June 13, 2014

Turning Normal "Spitting Up" Into a Disease

When does typical baby behavior become medically treatable baby behavior? When misguided doctors and scared parents promote it from what is normal to something that sounds ominous and urgent.

An essay published in the New York Times by Dr. Aaron E. Carroll says that calling an ordinary health problem a disease leads to bigger problems, and a primary example of it is brought to you by way too many people who care for babies.

Babies spit up. A lot. About half of all healthy infants, Carroll says, spit up more than twice a day. More than 9 in 10 completely stop this behavior without treatment. “When a majority of infants have (and have always had) a set of symptoms that go away on their own, it isn’t a disease — it’s a variation of normal,” Carroll writes.

Infants vomit more often than older people because their diet is all liquid, because they eat frequently and because their developing esophagus isn’t quite closed off from their small stomachs. Milk leaks back into the esophagus, producing symptoms of gastroesophageal reflux, one of which is regurgitation.

Gastroesophageal reflux disease (GERD) is different from this common baby behavior. Children with GERD are truly ill, but they are rare. “But over time,” Carroll says, “more and more babies with reflux were labeled as having a ‘disease.’ The incidence of a diagnosis of GERD in infants tripled from 2000 to 2005.”

We have a term for that, and readers of our patient safety blog will recognize it: disease-mongering. As defined by the journal PLoS Medicine it’s “the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments.”

Carroll is familiar with the phenomenon. “When I was a pediatrics resident,” he writes, “my hospital constructed foam wedges for infants to sleep on. The thinking was that infants who were sleeping at an angle would be less likely to have milk come back up.

“The wedges cost about $150. They didn’t work.”

Carroll’s pediatric colleagues have tried other ways to control infant regurgitation — special infant seats; thickened food; special formulas. “None of these things really work,” he concludes. “An incredible amount of time and money has been wasted.

“The bigger problem, though, is that the vast majority of these infants weren’t ‘sick.’ We just gave them an official diagnosis. This labeling of patients with a ‘disease’ can have significant consequences, for both people’s health and the nation’s health-care budget.”

Drugs, of course, play a large role in disease-mongering. Infants may be treated with a group of drugs called proton pump inhibitors (PPIs). You might recognize some of their brand names — Nexium, Prilosec, Prevacid and Protonix. Between 1999 and 2004, the use of one liquid PPI increased more than 16-fold, Carroll reports, never mind that PPIs have not been approved by the FDA for the treatment of GERD in infants.

In 2009, a randomized, controlled trial whose results were published in The Journal of Pediatrics examined how well a PPI worked for infants with symptoms of GERD. It found that the drug had no more of an effect than a placebo, or fake, inert pill. But — and here’s the harm of disease-mongering — the children who took the PPI had significantly more serious adverse events, including respiratory tract infections.

Another study Carroll recalls was published last year in the journal Pediatrics. The researchers randomly chose parents who were told either that their baby’s reflux was GERD or was, instead, “a problem.” Half of each of group also was told that medications were ineffective.

Parents who were told that their kid had GERD were far more interested in having their child take medication, even when they were told that it was ineffective. Parents of babies who were not labeled with GERD weren’t interested in medication when they were told it didn’t work.

“Words matter,” Carroll says. “Studies have shown that once people with high blood pressure are labeled ‘hypertensive,’ they are significantly more likely to be absent from work, regardless of whether treatment was begun. Many diseases have become so much broader in definition that they now encompass huge swaths of the public.”

But medicalizing normal variations in physiology so that they become “treatable conditions” leads to unintended — and unwelcome — consequences. Needless worry. Treatments with unpleasant and possibly dangerous side effects. Unnecessary costs.

As one of Carroll’s colleagues puts it, “Our job as doctors is to make sick patients healthy, not to make healthy patients sick.”

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May 16, 2014

Turning Childhood Into Illness

Hearing about the booming numbers of kids diagnosed with worrisome conditions like attention deficit hyperactivity disorder and bipolar disorder can make parenthood seem like punishment. But according to one reasoned mind, kids are no sicker now than they used to be, it’s just that we’re turning childhood into an illness.

