect new ones. Over time, the ecosystem is expanding. It’s evolving because it’s not yet set up.” The evolving skin microbiome on children was dominated by Streptococcus and Staphylococcus. In addition, children had higher levels of Streptococcus, Moraxella, Granulicatella, Gemella and Veillonella, compared with their adult mothers. Adult skin was colonized predominantly by Propionibacterium/Cutibacterium and Staphylococcus.
“The skin microbiome also increased in diversity over time on the forearm, but not face, of the mothers,” Dr. Capone said. “Previous studies have shown how stable the adult skin microbiome is, so it’s intriguing to see the changes that we saw on the mothers in this study.”
The increase in skin microbiome diversity observed in the children is likely due to a variety of factors, she continued, including inherent growth and development, dietary changes, as well as exposure to various environments and other people. “The fact remains that diversity is increasing over time, as the ecosystem evolves,” she said. “Eventually, the skin microbiome will become ‘adultlike’ in puberty, when lipid production increases. This drives increases in Cutibacterium acnes, particularly on the face.”
She acknowledged certain limitations of the study, including its relatively small size and the fact that some of the original subjects did not return for microbiome analysis at later time points. “We need larger cohort studies, additional deeper sequence data, metabolomics and transcriptomics to better understand the function of the skin microbiome over these various ages,” she said.
The study was sponsored by Johnson & Johnson Consumer. Dr. Capone and her two coauthors are employees of the company.
FROM AAD 20
Key clinical point: The skin’s microbial diversity changes with increasing age in children while remaining stable in adult mothers.
Major finding: The skin microbiome in children becomes more diverse between the ages of 3-4 to age 10.
Study details: A longitudinal analysis of 30 mothers and their 31 children.
Disclosures: The study was sponsored by Johnson & Johnson Consumer. Dr. Capone and her two coauthors are employees of the company.
Source: Capone K et al. AAD 20, Abstract F053.
Perfect storm of SARS-CoV-2 during flu season
COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.
Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.
Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.
Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?
The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?
Minimize double whammy infections. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.
Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.
One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.
Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days1 vs. 15-23 days2 for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.
Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.
1. Aim to exceed 75% influenza vaccine uptake in your patients.
a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.
2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.
3. Plan safe and efficient processes to vaccinate large numbers in August through November.
a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.
b. What social distancing and masking rules will be needed?
i. Will patients need to bring their own masks, or will you supply them?
c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?
d. Remember younger patients need two doses before Dec 1, 2020.
e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?
f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?
Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at [email protected].
References
1.. HCUP Statistical Brief #253. 2019 Oct.
2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.
Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.
Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.
Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?
The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?
Minimize double whammy infections. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.
Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.
One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.
Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days1 vs. 15-23 days2 for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.
Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.
1. Aim to exceed 75% influenza vaccine uptake in your patients.
a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.
2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.
3. Plan safe and efficient processes to vaccinate large numbers in August through November.
a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.
b. What social distancing and masking rules will be needed?
i. Will patients need to bring their own masks, or will you supply them?
c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?
d. Remember younger patients need two doses before Dec 1, 2020.
e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?
f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?
Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at [email protected].
References
1.. HCUP Statistical Brief #253. 2019 Oct.
2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.
Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.
Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.
Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?
The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?
Minimize double whammy infections. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.
Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.
One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.
Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days1 vs. 15-23 days2 for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.
Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.
1. Aim to exceed 75% influenza vaccine uptake in your patients.
a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.
2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.
3. Plan safe and efficient processes to vaccinate large numbers in August through November.
a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.
b. What social distancing and masking rules will be needed?
i. Will patients need to bring their own masks, or will you supply them?
c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?
d. Remember younger patients need two doses before Dec 1, 2020.
e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?
f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?
Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at [email protected].
References
1.. HCUP Statistical Brief #253. 2019 Oct.
2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
Pediatric Dermatology: A Supplement to Pediatric News & Dermatology News
Content includes:
- Early onset of atopic dermatitis linked to poorer control, could signify more persistent disease
- Patients with actopic dermatitis should be routinely asked about conjunctivitis
- Hope on the horizon: New cantharidin formulation alleviates molluscum contagiosum in pivotal trials
- Patch testing in atopic dermatitis: When and how
- Topical calcineurin inhibitors are an effective treatment option for periorificial dermatitis
- Psychology consults for children’s skin issues can boost adherence, wellness
Content includes:
- Early onset of atopic dermatitis linked to poorer control, could signify more persistent disease
- Patients with actopic dermatitis should be routinely asked about conjunctivitis
- Hope on the horizon: New cantharidin formulation alleviates molluscum contagiosum in pivotal trials
- Patch testing in atopic dermatitis: When and how
- Topical calcineurin inhibitors are an effective treatment option for periorificial dermatitis
- Psychology consults for children’s skin issues can boost adherence, wellness
Content includes:
- Early onset of atopic dermatitis linked to poorer control, could signify more persistent disease
- Patients with actopic dermatitis should be routinely asked about conjunctivitis
- Hope on the horizon: New cantharidin formulation alleviates molluscum contagiosum in pivotal trials
- Patch testing in atopic dermatitis: When and how
- Topical calcineurin inhibitors are an effective treatment option for periorificial dermatitis
- Psychology consults for children’s skin issues can boost adherence, wellness
New long-term data for antipsychotic in pediatric bipolar depression
The antipsychotic lurasidone (Latuda, Sunovion Pharmaceuticals) has long-term efficacy in the treatment of bipolar depression (BD) in children and adolescents, new research suggests.
