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ScienceDaily.com.June 26, 2013 — To keep costs low, companies often incentivize healthy lifestyles. Now, new research suggests that how these incentives are framed — as benefits for healthy-weight people or penalties for overweight people — makes a big difference.

The research, published in Psychological Science, a journal of the Association for Psychological Science, shows that policies that carry higher premiums for overweight individuals are perceived as punishing and stigmatizing.

Researcher David Tannenbaum of the Anderson School of Management at the University of California, Los Angeles wanted to investigate how framing healthcare incentives might influence people’s attitudes toward the incentives.

“Two frames that are logically equivalent can communicate qualitatively different messages,” Tannenbaum explains.

In the first study, 126 participants read about a fictional company grappling with managing their employee health-care policy. They were told that the company was facing rising healthcare costs, due in part to an increasing percentage of overweight employees, and were shown one of four final policy decisions.

The “carrot” plan gave a $500 premium reduction to healthy-weight people, while the “stick” plan increased premiums for overweight people by $500. The two plans were functionally equivalent, structured such that healthy-weight employees always paid $2000 per year in healthcare costs, and overweight employees always paid $2500 per year in healthcare costs.

There were also two additional “stick” plans that resulted in a $2400 premium for overweight people.

Participants were more likely to see the “stick” plans as punishment for being overweight and were less likely to endorse them.

But they didn’t appear to differentiate between the three “stick” plans despite the $100 premium difference. Instead, they seemed to evaluate the plans on moral grounds, deciding that punishing someone for being overweight was wrong regardless of the potential savings to be had.

The data showed that framing incentives in terms of penalties may have particular psychological consequences for affected individuals: People with higher body mass index (BMI) scores reported that they would feel particularly stigmatized and dissatisfied with their employer under the three “stick” plans.

Another study placed participants in the decision maker’s seat to see if “stick” and “carrot” plans actually reflected different underlying attitudes. Participants who showed high levels of bias against overweight people were more likely to choose the “stick” plan, but provided different justification depending on whether their bias was explicit or implicit:

“Participants who explicitly disliked overweight people were forthcoming about their decision, admitting that they chose a ‘stick’ policy on the basis of personal attitudes,” noted Tannenbaum. “Participants who implicitly disliked overweight people, in contrast, justified their decisions based on the most economical course of action.”

Ironically, if they were truly focused on economic concerns they should have opted for the “carrot” plan, since it would save the company $100 per employee. Instead, these participants tended to choose the strategy that effectively punished overweight people, even in instances when the “stick” policy implied a financial cost to the company.

Tannenbaum concludes that these framing effects may have important consequences across many different real-world domains:

“In a broad sense, our research affects policymakers at large,” says Tannenbaum. “Logically equivalent policies in various domains — such as setting a default option for organ donation or retirement savings — can communicate very different messages, and understanding the nature of these messages could help policymakers craft more effective policy.”

Co-authors on this research include Chad Valasek of the University of California, San Diego; Eric Knowles of New York University; and Peter Ditto of the University of California, Irvine.

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NIH Immediate Release: Tuesday, June 25, 2013

 

The National Institutes of Health has selected Jeremy Brown, M.D., to be the first permanent director of its Office of Emergency Care Research (OECR).

Brown is currently an associate professor of emergency medicine and chief of the clinical research section in the Department of Emergency Medicine at The George Washington University (GWU). He works clinically as an attending physician at the Washington D.C. VA Medical Center. His NIH appointment will begin in July.

Established in 2012 and housed in NIH’s National Institute of General Medical Sciences, OECR is a focal point for basic, clinical and translational emergency care research and training across NIH. It coordinates, catalyzes and communicates about NIH funding opportunities in emergency care research and fosters the training of future researchers in this field.

In addition to directing these activities, Brown will represent NIH in government-wide efforts to improve the nation’s emergency care system.

“Brown brings an impressive mix of clinical expertise, research experience, management abilities and communication skills to this important new position,” said NIGMS acting director Judith H. Greenberg, Ph.D.

