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Aggression and angry outbursts
Introduction
Aggressive behavior is one of the most common child psychiatric symptoms for which parents seek help. The difficulty with managing aggressive behavior is determining whether it is out of the ordinary from typical child development and then assessing the causes of the behavior before tackling the tough job of intervening. The following case is typical of what might present to the pediatrics office and provides a few ideas for the assessment and management of aggressive behavior.
Case summary
Dakota is a 6-year-old boy who presents for a well-child check with his father, Joe. Dakota is just finishing his kindergarten year, and the teachers have expressed concerns about his behavior in the classroom and on the playground. They note that he is often irritable and touchy, and that he will frequently have aggressive outbursts, particularly when asked to do something that he doesn’t like. He will often interrupt other children’s games, and will force children to play by his rules with a threat of, or occasional use of, hitting. In the classroom, he has been removed multiple times to the principal’s office, where he will go only with marked reluctance. He has been noted by his teachers to have difficulty attending to the classroom instructions, and frequently removes himself during circle time. They allow him to do this to avoid a power struggle. Similarly, Joe notes that the entire family is "walking on eggshells" because they never know what might set him off. They’ve tried "everything," including time out, sticker charts, and spanking, but with little effect. Joe says that he was "just like Dakota" when he was a child, and that he was "straightened out" in the Army. He wonders if some kind of boot camp or "scared straight" program would help Dakota learn his lesson.
Discussion
Diagnosis. Irritability and aggression are common manifestations of multiple child psychiatric conditions. While it’s easy to jump to the conclusion that the patient has oppositional-defiant disorder (ODD) or conduct disorder (CD) and move straight to treatment, care must be taken to evaluate common causes and co-occurring disorders that might change the treatment plan.
The differential diagnosis includes a primary mood disorder like depression, other disruptive behavior disorders such as attention-deficit/hyperactivity disorder (ADHD), a primary anxiety disorder, posttraumatic stress disorder, a learning or language disorder, and/or intellectual disability. One also must determine whether the aggression exhibited is greater than that shown by other boys his age. For this reason, the use of a scale that has normative values by age and sex makes sense. Having a standardized instrument filled out by parents and by the teachers also will help give an indication of how he is performing in multiple settings. Using a broad-based instrument that also covers mood, anxiety, and attention problems can be a quick and useful way to examine what type of co-occurring symptoms are present.
Aggression, while a heritable trait, also has a significant component from the environment. It is important to see how much of the aggression is being "caught, not taught" in the family setting. Querying as to the general level of negative, coercive parenting can be performed quickly by asking for a description of how the last outburst was managed – what the precipitant, the course, and the outcome were. Frequently, with ODD in particular, you will find a cycle of escalating threats and illogical consequences that serve to reinforce, rather than to reduce, aggressive and oppositional behavior. Practically, while the busy pediatrician may be able to manage some of this screening in a well-child check, it is likely that a separate appointment will be needed to go over the results of the screening instruments and to more fully assess the parenting environment.
At the scheduled visit designed to specifically assess the aggression:
• Make sure that both the parents and the child see this as a family-based problem. A treatment alliance with both parties is necessary to get the buy-in for any type of intervention that will occur.
• Assess the level of impairment. Are these outbursts severe only at home? In the school setting? With other people such as coaches or health care providers?
• Review the broadband screening instruments from multiple settings to make sure that this is a primary disruptive behavior disorder and not something else, particularly ADHD or a mood disorder, which will need to be managed differently.
• Determine if the aggressive behavior is impulsive/reactive or if it is planned/predatory. Is there remorse afterward (about the action, as opposed to remorse about being caught)? Lack of remorse could be an indicator of callous-unemotional traits, which have a worse prognosis.
Pearl: When asking about aggressive outbursts, make sure to concentrate not just on the outburst, but on the behavior and mood between outbursts. If the mood between outbursts is chronically irritable or sad, this might indicate a mood disorder rather than a primary disruptive behavior disorder.
Treatment. Treatment for aggressive behavior really calls for an "all hands on deck" family-based intervention. Parenting interventions will work best when the parents themselves are as healthy as they can be. Working with them to ensure that aggressive behavior, substance abuse, or anxiety is adequately treated through referral is an important step.
Next, the parenting interventions should involve those best informed by evidence-based practice, which typically include components of reducing the cycle of reinforcing aggressive behavior, noticing and rewarding prosocial behavior, and ceasing corporal punishment and replacing it with predictable, logical consequences for aggressive behavior. There are several excellent programs that therapists can use with parents, and referring to a therapist working with an evidence-based treatment program makes sense. There is a table listing parent management training packages that can be found in the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ODD (J. Am. Acad. Child. Adolesc. Psychiatry 2007;46:126-41).
Wellness interventions such as ensuring hydration and adequate caloric intake can make a difference in the management of aggression. It’s harder to maintain control when you are concentrating on the grumbling of your stomach. Further, using exercise and sports as an intervention allows children to channel some of their negative aggressive impulses into positive, prosocial activities.
Pharmacotherapy is not indicated for ODD or CD, except to target co-occurring symptoms. For example, treatment of ADHD or anxiety can quite successfully reduce impulsive or reactive aggression, and can make it easier to treat the ODD or CD through parent management techniques. In very severe cases of aggression, treatment with other agents such as mood stabilizers or antipsychotics might be indicated, but this would likely be implemented only in consultation with a child and adolescent psychiatrist.
Finally, there is little to no evidence for a mock incarceration or boot camp approach with children who exhibit oppositional behavior. In fact, it’s very possible that these kinds of programs can make the behaviors worse (J. Am. Acad. Child Adolesc. Psychiatry 1999;38:1320-1; "Aggression and Antisocial Behavior in Children and Adolescents: Research and Treatment" [New York: The Guilford Press, 2002]).
When to consult? Uncomplicated aggressive behavior can be managed by the primary care team with consultation from a therapist using evidence-based approaches. If there is poor treatment response, or if the aggression is severe enough to cause serious physical injury, or if there is concern for a cycling mood disorder (such as bipolar disorder – a topic for a later column), then consultation with a child psychiatrist is likely appropriate.
Dr. Althoff is an associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Dr. Althoff has received grants/research support from the National Institute of Mental Health, the National Institute of General Medical Sciences, and the Klingenstein Third Generation Foundation, and honoraria from the Oakstone General Publishing for CME presentations.
Introduction
Aggressive behavior is one of the most common child psychiatric symptoms for which parents seek help. The difficulty with managing aggressive behavior is determining whether it is out of the ordinary from typical child development and then assessing the causes of the behavior before tackling the tough job of intervening. The following case is typical of what might present to the pediatrics office and provides a few ideas for the assessment and management of aggressive behavior.
Case summary
Dakota is a 6-year-old boy who presents for a well-child check with his father, Joe. Dakota is just finishing his kindergarten year, and the teachers have expressed concerns about his behavior in the classroom and on the playground. They note that he is often irritable and touchy, and that he will frequently have aggressive outbursts, particularly when asked to do something that he doesn’t like. He will often interrupt other children’s games, and will force children to play by his rules with a threat of, or occasional use of, hitting. In the classroom, he has been removed multiple times to the principal’s office, where he will go only with marked reluctance. He has been noted by his teachers to have difficulty attending to the classroom instructions, and frequently removes himself during circle time. They allow him to do this to avoid a power struggle. Similarly, Joe notes that the entire family is "walking on eggshells" because they never know what might set him off. They’ve tried "everything," including time out, sticker charts, and spanking, but with little effect. Joe says that he was "just like Dakota" when he was a child, and that he was "straightened out" in the Army. He wonders if some kind of boot camp or "scared straight" program would help Dakota learn his lesson.
Discussion
Diagnosis. Irritability and aggression are common manifestations of multiple child psychiatric conditions. While it’s easy to jump to the conclusion that the patient has oppositional-defiant disorder (ODD) or conduct disorder (CD) and move straight to treatment, care must be taken to evaluate common causes and co-occurring disorders that might change the treatment plan.
The differential diagnosis includes a primary mood disorder like depression, other disruptive behavior disorders such as attention-deficit/hyperactivity disorder (ADHD), a primary anxiety disorder, posttraumatic stress disorder, a learning or language disorder, and/or intellectual disability. One also must determine whether the aggression exhibited is greater than that shown by other boys his age. For this reason, the use of a scale that has normative values by age and sex makes sense. Having a standardized instrument filled out by parents and by the teachers also will help give an indication of how he is performing in multiple settings. Using a broad-based instrument that also covers mood, anxiety, and attention problems can be a quick and useful way to examine what type of co-occurring symptoms are present.
Aggression, while a heritable trait, also has a significant component from the environment. It is important to see how much of the aggression is being "caught, not taught" in the family setting. Querying as to the general level of negative, coercive parenting can be performed quickly by asking for a description of how the last outburst was managed – what the precipitant, the course, and the outcome were. Frequently, with ODD in particular, you will find a cycle of escalating threats and illogical consequences that serve to reinforce, rather than to reduce, aggressive and oppositional behavior. Practically, while the busy pediatrician may be able to manage some of this screening in a well-child check, it is likely that a separate appointment will be needed to go over the results of the screening instruments and to more fully assess the parenting environment.
At the scheduled visit designed to specifically assess the aggression:
• Make sure that both the parents and the child see this as a family-based problem. A treatment alliance with both parties is necessary to get the buy-in for any type of intervention that will occur.
• Assess the level of impairment. Are these outbursts severe only at home? In the school setting? With other people such as coaches or health care providers?
• Review the broadband screening instruments from multiple settings to make sure that this is a primary disruptive behavior disorder and not something else, particularly ADHD or a mood disorder, which will need to be managed differently.
• Determine if the aggressive behavior is impulsive/reactive or if it is planned/predatory. Is there remorse afterward (about the action, as opposed to remorse about being caught)? Lack of remorse could be an indicator of callous-unemotional traits, which have a worse prognosis.
Pearl: When asking about aggressive outbursts, make sure to concentrate not just on the outburst, but on the behavior and mood between outbursts. If the mood between outbursts is chronically irritable or sad, this might indicate a mood disorder rather than a primary disruptive behavior disorder.
Treatment. Treatment for aggressive behavior really calls for an "all hands on deck" family-based intervention. Parenting interventions will work best when the parents themselves are as healthy as they can be. Working with them to ensure that aggressive behavior, substance abuse, or anxiety is adequately treated through referral is an important step.
Next, the parenting interventions should involve those best informed by evidence-based practice, which typically include components of reducing the cycle of reinforcing aggressive behavior, noticing and rewarding prosocial behavior, and ceasing corporal punishment and replacing it with predictable, logical consequences for aggressive behavior. There are several excellent programs that therapists can use with parents, and referring to a therapist working with an evidence-based treatment program makes sense. There is a table listing parent management training packages that can be found in the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ODD (J. Am. Acad. Child. Adolesc. Psychiatry 2007;46:126-41).
Wellness interventions such as ensuring hydration and adequate caloric intake can make a difference in the management of aggression. It’s harder to maintain control when you are concentrating on the grumbling of your stomach. Further, using exercise and sports as an intervention allows children to channel some of their negative aggressive impulses into positive, prosocial activities.
Pharmacotherapy is not indicated for ODD or CD, except to target co-occurring symptoms. For example, treatment of ADHD or anxiety can quite successfully reduce impulsive or reactive aggression, and can make it easier to treat the ODD or CD through parent management techniques. In very severe cases of aggression, treatment with other agents such as mood stabilizers or antipsychotics might be indicated, but this would likely be implemented only in consultation with a child and adolescent psychiatrist.
Finally, there is little to no evidence for a mock incarceration or boot camp approach with children who exhibit oppositional behavior. In fact, it’s very possible that these kinds of programs can make the behaviors worse (J. Am. Acad. Child Adolesc. Psychiatry 1999;38:1320-1; "Aggression and Antisocial Behavior in Children and Adolescents: Research and Treatment" [New York: The Guilford Press, 2002]).
When to consult? Uncomplicated aggressive behavior can be managed by the primary care team with consultation from a therapist using evidence-based approaches. If there is poor treatment response, or if the aggression is severe enough to cause serious physical injury, or if there is concern for a cycling mood disorder (such as bipolar disorder – a topic for a later column), then consultation with a child psychiatrist is likely appropriate.
Dr. Althoff is an associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Dr. Althoff has received grants/research support from the National Institute of Mental Health, the National Institute of General Medical Sciences, and the Klingenstein Third Generation Foundation, and honoraria from the Oakstone General Publishing for CME presentations.
Introduction
Aggressive behavior is one of the most common child psychiatric symptoms for which parents seek help. The difficulty with managing aggressive behavior is determining whether it is out of the ordinary from typical child development and then assessing the causes of the behavior before tackling the tough job of intervening. The following case is typical of what might present to the pediatrics office and provides a few ideas for the assessment and management of aggressive behavior.
Case summary
Dakota is a 6-year-old boy who presents for a well-child check with his father, Joe. Dakota is just finishing his kindergarten year, and the teachers have expressed concerns about his behavior in the classroom and on the playground. They note that he is often irritable and touchy, and that he will frequently have aggressive outbursts, particularly when asked to do something that he doesn’t like. He will often interrupt other children’s games, and will force children to play by his rules with a threat of, or occasional use of, hitting. In the classroom, he has been removed multiple times to the principal’s office, where he will go only with marked reluctance. He has been noted by his teachers to have difficulty attending to the classroom instructions, and frequently removes himself during circle time. They allow him to do this to avoid a power struggle. Similarly, Joe notes that the entire family is "walking on eggshells" because they never know what might set him off. They’ve tried "everything," including time out, sticker charts, and spanking, but with little effect. Joe says that he was "just like Dakota" when he was a child, and that he was "straightened out" in the Army. He wonders if some kind of boot camp or "scared straight" program would help Dakota learn his lesson.
Discussion
Diagnosis. Irritability and aggression are common manifestations of multiple child psychiatric conditions. While it’s easy to jump to the conclusion that the patient has oppositional-defiant disorder (ODD) or conduct disorder (CD) and move straight to treatment, care must be taken to evaluate common causes and co-occurring disorders that might change the treatment plan.
The differential diagnosis includes a primary mood disorder like depression, other disruptive behavior disorders such as attention-deficit/hyperactivity disorder (ADHD), a primary anxiety disorder, posttraumatic stress disorder, a learning or language disorder, and/or intellectual disability. One also must determine whether the aggression exhibited is greater than that shown by other boys his age. For this reason, the use of a scale that has normative values by age and sex makes sense. Having a standardized instrument filled out by parents and by the teachers also will help give an indication of how he is performing in multiple settings. Using a broad-based instrument that also covers mood, anxiety, and attention problems can be a quick and useful way to examine what type of co-occurring symptoms are present.
Aggression, while a heritable trait, also has a significant component from the environment. It is important to see how much of the aggression is being "caught, not taught" in the family setting. Querying as to the general level of negative, coercive parenting can be performed quickly by asking for a description of how the last outburst was managed – what the precipitant, the course, and the outcome were. Frequently, with ODD in particular, you will find a cycle of escalating threats and illogical consequences that serve to reinforce, rather than to reduce, aggressive and oppositional behavior. Practically, while the busy pediatrician may be able to manage some of this screening in a well-child check, it is likely that a separate appointment will be needed to go over the results of the screening instruments and to more fully assess the parenting environment.
At the scheduled visit designed to specifically assess the aggression:
• Make sure that both the parents and the child see this as a family-based problem. A treatment alliance with both parties is necessary to get the buy-in for any type of intervention that will occur.
• Assess the level of impairment. Are these outbursts severe only at home? In the school setting? With other people such as coaches or health care providers?
• Review the broadband screening instruments from multiple settings to make sure that this is a primary disruptive behavior disorder and not something else, particularly ADHD or a mood disorder, which will need to be managed differently.
• Determine if the aggressive behavior is impulsive/reactive or if it is planned/predatory. Is there remorse afterward (about the action, as opposed to remorse about being caught)? Lack of remorse could be an indicator of callous-unemotional traits, which have a worse prognosis.
Pearl: When asking about aggressive outbursts, make sure to concentrate not just on the outburst, but on the behavior and mood between outbursts. If the mood between outbursts is chronically irritable or sad, this might indicate a mood disorder rather than a primary disruptive behavior disorder.
Treatment. Treatment for aggressive behavior really calls for an "all hands on deck" family-based intervention. Parenting interventions will work best when the parents themselves are as healthy as they can be. Working with them to ensure that aggressive behavior, substance abuse, or anxiety is adequately treated through referral is an important step.
Next, the parenting interventions should involve those best informed by evidence-based practice, which typically include components of reducing the cycle of reinforcing aggressive behavior, noticing and rewarding prosocial behavior, and ceasing corporal punishment and replacing it with predictable, logical consequences for aggressive behavior. There are several excellent programs that therapists can use with parents, and referring to a therapist working with an evidence-based treatment program makes sense. There is a table listing parent management training packages that can be found in the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ODD (J. Am. Acad. Child. Adolesc. Psychiatry 2007;46:126-41).
Wellness interventions such as ensuring hydration and adequate caloric intake can make a difference in the management of aggression. It’s harder to maintain control when you are concentrating on the grumbling of your stomach. Further, using exercise and sports as an intervention allows children to channel some of their negative aggressive impulses into positive, prosocial activities.
Pharmacotherapy is not indicated for ODD or CD, except to target co-occurring symptoms. For example, treatment of ADHD or anxiety can quite successfully reduce impulsive or reactive aggression, and can make it easier to treat the ODD or CD through parent management techniques. In very severe cases of aggression, treatment with other agents such as mood stabilizers or antipsychotics might be indicated, but this would likely be implemented only in consultation with a child and adolescent psychiatrist.
Finally, there is little to no evidence for a mock incarceration or boot camp approach with children who exhibit oppositional behavior. In fact, it’s very possible that these kinds of programs can make the behaviors worse (J. Am. Acad. Child Adolesc. Psychiatry 1999;38:1320-1; "Aggression and Antisocial Behavior in Children and Adolescents: Research and Treatment" [New York: The Guilford Press, 2002]).