Writing on KevinMD.com, Dr. Allen Frances, a psychiatrist and professor emeritus at Duke University, wants people to reject commonly heard “statistics” such as:


  • ADHD has more than tripled in 20 years, and is diagnosed in 1 in 5 teenage boys.

  • Autism occurs in 1 in 68 children and that 20 years ago, it was 1 in 500.

  • Bipolar disorder increased recently by 40-fold.

Too often, said Frances, children are “mislabeled for behaviors that used to be considered part of normal variation.”

What he calls “misplaced diagnostic exuberance” is a product of classroom research that showed that the youngest kids in class are much more likely than the oldest to be diagnosed as having ADHD, and to receive stimulant treatment. (See our blog, “Should Age Determine When Kids Start School?”)

“It is shameful,” writes Frances, “that simple immaturity due to being younger is now mislabeled as mental illness and mistreated with a pill.”

He says diagnosing ADHD should be reserved for kids who have “an early onset of very severe and persistent symptoms displayed in a wide variety of family, school, and social contexts.” That requires not only thorough evaluation, but a period of watchful waiting. That’s more frustrating for many parents and caregivers than rushing to diagnostic judgment and treatment. Make that overtreatment.

Among the harms of such overtreatment for the 2 in 3 active kids who have been misdiagnosed with ADHD is suffering from unnecessary stigma, reduced expectations and drug side effects.

“We need to do a better job of protecting our children from such widespread careless diagnosis and reckless treatment,” he says.”

He blames marketing and greed by pharmaceutical companies for fueling this diagnostic fire. “Massive and cleverly misleading marketing has transformed the stimulant drug market from a minor player to a $10-billion-a-year cash cow,” he notes. “This is great for executives and shareholders but bad for the kids who are mislabeled and mistreated.”

He, like other doctors we’ve written about, wants to reduce the “formidable lobbying” of the pharmaceutical industry, and stop it from advertising directly to consumers.

He wants resources spent on schools, educational tools, not on hawking drugs. “What makes more sense,” he asks, “promiscuous use of pills or smaller class sizes and more facilities for physical activity that allow kids to blow off steam?”

“It is completely irrational to shortchange our schools and then spend a bundle on misguided medical treatment for normally active kids who don’t do well in a stressed school environment.”

“[L]et’s diagnosis and treat our classrooms and playgrounds,” Frances concludes, “not overdiagnose and overtreat our children.”

In other words, let a kid be a kid.

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April 18, 2014

Cholesterol Report Reinforces Screening Schedule for Kids

Most people don’t associate heart disease with children, and although it’s relatively rare, certain risk factors in childhood can increase a kid’s chances of developing heart and blood vessel problems as they get older. Some studies have shown that narrowing and hardening of the arteries can even begin in childhood.

Last month’s annual Scientific Session of the American College of Cardiology presented disturbing research about kids at risk for developing cardiovascular problems — approximately 1 in 3 children between the ages of 9 and 11 who received cholesterol screenings showed borderline or high results.

As summarized on ScienceDaily.com, the study was one of the largest of its kind, involving outpatient clinic visits of the Texas Children's Pediatrics Associates. It examined more than 12,700 medical records of children whose routine physical exams included screening for cholesterol.

The study’s lead researcher, Dr. Thomas Seery, a pediatric cardiologist, said "The sheer number of kids with abnormal lipid profiles provides further evidence that this is a population that needs attention and could potentially benefit from treatment. But we can only intervene if we diagnose the problem."

Seery said it’s important to identify kids with high levels of blood cholesterol/fats and to lower their blood values in order to stave off the chances of future disease.

The study showed that boys were more likely than girls to have elevated total cholesterol, low-density lipoprotein (LDL, or "bad" cholesterol) and triglycerides (blood fats), but girls had lower high-density lipoprotein (HDL, or "good" cholesterol).