In an open-label extension study involving patients aged 10-17 years, up to 2 years of treatment with lurasidone was associated with continued improvement in depressive symptoms. There were progressively higher rates of remission, recovery, and sustained remission.
Coinvestigator Manpreet K. Singh, MD, director of the Stanford Pediatric Mood Disorders Program, Stanford (Calif.) University, noted that early onset of BD is common. Although in pediatric populations, prevalence has been fairly stable at around 1.8%, these patients have “a very limited number of treatment options available for the depressed phases of BD,” which is often predominant and can be difficult to identify.
“A lot of youths who are experiencing depressive symptoms in the context of having had a manic episode will often have a relapsing and remitting course, even after the acute phase of treatment, so because kids can be on medications for long periods of time, a better understanding of what works ... is very important,” Dr. Singh said in an interview.
The findings were presented at the virtual American Society of Clinical Psychopharmacology (ASCP) 2020 annual meeting.
Long-term Efficacy
The Food and Drug Administration approved lurasidone as monotherapy for BD in children and adolescents in 2018. The aim of the current study was to evaluate the drug’s long-term efficacy in achieving response or remission in this population.
A total of 305 children who completed an initial 6-week double-blind study of lurasidone versus placebo entered the 2-year, open-label extension study. In the extension, they either continued taking lurasidone or were switched from placebo to lurasidone 20-80 mg/day. Of this group, 195 children completed 52 weeks of treatment, and 93 completed 104 weeks of treatment.
Efficacy was measured with the Children’s Depression Rating Scale, Revised (CDRS-R) and the Clinical Global Impression, Bipolar Depression Severity scale (CGI-BP-S). Functioning was evaluated with the clinician-rated Children’s Global Assessment Scale (CGAS); on that scale, a score of 70 or higher indicates no clinically meaningful functional impairment.
Remission criteria were met if a patient achieved a CDRS-R total score of 28 or less, a Young Mania Rating Scale (YMRS) total score of 8 or less, and a CGI-BP-S depression score of 3 or less.
Recovery criteria were met if a patient achieved remission and had a CGAS score of at least 70.
Sustained remission, a more stringent outcome, required that the patient meet remission criteria for at least 24 consecutive weeks.
In addition, there was a strong inverse correlation (r = –0.71) between depression severity, as measured by CDRS-R total score, and functioning, as measured by the CGAS.
“That’s the cool thing: As the depression symptoms and severity came down, the overall functioning in these kids improved,” Dr. Singh noted.
“This improvement in functioning ends up being much more clinically relevant and useful to clinicians than just showing an improvement in a set of symptoms because what brings a kid – or even an adult, for that matter – to see a clinician to get treatment is because something about their symptoms is causing significant functional impairment,” she said.
“So this is the take-home message: You can see that lurasidone ... demonstrates not just recovery from depressive symptoms but that this reduction in depressive symptoms corresponds to an improvement in functioning for these youths,” she added.
Potential Limitations
Commenting on the study, Christoph U. Correll, MD, professor of child and adolescent psychiatry, Charite Universitatsmedizin, Berlin, Germany, noted that BD is difficult to treat, especially for patients who are going through “a developmentally vulnerable phase of their lives.”
“Lurasidone is the only monotherapy approved for bipolar depression in youth and is fairly well tolerated,” said Dr. Correll, who was not part of the research. He added that the long-term effectiveness data on response and remission “add relevant information” to the field.
However, he noted that it is not clear whether the high and increasing rates of response and remission were based on the reporting of observed cases or on last-observation-carried-forward analyses. “Given the naturally high dropout rate in such a long-term study and the potential for a survival bias, this is a relevant methodological question that affects the interpretation of the data,” he said.
“Nevertheless, the very favorable results for cumulative response, remission, and sustained remission add to the evidence that lurasidone is an effective treatment for youth with bipolar depression. Since efficacy cannot be interpreted in isolation, data describing the tolerability, including long-term cardiometabolic effects, will be important complementary data to consider,” Dr. Correll said.