When to consult? Uncomplicated aggressive behavior can be managed by the primary care team with consultation from a therapist using evidence-based approaches. If there is poor treatment response, or if the aggression is severe enough to cause serious physical injury, or if there is concern for a cycling mood disorder (such as bipolar disorder – a topic for a later column), then consultation with a child psychiatrist is likely appropriate.
Dr. Althoff is an associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Dr. Althoff has received grants/research support from the National Institute of Mental Health, the National Institute of General Medical Sciences, and the Klingenstein Third Generation Foundation, and honoraria from the Oakstone General Publishing for CME presentations.
Big Data: The Paradigm Shift Needed to Revolutionize Musculoskeletal Clinical Research
One year ago, we wrote an editorial in The American Journal of Orthopedics on missing data.1 This year, data is once again the focus of our editorial but from a
different perspective. Rather than focus on the problems of incomplete data, we want to talk about the possibilities of collecting all data through advanced technology, a phenomenon better known as “Big Data.”
New Technology
The factors driving Big Data’s ascendency are the digitalization of useful data, increased means to gather digitalized data, and cheaper analytic power.2 Computer behemoth IBM claims that 90% of the data in the world today has been created in the last 2 years alone.3 Big Data is not just an industry buzzword; it is already an industry in itself. Revenue from Big Data reached $18 billion in 2013 and is predicted to rise to $50 billion in the next 5 years.4 While it is easy to see how Internet companies like Amazon can both collect and use all of the data they receive from customers (to suggest their next purchase, for example), it might be less easy to see how Big Data concepts can be applied to clinical research.
Health Care
Electronic data records are propelling the development of pools of information in health care. Almost half of all hospitals in the United States are participating in health information exchanges (HIEs).5 When these sources of data pools are integrated, the information collected can be used in a powerful way. For example, the health maintenance organization Kaiser Permanente uses a new computer system that drives data exchange between medical facilities. Patient benefits include improved outcomes of cardiovascular disease, and an estimated $1 billion has been saved due to reduced office visits and laboratory tests.5
Contemporary Studies
Let’s quickly consider how we currently conduct clinical studies. Because we do not usually collect data from the entire population, contemporary clinical studies offer only a snapshot of a subsection of patients. The results from this sample are then usually extrapolated to the general population. This was fine when there were insurmountable technological and logistical issues. So instead of trying to
collect data from everyone in the population of interest, we select a sample of patients and expend our energy on controlling for the suboptimal methods we currently employ, techniques which are the best ones available to us.
What are the consequences of all this? Those of us in clinical research are usually very concerned about dealing with confounding factors: selection bias, adjusting for missing data, controlling for errors, and so on. We can also see how imprecise our current methods are by how often a scientific manuscript ends with a call for larger-scale research. Indeed, a scientific research paper that does not list the study’s limitations is often regarded with suspicion, a telling indictment of the problems we expect to encounter in clinical research.
So what has historically been the best current solution to overcome these challenges? A meta-analysis of randomized controlled trials sits atop the evidence pyramid as being the best level of evidence. However, even the use of meta-analyses can be problematic. One group of researchers found that in 2005 and 2008, respectively, 18% and 30% of orthopedic meta-analyses had major to extensive flaws in their methodology.6 Indeed, implicit in the use of a meta-analysis is a criticism that our current studies with their limited sample sizes do not tell the whole story.
Paradigm Shift
We are in the middle of a paradigm shift in the way we can collect and analyze data. Our focus until now has been on identifying a causal relationship in our studies. New technology which allows for large-scale data collection and analysis means that we can now collect ALL patient data, in other words N = all. When you can collect all data, the why (causality) something is happening becomes less
important than the what (correlation) is happening.7 Studies will therefore begin to focus on effectiveness in the real world as opposed to measurements taken under the ideal (or nearly ideal) conditions of efficacy.
All of this is going to have implications, the greatest of which is the change in mindset that we are going to have to go through. How we conduct our studies and what their focus is will both change and expand. For example, the Mini-Sentinel project uses preexisting electronic health care data from multiple sources to monitor the safety of medical products that are regulated by the US Food and
Drug Administration (FDA). This FDA-sponsored initiative, which only began in 2008, had already collected data on 178 million individuals by July 2014.8
Since we cannot ignore Big Data, we must do what we can to ensure that its potential is harnessed to reduce costs and improve patient outcomes. Given the potential of using electronic clinical data, it is also necessary to strike a note of caution. We have to keep uppermost in mind that new technologies like Big Data can unsettle a lot of people. A central tenet of clinical research is that patient data belong to the patient. Robust and transparent processes need to be developed to ensure that patients do not feel compromised in any way by their data being used in such new and widespread methods. The need to rethink and implement safeguards is already being addressed. For example, the university-associated Regenstrief Institute does not pass along even deidentified data to their Big Data industry partner.9
However, we need to also be cognizant of the fact that society is changing in the way people use and regard their own information. Patient-reported data is already being shared among patients online, for both common and rare diseases. The data are also richer and can go beyond the usual outcomes that are recorded to give a bigger picture, eg, why patients are not adhering to treatment regimens.10
In summary, it is our earnest belief that if the health care industry can embrace the concept of Big Data and utilize it properly, our patients and medical practices will be all the better for it.
References
1. Helfet DL, Hanson BP, De Faoite D. Publish or perish; but what, when,
and how? Am J Orthop. 2013;42(9):399-400.
2. Nash DB. Harnessing the power of big data in healthcare. Am Health
Drug Benefits. 2014;7(2):69-70.
3. What is big data? IBM website. http://www-01.ibm.com/software/data/
bigdata/what-is-big-data.html. Accessed July 22, 2014.
4. Upbin B. Visualizing the big data industrial complex. Forbes website.
http://www.forbes.com/sites/bruceupbin/2013/08/30/visualizing-thebig-
data-industrial-complex-infographic/. Published August 30, 2013. Accessed July 22, 2014.
5. Kayyali B, Knott D, Van Kuiken S. The big-data revolution in US health
care: accelerating value and innovation. McKinsey & Company website.
http://www.mckinsey.com/insights/health_systems_and_services/
the_big-data_revolution_in_us_health_care. Published January 2013.
Accessed July 22, 2014.
6. Dijkman BG, Abouali JA, Kooistra BW, et al. Twenty years of meta-analyses
in orthopaedic surgery: has quality kept up with quantity? J Bone Joint Surg Am. 2010;92(1):48-57.
7. Cukier K, Mayer-Schonberger V. Big Data: A Revolution That Will Transform
How We Live, Work, and Think. New York, NY: Eamon Dolan/Houghton Mifflin Harcourt; 2013.
8. Mini-Sentinel distributed data “at a glance.” Mini-Sentinel website.
http://www.mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx. Accessed July 22, 2014.
9. Jain SH, Rosenblatt M, Duke J. Is big data the new frontier for academic-
industry collaboration? JAMA. 2014;311(21):2171-2172.
10. Okun S, McGraw D, Stang P, et al. Making the case for continuous
learning from routinely collected data. Institute of Medicine website.
http://www.iom.edu/Global/Perspectives/2013/~/media/Files/
Perspectives-Files/2013/Discussion-Papers/VSRT-MakingtheCase.pdf. Published April 15, 2013. Accessed July 22, 2014.
One year ago, we wrote an editorial in The American Journal of Orthopedics on missing data.1 This year, data is once again the focus of our editorial but from a
different perspective. Rather than focus on the problems of incomplete data, we want to talk about the possibilities of collecting all data through advanced technology, a phenomenon better known as “Big Data.”
New Technology
The factors driving Big Data’s ascendency are the digitalization of useful data, increased means to gather digitalized data, and cheaper analytic power.2 Computer behemoth IBM claims that 90% of the data in the world today has been created in the last 2 years alone.3 Big Data is not just an industry buzzword; it is already an industry in itself. Revenue from Big Data reached $18 billion in 2013 and is predicted to rise to $50 billion in the next 5 years.4 While it is easy to see how Internet companies like Amazon can both collect and use all of the data they receive from customers (to suggest their next purchase, for example), it might be less easy to see how Big Data concepts can be applied to clinical research.
Health Care
Electronic data records are propelling the development of pools of information in health care. Almost half of all hospitals in the United States are participating in health information exchanges (HIEs).5 When these sources of data pools are integrated, the information collected can be used in a powerful way. For example, the health maintenance organization Kaiser Permanente uses a new computer system that drives data exchange between medical facilities. Patient benefits include improved outcomes of cardiovascular disease, and an estimated $1 billion has been saved due to reduced office visits and laboratory tests.5
Contemporary Studies
Let’s quickly consider how we currently conduct clinical studies. Because we do not usually collect data from the entire population, contemporary clinical studies offer only a snapshot of a subsection of patients. The results from this sample are then usually extrapolated to the general population. This was fine when there were insurmountable technological and logistical issues. So instead of trying to
collect data from everyone in the population of interest, we select a sample of patients and expend our energy on controlling for the suboptimal methods we currently employ, techniques which are the best ones available to us.
What are the consequences of all this? Those of us in clinical research are usually very concerned about dealing with confounding factors: selection bias, adjusting for missing data, controlling for errors, and so on. We can also see how imprecise our current methods are by how often a scientific manuscript ends with a call for larger-scale research. Indeed, a scientific research paper that does not list the study’s limitations is often regarded with suspicion, a telling indictment of the problems we expect to encounter in clinical research.
So what has historically been the best current solution to overcome these challenges? A meta-analysis of randomized controlled trials sits atop the evidence pyramid as being the best level of evidence. However, even the use of meta-analyses can be problematic. One group of researchers found that in 2005 and 2008, respectively, 18% and 30% of orthopedic meta-analyses had major to extensive flaws in their methodology.6 Indeed, implicit in the use of a meta-analysis is a criticism that our current studies with their limited sample sizes do not tell the whole story.
Paradigm Shift
We are in the middle of a paradigm shift in the way we can collect and analyze data. Our focus until now has been on identifying a causal relationship in our studies. New technology which allows for large-scale data collection and analysis means that we can now collect ALL patient data, in other words N = all. When you can collect all data, the why (causality) something is happening becomes less
important than the what (correlation) is happening.7 Studies will therefore begin to focus on effectiveness in the real world as opposed to measurements taken under the ideal (or nearly ideal) conditions of efficacy.
All of this is going to have implications, the greatest of which is the change in mindset that we are going to have to go through. How we conduct our studies and what their focus is will both change and expand. For example, the Mini-Sentinel project uses preexisting electronic health care data from multiple sources to monitor the safety of medical products that are regulated by the US Food and
Drug Administration (FDA). This FDA-sponsored initiative, which only began in 2008, had already collected data on 178 million individuals by July 2014.8
Since we cannot ignore Big Data, we must do what we can to ensure that its potential is harnessed to reduce costs and improve patient outcomes. Given the potential of using electronic clinical data, it is also necessary to strike a note of caution. We have to keep uppermost in mind that new technologies like Big Data can unsettle a lot of people. A central tenet of clinical research is that patient data belong to the patient. Robust and transparent processes need to be developed to ensure that patients do not feel compromised in any way by their data being used in such new and widespread methods. The need to rethink and implement safeguards is already being addressed. For example, the university-associated Regenstrief Institute does not pass along even deidentified data to their Big Data industry partner.9
However, we need to also be cognizant of the fact that society is changing in the way people use and regard their own information. Patient-reported data is already being shared among patients online, for both common and rare diseases. The data are also richer and can go beyond the usual outcomes that are recorded to give a bigger picture, eg, why patients are not adhering to treatment regimens.10
In summary, it is our earnest belief that if the health care industry can embrace the concept of Big Data and utilize it properly, our patients and medical practices will be all the better for it.
References
1. Helfet DL, Hanson BP, De Faoite D. Publish or perish; but what, when,
and how? Am J Orthop. 2013;42(9):399-400.
2. Nash DB. Harnessing the power of big data in healthcare. Am Health
Drug Benefits. 2014;7(2):69-70.
3. What is big data? IBM website. http://www-01.ibm.com/software/data/
bigdata/what-is-big-data.html. Accessed July 22, 2014.
4. Upbin B. Visualizing the big data industrial complex. Forbes website.
http://www.forbes.com/sites/bruceupbin/2013/08/30/visualizing-thebig-
data-industrial-complex-infographic/. Published August 30, 2013. Accessed July 22, 2014.
5. Kayyali B, Knott D, Van Kuiken S. The big-data revolution in US health
care: accelerating value and innovation. McKinsey & Company website.
http://www.mckinsey.com/insights/health_systems_and_services/
the_big-data_revolution_in_us_health_care. Published January 2013.
Accessed July 22, 2014.
6. Dijkman BG, Abouali JA, Kooistra BW, et al. Twenty years of meta-analyses
in orthopaedic surgery: has quality kept up with quantity? J Bone Joint Surg Am. 2010;92(1):48-57.
7. Cukier K, Mayer-Schonberger V. Big Data: A Revolution That Will Transform
How We Live, Work, and Think. New York, NY: Eamon Dolan/Houghton Mifflin Harcourt; 2013.
8. Mini-Sentinel distributed data “at a glance.” Mini-Sentinel website.
http://www.mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx. Accessed July 22, 2014.
9. Jain SH, Rosenblatt M, Duke J. Is big data the new frontier for academic-
industry collaboration? JAMA. 2014;311(21):2171-2172.
10. Okun S, McGraw D, Stang P, et al. Making the case for continuous
learning from routinely collected data. Institute of Medicine website.
http://www.iom.edu/Global/Perspectives/2013/~/media/Files/
Perspectives-Files/2013/Discussion-Papers/VSRT-MakingtheCase.pdf. Published April 15, 2013. Accessed July 22, 2014.
One year ago, we wrote an editorial in The American Journal of Orthopedics on missing data.1 This year, data is once again the focus of our editorial but from a
different perspective. Rather than focus on the problems of incomplete data, we want to talk about the possibilities of collecting all data through advanced technology, a phenomenon better known as “Big Data.”
New Technology
The factors driving Big Data’s ascendency are the digitalization of useful data, increased means to gather digitalized data, and cheaper analytic power.2 Computer behemoth IBM claims that 90% of the data in the world today has been created in the last 2 years alone.3 Big Data is not just an industry buzzword; it is already an industry in itself. Revenue from Big Data reached $18 billion in 2013 and is predicted to rise to $50 billion in the next 5 years.4 While it is easy to see how Internet companies like Amazon can both collect and use all of the data they receive from customers (to suggest their next purchase, for example), it might be less easy to see how Big Data concepts can be applied to clinical research.
Health Care
Electronic data records are propelling the development of pools of information in health care. Almost half of all hospitals in the United States are participating in health information exchanges (HIEs).5 When these sources of data pools are integrated, the information collected can be used in a powerful way. For example, the health maintenance organization Kaiser Permanente uses a new computer system that drives data exchange between medical facilities. Patient benefits include improved outcomes of cardiovascular disease, and an estimated $1 billion has been saved due to reduced office visits and laboratory tests.5
Contemporary Studies
Let’s quickly consider how we currently conduct clinical studies. Because we do not usually collect data from the entire population, contemporary clinical studies offer only a snapshot of a subsection of patients. The results from this sample are then usually extrapolated to the general population. This was fine when there were insurmountable technological and logistical issues. So instead of trying to
collect data from everyone in the population of interest, we select a sample of patients and expend our energy on controlling for the suboptimal methods we currently employ, techniques which are the best ones available to us.
What are the consequences of all this? Those of us in clinical research are usually very concerned about dealing with confounding factors: selection bias, adjusting for missing data, controlling for errors, and so on. We can also see how imprecise our current methods are by how often a scientific manuscript ends with a call for larger-scale research. Indeed, a scientific research paper that does not list the study’s limitations is often regarded with suspicion, a telling indictment of the problems we expect to encounter in clinical research.
So what has historically been the best current solution to overcome these challenges? A meta-analysis of randomized controlled trials sits atop the evidence pyramid as being the best level of evidence. However, even the use of meta-analyses can be problematic. One group of researchers found that in 2005 and 2008, respectively, 18% and 30% of orthopedic meta-analyses had major to extensive flaws in their methodology.6 Indeed, implicit in the use of a meta-analysis is a criticism that our current studies with their limited sample sizes do not tell the whole story.
Paradigm Shift
We are in the middle of a paradigm shift in the way we can collect and analyze data. Our focus until now has been on identifying a causal relationship in our studies. New technology which allows for large-scale data collection and analysis means that we can now collect ALL patient data, in other words N = all. When you can collect all data, the why (causality) something is happening becomes less
important than the what (correlation) is happening.7 Studies will therefore begin to focus on effectiveness in the real world as opposed to measurements taken under the ideal (or nearly ideal) conditions of efficacy.
All of this is going to have implications, the greatest of which is the change in mindset that we are going to have to go through. How we conduct our studies and what their focus is will both change and expand. For example, the Mini-Sentinel project uses preexisting electronic health care data from multiple sources to monitor the safety of medical products that are regulated by the US Food and
Drug Administration (FDA). This FDA-sponsored initiative, which only began in 2008, had already collected data on 178 million individuals by July 2014.8
Since we cannot ignore Big Data, we must do what we can to ensure that its potential is harnessed to reduce costs and improve patient outcomes. Given the potential of using electronic clinical data, it is also necessary to strike a note of caution. We have to keep uppermost in mind that new technologies like Big Data can unsettle a lot of people. A central tenet of clinical research is that patient data belong to the patient. Robust and transparent processes need to be developed to ensure that patients do not feel compromised in any way by their data being used in such new and widespread methods. The need to rethink and implement safeguards is already being addressed. For example, the university-associated Regenstrief Institute does not pass along even deidentified data to their Big Data industry partner.9
However, we need to also be cognizant of the fact that society is changing in the way people use and regard their own information. Patient-reported data is already being shared among patients online, for both common and rare diseases. The data are also richer and can go beyond the usual outcomes that are recorded to give a bigger picture, eg, why patients are not adhering to treatment regimens.10
In summary, it is our earnest belief that if the health care industry can embrace the concept of Big Data and utilize it properly, our patients and medical practices will be all the better for it.
References
1. Helfet DL, Hanson BP, De Faoite D. Publish or perish; but what, when,
and how? Am J Orthop. 2013;42(9):399-400.