Brown oversaw research in the Department of Emergency Medicine at GWU, where he built a robust clinical research program. He directs an undergraduate course on clinical research at GWU, and has been the principal investigator on three NIDDK grants and on a number of industry-funded grants. He has also served on various NIH study sections.

“I am excited to join this world-class institution and lead its efforts to improve emergency care in the U.S.,” said Brown. “To pursue this goal, I look forward to partnering with all of the NIH institutes and centers, other government agencies, and a wide range of researchers and clinicians.”

Brown is an author of more than 30 peer-reviewed articles and three books, including the Oxford American Handbook of Emergency Medicine and a handbook on cardiology emergencies.

Brown earned his medical degrees from University College Hospital Medical School in London. He completed a residency in emergency medicine at Boston Medical Center and worked as an attending physician at the Beth Israel Medical Center and as an instructor at Harvard Medical School, Boston, before moving to Washington D.C.

He replaces Walter J. Koroshetz, M.D., deputy director of the National Institute of Neurological Disorders and Stroke, who had served as OECR’s acting director since its inception.

More information about OECR is available at http://www.nigms.nih.gov/About/Overview/OECR.

To arrange an interview with Brown, contact the NIGMS Office of Communications and Public Liaison at 301-496-7301 orinfo@nigms.nih.gov.

About the National Institute of General Medical Sciences (NIGMS): NIGMS supports basic research to increase our understanding of life processes and lay the foundation for advances in disease diagnosis, treatment and prevention. For more information on the institute’s research and training programs, see http://www.nigms.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visitwww.nih.gov.

 

DIA Presentation on eSource and Risk-based Monitoring

 

Dr. Mitchel will be presenting in an eSource Symposium on Thursday between 9:00-10:30am. His talk is entitled “Time to Change the Clinical Trial Monitoring Paradigm. Results From Clinical Trials Using eSource and Risk-based Monitoring.” Please let us know if you will be attending and/or want a copy of the slides.

 

Target Health will again be exhibiting. Please visit us at Booth #226 and feel free to have a seat on one of our couches!

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

How Music Therapy Can Help With Stroke Recovery

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CT scan slice of the brain showing a right-hemispheric ischemic stroke (left side of image)

 

A stroke, or cerebrovascular accident (CVA), is the rapid loss of brain function(s) due to disturbance in the blood supply to the 1) ___. This can be due to ischemia (lack of blood flow) caused by blockage (thrombosis, arterial embolism), or a hemorrhage. As a result, the affected area of the brain cannot function, which might result in an inability to move one or more limbs on one side of the body, inability to understand or formulate speech, or an inability to see one side of the visual field.

 

A stroke is a medical emergency and can cause permanent neurological 2) ___, complications, and death. Risk factors for stroke include old age, hypertension (high blood pressure), previous stroke or transient ischemic attack (TIA), diabetes, high cholesterol, cigarette smoking and atrial fibrillation. High blood pressure is the most important modifiable risk factor of stroke. It is the second leading cause of death worldwide. An ischemic stroke is occasionally treated in a hospital with thrombolysis (also known as a “clot buster”), and some hemorrhagic strokes benefit from neurosurgery. Treatment to recover any lost function is termed stroke rehabilitation, ideally in a stroke unit and involving health professions such as speech and language 3) ___, physical therapy and occupational therapy. Prevention of recurrence may involve the administration of antiplatelet drugs such as aspirin and dipyridamole, control and reduction of hypertension, and the use of statins. Selected patients may benefit from carotid endarterectomy and the use of anticoagulants.