The study was funded by Sunovion Pharmaceuticals. Dr. Singh is on the advisory board for Sunovion, is a consultant for Google X and Limbix, and receives royalties from American Psychiatric Association Publishing. She has also received research support from Stanford’s Maternal Child Health Research Institute and Department of Psychiatry, the National Institute of Mental Health, the National Institute on Aging, Johnson and Johnson, Allergan, PCORI, and the Brain and Behavior Research Foundation. Dr. Correll has been a consultant or adviser to and has received honoraria from Sunovion, as well as Acadia, Alkermes, Allergan, Angelini, Axsome, Gedeon Richter, Gerson Lehrman Group, Intra-Cellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, Medscape, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Sumitomo Dainippon, Supernus, Takeda, and Teva.
A version of this article originally appeared on Medscape.com.
The antipsychotic lurasidone (Latuda, Sunovion Pharmaceuticals) has long-term efficacy in the treatment of bipolar depression (BD) in children and adolescents, new research suggests.
In an open-label extension study involving patients aged 10-17 years, up to 2 years of treatment with lurasidone was associated with continued improvement in depressive symptoms. There were progressively higher rates of remission, recovery, and sustained remission.
Coinvestigator Manpreet K. Singh, MD, director of the Stanford Pediatric Mood Disorders Program, Stanford (Calif.) University, noted that early onset of BD is common. Although in pediatric populations, prevalence has been fairly stable at around 1.8%, these patients have “a very limited number of treatment options available for the depressed phases of BD,” which is often predominant and can be difficult to identify.
“A lot of youths who are experiencing depressive symptoms in the context of having had a manic episode will often have a relapsing and remitting course, even after the acute phase of treatment, so because kids can be on medications for long periods of time, a better understanding of what works ... is very important,” Dr. Singh said in an interview.
The findings were presented at the virtual American Society of Clinical Psychopharmacology (ASCP) 2020 annual meeting.
Long-term Efficacy
The Food and Drug Administration approved lurasidone as monotherapy for BD in children and adolescents in 2018. The aim of the current study was to evaluate the drug’s long-term efficacy in achieving response or remission in this population.
A total of 305 children who completed an initial 6-week double-blind study of lurasidone versus placebo entered the 2-year, open-label extension study. In the extension, they either continued taking lurasidone or were switched from placebo to lurasidone 20-80 mg/day. Of this group, 195 children completed 52 weeks of treatment, and 93 completed 104 weeks of treatment.
Efficacy was measured with the Children’s Depression Rating Scale, Revised (CDRS-R) and the Clinical Global Impression, Bipolar Depression Severity scale (CGI-BP-S). Functioning was evaluated with the clinician-rated Children’s Global Assessment Scale (CGAS); on that scale, a score of 70 or higher indicates no clinically meaningful functional impairment.
Remission criteria were met if a patient achieved a CDRS-R total score of 28 or less, a Young Mania Rating Scale (YMRS) total score of 8 or less, and a CGI-BP-S depression score of 3 or less.
Recovery criteria were met if a patient achieved remission and had a CGAS score of at least 70.
Sustained remission, a more stringent outcome, required that the patient meet remission criteria for at least 24 consecutive weeks.
In addition, there was a strong inverse correlation (r = –0.71) between depression severity, as measured by CDRS-R total score, and functioning, as measured by the CGAS.
“That’s the cool thing: As the depression symptoms and severity came down, the overall functioning in these kids improved,” Dr. Singh noted.
“This improvement in functioning ends up being much more clinically relevant and useful to clinicians than just showing an improvement in a set of symptoms because what brings a kid – or even an adult, for that matter – to see a clinician to get treatment is because something about their symptoms is causing significant functional impairment,” she said.
“So this is the take-home message: You can see that lurasidone ... demonstrates not just recovery from depressive symptoms but that this reduction in depressive symptoms corresponds to an improvement in functioning for these youths,” she added.
Potential Limitations
Commenting on the study, Christoph U. Correll, MD, professor of child and adolescent psychiatry, Charite Universitatsmedizin, Berlin, Germany, noted that BD is difficult to treat, especially for patients who are going through “a developmentally vulnerable phase of their lives.”
“Lurasidone is the only monotherapy approved for bipolar depression in youth and is fairly well tolerated,” said Dr. Correll, who was not part of the research. He added that the long-term effectiveness data on response and remission “add relevant information” to the field.
However, he noted that it is not clear whether the high and increasing rates of response and remission were based on the reporting of observed cases or on last-observation-carried-forward analyses. “Given the naturally high dropout rate in such a long-term study and the potential for a survival bias, this is a relevant methodological question that affects the interpretation of the data,” he said.