No surprise that obese children were more likely to have elevated total cholesterol, LDL and triglycerides, and lower HDL than were kids who weren’t obese.

You don’t know if your child’s values are normal, of course, unless they’re measured. The National Heart Lung and Blood Institute guidelines recommend universal cholesterol screening of children between the ages of 9 and 11, and again between 17 and 21. That practice is endorsed by the American Academy of Pediatrics. (See our blog, “Cholesterol Tests for Kids.”)

Like all screenings, however, this one isn’t without concern for overtreatment if a result isn’t precisely within what’s considered normal. Seery’s aware of that. "There is concern by some in the medical community that children will be started on medication unnecessarily," he said. So the first line of defense against rising blood cholesterol is for youngsters to adopt a healthful diet and to exercise regularly.

Seery said that cholesterol-lowering drugs usually aren’t necessary except for 1 or 2 children in 100 who have very high cholesterol, usually because of a genetic disorder. Such problems, including inherited high cholesterol, can be detected in childhood, but might be underdiagnosed. But if blood is tested at the recommended ages, it will be found.

The universal pediatric screening guidelines were initiated at the end of 2011, during the second year of the research. So one of the study’s limitations might be that we don’t know if testing was ordered for everybody, as a matter of course, or only for select subjects chosen for their individual risk factors or family history of premature heart disease.

Other studies have demonstrated that screening based on family history alone can overlook children who have abnormally high cholesterol. So further research is needed in order to determine how many health-care providers are following the guidelines, and how consistently they do so.

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June 7, 2013

Well-Child Visits Help Keep Kids Out of the Hospital

We have been among the voices raised against the overuse and abuse of medical resources (here and here, for example), but sometimes medical attention is wholly appropriate even without symptoms or complaints.

When it comes to kids, according to a new study in the American Journal of Managed Care, regularly scheduled doctor visits even in the absence of a problem might well be wise. Young children who missed more than half of their recommended well-child visits, the study concludes, had as much as twice the risk of hospitalization compared with children who attended theirs.

Not surprising was the fact that kids with chronic conditions such as asthma and heart disease and who missed their recommended appointments had as much as three times the risk of being hospitalized as those with chronic conditions who were seen as recommended.

The study involved more than 20,000 children enrolled in Group Health Cooperative, a large health-care system in Seattle, from 1999 to 2006. The study followed the subjects from birth to age 3 1/2 or until their first hospital stay, whichever came first.

As quoted in a story on ScienceDaily.com, lead study author Dr. Jeffrey Tom, said, "Well-child visits are important because this is where children receive preventive immunizations and develop a relationship with their provider. These visits allow providers to identify health problems early and help to manage those problems so the children are less likely to end up in the hospital."

It goes without saying (although the study made it clear) that regular, preventive care for children with special needs and chronic conditions is even more important because of possible complications.

Most children in the study—3 in 4—attended at least 3 in 4 of their recommended visits. But this could be such a high percentage because Group Health coverage required no copayment for such visits. The authors acknowledge that the lack of a financial burden, even a small one, is an important incentive to maintaining a recommended medical visit schedule.

Four in 100 children in the study, and 9 in 100 of them with a chronic condition, were hospitalized. The two most common reasons for hospitalization in both groups, according to Science Daily, were pneumonia and asthma.

Children who missed more than half of their visits had as much as twice the risk of hospitalization compared with those who attended most of theirs. Children with chronic conditions who missed more than half of their visits had nearly twice to more than three times the risk of hospitalization compared with those who attended most of their visits.

During the study period, Group Health recommended nine well-child visits between birth and 3 1/2 years of age: the first at 3 to 5 days old, then at 1, 2, 4, 6, 10 and 15 months, and at 2 and 3 ½ years.

Although the study is very clear about the value of well-baby visits, a huge consideration is that the findings might not apply to all health systems. Group Health is an integrated health-care system, or one where care is well-coordinated as a person ages or a disorder progresses. Also, most of the study’s subjects attended most of their well-child visits and belong to affluent, well-educated families. Although some research studies can adjust for certain variables within the population they study, this one couldn’t adjust for income, education, race, or ethnicity.