 

Music therapy helps stroke patients relearn old skills, like walking and talking, and reconnecting with life. Music therapy is an excellent way to help patients heal and recover after a 4) ___. It can help stroke patients regain movement, communicate, and lift their mood at the same time. Music therapy is the therapeutic use of music to help patients physically and psychologically recover from a variety of medical conditions, including stroke. Often, a patient will receive 5) ___ therapy because a doctor has recommended it along with other therapies, including physical therapy and occupational therapy. Music therapy has been around for thousands of years in various forms, but it wasn’t until 1950 that it was recognized in the United States with the formation of the American Music Therapy Association (AMTA). “There is a pretty strong research foundation for music therapy,” says Al Bumanis, MT-BC, director of communications for the AMTA, and a long-time music therapist.

 

Music therapy can help stroke patients recover by using music, specifically 6) ___, to relearn gait, and singing techniques can be used to help improve speech, says Bumanis, adding that music therapy also lets stroke victims feel like they belong. “People can’t feed themselves, but they can sing songs and remember the lyrics,” he says. If stroke patients are having trouble communicating clearly, or struggling to express themselves, music can help them communicate their mood and ease feelings of frustration. Drums are particularly effective in helping stroke patients communicate, says Bumanis. “They can learn patterns through music to help them 7) ___.” And music helps stroke patients better communicate with their caregivers. “It’s a great thing to share. It helps them reconnect — dancing, singing, listening to music,” adds Bumanis.

 

Besides helping with communication skills, music therapy can help a stroke patient regain control over their 8) ___ and regain lost skills, like walking. “It can energize people,” he explains. “To get stroke victims moving, we can match the tempo to where the client is,” Bumanis says. “We then can gradually increase it, with the eventual goal of dropping the music and having the person move on their own.”

 

Depression and anxiety are common after a stroke. “Relaxing to music, learning to breathe to music, almost meditating to music are powerful [healing] tools,” says Bumanis. Just participating in musical activities can lower blood 9) ___ and other anxiety-related markers.

 

According to the AMTA, your health insurance coverage may reimburse you for music therapy; Medicare has recognized it as a reimbursable service since 1994. To be reimbursable, the therapy must be:

 

1. Prescribed by your doctor

2. An important part of your therapy

3. Documented in a treatment plan

 

Anyone who is interested in music therapy as part of stroke rehabilitation should contact the American Music Therapy Association to find a music 10) ___ in their area. If you’re struggling with depression or finding it difficult to learn again after your stroke, music therapy can offer many of the same benefits as other types of post-stroke therapy, but in a more enjoyable, relaxed environment.

 

ANSWERS: 1) brain; 2) damage; 3) therapy; 4) stroke; 5) music; 6) rhythm; 7) communicate; 8) muscles; 9) pressure; 10) therapist

 

Getting reimbursement for music therapy

Healing Power of Music

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Richard Brockelsby MD – 1722-1797

 

Music therapy in the United States of America began in the late 18th century. However, using music as a healing medium dates back to ancient times. This is evident in biblical scriptures and historical writings of ancient civilizations such as Egypt, China, India, Greece and Rome.

 

Music has been used as a healing force for centuries. Apollo is god of music and of medicine. Aesculapius was said to cure diseases of the mind by using song and music, and music therapy was used in Egyptian temples. Plato said that music affected the emotions and could influence the character of an individual. Aristotle taught that music affects the soul and described music as a force that purified the emotions. Aulus Cornelius Celsus advocated the sound of cymbals and running water for the treatment of mental disorders. Music therapy goes back to biblical times, when David played the harp to rid King Saul of a bad spirit. As early as 400 BCE, Hippocrates, played music for his mental patients. In the 13th century, Arab hospitals contained music-rooms for the benefit of the patients. In the US, Native American medicine men often employed chants and dances as a method of healing patients. The Turco-Persian psychologist and music theorist al-Farabi (872–950), known as “Alpharabius” in Europe, dealt with music therapy in his treatise Meanings of the Intellect, where he discussed the therapeutic effects of music on the soul. Robert Burton wrote in the 17th century in his classic work, The Anatomy of Melancholy, that music and dance were critical in treating mental illness, especially melancholia.