2. Nash DB. Harnessing the power of big data in healthcare. Am Health
Drug Benefits. 2014;7(2):69-70.
3. What is big data? IBM website. http://www-01.ibm.com/software/data/
bigdata/what-is-big-data.html. Accessed July 22, 2014.
4. Upbin B. Visualizing the big data industrial complex. Forbes website.
http://www.forbes.com/sites/bruceupbin/2013/08/30/visualizing-thebig-
data-industrial-complex-infographic/. Published August 30, 2013. Accessed July 22, 2014.
5. Kayyali B, Knott D, Van Kuiken S. The big-data revolution in US health
care: accelerating value and innovation. McKinsey & Company website.
http://www.mckinsey.com/insights/health_systems_and_services/
the_big-data_revolution_in_us_health_care. Published January 2013.
Accessed July 22, 2014.
6. Dijkman BG, Abouali JA, Kooistra BW, et al. Twenty years of meta-analyses
in orthopaedic surgery: has quality kept up with quantity? J Bone Joint Surg Am. 2010;92(1):48-57.
7. Cukier K, Mayer-Schonberger V. Big Data: A Revolution That Will Transform
How We Live, Work, and Think. New York, NY: Eamon Dolan/Houghton Mifflin Harcourt; 2013.
8. Mini-Sentinel distributed data “at a glance.” Mini-Sentinel website.
http://www.mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx. Accessed July 22, 2014.
9. Jain SH, Rosenblatt M, Duke J. Is big data the new frontier for academic-
industry collaboration? JAMA. 2014;311(21):2171-2172.
10. Okun S, McGraw D, Stang P, et al. Making the case for continuous
learning from routinely collected data. Institute of Medicine website.
http://www.iom.edu/Global/Perspectives/2013/~/media/Files/
Perspectives-Files/2013/Discussion-Papers/VSRT-MakingtheCase.pdf. Published April 15, 2013. Accessed July 22, 2014.
But I’m Sick! Where’s My Script?
The approach of fall brings changes in weather and the start of school and (often) new jobs—with the requisite associated illnesses. Exposure to new germs makes us vulnerable to “catching everything.” Prime candidates for this phenomenon are children just entering school, who are magnets for the myriad pathogens lurking in classrooms and are quite adept at carrying them home to “share” with the family! As a result, upper respiratory infections (URIs) are common at this time of year.
With symptoms ranging from rhinorrhea, pharyngitis, and cough to difficulty breathing and fatigue, URIs are among the most frequent reasons for visits to health care providers and a leading cause of missed school or work in the United States.1 The combination of bothersome symptoms and lost productivity is often the impetus for a request for antibiotics. Distressingly, these requests all too frequently result in unnecessary—and inappropriate—prescriptions.
Why is this a big deal? According to the World Health Organization, bacterial infections, including respiratory tract and hospital-acquired infections, are becoming increasingly resistant to first-choice antibiotics. This places both individual patients and society at risk for severe infections acquired in either health care facilities or the community.2
In the US alone, each year there are at least 2 million antibiotic-resistant infections, with more than 20,000 deaths as a result.3 Among the major causes of resistance are overuse and misuse of antibiotics. Data indicate that 50% of hospitalized patients who are given antibiotics will receive unnecessary or redundant therapy, resulting in overuse. In the primary care setting, antibiotic overuse is associated with antibiotic resistance at the individual patient level.3 What is most concerning is that “the presence of antibiotic-resistant bacteria is greatest during the month following a patient’s antibiotic use and may persist for up to 12 months.”3
The Global Antibiotic Resistance Partnership has identified four major reasons for inappropriate antibiotic prescribing and overuse. Although the particular findings came from a study in India, I submit that two of the reasons are applicable to the US: patients’ expectations and the lack of awareness about the inappropriate use of antibiotics and its associated risks.4
Since the early 1980s, global efforts have attempted to address these issues and provide solutions, which include judicious use of antibiotics in an attempt to stem the rising tide of bacterial resistance. The Alliance for the Prudent Use of Antibiotics, affiliated with Tufts University School of Medicine, has devoted 30-plus years to research, education, and public policy advocacy on this topic.5 The CDC has an ongoing public service campaign, Get Smart About Antibiotics, to educate the general public about when antibiotics are appropriate and when they are not. And yet …
Not surprisingly, antibiotic overuse occurs most often among patients with common respiratory ailments. We as clinicians know that URIs caused by viruses are self-limited and thus require no specific treatment—especially not antibiotics. Yet, perhaps for the following reasons—the patient doesn’t want to “suffer” with the URI (which lasts between three and 14 days) or insists that he/she only gets better when taking antibiotics, or it is simply easier to concede than spend the extra time to explain why an antibiotic is not indicated (or effective) for viral infections—we write the prescription. Thus, we contribute to the problem.
We, as health care professionals, know better. We are armed with not only education and information that tells us when we should not prescribe an antibiotic, but also, increasingly, with recommendations and admonitions not to do it. These include
• One of the goals of Healthy People 2020 is to “increase immunization rates and reduce preventable infectious diseases.”6 Goal IID-6 is specific: “Reduce the number of courses of antibiotics prescribed for the sole diagnosis of the common cold.”6
• The Institute of Medicine has identified six key issues that must be addressed in today’s health care systems, including safety and effectiveness of care. Safety involves “avoiding injuries to patients from the care that is intended to help them.”7 Surely avoiding inappropriate use of antibiotics qualifies.
I’m not suggesting we should never prescribe antibiotics; we all know there are instances in which it is absolutely appropriate: in patients who are immunocompromised and in cases when we suspect strep throat, bacterial sinusitis, or epiglottitis. When we have these clinical suspicions, we need to obtain cultures to confirm them. And if treatment is the right course, we should prescribe the right antibiotic at the right dose for the right duration and be familiar with regional resistance trends.3
We—as primary care providers—can easily mitigate the global threat of antibiotic-resistant bacteria if we encourage symptomatic therapy for URIs: those simple, “tried and true” treatments. We know them, our patients know them, and just in case we forget, we have seasonal commercials to remind us. The treatment for the average URI is simple: Rest in bed, drink plenty of fluids, and take nonprescription medications to attenuate symptoms such as fever or myalgia. (For helpful patient education, see “When Patients Ask for Antibiotics, Arm Them With Handouts”)
We must base our decision whether to treat common URI complaints with antibiotics on sound clinical findings. Take the time to explain to your patients those findings and educate them about appropriate use of antibiotics. Moreover, when the clinical findings do not support the need for an antibiotic, tell your patients, “I’m not saying you aren’t sick; I’m telling you that you don’t need antibiotics for your illness!” Remind patients that they will get better, as one colleague of mine always said, “in seven days with, or in a week without, antibiotics.”’
So, when you must, write the prescription. But please: Prescribe “tincture of time.”
REFERENCES
1. Johns Hopkins. Upper respiratory infection (URI or common cold). www.hopkinsmed icine.org/healthlibrary/conditions/pediatrics/upper_respiratory_infection_uri_or_common_cold_90,P02966/. Accessed August 14, 2014.
2. World Health Organization. Antimicrobial resistance. www.who.int/mediacentre/fact sheets/fs194/en/. Accessed August 14, 2014.
3. CDC. Delivering smart care for patients: all healthcare providers play a role. www.cdc.gov/getsmart/healthcare/factsheets/hc_pro viders.html. Accessed August 14, 2014.
4. Global Antibiotic Resistance Partnership (GARP) India Working Group. Rationalizing antibiotic use to limit antibiotic resistance in India. Indian J Med Res. 2011;134(3):281-294.
5. Alliance for the Prudent Use of Antibiotics. www.tufts.edu/med/apua/about_us/what_we_do.shtml. Accessed August 14, 2014.
6. United States Department of Health and Human Services. Immunization and infectious disease. www.healthypeople.gov/2020/
topicsobjectives2020/overview.aspx?
topicid=23. Accessed August 14, 2014.
7. The Institute of Medicine. An agenda for crossing the chasm. In: Crossing the Quality Chasm: A New Health System for the 21st Century. 2001:5-6. http://books.nap.edu/openbook.php?record_id=10027&page=5. Accessed August 14, 2014.
The approach of fall brings changes in weather and the start of school and (often) new jobs—with the requisite associated illnesses. Exposure to new germs makes us vulnerable to “catching everything.” Prime candidates for this phenomenon are children just entering school, who are magnets for the myriad pathogens lurking in classrooms and are quite adept at carrying them home to “share” with the family! As a result, upper respiratory infections (URIs) are common at this time of year.
With symptoms ranging from rhinorrhea, pharyngitis, and cough to difficulty breathing and fatigue, URIs are among the most frequent reasons for visits to health care providers and a leading cause of missed school or work in the United States.1 The combination of bothersome symptoms and lost productivity is often the impetus for a request for antibiotics. Distressingly, these requests all too frequently result in unnecessary—and inappropriate—prescriptions.
Why is this a big deal? According to the World Health Organization, bacterial infections, including respiratory tract and hospital-acquired infections, are becoming increasingly resistant to first-choice antibiotics. This places both individual patients and society at risk for severe infections acquired in either health care facilities or the community.2
In the US alone, each year there are at least 2 million antibiotic-resistant infections, with more than 20,000 deaths as a result.3 Among the major causes of resistance are overuse and misuse of antibiotics. Data indicate that 50% of hospitalized patients who are given antibiotics will receive unnecessary or redundant therapy, resulting in overuse. In the primary care setting, antibiotic overuse is associated with antibiotic resistance at the individual patient level.3 What is most concerning is that “the presence of antibiotic-resistant bacteria is greatest during the month following a patient’s antibiotic use and may persist for up to 12 months.”3
The Global Antibiotic Resistance Partnership has identified four major reasons for inappropriate antibiotic prescribing and overuse. Although the particular findings came from a study in India, I submit that two of the reasons are applicable to the US: patients’ expectations and the lack of awareness about the inappropriate use of antibiotics and its associated risks.4
Since the early 1980s, global efforts have attempted to address these issues and provide solutions, which include judicious use of antibiotics in an attempt to stem the rising tide of bacterial resistance. The Alliance for the Prudent Use of Antibiotics, affiliated with Tufts University School of Medicine, has devoted 30-plus years to research, education, and public policy advocacy on this topic.5 The CDC has an ongoing public service campaign, Get Smart About Antibiotics, to educate the general public about when antibiotics are appropriate and when they are not. And yet …
Not surprisingly, antibiotic overuse occurs most often among patients with common respiratory ailments. We as clinicians know that URIs caused by viruses are self-limited and thus require no specific treatment—especially not antibiotics. Yet, perhaps for the following reasons—the patient doesn’t want to “suffer” with the URI (which lasts between three and 14 days) or insists that he/she only gets better when taking antibiotics, or it is simply easier to concede than spend the extra time to explain why an antibiotic is not indicated (or effective) for viral infections—we write the prescription. Thus, we contribute to the problem.
We, as health care professionals, know better. We are armed with not only education and information that tells us when we should not prescribe an antibiotic, but also, increasingly, with recommendations and admonitions not to do it. These include
• One of the goals of Healthy People 2020 is to “increase immunization rates and reduce preventable infectious diseases.”6 Goal IID-6 is specific: “Reduce the number of courses of antibiotics prescribed for the sole diagnosis of the common cold.”6
• The Institute of Medicine has identified six key issues that must be addressed in today’s health care systems, including safety and effectiveness of care. Safety involves “avoiding injuries to patients from the care that is intended to help them.”7 Surely avoiding inappropriate use of antibiotics qualifies.
I’m not suggesting we should never prescribe antibiotics; we all know there are instances in which it is absolutely appropriate: in patients who are immunocompromised and in cases when we suspect strep throat, bacterial sinusitis, or epiglottitis. When we have these clinical suspicions, we need to obtain cultures to confirm them. And if treatment is the right course, we should prescribe the right antibiotic at the right dose for the right duration and be familiar with regional resistance trends.3
We—as primary care providers—can easily mitigate the global threat of antibiotic-resistant bacteria if we encourage symptomatic therapy for URIs: those simple, “tried and true” treatments. We know them, our patients know them, and just in case we forget, we have seasonal commercials to remind us. The treatment for the average URI is simple: Rest in bed, drink plenty of fluids, and take nonprescription medications to attenuate symptoms such as fever or myalgia. (For helpful patient education, see “When Patients Ask for Antibiotics, Arm Them With Handouts”)
We must base our decision whether to treat common URI complaints with antibiotics on sound clinical findings. Take the time to explain to your patients those findings and educate them about appropriate use of antibiotics. Moreover, when the clinical findings do not support the need for an antibiotic, tell your patients, “I’m not saying you aren’t sick; I’m telling you that you don’t need antibiotics for your illness!” Remind patients that they will get better, as one colleague of mine always said, “in seven days with, or in a week without, antibiotics.”’
So, when you must, write the prescription. But please: Prescribe “tincture of time.”
REFERENCES
1. Johns Hopkins. Upper respiratory infection (URI or common cold). www.hopkinsmed icine.org/healthlibrary/conditions/pediatrics/upper_respiratory_infection_uri_or_common_cold_90,P02966/. Accessed August 14, 2014.
2. World Health Organization. Antimicrobial resistance. www.who.int/mediacentre/fact sheets/fs194/en/. Accessed August 14, 2014.
3. CDC. Delivering smart care for patients: all healthcare providers play a role. www.cdc.gov/getsmart/healthcare/factsheets/hc_pro viders.html. Accessed August 14, 2014.
4. Global Antibiotic Resistance Partnership (GARP) India Working Group. Rationalizing antibiotic use to limit antibiotic resistance in India. Indian J Med Res. 2011;134(3):281-294.
5. Alliance for the Prudent Use of Antibiotics. www.tufts.edu/med/apua/about_us/what_we_do.shtml. Accessed August 14, 2014.
6. United States Department of Health and Human Services. Immunization and infectious disease. www.healthypeople.gov/2020/
topicsobjectives2020/overview.aspx?
topicid=23. Accessed August 14, 2014.
7. The Institute of Medicine. An agenda for crossing the chasm. In: Crossing the Quality Chasm: A New Health System for the 21st Century. 2001:5-6. http://books.nap.edu/openbook.php?record_id=10027&page=5. Accessed August 14, 2014.
The approach of fall brings changes in weather and the start of school and (often) new jobs—with the requisite associated illnesses. Exposure to new germs makes us vulnerable to “catching everything.” Prime candidates for this phenomenon are children just entering school, who are magnets for the myriad pathogens lurking in classrooms and are quite adept at carrying them home to “share” with the family! As a result, upper respiratory infections (URIs) are common at this time of year.
With symptoms ranging from rhinorrhea, pharyngitis, and cough to difficulty breathing and fatigue, URIs are among the most frequent reasons for visits to health care providers and a leading cause of missed school or work in the United States.1 The combination of bothersome symptoms and lost productivity is often the impetus for a request for antibiotics. Distressingly, these requests all too frequently result in unnecessary—and inappropriate—prescriptions.
Why is this a big deal? According to the World Health Organization, bacterial infections, including respiratory tract and hospital-acquired infections, are becoming increasingly resistant to first-choice antibiotics. This places both individual patients and society at risk for severe infections acquired in either health care facilities or the community.2
In the US alone, each year there are at least 2 million antibiotic-resistant infections, with more than 20,000 deaths as a result.3 Among the major causes of resistance are overuse and misuse of antibiotics. Data indicate that 50% of hospitalized patients who are given antibiotics will receive unnecessary or redundant therapy, resulting in overuse. In the primary care setting, antibiotic overuse is associated with antibiotic resistance at the individual patient level.3 What is most concerning is that “the presence of antibiotic-resistant bacteria is greatest during the month following a patient’s antibiotic use and may persist for up to 12 months.”3
The Global Antibiotic Resistance Partnership has identified four major reasons for inappropriate antibiotic prescribing and overuse. Although the particular findings came from a study in India, I submit that two of the reasons are applicable to the US: patients’ expectations and the lack of awareness about the inappropriate use of antibiotics and its associated risks.4
Since the early 1980s, global efforts have attempted to address these issues and provide solutions, which include judicious use of antibiotics in an attempt to stem the rising tide of bacterial resistance. The Alliance for the Prudent Use of Antibiotics, affiliated with Tufts University School of Medicine, has devoted 30-plus years to research, education, and public policy advocacy on this topic.5 The CDC has an ongoing public service campaign, Get Smart About Antibiotics, to educate the general public about when antibiotics are appropriate and when they are not. And yet …
Not surprisingly, antibiotic overuse occurs most often among patients with common respiratory ailments. We as clinicians know that URIs caused by viruses are self-limited and thus require no specific treatment—especially not antibiotics. Yet, perhaps for the following reasons—the patient doesn’t want to “suffer” with the URI (which lasts between three and 14 days) or insists that he/she only gets better when taking antibiotics, or it is simply easier to concede than spend the extra time to explain why an antibiotic is not indicated (or effective) for viral infections—we write the prescription. Thus, we contribute to the problem.
We, as health care professionals, know better. We are armed with not only education and information that tells us when we should not prescribe an antibiotic, but also, increasingly, with recommendations and admonitions not to do it. These include
• One of the goals of Healthy People 2020 is to “increase immunization rates and reduce preventable infectious diseases.”6 Goal IID-6 is specific: “Reduce the number of courses of antibiotics prescribed for the sole diagnosis of the common cold.”6
• The Institute of Medicine has identified six key issues that must be addressed in today’s health care systems, including safety and effectiveness of care. Safety involves “avoiding injuries to patients from the care that is intended to help them.”7 Surely avoiding inappropriate use of antibiotics qualifies.