And of course there is no absolute cause-and-effect conclusion that missing well-child visits increases the chances of hospitalization. But it’s pretty clear that there’s an important association. In addition to well-baby visits providing the opportunity for preventive care, Science Daily notes that parents who miss well-child visits are probably less likely to manage their kids' illnesses and follow treatment regimens, which could result in higher rates of hospitalization for the children.

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June 8, 2011

Pediatricians update patient safety guidelines to reduce risk of malpractice to kids

The American Academy of Pediatrics (AAP) has revised its patient safety guidelines to reduce unintended harm to children by the healthcare system.

Noting that national awareness of patient safety risks has grown in this decade, Marlene Miller, MD, and AAP colleagues write in the June issue of Pediatrics that “the depth and breadth of harm incurred by the practice of medicine is still being defined as reports continue to uncover a variety of avoidable errors, from those that involve specific high-risk medications to those that are more generalizable, such as patient misidentification.”

As technology evolves and medical advances become increasingly complex, the risk of causing unintentional medical harm has also increased, they write, pointing to studies that show seven failures to prevent a clinically important deterioration per 100 hospitalized children, 100 prescribing errors per 1000 children seen in an emergency room, and three preventable adverse drug events per 100 children seen in pediatric practices.

"The field of pediatric patient safety has matured much in recent years; there are now more robust epidemiology of errors for children, a deep understanding of the concept and measurement of a culture of safety, clear guidance on key elements of patient-safety solutions and introduction of successful pediatric patient-safety solutions," the article says.

"Nonetheless, continued work is needed to infuse these data and concepts into everyday pediatric practice for all clinicians, and special attention should be paid to the training of new clinicians to ensure that the future workforce can exercise all the tenets of pediatric patient safety as part of their everyday work life.

The new AAP patient safety recommendations aim to:

Expand efforts to educate clinicians, ensuring that they can all identify pediatric patient-safety issues and know how to improve them individually and within healthcare systems.

Create a safety culture by challenging all organizations, including small practices, to implement a pediatric patient safety plan that informs, supports and educates using appropriate local examples.

Develop patient-safety metrics for the ambulatory settings, where most children in the U.S. primarily interact with the healthcare system (though most patient safety work to date has been in hospitals).

Develop and support broad-scale pediatric error-reporting systems and analysis of reported events.

Comply with proven best practices for improving pediatric patient safety to enhance pediatric healthcare outcomes.

Target drug safety by advocating for the development of effective and safe pediatric medications and formulations and for withdrawal of medications with unfavorable risk/benefit ratios.

Educate clinicians on strategies to reduce medication errors by ensuring that they maintain access to and proficiency in the use of a comprehensive and current pharmaceutical knowledge base.

Source: Medscape

You can read the full text of the AAP statement here.

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May 26, 2011

Atypical antipsychotic use high in children, study shows

Nearly half the children treated as inpatients for psychotic and mood disorders are given atypical antipsychotics, a new single-center study reports. About 44% of these young patients with a variety of conditions, ranging from psychosis to various mood and anxiety disorders, were treated with either first- or second-generation versions of the drugs, according to the study, which was recently presented at the American Psychiatric Association meeting in Honolulu.

To determine the prevalence of antipsychotic use and associated clinical characteristics - and to compare current use with past use - the researchers looked at 3,851 inpatients ages 5 to 17 who were seen at their facility between January 2000 and June 2010 for various diagnoses, including psychosis, behavioral disorder, depression, post-traumatic stress disorder (PTSD) and anxiety.

They found that antipsychotics were prescribed for 44.3% of patients, and that a higher proportion of those scrips were written for children (ages 5 to 12) than adolescents (ages 13 to 17) - 51.7% versus 41.7%.

