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Posts tagged Friday Features

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Asthma drugs in pregnancy do not lead to strong risks of congenital anomalies

Today’s guest post is from Susan Jick, DSc, a Professor of Epidemiology and Director of the Boston Collaborative Drug Surveillance Program at the Boston University School of Public Health.  She writes….

Three theories have been hypothesized to explain the increased rates of poor pregnancy outcomes among asthmatic women: hypoxia and other physiologic consequences of poor asthma control, adverse effects of medicines for treatment of asthma symptoms, and other unknown factors associated with asthma but not due to the disease or its treatment.

Most research suggests that there is no increased risk of congenital anomalies associated with use of short-acting beta agonists in pregnancy. There has been no information available on the newer long-acting beta agonists in humans, and a recent study reported an increased risk of heart defects associated with asthma and with use of bronchodilators. Additionally, the same author recently reported an increased risk of gastroschisis among the offspring of users of bronchodilators in early pregnancy.

Inhaled steroids have not been associated with abnormalities except for a possible association with cleft palate.Little information is available regarding the risk of theophylline use during pregnancy and leukotriene inhibitors are a new class of drugs for which there is currently no information in the literature on effects in human pregnancy.

To estimate the prevalence of congenital anomalies among the offspring of women exposed and unexposed to asthma drugs during early pregnancy we conducted a matched cohort study using data from the United Kingdom’s General Practice Research Database.

We followed women exposed to asthma drugs during early pregnancy and a sample of unexposed pregnant women and identified their babies and determine what congenital anomalies were present. We then compared the rates in the asthma drug exposed women to the rates in the unexposed women.

The prevalences of any anomaly among unexposed and exposed women were 27.8 (95% CI 25.4-30.6) per 1,000 pregnancies and 31.3 (95% CI 27.7-35.5) per 1,000 pregnancies respectively (RR 1.1 95% CI 1.0-1.3). These findings suggest that asthma drugs overall do not increase the risk of congenital anomalies in the offspring when taken during the first trimester of pregnancy.

However, while we found no overall increased risk of congenital anomalies we did find some increased risks of specific anomalies associated with specific asthma drugs including: increased risk of cleft lip or palate associated with exposure to long-acting beta agonists, short-acting beta agonists, and oral steroids; increased risk of musculoskeletal anomalies associated with exposure to long-acting beta agonists, and; increased risk of multiple anomalies among the offspring of women exposed to long-acting beta agonists and inhaled steroids. It is important to keep in mind that these findings are based on small numbers and are not statistically significant.

We plan to update this study as more data become available and hope to have more data on this topic soon, but these data add to the current sparse knowledge about this topic and do provide some reassurance that use of asthma drugs in pregnancy does not lead to strong risks of congenital anomalies.

 

Filed under Friday features Pregnancy

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Identifying and addressing financial barriers to asthma care

Today’s guest post is from Vicki Fung, PhD, a Senior Scientist in the Mongan Institute for Health Policy, Massachusetts General Hospital and Harvard Medical School. She writes about a study she presented at the Pediatrics Academic Societies Annual Meeting earlier this week. She writes….

The amount that patients have to pay for their medical care is increasing. Even among patients with health insurance coverage, many insurers and employers are requiring that patients cover a greater share of their medical care costs, such as through higher copayments and deductibles. These out-of-pocket costs can be substantial, especially for patients with chronic medical conditions like asthma who require regular medical care.

We know that patients use fewer health care services when their out-of-pocket costs increase. This is not necessarily a bad thing: if patients stop using medications or avoid visits that they don’t need or that don’t provide clinical value, this could help reduce medical spending, without sacrificing health. However, the available evidence suggests that patients reduce their use of both medically necessary and unnecessary care when costs increase, which can lead to worse clinical outcomes and increase total medical spending.

Less is known about how costs affect care for patients, and especially children, with asthma, as well as how responses vary across household income levels. As part of a federally funded study focused on asthma (led by your fearless blogger, Ann Wu!), we conducted a survey within an insured population to ask parents of children with asthma whether they changed their care-seeking due to their out-of-pocket costs.