I’m not suggesting we should never prescribe antibiotics; we all know there are instances in which it is absolutely appropriate: in patients who are immunocompromised and in cases when we suspect strep throat, bacterial sinusitis, or epiglottitis. When we have these clinical suspicions, we need to obtain cultures to confirm them. And if treatment is the right course, we should prescribe the right antibiotic at the right dose for the right duration and be familiar with regional resistance trends.3
We—as primary care providers—can easily mitigate the global threat of antibiotic-resistant bacteria if we encourage symptomatic therapy for URIs: those simple, “tried and true” treatments. We know them, our patients know them, and just in case we forget, we have seasonal commercials to remind us. The treatment for the average URI is simple: Rest in bed, drink plenty of fluids, and take nonprescription medications to attenuate symptoms such as fever or myalgia. (For helpful patient education, see “When Patients Ask for Antibiotics, Arm Them With Handouts”)
We must base our decision whether to treat common URI complaints with antibiotics on sound clinical findings. Take the time to explain to your patients those findings and educate them about appropriate use of antibiotics. Moreover, when the clinical findings do not support the need for an antibiotic, tell your patients, “I’m not saying you aren’t sick; I’m telling you that you don’t need antibiotics for your illness!” Remind patients that they will get better, as one colleague of mine always said, “in seven days with, or in a week without, antibiotics.”’
So, when you must, write the prescription. But please: Prescribe “tincture of time.”
REFERENCES
1. Johns Hopkins. Upper respiratory infection (URI or common cold). www.hopkinsmed icine.org/healthlibrary/conditions/pediatrics/upper_respiratory_infection_uri_or_common_cold_90,P02966/. Accessed August 14, 2014.
2. World Health Organization. Antimicrobial resistance. www.who.int/mediacentre/fact sheets/fs194/en/. Accessed August 14, 2014.
3. CDC. Delivering smart care for patients: all healthcare providers play a role. www.cdc.gov/getsmart/healthcare/factsheets/hc_pro viders.html. Accessed August 14, 2014.
4. Global Antibiotic Resistance Partnership (GARP) India Working Group. Rationalizing antibiotic use to limit antibiotic resistance in India. Indian J Med Res. 2011;134(3):281-294.
5. Alliance for the Prudent Use of Antibiotics. www.tufts.edu/med/apua/about_us/what_we_do.shtml. Accessed August 14, 2014.
6. United States Department of Health and Human Services. Immunization and infectious disease. www.healthypeople.gov/2020/
topicsobjectives2020/overview.aspx?
topicid=23. Accessed August 14, 2014.
7. The Institute of Medicine. An agenda for crossing the chasm. In: Crossing the Quality Chasm: A New Health System for the 21st Century. 2001:5-6. http://books.nap.edu/openbook.php?record_id=10027&page=5. Accessed August 14, 2014.
Kegel exercises
The prevalence of urinary incontinence is 17%-55% among older women and 12%-42% among younger and middle-aged women. Only 45% of women with at least weekly symptoms seek medical care to address their symptoms.
For most of us, offering conservative measures is the most reasonable approach when women present. Pelvic floor muscle training, sometimes referred to as Kegel exercises, is usually one of the first things we discuss. Many women have heard this spiel before and may report having tried but not benefited from the exercises. This real or perceived lack of benefit may be related to either poor adherence or lack of efficacy.
In theory, pelvic floor muscle training builds strength and improves muscle tone, enhances conscious awareness of muscle groups, and increases perineal support by lifting pelvic viscera. But do clinical trial data support the use of pelvic muscle training for reducing urinary incontinence?
Dr. O. Celiker Tosun of Dokuz Eylül University, Izmir, Turkey, and colleagues published the results of a randomized clinical trial evaluating the effectiveness of an individually prescribed 12-week home-based pelvic floor muscle exercise program (Clin. Rehabil. 2014 Aug. 20 [doi:10.1177/0269215514546768]). Women with stress or mixed urinary incontinence were selected from a urogynecology clinic and randomized to pelvic floor muscle training (65 patients) or a control condition (65 patients).
The pelvic floor muscle training group had significant improvement in their symptoms of urinary incontinence and pelvic floor muscle strength, compared with the control group. Symptoms of urinary incontinence were significantly decreased in the training group.
This study is important because it demonstrates the utility of pelvic floor muscle training exercises under ideal circumstances.
However, the intervention provided in this study was intense and sophisticated – and it will be difficult, if not impossible, for most of us to replicate. A physiotherapist provided the training over a 12-week period, with 30-minute sessions three times a week for the first 2 weeks. Women also kept a training diary. Adherence to the protocol was 89% in the training group.
This is very different from the handout on Kegel’s we might be giving to our patients – with adherence to recommendations likely approaching 0%.
But now that we have these data, perhaps we can talk to our female patients more consistently and convincingly about the utility of this approach for reducing incontinence. If we are lucky and have a women’s health clinic with access to this type of expertise, this might be another option – at least before we refer them for higher-risk surgical procedures.
Dr. Ebbert is professor of medicine and a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. They should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
The prevalence of urinary incontinence is 17%-55% among older women and 12%-42% among younger and middle-aged women. Only 45% of women with at least weekly symptoms seek medical care to address their symptoms.
For most of us, offering conservative measures is the most reasonable approach when women present. Pelvic floor muscle training, sometimes referred to as Kegel exercises, is usually one of the first things we discuss. Many women have heard this spiel before and may report having tried but not benefited from the exercises. This real or perceived lack of benefit may be related to either poor adherence or lack of efficacy.
In theory, pelvic floor muscle training builds strength and improves muscle tone, enhances conscious awareness of muscle groups, and increases perineal support by lifting pelvic viscera. But do clinical trial data support the use of pelvic muscle training for reducing urinary incontinence?
Dr. O. Celiker Tosun of Dokuz Eylül University, Izmir, Turkey, and colleagues published the results of a randomized clinical trial evaluating the effectiveness of an individually prescribed 12-week home-based pelvic floor muscle exercise program (Clin. Rehabil. 2014 Aug. 20 [doi:10.1177/0269215514546768]). Women with stress or mixed urinary incontinence were selected from a urogynecology clinic and randomized to pelvic floor muscle training (65 patients) or a control condition (65 patients).
The pelvic floor muscle training group had significant improvement in their symptoms of urinary incontinence and pelvic floor muscle strength, compared with the control group. Symptoms of urinary incontinence were significantly decreased in the training group.
This study is important because it demonstrates the utility of pelvic floor muscle training exercises under ideal circumstances.
However, the intervention provided in this study was intense and sophisticated – and it will be difficult, if not impossible, for most of us to replicate. A physiotherapist provided the training over a 12-week period, with 30-minute sessions three times a week for the first 2 weeks. Women also kept a training diary. Adherence to the protocol was 89% in the training group.
This is very different from the handout on Kegel’s we might be giving to our patients – with adherence to recommendations likely approaching 0%.
But now that we have these data, perhaps we can talk to our female patients more consistently and convincingly about the utility of this approach for reducing incontinence. If we are lucky and have a women’s health clinic with access to this type of expertise, this might be another option – at least before we refer them for higher-risk surgical procedures.
Dr. Ebbert is professor of medicine and a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. They should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
The prevalence of urinary incontinence is 17%-55% among older women and 12%-42% among younger and middle-aged women. Only 45% of women with at least weekly symptoms seek medical care to address their symptoms.
For most of us, offering conservative measures is the most reasonable approach when women present. Pelvic floor muscle training, sometimes referred to as Kegel exercises, is usually one of the first things we discuss. Many women have heard this spiel before and may report having tried but not benefited from the exercises. This real or perceived lack of benefit may be related to either poor adherence or lack of efficacy.
In theory, pelvic floor muscle training builds strength and improves muscle tone, enhances conscious awareness of muscle groups, and increases perineal support by lifting pelvic viscera. But do clinical trial data support the use of pelvic muscle training for reducing urinary incontinence?
Dr. O. Celiker Tosun of Dokuz Eylül University, Izmir, Turkey, and colleagues published the results of a randomized clinical trial evaluating the effectiveness of an individually prescribed 12-week home-based pelvic floor muscle exercise program (Clin. Rehabil. 2014 Aug. 20 [doi:10.1177/0269215514546768]). Women with stress or mixed urinary incontinence were selected from a urogynecology clinic and randomized to pelvic floor muscle training (65 patients) or a control condition (65 patients).
The pelvic floor muscle training group had significant improvement in their symptoms of urinary incontinence and pelvic floor muscle strength, compared with the control group. Symptoms of urinary incontinence were significantly decreased in the training group.
This study is important because it demonstrates the utility of pelvic floor muscle training exercises under ideal circumstances.
However, the intervention provided in this study was intense and sophisticated – and it will be difficult, if not impossible, for most of us to replicate. A physiotherapist provided the training over a 12-week period, with 30-minute sessions three times a week for the first 2 weeks. Women also kept a training diary. Adherence to the protocol was 89% in the training group.
This is very different from the handout on Kegel’s we might be giving to our patients – with adherence to recommendations likely approaching 0%.
But now that we have these data, perhaps we can talk to our female patients more consistently and convincingly about the utility of this approach for reducing incontinence. If we are lucky and have a women’s health clinic with access to this type of expertise, this might be another option – at least before we refer them for higher-risk surgical procedures.
Dr. Ebbert is professor of medicine and a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. They should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
Antidepressants and Youths: What we’ve learned in the decade since the black box
Ten years ago, the Food and Drug Administration required that all antidepressants carry a severe black box warning to alert prescribers to the possibility that these medications could cause worsening suicidal thoughts and behavior. A decade later, this issue had faded from the public eye and the media headlines. Nevertheless, research into their use has continued, and antidepressants continue to be prescribed. Have things changed since all the attention in the past? The results may be surprising.
Although there are undoubtedly different views, here is my summary of the five key points with direct implications for pediatricians:
1. The risk of suicide due to antidepressants was overstated. Subsequent analyses from additional clinical trials comparing suicidal thoughts or behavior between youths taking antidepressants versus placebo have increasingly struggled to find that "signal" related to active drug. Perhaps more importantly, several other studies that have examined actual suicides and/or suicide attempts from large databases have not shown links to the taking of antidepressants and, if anything, have suggested that untreated depression poses a greater risk (BMJ 2014;348:g3596). It is worth repeating that there still has never been an actual suicide in any of the antidepressant trials.
2. The efficacy of antidepressants also was overstated. As people began to examine more closely the issue of suicidal behavior and antidepressants, it became evident that there was much more data on this than was obvious from published studies. Many more trials of depression and antidepressants were performed, usually funded by pharmaceutical companies, and many of these trials did not show that antidepressants were superior to placebo (N. Engl. J. Med. 2008;358:252-60). As opposed to the positive trials, however, the negative ones tended not to be published or featured. Overall, it seems that about 60% of depressed children and adolescents respond to antidepressant medication, compared with 50% who respond to placebo.
3. The prescribing of antidepressants is making a comeback. After the 2004 warnings, the number of antidepressant prescriptions dropped. Since around 2008, however, the rate of antidepressant prescribing has increased again, although not at 2004 levels, according to some studies.
4. Antidepressants don’t work by fixing a serotonin "chemical imbalance." Although it is true that antidepressants result in more serotonin being available in brain synapses acutely, depression is not caused by a simple serotonin deficit. Medications likely work by changing the expression of certain genes that relate to how strongly particular brain pathways are connected. This process may explain why antidepressants take time to be effective.
5. Antidepressants actually work better for youths with anxiety rather than depression. More promising results with antidepressants have been found for children with anxiety disorder and obsessive-compulsive disorder (N. Engl. J. Med. 2008;359:2753-66). Although cognitive-behavior therapy remains the recommended first-line intervention for children with anxiety disorders, antidepressants have been shown to be effective both alone and in combination with cognitive-behavior therapy.
There is still much to learn. Children and adolescents who are extremely irritable, unmotivated, and at times suicidal are a diverse group of people whose difficulties can arise from many factors that deserve investigation. When it comes to antidepressants, it appears that both the amount of risk and the amount of benefit associated with this class of medications may be less than what was believed a decade ago.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych. Dr. Rettew said he had no financial disclosures relevant to this article.
Ten years ago, the Food and Drug Administration required that all antidepressants carry a severe black box warning to alert prescribers to the possibility that these medications could cause worsening suicidal thoughts and behavior. A decade later, this issue had faded from the public eye and the media headlines. Nevertheless, research into their use has continued, and antidepressants continue to be prescribed. Have things changed since all the attention in the past? The results may be surprising.
Although there are undoubtedly different views, here is my summary of the five key points with direct implications for pediatricians:
1. The risk of suicide due to antidepressants was overstated. Subsequent analyses from additional clinical trials comparing suicidal thoughts or behavior between youths taking antidepressants versus placebo have increasingly struggled to find that "signal" related to active drug. Perhaps more importantly, several other studies that have examined actual suicides and/or suicide attempts from large databases have not shown links to the taking of antidepressants and, if anything, have suggested that untreated depression poses a greater risk (BMJ 2014;348:g3596). It is worth repeating that there still has never been an actual suicide in any of the antidepressant trials.
2. The efficacy of antidepressants also was overstated. As people began to examine more closely the issue of suicidal behavior and antidepressants, it became evident that there was much more data on this than was obvious from published studies. Many more trials of depression and antidepressants were performed, usually funded by pharmaceutical companies, and many of these trials did not show that antidepressants were superior to placebo (N. Engl. J. Med. 2008;358:252-60). As opposed to the positive trials, however, the negative ones tended not to be published or featured. Overall, it seems that about 60% of depressed children and adolescents respond to antidepressant medication, compared with 50% who respond to placebo.
3. The prescribing of antidepressants is making a comeback. After the 2004 warnings, the number of antidepressant prescriptions dropped. Since around 2008, however, the rate of antidepressant prescribing has increased again, although not at 2004 levels, according to some studies.
4. Antidepressants don’t work by fixing a serotonin "chemical imbalance." Although it is true that antidepressants result in more serotonin being available in brain synapses acutely, depression is not caused by a simple serotonin deficit. Medications likely work by changing the expression of certain genes that relate to how strongly particular brain pathways are connected. This process may explain why antidepressants take time to be effective.
5. Antidepressants actually work better for youths with anxiety rather than depression. More promising results with antidepressants have been found for children with anxiety disorder and obsessive-compulsive disorder (N. Engl. J. Med. 2008;359:2753-66). Although cognitive-behavior therapy remains the recommended first-line intervention for children with anxiety disorders, antidepressants have been shown to be effective both alone and in combination with cognitive-behavior therapy.
There is still much to learn. Children and adolescents who are extremely irritable, unmotivated, and at times suicidal are a diverse group of people whose difficulties can arise from many factors that deserve investigation. When it comes to antidepressants, it appears that both the amount of risk and the amount of benefit associated with this class of medications may be less than what was believed a decade ago.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych. Dr. Rettew said he had no financial disclosures relevant to this article.
Ten years ago, the Food and Drug Administration required that all antidepressants carry a severe black box warning to alert prescribers to the possibility that these medications could cause worsening suicidal thoughts and behavior. A decade later, this issue had faded from the public eye and the media headlines. Nevertheless, research into their use has continued, and antidepressants continue to be prescribed. Have things changed since all the attention in the past? The results may be surprising.
Although there are undoubtedly different views, here is my summary of the five key points with direct implications for pediatricians:
1. The risk of suicide due to antidepressants was overstated. Subsequent analyses from additional clinical trials comparing suicidal thoughts or behavior between youths taking antidepressants versus placebo have increasingly struggled to find that "signal" related to active drug. Perhaps more importantly, several other studies that have examined actual suicides and/or suicide attempts from large databases have not shown links to the taking of antidepressants and, if anything, have suggested that untreated depression poses a greater risk (BMJ 2014;348:g3596). It is worth repeating that there still has never been an actual suicide in any of the antidepressant trials.
2. The efficacy of antidepressants also was overstated. As people began to examine more closely the issue of suicidal behavior and antidepressants, it became evident that there was much more data on this than was obvious from published studies. Many more trials of depression and antidepressants were performed, usually funded by pharmaceutical companies, and many of these trials did not show that antidepressants were superior to placebo (N. Engl. J. Med. 2008;358:252-60). As opposed to the positive trials, however, the negative ones tended not to be published or featured. Overall, it seems that about 60% of depressed children and adolescents respond to antidepressant medication, compared with 50% who respond to placebo.
3. The prescribing of antidepressants is making a comeback. After the 2004 warnings, the number of antidepressant prescriptions dropped. Since around 2008, however, the rate of antidepressant prescribing has increased again, although not at 2004 levels, according to some studies.
4. Antidepressants don’t work by fixing a serotonin "chemical imbalance." Although it is true that antidepressants result in more serotonin being available in brain synapses acutely, depression is not caused by a simple serotonin deficit. Medications likely work by changing the expression of certain genes that relate to how strongly particular brain pathways are connected. This process may explain why antidepressants take time to be effective.
5. Antidepressants actually work better for youths with anxiety rather than depression. More promising results with antidepressants have been found for children with anxiety disorder and obsessive-compulsive disorder (N. Engl. J. Med. 2008;359:2753-66). Although cognitive-behavior therapy remains the recommended first-line intervention for children with anxiety disorders, antidepressants have been shown to be effective both alone and in combination with cognitive-behavior therapy.
There is still much to learn. Children and adolescents who are extremely irritable, unmotivated, and at times suicidal are a diverse group of people whose difficulties can arise from many factors that deserve investigation. When it comes to antidepressants, it appears that both the amount of risk and the amount of benefit associated with this class of medications may be less than what was believed a decade ago.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych. Dr. Rettew said he had no financial disclosures relevant to this article.
ADHD boundaries with normal behavior
Case summary
Dylan is a bright and lively 10-year-old boy who has always been energetic and passionate. His parents have celebrated his exuberance but now have become concerned that there is "something more," after his teacher has needed to remove him from class for several episodes of impulsive and disruptive behavior. Further history reveals that, compared with his classmates, he can be quite distractible and often needs a lot of prompting and redirection to complete his work. Dylan is an intelligent child who has always managed to do well in school despite some longstanding challenges with attention. His performance has slipped somewhat as the academic load increases, although not to the point that he is in jeopardy of being held back.
At home, Dylan enjoys playing outside but also is drawn to video games, an activity that seems to hold his attention well. His parents get frustrated with needing to repeat requests several times and having to remind him to be quieter in the house.
Discussion
Attention-deficit/hyperactivity disorder, like all other psychiatric disorders, is defined in binary terms as being present or not-present. Nonetheless, it has become abundantly clear from research studies that the symptoms exist dimensionally and are normally distributed in a manner such as height. As such, diagnosing ADHD is analogous to diagnosing someone as being tall. Given this reality, how does a clinician figure out when a child really "has" a disorder, versus the behavior being "just" part of normal behavior?