 

The writings of 18th century physicians are pivotal in the development of music therapy, for it was these individuals who first began to depend greatly upon scientific experimentation and observation to formulate their procedures. Representative of this stage in the history of music therapy are the findings of the renowned London physician Richard Brockelsby, the only doctor to write a treatise on music therapy in eighteenth-century England. The subjects treated by Brocklesby in his Reflections on the Power of Music (1749) include his musical remedies for the excesses of various emotions-particularly fear, excessive joy, and excessive sadness. He also discusses his musical remedies for diseases of the mind recognized in the eighteenth century-delirium, frenzy, melancholia, and maniacal cases. He considers music as well an aid to the elderly and to pregnant women.

 

In short, Brocklesby provides a lively account of the curative powers of music as viewed in the mid-18th century by an excellent medical mind. The eighteenth century was a major turning point in the relationship of music to medicine because physicians for the first time began to rely heavily upon experimentation and observation in drawing their conclusions. The first music historian to document this eighteenth-century inclination was Charles Burney in his famous telling of Farinelli’s** performances curing the “total dejection of spirits” suffered by Philip V, King of Spain. Burney uses the very word “experimentation” in relating the story. The Queen, who had in vain tried every common expedient that was likely to contribute to his recovery, determined that an experiment should be made of the effects of music upon the King her husband, who was extremely sensible to its charms. The singing of the great Farinelli, cured the King of whatever ailed him.

 

This new stage in the history of music therapy is captured in the single book known to be written on this subject in 18th century England, Richard Brocklesby’s Reflections on Ancient and Modern Music with the Application to the Cure of Disease. Brocklesby (1722-1797), one of the outstanding physicians of late eighteenth- century London, published his 82 page treatise in London in 1749. It was also given the title Reflections on the Power of Music.

 

Brocklesby himself was very knowledgeable throughout his life about current medical theories and practices. He started his medical studies at the University of Edinburgh in 1741 and transferred to the University of Leyden in 1743. Both universities had excellent reputations in the early eighteenth century for the study of medicine. He graduated from Leyden in 1745 and was elected to the Royal Society in 1747. He was nominated for membership by Richard Mead, then the most famous physician in London.

 

Brocklesby was characterized in the minutes taken at his induction as “a gentleman well versed in natural, mathematical and medical knowledge”. In 1754 he received a medical degree from Dublin and the Cambridge M.D. Brocklesby was especially well known for his generosity. He always took charity cases and even supported them financially. He was a friend of both Samuel Johnson and the statesman Edmund Burke. In addition to his Reflections on the Power of Music, Brocklesby made one other significant contribution to medicine and public health through his writings. From I758 to 1763, he served as Physician to the English Army during the Seven Years’ War.

 

Brocklesby begins his Reflections on the Power of Music with his chief thesis: the further and more frequent application of music will cure or mitigate various disorders. He adds that the Ancients (the early Greeks in particular) have recounted many instances of the curative powers of music, but examples are also available in his time. At the end of Chapter I, Brocklesby discusses how the mind is affected by music. He believes that “the mind has a faculty, or disposition, to be pleased, or displeased with certain airs, or systems of sounds”. The cause, he holds, seems to depend upon the mind’s liking of the greatest quantity of uniformity amidst the greatest degree of variety. Therefore, he concludes that the “most generally affecting compositions in music,” are made up of consonant chords or, as Brocklesby puts it, “divers notes, whose vibrations regularly coincide with each other”.

 

The degree of pleasure upon hearing notes varies from person to person. One other source of pleasure from musical compositions, Brocklesby adds, is their ability to imitate the sounds of nature. These sounds speak to everyone. The bulk of Brocklesby’s treatise is devoted to the passions/emotions and the diseases of the mind and how these can be affected by music. He begins these discussions with his prescription for health that reads: To preserve perfect health of body, and a sound state of the animal nature in us, it is necessary that the superintending faculties of the mind be for the most part well-balanced, without an undue bias from any particular affection, which being too far strained, diminishes proportionally the vigor and constitution of the whole; for every turbulent passion of the mind is indicated by a peculiar alteration in some parts of the animal frame at that time. Generally, passions, he says, increase and become habitual. Brocklesby further explains that “the most violent passions of the mind produce the most apparent alterations on the body”.