Atypical prescribing varied by diagnosis, with prescriptions written for:


• 76% of psychosis patients (including schizophrenia and bipolar disorder)

• 45% of behavioral patients (including ADHD, panic disorder, and social phobia)

• 24% of depression patients

• 46% of PTSD patients

• 31% of anxiety patients

• 20% of patients with other diagnoses


The study authors expected atypical use to be most common in people with psychotic systems, but were surprised to see such high use of atypicals in behavioral diagnoses. The likely explanation is that the study focused on inpatients, who may exhibit more severe behavioral issues than outpatients.

Atypical antipsychotics were also more likely to be prescribed to males, nonwhites and those with a longer length of stay. Surprisingly, the general use of atypicals decreased over the study period, from 47% between 2001 and 2003 to 43.5% between 2006 to 2010.

The study was limited because it was done at a single center and because it lacked follow-up after discharge, and the study authors called for further study and the need for comparison with other institutions.

Source: Medpage Today

Study reference: Stevens M, et al "Current prescribing practices: antipsychotic use in children and adolescents" APA 2011; Abstract 12-41

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April 6, 2011

Which kids should get their tonsils removed? At long last, some guidance

Prompted by a lack of consensus on who should get their tonsils removed and how it should be done, the American Academy of Otolaryngology–Head and Neck Surgery has issued the first-ever clinical guidelines for tonsillectomy in children in the U.S.

Child safety advocates have argued for years that tonsillectomy is done way too often. This exposes kids to risks of an operation they may not need -- mainly from anesthesia and bleeding. Because the tonsils are situated at the junction of several blood vessels, the procedure carries a relatively high risk of hemorrhage.)

For example, it's been known for decades that children’s health in areas with high rates of tonsillectomy is no better than in areas in which fewer tonsillectomies are performed.

But the operation still gets done for preventive or “prophylactic” reasons. As a result, tonsillectomy currently is the third most common surgery in U.S. children younger than 15 years, with more than 530,000 performed annually, primarily for recurrent throat infections and sleep-disordered breathing, despite the risks.

The guidelines provide evidence-based guidance in identifying children who may benefit from tonsillectomy. They also offer recommendations intended to optimize the "perioperative" management of children undergoing the procedure and provide guidance on how to improve counseling and education of parents of children who may be candidates for tonsillectomy and suggests ways to reduce inappropriate or unnecessary variations in care.

According to the new guidelines, the need for a tonsillectomy is determined by the frequency of a child’s sore throats. Tonsillectomy should be considered when a child has (a) seven sore throats in a single year; (b) five sore throats for 2 years running; or (c) three sore throats for 3 years running. To count for this purpose, each sore throat must be accompanied by a fever of at least 38.3C (101F), swollen lymph nodes in the neck, pus or blood draining from the tonsils, or documented infection with a bacteria called hemolytic streptococcus.

The guidelines also recommend:

Watchful waiting for recurrent throat infection if there have been fewer than 7 episodes in the past year or fewer than 5 episodes per year in the past 2 years or fewer than 3 episodes per year in the past 3 years.

Assessing the child with recurrent throat infection who does not meet the criteria above for modifying factors that may nonetheless favor tonsillectomy, which may include multiple antibiotic allergy/intolerance, periodic fever, aphthous stomatitis, pharyngitis and adenitis, or history of peritonsillar abscess.

Asking caregivers of children with sleep-disordered breathing and tonsil enlargement about comorbid conditions that might improve after tonsillectomy, including growth retardation, poor school performance, enuresis and behavioral problems.

Counseling caregivers about tonsillectomy as a means to improve health in children with abnormal polysomnography who also have tonsil hypertrophy and sleep-disordered breathing.

Counseling caregivers that sleep-disordered breathing may persist or recur after tonsillectomy and may require further management.

Advocating for pain management after tonsillectomy and educating caregivers about the importance of managing and reassessing pain.

Self-monitoring by clinicians who perform tonsillectomy at least annually to determine their rate of primary and secondary posttonsillectomy hemorrhage.

Source: American Academy of Otolaryngology – Head and Neck Surgery

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