All of the diagnostic criteria for ADHD include behaviors that at age-appropriate levels are considered completely normal. To qualify as a symptom that is present, the behaviors have to occur "often" and be inappropriate to the child’s developmental level. These subjective judgments about moving targets make drawing the line difficult for clinicians. Most children are well within normal limits and others are clearly beyond them, yet that leaves a sizable group somewhere in that middle "gray zone."
Making matters more complicated is the increasing but still insufficient evidence suggesting that this dimensionality exists when it comes to the underlying neurobiology of ADHD as well. In other words, the genes, environmental factors, brain regions, neurotransmitters, etc., that determine why a child has an average attention span or activity level are the same ones involved in ADHD. Such a revelation, however, in no way should be interpreted as ADHD being not "real," any more than other dimensional nonpsychiatric conditions (hypertension, hyperlipidemia).
This continuum of behaviors, however, does present a real diagnostic challenge. The inconvenient reality is that there really may not be any "true" rate of ADHD at 5%, 7%, or more recently, 11%. Many people make much of assessing whether or not there is associated impairment with the behaviors, but the truth of the matter is that impairment itself is dimensional.
Thus, we need to appreciate the complexities and limitations of this challenging diagnosis without throwing up our hands in frustration and giving up. After all, these problems can get significantly better with treatment. Here are a few tips to consider.
1. In making an ADHD diagnosis, use quantitative rating scales that appreciate this dimensional nature. Ideally, these instruments should be standardized by age and sex so that, for example, scores of 8-year-old boys can be compared to those of other 8-year-old boys. Don’t feel compelled to come up with a diagnosis on the spot if this procedure takes a little time in getting input from multiple people (parents, teachers, self-report).
2. Don’t stop investigating just because you arrive at an ADHD diagnosis. There are many factors that can result in a child struggling with these behaviors. Poor sleep, excessive screen time, inadequate nutrition, suboptimal parenting practices, exposures to lead and other substances, and lack of exercise are some factors that can underlie these problems. Correcting them can often make a big difference and in some cases can obviate the need for medication.
3. Approach a dimensional diagnosis with dimensional treatment. Just as many patients with borderline levels of hypertension or borderline glucose levels might be recommended to try nonpharmacological interventions first, the same principle can be applied to ADHD. Parent behavioral management, skills training, and addressing potential causes or exacerbating causes described in No. 2 can all provide important benefits.
The bottom line here, in my view, is to appreciate and respect the inherent blurriness of these boundaries without it leading to clinical paralysis. Children who struggle with inattention and hyperactivity are well known to be at risk for a variety of negative outcomes. Pediatricians have a large number of options to help these children that have been shown to be effective and can be individually tailored to each specific case.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych.
Case summary
Dylan is a bright and lively 10-year-old boy who has always been energetic and passionate. His parents have celebrated his exuberance but now have become concerned that there is "something more," after his teacher has needed to remove him from class for several episodes of impulsive and disruptive behavior. Further history reveals that, compared with his classmates, he can be quite distractible and often needs a lot of prompting and redirection to complete his work. Dylan is an intelligent child who has always managed to do well in school despite some longstanding challenges with attention. His performance has slipped somewhat as the academic load increases, although not to the point that he is in jeopardy of being held back.
At home, Dylan enjoys playing outside but also is drawn to video games, an activity that seems to hold his attention well. His parents get frustrated with needing to repeat requests several times and having to remind him to be quieter in the house.
Discussion
Attention-deficit/hyperactivity disorder, like all other psychiatric disorders, is defined in binary terms as being present or not-present. Nonetheless, it has become abundantly clear from research studies that the symptoms exist dimensionally and are normally distributed in a manner such as height. As such, diagnosing ADHD is analogous to diagnosing someone as being tall. Given this reality, how does a clinician figure out when a child really "has" a disorder, versus the behavior being "just" part of normal behavior?
All of the diagnostic criteria for ADHD include behaviors that at age-appropriate levels are considered completely normal. To qualify as a symptom that is present, the behaviors have to occur "often" and be inappropriate to the child’s developmental level. These subjective judgments about moving targets make drawing the line difficult for clinicians. Most children are well within normal limits and others are clearly beyond them, yet that leaves a sizable group somewhere in that middle "gray zone."
Making matters more complicated is the increasing but still insufficient evidence suggesting that this dimensionality exists when it comes to the underlying neurobiology of ADHD as well. In other words, the genes, environmental factors, brain regions, neurotransmitters, etc., that determine why a child has an average attention span or activity level are the same ones involved in ADHD. Such a revelation, however, in no way should be interpreted as ADHD being not "real," any more than other dimensional nonpsychiatric conditions (hypertension, hyperlipidemia).
This continuum of behaviors, however, does present a real diagnostic challenge. The inconvenient reality is that there really may not be any "true" rate of ADHD at 5%, 7%, or more recently, 11%. Many people make much of assessing whether or not there is associated impairment with the behaviors, but the truth of the matter is that impairment itself is dimensional.
Thus, we need to appreciate the complexities and limitations of this challenging diagnosis without throwing up our hands in frustration and giving up. After all, these problems can get significantly better with treatment. Here are a few tips to consider.
1. In making an ADHD diagnosis, use quantitative rating scales that appreciate this dimensional nature. Ideally, these instruments should be standardized by age and sex so that, for example, scores of 8-year-old boys can be compared to those of other 8-year-old boys. Don’t feel compelled to come up with a diagnosis on the spot if this procedure takes a little time in getting input from multiple people (parents, teachers, self-report).
2. Don’t stop investigating just because you arrive at an ADHD diagnosis. There are many factors that can result in a child struggling with these behaviors. Poor sleep, excessive screen time, inadequate nutrition, suboptimal parenting practices, exposures to lead and other substances, and lack of exercise are some factors that can underlie these problems. Correcting them can often make a big difference and in some cases can obviate the need for medication.
3. Approach a dimensional diagnosis with dimensional treatment. Just as many patients with borderline levels of hypertension or borderline glucose levels might be recommended to try nonpharmacological interventions first, the same principle can be applied to ADHD. Parent behavioral management, skills training, and addressing potential causes or exacerbating causes described in No. 2 can all provide important benefits.
The bottom line here, in my view, is to appreciate and respect the inherent blurriness of these boundaries without it leading to clinical paralysis. Children who struggle with inattention and hyperactivity are well known to be at risk for a variety of negative outcomes. Pediatricians have a large number of options to help these children that have been shown to be effective and can be individually tailored to each specific case.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych.
Case summary
Dylan is a bright and lively 10-year-old boy who has always been energetic and passionate. His parents have celebrated his exuberance but now have become concerned that there is "something more," after his teacher has needed to remove him from class for several episodes of impulsive and disruptive behavior. Further history reveals that, compared with his classmates, he can be quite distractible and often needs a lot of prompting and redirection to complete his work. Dylan is an intelligent child who has always managed to do well in school despite some longstanding challenges with attention. His performance has slipped somewhat as the academic load increases, although not to the point that he is in jeopardy of being held back.
At home, Dylan enjoys playing outside but also is drawn to video games, an activity that seems to hold his attention well. His parents get frustrated with needing to repeat requests several times and having to remind him to be quieter in the house.
Discussion
Attention-deficit/hyperactivity disorder, like all other psychiatric disorders, is defined in binary terms as being present or not-present. Nonetheless, it has become abundantly clear from research studies that the symptoms exist dimensionally and are normally distributed in a manner such as height. As such, diagnosing ADHD is analogous to diagnosing someone as being tall. Given this reality, how does a clinician figure out when a child really "has" a disorder, versus the behavior being "just" part of normal behavior?
All of the diagnostic criteria for ADHD include behaviors that at age-appropriate levels are considered completely normal. To qualify as a symptom that is present, the behaviors have to occur "often" and be inappropriate to the child’s developmental level. These subjective judgments about moving targets make drawing the line difficult for clinicians. Most children are well within normal limits and others are clearly beyond them, yet that leaves a sizable group somewhere in that middle "gray zone."
Making matters more complicated is the increasing but still insufficient evidence suggesting that this dimensionality exists when it comes to the underlying neurobiology of ADHD as well. In other words, the genes, environmental factors, brain regions, neurotransmitters, etc., that determine why a child has an average attention span or activity level are the same ones involved in ADHD. Such a revelation, however, in no way should be interpreted as ADHD being not "real," any more than other dimensional nonpsychiatric conditions (hypertension, hyperlipidemia).
This continuum of behaviors, however, does present a real diagnostic challenge. The inconvenient reality is that there really may not be any "true" rate of ADHD at 5%, 7%, or more recently, 11%. Many people make much of assessing whether or not there is associated impairment with the behaviors, but the truth of the matter is that impairment itself is dimensional.
Thus, we need to appreciate the complexities and limitations of this challenging diagnosis without throwing up our hands in frustration and giving up. After all, these problems can get significantly better with treatment. Here are a few tips to consider.
1. In making an ADHD diagnosis, use quantitative rating scales that appreciate this dimensional nature. Ideally, these instruments should be standardized by age and sex so that, for example, scores of 8-year-old boys can be compared to those of other 8-year-old boys. Don’t feel compelled to come up with a diagnosis on the spot if this procedure takes a little time in getting input from multiple people (parents, teachers, self-report).
2. Don’t stop investigating just because you arrive at an ADHD diagnosis. There are many factors that can result in a child struggling with these behaviors. Poor sleep, excessive screen time, inadequate nutrition, suboptimal parenting practices, exposures to lead and other substances, and lack of exercise are some factors that can underlie these problems. Correcting them can often make a big difference and in some cases can obviate the need for medication.
3. Approach a dimensional diagnosis with dimensional treatment. Just as many patients with borderline levels of hypertension or borderline glucose levels might be recommended to try nonpharmacological interventions first, the same principle can be applied to ADHD. Parent behavioral management, skills training, and addressing potential causes or exacerbating causes described in No. 2 can all provide important benefits.
The bottom line here, in my view, is to appreciate and respect the inherent blurriness of these boundaries without it leading to clinical paralysis. Children who struggle with inattention and hyperactivity are well known to be at risk for a variety of negative outcomes. Pediatricians have a large number of options to help these children that have been shown to be effective and can be individually tailored to each specific case.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych.
What are people reading in your waiting room?
No matter how hard we try to run on-schedule, most patients usually experience some down time in our waiting rooms. So, in the honored tradition of our ancestors, we supply magazines to read.
These days – the era of iPads – many bring their own reading material, but a good percentage still don’t and leaf through the glossies out there.
I try not to subject them to much. You won’t see drug rep pamphlets in my lobby. I get a free subscription to a celebrity gossip rag (thanks, pharma), but it goes straight to recycling on arrival. Many of my patients are seriously ill, and the last thing I want to do is have them read about people who think the worst thing in the world is to have make-up with the wrong foundation color. If professional celebrities want to see real problems, they can hang out at my office, or (better yet) an oncologist’s.
So what do I put out? I get a local parenting magazine, and my mother’s friend donates recent issues of Sunset and Good Housekeeping (thanks, Nancy). People are okay with them.
My dad once got me a big coffee table book about the history of medicine. He found it at a garage sale for 25 cents. On a whim, I put it out, and it’s been surprisingly popular. I even have a patient who makes a note of where he left off when called back, so that he can resume at his next visit.
Six months ago, while straightening up a home bookcase, I found a few "Far Side" collections, and put them out in my lobby. They quickly passed the magazines in popularity, and cemented my already solid reputation as an eccentric.
I don’t know how many other doctors have done this. I’ve heard there’s a doc on the west side of town who only has the complete P.G. Wodehouse "Bertie & Jeeves" series in his lobby. I think that would be perfectly fine, too, but takes longer to read, and I try to minimize waiting room time.
One of my strangest discoveries about private practice is that my most popular lobby magazines aren’t magazines at all. And I found them on my own bookshelf.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
No matter how hard we try to run on-schedule, most patients usually experience some down time in our waiting rooms. So, in the honored tradition of our ancestors, we supply magazines to read.
These days – the era of iPads – many bring their own reading material, but a good percentage still don’t and leaf through the glossies out there.
I try not to subject them to much. You won’t see drug rep pamphlets in my lobby. I get a free subscription to a celebrity gossip rag (thanks, pharma), but it goes straight to recycling on arrival. Many of my patients are seriously ill, and the last thing I want to do is have them read about people who think the worst thing in the world is to have make-up with the wrong foundation color. If professional celebrities want to see real problems, they can hang out at my office, or (better yet) an oncologist’s.
So what do I put out? I get a local parenting magazine, and my mother’s friend donates recent issues of Sunset and Good Housekeeping (thanks, Nancy). People are okay with them.
My dad once got me a big coffee table book about the history of medicine. He found it at a garage sale for 25 cents. On a whim, I put it out, and it’s been surprisingly popular. I even have a patient who makes a note of where he left off when called back, so that he can resume at his next visit.
Six months ago, while straightening up a home bookcase, I found a few "Far Side" collections, and put them out in my lobby. They quickly passed the magazines in popularity, and cemented my already solid reputation as an eccentric.
I don’t know how many other doctors have done this. I’ve heard there’s a doc on the west side of town who only has the complete P.G. Wodehouse "Bertie & Jeeves" series in his lobby. I think that would be perfectly fine, too, but takes longer to read, and I try to minimize waiting room time.
One of my strangest discoveries about private practice is that my most popular lobby magazines aren’t magazines at all. And I found them on my own bookshelf.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
No matter how hard we try to run on-schedule, most patients usually experience some down time in our waiting rooms. So, in the honored tradition of our ancestors, we supply magazines to read.
These days – the era of iPads – many bring their own reading material, but a good percentage still don’t and leaf through the glossies out there.
I try not to subject them to much. You won’t see drug rep pamphlets in my lobby. I get a free subscription to a celebrity gossip rag (thanks, pharma), but it goes straight to recycling on arrival. Many of my patients are seriously ill, and the last thing I want to do is have them read about people who think the worst thing in the world is to have make-up with the wrong foundation color. If professional celebrities want to see real problems, they can hang out at my office, or (better yet) an oncologist’s.
So what do I put out? I get a local parenting magazine, and my mother’s friend donates recent issues of Sunset and Good Housekeeping (thanks, Nancy). People are okay with them.
My dad once got me a big coffee table book about the history of medicine. He found it at a garage sale for 25 cents. On a whim, I put it out, and it’s been surprisingly popular. I even have a patient who makes a note of where he left off when called back, so that he can resume at his next visit.
Six months ago, while straightening up a home bookcase, I found a few "Far Side" collections, and put them out in my lobby. They quickly passed the magazines in popularity, and cemented my already solid reputation as an eccentric.
I don’t know how many other doctors have done this. I’ve heard there’s a doc on the west side of town who only has the complete P.G. Wodehouse "Bertie & Jeeves" series in his lobby. I think that would be perfectly fine, too, but takes longer to read, and I try to minimize waiting room time.
One of my strangest discoveries about private practice is that my most popular lobby magazines aren’t magazines at all. And I found them on my own bookshelf.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Obsessive-compulsive disorder
Case summary
Owen, an 8-year-old boy, is brought to his pediatrician by his mother. She has noticed that Owen is spending increasing amounts of time doing some repetitive behaviors such as counting to himself and needing to tap particular objects a specified number of times. Certain numbers seem to have special significance, and Owen has expressed some vague concern that something bad could happen if he does not do these behaviors. The rituals are starting to impact his schoolwork, as he often can get "stuck" during assignments. The mother is aware that many kids have some superstitions and wants to know if this is "something more."
Discussion
Obsessive-compulsive disorder (OCD) is a relatively common condition that can respond quite well to treatment. This case example outlines an approach that pediatricians can take to its diagnosis and management in a primary care setting.
Diagnosis
The diagnosis of OCD, according to DSM-5, requires the presence of distressing or impairing obsessions or compulsions. The definition didn’t change much from DSM-IV. Obsessions in children can revolve around things like contamination, disturbing thoughts of harm coming to others, sexual thoughts, or special numbers or words. Compulsions can include rituals with washing, checking, counting, arranging, and hoarding, among other behaviors.
When beginning to evaluate for possible OCD, it is important to talk to both the child and the parent, as it is common for parents to be unaware of the extent of the problem. An instrument called the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) is considered to be the standard in the quantitative assessment of OCD. The rating scale and checklist are easy to administer and appear to be in the public domain.
While the diagnosis is often fairly straightforward, it does take some time, and pediatricians should feel comfortable with the idea of not trying to do everything in one visit. Instead, consider scheduling another visit or two to obtain more time to do a careful assessment. During this evaluation, a couple questions are good to keep in mind.
1. Was a diagnosis of an autistic spectrum disorder missed? OCD behaviors are extremely common among children with autistic spectrum disorders. It might be worthwhile to make sure that the developmental history (pointing, babbling, social smile, odd mannerisms) doesn’t suggest the possibility of autism.
2. Could this be a case of a PANS? There remains discussion about the possibility of an autoimmune origin to some children with OCD. The previous term of Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS) has been changed to Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) to reflect a broader profile of behaviors and possible infectious triggers. While the idea remains debated in some circles, there may be value in making sure that there is not an infection lurking that should be treated.
Pearl
When querying about particular OCD symptoms, go through a list with a patient (such as provided on the CY-BOCS), and don’t rely on self-disclosure, as some symptoms, such as seeing violent or sexual images, can be quite disturbing to the child, who often won’t bring them up on his or her own.
Treatment
The recommended first-line treatment for OCD is a type of cognitive-behavioral therapy called exposure and response prevention (ERP). It is a structured form of therapy that involves patients unlearning the association that rituals are necessary in order for their fears not to be realized. While effective, the challenge is often finding a therapist with this type of training.
In many cases, it is reasonable to wait on medication treatment until after a course of ERP has been tried. For more severe cases, it is also reasonable to use both psychotherapy and medications at the same time. Some patients will say that the medication helps them do the work required in therapy.