What did we find? Overall, 10% of parents reported their child used less medication than their doctor prescribed because of cost; 7% delayed or avoided a doctor’s office visit due to cost; and 6% delayed or avoided an emergency room visit due to cost. In addition, 16% reported that the cost of their child’s asthma care created financial stress, which we defined as needing to borrow money or cut back on some necessity (like food, rent or other basics) to pay for their child’s asthma care.

Not surprisingly, we found that these responses were greater among those with higher cost-sharing (brand drug and office visit copayments of $30+, or emergency room copayments of $75+), and among families with lower household incomes (<400% of the Federal Poverty Level (FPL)). These responses were most common among those with household incomes less than 250% FPL who were not receiving public subsidies through Medicaid or the state children’s health insurance program (SCHIP). 

Even among those receiving subsidies, however, some of these behaviors were more common. For example, those with SCHIP were more likely than higher income families (incomes>400% FPL) to delay or avoid an ED visit due to costs. Those with either Medicaid or SCHIP were also more likely to report that their child’s asthma care costs resulted in financial stress than higher income families.

What should we make of these results? First, it’s important to note that we conducted this survey among families with insurance coverage through an integrated health system. This health system historically has provided care at lower costs, so this likely represents a conservative estimate of the frequency of these behaviors in the general insured population and the U.S. population at-large. The survey was also conducted in English only; those with language barriers could also face greater difficulties discussing these issues with their provider or gathering information to make informed decisions.

Nevertheless, the finding that patients are avoiding care because of the amount they have to pay raises concerns about whether these children experienced adverse asthma outcomes as a result. In addition, nearly one-in-six parents reported that the cost of their child’s asthma care created financial stresses for their family, which could lead to difficult decisions by families about whether to incur medical debt or to cut back other basic necessities like food, rent or utilities to pay for care.

Will health reform help address these issues? The recently passed Patient Protection and Affordable Care Act contains a number of provisions that will expand access to coverage, such as through Medicaid expansions. In addition, the ACA provides two types of subsidies for families purchasing insurance through the newly implemented health insurance exchanges: 1) for families with incomes less than 400% FPL, a premium assistance tax credit will lower the premium amount, and 2) for families with incomes less than 250% FPL, cost-sharing subsidies to limit maximum out-of-pocket costs, and cost-sharing requirements like copayments and deductibles, will be available.

These are important steps for expanding coverage and improving the affordability of health care, especially for those with chronic conditions like asthma. However, some individuals, including those with incomes between 250-400% FPL and those with employer-sponsored insurance with incomes less than 250% FPL will not be eligible for cost-sharing subsidies. The findings from this study suggest that it will be critical to monitor the effects of these policies, especially among lower income populations, to identify gaps in coverage and access to improve and refine policies over time to reduce adverse outcomes.

Filed under Friday features

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Friday Feature: Skin in the Game

This week’s Friday featured researcher is Alison Galbraith, MD MPH.  She writes….

You’ve probably noticed that the amount you have to pay out-of-pocket for health care for asthma and other conditions has been increasing in recent years, and your insurance is increasingly likely to include a deductible. In high-deductible health plans (HDHPs), enrollees have to pay the full cost of care until they meet an annual deductible that can be more than $2000 per family.  In theory, people with HDHPs will act as more engaged consumers and will seek high-value care and avoid less necessary, costly care when the deductible gives them more “skin in the game.”    In reality, it’s really hard to determine when it’s okay not to get care or what it would cost you if you did get care, so some people end up not getting important health care services while others get care but end up with unexpected large out-of-pocket costs for care they might not have really needed.

Having a chronic condition like asthma in an HDHP can give you even more skin in the game.  If your asthma is under good control and the health care you need is limited and predictable, you could figure out what your out-of-pocket costs would be for the year in an HDHP, add that to the lower HDHP monthly premium, and maybe come out ahead compared to a traditional plan with a higher premium.  But if your asthma is hard to predict and you end up hospitalized with an asthma flare, the out-of-pocket costs in an HDHP could be a big financial setback. 