 

According to Brocklesby, the violent passions that have been known to be allayed by music are fear, anger, grief, excessive joy, and enthusiasm in religion or love. He then discusses cases from both ancient and his own times in which music has been known to allay these passions. Throughout this book, Brocklesby shows himself to be very knowledgeable about the writings of the early Greeks and Romans concerning the healing powers of music. He, in fact, relates dozens of examples from these writings. More interesting here, however, are the cases that he cites from his own era. These show the Age of Enlightenment’s new emphasis on experimentation and observation in the study of music’s effects upon the human mind and body.

 

Music, according to Brocklesby, put in proper order the irregular motion of the animal spirits. Delirium, Brocklesby states, is the condition in which the mind is only attentive to the creatures of its own fancy. The best remedy for delirium is music, he says, “as it awakes the attention in the most agreeable manner, and relieves the anxious mind; by substituting a more agreeable series of images” Frenzy, Brocklesby explains, is a disorder having all the symptoms of a delirium plus an acute fever. Music works well here also as a cure. To substantiate this, he tells of a case found in the records of the Royal Academy of Sciences in Paris in 1708. A dancing master, after too much fatigue, fell ill of a fever, that in five days was accompanied with comatose symptoms, which afterwards changed into a mute frenzy, in which he continually strove to get out of bed, and threatened with his head and stern countenance all who opposed him, and in a sullen mood obstinately refused all remedies. In these circumstances Mr. de Mandajor proposed to try the power of music; and by his advice an acquaintance played such airs in audience of the patient, as he knew formerly were most agreeable; when the patient heard the music, he raised himself with an agreeable surprise, and attempted to keep time with his hands, which being prevented by force, he continued nodding his head in expression of pleasure; and after a quarter of an hour he fell into a deep sleep, and had, during his nap, a happy crisis.

 

Brocklesby quotes Areteus, an ancient Greek, to emphasize the point that music is likely to work especially well on patients who had enjoyed music before their illnesses. Melancholia is a disorder characterized by moping. Brocklesby attributes it to atmospheric conditions and the alterations they affect on the vessels of the brain. “This,” says Brocklesby, “everyone experiences in himself from the difference discovered in his own temper and mind, between foul and fair weather, a hot or cold day”. Brocklesby had learned from a gentleman who had visited Gallipoli that its cure is music. Brocklesby states: It is remarkable that different tunes affect different persons, but generally the briskest airs do most service to this melancholy people; and such is the power of music at the time, that they often fall a dancing upon hearing it, though before they could scarce speak, or be supposed capable of any degree of motion; and in this ecstatic way they continue until their former health of body and mind is restored. Maniacal cases, cases of institutionalized madness, says Brocklesby, are accompanied by, if not caused by, violent excesses or defects of the passions. In particular, music calms the wildly agitated affections and quiets the wanderings of the fancy so that the medicines administered will work more effectively.

 

Towards the end of Reflections on the Power of Music, Brocklesby addresses two other groups: the elderly and pregnant women. He believes that one of the chief duties of a physician is to prolong life, and he advocates the use of music to retard the aging process. Aging, he says, is caused by the dissipation of the animal spirits. The aim, therefore, should be to conserve the store of animal spirits, which is depleted by immoderate passions, pain, excessive evacuations, and the like. He advises all “to recreate their spirits every day with a piece of good music”. In closing, he quotes Shakespeare: “Sweet recreation barr’d, what doth ensue But moody, moping, and dull melancholy Akin to grim and comfortless despair And at her heels a huge infectious troop Of pale dis temperatures and foes to life.”