When it comes to medications, there are a number of selective serotonin reuptake inhibitors (SSRIs) that have shown to be effective and have Food and Drug Administration approvals for pediatric OCD (for some reason that escapes me, many pharmaceutical companies have sought FDA approval for OCD and not other child psychiatric disorders). Fluoxetine, sertraline, and fluvoxamine all have FDA approval, in addition to the tricyclic clomipramine for use in refractory cases. As in all children, starting at a low dose is usually prudent (5-10 mg of fluoxetine, 12.5-25 mg of sertraline), but with OCD higher doses are often required for maximal response (more than 100 mg of sertraline or 40 mg of fluoxetine, depending on the patient’s age, size, and tolerance). It is also important to remember that the suicide warning present for the SSRIs also applies to children with anxiety disorders.
An overall treatment plan for an OCD patient, according to a previously discussed model for mental health treatment, might look like the following:
• Education. Discuss diagnosis of OCD with children and family. Let them know about support organizations such as the OC Foundation.
• Individual therapy. Referral to a cognitive-behavioral therapist for exposure and response prevention.
• Parents. Screen parents for their own OCD or other psychopathology and refer if positive. Parental guidance regarding how best to approach the child will occur within cognitive-behavioral therapy.
• School. (This is indicated if the child’s symptoms are affecting school.) Consider a request for evaluation at school to assess the need for a 504 or individualized education plan (IEP).
• Environment. Discuss minimizing OCD triggers at home.
• Medications. Begin fluoxetine 5 mg per day. Informed consent is important, including suicide warnings. (You might delay this step if a therapist is available to begin ERP first.)
• Follow-up should take place in 2 weeks, with a possible increase of fluoxetine to 10 mg and reassessment with CY-BOCS.
When to consult? Many patients with relatively uncomplicated OCD can be effectively managed in the primary care setting. Consultation may be useful for instances of poor treatment response, other occurring psychiatric disorders (such as autism, attention-deficit/hyperactivity disorder), family conflict and resistance, or diagnostic uncertainty with other conditions, such as a psychotic disorder.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. He is the author of "Child Temperament: New Thinking About the Boundary between Traits and Illness." Follow him on Twitter @pedipsych.
Case summary
Owen, an 8-year-old boy, is brought to his pediatrician by his mother. She has noticed that Owen is spending increasing amounts of time doing some repetitive behaviors such as counting to himself and needing to tap particular objects a specified number of times. Certain numbers seem to have special significance, and Owen has expressed some vague concern that something bad could happen if he does not do these behaviors. The rituals are starting to impact his schoolwork, as he often can get "stuck" during assignments. The mother is aware that many kids have some superstitions and wants to know if this is "something more."
Discussion
Obsessive-compulsive disorder (OCD) is a relatively common condition that can respond quite well to treatment. This case example outlines an approach that pediatricians can take to its diagnosis and management in a primary care setting.
Diagnosis
The diagnosis of OCD, according to DSM-5, requires the presence of distressing or impairing obsessions or compulsions. The definition didn’t change much from DSM-IV. Obsessions in children can revolve around things like contamination, disturbing thoughts of harm coming to others, sexual thoughts, or special numbers or words. Compulsions can include rituals with washing, checking, counting, arranging, and hoarding, among other behaviors.
When beginning to evaluate for possible OCD, it is important to talk to both the child and the parent, as it is common for parents to be unaware of the extent of the problem. An instrument called the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) is considered to be the standard in the quantitative assessment of OCD. The rating scale and checklist are easy to administer and appear to be in the public domain.
While the diagnosis is often fairly straightforward, it does take some time, and pediatricians should feel comfortable with the idea of not trying to do everything in one visit. Instead, consider scheduling another visit or two to obtain more time to do a careful assessment. During this evaluation, a couple questions are good to keep in mind.
1. Was a diagnosis of an autistic spectrum disorder missed? OCD behaviors are extremely common among children with autistic spectrum disorders. It might be worthwhile to make sure that the developmental history (pointing, babbling, social smile, odd mannerisms) doesn’t suggest the possibility of autism.
2. Could this be a case of a PANS? There remains discussion about the possibility of an autoimmune origin to some children with OCD. The previous term of Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS) has been changed to Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) to reflect a broader profile of behaviors and possible infectious triggers. While the idea remains debated in some circles, there may be value in making sure that there is not an infection lurking that should be treated.
Pearl
When querying about particular OCD symptoms, go through a list with a patient (such as provided on the CY-BOCS), and don’t rely on self-disclosure, as some symptoms, such as seeing violent or sexual images, can be quite disturbing to the child, who often won’t bring them up on his or her own.
Treatment
The recommended first-line treatment for OCD is a type of cognitive-behavioral therapy called exposure and response prevention (ERP). It is a structured form of therapy that involves patients unlearning the association that rituals are necessary in order for their fears not to be realized. While effective, the challenge is often finding a therapist with this type of training.
In many cases, it is reasonable to wait on medication treatment until after a course of ERP has been tried. For more severe cases, it is also reasonable to use both psychotherapy and medications at the same time. Some patients will say that the medication helps them do the work required in therapy.
When it comes to medications, there are a number of selective serotonin reuptake inhibitors (SSRIs) that have shown to be effective and have Food and Drug Administration approvals for pediatric OCD (for some reason that escapes me, many pharmaceutical companies have sought FDA approval for OCD and not other child psychiatric disorders). Fluoxetine, sertraline, and fluvoxamine all have FDA approval, in addition to the tricyclic clomipramine for use in refractory cases. As in all children, starting at a low dose is usually prudent (5-10 mg of fluoxetine, 12.5-25 mg of sertraline), but with OCD higher doses are often required for maximal response (more than 100 mg of sertraline or 40 mg of fluoxetine, depending on the patient’s age, size, and tolerance). It is also important to remember that the suicide warning present for the SSRIs also applies to children with anxiety disorders.
An overall treatment plan for an OCD patient, according to a previously discussed model for mental health treatment, might look like the following:
• Education. Discuss diagnosis of OCD with children and family. Let them know about support organizations such as the OC Foundation.
• Individual therapy. Referral to a cognitive-behavioral therapist for exposure and response prevention.
• Parents. Screen parents for their own OCD or other psychopathology and refer if positive. Parental guidance regarding how best to approach the child will occur within cognitive-behavioral therapy.
• School. (This is indicated if the child’s symptoms are affecting school.) Consider a request for evaluation at school to assess the need for a 504 or individualized education plan (IEP).
• Environment. Discuss minimizing OCD triggers at home.
• Medications. Begin fluoxetine 5 mg per day. Informed consent is important, including suicide warnings. (You might delay this step if a therapist is available to begin ERP first.)
• Follow-up should take place in 2 weeks, with a possible increase of fluoxetine to 10 mg and reassessment with CY-BOCS.
When to consult? Many patients with relatively uncomplicated OCD can be effectively managed in the primary care setting. Consultation may be useful for instances of poor treatment response, other occurring psychiatric disorders (such as autism, attention-deficit/hyperactivity disorder), family conflict and resistance, or diagnostic uncertainty with other conditions, such as a psychotic disorder.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. He is the author of "Child Temperament: New Thinking About the Boundary between Traits and Illness." Follow him on Twitter @pedipsych.
Case summary
Owen, an 8-year-old boy, is brought to his pediatrician by his mother. She has noticed that Owen is spending increasing amounts of time doing some repetitive behaviors such as counting to himself and needing to tap particular objects a specified number of times. Certain numbers seem to have special significance, and Owen has expressed some vague concern that something bad could happen if he does not do these behaviors. The rituals are starting to impact his schoolwork, as he often can get "stuck" during assignments. The mother is aware that many kids have some superstitions and wants to know if this is "something more."
Discussion
Obsessive-compulsive disorder (OCD) is a relatively common condition that can respond quite well to treatment. This case example outlines an approach that pediatricians can take to its diagnosis and management in a primary care setting.
Diagnosis
The diagnosis of OCD, according to DSM-5, requires the presence of distressing or impairing obsessions or compulsions. The definition didn’t change much from DSM-IV. Obsessions in children can revolve around things like contamination, disturbing thoughts of harm coming to others, sexual thoughts, or special numbers or words. Compulsions can include rituals with washing, checking, counting, arranging, and hoarding, among other behaviors.
When beginning to evaluate for possible OCD, it is important to talk to both the child and the parent, as it is common for parents to be unaware of the extent of the problem. An instrument called the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) is considered to be the standard in the quantitative assessment of OCD. The rating scale and checklist are easy to administer and appear to be in the public domain.
While the diagnosis is often fairly straightforward, it does take some time, and pediatricians should feel comfortable with the idea of not trying to do everything in one visit. Instead, consider scheduling another visit or two to obtain more time to do a careful assessment. During this evaluation, a couple questions are good to keep in mind.
1. Was a diagnosis of an autistic spectrum disorder missed? OCD behaviors are extremely common among children with autistic spectrum disorders. It might be worthwhile to make sure that the developmental history (pointing, babbling, social smile, odd mannerisms) doesn’t suggest the possibility of autism.
2. Could this be a case of a PANS? There remains discussion about the possibility of an autoimmune origin to some children with OCD. The previous term of Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS) has been changed to Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) to reflect a broader profile of behaviors and possible infectious triggers. While the idea remains debated in some circles, there may be value in making sure that there is not an infection lurking that should be treated.
Pearl
When querying about particular OCD symptoms, go through a list with a patient (such as provided on the CY-BOCS), and don’t rely on self-disclosure, as some symptoms, such as seeing violent or sexual images, can be quite disturbing to the child, who often won’t bring them up on his or her own.
Treatment
The recommended first-line treatment for OCD is a type of cognitive-behavioral therapy called exposure and response prevention (ERP). It is a structured form of therapy that involves patients unlearning the association that rituals are necessary in order for their fears not to be realized. While effective, the challenge is often finding a therapist with this type of training.
In many cases, it is reasonable to wait on medication treatment until after a course of ERP has been tried. For more severe cases, it is also reasonable to use both psychotherapy and medications at the same time. Some patients will say that the medication helps them do the work required in therapy.
When it comes to medications, there are a number of selective serotonin reuptake inhibitors (SSRIs) that have shown to be effective and have Food and Drug Administration approvals for pediatric OCD (for some reason that escapes me, many pharmaceutical companies have sought FDA approval for OCD and not other child psychiatric disorders). Fluoxetine, sertraline, and fluvoxamine all have FDA approval, in addition to the tricyclic clomipramine for use in refractory cases. As in all children, starting at a low dose is usually prudent (5-10 mg of fluoxetine, 12.5-25 mg of sertraline), but with OCD higher doses are often required for maximal response (more than 100 mg of sertraline or 40 mg of fluoxetine, depending on the patient’s age, size, and tolerance). It is also important to remember that the suicide warning present for the SSRIs also applies to children with anxiety disorders.
An overall treatment plan for an OCD patient, according to a previously discussed model for mental health treatment, might look like the following:
• Education. Discuss diagnosis of OCD with children and family. Let them know about support organizations such as the OC Foundation.
• Individual therapy. Referral to a cognitive-behavioral therapist for exposure and response prevention.
• Parents. Screen parents for their own OCD or other psychopathology and refer if positive. Parental guidance regarding how best to approach the child will occur within cognitive-behavioral therapy.
• School. (This is indicated if the child’s symptoms are affecting school.) Consider a request for evaluation at school to assess the need for a 504 or individualized education plan (IEP).
• Environment. Discuss minimizing OCD triggers at home.
• Medications. Begin fluoxetine 5 mg per day. Informed consent is important, including suicide warnings. (You might delay this step if a therapist is available to begin ERP first.)
• Follow-up should take place in 2 weeks, with a possible increase of fluoxetine to 10 mg and reassessment with CY-BOCS.
When to consult? Many patients with relatively uncomplicated OCD can be effectively managed in the primary care setting. Consultation may be useful for instances of poor treatment response, other occurring psychiatric disorders (such as autism, attention-deficit/hyperactivity disorder), family conflict and resistance, or diagnostic uncertainty with other conditions, such as a psychotic disorder.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. He is the author of "Child Temperament: New Thinking About the Boundary between Traits and Illness." Follow him on Twitter @pedipsych.
Medical peer review
Question: Which of the following statements regarding medical peer review is best?
A) The purpose is to evaluate quality of patient care and monitor physician performance.
B) A physician under peer review must be accorded due process, which at a minimum includes notice and opportunity to be heard.
C) Proceedings are confidential and nondiscoverable.
D) Medical peer review has been criticized for being biased, inconsistent, and lacking transparency.
E) All are correct.
Answer: E. Medical peer review, a requirement of the Joint Commission, has been called the cornerstone of quality assurance. A committee of doctors typically reviews applications for hospital staff membership, reappointments, and medical care rendered. To encourage candid, effective, and meaningful discussions, federal and state laws shield committee members from liability by granting qualified immunity and protecting the confidential information from discovery.
Due process, antitrust liability, and records protection are three issues in peer review deserving of special attention.
The requirements of procedural due process are typically spelled out in hospital medical staff bylaws. In addition, peer review deliberations and decisions are expected, as specifically outlined at Yale-New Haven (Conn.) Hospital, to be consistent, timely, rational, defensible, balanced, and useful.1
One of the earlier litigated cases was Silver v. Castle Memorial Hospital,2 which involved a Hawaii neurosurgeon whose hospital privileges were not renewed after a 1-year probationary period. The court found that prior to his termination, Dr. Silver was never provided with specific written charges as to why his performance was not deemed acceptable, and the hospital board made its decision prior to an ineffective hearing. The court emphasized that due process required fair and thorough consideration. The doctor must be on notice that a hearing is available to him, and be given timely notification sufficiently prior to the hearing for him to adequately prepare a defense.
Other requirements include the provision of a written statement specifying the reasons for any adverse decision, which must come from substantial evidence produced at the hearing. As such, the board cannot rely on ex parte communications that were not made known to the doctor in question.
The doctor who is judged wanting in peer review not infrequently files an antitrust lawsuit in retaliation, claiming an anticompetitive intent.
The most publicized case is Patrick v. Burget,3 which dealt with an adverse peer review action against Dr. Timothy Patrick, a vascular surgeon. His decision to leave the Astoria Clinic in Oregon for an independent practice was followed by revocation of his hospital privileges for alleged substandard care, but Dr. Patrick claimed that the medical staff’s true purpose was to eliminate him as a competitor.
After Dr. Patrick won a $2.1 million jury verdict, the hospital appealed the decision and was initially successful in invoking the so-called "state action doctrine" immunity against antitrust liability. However, the U.S. Supreme Court unanimously found that the "state action doctrine" required proof of active state supervision of the peer review process, which was not evident in the case.
Following Burget, the U.S. Congress enacted the Health Care Quality Improvement Act of 1986,4 in the belief that the threat of liability under federal antitrust laws unreasonably discouraged physicians from participating in effective professional peer review. The act confers immunity upon participants sitting in judgment so long as the action taken was in the furtherance of quality health care, and the process carried out in a legitimate fashion with appropriate due process safeguards. These safeguards include, among others, a reasonable effort to obtain the facts, an adequate notice and hearing procedure, a reasonable belief that the action was warranted, and reporting any adverse outcome to the National Practitioner Data Bank.
A third issue in peer review involves disclosure. State statutes universally require that peer review be carried out in confidence, and committee minutes are to be nondiscoverable. This is to allow participants to speak freely and candidly without risk of legal discovery in the event there is an accompanying or subsequent malpractice lawsuit.
However, motions by plaintiff attorneys for production of supposedly protected documents may occasionally prove successful. Where federal laws conflict with state statutes, one federal court has asserted that its interests in "ascertaining the truth through an examination of all the available facts" would trump a state’s concern for privacy.
Courts have also found certain clinical information to be beyond statutory protection. For example, a Missouri appellate court ordered the production of hospital quality assurance and infection control records sought by the plaintiff. The Connecticut Supreme Court has made a similar determination, and the Nevada Supreme Court has ruled that hospital incident reports are not covered by the state peer review privilege.
What about an aggrieved physician who sues the committee members and hospital? Is he/she entitled to the records?
The Supreme Court of Pennsylvania has held that there was no statutory protection of such records where a physician challenged his own peer review process, because the statute’s intent was directed only at preventing disclosure to outside litigants in negligence actions.
West Covino Hospital v. Superior Court5 went even further. In that malpractice case against a surgeon, the California Supreme Court allowed a physician who served on the peer review committee to voluntarily testify about the confidential proceedings, to the obvious distress of the hospital as well as other members who had neither volunteered nor agreed to such disclosure. The court reasoned that the confidentiality rule was intended to preclude involuntary testimony, not that given voluntarily by one with access to peer review information.
Unfortunately, the decision may spawn unintended consequences. For example, the Joint Commission has instituted confidential medical error reporting systems designed to improve patient safety. These programs are unlikely to go very far if physicians were to fear disclosure without consent.
Peer review is an integral part of medical practice, and self-scrutiny is a laudable expression of quality assurance. Professional organizations such as the Joint Commission and the American Medical Association understandably support the practice.
The AMA, for example, subscribes to the view that peer review, which "balances the physician’s rights to exercise medical judgment freely with the obligation to do so wisely and temperately," is both necessary and ethical, so long as principles of due process are observed.6
Still, some observers both inside and outside the profession are skeptical. They believe that deliberations by a commonly transient, unschooled, and inexperienced committee sitting in judgment are too often tainted by conflicts of interest, refusal to censure a colleague, or a punitive agenda based on biases and/or anticompetitive motives.
In 2008, Lumetra, a nonprofit health care consulting organization, completed a legislature-sponsored study of medical peer review in the state of California.7 It found a "broken" system that needed a "major fix." There were significant inconsistencies in the way entities conducted peer review, variations in the selection and application of criteria, and confusion over reporting requirements. The authors felt that these variations could result in the perpetuation of the provision of substandard care, which in turn imperiled public safety.
Among its recommendations was a redesign of the peer review process to include establishing a separate, independent peer review organization with no vested interest in the review outcome except the protection of the public, improved physician education of the process, and public disclosure.
References
1. Yale-New Haven Hospital, Department of Physician Services: www.ynhh.org/vSiteManager/Upload/Images/Professionals/OPPE.pdf.