Read more …

Filed under Insurance Friday features

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Friday Feature: Asthma Smartphone/Tablet Applications

Today’s return guest researcher is Blanca Himes PhD. She writes…

The number of asthma apps available for patients is rapidly increasing: 
there are currently 56 that offer asthma disease information and 47 that 
provide asthma self-management tools. However, it is unclear how many of 
these apps are useful to patients. A recent review of these apps found 
that none provided advice on lay management of acute asthma, and many
(32 of 72) made unequivocal recommendations that were not supported by 
clinical evidence. Further, only 55% of apps provided creator contact
details, only 18% stated a funding source, and only 17% stated a 
confidentiality policy. Out of curiosity, I looked at some of the 
asthma apps that are available:

  • Asthma Charter (Lee Konowe, Ph.D, New Zealand)
  • Asthma Journal Pro (Ringful LLC, Austin, TX)
  • AsthmaCheck (mutterelbe medical UG, Hamburg, Germany)
  • AsthmaCoach (Asthma Society of Ireland)
  • AsthmaMD (Sam Pejham, MD, San Francisco, CA)
  • AsthmaSense (iSonea Ltd., Oceanside, CA)


All of these can be used to keep a peak flow measurements and medication 
diary and to provide feedback to patients. Additionally, some can be 
used to record triggers and symptoms, and a few deliver feedback to 
healthcare providers. Most are free but Asthma Charter costs $0.99 while 
Asthma Journal Pro costs $4.99. Do any of you use asthma apps? If so,
have they been helpful to improve your symptoms? Have your healthcare
providers ever discussed asthma apps with you?

The full asthma app review can be found here:
Huckvale K, Car M, Morrison C, Car J. Apps for asthma self-management: a systematic assessment of content and tools. BMC Med. 2012 Nov 22;10(1):144.

Filed under Friday features Innovations

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Friday Feature: Smoking parents often expose children to tobacco smoke in their cars

This week’s featured researchers are Jonathan Winickoff MD MPH, Associate Professor of Pediatrics at Harvard Medical School and Emara Nabi, MBBS, MS, research associate in Pediatrics at Harvard Medical School.  They work in the Center for Child and Adolescent Health Policy at MassGeneral Hospital for Children (MGHfC).  They report on the results of a recent study that they published in the December 2012 issue of Pediatrics

We found that a majority of interviewed smoking parents exposed their children to tobacco smoke in their cars, even though many had smoke-free policies at home. Parents may not recognize the dangers of smoking in their cars with a child present.

Workplaces, restaurants, homes and even bars are mostly smoke-free, but cars have been forgotten. Smoking in cars is not safe for motorists and nonsmokers – especially children, who have no way to avoid tobacco smoke exposure in their parent’s car. Now that we know the magnitude of the problem, pediatricians and the public can act to help these children.

Tobacco smoke can contribute to an increased risk of respiratory infections, cancer and even death in children. Homes have traditionally been considered the main indoor source of smoke exposure for children, but recent studies have found elevated levels of tobacco smoke contaminants in cars.  Children may spend a considerable amount of time in their family’s car.  

In the study, we interviewed 795 smoking parents about their car-smoking policy and behavior, including whether they exposed their children to tobacco smoke in their cars. The participants were approached while bringing a child to one of 10 pediatric practices in eight states. Seventy-three percent of the parents admitted that someone had smoked in their car in the past 3 months. Of the 562 parents who did not have a smoke-free car policy, 48 percent smoked in the car when their children were present. Most parents adopted a “strictly enforced” smoke-free policy in their homes, but only 24 percent of parents had a strictly enforced smoke-free policy for their cars.

Only about one-fifth of the parents reported being asked by a pediatric health care provider about their smoking status. Few of the parents who smoked (12 percent) were advised by the provider to avoid smoking in their cars. This is the first known study to examine the rates at which pediatricians address smoking in cars; and due to the low percentage of parents counseled on this issue, we conclude that pediatricians should address tobacco use with parents and encourage them to have strict smoke-free home and car policies to help reduce tobacco smoke exposure of children.

Because of their role in advocating for children’s health, pediatricians have the unique opportunity to counsel parents on creating a strict smoke-free car policy.  An infant strapped in a car seat cannot advocate effectively for herself in the face of parental tobacco addiction. The pediatrician can help the parent set a no-smoking policy in the car.

Please visit this website www.ceasetobacco.org for more information.  