 

Brocklesby also recommends music for lifting the spirits and aiding in other ills of pregnant women and thereby helping much the unborn baby. In his sixth and final chapter, Brocklesby compares ancient Greek music and the music of his day, recommending as modern examples George Frideric Handel’s L’Allegro and Il Penseroso and Acis and Galatea. He believes that the healing power of Greek music derived from its simplicity. Brocklesby thinks that simple music appeals to the senses and does not overwhelm the mind by requiring it to make connections among a composition’s parts. One who has a keen understanding of music would prefer, however, the complex and ornamented music of the 18th century. Sorting out the connections between a composition’s parts appeals to the initiated’s facility of reasoning and the mind’s liking for the greatest unity amidst the greatest variety. Of course, modern medical science views differently many of the elements that Brocklesby discusses concerning disorders and physiology. However, many of Brocklesby’s ideas on music’s curative powers, whether derived from his own observations or those of other eighteenth-century physicians or musicians, remain sound to this day. We still believe-that music can alter emotions, and we still advocate music’s use among the elderly and pregnant women. Music does awaken attention, relieve the anxious mind, substitute more agreeable series of images, and aid medicine to work more effectively. Simple music often works best in treatment, but patients educated in music often respond better to more complex music, and particularly that known to them before their illnesses.

 

The accuracy of Brocklesby’s medical advice results in large part from the 18th century’s new reliance upon experimentation and observation in drawing conclusions, the same method used today.

 

Music therapy as we know it began in the aftermath of World Wars I and II. Musicians would travel to hospitals, particularly in the United Kingdom, and play music for soldiers suffering from war-related emotional and physical trauma. The profession of music therapy in the United States began to develop during W.W.I and W.W. II, when music was used in Veterans Administration Hospitals as an intervention to address traumatic war injuries. cognitive, and emotional state. Since then, colleges and universities developed programs to train musicians how to use music for therapeutic purposes. In 1950 a professional organization was formed by a collaboration of music therapists that worked with veterans, mentally retarded, hearing/visually impaired, and psychiatric populations This was the birth of the National Association for Music Therapy (NAMT). In 1998, NAMT joined forces with another music therapy organization to become what is now known as the American Music Therapy Association (AMTA).

 

**Farinelli  (1705 – 1782), was the stage name of Carlo Maria Michelangelo Nicola Broschi, celebrated Italian castrato singer of the 18th century and one of the greatest singers in the history of opera.

Hospital Outbreak of Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

 

In September 2012, the World Health Organization reported the first cases of pneumonia caused by the novel Middle East respiratory syndrome coronavirus (MERS-CoV). A report, published online in the New England Journal of Medicine (19 June 2013), describes a cluster of health care–acquired MERS-CoV infections with a 65% mortality rate.

 

For the study, medical records were reviewed for clinical and demographic information and determination of potential contacts and exposures. Case patients and contacts were interviewed. The incubation period and serial interval (the time between the successive onset of symptoms in a chain of transmission) were estimated and viral RNA was sequenced.

 

Results showed that between April 1 and May 23, 2013, a total of 23 cases of MERS-CoV infection were reported in the eastern province of Saudi Arabia. Symptoms included fever in 20 patients (87%), cough in 20 (87%), shortness of breath in 11 (48%), and gastrointestinal symptoms in 8 (35%); 20 patients (87%) presented with abnormal chest radiographs. As of June 12, a total of 15 patients (65%) had died, 6 (26%) had recovered, and 2 (9%) remained hospitalized. The median incubation period was 5.2 days, and the serial interval was 7.6 days. A total of 21 of the 23 cases were acquired by person-to-person transmission in hemodialysis units, intensive care units, or in-patient units in three different health care facilities. Sequencing data from four isolates revealed a single monophyletic clade. Among 217 household contacts and more than 200 health care worker contacts whom we identified, MERS-CoV infection developed in 5 family members (3 with laboratory-confirmed cases) and in 2 health care workers (both with laboratory-confirmed cases).