2. Silver v. Castle Memorial Hospital, 497 P.2d 564 (Haw. 1972).
3. Patrick v. Burget, 108 S. Ct. 1658 (1988).
4. 42 U.S.C.A. Sections 11101-11152.
5. West Covino Hospital v. Superior Court, 718 P.2d 119 (Cal 1986).
6. Code of Medical Ethics of the American Medical Association, 2012-2013 edition, section 9.10.
7. Comprehensive Study of Peer Review in California Final Report. Available at www.mbc.ca.gov/publications/peer_review.pdf.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].
Question: Which of the following statements regarding medical peer review is best?
A) The purpose is to evaluate quality of patient care and monitor physician performance.
B) A physician under peer review must be accorded due process, which at a minimum includes notice and opportunity to be heard.
C) Proceedings are confidential and nondiscoverable.
D) Medical peer review has been criticized for being biased, inconsistent, and lacking transparency.
E) All are correct.
Answer: E. Medical peer review, a requirement of the Joint Commission, has been called the cornerstone of quality assurance. A committee of doctors typically reviews applications for hospital staff membership, reappointments, and medical care rendered. To encourage candid, effective, and meaningful discussions, federal and state laws shield committee members from liability by granting qualified immunity and protecting the confidential information from discovery.
Due process, antitrust liability, and records protection are three issues in peer review deserving of special attention.
The requirements of procedural due process are typically spelled out in hospital medical staff bylaws. In addition, peer review deliberations and decisions are expected, as specifically outlined at Yale-New Haven (Conn.) Hospital, to be consistent, timely, rational, defensible, balanced, and useful.1
One of the earlier litigated cases was Silver v. Castle Memorial Hospital,2 which involved a Hawaii neurosurgeon whose hospital privileges were not renewed after a 1-year probationary period. The court found that prior to his termination, Dr. Silver was never provided with specific written charges as to why his performance was not deemed acceptable, and the hospital board made its decision prior to an ineffective hearing. The court emphasized that due process required fair and thorough consideration. The doctor must be on notice that a hearing is available to him, and be given timely notification sufficiently prior to the hearing for him to adequately prepare a defense.
Other requirements include the provision of a written statement specifying the reasons for any adverse decision, which must come from substantial evidence produced at the hearing. As such, the board cannot rely on ex parte communications that were not made known to the doctor in question.
The doctor who is judged wanting in peer review not infrequently files an antitrust lawsuit in retaliation, claiming an anticompetitive intent.
The most publicized case is Patrick v. Burget,3 which dealt with an adverse peer review action against Dr. Timothy Patrick, a vascular surgeon. His decision to leave the Astoria Clinic in Oregon for an independent practice was followed by revocation of his hospital privileges for alleged substandard care, but Dr. Patrick claimed that the medical staff’s true purpose was to eliminate him as a competitor.
After Dr. Patrick won a $2.1 million jury verdict, the hospital appealed the decision and was initially successful in invoking the so-called "state action doctrine" immunity against antitrust liability. However, the U.S. Supreme Court unanimously found that the "state action doctrine" required proof of active state supervision of the peer review process, which was not evident in the case.
Following Burget, the U.S. Congress enacted the Health Care Quality Improvement Act of 1986,4 in the belief that the threat of liability under federal antitrust laws unreasonably discouraged physicians from participating in effective professional peer review. The act confers immunity upon participants sitting in judgment so long as the action taken was in the furtherance of quality health care, and the process carried out in a legitimate fashion with appropriate due process safeguards. These safeguards include, among others, a reasonable effort to obtain the facts, an adequate notice and hearing procedure, a reasonable belief that the action was warranted, and reporting any adverse outcome to the National Practitioner Data Bank.
A third issue in peer review involves disclosure. State statutes universally require that peer review be carried out in confidence, and committee minutes are to be nondiscoverable. This is to allow participants to speak freely and candidly without risk of legal discovery in the event there is an accompanying or subsequent malpractice lawsuit.
However, motions by plaintiff attorneys for production of supposedly protected documents may occasionally prove successful. Where federal laws conflict with state statutes, one federal court has asserted that its interests in "ascertaining the truth through an examination of all the available facts" would trump a state’s concern for privacy.
Courts have also found certain clinical information to be beyond statutory protection. For example, a Missouri appellate court ordered the production of hospital quality assurance and infection control records sought by the plaintiff. The Connecticut Supreme Court has made a similar determination, and the Nevada Supreme Court has ruled that hospital incident reports are not covered by the state peer review privilege.
What about an aggrieved physician who sues the committee members and hospital? Is he/she entitled to the records?
The Supreme Court of Pennsylvania has held that there was no statutory protection of such records where a physician challenged his own peer review process, because the statute’s intent was directed only at preventing disclosure to outside litigants in negligence actions.
West Covino Hospital v. Superior Court5 went even further. In that malpractice case against a surgeon, the California Supreme Court allowed a physician who served on the peer review committee to voluntarily testify about the confidential proceedings, to the obvious distress of the hospital as well as other members who had neither volunteered nor agreed to such disclosure. The court reasoned that the confidentiality rule was intended to preclude involuntary testimony, not that given voluntarily by one with access to peer review information.
Unfortunately, the decision may spawn unintended consequences. For example, the Joint Commission has instituted confidential medical error reporting systems designed to improve patient safety. These programs are unlikely to go very far if physicians were to fear disclosure without consent.
Peer review is an integral part of medical practice, and self-scrutiny is a laudable expression of quality assurance. Professional organizations such as the Joint Commission and the American Medical Association understandably support the practice.
The AMA, for example, subscribes to the view that peer review, which "balances the physician’s rights to exercise medical judgment freely with the obligation to do so wisely and temperately," is both necessary and ethical, so long as principles of due process are observed.6
Still, some observers both inside and outside the profession are skeptical. They believe that deliberations by a commonly transient, unschooled, and inexperienced committee sitting in judgment are too often tainted by conflicts of interest, refusal to censure a colleague, or a punitive agenda based on biases and/or anticompetitive motives.
In 2008, Lumetra, a nonprofit health care consulting organization, completed a legislature-sponsored study of medical peer review in the state of California.7 It found a "broken" system that needed a "major fix." There were significant inconsistencies in the way entities conducted peer review, variations in the selection and application of criteria, and confusion over reporting requirements. The authors felt that these variations could result in the perpetuation of the provision of substandard care, which in turn imperiled public safety.
Among its recommendations was a redesign of the peer review process to include establishing a separate, independent peer review organization with no vested interest in the review outcome except the protection of the public, improved physician education of the process, and public disclosure.
References
1. Yale-New Haven Hospital, Department of Physician Services: www.ynhh.org/vSiteManager/Upload/Images/Professionals/OPPE.pdf.
2. Silver v. Castle Memorial Hospital, 497 P.2d 564 (Haw. 1972).
3. Patrick v. Burget, 108 S. Ct. 1658 (1988).
4. 42 U.S.C.A. Sections 11101-11152.
5. West Covino Hospital v. Superior Court, 718 P.2d 119 (Cal 1986).
6. Code of Medical Ethics of the American Medical Association, 2012-2013 edition, section 9.10.
7. Comprehensive Study of Peer Review in California Final Report. Available at www.mbc.ca.gov/publications/peer_review.pdf.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].
Question: Which of the following statements regarding medical peer review is best?
A) The purpose is to evaluate quality of patient care and monitor physician performance.
B) A physician under peer review must be accorded due process, which at a minimum includes notice and opportunity to be heard.
C) Proceedings are confidential and nondiscoverable.
D) Medical peer review has been criticized for being biased, inconsistent, and lacking transparency.
E) All are correct.
Answer: E. Medical peer review, a requirement of the Joint Commission, has been called the cornerstone of quality assurance. A committee of doctors typically reviews applications for hospital staff membership, reappointments, and medical care rendered. To encourage candid, effective, and meaningful discussions, federal and state laws shield committee members from liability by granting qualified immunity and protecting the confidential information from discovery.
Due process, antitrust liability, and records protection are three issues in peer review deserving of special attention.
The requirements of procedural due process are typically spelled out in hospital medical staff bylaws. In addition, peer review deliberations and decisions are expected, as specifically outlined at Yale-New Haven (Conn.) Hospital, to be consistent, timely, rational, defensible, balanced, and useful.1
One of the earlier litigated cases was Silver v. Castle Memorial Hospital,2 which involved a Hawaii neurosurgeon whose hospital privileges were not renewed after a 1-year probationary period. The court found that prior to his termination, Dr. Silver was never provided with specific written charges as to why his performance was not deemed acceptable, and the hospital board made its decision prior to an ineffective hearing. The court emphasized that due process required fair and thorough consideration. The doctor must be on notice that a hearing is available to him, and be given timely notification sufficiently prior to the hearing for him to adequately prepare a defense.
Other requirements include the provision of a written statement specifying the reasons for any adverse decision, which must come from substantial evidence produced at the hearing. As such, the board cannot rely on ex parte communications that were not made known to the doctor in question.
The doctor who is judged wanting in peer review not infrequently files an antitrust lawsuit in retaliation, claiming an anticompetitive intent.
The most publicized case is Patrick v. Burget,3 which dealt with an adverse peer review action against Dr. Timothy Patrick, a vascular surgeon. His decision to leave the Astoria Clinic in Oregon for an independent practice was followed by revocation of his hospital privileges for alleged substandard care, but Dr. Patrick claimed that the medical staff’s true purpose was to eliminate him as a competitor.
After Dr. Patrick won a $2.1 million jury verdict, the hospital appealed the decision and was initially successful in invoking the so-called "state action doctrine" immunity against antitrust liability. However, the U.S. Supreme Court unanimously found that the "state action doctrine" required proof of active state supervision of the peer review process, which was not evident in the case.
Following Burget, the U.S. Congress enacted the Health Care Quality Improvement Act of 1986,4 in the belief that the threat of liability under federal antitrust laws unreasonably discouraged physicians from participating in effective professional peer review. The act confers immunity upon participants sitting in judgment so long as the action taken was in the furtherance of quality health care, and the process carried out in a legitimate fashion with appropriate due process safeguards. These safeguards include, among others, a reasonable effort to obtain the facts, an adequate notice and hearing procedure, a reasonable belief that the action was warranted, and reporting any adverse outcome to the National Practitioner Data Bank.
A third issue in peer review involves disclosure. State statutes universally require that peer review be carried out in confidence, and committee minutes are to be nondiscoverable. This is to allow participants to speak freely and candidly without risk of legal discovery in the event there is an accompanying or subsequent malpractice lawsuit.
However, motions by plaintiff attorneys for production of supposedly protected documents may occasionally prove successful. Where federal laws conflict with state statutes, one federal court has asserted that its interests in "ascertaining the truth through an examination of all the available facts" would trump a state’s concern for privacy.
Courts have also found certain clinical information to be beyond statutory protection. For example, a Missouri appellate court ordered the production of hospital quality assurance and infection control records sought by the plaintiff. The Connecticut Supreme Court has made a similar determination, and the Nevada Supreme Court has ruled that hospital incident reports are not covered by the state peer review privilege.
What about an aggrieved physician who sues the committee members and hospital? Is he/she entitled to the records?
The Supreme Court of Pennsylvania has held that there was no statutory protection of such records where a physician challenged his own peer review process, because the statute’s intent was directed only at preventing disclosure to outside litigants in negligence actions.
West Covino Hospital v. Superior Court5 went even further. In that malpractice case against a surgeon, the California Supreme Court allowed a physician who served on the peer review committee to voluntarily testify about the confidential proceedings, to the obvious distress of the hospital as well as other members who had neither volunteered nor agreed to such disclosure. The court reasoned that the confidentiality rule was intended to preclude involuntary testimony, not that given voluntarily by one with access to peer review information.
Unfortunately, the decision may spawn unintended consequences. For example, the Joint Commission has instituted confidential medical error reporting systems designed to improve patient safety. These programs are unlikely to go very far if physicians were to fear disclosure without consent.
Peer review is an integral part of medical practice, and self-scrutiny is a laudable expression of quality assurance. Professional organizations such as the Joint Commission and the American Medical Association understandably support the practice.
The AMA, for example, subscribes to the view that peer review, which "balances the physician’s rights to exercise medical judgment freely with the obligation to do so wisely and temperately," is both necessary and ethical, so long as principles of due process are observed.6
Still, some observers both inside and outside the profession are skeptical. They believe that deliberations by a commonly transient, unschooled, and inexperienced committee sitting in judgment are too often tainted by conflicts of interest, refusal to censure a colleague, or a punitive agenda based on biases and/or anticompetitive motives.
In 2008, Lumetra, a nonprofit health care consulting organization, completed a legislature-sponsored study of medical peer review in the state of California.7 It found a "broken" system that needed a "major fix." There were significant inconsistencies in the way entities conducted peer review, variations in the selection and application of criteria, and confusion over reporting requirements. The authors felt that these variations could result in the perpetuation of the provision of substandard care, which in turn imperiled public safety.
Among its recommendations was a redesign of the peer review process to include establishing a separate, independent peer review organization with no vested interest in the review outcome except the protection of the public, improved physician education of the process, and public disclosure.
References
1. Yale-New Haven Hospital, Department of Physician Services: www.ynhh.org/vSiteManager/Upload/Images/Professionals/OPPE.pdf.
2. Silver v. Castle Memorial Hospital, 497 P.2d 564 (Haw. 1972).
3. Patrick v. Burget, 108 S. Ct. 1658 (1988).
4. 42 U.S.C.A. Sections 11101-11152.
5. West Covino Hospital v. Superior Court, 718 P.2d 119 (Cal 1986).
6. Code of Medical Ethics of the American Medical Association, 2012-2013 edition, section 9.10.
7. Comprehensive Study of Peer Review in California Final Report. Available at www.mbc.ca.gov/publications/peer_review.pdf.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk," and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].
The ‘I’s have it: Ethics and the vascular community
Who in their right mind would organize the main event of a surgeons’ convention around the topic of unnecessary procedures? Surely this would almost certainly guarantee an empty auditorium. But Dr. Peter F. Lawrence, President of the Society for Vascular Surgery, had the wisdom and courage to do just that when he organized the Stanley Crawford Symposium at the recent Vascular Annual Meeting. Amazingly, he was rewarded not with approbation but rather with a standing-room turnout and congratulatory remarks. For Dr. Lawrence had the foresight to realize that vascular surgeons acknowledge that it is not only physicians from other specialties who are guilty of performing unnecessary procedures but also some of our own. Further, he had the insight that the attendees would share his desire to discuss what, in prior years, may have been a taboo subject.
When he first approached me to present at that symposium on the ethics of unnecessary procedures I thought I would produce a talk that would point out how the SVS could help its members reach an ethical high ground. But I soon realized that the SVS cannot be responsible for its members’ ethics. Ethics is, after all, an individual matter. Yes, I am certain that the vast majority of our members are indeed ethical and place their patients’ interests ahead of their own.
However, as in any large group, there will be individuals who value "I" in the word "Individual" as being more important than the "i" in the word "Ethics." "I" becomes "Me" and, unfortunately, "Me" becomes the defining factor in the equation that describes the doctor and patient relationship.
In preparing the talk I was struck that the word Individual provides clues to unethical behavior. The word contains three I’s, and three words that begin with the letter I are primarily responsible for unethical and unnecessary procedures. They are Indifference, Ignorance, and Incompetence. Perhaps the most unethical is the physician who is Indifferent: Indifferent to data, indifferent to results, indifferent to complaints, indifferent to patient suffering. This physician has no moral compass and will do whatever he or she pleases.
However, let’s start with Ignorance. I don’t want to come across as biased against other specialties, but I will not step away from a position I have frequently stated: Some of our colleagues in other specialties are not sufficiently educated in vascular diseases to be able to recognize that they do not have the judgment or skills to offer appropriate treatment. Nor do they recognize when they should refer to a vascular surgeon rather than attempt a procedure they should not be doing. How else can we explain the full metal jacket superficial femoral artery in a patient who was not even complaining of anything but was found to have a stenotic artery on routine testing?
Well, I’ll give the physician the benefit of the doubt. Perhaps the physician is uneducated about the natural history of peripheral arterial disease and believes that he or she was preventing an amputation. However, with some physicians I believe ignorance is not only a choice but an excuse!
Similarly, Incompetence is an individual problem. It seems it is a little-appreciated fact that surgery and endovascular procedures are not generic. Just as not every golfer can play scratch golf and join the professional circuit, not every surgeon or interventionalist is proficient. Rather, some will have bad results and bad results cause more procedures.
By coincidence, there are other factors that begin with the letter I that may promote unnecessary procedures and that are not necessarily related to individual mischief. Perhaps the most important I word is Insensitivity. It is the inability to recognize that one actually is ignorant, incompetent, or lacking in strength of character to the point of being indifferent to the effects of unethical behavior; that one is indifferent to the suffering of others or the moral responsibility of being an ethical physician.
But it’s not only self-driven issues that promote unethical procedures. It’s those other I’s, and first amongst all must be Income, or rather, lack of it. As long as our government does not adequately reimburse us for our work, some physicians will see volume as the only method to rectify the disparity. I believe that there were fewer inappropriate procedures when there were not as many surgeons, cardiologists, and radiologists and when they were all paid more appropriately. Related to Income is the I of Insurance reimbursement, which also drives procedures. We have only to see what happened to atherectomy after it was finally reimbursed. I am not necessarily implying that the tremendous increase in volume is inappropriate but surely it can be explained only by the fact that we are now being paid for a procedure that previously was not being compensated.
I was consulted on a patient who exemplified this point. He had no complaints whatsoever but during a cardiac evaluation was found to have an absent dorsalis pedis pulse. For no apparent reason, he was taken to the privately-owned angiography suite where he had a pedal access procedure to atherectomize an occluded anterior tibial artery. This resulted in an anterior compartment syndrome, yet the interventionalist was still enriched by many thousands of dollars. Of course, Innovations such as atherectomy may be important clinically but they invariably spur increased utilization. There is pressure to be the first to bring a new advance to the community. This may be entirely ethical if one is well trained in the procedure, but is not so if the physician jumps on the bandwagon with minimal instruction. Furthermore, Industry may also be guilty in promoting overuse by advertising benefits beyond what is known about these new procedures and by encouraging adoption with minimal oversight as to credentials. I may be overly cynical but why should Industry care who uses its device as long as it is used?