Filed under Friday features Tobacco and Asthma

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When Does Somebody with Asthma Need to See an Allergist?

At Boston Children’s Hospital, Dr. Wanda Phipatanakul and her team of researchers at the Asthma Clinical Research Center (ACRC) are leading the crusade to understand and combat the prevalence of childhood asthma through the development of new treatments, environmental interventions, and management plans.

Dr. Phipatanakul lists the top 5 reasons she sees asthma patients in allergy clinic

Nearly all kids with asthma have allergy and allergic diseases (atopic dermatitis (eczema), food allergy, allergic rhinitis (hay fever)).

Environmental triggers can be identified and strategies to reduce these triggers can be implemented.

Families need help clinically going down the atopic march path.  I help families cope and learn of research strategies being investigated to intervene.

I offer opportunities to contribute to exciting clinical research in our Boston Children’s Asthma Clinical Research Center

I help EDUCATE, EDUCATE, EDUCATE on proper use of therapies (medication, environmental, and otherwise). 

Here is a snapshot into research that Dr. Phipatanakul is doing….

A study to decrease mouse exposure in patients with asthma.  In the homes of asthmatic children throughout Greater Boston you will find the MAAIT team (The Mouse Allergen Asthma Intervention Study) studying if mouse- targeted integrated pest management intervention is helpful in reducing the effects of asthma and mouse allergy in children ages 6 to 17 years old. Prior research has suggested mouse exposure can be a trigger for asthmatic children. This NIH funded study is a unique collaboration between Boston Children’s Hospital, Columbia University and Johns Hopkins University. Participants in this study receive asthma management education, pest extermination services, air purifiers, and allergen-proof mattress covers.

Working within the Boston Public Schools, you will find the SICAS Team (School Inner- City Asthma Study) working with elementary school students to determine the role of the environment and allergens in schools and homes in order to further understand the relationship between allergens and asthma.  If meaningful relationships are present, interventions targeting school classrooms and home environments could help many students with asthma.

For the younger pediatric population, Dr. Phipatanakul along with other researchers within the AsthmaNet Network, are investigating if standard treatments for asthma and wheeze symptoms are as effective in very young children, ages 1 to 6 years, as they are in older patients. The study is evaluating whether starting azithromycin at the onset of an upper respiratory tract illness is effective in preventing the development of clinically significant lower respiratory tract symptoms. It is also studying if the addition of oral corticosteroids (prednisolone) is effective at reducing the severity of wheezing episode exacerbations. Participants receive asthma supplies, physical exams and patient- specific education on identifying their child’s respiratory symptoms.

In the near future, Dr. Phipatanakul and the Asthma Clinical Research Center are gearing up for many exciting studies that are coming down the line. These studies will not only assist researchers and practitioners in better understand the etiological nature but determine the best standards of treatment for asthmatic children of different ages.

SARP, a three year, longitudinal characterization study, will improving our understanding of severe asthma so we can develop better treatments. The study will help define the disease by determining the mechanism of why certain children and adults go on to develop severe persistent asthma.

The AsthmaNet network will be launching a new pediatric trial, INFANT AVICA, that will investigate two important questions in the field: what is the best use of step 2 asthma controller therapies in children ages 12 to 59 months and whether there is a difference in asthma control in children who use acetaminophen verses ibuprofen as needed for pain or fever. Lastly, the center is participating in a federally mandated study that’s goal is to further understand the safety and effectiveness of both an inhaled fluticasone propionate/salmeterol (Advair) combination and an inhaled fluticasone propionate (Flovent). As the Asthma Clinical Research Center continues to expand, Dr. Phipatanakul and her team of researchers are excited to learn and provide treatments and interventions to patients and the Greater Boston area.

For those interested in participating or learning more about research conducted in the ACRC at Boston Children’s Hospital, please contact us at 857-218-5336 or at asthma@childrens.harvard.edu.