“Nevertheless, the very favorable results for cumulative response, remission, and sustained remission add to the evidence that lurasidone is an effective treatment for youth with bipolar depression. Since efficacy cannot be interpreted in isolation, data describing the tolerability, including long-term cardiometabolic effects, will be important complementary data to consider,” Dr. Correll said.
The study was funded by Sunovion Pharmaceuticals. Dr. Singh is on the advisory board for Sunovion, is a consultant for Google X and Limbix, and receives royalties from American Psychiatric Association Publishing. She has also received research support from Stanford’s Maternal Child Health Research Institute and Department of Psychiatry, the National Institute of Mental Health, the National Institute on Aging, Johnson and Johnson, Allergan, PCORI, and the Brain and Behavior Research Foundation. Dr. Correll has been a consultant or adviser to and has received honoraria from Sunovion, as well as Acadia, Alkermes, Allergan, Angelini, Axsome, Gedeon Richter, Gerson Lehrman Group, Intra-Cellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, Medscape, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Sumitomo Dainippon, Supernus, Takeda, and Teva.
A version of this article originally appeared on Medscape.com.
The antipsychotic lurasidone (Latuda, Sunovion Pharmaceuticals) has long-term efficacy in the treatment of bipolar depression (BD) in children and adolescents, new research suggests.
In an open-label extension study involving patients aged 10-17 years, up to 2 years of treatment with lurasidone was associated with continued improvement in depressive symptoms. There were progressively higher rates of remission, recovery, and sustained remission.
Coinvestigator Manpreet K. Singh, MD, director of the Stanford Pediatric Mood Disorders Program, Stanford (Calif.) University, noted that early onset of BD is common. Although in pediatric populations, prevalence has been fairly stable at around 1.8%, these patients have “a very limited number of treatment options available for the depressed phases of BD,” which is often predominant and can be difficult to identify.
“A lot of youths who are experiencing depressive symptoms in the context of having had a manic episode will often have a relapsing and remitting course, even after the acute phase of treatment, so because kids can be on medications for long periods of time, a better understanding of what works ... is very important,” Dr. Singh said in an interview.
The findings were presented at the virtual American Society of Clinical Psychopharmacology (ASCP) 2020 annual meeting.
Long-term Efficacy
The Food and Drug Administration approved lurasidone as monotherapy for BD in children and adolescents in 2018. The aim of the current study was to evaluate the drug’s long-term efficacy in achieving response or remission in this population.
A total of 305 children who completed an initial 6-week double-blind study of lurasidone versus placebo entered the 2-year, open-label extension study. In the extension, they either continued taking lurasidone or were switched from placebo to lurasidone 20-80 mg/day. Of this group, 195 children completed 52 weeks of treatment, and 93 completed 104 weeks of treatment.
Efficacy was measured with the Children’s Depression Rating Scale, Revised (CDRS-R) and the Clinical Global Impression, Bipolar Depression Severity scale (CGI-BP-S). Functioning was evaluated with the clinician-rated Children’s Global Assessment Scale (CGAS); on that scale, a score of 70 or higher indicates no clinically meaningful functional impairment.
Remission criteria were met if a patient achieved a CDRS-R total score of 28 or less, a Young Mania Rating Scale (YMRS) total score of 8 or less, and a CGI-BP-S depression score of 3 or less.
Recovery criteria were met if a patient achieved remission and had a CGAS score of at least 70.
Sustained remission, a more stringent outcome, required that the patient meet remission criteria for at least 24 consecutive weeks.
In addition, there was a strong inverse correlation (r = –0.71) between depression severity, as measured by CDRS-R total score, and functioning, as measured by the CGAS.
“That’s the cool thing: As the depression symptoms and severity came down, the overall functioning in these kids improved,” Dr. Singh noted.
“This improvement in functioning ends up being much more clinically relevant and useful to clinicians than just showing an improvement in a set of symptoms because what brings a kid – or even an adult, for that matter – to see a clinician to get treatment is because something about their symptoms is causing significant functional impairment,” she said.
“So this is the take-home message: You can see that lurasidone ... demonstrates not just recovery from depressive symptoms but that this reduction in depressive symptoms corresponds to an improvement in functioning for these youths,” she added.
Potential Limitations
Commenting on the study, Christoph U. Correll, MD, professor of child and adolescent psychiatry, Charite Universitatsmedizin, Berlin, Germany, noted that BD is difficult to treat, especially for patients who are going through “a developmentally vulnerable phase of their lives.”
“Lurasidone is the only monotherapy approved for bipolar depression in youth and is fairly well tolerated,” said Dr. Correll, who was not part of the research. He added that the long-term effectiveness data on response and remission “add relevant information” to the field.