 

According to the authors, person-to-person transmission of MERS-CoV can occur in health care settings and may be associated with considerable morbidity. Surveillance and infection-control measures are critical to a global public health response.

Effects of the Live Attenuated Measles-Mumps-Rubella Booster Vaccination on Disease Activity in Patients With Juvenile Idiopathic Arthritis

 

The immunogenicity and the effects of live attenuated measles-mumps-rubella (MMR) vaccination on disease activity in patients with juvenile idiopathic arthritis (JIA) are matters of concern, especially in patients treated with immunocompromising therapies. As a result, a study published in the Journal of the American Medical Association (2013;309:2449-2456), was performed to assess whether MMR booster vaccination affects disease activity and to describe MMR booster immunogenicity in patients with JIA.

 

The study was a randomized, multicenter, open-label clinical equivalence trial including 137 patients with JIA aged 4 to 9 years who were recruited from 5 academic hospitals in the Netherlands between May 2008 and July 2011. Patients were randomly assigned to receive MMR booster vaccination (n=68) or no vaccination (control group; n=69). Among patients taking biologics, these treatments were discontinued at 5 times their half-lives prior to vaccination.

 

The main outcome measure was change in disease activity as measured by the Juvenile Arthritis Disease Activity Score (JADAS-27), ranging from 0 (no activity) to 57 (high activity). Disease activity in the year following randomization was compared between revaccinated patients and controls using a linear mixed model. A difference in JADAS-27 of 2.0 was the equivalence margin. Primary immunogenicity outcomes were seroprotection rates and MMR-specific antibody concentrations at 3 and 12 months.

 

Results showed that of the 137 randomized patients, 131 were analyzed in the modified intention-to-treat analysis, including 60 using methotrexate and 15 using biologics. Disease activity during complete follow-up did not differ between 63 revaccinated patients (JADAS-27, 2.8) and 68 controls (JADAS-27, 2.4), with a difference of 0.4, within the equivalence margin of 2.0. At 12 months, seroprotection rates were higher in revaccinated patients vs. controls (measles, 100% vs. 92%; mumps, 97% vs. 81%; and rubella, 100% vs. 94%, respectively), as were antibody concentrations against measles (1.63 vs. 0.78 IU/mL; P = .03), mumps (168 vs. 104 RU/mL; P = .03), and rubella (69 vs. 45 IU/mL; P = .01). Methotrexate and biologics did not affect humoral responses, but low patient numbers precluded definite conclusions.

 

According to the authors, among children with JIA who had undergone primary immunization, MMR booster vaccination compared with no booster did not result in worse JIA disease activity and was immunogenic. However, the authors added that larger studies are needed to assess MMR effects in patients using biologic agents.

Texting While Driving and Other Risky Motor Vehicle Behaviors Among US High School Students

 

According to an article published online in Pediatrics (13 May 2013), a study was performed to assess the prevalence of texting/e-mailing while driving (TWD) and association of TWD with other risky motor vehicle (MV) behaviors among US high school students.

 

For the study, data were used from the Centers for Disease Control and Prevention’s (CDC) 2011 national Youth Risk Behavior Survey, which assessed TWD during the 30 days before the survey among 8,505 students aged >16 years from a nationally representative sample of US high school students. TWD frequency was coded into dichotomous and polychotomous variables. Logistic regression assessed the relationship between TWD and other risky driving behaviors, controlling for age, race/ethnicity, and gender.

 

Results showed that the prevalence of TWD on >1 days during the 30 days before the survey was 44.5%. Students who engaged in TWD were more likely than their non-TWD counterparts to not always wear their seatbelt (prevalence ratio 1.1), ride with a driver who had been drinking alcohol (prevalence ratio 1.74), and drink alcohol and drive (prevalence ratio 5.33). These other risky MV behaviors were most likely to occur among students who frequently engaged in TWD.

 

According to the authors, with nearly half of US high school students aged >16 years report TWD during the past 30 days, this suggests there is a subgroup of students who may place themselves, their passengers, and others on the road at elevated risk for a crash-related injury or fatality by engaging in multiple risky MV behaviors.