Inefficient treatments with unacceptable long-term outcomes also pose an ethical dilemma. Perform a highly compensated atherectomy, angioplasty, and stent of a totally occluded tibial artery knowing that one will be back for the next procedure in the not-too-distant future? Alternatively, bypass the blocked artery with a less well paid and time-consuming autogenous vein graft that may last for years?
Further, at first glance you may wonder how I consider Indications as driving unnecessary procedures. But consider a procedure such as renal artery denervation for treatment of hypertension that has, as yet, not proved to be worthwhile.
Couldn’t a physician justify performing it until such time as it is shown to be inappropriate even if that physician may not have much faith in its benefits?
Dr. Lawrence also charged me with evaluating whether there were differences in ethical issues between employed physicians (at universities, for example) and those in community practice who are self-employed. I would suggest that there is such a difference, especially when we evaluate the I of Incentives. And here I refer specifically to relative-value units and academic promotion.
Although I do not have a better method of evaluating work, I believe that institutions that reward employed physicians based on RVUs cause a perverse incentive to do more. Certainly the single physician is not going to be enticed by this manufactured number. Academic promotion may also incentivize a surgeon to do more, especially if it is in the area of research for which the surgeon is renowned. The surgeon who has made a reputation studying surgery for small aneurysms may find the need to operate on ever smaller ones!
Perhaps one of the most important causes of ethical lapses is the absence of oversight in Independent outpatient environments separate from hospitals. This is where most bad things are happening. Here anyone can do anything and the intervention occurs only when a major complication sends the patient to a hospital or a negligent act results in a malpractice suit. As long as the government refuses to credential who can do what in the outpatient setting we may have poorly qualified, immoral doctors let loose on their unsuspecting prey. Physicians from almost every medical specialty are ablating saphenous veins in so-called "vein centers."
Further, some cardiologists without vascular training – and even some surgeons – with little indication are lasering tibials or inserting stents into every known artery in outpatient cath labs.
Fortunately, although the three I’s in the word Individual may explain unnecessary procedures, there is one I word derived from the single I in Ethics that denotes why almost all of us will do what is right. That word is Integrity – the quality of being honest and having strong moral principles – that will prevent us from doing what we know is wrong.
So this leads to Dr. Lawrence’s final charge to the speakers: to come up with three suggestions to help reduce unethical procedures. Although there must be many more, I would suggest the three most important would be the following:
• Only physicians who are board certified by a recognized specialty and who have been appropriately trained and credentialed should be allowed to perform procedures in hospitals and independent facilities.
• Payment must ultimately be based on outcomes where not only the result but also the indication needs to be taken into consideration.
• Medical schools need to provide courses in ethical behavior, which must be conceived as being equally as important as anatomy and physiology.
In conclusion, I congratulate Dr. Lawrence and the SVS VAM organizing committee under the leadership of Dr. Ronald M. Fairman for putting this potentially contentious subject on the program. For by so doing, vascular surgeons demonstrate that we have the courage and ethics to acknowledge some of our shortcomings. At the same time we prove our leadership as the specialty most suited to treat and protect patients with vascular disease.
Who in their right mind would organize the main event of a surgeons’ convention around the topic of unnecessary procedures? Surely this would almost certainly guarantee an empty auditorium. But Dr. Peter F. Lawrence, President of the Society for Vascular Surgery, had the wisdom and courage to do just that when he organized the Stanley Crawford Symposium at the recent Vascular Annual Meeting. Amazingly, he was rewarded not with approbation but rather with a standing-room turnout and congratulatory remarks. For Dr. Lawrence had the foresight to realize that vascular surgeons acknowledge that it is not only physicians from other specialties who are guilty of performing unnecessary procedures but also some of our own. Further, he had the insight that the attendees would share his desire to discuss what, in prior years, may have been a taboo subject.
When he first approached me to present at that symposium on the ethics of unnecessary procedures I thought I would produce a talk that would point out how the SVS could help its members reach an ethical high ground. But I soon realized that the SVS cannot be responsible for its members’ ethics. Ethics is, after all, an individual matter. Yes, I am certain that the vast majority of our members are indeed ethical and place their patients’ interests ahead of their own.
However, as in any large group, there will be individuals who value "I" in the word "Individual" as being more important than the "i" in the word "Ethics." "I" becomes "Me" and, unfortunately, "Me" becomes the defining factor in the equation that describes the doctor and patient relationship.
In preparing the talk I was struck that the word Individual provides clues to unethical behavior. The word contains three I’s, and three words that begin with the letter I are primarily responsible for unethical and unnecessary procedures. They are Indifference, Ignorance, and Incompetence. Perhaps the most unethical is the physician who is Indifferent: Indifferent to data, indifferent to results, indifferent to complaints, indifferent to patient suffering. This physician has no moral compass and will do whatever he or she pleases.
However, let’s start with Ignorance. I don’t want to come across as biased against other specialties, but I will not step away from a position I have frequently stated: Some of our colleagues in other specialties are not sufficiently educated in vascular diseases to be able to recognize that they do not have the judgment or skills to offer appropriate treatment. Nor do they recognize when they should refer to a vascular surgeon rather than attempt a procedure they should not be doing. How else can we explain the full metal jacket superficial femoral artery in a patient who was not even complaining of anything but was found to have a stenotic artery on routine testing?
Well, I’ll give the physician the benefit of the doubt. Perhaps the physician is uneducated about the natural history of peripheral arterial disease and believes that he or she was preventing an amputation. However, with some physicians I believe ignorance is not only a choice but an excuse!
Similarly, Incompetence is an individual problem. It seems it is a little-appreciated fact that surgery and endovascular procedures are not generic. Just as not every golfer can play scratch golf and join the professional circuit, not every surgeon or interventionalist is proficient. Rather, some will have bad results and bad results cause more procedures.
By coincidence, there are other factors that begin with the letter I that may promote unnecessary procedures and that are not necessarily related to individual mischief. Perhaps the most important I word is Insensitivity. It is the inability to recognize that one actually is ignorant, incompetent, or lacking in strength of character to the point of being indifferent to the effects of unethical behavior; that one is indifferent to the suffering of others or the moral responsibility of being an ethical physician.
But it’s not only self-driven issues that promote unethical procedures. It’s those other I’s, and first amongst all must be Income, or rather, lack of it. As long as our government does not adequately reimburse us for our work, some physicians will see volume as the only method to rectify the disparity. I believe that there were fewer inappropriate procedures when there were not as many surgeons, cardiologists, and radiologists and when they were all paid more appropriately. Related to Income is the I of Insurance reimbursement, which also drives procedures. We have only to see what happened to atherectomy after it was finally reimbursed. I am not necessarily implying that the tremendous increase in volume is inappropriate but surely it can be explained only by the fact that we are now being paid for a procedure that previously was not being compensated.
I was consulted on a patient who exemplified this point. He had no complaints whatsoever but during a cardiac evaluation was found to have an absent dorsalis pedis pulse. For no apparent reason, he was taken to the privately-owned angiography suite where he had a pedal access procedure to atherectomize an occluded anterior tibial artery. This resulted in an anterior compartment syndrome, yet the interventionalist was still enriched by many thousands of dollars. Of course, Innovations such as atherectomy may be important clinically but they invariably spur increased utilization. There is pressure to be the first to bring a new advance to the community. This may be entirely ethical if one is well trained in the procedure, but is not so if the physician jumps on the bandwagon with minimal instruction. Furthermore, Industry may also be guilty in promoting overuse by advertising benefits beyond what is known about these new procedures and by encouraging adoption with minimal oversight as to credentials. I may be overly cynical but why should Industry care who uses its device as long as it is used?
Inefficient treatments with unacceptable long-term outcomes also pose an ethical dilemma. Perform a highly compensated atherectomy, angioplasty, and stent of a totally occluded tibial artery knowing that one will be back for the next procedure in the not-too-distant future? Alternatively, bypass the blocked artery with a less well paid and time-consuming autogenous vein graft that may last for years?
Further, at first glance you may wonder how I consider Indications as driving unnecessary procedures. But consider a procedure such as renal artery denervation for treatment of hypertension that has, as yet, not proved to be worthwhile.
Couldn’t a physician justify performing it until such time as it is shown to be inappropriate even if that physician may not have much faith in its benefits?
Dr. Lawrence also charged me with evaluating whether there were differences in ethical issues between employed physicians (at universities, for example) and those in community practice who are self-employed. I would suggest that there is such a difference, especially when we evaluate the I of Incentives. And here I refer specifically to relative-value units and academic promotion.
Although I do not have a better method of evaluating work, I believe that institutions that reward employed physicians based on RVUs cause a perverse incentive to do more. Certainly the single physician is not going to be enticed by this manufactured number. Academic promotion may also incentivize a surgeon to do more, especially if it is in the area of research for which the surgeon is renowned. The surgeon who has made a reputation studying surgery for small aneurysms may find the need to operate on ever smaller ones!
Perhaps one of the most important causes of ethical lapses is the absence of oversight in Independent outpatient environments separate from hospitals. This is where most bad things are happening. Here anyone can do anything and the intervention occurs only when a major complication sends the patient to a hospital or a negligent act results in a malpractice suit. As long as the government refuses to credential who can do what in the outpatient setting we may have poorly qualified, immoral doctors let loose on their unsuspecting prey. Physicians from almost every medical specialty are ablating saphenous veins in so-called "vein centers."
Further, some cardiologists without vascular training – and even some surgeons – with little indication are lasering tibials or inserting stents into every known artery in outpatient cath labs.
Fortunately, although the three I’s in the word Individual may explain unnecessary procedures, there is one I word derived from the single I in Ethics that denotes why almost all of us will do what is right. That word is Integrity – the quality of being honest and having strong moral principles – that will prevent us from doing what we know is wrong.
So this leads to Dr. Lawrence’s final charge to the speakers: to come up with three suggestions to help reduce unethical procedures. Although there must be many more, I would suggest the three most important would be the following:
• Only physicians who are board certified by a recognized specialty and who have been appropriately trained and credentialed should be allowed to perform procedures in hospitals and independent facilities.
• Payment must ultimately be based on outcomes where not only the result but also the indication needs to be taken into consideration.
• Medical schools need to provide courses in ethical behavior, which must be conceived as being equally as important as anatomy and physiology.
In conclusion, I congratulate Dr. Lawrence and the SVS VAM organizing committee under the leadership of Dr. Ronald M. Fairman for putting this potentially contentious subject on the program. For by so doing, vascular surgeons demonstrate that we have the courage and ethics to acknowledge some of our shortcomings. At the same time we prove our leadership as the specialty most suited to treat and protect patients with vascular disease.
Who in their right mind would organize the main event of a surgeons’ convention around the topic of unnecessary procedures? Surely this would almost certainly guarantee an empty auditorium. But Dr. Peter F. Lawrence, President of the Society for Vascular Surgery, had the wisdom and courage to do just that when he organized the Stanley Crawford Symposium at the recent Vascular Annual Meeting. Amazingly, he was rewarded not with approbation but rather with a standing-room turnout and congratulatory remarks. For Dr. Lawrence had the foresight to realize that vascular surgeons acknowledge that it is not only physicians from other specialties who are guilty of performing unnecessary procedures but also some of our own. Further, he had the insight that the attendees would share his desire to discuss what, in prior years, may have been a taboo subject.
When he first approached me to present at that symposium on the ethics of unnecessary procedures I thought I would produce a talk that would point out how the SVS could help its members reach an ethical high ground. But I soon realized that the SVS cannot be responsible for its members’ ethics. Ethics is, after all, an individual matter. Yes, I am certain that the vast majority of our members are indeed ethical and place their patients’ interests ahead of their own.
However, as in any large group, there will be individuals who value "I" in the word "Individual" as being more important than the "i" in the word "Ethics." "I" becomes "Me" and, unfortunately, "Me" becomes the defining factor in the equation that describes the doctor and patient relationship.
In preparing the talk I was struck that the word Individual provides clues to unethical behavior. The word contains three I’s, and three words that begin with the letter I are primarily responsible for unethical and unnecessary procedures. They are Indifference, Ignorance, and Incompetence. Perhaps the most unethical is the physician who is Indifferent: Indifferent to data, indifferent to results, indifferent to complaints, indifferent to patient suffering. This physician has no moral compass and will do whatever he or she pleases.
However, let’s start with Ignorance. I don’t want to come across as biased against other specialties, but I will not step away from a position I have frequently stated: Some of our colleagues in other specialties are not sufficiently educated in vascular diseases to be able to recognize that they do not have the judgment or skills to offer appropriate treatment. Nor do they recognize when they should refer to a vascular surgeon rather than attempt a procedure they should not be doing. How else can we explain the full metal jacket superficial femoral artery in a patient who was not even complaining of anything but was found to have a stenotic artery on routine testing?
Well, I’ll give the physician the benefit of the doubt. Perhaps the physician is uneducated about the natural history of peripheral arterial disease and believes that he or she was preventing an amputation. However, with some physicians I believe ignorance is not only a choice but an excuse!
Similarly, Incompetence is an individual problem. It seems it is a little-appreciated fact that surgery and endovascular procedures are not generic. Just as not every golfer can play scratch golf and join the professional circuit, not every surgeon or interventionalist is proficient. Rather, some will have bad results and bad results cause more procedures.
By coincidence, there are other factors that begin with the letter I that may promote unnecessary procedures and that are not necessarily related to individual mischief. Perhaps the most important I word is Insensitivity. It is the inability to recognize that one actually is ignorant, incompetent, or lacking in strength of character to the point of being indifferent to the effects of unethical behavior; that one is indifferent to the suffering of others or the moral responsibility of being an ethical physician.
But it’s not only self-driven issues that promote unethical procedures. It’s those other I’s, and first amongst all must be Income, or rather, lack of it. As long as our government does not adequately reimburse us for our work, some physicians will see volume as the only method to rectify the disparity. I believe that there were fewer inappropriate procedures when there were not as many surgeons, cardiologists, and radiologists and when they were all paid more appropriately. Related to Income is the I of Insurance reimbursement, which also drives procedures. We have only to see what happened to atherectomy after it was finally reimbursed. I am not necessarily implying that the tremendous increase in volume is inappropriate but surely it can be explained only by the fact that we are now being paid for a procedure that previously was not being compensated.
I was consulted on a patient who exemplified this point. He had no complaints whatsoever but during a cardiac evaluation was found to have an absent dorsalis pedis pulse. For no apparent reason, he was taken to the privately-owned angiography suite where he had a pedal access procedure to atherectomize an occluded anterior tibial artery. This resulted in an anterior compartment syndrome, yet the interventionalist was still enriched by many thousands of dollars. Of course, Innovations such as atherectomy may be important clinically but they invariably spur increased utilization. There is pressure to be the first to bring a new advance to the community. This may be entirely ethical if one is well trained in the procedure, but is not so if the physician jumps on the bandwagon with minimal instruction. Furthermore, Industry may also be guilty in promoting overuse by advertising benefits beyond what is known about these new procedures and by encouraging adoption with minimal oversight as to credentials. I may be overly cynical but why should Industry care who uses its device as long as it is used?
Inefficient treatments with unacceptable long-term outcomes also pose an ethical dilemma. Perform a highly compensated atherectomy, angioplasty, and stent of a totally occluded tibial artery knowing that one will be back for the next procedure in the not-too-distant future? Alternatively, bypass the blocked artery with a less well paid and time-consuming autogenous vein graft that may last for years?
Further, at first glance you may wonder how I consider Indications as driving unnecessary procedures. But consider a procedure such as renal artery denervation for treatment of hypertension that has, as yet, not proved to be worthwhile.
Couldn’t a physician justify performing it until such time as it is shown to be inappropriate even if that physician may not have much faith in its benefits?
Dr. Lawrence also charged me with evaluating whether there were differences in ethical issues between employed physicians (at universities, for example) and those in community practice who are self-employed. I would suggest that there is such a difference, especially when we evaluate the I of Incentives. And here I refer specifically to relative-value units and academic promotion.
Although I do not have a better method of evaluating work, I believe that institutions that reward employed physicians based on RVUs cause a perverse incentive to do more. Certainly the single physician is not going to be enticed by this manufactured number. Academic promotion may also incentivize a surgeon to do more, especially if it is in the area of research for which the surgeon is renowned. The surgeon who has made a reputation studying surgery for small aneurysms may find the need to operate on ever smaller ones!
Perhaps one of the most important causes of ethical lapses is the absence of oversight in Independent outpatient environments separate from hospitals. This is where most bad things are happening. Here anyone can do anything and the intervention occurs only when a major complication sends the patient to a hospital or a negligent act results in a malpractice suit. As long as the government refuses to credential who can do what in the outpatient setting we may have poorly qualified, immoral doctors let loose on their unsuspecting prey. Physicians from almost every medical specialty are ablating saphenous veins in so-called "vein centers."
Further, some cardiologists without vascular training – and even some surgeons – with little indication are lasering tibials or inserting stents into every known artery in outpatient cath labs.
Fortunately, although the three I’s in the word Individual may explain unnecessary procedures, there is one I word derived from the single I in Ethics that denotes why almost all of us will do what is right. That word is Integrity – the quality of being honest and having strong moral principles – that will prevent us from doing what we know is wrong.
So this leads to Dr. Lawrence’s final charge to the speakers: to come up with three suggestions to help reduce unethical procedures. Although there must be many more, I would suggest the three most important would be the following:
• Only physicians who are board certified by a recognized specialty and who have been appropriately trained and credentialed should be allowed to perform procedures in hospitals and independent facilities.
• Payment must ultimately be based on outcomes where not only the result but also the indication needs to be taken into consideration.
• Medical schools need to provide courses in ethical behavior, which must be conceived as being equally as important as anatomy and physiology.
In conclusion, I congratulate Dr. Lawrence and the SVS VAM organizing committee under the leadership of Dr. Ronald M. Fairman for putting this potentially contentious subject on the program. For by so doing, vascular surgeons demonstrate that we have the courage and ethics to acknowledge some of our shortcomings. At the same time we prove our leadership as the specialty most suited to treat and protect patients with vascular disease.