However, he noted that it is not clear whether the high and increasing rates of response and remission were based on the reporting of observed cases or on last-observation-carried-forward analyses. “Given the naturally high dropout rate in such a long-term study and the potential for a survival bias, this is a relevant methodological question that affects the interpretation of the data,” he said.
“Nevertheless, the very favorable results for cumulative response, remission, and sustained remission add to the evidence that lurasidone is an effective treatment for youth with bipolar depression. Since efficacy cannot be interpreted in isolation, data describing the tolerability, including long-term cardiometabolic effects, will be important complementary data to consider,” Dr. Correll said.
The study was funded by Sunovion Pharmaceuticals. Dr. Singh is on the advisory board for Sunovion, is a consultant for Google X and Limbix, and receives royalties from American Psychiatric Association Publishing. She has also received research support from Stanford’s Maternal Child Health Research Institute and Department of Psychiatry, the National Institute of Mental Health, the National Institute on Aging, Johnson and Johnson, Allergan, PCORI, and the Brain and Behavior Research Foundation. Dr. Correll has been a consultant or adviser to and has received honoraria from Sunovion, as well as Acadia, Alkermes, Allergan, Angelini, Axsome, Gedeon Richter, Gerson Lehrman Group, Intra-Cellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, Medscape, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Sumitomo Dainippon, Supernus, Takeda, and Teva.
A version of this article originally appeared on Medscape.com.
FROM ASCP 2020
Liposomal bupivacaine excreted in breast milk, but levels appear safe
based on a prospective cohort study.
Over the course of 4 days, relative neonatal dosages of bupivacaine were less than 1%, remaining below the 10% threshold of concern, reported Hiba J. Mustafa, MD, of the University of Minnesota, Minneapolis, and colleagues.
Liposomal bupivacaine can achieve up to 4 days of postcesarean pain control, which is significantly longer than the 8 hours provided by standard bupivacaine, the investigators wrote in Obstetrics & Gynecology. But usage of the liposomal formulation has not been widespread, they noted, partly because of a lack of clinical studies evaluating breast milk transfer and neonatal safety.
To address this knowledge gap, Dr. Mustafa and colleagues enrolled 30 healthy pregnant women scheduled to undergo cesarean birth at full term. All patients were aged 18-40 years, with an American Society of Anesthesiologists physical status of I or II. Exclusion criteria included a number of maternal and neonatal health concerns, such as sensitivity to local anesthetics, metabolic disorders, fetal anomaly, fetal growth restriction, and others.
The day of surgery, before the procedure, maternal blood samples were collected and used for baseline measurements.
Each woman received a spinal anesthetic including 150 mcg of morphine, 15 mcg of intrathecal fentanyl, and 1.4-1.6 mL of 0.75% hyperbaric bupivacaine hydrochloride. Within 30 minutes after birth, a bilateral transversus abdominus plane block was performed using 266 mg of 1.3% liposomal bupivacaine and 52 mg of 0.25% bupivacaine hydrochloride.
Using the block as time point zero, maternal blood and breast milk samples were collected at hour 2, 6, 12, 24, 48, 72, and 96. Sparse sampling was employed, such that participants were randomly assigned in a 1:1 ratio to provide paired blood and milk samples at hour 2, 12, and 48; or hour 6, 24, 72, and 96. Bupivacaine was quantified in samples by liquid chromatography–tandem mass spectrometry.
Using these data, the investigators determined bupivacaine concentrations in plasma and milk, milk/plasma area under the curve (AUC) ratios, neonatal dosage, and relative neonatal dosage. In addition, adverse events in both mothers and neonates were recorded for 2 weeks post partum.
Mean bupivacaine concentrations peaked in breast milk at 6 hours, at 58 ng/mL. This peak was followed by a steady reduction to an “almost undetectable” level of 5.2 ng/mL at 96 hours. Maternal plasma levels peaked first at hour 6 (155.9 ng/mL), then again at hour 48 (225.8 ng/mL), followed by a steady decline until hour 96, when the level reached 80.6 ng/mL.
Relative mean concentrations of milk to plasma were 44%, 36%, 28%, and 18% at hour 2, 6, 12, and 24, respectively. AUC ratios were used to represent exposure across various time intervals. For instance, the AUC ratio for milk/plasma from hour 0 to hour 2 was 0.45. The AUC findings declined steadily until the final ratio, which spanned hour 0 to hour 96, at 0.15.
These AUC ratios allowed for calculation of neonatal dosage and relative neonatal dosage using an average daily milk intake of 150 mL/kg per day. For the longest range, spanning from hour 0 to hour 96, the neonatal dosage was 15,155.4 ng/kg, which translated to a relative neonatal dosage of 0.396%.