Filed under Friday features

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Friday Feature: Vitamin D Plays Important Role in Asthma

Gus Litonjua, MD MPH, an Assistant Professor at Harvard Medical School, is an expert who studies vitamin D and asthma.  He writes…

Vitamin D may be one of the reasons more and more people have asthma.  The prevalence of asthma, and associated allergic conditions, has been increasing worldwide over the past few decades. While no one knows for sure why this is happening, researchers think it is likely due to the fact that lifestyles in industrialized countries has changed dramatically during this time period. Thus, factors associated with this type of lifestyle:

More processed food in our diet

Less exercise

Less exposure to deadly infections early in life

Vitamin D deficiency

And more

Facts about Vitamin D:

Vitamin D not really a vitamin in the strict sense of the word, since humans can produce it in our skin when exposed to sunshine (hence the name “the sunshine vitamin”).

Vitamin D deficiency is more common now because:

Humans have been spending more of their time indoors

We have been using sunscreen liberally

Few foods we eat are fortified with vitamin D (such as milk, yogurt, and bread in the US)

Some examples of foods that are high in vitamin D include fatty fish (such as salmon) and eggs.

US national surveys have shown that circulating vitamin D levels in the blood have dropped by an average of about 20% over a span of about 10 years, between the early 1990s and the early 2000s, suggesting that the amount of vitamin D found in food is not sufficient to counteract the lack of production from avoidance of sun exposure.

Vitamin D can affect the development of asthma.

These include effects on the developing lung and immune system in early life, and protection from the effects of respiratory virus infections.

Many studies have now suggested that vitamin D deficiency can lead to asthma.

While many studies show that children born to mothers who consume more vitamin D during pregnancy have lower rates of wheezing during later childhood, other studies have not found the same effect. To answer this question, we are currently conducting a multi-center trial of vitamin D supplementation in pregnant women. We plan to follow these women through pregnancy and then follow the children up to age 3 to determine whether vitamin D supplementation prevents the development of asthma. A similar trial is also being conducted in Europe.

Vitamin D may play a role in worsening of asthma symptoms.

Several studies have shown that asthmatic children who have higher vitamin D levels are at lower risk for developing asthma exacerbations in the near future. These studies have also shown that children with higher vitamin D levels have less severe disease.

Two small clinical trials have shown promising results with regard to preventing asthma exacerbations. The first study was a clinical trial of vitamin D in 234 Japanese schoolchildren, who were supplemented with 1200 IU of vitamin D daily. The main aim of the study was to determine whether vitamin D supplementation could decrease the rate of infection of influenza. There were 51 asthmatic children in the supplementation arm and 59 asthmatic children in the placebo arm. Secondary analyses of these data showed that the asthmatic children in the vitamin D supplementation arm had decreased rates of exacerbation of the 6-month period of the trial.

The second trial consisted of 48 Polish children with newly diagnosed asthma and allergies to house dust mite. The children who were supplemented with 500 IU of vitamin D daily had significantly lower rates of exacerbation than those who were in the placebo arm.

What does this mean?  Consider vitamin D if asthma is worsening.         

Look out for upcoming results from clinical trials.  While the results of these epidemiologic studies and small clinical trials are promising, larger and better designed clinical trials are ongoing and should provide more definitive answers on whether vitamin D supplementation can prevent either development of asthma or exacerbation of existing disease.

Consider asking your doctor to check vitamin D levels and consider vitamin D supplements, if asthma is not well-controlled with current anti-inflammatory medications such as inhaled corticosteroids

Filed under Friday Features Vitamin D

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Friday Feature: The Genetics of Asthma

This week’s Friday Featured Researcher is Blanca Himes, PhD, an Instructor at Harvard Medical School who conducts research in asthma genetics and genomics.  Blanca writes…

Everybody knows asthma “runs in families,” but that is only part of the story. Asthma is a complex disease that is not caused by a single gene or even a small group of genes.  It is strongly influenced by the environment (as anyone with asthma knows!).