 

Editor’s note:  Imagine the consequences of teen drinking, texting and driving. 

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area

 

FDA Obtains Waiver From the European Commission to Facilitate Export For U.S. Pharmaceutical Manufacturers

 

The FDA has announced that the U.S. is now a “listed” country with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe. Without the waiver, all U.S. companies shipping active pharmaceutical ingredients (APIs) to Europe after July 1, 2013 would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe’s good manufacturing practices.

 

To avoid that burden for companies, the FDA filed a formal “listing request” with the EC in January 2013 that the FDA’s good manufacturing practices be considered at least equivalent to those in Europe. The EC has now approved that request following a comprehensive audit of the FDA’s regulatory and inspectional oversight of APIs. The audit took place from May 13 – 20, 2013.

 

Europe’s requirement for the import of APIs falls under its Falsified Medicines Directive, enacted in 2011 in response to the challenges posed in keeping the pharmaceutical supply chain safe at a time when products are increasingly sourced from around the world. Protecting consumers around the globe from falsified medicines is an enormous and complex undertaking that requires international cooperation. Over the past several years, the FDA has been transforming from a domestically-focused agency to a proactive, global public health agency in order to carry out our mission more effectively in a world where trade, and product safety and quality, have no borders.

Sweet Potato Patty Cakes

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Ingredients

 

4 medium sweet potatoes

1 cup Panko (light Japanese crumbs)

2 large eggs, room temperature, lightly beaten

1 teaspoon prepared horse radish

2 Tablespoons finely chopped fresh mint

2/3 cup fresh cilantro, chopped

Pinch salt or to taste; pinch black pepper or to taste (optional)

2 garlic cloves, juiced

1 teaspoon Turmeric

Finely grated zest of 1 lime

Juice of 1 lime, plus additional, so get 2 limes

Olive oil, for cooking

 

Directions

 

1. Preheat the oven to 400 degrees F; position the rack in the middle. Bake, until soft when pierced with a knife, about 1 hour. Transfer to a cooling rack and allow to cool to room temperature.

2. While the potatoes are roasting, sauté the onion until transparent, in a pan with one spray of olive oil, stir while cooking. Then set aside

3. When the potatoes are baked and then cooled, scoop out the flesh and transfer to a large bowl.

4. To the potatoes, add the Panko, beaten eggs, horse radish, mint, cilantro, salt, pepper, turmeric, onion, garlic juice, lime zest and lime juice and mix well to incorporate. Cover and let sit for 1 hour or refrigerate until ready to cook.

5. In a large pan (preferably nonstick), set over medium heat, warm enough oil to cover the bottom of the pan until it shimmers.

6. While the oil warms, set a bowl of cold water nearby, with the sweet potato mixture next to it. Dip your hands in the water and then shape the patty; place the patty in the pan. Repeat with the remaining sweet potato mixture. You may need to do this in batches.

7. Cook the patties for about 3 minutes, or until the bottom is well browned. Gently, using a spatula, flip the patties over and cook for another 3 minutes.

8. Add a squeeze of lime juice (from a second lime) just before serving.

9. Have some fat-free sour cream on hand, in case someone wants a dollop of this with the sweet potato patties.

 

This time my dearest husband and sweet potato guinea pig, got to sample this recipe after the third adjustment, the Goldilocks affect.  Luckily, he was doing business in Europe for the first two attempts.  The first time I made these sweet potato patty cakes, they were too bland. The second time I included too much spice, and the third time, when I eliminated the onion and chili pepper, they tasted just right. He loved them; we both did.

 

Because these patty cakes are yummy hot or cold, they’re a perfect accompaniment for any summer meal and great as a snack. We had them with a simple poached salmon and green bean/blue cheese salad, which we both love. We’re in a wine rut; we can’t seem to stop drinking icy white wine, but things could be worse, right? No one’s complaining here.

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Enjoy!

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