No mothers or neonates experienced adverse events.
“Bupivacaine was transferred into mother’s milk such that an exclusively breastfeeding neonate would ingest less than 1% (relative neonatal dosage) of the maternal dose,” the investigators wrote, noting that this falls safely below the acceptable threshold of 10%.
“Because bupivacaine is metabolized primarily in the liver, a neonate’s absorption will likely be even lower [than modeled] given the first-pass effect,” they added.
Based on these findings, Dr. Mustafa and colleagues concluded that “the level of bupivacaine ingested by the sucking neonate is acceptable and compatible with breastfeeding.”
Michael G. Ross MD, MPH, Distinguished Professor of Obstetrics and Gynecology and Public Health at Geffen School of Medicine at the University of California, Los Angeles, commented that, this study adds to the literature of drug excretion into breast milk. “For the vast majority of drugs with passive transfer from maternal plasma to breast milk, the effective dosages of exclusive breastfeeding neonates are approximately 5% of the maternal (oral) dose. In the present study, the authors demonstrated a relative neonatal dosage of less than 1%. This low value results from consequences of minimal maternal plasma absorption (in the present case from transversus abdominis injection), maternal volume of distribution, transfer into breast milk, and the volume of milk ingestion. These results should provide reassurance for the safety of breastfeeding term infants under the conditions of the study.
“There are a number of study concerns, including the inability to differentiate absorption of the spinal bupivacaine from the liposomal bupivacaine, the lack of paired maternal plasma and breast milk sample, and the lack of detail as to how much milk was expressed for each sample. Importantly, breast milk composition varies from foremilk to hindmilk. Thus, a single sample may not accurately reflect the composition ingested by the infant. The suggestion of two peaks in maternal plasma concentration was not demonstrated statistically and may be an artifact of the timing of spinal and liposomal injections, or the fact that different patients were studied at each time period.
“Most importantly, despite the demonstrated safety, the authors acknowledge conflicting results of clinical benefits of liposomal bupivacaine injection. As such, I recommend that postcesarean transversus abdominis blocks be performed only under institutional review board-approved study protocols,” said Dr. Ross, codirector of the Institute for Women’ and Children’s Health at the Lundquist Institute, Torrance, Calif.*
The study was funded by the Thrasher Research Fund. The investigators reported no conflicts of interest. Dr. Ross had no relevant financial disclosures.
SOURCE: Mustafa et al. Obstet Gynecol. 2020 Jun 6. doi: 10.1097/AOG.0000000000003886.
*This article was updated 6/16/2020.
based on a prospective cohort study.
Over the course of 4 days, relative neonatal dosages of bupivacaine were less than 1%, remaining below the 10% threshold of concern, reported Hiba J. Mustafa, MD, of the University of Minnesota, Minneapolis, and colleagues.
Liposomal bupivacaine can achieve up to 4 days of postcesarean pain control, which is significantly longer than the 8 hours provided by standard bupivacaine, the investigators wrote in Obstetrics & Gynecology. But usage of the liposomal formulation has not been widespread, they noted, partly because of a lack of clinical studies evaluating breast milk transfer and neonatal safety.
To address this knowledge gap, Dr. Mustafa and colleagues enrolled 30 healthy pregnant women scheduled to undergo cesarean birth at full term. All patients were aged 18-40 years, with an American Society of Anesthesiologists physical status of I or II. Exclusion criteria included a number of maternal and neonatal health concerns, such as sensitivity to local anesthetics, metabolic disorders, fetal anomaly, fetal growth restriction, and others.
The day of surgery, before the procedure, maternal blood samples were collected and used for baseline measurements.
Each woman received a spinal anesthetic including 150 mcg of morphine, 15 mcg of intrathecal fentanyl, and 1.4-1.6 mL of 0.75% hyperbaric bupivacaine hydrochloride. Within 30 minutes after birth, a bilateral transversus abdominus plane block was performed using 266 mg of 1.3% liposomal bupivacaine and 52 mg of 0.25% bupivacaine hydrochloride.
Using the block as time point zero, maternal blood and breast milk samples were collected at hour 2, 6, 12, 24, 48, 72, and 96. Sparse sampling was employed, such that participants were randomly assigned in a 1:1 ratio to provide paired blood and milk samples at hour 2, 12, and 48; or hour 6, 24, 72, and 96. Bupivacaine was quantified in samples by liquid chromatography–tandem mass spectrometry.
Using these data, the investigators determined bupivacaine concentrations in plasma and milk, milk/plasma area under the curve (AUC) ratios, neonatal dosage, and relative neonatal dosage. In addition, adverse events in both mothers and neonates were recorded for 2 weeks post partum.