Here is a brief history of asthma genetics studies:

  • Since the mid-90s, there have been experimental techniques available to widely study human genetics of complex diseases. The initial studies of asthma genetics were performed between 1996 and 2005, and they were so-called linkage and candidate gene association studies. During this time, researchers published in 492 papers associations of over 100 genes with asthma and related traits.
  • Of this long list of genes, only about 10 seemed very important because the associations were found frequently (>10 times) in independent populations (the gold standard for gene association studies to be deemed reliable is that they consistently replicate in large independent studies) [Ref 1]. The 10 most salient genes that arose in this time span are: IL4, IL13, CD14, ADRB2, HLA-DRB1, HLA-DQB1, TNF, FCER1B, IL4RA, ADAM33.
  • Starting in 2007, as newer technologies were developed and became cheaper, genome-wide association studies (GWAS) of asthma have been conducted. Unlike the candidate gene studies, GWAS look at common genetic variants across the entire genome. Initially, asthma GWAS were conducted in relatively small cohorts, and these GWAS mostly reported different “top” associations with little replication across studies.
  • One exception, and the region of the genome that has most strongly been associated with asthma, is the ORMDL3 and GSDMB gene region. To date, strong associations in this region have been reported in over 15 independent cohorts. Most recently, many of the investigators who had reported individual cohort GWAS, became part of large multi-center collaboration efforts. In Europe, this collaboration was called GABRIEL [Ref 2], while in the US, it was called EVE [Ref 3]. These large-scale GWAS have begun to consistently identify genes that are strongly associated with asthma.
  • Such genes include GSDMB-ORMDL3 locus, HLA-DQ, IL1RL1, IL18RL1, IL33, TSLP, SLC22A5, SMAD3, and RORA.The reproducibility of the latest asthma GWAS findings is promising, but much work remains to be done in asthma genetics. Most importantly, we have yet to identify the function of most of the variants that have been identified.

What does all this mean? Personalized asthma diagnosis and treatment is not yet possible, but as the asthma-associated genes and variants are better understood functionally and in relation to the environment, it may be possible to provide genetic risk and/or personalized treatment tests for patients. For now, asthma genetics remains a research endeavor.

Filed under Friday Features Genomics

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Friday Feature: Asthma and Cardiovascular Risk

On Fridays, I will feature an entry from a guest asthma researcher.  The first Friday Featured Researcher is Carlos Iribarren, MD, MPH, PhD, an Associate Scientist at Kaiser Permanente Division of Research, who writes about a recently published article.

Dr. Iribarren writes…

Prior epidemiological studies have documented higher than expected cardiovascular mortality in patients with asthma.  In this new cohort study published in the American Journal of Epidemiology we examined, utilizing the large Kaiser Permanente of Northern California databases, the role that gender, co-morbid allergy and asthma medications may play in this relationship.    Our findings confirmed the notion that adult patients with asthma, relative to counterparts with no history of asthma, had an increased risk of incident coronary heart disease, stroke and heart failure above and beyond the risk imparted by age, gender, race/ethnicity, traditional cardiac risk factors as well as history of allergy as a proxy of atopy. 

We noted stronger risk relations in women than in men, suggesting that sex hormones may play a role in modulating immune response and chronic human lung diseases.   Another noteworthy finding was the lack of evidence of a positive synergistic effect of asthma and history of allergy on the risk of major cardiovascular disease.  Instead, we noted a significant effect of allergy with no asthma on the risk of coronary heart disease, stroke and heart failure.   Finally, our data demonstrated clear risk stratification according to asthma medication use such that those taking combination therapy (particularly involving oral corticosteroids) exhibited the greatest cardiovascular risk. 

The mechanisms for the asthma-CVD epidemiological association (common risk factors, systemic inflammation or effect of asthma medications) remain unclear.   There is mounting evidence that asthma is associated with obesity and type 2 diabetes.  It is well established that lung function impairment is an independent predictor of cardiovascular events.  Another theory is that chronic airway inflammation may contribute to systemic inflammation and to vulnerability to vascular disease.  

Health professionals should be aware of this connection and closely scrutinize known cardiovascular risk factors in this patient population.  Moreover, future pharmaco-epidemiological studies should focus on clarifying potential cardiovascular signals of asthma medications and clinical trials of asthma therapies should take into account the potential increased risk of cardiovascular disease among persons with asthma. 

Iribarren C, Tolstykh IV, Miller MK, Sobel E, Eisner MD. Adult Asthma and Risk of Coronary Heart Disease, Cerebrovascular Disease and Heart Failure: a Prospective Study of Two Matched Cohorts. Am J Epidemiol 2012;176:1014-1024

Filed under Friday Features