Mean bupivacaine concentrations peaked in breast milk at 6 hours, at 58 ng/mL. This peak was followed by a steady reduction to an “almost undetectable” level of 5.2 ng/mL at 96 hours. Maternal plasma levels peaked first at hour 6 (155.9 ng/mL), then again at hour 48 (225.8 ng/mL), followed by a steady decline until hour 96, when the level reached 80.6 ng/mL.
Relative mean concentrations of milk to plasma were 44%, 36%, 28%, and 18% at hour 2, 6, 12, and 24, respectively. AUC ratios were used to represent exposure across various time intervals. For instance, the AUC ratio for milk/plasma from hour 0 to hour 2 was 0.45. The AUC findings declined steadily until the final ratio, which spanned hour 0 to hour 96, at 0.15.
These AUC ratios allowed for calculation of neonatal dosage and relative neonatal dosage using an average daily milk intake of 150 mL/kg per day. For the longest range, spanning from hour 0 to hour 96, the neonatal dosage was 15,155.4 ng/kg, which translated to a relative neonatal dosage of 0.396%.
No mothers or neonates experienced adverse events.
“Bupivacaine was transferred into mother’s milk such that an exclusively breastfeeding neonate would ingest less than 1% (relative neonatal dosage) of the maternal dose,” the investigators wrote, noting that this falls safely below the acceptable threshold of 10%.
“Because bupivacaine is metabolized primarily in the liver, a neonate’s absorption will likely be even lower [than modeled] given the first-pass effect,” they added.
Based on these findings, Dr. Mustafa and colleagues concluded that “the level of bupivacaine ingested by the sucking neonate is acceptable and compatible with breastfeeding.”
Michael G. Ross MD, MPH, Distinguished Professor of Obstetrics and Gynecology and Public Health at Geffen School of Medicine at the University of California, Los Angeles, commented that, this study adds to the literature of drug excretion into breast milk. “For the vast majority of drugs with passive transfer from maternal plasma to breast milk, the effective dosages of exclusive breastfeeding neonates are approximately 5% of the maternal (oral) dose. In the present study, the authors demonstrated a relative neonatal dosage of less than 1%. This low value results from consequences of minimal maternal plasma absorption (in the present case from transversus abdominis injection), maternal volume of distribution, transfer into breast milk, and the volume of milk ingestion. These results should provide reassurance for the safety of breastfeeding term infants under the conditions of the study.
“There are a number of study concerns, including the inability to differentiate absorption of the spinal bupivacaine from the liposomal bupivacaine, the lack of paired maternal plasma and breast milk sample, and the lack of detail as to how much milk was expressed for each sample. Importantly, breast milk composition varies from foremilk to hindmilk. Thus, a single sample may not accurately reflect the composition ingested by the infant. The suggestion of two peaks in maternal plasma concentration was not demonstrated statistically and may be an artifact of the timing of spinal and liposomal injections, or the fact that different patients were studied at each time period.
“Most importantly, despite the demonstrated safety, the authors acknowledge conflicting results of clinical benefits of liposomal bupivacaine injection. As such, I recommend that postcesarean transversus abdominis blocks be performed only under institutional review board-approved study protocols,” said Dr. Ross, codirector of the Institute for Women’ and Children’s Health at the Lundquist Institute, Torrance, Calif.*
The study was funded by the Thrasher Research Fund. The investigators reported no conflicts of interest. Dr. Ross had no relevant financial disclosures.
SOURCE: Mustafa et al. Obstet Gynecol. 2020 Jun 6. doi: 10.1097/AOG.0000000000003886.
*This article was updated 6/16/2020.
based on a prospective cohort study.
Over the course of 4 days, relative neonatal dosages of bupivacaine were less than 1%, remaining below the 10% threshold of concern, reported Hiba J. Mustafa, MD, of the University of Minnesota, Minneapolis, and colleagues.
Liposomal bupivacaine can achieve up to 4 days of postcesarean pain control, which is significantly longer than the 8 hours provided by standard bupivacaine, the investigators wrote in Obstetrics & Gynecology. But usage of the liposomal formulation has not been widespread, they noted, partly because of a lack of clinical studies evaluating breast milk transfer and neonatal safety.
To address this knowledge gap, Dr. Mustafa and colleagues enrolled 30 healthy pregnant women scheduled to undergo cesarean birth at full term. All patients were aged 18-40 years, with an American Society of Anesthesiologists physical status of I or II. Exclusion criteria included a number of maternal and neonatal health concerns, such as sensitivity to local anesthetics, metabolic disorders, fetal anomaly, fetal growth restriction, and others.
The day of surgery, before the procedure, maternal blood samples were collected and used for baseline measurements.
Each woman received a spinal anesthetic including 150 mcg of morphine, 15 mcg of intrathecal fentanyl, and 1.4-1.6 mL of 0.75% hyperbaric bupivacaine hydrochloride. Within 30 minutes after birth, a bilateral transversus abdominus plane block was performed using 266 mg of 1.3% liposomal bupivacaine and 52 mg of 0.25% bupivacaine hydrochloride.
Using the block as time point zero, maternal blood and breast milk samples were collected at hour 2, 6, 12, 24, 48, 72, and 96. Sparse sampling was employed, such that participants were randomly assigned in a 1:1 ratio to provide paired blood and milk samples at hour 2, 12, and 48; or hour 6, 24, 72, and 96. Bupivacaine was quantified in samples by liquid chromatography–tandem mass spectrometry.
Using these data, the investigators determined bupivacaine concentrations in plasma and milk, milk/plasma area under the curve (AUC) ratios, neonatal dosage, and relative neonatal dosage. In addition, adverse events in both mothers and neonates were recorded for 2 weeks post partum.
Mean bupivacaine concentrations peaked in breast milk at 6 hours, at 58 ng/mL. This peak was followed by a steady reduction to an “almost undetectable” level of 5.2 ng/mL at 96 hours. Maternal plasma levels peaked first at hour 6 (155.9 ng/mL), then again at hour 48 (225.8 ng/mL), followed by a steady decline until hour 96, when the level reached 80.6 ng/mL.
Relative mean concentrations of milk to plasma were 44%, 36%, 28%, and 18% at hour 2, 6, 12, and 24, respectively. AUC ratios were used to represent exposure across various time intervals. For instance, the AUC ratio for milk/plasma from hour 0 to hour 2 was 0.45. The AUC findings declined steadily until the final ratio, which spanned hour 0 to hour 96, at 0.15.
These AUC ratios allowed for calculation of neonatal dosage and relative neonatal dosage using an average daily milk intake of 150 mL/kg per day. For the longest range, spanning from hour 0 to hour 96, the neonatal dosage was 15,155.4 ng/kg, which translated to a relative neonatal dosage of 0.396%.
No mothers or neonates experienced adverse events.
“Bupivacaine was transferred into mother’s milk such that an exclusively breastfeeding neonate would ingest less than 1% (relative neonatal dosage) of the maternal dose,” the investigators wrote, noting that this falls safely below the acceptable threshold of 10%.
“Because bupivacaine is metabolized primarily in the liver, a neonate’s absorption will likely be even lower [than modeled] given the first-pass effect,” they added.
Based on these findings, Dr. Mustafa and colleagues concluded that “the level of bupivacaine ingested by the sucking neonate is acceptable and compatible with breastfeeding.”
Michael G. Ross MD, MPH, Distinguished Professor of Obstetrics and Gynecology and Public Health at Geffen School of Medicine at the University of California, Los Angeles, commented that, this study adds to the literature of drug excretion into breast milk. “For the vast majority of drugs with passive transfer from maternal plasma to breast milk, the effective dosages of exclusive breastfeeding neonates are approximately 5% of the maternal (oral) dose. In the present study, the authors demonstrated a relative neonatal dosage of less than 1%. This low value results from consequences of minimal maternal plasma absorption (in the present case from transversus abdominis injection), maternal volume of distribution, transfer into breast milk, and the volume of milk ingestion. These results should provide reassurance for the safety of breastfeeding term infants under the conditions of the study.
“There are a number of study concerns, including the inability to differentiate absorption of the spinal bupivacaine from the liposomal bupivacaine, the lack of paired maternal plasma and breast milk sample, and the lack of detail as to how much milk was expressed for each sample. Importantly, breast milk composition varies from foremilk to hindmilk. Thus, a single sample may not accurately reflect the composition ingested by the infant. The suggestion of two peaks in maternal plasma concentration was not demonstrated statistically and may be an artifact of the timing of spinal and liposomal injections, or the fact that different patients were studied at each time period.
“Most importantly, despite the demonstrated safety, the authors acknowledge conflicting results of clinical benefits of liposomal bupivacaine injection. As such, I recommend that postcesarean transversus abdominis blocks be performed only under institutional review board-approved study protocols,” said Dr. Ross, codirector of the Institute for Women’ and Children’s Health at the Lundquist Institute, Torrance, Calif.*
The study was funded by the Thrasher Research Fund. The investigators reported no conflicts of interest. Dr. Ross had no relevant financial disclosures.
SOURCE: Mustafa et al. Obstet Gynecol. 2020 Jun 6. doi: 10.1097/AOG.0000000000003886.
*This article was updated 6/16/2020.
FROM OBSTETRICS & GYNECOLOGY
